§ 1 The citations

The citations included in the preamble to the Machinery Directive indicate the legal basis of the Directive, the opinions expressed by the relevant consultative Committee and the procedure according to which the Directive was adopted.

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty establishing the European Community, and in particular Article 95 thereof,

Having regard to the proposal from the Commission, (1)

Having regard to the opinion of the European Economic and

Social Committee, (2)

Acting in accordance with the procedure laid down in Article 251 of the Treaty, (3)

(1) OJ C 154 E, 29.5.2001, p. 164.

(2) OJ C 311, 7.11.2001, p. 1.

(3) Opinion of the European Parliament of 4 July 2002 (OJ C 271 E, 12.11.2003, p. 491), Council Common Position of 18 July 2005 (OJ C 251 E, 11.10.2005, p. 1) and Position of the European Parliament of 15 December 2005 (not yet published in the Official Journal). Council Decision of 25 April 2006.

§ 2 The legal basis of the Machinery Directive

The legal basis of the Machinery Directive is provided by Article 95 of the EC Treaty (now replaced by Article 114 of the Treaty on the Functioning of the European Union – TFEU) that enables the EU to adopt measures to harmonise the legislation of the Member States in order to ensure the establishment and functioning of the internal market. Such measures must take as a base a high level of protection of the health and safety of people and of the environment.

The Machinery Directive thus has a dual objective: to permit the free movement of machinery within the internal market whilst ensuring a high level of protection of health and safety.

Following the proposal by the Commission, the Machinery Directive was adopted by the European Parliament and the Council, after consulting the Economic and Social Committee, according to the co-decision procedure set out in Article 251 of the EC Treaty (now referred to as the ordinary legislative procedure in Article 294 of the TFEU).

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The footnotes to the citation give the references and dates of the successive steps of the procedure. (The Position of the European Parliament of 15 December 2005 was not published in the OJEU).

PREAMBLE TO THE MACHINERY DIRECTIVE – THE RECITALS

§3 The recitals

The recitals introduce the main provisions of the Directive and present the reasons for their adoption. Several of the recitals explain the changes that have been made in the new Machinery Directive compared with Directive 98/37/EC.

The recitals do not have legal force as such and do not usually figure in the national legislation implementing the Directive. However, they help to understand the Directive, in particular, by clarifying the meaning of certain provisions. When interpreting the text of the Directive, the Courts may take the recitals into consideration in order to ascertain the intention of the legislators.

In the following comments, reference is made to the Articles and Annexes of the Directive introduced by each of the recitals. For further explanations, please refer to the comments on the Articles and Annexes concerned.

(1) Directive 98/37/EC of the European Parliament and of the Council of 22 June 1998 on the approximation of the laws of the Member States relating to machinery (4) codified Directive 89/392/EEC (5). Now that new substantial amendments are being made to Directive 98/ 37/EC, it is desirable, in order to clarify matters, that that Directive should be recast.

(4) OJ L 207, 23.7.1998, p. 1. Directive as amended by Directive 98/79/EC (OJ L 331, 7.12.1998, p. 1).

§ 4 The History of the Machinery Directive

The first recital recalls that Directive 2006/42/EC is not an entirely new Directive but is based on Directive 98/37/EC5 which codified the Machinery Directive 89/392/EEC6 as amended. Codification means bringing into one legal text the original Directive and its successive amendments:

− Directive 91/368/EEC7 extended the scope of the Machinery Directive to interchangeable equipment, mobile machinery and machinery for lifting goods. Parts 3, 4 and 5 were added to Annex I.

− Directive 93/44/EEC8 extended the scope of the Machinery Directive to safety components and machinery for lifting and moving persons. Part 6 was added to Annex I.

− Directive 93/68/EEC9 introduced harmonised provisions relating to the CE-marking.

Directive 98/37/EC was subject to a minor amendment by Directive 98/79/EC relating to the exclusion of medical devices.

Directive 98/37/EC remains in force until 29 December 2009.

Directive 2006/42/EC is termed a recast of the Machinery Directive since the modifications are presented in the form of a new Directive.

Directive 2009/127/EC modified the scope of Directive 2006/42/EC by adding environmental protection risks for “machinery for pesticide application”. It introduced a new section in Annex I part 2 to deal with this aspect. Note that it did not extend the scope of the Directive, with respect to the environment, to other types of machinery.

(2) The machinery sector is an important part of the engineering industry and is one of the industrial mainstays of the Community economy. The social cost of the large number of accidents caused directly by the use of machinery can be reduced by inherently safe design and construction of machinery and by proper installation and maintenance.

§ 5 The economic and social importance of the Machinery Directive

The second recital underlines the economic and social importance of the dual objectives of the Machinery Directive. The establishment of a harmonised regulatory framework for the design and construction of machinery is of vital economic importance to the European engineering industry. At the same time, safer machinery makes an important contribution to the reduction of the social cost of accidents and damage to health, both in the workplace and in the home.

(3) Member States are responsible for ensuring the health and safety on their territory of persons, in particular of workers and consumers and, where appropriate, of domestic animals and goods, notably in relation to the risks arising out of the use of machinery.

 

§6 Health and safety

The protection of health and safety is both a fundamental duty and a prerogative of the Member States. Since the Machinery Directive harmonises the health and safety requirements for the design and construction of machinery at EU level, the responsibility of Member States to protect health and safety of people with regard to the risks associated with machinery implies ensuring that the requirements of the Machinery Directive are correctly applied.

(4) In order to ensure legal certainty for users, the scope of this Directive and the concepts relating to its application should be defined as precisely as possible.

§7 Definitions

The fourth recital underlines the fact that the new Machinery Directive provides a clearer presentation of the scope and includes definitions of the key terms and concepts used in the text. Definitions of terms used in the Directive are given in Article 2 and additional definitions of concepts relating to the essential health and safety requirements are given in sections 1.1.1, 3.1.1 and 4.1.1 of Annex I.

(5) The Member States’ mandatory provisions governing construction site hoists intended for lifting persons or persons and goods, which are often supplemented by de facto compulsory technical specifications and/or by voluntary standards, do not necessarily lead to different levels of health and safety but, because of their disparities, do nevertheless constitute barriers to trade within the Community. Moreover, the national systems for the conformity assessment and certification of these machines diverge considerably. It is therefore desirable not to exclude from the scope of this Directive construction site hoists intended for lifting persons or persons and goods.

§8 Inclusion of construction site hoists

Construction site hoists, that were previously excluded from the scope of the Machinery Directive 98/37/EC and the Lifts Directive 95/16/EC, are lifting appliances intended to be temporarily installed for transporting persons or persons and materials to the different levels of a building during construction or repair. The fifth recital explains that such construction site hoists are no longer excluded from the scope of the Machinery Directive. Certain new essential health and safety requirements relating to machinery serving fixed landings have been added to Annex I to deal with specific risks associated with this type of machinery.

With respect to the conformity assessment procedure applicable to construction site hoists, it should also be noted that construction site hoists involving a hazard of falling from a vertical height of more than three metres are included among the devices for the lifting of persons or of persons and goods listed in Annex IV, item 17.

(6) It is appropriate to exclude from the scope of this Directive weapons, including firearms, that are subject to Council Directive 91/477/EEC of 18 June 1991 on control of the acquisition and possession of weapons(6); the exclusion of firearms should not apply to portable cartridge-operated fixing and other impact machinery designed for industrial or technical purposes only. It is necessary to provide for transitional arrangements enabling Member States to authorise the placing on the market and putting into service of such machinery manufactured in accordance with national provisions in force upon adoption of this Directive, including those implementing the Convention of 1 July 1969 on the Reciprocal Recognition of Proofmarks on Small Arms. Such transitional arrangements will also enable the European standardisation organisations to draft standards ensuring the safety level based on the state of the art.

(6) OJ L 256, 13.9.1991, p. 51.

§9 Inclusion of portable cartridge-operated fixing and other impact machinery

Weapons, including firearms, are excluded from the scope of the Machinery Directive – see §51: comments on Article 1 (2) (d). The sixth recital explains that this exclusion is to be understood in light of the scope of the EU legislation on the control of

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weapons, which does not apply to equipment designed for industrial or technical purposes only.

Cartridge-operated fixing and other cartridge-operated impact machinery designed for industrial or technical purposes that was excluded from the original Machinery Directive by amending Directive 91/368/EEC, is thus reintroduced into the scope of the new Machinery Directive. In addition, certain essential health and safety requirements relating to specific risks associated with portable fixing and other impact machinery have been added to Annex I. It should be noted that these requirements apply both to cartridge-operated fixing and impact machinery and fixing and impact machinery using other sources of energy – see §280: comments on section 2.2.2 of Annex I. With respect to the conformity assessment of such machinery, it should also be noted that portable cartridge-operated fixing and other cartridge-operated impact machinery is listed in Annex IV, item 18 – see §388: comments on Annex IV, item 18.

For the transitional arrangements mentioned in the last sentence of the sixth recital – see §154: comments on Article 27.

(7) This Directive does not apply to the lifting of persons by means of machines not designed for the lifting of persons. However, this does not affect the right of Member States to take national measures, in accordance with the Treaty, with respect to such machines, with a view to implementing Council Directive 89/655/EEC of 30 November 1989 concerning the minimum safety and health requirements for the use of work equipment by workers at work (second individual Directive within the meaning of Article 16(1) of Directive 89/391/EEC)(7).

(7) OJ L 393, 30.12.1989, p. 13. Directive as last amended by Directive 2001/45/EC of the European Parliament and of the Council (OJ L 195, 19.7.2001, p. 46).

§10 Equipment intended for lifting persons with machinery designed for lifting goods

Exceptional use of machinery designed for lifting goods for the purpose of lifting persons may be subject to national regulations in the framework of provisions implementing Directive 2009/104/EC – see §140: comments on Article 15. Recital 7 implies that equipment placed on the market for such exceptional use with machinery designed for lifting goods is not in the scope of the Machinery Directive. Placing on the market of such equipment may therefore be subject to national regulations.

Equipment for such exceptional use should be distinguished from interchangeable equipment designed to be assembled with lifting machinery in order to confer a new function for lifting persons. Such interchangeable equipment is subject to the machinery Directive10 – see §388: comments on Annex IV, item 17.

10 See guidance on Interchangeable equipment for lifting persons and equipment used with machinery designed for lifting goods for the purpose of lifting persons.

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(8) In relation to agricultural and forestry tractors, the provisions of this Directive concerning the risks currently not covered by Directive 2003/37/EC of the European Parliament and of the Council of 26 May 2003 on type approval of agricultural or forestry tractors, their trailers and interchangeable towed machinery, together with their systems, components and separate technical units (1) should no longer apply when such risks are covered by Directive 2003/37/EC.

(1) OJ L 171, 9.7.2003, p. 1. Directive as last amended by Commission Directive 2005/67/EC (OJ L 273, 19.10.2005, p. 17).

§11 Agricultural and forestry tractors

The eighth recital refers to the exclusion of agricultural and forestry tractors from the scope of the Machinery Directive for the risks covered by Directive 2003/37/EC. This Directive was replaced by Regulation (EU) No 167/2013 which modified the Machinery Directive to exclude completely Agricultural and Forestry Tractors – see §53: comments on the first indent of Article 1 (2) (e).

(9) Market surveillance is an essential instrument inasmuch as it ensures the proper and uniform application of Directives. It is therefore appropriate to put in place the legal framework within which market surveillance can proceed harmoniously.

(10) Member States are responsible for ensuring that this Directive is effectively enforced on their territory and that the safety of the machinery concerned is, as far as possible, improved in accordance with its provisions. Member States should ensure their capacity to carry out effective market surveillance, taking account of guidelines developed by the Commission, in order to achieve the proper and uniform application of this Directive.

§12 Market surveillance

The term “market surveillance” designates the activity of the authorities of the Member States checking the conformity of products subject to the Directive after they have been placed on the market or put into service and taking the necessary action to deal with non-compliant products. The ninth and tenth recitals introduce several provisions in the new Machinery Directive which establish a stronger legal basis for market surveillance and enforcement action and also provide for the necessary cooperation between the Members States and the Commission in this area – see §93 to §102: comments on Articles 4, §118: comments on Article 9, §122 to §126: comments on Article 11 and §144: comments on Article 19.

(11) In the context of market surveillance, a clear distinction should be established between the disputing of a harmonised standard conferring a presumption of conformity on machinery and the safeguard clause relating to machinery.

§13 Formal objection to standards and the safeguard clause

The eleventh recital indicates that the procedure for disputing a harmonised standard (known as a formal objection) and the safeguard procedure for dealing with non-compliant and dangerous products are different procedures that are set out in distinct

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Articles of the Directive – see §119 to §121: comments on Articles 10, and §122 to §126: comments on Article 11.

(12) The putting into service of machinery within the meaning of this Directive can relate only to the use of the machinery itself for its intended purpose or for a purpose which can reasonably be foreseen. This does not preclude the laying down of conditions of use external to the machinery, provided that it is not thereby modified in a way not specified in this Directive.

§14 Regulations on use of machinery

The twelfth recital clarifies the notion of putting into service of machinery that is regulated by the Machinery Directive – see §86: comments on Article 2 (k). Putting into service is to be distinguished from use of machinery that can be regulated by the Member States, in particular, within the framework of the EU legislation on the use of work equipment provided that such national regulations do not conflict with the provisions of this Directive – see §139 and §140: comments on Article 15.

(13) It is also necessary to provide for an adequate mechanism allowing for the adoption of specific measures at Community level requiring Member States to prohibit or restrict the placing on the market of certain types of machinery presenting the same risks to the health and safety of persons either due to shortcomings in the relevant harmonised standard(s) or by virtue of their technical characteristics, or to make such machinery subject to special conditions. In order to ensure the appropriate assessment of the need for such measures, they should be taken by the Commission, assisted by a committee, in the light of consultations with the Member States and other interested parties. Since such measures are not directly applicable to economic operators, Member States should take all necessary measures for their implementation.

§15 Measures to deal with groups of hazardous machinery presenting the same risks

The safeguard procedure set out in Article 11 requires Member States to take the necessary measures to deal with particular models of machinery that fail to comply with the requirements of the Directive and threaten the health and safety of persons. The thirteenth recital introduces a provision which enables measures to be taken at EU level if it becomes clear that an entire group of similar models of machinery give rise to the same risk – see §118: comments on Article 9.

The measures concerned must be submitted to the Machinery Committee according to the regulatory procedure with scrutiny – see §147: comments on Article 22.

(14) The essential health and safety requirements should be satisfied in order to ensure that machinery is safe; these requirements should be applied with discernment to take account of the state of the art at the time of construction and of technical and economic requirements.

§16 The state of the art

Recital (14) introduces the concept of ‘the state of the art’ which shall be taken into account when applying the essential health and safety requirements (EHSRs) set out in Annex I. This concept is very important as it means that the EHSRs are not absolute requirements irrespective of economic cost and technical possibilities available on the market for manufacturers – see §161 and §162: comments on General Principle 3, Annex I.

(15) Where the machinery may be used by a consumer, that is to say, a non-professional operator, the manufacturer should take account of this in the design and construction. The same applies where a machine is normally used to provide a service to a consumer.

§17 Machinery for consumer use

The Machinery Directive applies both to machinery for use by workers at work and to machinery for use by consumers or providing a service to consumers, i.e. where the consumer either uses the item or would be directly affected by any defect. In general, the design and construction of machinery must take account of the intended use. Recital 15 stresses that the machinery manufacturer must consider whether the machinery is intended to be used by a professional or a non-professional operator or is intended to provide a service to consumers. The Directive includes a specific requirement relating to the drafting of the instructions for machinery intended for use by non-professional operators – see §259: comments on section 1.7.4.1 (d) of Annex I.

(16) Although the requirements of this Directive do not apply to partly completed machinery in their entirety, it is nevertheless important that the free movement of such machinery be guaranteed by means of a specific procedure.

§18 Partly completed machinery

Recital 16 introduces the concept of partly completed machinery – see §46: comments on Articles 1 (1) (g) and 2 (g). The placing on the market of partly completed machinery is subject to a specific procedure – see §131: comments on Article 13. Partly completed machinery cannot comply fully with the essential health and safety requirements set out in Annex I, since certain of the risks may result from the fact that the machinery is not complete or from the interface between the partly completed machinery and the machinery or assembly of machinery into which it is to be incorporated. However, the manufacturer of partly completed machinery must state, in a Declaration of Incorporation, which of the essential health and safety requirements he has fulfilled – see §385: comments on Annex II 1 B, and §394: comments on Annex VII, B.

(17) For trade fairs, exhibitions and such like, it should be possible to exhibit machinery which does not satisfy the requirements of this Directive. However, interested parties should be properly informed that the machinery does not conform and cannot be purchased in that condition.

§19 Trade fairs and exhibitions

Recital 17 introduces the provision that enables manufacturers to exhibit new models of machinery at trade fairs and exhibitions before the conformity of such products with the Machinery Directive has been assessed or to exhibit machinery with certain elements such as, for example, guards removed for demonstration purposes. In such cases, the exhibitor must display an appropriate sign and take adequate safety measures to protect persons from the risks presented by the exhibited machinery – see §108: comments on Article 6 (3).

(18) This Directive defines only the essential health and safety requirements of general application, supplemented by a number of more specific requirements for certain categories of machinery. In order to help manufacturers to prove conformity to these essential requirements, and to allow inspection of conformity to the essential requirements, it is desirable to have standards that are harmonised at Community level for the prevention of risks arising out of the design and construction of machinery. These standards are drawn up by private-law bodies and should retain their non-binding status.

§20 The New Approach and the New Legislative Framework

Recital 18 recalls that the Machinery Directive relies on the regulatory method known as the “New Approach to technical harmonization and standards”. The legislation itself sets out the mandatory essential health and safety requirements that products placed on the EU market must fulfil and the procedures for assessing their conformity – see §103: comments on Articles 5 (1) (a), and §163: comments on General Principle 4 of Annex I.

Detailed technical solutions for meeting these essential health and safety requirements are given in European harmonised standards. Application of harmonised standards remains voluntary, but confers a presumption of conformity with the essential health and safety requirements they cover – see §87: comments on Articles 2 (l), and §110: comments on Article 7 (2).

The “New Approach” has been improved and updated by the “New Legislative Framework”, through a set of legislative acts such as Regulation (EC) No 765/2008 and Decision 768/2008/EC11.

11 See http://ec.europa.eu/growth/single-market/goods/new-legislative-framework/ and “The ‘Blue Guide’ on the implementation of EU product rules” http://ec.europa.eu/DocsRoom/documents/12661.

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(19) In view of the nature of the risks involved in the use of machinery covered by this Directive, procedures for assessing conformity to the essential health and safety requirements should be established. These procedures should be devised in the light of the extent of the danger inherent in such machinery. Consequently, each category of machinery should have its appropriate procedure in conformity with Council Decision 93/465/EEC of 22 July 1993 concerning the modules for the various phases of the conformity assessment procedures and the rules for the affixing and use of the CE conformity marking, which are intended to be used in the technical harmonisation directives (2), taking account of the nature of the verification required for such machinery.

(2) OJ L 220, 30.8.1993, p. 23.

§21 Conformity assessment

Recital 19 refers to the procedures for the person responsible for the CE marking, assessing the conformity of machinery with the essential health and safety requirements – see §127 to §130: comments on Article 12 – and the rules for the CE marking – see §141: comments on Article 16.

(20) Manufacturers should retain full responsibility for certifying the conformity of their machinery to the provisions of this Directive. Nevertheless, for certain types of machinery having a higher risk factor, a stricter certification procedure is desirable.

§22 Annex IV machinery

The conformity assessment procedure applicable to a given product depends on whether or not it belongs to one of the categories listed in Annex IV which are considered to have a high risk factor or which serve a critical protective function. The different conformity assessment procedures are set out in Annexes VIII, IX and X and the rules for their selection are given in Article 12.

(21) The CE marking should be fully recognised as being the only marking which guarantees that machinery conforms to the requirements of this Directive. All other markings which are likely to mislead third parties as to the meaning or the form of the CE marking, or both, should be prohibited.

(22) In order to ensure the same quality for the CE marking and the manufacturer’s mark, it is important that they be affixed according to the same techniques. In order to avoid confusion between any CE markings which might appear on certain components and the CE marking corresponding to the machinery, it is important that the latter marking be affixed alongside the name of the person who has taken responsibility for it, namely the manufacturer or his authorised representative.

§23 The CE-marking

Recitals 21 and 22 introduce the provisions relating to the CE-marking – see §141: comments on Article 16, §250: comments on section 1.7.3 of Annex I, and §387: comments on Annex III.

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(23) The manufacturer or his authorised representative should also ensure that a risk assessment is carried out for the machinery which he wishes to place on the market. For this purpose, he should determine which are the essential health and safety requirements applicable to his machinery and in respect of which he must take measures.

§24 Risk assessment

Recital 23 refers to the requirement in Annex I on the risk assessment for the machinery which determines the application of the essential health and safety requirements – see §158 and §159: comments on General Principle 1 of Annex I.

(24) It is essential that, before drawing up the EC declaration of conformity, the manufacturer or his authorised representative established in the Community should prepare a technical construction file. However, it is not essential that all documentation should be permanently available in material form, but it must be possible to make it available on request. It need not include detailed plans of subassemblies used for the manufacture of machinery, unless knowledge of such plans is essential in order to ascertain conformity with the essential health and safety requirements.

§25 The technical construction file

The manufacturer’s technical construction file referred to in Recital 24 is both a means to enable the market surveillance authorities to check the conformity of machinery after it has been placed on the market and a means for the manufacturer to demonstrate the conformity of his product – see §103: comments on Article 5 (1) (b), §383: comments on Annex II 1 A (2), and §391 to §393: comments on Annex VII A.

(25) The addressees of any decision taken under this Directive should be informed of the reasons for such a decision and of the legal remedies open to them.

§26 Legal remedies

Recital 25 introduces the provisions relating to the rights of manufacturers or other stakeholders subject to decisions taken under the Machinery Directive – see §135: comments on Articles 14 (6), and §145: comments on Article 20.

(26) Member States should provide for penalties applicable to infringements of the provisions of this Directive. Those penalties should be effective, proportionate and dissuasive.

§27 Enforcement

Recital 26 is a reminder that the national authorities in charge of enforcement of the provisions of the Machinery Directive (the market surveillance authorities) must be able to impose appropriate penalties if those provisions are not correctly applied. The

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penalties must be foreseen by the national laws and regulations transposing the provisions of the Directive into national law – see §153: comments on Article 26.

(27) The application of this Directive to a number of machines intended for lifting persons requires a better delimitation of the products covered by this Directive with respect to those covered by Directive 95/16/EC of the European Parliament and of the Council of 29 June 1995 on the approximation of the laws of the Member States relating to lifts.(1) A redefinition of the scope of the latter Directive is thus deemed necessary. Directive 95/16/EC should therefore be amended accordingly.

(1) OJ L 213, 7.9.1995, p. 1. Directive as amended by Regulation (EC) No 1882/2003 (OJ L 284, 31.10.2003, p. 1).

§28 Amendment of the Lifts Directive

Recital 27 explains that the new Machinery Directive 2006/42/EC includes an amendment of the Lifts Directive 95/16/EC (replaced by Directive 2014/33/EC as of 20 April 2016) in order to clarify the borderline between the scopes of the two Directives – see §151: comments on Article 24.

(28) Since the objective of this Directive, namely, to lay down the essential health and safety requirements in relation to design and manufacture in order to improve the safety of machinery placed on the market, cannot be sufficiently achieved by the Member States and can be better achieved at Community level, the Community may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty. In accordance with the principle of proportionality, as set out in that Article, this Directive does not go beyond what is necessary in order to achieve that objective.

§29 Subsidiarity and proportionality

Recital 28 is a justification of the Machinery Directive with respect to the principles of subsidiarity and proportionality set out in Article 5 of the EC Treaty (now Article 5 of the Treaty on European Union – TEU). According to these principles, the EU shall take action only if the same objectives cannot be better achieved by the action of the Member States. It is clear that without the Machinery Directive, manufacturers of machinery would have to apply different rules and procedures for machinery safety in each Member State, which would both constitute a serious obstacle to the internal market and be a less effective means of improving machinery safety.

(29) In accordance with point 34 of the Interinstitutional Agreement on better law-making,(2) Member States are encouraged to draw up, for themselves and in the interests of the Community, their own tables illustrating, as far as possible, the correlation between this Directive and the transposition measures, and to make them public.

(2) OJ C 321, 31.12.2003, p. 1.

§30 National correlation tables

Recital 29 refers to an agreement between the European Parliament, the Council and the Commission on improving the quality and transparency of EU law-making. Under the heading of better transposition and application, Member States are encouraged to publish correlation tables showing the relationship between the provisions of the Directive and the measures transposing them into national law. This is important since, while it is the national transposition measures that have force of law, in the dialogue between economic actors, the text of the Machinery Directive itself naturally provides a common reference. A correlation table must also be communicated by the Member States to the Commission together with the text of the measures transposing the Directive into national law – see §153: comments on Article 26.

(30) The measures necessary for the implementation of this Directive should be adopted in accordance with Council Decision 1999/468/EC of 28 June 1999 laying down the procedures for the exercise of implementing powers conferred on the Commission,(3)

(3) OJ L 184, 17.7.1999, p. 23.

§31 The Machinery Committee

Recital 30 refers to certain measures that can be taken by the Commission after consulting the Machinery Committee – see §116: comments on Articles 8, and §147: comments on Article 22.

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THE ARTICLES OF THE MACHINERY DIRECTIVE

Article 1 Scope

1. This Directive applies to the following products:

(a) machinery;

(b) interchangeable equipment;

(c) safety components;

(d) lifting accessories;

(e) chains, ropes and webbing;

(f) removable mechanical transmission devices;

(g) partly completed machinery.

2. The following are excluded from the scope of this Directive:

(a) safety components intended to be used as spare parts to replace identical components and supplied by the manufacturer of the original machinery;

(b) specific equipment for use in fairgrounds and/or amusement parks;

(c) machinery specially designed or put into service for nuclear purposes which, in the event of failure, may result in an emission of radioactivity;

(d) weapons, including firearms;

(e) the following means of transport:

— agricultural and forestry tractors for the risks covered by Directive 2003/37/EC, with the exclusion of machinery mounted on these vehicles,

— motor vehicles and their trailers covered by Council Directive 70/156/EEC of 6 February 1970 on the approximation of the laws of the Member States relating to the type-approval of motor vehicles and their trailers (1), with the exclusion of machinery mounted on these vehicles,

— vehicles covered by Directive 2002/24/EC of the European Parliament and of the Council of 18 March 2002 relating to the type-approval of two or three-wheel motor vehicles (2), with the exclusion of machinery mounted on these vehicles,

— motor vehicles exclusively intended for competition,

and

— means of transport by air, on water and on rail networks with the exclusion of machinery mounted on these means of transport;

(f) seagoing vessels and mobile offshore units and machinery installed on board such vessels and/or units;

(g) machinery specially designed and constructed for military or police purposes;

(h) machinery specially designed and constructed for research purposes for temporary use in laboratories;

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(i) mine winding gear;

(j) machinery intended to move performers during artistic performances;

(k) electrical and electronic products falling within the following areas, insofar as they are covered by Council Directive 73/23/EEC of 19 February 1973 on the harmonisation of the laws of Member States relating to electrical equipment designed for use within certain voltage limits (3):

— household appliances intended for domestic use,

— audio and video equipment,

— information technology equipment,

— ordinary office machinery,

— low-voltage switchgear and control gear,

— electric motors;

(l) the following types of high-voltage electrical equipment:

— switch gear and control gear,

— transformers.

(1) OJ L 42, 23.2.1970, p. 1 Directive as last amended by Commission Directive 2006/28/EC (OJ L 65, 7.3.2006, p. 27).

(2) OJ L 124, 9.5.2002, p. 1. Directive as last amended by Commission Directive 2005/30/EC (OJ L 106, 27.4.2005, p. 17).

Article 2 Definitions

For the purposes of this Directive, ‘machinery’ designates the products listed in Article 1(1 )(a) to (f).

The following definitions shall apply:

(a) ‘machinery’ means:

− an assembly, fitted with or intended to be fitted with a drive system other than directly applied human or animal effort, consisting of linked parts or components, at least one of which moves, and which are joined together for a specific application,

− an assembly referred to in the first indent, missing only the components to connect it on site or to sources of energy and motion,

− an assembly referred to in the first and second indents, ready to be installed and able to function as it stands only if mounted on a means of transport, or installed in a building or a structure,

− assemblies of machinery referred to in the first, second and third indents or partly completed machinery referred to in point (g) which, in order to achieve the same end, are arranged and controlled so that they function as an integral whole,

− an assembly of linked parts or components, at least one of which moves and which are joined together, intended for lifting loads and whose only power

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source is directly applied human effort;

(b) ‘interchangeable equipment’ means a device which, after the putting into service of machinery or of a tractor, is assembled with that machinery or tractor by the operator himself in order to change its function or attribute a new function, in so far as this equipment is not a tool;

(c) ‘safety component’ means a component:

− which serves to fulfil a safety function,

− which is independently placed on the market,

− the failure and/or malfunction of which endangers the safety of persons, and

− which is not necessary in order for the machinery to function, or for which normal components may be substituted in order for the machinery to function.

An indicative list of safety components is set out in Annex V, which may be updated in accordance with Article 8 (1) (a);

(d) ‘lifting accessory’ means a component or equipment not attached to the lifting machinery, allowing the load to be held, which is placed between the machinery and the load or on the load itself, or which is intended to constitute an integral part of the load and which is independently placed on the market; slings and their components are also regarded as lifting accessories;

(e) ‘chains, ropes and webbing’ means chains, ropes and webbing designed and constructed for lifting purposes as part of lifting machinery or lifting accessories;

(f) ‘removable mechanical transmission device’ means a removable component for transmitting power between self-propelled machinery or a tractor and another machine by joining them at the first fixed bearing. When it is placed on the market with the guard it shall be regarded as one product;

(g) ‘partly completed machinery’ means an assembly which is almost machinery but which cannot in itself perform a specific application. A drive system is partly completed machinery. Partly completed machinery is only intended to be incorporated into or assembled with other machinery or other partly completed machinery or equipment, thereby forming machinery to which this Directive applies;

. . .

§32 The products covered by the Machinery Directive

Article 1 (1) sets out the scope of the Directive, that is to say the products to which the provisions of the Directive are applicable. Each of the seven categories listed in Article 1 (1), (a) to (g) is subject to a definition given in Article 2, (a) to (g). Consequently, Article 1 must be read together with Article 2. In the following comments, each of the seven categories of product subject to the Machinery Directive is examined in turn, together with its definition.

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Article 2 Definitions

For the purposes of this Directive, ‘machinery’ designates the products listed in Article 1(1)(a) to (f).

. . .

§33 The use of the term ‘machinery’ in the broad sense

The first product category referred to in Article 1 (1) (a) and defined in Article 2 (a) is machinery. In Article 1 (1) (a) and Article 2 (a) the term ‘machinery’ is used in the strict sense. However, the definitions of the product categories set out in Article 2 are preceded by a sentence explaining that the term ‘machinery’ is also to be understood in a broad sense to refer to the six product categories referred to in Article 1 (1), (a) to (f).

The obligations set out in the articles of the Directive that apply to machinery shall thus be understood as applying both to machinery in the strict sense referred to in Article 1(1) (a) and also to the products referred to in Article 1(1) (b) to (f): interchangeable equipment, safety components, lifting accessories, chains, ropes and webbing and removable mechanical transmission devices.

This is the case, for example, for the obligations set out in Article 4 (1) on market surveillance, Article 5 (1) relating to placing on the market and putting into service, Article 6 (1) on freedom of movement, Article 7 (1) and (2) on presumption of conformity and harmonised standards, Article 9 on specific measures to deal with potentially hazardous machinery, Article 11 on the safeguard clause, Article 12 on the procedures for assessing the conformity of machinery, Article 15 on installation and use of machinery, Article 16 on CE marking, Article 17 on non-conformity of marking and Article 20 on legal remedies. The obligations set out in these Articles do not apply to partly completed machinery referred to in Article 1 (1) (g).

Where obligations apply to partly completed machinery, this is explicitly stated, for example, in Article 4 (2) on market surveillance, Article 5 (2) relating to placing on the market, Article 6 (2) on freedom of movement and Article 13 on the procedure for partly completed machinery.

Where obligations apply both to machinery in the broad sense and also to partly completed machinery, this is also explicitly stated, for example, in Article 4 (3) on market surveillance and Article 6 (3) on freedom of movement.

In the essential health and safety requirements of Annex I to the Machinery Directive, the term ‘machinery’ is generally to be understood in the broad sense to designate any of the product categories referred to in Article 1 (1), (a) to (f). Where certain essential health and safety requirements are applicable to only one or more of these categories, this is explicitly stated or can be inferred from the context. For example, in part 4 of Annex I, certain requirements explicitly apply only to lifting accessories.

§34 Machinery in the strict sense

The product category referred to in Article 1 (1) (a), that is to say machinery in the strict sense, is defined in Article 2 (a). The definition includes five indents. In the following comments, the different elements of each indent of the definition are examined in turn.

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Article 2 (a) – first indent

‘machinery’ means:

− an assembly, fitted with or intended to be fitted with a drive system other than directly applied human or animal effort, consisting of linked parts or components, at least one of which moves, and which are joined together for a specific application,

. . .

§35 The basic definition

The first indent of the definition of ‘machinery’ includes the following elements:

. . . an assembly . . . consisting of linked parts or components . . .

Products with parts or components that are not linked together in an assembly are not considered as machinery.

This does not preclude the supply of machinery with certain parts disassembled for storage or transport purposes. In such cases, the machinery must be designed and constructed in order to prevent errors of fitting when the separate parts are assembled. This is particularly important if the machinery is intended for untrained non-professional users. The manufacturer must also provide adequate assembly instructions, taking account, where appropriate, of the level of general education and acumen that can reasonably be expected from non-professional users – see §225: comments on section 1.5.4, §259: comments on section 1.7.4.1 (d), and §264: comments on section 1.7.4.2 (i) of Annex I.

. . . at least one of which moves . . .

Products without moving parts are not considered as machinery.

. . . fitted with or intended to be fitted with a drive system . . .

The moving parts of machinery are powered by a drive system using one or more sources of energy such as thermal, electric, pneumatic, hydraulic or mechanical energy. The machinery may have a motor using its own source of energy such as thermal energy or energy provided by a battery. It may be connected to one or more external sources of energy such as a supply of electricity or compressed air. Machinery may use mechanical energy supplied by other equipment such as, for example, towed agricultural machinery that is driven by the power take-off of a tractor, or test beds for motor vehicles that are driven by the vehicles being tested; machinery may also be powered by natural sources of energy such as wind or water power.

Usually the manufacturer of complete machinery supplies the machinery fitted with its drive system. However, machines intended to be fitted with a drive system but supplied without it may also be considered as machinery. This provision takes account, for example, of the fact that certain users of machinery prefer to have a homogeneous stock of motors for their machines in order to facilitate maintenance.

For machinery to be supplied without a drive system:

− the manufacturer’s risk assessment must take into account all the risks associated with the machinery, including those relating to the drive system to

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be fitted to the machinery – see §158: comments on General Principle 1 of Annex I;

− the machinery manufacturer must set out in his instructions all the necessary specifications for the drive system to be fitted such as the type, power and means of connection, and provide precise fitting instructions for the drive system – see §264: comments on section 1.7.4.2 (i) of Annex I;

− the conformity assessment of the machinery must cover the specifications of the drive system to be fitted and the fitting instructions;

− the CE-marking on the machinery and the EC Declaration of Conformity that accompanies the machinery must cover the specifications and instructions relating to the drive system to be fitted.

If the above conditions are not fulfilled, machinery without a fully specified drive system must be considered as partly completed machinery (PCM) – see §46: comments on Article 2 (g). In that case, the combination of such partly completed machinery and the drive system must be considered as the final machinery and must be subject to a specific conformity assessment – see §38: comments on the fourth indent of Article 1 (a).

. . . other than directly applied human or animal effort . . .

The moving parts of machinery subject to the Machinery Directive must be driven by a source of energy other than directly applied human or animal effort. Machinery driven by directly applied human or animal effort, such as, for example, hand-driven lawn mowers, hand drills or hand-pushed trolleys, which cease to operate as soon as the manual effort is no longer applied, are not subject to the Machinery Directive. Lifting machinery is the only exception to this general rule – see §40: comments on the fifth indent of Article 2 (a).

On the other hand, the Machinery Directive is applicable to machinery driven by manual effort which is not applied directly but stored, for example, in springs or in hydraulic or pneumatic accumulators, so that the machinery can function after the manual effort has ceased.

. . . which are joined together for a specific application . . .

Machinery must be useable for a specific application as applying to the complete machine and its intended use. Typical machinery specific applications include, for example, the processing, treatment, or packaging of materials, or the moving of materials, objects or persons.

Article 2 (a) – second indent

. . .

‘machinery’ means:

. . .

– an assembly referred to in the first indent, missing only the components to connect it on site or to sources of energy and motion,

. . .

§36 Machinery supplied without connection components

The second indent of the definition of machinery recognises that the characteristics of the components needed to connect a machine on site to the sources of energy and motion may depend on the site where the machinery is to be used or installed. Machinery may therefore be supplied without these components. In that case, the machinery manufacturer must set out in his instructions all the necessary specifications for the safe means of connection – see §264: comments on section 1.7.4.2 (i) of Annex I.

Article 2 (a) – third indent

. . .

‘machinery’ means:

. . .

— an assembly referred to in the first and second indents, ready to be installed and able to function as it stands only if mounted on a means of transport, or installed in a building or a structure,

. . .

§37 Machinery to be installed on a specific support

The third indent of the definition of machinery refers to machinery intended for installation on a means of transport or in a building or a structure.

Means of transport are, in general, excluded from the scope of the Machinery Directive, but machinery mounted on means of transport are subject to the Machinery Directive – see §54: comments on Article 1 (2) (e). Examples of machinery mounted on means of transport include, for example, loader cranes, tail lifts, tipper bodies, vehicle or trailer-mounted compressors, vehicle-mounted compaction systems, vehicle-mounted concrete mixers, skip loaders, powered winches, tippers, telescopic lifting arms and vehicle-mounted mobile elevating work platforms.

Where such machinery is mounted on road vehicles, road trailers or tractors that are excluded from the scope of the Machinery Directive, the requirements of the Machinery Directive do not apply to the road vehicle, road trailer or tractor itself. However, the requirements of the Machinery Directive apply both to the mounted machinery and to all aspects of the interface between the machinery and the chassis on which it is mounted which may affect the safe travel and operation of the machinery. Machinery mounted on means of transport is therefore distinguished from self-propelled mobile machinery such as, for example, self-propelled construction machinery or self-propelled agricultural machinery, which is subject to the Machinery Directive in its entirety.

The third indent of the definition of machinery implies that the manufacturer of machinery intended to be installed on a means of transport or installed in a building or a structure is responsible for the conformity of the machinery with the relevant essential health and safety requirements. He must affix the CE-marking on the machinery and draw up and sign the EC Declaration of Conformity. The manufacturer of such machinery must take into account in his risk assessment all the risks associated with the machine, including those relating to installation of the machinery on the chassis of a vehicle or trailer or on a supporting structure – see §158: comments on General Principle 1 of Annex I. The machinery manufacturer

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shall set out in his instructions the necessary specifications for the supporting structure and provide precise installation instructions – see §264: comments on section 1.7.4.2 (i) of Annex I.

Manufacturers of machinery intended to be installed on means of transport must therefore specify the vehicles or trailers on which the machinery can be safely installed, either by reference to their technical characteristics or, where necessary, by reference to specific models of vehicle.

If a product intended to be installed on a means of transport is not supplied ready to install, for example, if important elements such as the supporting frame or stabilisers are missing, it should rather be considered as partly completed machinery – see §46: comments on Article 2 (g). In that case, the person who assembles the partly completed machinery and the other elements on the means of transport is to be considered as the manufacturer of the final machinery.

Manufacturers of machinery intended to be installed in a building or structure such as, for example, gantry cranes, certain lifts or escalators must specify the characteristics, in particular the load-bearing characteristics, of the structure needed to support the machinery. However, the machinery manufacturer is not responsible for the construction of the building or structure itself – see §262: comments on section 1.7.4.2 (i), and §361: comments on 4.4.2 (a) of Annex I.

The person who installs such a machine on a means of transport or in a building or structure is responsible for carrying out the machinery manufacturers’ installation instructions.

The conformity assessment of machinery intended to be installed on a means of transport or in a building or structure covers the machinery itself, the specifications for the supporting structure and the installation instructions. The necessary tests and inspections must be carried out on the machinery installed on its support in order to check the conformity with the essential health and safety requirements. The CE-marking on the machine and the EC Declaration of Conformity that must accompany the machine cover the conformity of the machine itself and the specifications and instructions relating to its installation.

In the case of machinery intended for lifting operations, the manufacturer is responsible for checking the fitness for purpose of the machinery ready to be put into service – see §350 to §352: comments on section 4.1.3, and §361: comments on section 4.4 2 (e) of Annex I.

Certain categories of machinery to be installed in buildings are also subject to Directive 89/106/EC on Construction Products, such as, for example, powered gates, doors, windows, shutters and blinds – see §92: comments on Article 3.

Article 2 (a) – fourth indent

. . .

‘machinery’ means:

. . .

– assemblies of machinery referred to in the first, second and third indents or partly completed machinery referred to in point (g) which, in order to achieve the same end, are arranged and controlled so that they function as an integral whole,

. . .

§38 Assemblies of machinery

The fourth indent deals with assemblies of machinery consisting of two or more machines or partly completed machines assembled together for a specific application. Assemblies of machinery may be constituted by two units such as, for example, a packaging machine and a labelling machine, or by several units assembled together, for example, in a production line.

The definition of assemblies of machinery indicates that assemblies are arranged and controlled so that they function as an integral whole in order to achieve the same end. For a group of units of machinery or partly completed machinery to be considered as an assembly of machinery, all of these criteria must be fulfilled:

− the constituent units are assembled together in order to carry out a common function, for example, the production of a given product;

− the constituent units are functionally linked in such a way that the operation of each unit directly affects the operation of other units or of the assembly as a whole, so that a risk assessment is necessary for the whole assembly;

− the constituent units have a common control system – see §184: comments on section 1.2.1, and §203: comments on section 1.2.4.4 of Annex I.

A group of machines that are connected to each other but where each machine functions independently of the others is not considered as an assembly of machinery in the above sense.

The definition of assemblies of machinery does not extend to a complete industrial plant consisting of a number of production lines each made up of a number of machines, assemblies of machinery and other equipment, even if they are controlled together by a single production control system. Only if the plant (which may be any combination of machinery, partly completed machinery and other equipment resulting in machinery subject to the Machinery Directive) forms a single integrated line is it subject to the Machinery Directive as an assembly. So for the purpose of applying the Machinery Directive, most industrial plants can be divided into different sections, each of which may be a distinct assembly (of machinery) or even an independent machine (e.g. a mixing vessel). Even a single production line may be divided into separate assemblies and/or machines if there is no safety related connection between constituent assemblies or machinery.

However, where risks are created by the interfaces with other sections of the plant these must be covered by the installation instructions – see §264: comments on section 1.7.4.2 (i) of Annex I.

It should also be noted that the placing on the market of equipment installed in industrial plants that is not in the scope of the Machinery Directive may be subject to other EU internal market legislation – see §89-92: comments on Article 3.

The person constituting an assembly of machinery is considered as the manufacturer of the assembly of machinery and is responsible for ensuring that the assembly as a whole complies with the health and safety requirements of the Machinery Directive – see § 79: comments on Articles 2 (i). In some cases, the manufacturer of the assembly of machinery is also the manufacturer of the constituent units. However, more frequently, the constituent units are placed on the market by other manufacturers, either as complete machinery that could also operate independently

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according to the first, second or third indents of Article 2 (a), or as partly completed machinery according to Article 2 (g).

If the units concerned are placed on the market as complete machinery that could also operate independently, they must bear the CE marking and be accompanied by an EC Declaration of Conformity – see §103: comments on Article 5 (1). If they are placed on the market as partly completed machinery, they must not bear the CE-marking, but note that if other legislation providing for CE marking also apply (e.g. ATEX Directive, Radio Equipment Directive, etc.), a CE marking will have been applied, in which case the Declaration of Conformity should state it only covers that legislation. In all cases the partly completed machine must be accompanied by a Declaration of Incorporation under the Machinery Directive together with assembly instructions – see §104: comments on Articles 5 (2), and §131, comments on Article 13.

Assemblies of machinery are subject to the Machinery Directive because their safety depends not just on the safe design and construction of their constituent units but also on the suitability of the units linked together and the safety of the interfaces between them. At the interface modifications to or extra, guarding/protection devices may need to be designed and fitted so that the assembly as a whole is compliant. The risk assessment to be carried out by the manufacturer of an assembly of machinery must therefore cover both the suitability of the constituent units for the safety of the assembly as a whole and the hazards resulting from the interfaces between the constituent units. It must also cover any hazards resulting from the assembly that are not covered by the EC Declaration of Conformity (for machinery) or the Declaration of Incorporation and the assembly instructions (for partly completed machinery) supplied by the manufacturers of the constituent units.

The manufacturer of the assembly of machinery must:

− carry out the appropriate conformity assessment procedure for the assembly of machinery – see §127 to §130: comments on Article 12;

− affix a specific marking (for example, a specific plate) to the assembly of machinery with the information required by section 1.7.3 and, where appropriate, sections 3.6.2, 4.3.3 and 6.5 of Annex I, including the CE marking;

− draw up and sign an EC Declaration of Conformity for the assembly of machinery – see §103: comments on Article 5 (1).

− compile the technical file which must contain the results of the risk assessment and the design details of the interfaces (e.g. guards, linking conveyers, hoppers, feeders and electronic interface devices) between the items. It must also document any modifications that have been made to the constituent units when incorporating the new items into the assembly. The EC Declaration of Conformity for complete machines and the Declaration of Incorporation and the assembly instructions for partly completed machinery incorporated into the assembly of machinery must also be included in the technical file for the assembly of machinery – see §392: comments on Annex VII A 1 (a).

§39 Assemblies comprising new and existing machinery

The Machinery Directive applies to machinery when it is first placed on the market and put into service in the EU. This is, in general, new machinery – see §72: comments on Article 2 (h). Consequently, the assemblies of machinery referred to in

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the fourth indent of Article 2 (a) are often new assemblies of new machinery. For machinery in service (used at work), the employer must ensure that the conformity and safety of the machinery is maintained throughout its working life, according to the national regulations implementing Directive 2009/104/EC – see §140: comments on Article 15 and following the manufacturer’s instructions – see §272, comments on section 1.7.4.2 (r) of Annex I.

Where, one or more of the constituent units of existing assemblies of machinery may be replaced by new units, or new units may be added to an existing assembly of machinery, the question arises as to whether an assembly of machinery comprising new and existing units is, as a whole, subject to the Machinery Directive. It is not possible to give precise criteria for answering this question in each particular case. In doubt, it is therefore advisable for the person constituting such an assembly of machinery to consult the relevant national authorities. However, the following general guidance can be given:

1. If the risk assessment12 shows that the replacement or the addition of a constituent unit in an existing assembly of machinery does not add a new hazard, nor increase an existing risk, no action is required according to the Machinery Directive for the parts of the assembly that are not affected by the modification. The same applies where there is a new hazard, or an increase in an existing risk, but the existing protective measures present on the assembly before the modification are still sufficient so that the assembly can still be considered safe after modification. However, for those parts of the assembly that are affected by the replacement or the addition of a constituent unit, action under the Machinery Directive will be required. The employer remains responsible for the safety of the whole assembly according to the national provisions implementing Directive 2009/104/EC – see §140: comments on Article 15.

− If the risk assessment13 for the new unit shows it does not have any safety implications (e.g. by requiring modifications) on the existing assembly and it is a complete machinery that could also operate independently, that bears the CE-marking and is accompanied by an EC Declaration of Conformity, then the addition of this new unit (as a complete machinery) into the existing assembly is to be considered as the installation of the new unit (machinery) and this does not give rise to a new conformity assessment, CE marking or EC Declaration of Conformity for either the new unit (machinery) or the assembly to which is added..

− However, if the new unit to be added to the assembly comprises partly completed machinery (PCM) as defined by Art. 2 (g) , which must be accompanied by a Declaration of Incorporation and assembly instructions, the person incorporating the PCM into the assembly is to be considered as the manufacturer of the new unit (as by incorporating the PCM in the assembly, ‘new’ machinery is being put into service). He must therefore assess any risks arising from the interface between the PCM, other equipment and the assembly of machinery, fulfil any relevant EHSRs that have not been applied by the manufacturer of the

12 The risk assessment carried out by the manufacturer, preceding the conformity assessment.

13 The risk assessment carried out by the manufacturer, preceding the conformity assessment.

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PCM, apply the assembly instructions, draw up an EC Declaration of conformity, compile the technical file for the modified parts of the assembly (essentially how the PCM has been put into service, including any changes to the existing assembly) and affix the CE marking to the new unit as assembled. For example, if a new automatic reel change unit, which is a partly completed machinery, is added to the end of a paper making line which will not affect the main parts of the line, then only the interface design and any modifications to the control system or to the existing assembly will need to be assessed for the purposes of CE marking the unit, as fitted.

2. If the replacement or the addition of new constituent units in an existing assembly of machinery has a substantial impact on the operation or the safety of the assembly as a whole or involves substantial modifications of the assembly, it may be considered that the modification amounts to the constitution of a new assembly of machinery to which the Machinery Directive must be applied. In that case, the whole assembly, including all its constituent units, must comply with the provisions of the Machinery Directive. This may also be required if a new assembly of machinery is constituted from new and second-hand units.

Article 2 (a) – fifth indent

. . .

‘machinery’ means:

. . .

— an assembly of linked parts or components, at least one of which moves and which are joined together, intended for lifting loads and whose only power source is directly applied human effort;

. . .

§40 Manually powered machinery for lifting loads

The fifth indent of the definition of machinery sets out an exception to the general rule that manually powered machinery is excluded from the Machinery Directive. Manually powered machinery intended for lifting loads, whether goods or persons or both, is subject to the Machinery Directive – see §328: comments on section 4.1.1 (a) of Annex I. Examples of such machinery include manually powered hoists and cranes, jacks, lifting tables, pallet and stacker trucks and mobile elevating work platforms. Products which do not lift a load but simply maintain it at a given height are not covered by this definition.

Article 2

. . .

(b) ‘interchangeable equipment’ means a device which, after the putting into service of machinery or of a tractor, is assembled with that machinery or tractor by the operator himself in order to change its function or attribute a new function, in so far as this equipment is not a tool;

§41 Interchangeable equipment

Interchangeable equipment referred to in Article 1 (1) (b) is defined in Article 2 (b). It should be noted that interchangeable equipment is also designated by the term ‘machinery’ used in the broad sense – see §33: comments on the first paragraph of Article 2.

In the following comments, the different elements of the definition of interchangeable equipment are examined in turn.

. . . after the putting into service of machinery or of a tractor . . .

Interchangeable equipment is equipment that is designed and constructed in order to be assembled with machinery after the basic machinery has been put into service. Equipment that is assembled with machinery by the manufacturer when the machinery is placed on the market and that is not intended to be changed by the user is not considered as interchangeable equipment but is considered as part of the machinery.

One or more items of interchangeable equipment may be supplied by the machinery manufacturer together with the basic machinery or by another manufacturer. In either case, each item of interchangeable equipment shall be considered as a separate product and must be accompanied by a separate EC Declaration of Conformity, bear the CE marking and be supplied with its own instructions.

. . . is assembled with that machinery or tractor by the operator himself . . .

The fact that interchangeable equipment is intended to be assembled with the machinery implies that the combination of the basic machinery and the interchangeable equipment functions as an integral whole. Equipment that is used with the machinery but not assembled with it is not to be considered as interchangeable equipment. Equipment that requires significant modifications to the “parent machine” by the user when adding and removing the item or it is not designed to be removed or added on a routine basis, is not regarded as “interchangeable equipment”.

. . . in order to change its function or attribute a new function, in so far as this equipment is not a tool . . .

Interchangeable equipment should not be confused with spare parts that do not change the function of the machinery or attribute a new function to it but that are simply intended to replace worn or damaged parts.

Interchangeable equipment is also distinguished from tools, such as, for example, blades, bits, simple earthmoving buckets, etc. which do not change or attribute a new function to the basic machinery. Tools as such are not subject to the Machinery Directive (although the machinery manufacturer must specify the essential characteristics of tools which may be fitted to the machinery – see §268: comments on section 1.7.4.2 (n) of Annex I.

Examples of interchangeable equipment include equipment assembled with agricultural or forestry tractors for functions such as ploughing, harvesting, lifting or loading, and equipment assembled with earth-moving equipment, for functions such as drilling or demolition. Work platforms intended to be assembled with lifting machinery in order to modify its function for the purpose of lifting persons are

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interchangeable equipment – see §388: comments on Annex IV, item 17. Other examples of interchangeable equipment are supports intended for assembly with portable hand-held machines to convert them into fixed machines and interchangeable power-feed units for woodworking machinery.

Interchangeable equipment may be placed on the market by the manufacturer of the basic machinery or by another manufacturer. In either case, the manufacturer of the interchangeable equipment must specify in his instructions the machinery with which it can be safely assembled and used, either by reference to the technical characteristics of the machinery or, where necessary, by reference to specific models of machinery. He must also provide the necessary instructions for safe assembly and use of the interchangeable equipment – see §264: comments on section 1.7.4.2 (i) of Annex I.

The manufacturer of the interchangeable equipment must ensure that the combination of the interchangeable equipment and the basic machinery with which it is intended to be assembled fulfils all the relevant essential health and safety requirements of Annex I and must carry out the appropriate conformity assessment procedure.

It should be noted that the assembly of interchangeable equipment with basic machinery may have the effect of creating a combination that belongs to one of the categories of machinery listed in Annex IV. This may be the case, for example, if a support is assembled with hand-held woodworking machine to convert it into fixed machinery such as a circular saw bench or a vertical spindle moulding machine; or when a work platform is assembled with lifting machinery in order to modify its function for the purpose of lifting persons.14 In such cases, the manufacturer of the interchangeable equipment must carry out a risk assessment for the combination of the interchangeable equipment and the basic machinery and apply one of the conformity assessment procedures foreseen for Annex IV machinery – see §129 and §130: comments on Article 12. The conformity assessment must ensure that the assembly of the interchangeable equipment and the type or types of basic machinery with which it is intended to be assembled complies with all the relevant essential health and safety requirements of Annex I.

The requisite information relating to the conformity assessment of the combination of the interchangeable equipment and the basic machinery shall be mentioned in the EC Declaration of conformity for the interchangeable equipment. The instructions for the interchangeable equipment must also specify the type or types of basic machinery with which the equipment is intended to be assembled and include the necessary assembly instructions – see §264: comments on section 1.7.4.2 (i) and §416: guidance document on interchangeable equipment for lifting persons.

14 See §416: Interchangeable equipment for lifting persons and equipment used with machinery designed for lifting goods for the purpose of lifting persons.

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Article 2

. . .

(c) ‘safety component’ means a component:

− which serves to fulfil a safety function,

− which is independently placed on the market,

− the failure and/or malfunction of which endangers the safety of persons, and

− which is not necessary in order for the machinery to function, or for which normal components may be substituted in order for the machinery to function.

An indicative list of safety components is set out in Annex V, which may be updated in accordance with Article 8(1)(a);

§42 Safety components

Safety components referred to in Article 1 (1) (c) are defined in Article 2 (c). It should be noted that safety components are also designated by the term ‘machinery’ used in the broad sense – see §33: comments on the first paragraph of Article 2.

The safety function serves to fulfil a protective measure to eliminate or, if not possible, to reduce a risk: this action being either inherent in the design or triggered either automatically, or through intervention by the operator on the safety component (as is the case with an emergency stop device, seat belt or two-hand control device).

Safety components are considered to be physical devices (like machinery or interchangeable equipment). Software which performs a safety function and which is placed independently on the market is not considered a ‘safety component’. However, physical components incorporating software and fulfilling the definition at Art 2 (c) are ‘safety components’, and may also be ‘logic units to ensure safety functions’ (item 21, Annex IV – see: §388 Categories of machinery that may be subject to one of the conformity assessment procedures involving a Notified Body).

Many machinery components are critical for the health and safety of persons. However, purely operational components, by virtue of the fourth indent in Article 2 (c) above, are not considered as safety components. Safety components are components intended by the component manufacturer to be fitted to machinery specifically to fulfil a protective role, in addition to any operational duty. Components placed independently on the market that are intended by the component manufacturer for functions that are both safety and operational functions, or that are intended by the component manufacturer to be used either for safety or for operational functions are to be considered as safety components. For example, a hydraulic valve designed and specified as being capable of performing a safety function as well as normal production use, is a “safety component” where other parts of the definition are met. However, a similar valve where the manufacturer markets it only for normal production use would not be considered a safety component. Similarly, a control unit/board delivering safety functions is a “safety component” where the other parts of the definition are met – see §417: Status of machinery control units under the Machinery Directive.

The exclusion of low-voltage switchgear and control gear set out in the fifth indent of Article 1 (2) (k) does not apply to electrical safety components – see §68: comments on Article 1 (2) (k).

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The last sentence of the definition refers to the list of safety components given in Annex V. Annex V lists categories of safety component that are commonly fitted to machinery. Examination of the list helps to understand the definition of ‘safety component’. However, the list is indicative, not limitative. In other words, any component that complies with the definition set out in Article 2 (c) is to be considered as a safety component subject to the Machinery Directive, even if it is not it is included in the list given in Annex V.

If, in future, safety components are identified which are not included in the list given in Annex V, for example, innovative safety components, the Commission can adopt an implementing Decision to update the list, after consulting the Machinery Committee according to the Regulatory procedure with scrutiny – see §116: comments on Article 8 (1) (a), and §147: comments on Article 22 (3). However, this procedure is not a requirement for the item to be considered as a “safety component” as this list is only indicative, this guide includes, at paragraph §389, some other items that meet the definition of “safety components” that are not currently on the list in Annex V.

The second indent of the definition set out in Article 2 (c) implies that only safety components independently placed on the market are subject as such to the Machinery Directive. Safety components manufactured by a machinery manufacturer to be incorporated in his own machinery are not subject to the Directive as such, although they must enable the machinery to comply with the relevant essential health and safety requirements. It should be noted that when such a manufacturer supplies safety components as spare parts to replace the original safety components on machinery he has placed on the market, they are not subject to the Machinery Directive – see § 48: comments on Article 1 (2) (a).

With respect to the conformity assessment procedure applicable to safety components, it should be noted that certain safety components are listed in Annex IV – see §129 and §130: comments on Article 12, and §388: comments on items 19 to 23 of Annex IV.

Specific guidance on safety fences as a safety component is given in section §411.

Article 2

. . .

(d) ‘lifting accessory’ means a component or equipment not attached to the lifting machinery, allowing the load to be held, which is placed between the machinery and the load or on the load itself, or which is intended to constitute an integral part of the load and which is independently placed on the market; slings and their components are also regarded as lifting accessories;

§43 Lifting accessories

Lifting accessories referred to in Article 1 (1) (d) are defined in Article 2 (d). It should be noted that lifting accessories are also designated by the term ‘machinery’ used in the broad sense – see § 33: comments on the first paragraph of Article 2.

Lifting machinery usually has a device for holding the load such as, for example, a hook. Such load holding devices incorporated into lifting machinery are not to be considered as lifting accessories. However, given the varied shape, size and nature of the loads to be lifted, equipment is often placed between the holding device of the

44

lifting machinery and the load, or on the load itself, in order to hold the load during the lifting operation. Such equipment is referred to as a lifting accessory. Products that are independently placed on the market to be incorporated into loads for this purpose are also considered as lifting accessories.

Equipment placed between the holding device of lifting machinery and the load is considered as a lifting accessory, even if it is placed on the market with the lifting machinery or with the load.

The last part of the definition of ‘lifting accessories’ states:

. . . slings and their components are also regarded as lifting accessories

This implies that equipment intended to be used as an independent sling or in a variety of combinations in slings to be made up by a user, for example, to make up a multi-leg sling, is considered as a lifting accessory. On the other hand, components that are intended to be incorporated in slings and that are not intended to be used independently to make up a sling are not considered as lifting accessories – see §358: comments on section 4.3.2 of Annex I.

The Machinery Committee has drawn up a list of various categories of equipment used for lifting operations, indicating which categories are considered as lifting accessories: see section §412. The list is not exhaustive but is intended to facilitate uniform interpretation and application of the Machinery Directive to lifting accessories.

Lifting accessories are subject to certain specific essential health and safety requirements in Part 4 of Annex I – see §337 to §341: comments on sections 4.1.2.3, 4.1.2.4 and 4.1.2.5, §358: comments on section 4.3.2, and §360: comments on section 4.4.1 of Annex I.

Article 2

. . .

(e) ‘chains, ropes and webbing’ means chains, ropes and webbing designed and constructed for lifting purposes as part of lifting machinery or lifting accessories;

§44 Chains, ropes and webbing

Chains, ropes and webbing referred to in Article 1 (1) (e) are defined in Article 2 (e).

The products designated by the terms ‘chains, ropes and webbing’ are chains, ropes and webbing designed and constructed for incorporation into lifting machinery or lifting accessories for lifting purposes – see §328: comments on section 4.1.1 (a) of Annex I. Chains, ropes or webbing designed for purposes other than lifting are not subject to the Machinery Directive as such. However, chains, ropes or webbing that are designed, constructed and specified by the manufacturer for dual or multiple purposes including lifting purposes are subject to the Directive.

Since chains, ropes and webbing for lifting purposes are among the products designated by the term ‘machinery’ used in the broad sense – see §33: comments on the first paragraph of Article 2 – manufacturers of chains ropes and webbing for lifting purposes must fulfil all of the obligations set out in Article 5 (1) – see §103: comments on Article 5 (1).

45

It should be noted that the products designated by the terms ‘chains, ropes and webbing’ are the products placed on the market by the chain, rope or webbing manufacturer in the form of bulk reels, drums, rolls, coils or bundles of chain, rope or webbing. They may be supplied by the chain, rope or webbing manufacturer to distributors, to manufacturers of lifting machinery or lifting accessories, or to users.

The obligations set out in Article 5 (1) apply when the chains, ropes or webbing are first placed on the market. The distributor or user does not become a manufacturer in the sense of the Directive by cutting individual lengths for incorporation into lifting machinery or lifting accessories. Therefore, the obligations set out in Article 5 (1) do not apply again to lengths of chain, rope or webbing cut from the products already placed on the market by the chain, rope or webbing manufacturer. Such lengths are to be considered as components of the lifting machinery or the lifting accessories into which they are incorporated.

However, distributors of chains, ropes and webbing must ensure that the relevant EC Declaration of Conformity, the reference of the certificate setting out the characteristics of the chain, rope or webbing and the manufacturer’s instructions are supplied with the cut length of chain, rope or webbing to manufacturers of lifting machinery or lifting accessories or to users – see §83: comments on Article 2 (i), and §357: comments on section 4.3.1 of Annex I.

Article 2

. . .

(f) ‘removable mechanical transmission device’ means a removable component for transmitting power between self-propelled machinery or a tractor and another machine by joining them at the first fixed bearing. When it is placed on the market with the guard it shall be regarded as one product;

§45 Removable mechanical transmission devices

Removable mechanical transmission devices referred to in Article 1 (1) (f) are defined in Article 2 (f). It should be noted that removable mechanical transmission devices are also designated by the term ‘machinery’ used in the broad sense – see §33: comments on the first paragraph of Article 2.

Removable mechanical transmission devices are subject to specific essential health and safety requirements in Part 3 of Annex I – see §319: comments on section 3.4.7 of Annex I.

It should be noted that guards for removable mechanical transmission devices are included as item 1 in the indicative list of safety components set out in Annex V. When they are placed on the market independently, such guards are therefore subject to the Machinery Directive as safety components. However, according to the second sentence of the above definition, when a removable mechanical transmission device is placed on the market together with its guard, it is subject to the Machinery Directive as a single product.

With respect to the conformity assessment procedure, it should also be noted that removable mechanical transmission devices including their guards are listed in Annex IV, item 14, and guards for removable mechanical transmission devices are listed in Annex IV, item 15.

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Article 2

. . .

(g) ‘partly completed machinery’ means an assembly which is almost machinery but which cannot in itself perform a specific application. A drive system is partly completed machinery. Partly completed machinery is only intended to be incorporated into or assembled with other machinery or other partly completed machinery or equipment, thereby forming machinery to which this Directive applies;

§46 Partly completed machinery

Partly completed machinery (PCM) referred to in Article 1 (g) is defined in Article 2 (g). It should be noted that partly completed machinery is not among the products designated by the term ‘machinery’ used in the broad sense – see § 33: comments on the first paragraph of Article 2. Partly completed machinery cannot be considered as interchangeable equipment.

The placing on the market of partly completed machinery is subject to a specific procedure – see §104: comments on Article 5 (2), §131: comments on Article 13, §384 and §385: comments on Annex II 1 B, and comments on Annexes VI and VII.

Partly completed machinery subject to the Machinery Directive is a product intended to form machinery that is in the scope of the Machinery Directive after incorporation.

‘An assembly which is almost machinery’ means that partly completed machinery is a product that is similar to machinery in the strict sense referred in Article 1 (1) (a), that is to say, an assembly consisting of linked parts or components at least one of which moves, but which lacks some elements necessary to perform its specific application. Partly completed machinery must thus undergo further construction in order to become final machinery that can perform its specific application. As an example, industrial robots are usually designed without a specific application until incorporated into the final machinery – see Article 2(g) of the Machinery Directive. The manufacturer of the final machinery takes the necessary measures so that the robot can perform its specific application safely within the assembly. In practice, only an industrial “stand and function alone-robot” provided with both an end-effector and control system so that it can itself perform a specific application, is a complete machinery under the Machinery Directive.

This further construction is not the fitting of a drive system to machinery supplied without a drive system where the drive system to be fitted is covered by the manufacturer’s conformity assessment – see §35: comments on the first indent of Article 2 (a) – or the connection on site or with sources of energy or motion – see §36: comments on the second indent of Article 2 (a). Partly completed machinery should also be distinguished from machinery ready to be installed on a means of transport or in a building or a structure – see §37: comments on the third indent of Article 2 (a).

Machinery that meets the definition in the first three indents of Article 2(a) so it can in itself operate independently, performing its specific application – see §35: comments on the first indent of Article 2 (a) – but which only lacks the necessary protective means or safety components, such as guards, is not to be considered as partly completed machinery. Such incomplete machinery does not meet the requirements

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of the Machinery Directive and must not be CE marked and cannot be placed on the EU/EEA market – see §103: comments on Article 5 (1).

Machinery constructed in situ is not to be considered a PCM because on arrival at site it comprises a number of parts which may not be compliant (unless one or more of those parts meet the definition of a PCM, which includes being specifically intended for incorporation). It is still a machinery to which Machinery Directive applies so it must undergo conformity assessment and CE marking before it is first put into service.

Sometimes complete machinery missing some parts is confused with a PCM. If the missing parts are not constitutional parts of the machinery (e.g. a motor as a source of energy) and do not give rise to substantial impact on the safety of that machinery (so must be considered as part of conformity assessment) and the machinery manufacturer’s instructions provide clear information for the installation of the missing parts such that the safety and compliance of the final machinery is guaranteed with the Machinery Directive, then the completion of the machinery can be made later according to those instructions, prior to being put into service for the first time, according to Art 2(a) second indent.

Since partly completed machinery is ‘almost machinery’, it is to be distinguished from machinery components that are not subject to the Machinery Directive as such – see §35: comments on the first indent of Article 2 (a). Machinery components can usually be integrated into a wide range of categories of machinery with different applications.

The second sentence of the definition of partly completed machinery states:

. . . A drive system is partly completed machinery.

This provision also applies to drive systems ready to be fitted to machinery and not to the individual components of such systems.

For example, an internal combustion engine or a high voltage electric motor placed on the market ready to be fitted, i.e. with the connections necessary for the fitting, to machinery that is subject to the Machinery Directive are to be considered as partly completed machinery. Electric motors that are marketed for a wide variety of uses and hence not specifically designed or equipped for fitting to a particular type of machinery are not partly completed machinery.

It should be noted that most low voltage (50 – 1000 volts a.c. or between 75 and 1500 volts d.c.) electric motors are excluded from the scope of the Machinery Directive and are subject to the Low Voltage Directive 2014/35/EU, unless they are subject to ATEX Directive 2014/34/EU – see §69: comments on Article 1 (2) (k) –, or form part of the drive system discussed above as PCM. It should also be noted that low voltage electric motors for ATEX application are excluded from the LVD. Consequently such motors fall under the scope of the MD – see §69: comments on Article 1 (2) (k).

Machinery Directive does not prescribe requirements for PCM manufacturers to meet the EHSRs of Annex I. However, All EHSRs met by the PCM must be declared on the accompanying Declaration of Incorporation – see § 385: comments on Annex II 1 B. PCMs must be accompanied by assembly instructions which should include the essential information to enable safe incorporation, including, where relevant, for the final machine’s control system, the relevant data on safety performance/reliability – see §417: Status of machinery control units under the Machinery Directive. This is

48

particularly important where a control unit/board is an integral part of the PCM and delivers safety functions (note: the control board need not be supplied in the same enclosure as the PCM, but must be marketed as a single PCM product).

Manufacturers of final machinery are advised to check the Declaration of Incorporation, technical specifications and the assembly instructions prior to purchasing, to satisfy themselves that the PCM is suitable for integration into the final machinery.

The Machinery Directive does not apply as such to separate machinery components or subassemblies such as, for example seals, ball-bearings, pulleys, elastic couplings, solenoid valves, hydraulic cylinders, and the like, that do not have a specific application and that are intended to be incorporated into machinery; unless they fulfil one of the other definitions of products, e.g. a safety component, that are in the scope of the Machinery Directive by virtue of Art 2 (b) to (f), or are partly completed machinery as defined by Art. 2(g). The complete machinery incorporating such components must comply with the relevant essential health and safety requirements. The machinery manufacturer must therefore choose components with adequate specifications and characteristics. Component manufacturers may provide customers with relevant technical documentation to allow such subassemblies and components, to be installed correctly and safely. As these items are not in the scope of the Machinery Directive, the component manufacturers are not required to provide any declarations of conformity or to produce a technical file according to Annex VII or assembly instructions to Annex VI.

§47 Products excluded from the scope of the Machinery Directive

The scope of the Machinery Directive set out in Article 1 (1) is limited in two ways:

− Certain products corresponding to the definitions set out in Articles 2 (a) to (g) are explicitly excluded from the scope of the Machinery Directive. The list of explicitly excluded products is set out in Article 1 (2), (a) to (l).

− According to Article 3 – Specific Directives, the Machinery Directive does not apply to products listed in Article 1 (1) for the risks covered more specifically by other EU legislation. When these specific Directives cover all the risks associated with the products concerned, such products are entirely excluded from the scope of the Machinery Directive. When the specific Directives only cover certain of the risks associated with the products concerned, as for example ignition sources (according to the ATEX Directive 2014/34/EU), such products remain in the scope of the Machinery Directive for the other risks – see §89 to §91: comments on Article 3.

Article 1 (2)

(a) Safety components intended to be used as spare parts to replace identical components and supplied by the manufacturer of the original machinery;

§48 Safety components intended to be used as spare parts to replace identical components and supplied by the manufacturer of the original machinery

The exclusion set out in Article 1 (2) (a) concerns only components identical to components manufactured by the machinery manufacturer and fitted to their own machinery. Such components are not subject to the Machinery Directive as such because they are not placed on the market independently – see §42: comments on Article 2 (c).

When such a machinery manufacturer supplies identical components as spare parts to replace the original components, those spare parts do not thereby become subject to the Machinery Directive. It is important not to take the term “identical” too far, it should be taken to refer to the identical parameters of the unit. This means the exemption also applies in cases where the exact same components are no longer available and the machinery manufacturer supplies spare parts with the identical safety function and with the identical safety performance as the components that were originally fitted to the machinery.

Article 1 (2)

. . .

(b) Specific equipment for use in fairgrounds and/or amusement parks;

§49 Equipment for use in fairgrounds and/or amusement parks

Equipment designed and constructed specifically for use in fairground or amusement parks is excluded from the scope of the Machinery Directive by Article 1 (2) (b). This includes powered seating to contain or restrain a person, or move in response to other stimuli, such as a simulator experience, but only where specifically intended for use in fairgrounds or amusement parks (see also comments on electrically-operated furniture at §64). The design and construction of equipment specifically intended for use in fairgrounds or amusement is not subject to any EU legislation and may therefore be subject to national regulations. It can be noted that there are two European standards for such equipment15.

Use of such equipment by workers (for example, during erection, dismantling or maintenance operations) is subject to national provisions implementing Directive 2009/104/EC on use of work equipment by workers at work – see §140: comments on Article 15.

Article 1 (2)

. . .

(c) machinery specially designed or put into service for nuclear purposes which, in the event of failure, may result in an emission of radioactivity;

§50 Machinery for nuclear purposes

15 EN 13814:2004 Fairground and amusement park machinery and structures – Safety; EN 13782:2005 Temporary structures – Tents – Safety.

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The exclusion set out in Article 1 (2) (c) concerns machinery specially designed for the purposes of the nuclear power industry or for the production or processing of radioactive materials, the failure of which may result in an emission of radioactivity.

Machinery used in the nuclear power industry, such as fork lift trucks, cranes and generators, which do not give rise to a risk of emission of radioactivity and/or failure of which do not directly generate radioactive emission, are not excluded from the scope of the Machinery Directive.

The machinery concerned by the exclusion set out in Article 1 (2) (c) is also to be distinguished from machinery incorporating radioactive sources, for example, for the purposes of measurement, non-destructive testing or preventing the accumulation of static electric charge. As they are not designed or used for nuclear purposes and thus are not excluded from the scope of the Machinery Directive – see §232: comments on section 1.5.10 of Annex I.

It should be noted that the use of radioactive sources may be subject to authorisation and control according to the national provisions implementing Directive 96/29/Euratom and Directive 2003/122/Euratom16.

Article 1 (2)

. . .

(d) weapons, including firearms;

§51 Weapons, including firearms

As explained in Recital 6, the exclusion of weapons, including firearms, set out in Article 1 (2) (d), is to be understood in light of the scope of the EU legislation on control of the acquisition and possession of weapons set out in Annex I to Council Directive 91/477/EEC17. Section III (b) of that Annex excludes devices designed for industrial or technical purposes provided that they can be used for the stated purpose only.

Consequently, the exclusion of weapons, including firearms, from the scope of the Machinery Directive does not extend to cartridge-operated fixing and other cartridge-operated impact machinery designed for industrial or technical purposes – see §9: comments on Recital 6.

§52 Means of transport

The exclusions relating to various means of transport are set out in the five indents of Article 1 (2) (e). In the following comments, these indents are examined in turn.

16 Council Directive 96/29/Euratom of 13 May 1996 laying down basic safety standards for the protection of the health of workers and the general public against the dangers arising from ionizing radiation. OJ L 159, 29.06.1996 p. 1; Council Directive 2003/122/Euratom of 22 December 2003 on the control of high-activity sealed radioactive sources and orphan sources. OJ L 346, 31.12.2003, p. 57.

17 OJ L 256, 13.9.1991, p. 51.

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Article 1 (2) (e) – first indent18

the following means of transport:

. . .

— agricultural and forestry tractors for the risks covered by Directive 2003/37/EC, with the exclusion of machinery mounted on these vehicles.

. . .

§53 Agricultural and forestry tractors

The exclusion set out in the first indent of Article 1 (2) (e) concerns agricultural and forestry tractors covered by Regulation 167/2013 on the approval and market surveillance of agricultural and forestry vehicles (Tractors) which replaced Directive 2003/37/EC on 1st January 2016. The amendment brought to Article 1(2)(e) of the Machinery Directive, is removing the reference to the exclusion being only for the risks covered by that Directive. Such tractors supplied under Regulation 167/2013 as of 1 January 2016 are completely excluded from the Machinery Directive. However, there is a two-year transition period where tractors supplied under national legislation implementing Directive 2003/37/EC can still be supplied up to 31st December 2017, and are thus also in scope of the Machinery Directive 2006/42/EC.

This change was made because at the time the new Machinery Directive was adopted; the Tractors Directive did not deal with all the risks associated with the use of tractors. The new Regulation 167/2013 was drafted to cover all risks including those previously covered by the Machinery Directive, and so a complete exclusion could be made. This change was anticipated when the Machinery Directive 2006/42/EC was adopted, the following joint declaration was made by the European Parliament, the Council and the Commission:

The Parliament, the Council and the Commission declare that, in order to cover all aspects related to the health and safety of agricultural and forestry tractors in one harmonising Directive, the Directive 2003/37/EC on type-approval of agricultural and forestry tractors, their trailers and interchangeable towed machinery, together with their systems, components and separate technical units needs to be modified so as to address all the relevant risks of the Machinery Directive.

Such a modification of Directive 2003/37/EC should include an amendment of the Machinery Directive, in order to delete the expression “for the risks” in Article 1 (2) (e), first indent.

The Commission recognises the need to include in the agricultural and forestry tractors directives further requirements for risks not yet covered by these directives. To this end, the Commission is considering appropriate measures that include references to United Nations regulations, CEN and ISO standards and OECD codes.

It is important to note that the exclusion relating to agricultural and forestry tractors applies only to the tractors themselves and not to their trailers, to towed or pushed machinery or to mounted or semi-mounted machinery on the tractor.

Examples of mounted and semi-mounted machinery that are in scope of the Machinery Directive are: telescopic booms; digging equipment; post drivers; cutting

18 Article 1(2)(e) was amended by Regulation (EU) 167/2013 on the approval and market surveillance of agricultural and forestry vehicles.

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devices mounted under tractors and equipment for vegetation maintenance. Where the tractor is designed with such items fitted in the production process, whether an integral part of the tractor or not, they are still considered as being “mounted” and so are in scope of the Machinery Directive. Where the “vehicle” is primarily designed for a task such that it does not meet the definition of an agricultural vehicle in Regulation (EU) No 167/2013, such as some models of telescopic material handler, then it is considered a product under the Machinery Directive.

Trailers and interchangeable towed machinery are in the scope of both Tractors Regulation 167/2013 and the Machinery Directive.

The requirements for the safe road circulation of such trailers and towed machinery are harmonised by Regulation (EU) No 167/2013 while the health and safety requirements of such machinery remain subject to the Machinery Directive.

Article 1 (2) (e) – second indent

. . .

the following means of transport:

. . .

— motor vehicles and their trailers covered by Council Directive 70/156/EEC of 6 February 1970 on the approximation of the laws of the Member States relating to the type-approval of motor vehicles and their trailers, with the exclusion of machinery mounted on these vehicles,

. . .

§54 Four-or-more-wheeled road vehicles and their trailers

The exclusion set out in the second indent of Article 1 (2) (e) concerns motor vehicles and their trailers. When Directive 2006/42/EC was adopted, the type-approval of such vehicles was covered by Council Directive 70/156/EEC. As from 29 April 2009, Directive 70/156/EEC is replaced by Directive 2007/46/EC19 This Directive applies to power-driven vehicles having at least four wheels, with a maximum design speed exceeding 25 km/h, designed and constructed in one or more stages for use on the road, and of systems, components and separate technical units designed and constructed for such vehicles, as well as non-self-propelled vehicles on wheels designed and constructed to the towed by a motor vehicle.

Article 2 (3) of Directive 2007/46/EC foresees the possibility of optional type-approval or individual approval for mobile machinery, while stating that such optional approvals shall be without prejudice to the application of the Machinery Directive 2006/42/EC. Consequently, any mobile machinery subject to type-approval or individual approval for circulation on the road remains subject to the Machinery Directive for all risks other than those linked to road circulation.

Vehicles not intended for use on the road such as, for example, off-road quads, ATVs, go-karts, golf-carts buggies and snowmobiles, are subject to the Machinery Directive, unless they are exclusively intended for competition – see §56: comments on Article 1 (2) (e) – fourth indent.

19 Directive 2007/46/EC of the European Parliament and of the Council of 5 September 2007 establishing a framework for the approval of motor vehicles and their trailers, and of systems, components and separate technical units intended for such vehicles. OJ L 263, 9.10.2007, p. 1.

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The same is true of vehicles with a maximum design speed not exceeding 25 km/h such as, for example, certain compact road sweepers.

Machinery mounted on road vehicles or trailers such as, for example, loader cranes, tail-lifts, vehicle or trailer-mounted compressors, vehicle-mounted compaction systems, vehicle mounted concrete mixers, skip loaders, powered winches, tipper bodies and vehicle or trailer-mounted mobile elevating work platforms, are subject to the Machinery Directive – see §37: comments on Article 2 (a) – third indent.

Article 1 (2) (e) – third indent

. . .

— vehicles covered by Directive 2002/24/EC of the European Parliament and of the Council of 18 March 2002 relating to the type-approval of two or three-wheel motor vehicles (2), with the exclusion of machinery mounted on these vehicles,

. . .

§55 Two- and three-wheeled road vehicles

The exclusion set out in the third indent of Article 1 (2) (e) concerns vehicles covered by Directive 2002/24/EC20 which applies to two or three-wheel motor vehicles, whether twin-wheeled or otherwise, intended to travel on the road.

The exclusion does not apply to vehicles not intended for use on the road such as, for example, off-road motorcycles, which are thus subject to the Machinery Directive unless they are exclusively intended for competition – see §56: comments on Article 1 (2) (e) – fourth indent.

The exclusion does not apply to vehicles with a maximum design speed of less than 6 km/h, pedestrian controlled vehicles, vehicles intended for use by the physically handicapped, off-road vehicles, or electrically power assisted cycles (EPACs or pedelecs) that are outside the scope of Directive 2002/24/EC. These categories of two or three-wheel motor vehicles are therefore subject to the Machinery Directive.

Hoverboards or self-balancing scooters, which commonly have a single or pair of wheels on either side, are also subject to the Machinery Directive unless explicitly covered by the Toys Directive 2009/48/EC21.

Article 1 (2) (e) – fourth indent

. . .

— motor vehicles exclusively intended for competition,

. . .

§56 Motor vehicles intended for competition

The exclusion set out in the fourth indent of Article 1 (2) (e) concerns motor vehicles intended for competition. Such vehicles are excluded from the scope of the Machinery Directive whether they are intended for road use or for off-road use.

20 OJ L 124, 9.5.2012, p. 1.

21 OJ L 170, 30.6.2009, p.1

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The exclusion concerns vehicles exclusively intended for competition, thus, for example, vehicles intended for leisure use that may also be used for informal competitions are not excluded. The main criterion to be applied to judge whether vehicles are to be considered as exclusively intended for competition is whether they are designed according to the technical specifications laid down by one of the officially recognised racing associations.

For competition motorcycles, competition quads or All-Terrain Vehicles (ATVs) and competition snowmobiles, the technical specifications are laid down by the FIM (Fédération Internationale de Motocyclisme) and its national affiliated federations. To assist market surveillance authorities to distinguish competition models from others, the FIM publishes on its Website the list of competition motorcycles, quads and snowmobiles that comply with its technical specifications and that participate in national or international motor sports competitions organized under the auspices of the international federation and its national affiliates.

Article 1 (2) (e) – fifth indent

. . .

— means of transport by air, on water and on rail networks with the exclusion of machinery mounted on these means of transport;

§57 Means of transport by air, on water and on rail networks

According to the exclusion set out in the fifth indent of Article 1 (2) (e), the Machinery Directive does not cover any kind of aircraft or means of water-borne transport. This exclusion applies as well to hovercrafts22.

Craft subject to the Recreational Craft Directive 94/25/EC as amended by Directive 2003/44/EC are excluded from the scope of the Machinery Directive. The Machinery Directive does not therefore apply to inboard and stern-drive engines that are considered as part of the craft.

Concerning “unmanned aerial vehicles” or “drones”, they can be considered as covered by the Machinery Directive 2006/42/EC as long as they are not treated as “means of transport”, so not in the specific exclusion for aircrafts stated in the Directive (e.g. specially designed and constructed for military or police purposes or designed and constructed for transporting loads, as well as drones covered by the Directive 2009/48/EC for toys). In addition, other EU legislation can apply to drones according to the specific characteristics of the product, such as the Electromagnetic Compatibility (EMC) Directive 2014/30/EU or the Radio Equipment Directive (RED) 2014/53/EC.

However, the Machinery Directive is applicable to outboard engines, with the exception of the requirements that are specifically included in the Recreational Craft Directive 2013/53/EU relating to the owner’s manual, the handling characteristics of the craft, the starting of outboard engines and exhaust and noise emissions.

Machinery mounted on water-borne vessels, such as, for example floating cranes, drills, excavators and dredgers, are not excluded from the scope of the Machinery

22 Decision of the Machinery Working Group on 5 November 2014.

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Directive. It should be noted that lifting appliances fitted on a means of transport are subject to the Machinery Directive – see §151: comments on Article 24.

The exclusion of means of transport on rail networks concerns machinery intended for the transport of persons and/or goods on international, national, regional, suburban or urban rail networks or on rail systems connected to such networks. Railway turnouts (also known as points or switches) are not covered by the Machinery Directive23 and they are subject to Directive 2008/57/EC24 on the interoperability of the rail system.

On the other hand, machinery intended for use on rail systems not connected to such networks such as, for example, self-propelled machinery running on rails for underground work, are in the scope of the Machinery Directive.

Machinery intended for use on rail networks that is not intended for the transport of persons and/or goods such as, for example, railbound machinery for the construction, maintenance and inspection of the rail track and structures, is also in the scope of the Machinery Directive. The same goes for machinery mounted on railbound vehicles, such as, for example, loader cranes and mobile elevating work platforms.

Article 1 (2)

(f) Seagoing vessels and mobile offshore units and machinery installed on board such vessels and/or units;

§58 Seagoing vessels and mobile offshore units and machinery installed on board such vessels and/or units

Seagoing vessels and mobile offshore units such as, for example, mobile drilling rigs, and machinery installed on them are excluded from the scope of the Machinery Directive by Article 1 (2) (f) since they are subject to the Conventions of the International Maritime Organisation.

Some of the equipment concerned by this exclusion may also be subject to the Marine Equipment Directive 96/98/EC25 as amended by Directive 2002/75/EC26.

A mobile offshore unit is an offshore unit that is not intended to be located on the oil field permanently or for the long term, but is designed to be moved from location to location, whether or not it has a means of propulsion or of lowering legs to the seafloor. There are three main types of offshore units for drilling: jack-up; semi-submersible and drill-ship.

However, permanently placed floating units intended for production, such as, for example, FPSOs (Floating Production, Storage and Offloading installations – usually based on tanker designs) and FPPs (Floating Production Platforms – based on semi-submersible vessels) and the machinery installed on such units are not excluded from the scope of the Machinery Directive.

23 Decision of the Machinery Working Group on 23 March 2015.

24 OJ L191, 18.7.2008, p. 1.

25 OJ L 46 of 17/2/1997, p. 25.

26 OJ L 254, 23/9/2002, p. 1.

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Machinery on permanently placed offshore platforms such as, for example, oil production rigs, and machinery which is designed to be used on both fixed and mobile offshore units is also subject to the Machinery Directive.

Article 1 (2)

(g) Machinery specially designed and constructed for military or police purposes;

§59 Machinery for military or police purposes

The exclusion set out in Article 1 (2) (g) applies to machinery specially designed and constructed for defence purposes or for the purpose of maintaining order. Ordinary machinery used by the armed forces or by the police but which is not specially designed for defence purposes or for the purpose of maintaining order is subject to the Machinery Directive.

In some countries, certain fire services belong to the military, however machinery designed for use by such fire-fighters is not thereby considered to be designed and constructed for military purposes and is thus subject to the Machinery Directive.

Article 1 (2)

(h) Machinery specially designed and constructed for research purposes for temporary use in laboratories;

§60 Machinery for research purposes

The exclusion set out in Article 1 (2) (h) was introduced since it was not considered reasonable to submit to the requirements of the Machinery Directive laboratory equipment specially designed and constructed for the needs of particular research projects. Consequently, the exclusion does not apply to machinery permanently installed in laboratories that may be used for general research purposes or to machinery installed in laboratories for purposes other than research such as, for example, for testing purposes.

The exclusion only applies to equipment designed and constructed for temporary research use, that is to say, equipment that will cease to be used when the research projects for which it was designed and constructed have been completed.

Article 1 (2)

(i) Mine winding gear;

§61 Mine winding gear

The exclusion set out in Article 1 (2) (i) concerns lifts equipping mine shafts. Mine winding gear is also excluded from the scope of the Lifts Directive 95/16/EC. It was considered that such lifts were specific installations the characteristics of which varied according to the site and which gave rise to few obstacles to trade. Mine winding gear thus remains subject to national regulations.

It should be noted that this exclusion concerns installations in the mine shaft. Lifts installed in other parts of a mine are not concerned by the exclusion and thus may be

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subject to either the Lifts Directive or the Machinery Directive, as the case may be – see §90: comments on Article 3, and §151: comments on Article 24.

Article 1 (2)

(j) Machinery intended to move performers during artistic performances;

§62 Machinery intended to move performers during artistic performances

The exclusion set out in Article 1 (2) (j) concerns machinery intended to be used to move performers in the course of the artistic performance. Such equipment is excluded from the scope of the Machinery Directive and the Lifts Directive 95/16/EC, since application of the requirements of these Directives could be incompatible with the artistic function of the equipment concerned – see §151: comments on Article 24.

The exclusion does not apply to machinery intended only to move objects such as, for example, scenery or lighting, or to machinery intended to move persons other than the performers such as, for example, technicians.

It should also be noted that the exclusion does not concern other equipment, such as escalators or lifts, designed for moving persons in theatres or other entertainment premises for purposes not directly linked to the execution of the artistic performance. Such equipment is subject to either the Lifts Directive or the Machinery Directive, as the case may be – see §90: comments on Article 3, and §151: comments on Article 24.

Article 1 (2)

(k) Electrical and electronic products falling within the following areas, insofar as they are covered by Council Directive 73/23/EEC of 19 February 1973 on the harmonisation of the laws of Member States relating to electrical equipment designed for use within certain voltage limits:

— household appliances intended for domestic use,

— audio and video equipment,

— information technology equipment,

— ordinary office machinery,

— low-voltage switchgear and control gear,

— electric motors.

§63 Machinery covered by the Low Voltage Directive

One of the objectives of the revision of the Machinery Directive was to clarify the borderline between the scope of the Machinery Directive and the Low Voltage Directive 2014/35/EU27 (replacing Directive 2006/95/EC from 20 April 2016) in order to provide greater legal certainty.

27 OJ L 96, 29.3.2014, p. 357.

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Article 1 (2) (k) lists the categories of low voltage electrical and electronic machinery that are excluded from the scope of the Machinery Directive.

Electrical machinery that is not in any of the categories listed in Article 1 (2) (k) (and that is not concerned by one of the other exclusions) is in the scope of the Machinery Directive. When such machinery has an electrical supply within the voltage limits of the Low Voltage Directive (between 50 and 1000 V for alternating current or between 75 and 1500 V for direct current), it must fulfil the safety objectives of the Low Voltage Directive – see §222: comments on section 1.5.1 of Annex I. However, in that case, the manufacturer’s EC Declaration of Conformity should not refer to the Low Voltage Directive.

On the other hand, low voltage electrical equipment placed on the market independently for incorporation into machinery is subject to the Low Voltage Directive as such28.

Article 1 (2) (k) – first indent

. . .

− household appliances intended for domestic use,

. . .

§64 Household appliances intended for domestic use

Concerning the exclusion mentioned in the first indent of Article 1 (2) (k), several clarifications are necessary:

− the expression ‘household appliances’ designates equipment intended for housekeeping functions such as washing, cleaning, heating, cooling, cooking, etc. Examples of household appliances include washing machines, dish washers, vacuum cleaners and machinery for food preparation and cooking, and machinery for domestic personal care, such as hair dryers, shavers, etc. On the other hand, electrical gardening machinery or electrical power tools intended for construction and repair work in the home are not concerned by this exclusion and are subject to the Machinery Directive;

− the exclusion concerns appliances ‘intended for domestic use’, in other words, appliances intended for use by private persons (consumers) in the home environment. Thus appliances for the housekeeping functions mentioned above that are intended for commercial or industrial use are not excluded from the scope of the Machinery Directive;

− electrically operated furniture, such as beds, chairs, tables, storage furniture including kitchen furniture, remain subject to the Machinery Directive as they are not household appliances of the types indicated above. This includes electrically-operated furniture which ‘entertains’, e.g. by responding to a sound or film track, events in a video game, ‘simulates’ function such as machinery at shows or exhibitions, or provides a non-medical stimuli (e.g. for relaxation), unless the products are specifically intended for use in fairgrounds or amusement parks – see §49 comments on the exclusion of Article 1 (2) b. However, where provided

28 See the Guidelines on the application of the Directive, available on http://ec.europa.eu/growth/sectors/electrical-engineering/lvd-directive/.

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for medical purposes such that they are within scope of the Directive 93/42/EEC (as amended)

29 concerning medical devices, that Directive applies instead of the Machinery Directive.

− drives for storage furniture (such as the powered movement of kitchen storage unit doors, flaps, drawers and similar applications) and powered table/desk tops may be placed on the market either as:

o partly completed machinery according to Article 2 (g) if all the provisions of Article 13 are fully applied (see the comments at §46), or

o as complete machinery according to Article 2 (a) if all the provisions of Article 5 are applied (see the end of §35 – comments on the definition of machinery).

− electrically operated furniture incorporating multiple drives for the opening or closing of doors, drawers or lift-ups (including those in separate units located in the same room) are not to be considered an assembly of machinery unless the criteria of the fourth indent of Article 2 (a) are fully met (see §38 Assemblies of machinery).

−

While it is possible for a consumer to acquire an appliance intended for commercial use or for a commerce to acquire an appliance intended for domestic use, the criterion to be taken into account for determining the intended use is the use intended and stated by the manufacturer of the appliance in his product information or his Declaration of Conformity. Evidently, this statement must accurately reflect the foreseeable use of the product.

Article 1 (2) (k) – second indent

. . .

– audio and video equipment,

. . .

§65 Audio and video equipment

The exclusion mentioned in the second indent of Article 1 (2) (k) concerns equipment such as, for example, radio and television receivers, tape and video players and recorders, CD and DVD players and recorders, amplifiers and loud speakers, cameras and projectors.

Article 1 (2) (k) – third indent

. . .

– information technology equipment,

. . .

§66 Information technology equipment

The exclusion mentioned in the third indent of Article 1 (2) (k) concerns equipment used for the processing, conversion, transmission, storage, protection and retrieval of data or information. The equipment concerned includes, for example, computer hardware, communication network equipment and telephone and telecommunication equipment.

29 OJ L 169, 12.7.1993, p. 1.

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The exclusion does not extend to electronic equipment incorporated into machinery such as, for example, programmable electronic control systems, which is considered as an integral part of the machinery subject to the Machinery Directive and must enable the machinery to fulfil the relevant essential health and safety requirements of Annex I to the Directive. Certain devices incorporating information technology equipment may also be subject to the Machinery Directive as safety components.

Article 1 (2) (k) – fourth indent

. . .

– ordinary office machinery,

. . .

§67 Ordinary office machinery

The exclusion set out in the fourth indent of Article 1 (2) (k) applies to electrical equipment such as, for example, printers, copiers, fax machines, sorters, binders and staplers.

This exclusion does not concern machinery with similar functions intended for use in industries such as, for example, the printing or paper industries, additive printing machinery for producing 3-dimentional products in home, office, laboratory or similar environments, or production printers (even when for use in office environments).

The exclusion of ordinary office machinery does not extend to electrically powered office furniture which is subject to the Machinery Directive.

Article 1 (2) (k) – fifth indent

. . .

– low-voltage switchgear and control gear,

. . .

§68 Low-voltage switchgear and control gear

Low voltage switchgear and control gear referred to in the fifth indent of Article 1 (2) (k) are devices for making and breaking the current in electrical circuits and associated control, measuring and regulating equipment for the control of electrical energy using equipment.

Such equipment is not subject to the Machinery Directive as such. Where such equipment is incorporated into machinery, it must enable the machinery to fulfil the relevant essential health and safety requirements of Annex I to the Machinery Directive.

It should also be noted that this exclusion does not apply to low voltage electrical safety components – see §42: comments on Article 2 (c).

Article 1 (2) (k) – sixth indent

. . .

– electric motors;

§ 69 Electric motors

The exclusion set out in the sixth indent of Article 1 (2) (k) implies that electric motors that are in the scope of the Low Voltage Directive 2014/35/EU (that is to say, electric motors with an electricity supply within the voltage limits and that are not listed in Annex II of that Directive) are subject to the Low Voltage Directive only.

An electric motor is a device for converting electrical energy into mechanical energy. The exclusion applies to the motor itself without a specific application and without additional mechanical elements of a drive system.

The exclusion also applies to low voltage electric motor-generators which are similar devices for converting mechanical energy into electrical energy. On the other hand, generator sets, comprising a source of mechanical energy such as, for example, an internal combustion engine, and an electric generator, are subject to the Machinery Directive.

The exclusion does not apply to electric motors that are intended for use in potentially explosive atmospheres and that are subject to the ATEX-Directive 2014/34/EU, because such motors are excluded from the Low Voltage Directive. Electric motors that are intended for use in potentially explosive atmospheres are therefore subject to the Machinery Directive.

Article 1 (2)

(l) the following types of high-voltage electrical equipment:

– switch gear and control gear,

– transformers.

§ 70 High-voltage electrical equipment

The high-voltage electrical equipment excluded by Article 1 (2) (l) comprises switch gear and control gear and transformers forming part of or connected to a high-voltage electricity supply (above 1000 V for alternating current or above 1500 V for direct current).

This high-voltage electrical equipment is not subject to the Machinery Directive as such. Where such equipment is incorporated into machinery, it must enable the machinery to fulfil the relevant essential health and safety requirements of Annex I to the Machinery Directive – see §222: comments on section 1.5.1 of Annex I.

Article 2

(h) ‘placing on the market’ means making available for the first time in the Community machinery or partly completed machinery with a view to distribution or use, whether for reward or free of charge;

§ 71 The definition of ‘placing on the market’

The term ‘machinery’ in the definition of ‘placing on the market’ is used in the broad sense, that is to say, the definition applies to the placing on the market of any of the products listed in Article 1, (a) to (f) and defined in Article 2 (a) to (f) – see §33:

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comments on the first paragraph of Article 2 – as well as to partly completed machinery.

The Machinery Directive applies to machinery or partly completed machinery placed on the EU market. It does not apply to products manufactured in the EU with a view to being placed on the market or put into service in countries outside the EU, although certain of these countries may have national regulations based on the Machinery Directive or accept machinery on their market that complies with the Directive.

§ 72 New and used machinery

Machinery is considered as placed on the market when it is made available in the EU for the first time. The Machinery Directive therefore applies to all new machinery placed on the market or put into service in the EU, whether such machinery is manufactured in the EU or outside the EU.

In general, the Machinery Directive does not apply to the placing on the market of used or second-hand machinery. In some Member States, the placing on the market of used or second-hand machinery is subject to specific national regulations. Otherwise the putting into service and use of second-hand machinery for professional use is subject to the national regulations on the use of work equipment implementing the provisions of Directive 2009/104/EC – see §140: comments on Article 15.

There is one exception to this general rule. The Machinery Directive applies to used or second-hand machinery that was first made available with a view to distribution or use outside the EU when it is subsequently placed on the market or put into service for the first time in the EU.30 The person responsible for placing on the market or putting into service such used machinery for the first time in the EU, whether he is the manufacturer of the machinery, an importer, a distributor or the user himself, must fulfil all the obligations set out in Article 5 of the Directive.

The question arises as to when a transformation of machinery is considered as construction of new machinery subject to the Machinery Directive. It is not possible to give precise criteria for answering this question in each particular case. In doubt, it is therefore advisable for the person placing such rebuilt machinery on the market or putting it into service to consult the relevant national authorities.

§73 The stage at which the Machinery Directive applies to machinery

The definition of ‘placing on the market’, together with the definition of ‘putting into service’ given in Article 2 (k), determines the stage at which machinery must comply with the relevant provisions of the Directive. The manufacturer or his authorised representative must have fulfilled all their obligations relating to the conformity of machinery when it is placed on the market or put into service – see §103: comments on Article 5.

Placing on the market refers to each individual item of machinery or partly completed and not to a model or type. The relevant provisions of Directive 2006/42/EC therefore

30 Machinery first placed on the market in countries that subsequently acceded to membership of the European Union is considered as having been placed on the market in the EU.

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apply to all items of machinery or partly completed machinery placed on the market as from 29th December 2009 – see §153: comments on Article 26.

The Machinery Directive does not apply to machinery before it is placed on the market or put into service. In particular, machinery transferred by the manufacturer to his authorised representative in the EU in order to fulfil all or part of the obligations set out in Article 5 is not considered to be placed on the market until it is made available with a view to distribution or use – see §84 and §85: comments on Article 2 (j). The same goes for machinery still under construction, transferred by a manufacturer from manufacturing facilities outside the EU with a view to its completion in manufacturing facilities in the EU.

The manufacturer may need to operate or test the machinery or parts of it during construction, assembly, installation or adjustment before it is placed on the market or put into service. In that case, he must take the necessary precautions to protect the health and safety of operators and other exposed persons when carrying out such operations, in accordance with the national regulations on health and safety at work and on the use of work equipment implementing the provisions of Directives 89/391/EEC and 2009/104/EC – see §140: comments on Article 15. However, the machinery concerned is not required to comply with the provisions of the Machinery Directive until it is placed on the market or put into service.

Particular rules apply to machinery exhibited at trade fairs, exhibitions and demonstrations – see §108: comments on Article 6 (3).

§ 74 The legal and contractual forms of placing on the market

Placing on the market is defined as making machinery available with a view to distribution or use. Making machinery available implies that the machinery will be transferred from the manufacturer to another person such as a distributor or a user. However, it could be that the distribution operation is part of the manufacturer’s own business, in which case it is when the item moves from the production area/factory to the distribution warehouse ready to be supplied. There is no restriction as to the legal or contractual form of this transfer.

In many cases, but not exclusively, placing on the market involves a transfer of the ownership of the machinery from the manufacturer to the distributor or user in exchange for payment (for example, sale or hire-purchase). In other cases, placing on the market may take other contractual forms (such as, for example, lease or rental). In such cases, the right to use the machinery is granted in exchange for payment, without transfer of ownership. The Machinery Directive applies to such machinery when it is first subject to a lease or rental contract in the EU. The Machinery Directive does not apply when used machinery that was first placed on the market according to the Machinery Directive is subject to subsequent lease or rental contracts in the EU. Rental or lease of used machinery may be subject to national regulations – see §140: comments on Article 15.

Placing on the market includes any offer for distribution, consumption or use on the EU market which could result in actual supply (e.g. an invitation to purchase, advertising campaigns) and this includes the general offer to supply into the EU on the internet. Therefore, if a machine is offered or advertised for supply (and hence use) on the internet into the EU it is considered as being placed on the market in the same way as a machine may be advertised for supply in a newspaper or magazine, and so the machinery must comply with the Machinery Directive.

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Machinery is also considered to be placed on the market if it is made available with a view to distribution or use free of charge (for example, as a gift or a loan).

Placing on the market is considered not to take place where a machine is introduced from a third country in the EU customs territory and has not been released for free circulation. This includes the cases of products in transit, placed in free zones, warehouses or temporary storage31.

§ 75 Auctions

Auctions held in free zones

One of the ways in which machinery is placed on the market is through auctions. Such auctions may be held in a free zone32. The main purpose of holding auctions in a free zone is to sell new and used machinery from outside the EU for use in countries outside the EU. Machinery sold for that purpose is not considered to be placed on the market in the EU.

On the other hand, the machinery offered for sale at such an auction is considered to be placed on the market or put into service in the EU if and when it leaves the free zone in order to be distributed or used in the EU. If the machinery concerned is new or is used machinery that is placed on the market or put into service in the EU market for the first time, and if the manufacturer of the machinery concerned or his authorised representative has not fulfilled his obligations according to the Machinery Directive, the person who purchases the machinery at the auction and brings it from the free zone into the EU with a view to its distribution or use is to be considered as the person placing the machinery on the market or putting it into service in the EU and must fulfil all the obligations set out in Article 5.

Auctions held outside free zones

If an auction is held in the EU outside a free zone, it can be assumed that the machinery is being offered for sale with a view to its distribution or use in the EU and it is therefore to be considered as placed on the market in the EU.

If machinery offered for sale at an auction held in the EU outside a free zone is new, whether manufactured in or outside the EU, it must comply with the relevant provisions of the Machinery Directive. The same goes for used machinery offered for sale at such an auction if it is placed on the market in the EU for the first time – see §72: comments on Article 2 (h).

If the manufacturer of the machinery concerned or his authorised representative has not fulfilled his obligations according to the Machinery Directive, the person offering the machinery for sale at such an auction (the consignor) is to be considered as the

31 See Council Regulation (EEC) No 2913/92 establishing the Community customs code.

32 The EU has “Free Zones” which allow for temporary storage of goods prior to being exported or re-exported from the customs territory of the EU or brought into another part of the customs territory of the EU – see Articles 155 to 161 of Regulation (EC) No 450/2008 of the European Parliament and of the Council of 23 April 2008 laying down the Community Customs Code (Modernised Customs Code). OJ L 145, 4.6.2008, p. 1. Zone are subject to customs supervision and do not benefit from the free circulation in the internal market. Before benefiting from the free circulation in the internal market, these goods must be declared for release for free circulation. That entails application of commercial policy measures, completion of the other formalities laid down in respect of the importation of goods and the charging of any duties legally due.

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person placing the machinery on the market in the EU and must therefore fulfil all the obligations of the manufacturer set out in Article 5. These obligations include ensuring that the machinery satisfies the relevant essential health and safety requirements, ensuring that the technical file is available, providing the instructions, carrying out the appropriate conformity assessment procedure, drawing up and signing the EC Declaration of Conformity of the machinery and affixing the CE-marking – see §81: comments on Article 2 (i).

The auctioneer who organises the sale by auction of such machinery offered for sale by consignors is be considered as a distributor and must therefore ensure that the machinery bears the CE marking, is accompanied by the EC Declaration of Conformity drawn up and signed by the manufacturer or his authorised representative and is accompanied by instructions – see §83: comments on Article 2 (i).

§ 76 Placing on the market of assemblies of machinery

Assemblies of machinery that are assembled in user’s premises by a person other than the user are considered to be placed on the market when the assembly operations have been completed and the assembly is handed over to the user for use – see §38: comments on Article 2 (a) – fourth indent, and §79: comments on Article 2 (i).

§ 77 Placing on the market of partly completed machinery

Partly completed machinery is considered to be placed on the market when it is made available to a manufacturer of complete machinery or of an assembly of machinery into which it is to be incorporated – see §46: comments on Article 2 (g).

Article 2

(i) ‘manufacturer’ means any natural or legal person who designs and/or manufactures machinery or partly completed machinery covered by this Directive and is responsible for the conformity of the machinery or the partly completed machinery with this Directive with a view to its being placed on the market, under his own name or trademark or for his own use. In the absence of a manufacturer as defined above, any natural or legal person who places on the market or puts into service machinery or partly completed machinery covered by this Directive shall be considered a manufacturer;

§ 78 The definition of ‘manufacturer’

The obligations created by the Machinery Directive relating to the conformity of machinery and partly completed machinery fall on the manufacturer or his authorised representative. These obligations are summarised in Article 5. The definition of ‘manufacturer’, together with the following definition of ‘authorised representative’, determine who shall fulfil these obligations. It is important to understand that the term manufacturer used here is not the same as used in general language, this is explained below in § 79.

The term ‘machinery’ in the definition of ‘manufacturer’ is used in the broad sense, that is to say, the definition applies to the manufacturer of any of the products listed in Article 1, (a) to (f) and defined in Article 2 (a) to (f) – see §33: comments on the

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first paragraph of Article 2. The definition also applies to the manufacturer of partly completed machinery.

§ 79 Who is the manufacturer?

A manufacturer can be a natural or legal person, that is to say, an individual or a legal entity such as a company or association. The process of design and construction of machinery or partly completed machinery may involve several individuals or companies, but in this case one of them must take the responsibility, as the manufacturer, for the conformity of the machinery or partly completed machinery with the Directive. However, the term manufacturer in this Directive also can apply to other persons who have the responsibilities for conformity assessment and CE marking – see §81: comments on Article 2 (i).

Since the essential health and safety requirements of the Directive mainly concern the design and construction of machinery, the person who is in the best position to fulfil these requirements is clearly the person who actually designs and constructs the machinery, or who at least controls the design and construction process. In some cases, the manufacturer may design and construct the machinery himself. In other cases, all or part of the design or the construction of the machinery may be carried out by other persons (suppliers or sub-contractors). However, the person who assumes the legal responsibility for the conformity of the machinery or the partly completed machinery with a view to its being placed on the market under his own name or trademark must ensure sufficient control over the work of his suppliers and sub-contractors and possess sufficient information to ensure that he is able to fulfil all his obligations under the Directive as set out in Article 5 – see §105: comments on Article 5 (3).

A person constituting an assembly of machinery is considered as the manufacturer of the assembly – see §38: comments on Article 2 (a). Usually, the elements constituting an assembly of machinery are supplied by different manufacturers, however one person must assume the responsibility for the conformity of the assembly as a whole. This responsibility can be assumed by the manufacturer of one or more of the constituent units, by a contractor or by the user. If a user constitutes an assembly of machinery for his own use he is considered as the manufacturer of the assembly – see §80 below.

§ 80 A person manufacturing machinery for his own use

A person who manufactures machinery for his own use is considered as a manufacturer and must fulfil all the obligations set out in Article 5. In that case, the machinery is not placed on the market, since it is not made available by the manufacturer to another person but used by the manufacturer himself. However, such machinery must comply with the Machinery Directive before it is put into service – see §86: comments on Article 2 (k). The same goes for a user constituting an assembly of machinery for his own use – see §79 above.

§ 81 Other persons who may be considered as manufacturers

The provision set out in the second sentence of the definition of ‘manufacturer’ is intended to deal with the situation that arises for certain machinery imported into the EU. If a machinery manufacturer established outside the EU takes the decision to place his products on the market in the EU, he is able to fulfil his obligations under

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the Machinery Directive himself or mandate an authorised representative to perform all or part of these obligations on his behalf – see §84 and §85: comments on Article 2 (j). In this case a person purchasing such CE marked machinery from outside the EU does not take on “the manufacturers” duties. On the other hand, the decision to import non-CE marked machinery into the EU may be taken by an importer, distributor or user. In some cases, the machinery may be ordered from an intermediary such as an export company. In other cases, a person may purchase the machinery outside the EU and bring it into the EU himself, order machinery via the Internet, or purchase machinery in a free zone (such as an auction site) with a view to its distribution or use in the EU.

The person placing such machinery on the market in the EU may be able to arrange for the “original manufacturer” to fulfil the obligations according to the Directive, and have the item CE marked. However, if that is not the case, the person placing the machinery on the market in the EU must fulfil these obligations himself. The same goes for a person importing machinery into the EU for his own use. In these cases, the person placing the machinery or partly completed machinery on the EU market or putting machinery into service in the EU is considered as the manufacturer and must therefore fulfil all of the obligations of manufacturer set out in Article 5.

This entails that the person placing the machinery on the market must have the means to satisfy these obligations, which include ensuring that the machinery satisfies the relevant essential health and safety requirements, ensuring that the technical file is available, providing the instructions, carrying out the appropriate conformity assessment procedure, drawing up and signing the EC Declaration of Conformity of the machinery and affixing the CE-marking – see §103 to §105: comments on Article 5.

It should be noted that the provision set out in the second sentence of the definition given in Article 2 (i) cannot be invoked by a manufacturer in the EU or by a manufacturer outside the EU who takes the initiative to place machinery on the EU market, in order to avoid their obligations under the Machinery Directive.

Another case where the duties of a manufacturer rest with a person/company other than who actually designed and made the machine, is where it is marketed and supplied under the distributors name or “brand”. This is a common situation with power tools and appliances sold in a number of chain stores and outlets marketed under a “brand” name owned by the store.

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The flow chart below illustrates the various economic operators who can take on the duties of the manufacturer of machinery.

§ 82 Machinery modified before it is first put into service

In some cases, machinery is sold to an importer or a distributor who then modifies the machinery at the request of a customer before the machinery is put into service for the first time. If the modifications were foreseen or agreed by the manufacturer and covered by the manufacturer’s risk assessment, technical documentation and EC Declaration of Conformity, the original manufacturer’s CE marking remains valid. On the other hand, if the modification is substantial (for example, a change of function and/or performance of the machinery) and not foreseen or agreed by the manufacturer, the original manufacturer’s CE-marking becomes invalid and has to be renewed – see §72: comments on Article 2 (h). The modifier is then considered as the manufacturer and must fulfil all the obligations set out in Article 5 (1).

§ 83 Distributors

Regulation (EC) No 765/2008 setting out the requirements for accreditation and market surveillance relating to the marketing of products defines ‘distributor’ as “any natural or legal person in the supply chain, other than the manufacturer or the importer, who makes a product available on the market”33. The Machinery Directive does not include explicit obligations for distributors of Machinery, unless the distributor is the authorised representative of the manufacturer or is the person placing the machinery on the market – see §81 above.

33 Article 2 (6) of Regulation (EC) No 765/2008 of the European Parliament and of the Council of 9 July 2008 setting out the requirements for accreditation and market surveillance relating to the marketing of products and repealing Regulation (EEC) No 339/93.

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The role of distributors of machinery was clarified by a judgement of the European Court of Justice34. The Court judged that national provisions may require distributors to ensure that, before machinery is delivered to the user, it:

− bears the CE marking,

− is accompanied by the EC Declaration of Conformity drawn up and signed by the manufacturer or his authorised representative, translated into one of the official languages of the Member State in which the machinery is placed on the market,

− is accompanied by instructions in the official language or languages of the Member State concerned.

If the manufacturer has not provided original instructions in that or those languages, a distributor who brings the machinery into the language area in question must provide a translation – see §257: comments on section 1.7.4.1 of Annex I. If the Distributor installs the item or has the opportunity to see it in its working configuration, for example if they supply and install industrial equipment, they should be aware of any obvious defect such as missing guards or interlocks that are required to meet the essential health and safety requirements of the Directive. In such cases they should seek to correct the non-compliance with the manufacturer.

A distributor is generally expected to exercise due care with respect to the machinery he supplies, to be aware of the regulations to which it is subject and to refrain from supplying machinery which evidently fails to comply with the requirements of the Machinery Directive. However, the distributor cannot be required to verify himself the conformity of the machinery with the essential health and safety requirements of the Machinery Directive.

In case of doubt about the conformity of machinery, the distributor is expected to cooperate with the market surveillance authorities, for example, by assisting them in establishing contact with the manufacturer or his authorised representative and in obtaining from the latter the necessary information such as the relevant elements of the technical file – see §98: comments on Article 4.

With respect to specific obligations of distributors of chains, ropes and webbing – see §44: comments on Article 2 (e) and §357: comments on section 4.3.1 of Annex I.

Article 2

(j) ‘authorised representative’ means any natural or legal person established in the Community who has received a written mandate from the manufacturer to perform on his behalf all or part of the obligations and formalities connected with this Directive;

§ 84 The possibility to appoint an authorised representative

The obligations relating to the placing on the market and putting into service of machinery and the placing on the market of partly completed machinery fall on the manufacturer or his authorised representative. The nomination of an authorised representative in the EU is a solution available to manufacturers of machinery or

34 Judgement of the ECJ, 8th September 2005, Case C-40/04.

70

partly completed machinery, whether established within or outside the EU, in order to facilitate the accomplishment of their obligations under the Directive. The authorised representative must have a written mandate from the manufacturer that specifies explicitly which of the obligations set out in Article 5 are entrusted to him. The authorised representative is thus different from a commercial agent or distributor.

An authorised representative can be a legal or natural person, that is to say, an individual or a legal entity such as a company or association. He must be established in the EU, in other words, he must have an address in the territory of one of the Member States.

The manufacturer must ensure that his authorised representative is given the means necessary to accomplish all of the obligations that are conferred on him. This is particularly important if the authorised representative is given the task of carrying out the conformity assessment of the machinery – see §105: comments on Article 5 (3).

It is not an obligation for a manufacturer established outside the EU to nominate an authorised representative: such a manufacturer can accomplish all of his obligations directly. However, whether or not such a manufacturer appoints an authorised representative, he must always indicate in the EC Declaration of Conformity or the Declaration of Incorporation the name and address of the person established in the EU who is authorised to compile the technical file or the relevant technical documentation – see §383: comments on Annex II 1 A (2), and §385: comments on Annex II 1 B (2). This duty is limited to putting together the technical information as supplied to this person by the manufacturer and to liaise and facilitate the supply of it to the Market Surveillance Authority who has requested to see the relevant parts of the technical file. They have no technical responsibility for the content of the technical file or have other compliance duties. Thus this person is not to be confused with an authorised representative.

It should also be noted that if the manufacturer has nominated an authorised representative for any of the obligations set out in Article 5, the EC Declaration of Conformity of the machinery or the Declaration of Incorporation of partly completed machinery must include the name and address of both the manufacturer and of his authorised representative – see §383: comments on Annex II 1 A (1), §385: comments on Annex II 1 B (1).

§ 85 The tasks of an authorised representative

A manufacturer can give a mandate to an authorised representative to carry all or part of the obligations mentioned in Article 5.

In the case of machinery, the tasks given by the manufacturer to the authorised representative may therefore include ensuring that the machinery satisfies the relevant essential health and safety requirements, ensuring that the technical file is available, providing the instructions, carrying out the appropriate conformity assessment procedure, drawing up and signing the EC Declaration of Conformity of the machinery and affixing the CE-marking – see §103 to §105: comments on Article 5.

In the case of partly completed machinery, the authorised representative of the manufacturer may be mandated to compile the relevant technical documentation, to prepare and provide the assembly instructions and to draw up and sign the

71

Declaration of Incorporation of partly completed machinery – see §131: comments on Article 13.

Article 2

(k) ‘putting into service’ means the first use, for its intended purpose, in the Community, of machinery covered by this Directive;

§ 86 The definition of ‘putting into service’

The Machinery Directive applies to machinery when it is placed on the market and/or put into service. Machinery that is placed on the market in the EU is put into service when it is used in the EU for the first time. This applies to new machines that are completed and tested at the users site (may be referred to as ‘in-situ’ manufacturing), including both machines the user has built himself or have been built for him by another. Existing machinery originally first put into service outside the EU and moved by the user to his own site in the EU is also subject to the Machinery Directive as it is now being put into service for the first time in the EU. However, ‘putting into service’ does not apply to existing machinery (which was originally been put into service or placed on the market in the EU) that has had modifications carried out, unless they are so extensive that the machine is considered as new – see §72: comments on Article 2 (h). In such cases, the obligations of the manufacturer with respect to the placing on the market and the putting into service of the machinery are the same.

In the case of machinery manufactured by a person for his own use or an assembly of machinery constituted by the user (that is not placed on the market), the Machinery Directive applies when the machinery or assembly of machinery is first put into service. In other words, such machinery must comply with all the provisions of the Directive before it is first used for its intended purpose in the EU. The machinery may need to be tested as part of the installation and commissioning process for a short and limited period under the full control of the manufacturer, which includes the control of the persons involved in the testing. This process may then result in further modifications being required prior to CE marking and the issuing of the Declaration of Conformity. Only then it can be “cleared” for use or production and handed over to the user. This testing process must not be used for production as a way of getting around the legislation. This testing is considered to be part of the manufacturing process and not being put into service. However, during this period, full compliance must be fulfilled with the requirements of the national legislation that implements Directive 2009/104/EC concerning the minimum health and safety requirements for the use of work equipment by workers at work.

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Article 2

(l) ‘harmonised standard’ means a non-binding technical specification adopted by a standardisation body, namely the European Committee for Standardisation (CEN), the European Committee for Electrotechnical Standardisation (CENELEC) or the European Telecommunications Standards Institute (ETSI), on the basis of a remit issued by the Commission in accordance with the procedures laid down in Directive 98/34/EC of the European Parliament and of the Council of 22 June 1998 laying down a procedure for the provision of information in the field of technical standards and regulations and of rules on Information Society services (1).

(1) OJ L 204, 21.7.1998, p. 37. Directive as last amended by the 2003 Act of Accession.

§ 87 The definition of ‘harmonised standard’

Harmonised standards are essential tools for applying the Machinery Directive. Their application is not mandatory. However, when the references of harmonised standards are published in the Official Journal of the European Union, application of their specifications confers a presumption of conformity with the essential health and safety requirements they cover – see §110: comments on Article 7 (2).

Furthermore, harmonised standards provide a good indication of the state of the art that must be taken into account when applying the essential health and safety requirements set out in Annex I – see §162: comments on General Principle 3 of Annex I.

Although the definition of ‘harmonised standards’ refers to the three European Standardisation Organisations (ESOs), in practice, only two ESOs, CEN and CENELEC, are involved in the development of standards supporting the Machinery Directive – see §112: comments on Article 7 (2).

The remit issued by the Commission mentioned in the definition is generally referred to as a mandate. On 19th December 2006, the Commission issued the mandate M/396 to CEN and CENELEC requesting the ESOs to review the existing body of harmonised standards for machinery in light of Directive 2006/42/EC and to develop the necessary new standards35.

Article 236

(m) ‘essential health and safety requirements’ means mandatory provisions relating to the design and construction of the products subject to this Directive to ensure a high level of protection of the health and safety of persons and, where appropriate, of domestic animals and property and, where applicable, of the environment. The essential health and safety requirements are set out in Annex I. Essential health and safety requirements for the protection of the environment are applicable only to the machinery referred to in section 2.4 of that Annex.

§ 88 Essential health and safety requirements

Machinery subject to the Machinery Directive must fulfil the relevant essential health and safety requirements set out in Annex I. The essential health and safety requirements are to be applied in light of the General principles set out in introduction to Annex I – see §157 to §163: comments on the General Principles of Annex I.

The essential health and safety requirements set out in Annex I may be supported by European harmonised standards – see §110 to §114: comments on Article 7 (2) and (3).

Most of the essential health and safety requirements concern primarily the protection of the health and safety of persons, including operators and other exposed persons – see §166: comments on section 1.1.1 of Annex I. They also concern the protection of domestic animals, including pets and livestock, insofar as such animals are liable to be exposed to the hazards generated by the machinery. There are no specific essential health and safety requirements relating to the protection of property, however certain of the essential requirements deal with hazards that are liable to damage property, such as, for example, the fire and explosion hazards.

The only essential health and safety requirements of the Machinery Directive that concern the protection of the environment are those set out in section 2.4 of Annex I which apply to machinery for pesticide application – see §282 to §290: comments on section 2.4 of Annex I. Other categories of machinery may be subject to environmental protection requirements set out in other specific Directives – see §92: comments on Article 3.

Article 3

Specific Directives

Where, for machinery, the hazards referred to in Annex I are wholly or partly covered more specifically by other Community Directives, this Directive shall not apply, or shall cease to apply, to that machinery in respect of such hazards from the date of implementation of those other Directives.

§ 89 The Machinery Directive and other internal market legislation

According to Article 3, for products in the scope of the Machinery Directive, the provisions of the Machinery Directive may be totally or partially superseded by other EU legislation (Directives or Regulations) that cover all or certain of the hazards concerned more specifically.

This specific legislation may be comprehensive health and safety Directives covering all of the machinery hazards for the products in their scope. According to Article 3, these Directives are to be applied instead of the Machinery Directive for the products in their scope – see §90 below.

In other cases, the overlap between the specific Directives and the Machinery Directive is limited to one or a few hazards. According to Article 3, in these cases the relevant requirements of the specific Directive are to be applied instead of the corresponding essential health and safety requirements of the Machinery Directive – see §91 below.

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Besides the specific Directives referred to in Article 3, other EU Directives may apply in a complementary way to machinery in the scope of the Machinery Directive for aspects not covered by the Machinery Directive, such as electromagnetic compatibility or the protection of the environment – see §92 below.

The other EU legislation referred to in the following paragraphs are Directives or Regulations for ensuring the free movement of goods through technical harmonisation based on Article 95 of the EC Treaty (now Article 114 of the TFEU). They do not include Directives based on Article 175 EC (now Article 192 of the TFEU) relating to the protection of the environment, or Directives based on Article 137 EC (now Article 153 of the TFEU) relating to the protection of workers’ health and safety. For the relationship between the Machinery Directive and the Directives based on Article 137 EC (Article 153 TFEU) – see §140: comments on Article 15.

The Directives referred to in §90 to §92 may also be applicable to partly completed machinery referred to in Article 1 (g).

It should be noted that when more than one Directive is applicable to machinery, the conformity assessment procedure required by each Directive may be different. In that case, the conformity assessment to be carried out under each Directive concerns only the aspects that are covered more specifically by that Directive.

The CE-marking affixed on the machinery signifies that the machinery complies with all of the applicable EU legislation requiring the CE-marking – see §106: comments on Article 5 (4), and §141: comments on Article 16. Note that although partly completed machinery must not bear the CE mark under the Machinery Directive, it may bear the CE mark if it also comes under other relevant legislation such as ATEX – see §251: comments on Annex I 1.7.3 – 3rd paragraph..

When, in addition to the Machinery Directive, one or more other Directives requiring an EC Declaration of Conformity are applicable to machinery, the manufacturer may draw up a single EC Declaration of Conformity for all of the Directives concerned, providing this Declaration contains all the information required by each Directive. This may not be possible in all cases, since certain Directives specify a particular format for the Declaration of Conformity. In any case, the EC Declaration of Conformity of the machinery must include a declaration that the machinery complies with the other applicable Directives – see §383: comments on Annex II 1 A (4).

§90 Specific EU legislation that apply instead of the Machinery Directive to machinery that is in their scope

Directive 2014/35/EU37 (*)

on electrical equipment designed for use within certain voltage limits

(Low Voltage Directive, LVD)

(*) replacing the previous LVD 2006/95/EC38 from 20 April 2016

Electrical and electronic products that are any of the categories listed in Article 1(2) (k) of Machinery Directive 2006/42/EC (MD) shall comply with the LVD.

Electrical and electronic products that is not in any of the categories listed in Article 1(2) (k) of the MD but meet the definitions of article 2 of the MD, shall comply with the MD. It should be noted that section 1.5.1 of Annex I to the MD requires the electrical aspects of machinery to meet the safety objectives of the LVD. [..] Thus, whilst machinery with an electrical supply, which is not in any of the categories listed in Article 1(2) (k) of MD, shall fulfil the safety objectives of the LVD, the manufacturer’s EC Declaration of conformity shall not refer to the LVD but to the MD

Directive 2009/48/EC39

on the safety of toys

The Toys Directive is a comprehensive health and safety Directive, dealing more specifically than the MD with the hazards of machinery intended to be used as toys.

In accordance with Article 3, the MD is thus not applicable to machinery that is within the scope of the Toys Directive.

Directive 89/686/EEC40 (*)

on personal protective equipment

(PPED)

(*) a new Regulation (EU) 2016/425 on PPE was approved in 2016 and will be applicable from 21.04.201841

The PPED is a comprehensive health and safety Directive, dealing more specifically than the MD with the hazards of machinery intended for use as PPE.

In accordance with Article 3, the MD is thus not applicable to machinery that is within the scope of the PPED.

It should be noted that products that are subject to the PPED may be fitted to machinery, such as, for example, rigid or flexible guides for personal fall arrest equipment.

37 OJ L 96, 29.3.2014, p. 357.

38 OJ L 374, 27.12.2006.

39 OJ L 170, 30.6.2009 p. 1.

40 OJ L 399, 30.12.1989 p. 18.

41 OJ L 81,31.3.2016 p.51.

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Directive 93/42/EEC42 (*) as amended by Directive 2007/47/EC43

on medical devices

(MDD)

(*) a new Regulation (EU) 2017/475 on medical devices was approved in 2017 and will be applicable from 26.05.2020

The MDD is a comprehensive health and safety Directive, dealing more specifically than the MD with the hazards of machinery intended for medical use.

In accordance with Article 3, the MD is thus not applicable to machinery that is within the scope of the MDD.

It should be noted that Article 3 of the MDD as amended makes any essential health and safety requirements of the MD that are relevant and that are more specific than the ones included in the MDD applicable to medical devices that are machinery, while all the other obligations relating to the placing on the market of such devices, including the conformity assessment procedure and the risk assessment, are set by the MDD only.

Directive 2014/33/EU44 (*)

on lifts

(LD)

(*) replacing the previous LD 95/16/EC45 from 20 April 2016

The LD is a comprehensive health and safety Directive, dealing more specifically than the MD with the hazards of machinery intended for use as a lift and those of safety components for lifts.

In accordance with Article 3, the MD is not thus applicable to the lifts or safety components that are within the scope of the LD.

It should be noted that section 1.1 of Annex I of the LD makes any relevant essential health and safety requirements of the MD, that are not included in Annex I of the LD, applicable to lifts, while all the other obligations relating to the placing on the market of such lifts, including the conformity assessment procedure, are set by the LD only.

The MD applies to lifts that are excluded from the scope of the LD, unless they are also excluded from the scope of the MD – see §47 to §70: comments on Articles 1 (2), and §151: comments on Article 24.

42 OJ L 169, 12.7.1993 p. 1.

43 OJ L 247, 21.9.2007 p. 21.

44 OJ L 96, 29.3.2014, p. 251.

45 OJ L 213, 7.9.1995, p. 1.

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Directive 2000/9/EC46 (*)

on cableway installations designed to carry persons

(*) a new Regulation (EU) 2016/424 on Cableways was approved in 2016 and should be applicable in 2018

The Cableways Directive is a comprehensive health and safety Directive, dealing more specifically than the MD with the hazards of machinery intended for use as cableways designed to carry persons.

In accordance with Article 3, the MD is thus not applicable to cableways designed to carry persons that are within the scope of the Cableways Directive.

The MD applies to certain cableways that are outside or excluded from the scope of the Cableways Directive such as, for example, cableways for the transport of goods only and cableways for agricultural, mining or industrial purposes.

Other installations that are excluded from the scope of the Cableways Directive are also excluded from the scope of the MD, for example, as means of transport on water or on rail networks or as specific equipment for use in fairgrounds or amusement parks – see §49 and §57: comments on Article 1 (2).

Regulation (EU) No 167/201347

on agricultural and forestry vehicles

This Regulation covers all identified risks including those previously covered by the Machinery Directive, for agricultural and forestry tractors, and so a complete exclusion from the Machinery Directive could be made. To do this it modified Article 1(2)(e) of the Machinery Directive, removing the reference to the exclusion being only for the risks covered by that Directive. Such tractors supplied under Regulation 167/2013 from 1 January 2016 are completely excluded from the Machinery Directive.

However, there is a two-year transition period where tractors supplied under national legislation implementing Directive 2003/37/EC can still be supplied up to 31 December 2017, and are thus also in scope of the Machinery Directive 2006/42/EC.

46 OJ L 106, 3.5.2000, p. 21.

47 OJ L 60, 2.3.2013, p. 1.

§91 Specific EU legislation that may apply to machinery instead of the Machinery Directive for specific hazards

Directive 2014/34/EU48 (*)

on equipment and protective systems intended for use in potentially explosive atmospheres

(ATEX Directive)

(*) replacing the previous ATEX Directive 94/9/EC49 from 20 April 2016

In accordance with Article 3, the ATEX Directive applies, for the explosion hazard, to machinery intended for use in potentially explosive atmospheres.

The reference to “the specific Community Directives” in the second paragraph of section 1.5.7 of Annex I of the MD is to be understood as a reference to the ATEX Directive.

It should be noted that the ATEX Directive does not apply to areas within machinery where a potentially explosive atmosphere may exist or to explosion hazards that are not due to atmospheric conditions50.

The risk of explosion posed by or within the machinery itself or by gases, liquids, dust, vapours or other substances produced or used by the machinery are covered by the MD – see §228: comments on section 1.5.7 of Annex I.

A machinery manufacturer may incorporate ATEX equipment, protective systems or components that have already been placed on the market in order to prevent the risk of explosion in areas within the machinery. In that case, the EC Declaration of Conformity of the machinery should not refer to the ATEX Directive but the EC Declarations of conformity of the ATEX equipment, systems or components incorporated into the machinery must be included in the machinery manufacturer’s technical file – see §392: comments on Annex VII A 1 (a).

Directive 84/500/EEC51

on ceramic articles to come into contact with foodstuffs

Regulation (EC) No 1935/200452

on materials and articles intended to come into contact with food and repealing Directives 80/590/EEC and 89/109/EEC

Directive 2002/72/EC53

on plastic materials and articles intended to come into contact with foodstuffs

In accordance with Article 3, the EU provisions on materials and articles intended to come into contact with food apply to the relevant parts of foodstuffs machinery.

The reference in section 2.1.1 (a) of Annex I of the Machinery Directive to “the relevant Directives” is to be understood as a reference to Directive 84/500/EEC, Regulation (EC) No 1935/2004 and Directive 2002/72/EC.

48 OJ L 96, 29.3.2014, p. 309.

49 OJ L 100, 19.4.1994, p. 1.

50 See the Guidelines on the application of Directive 2014/34/EU (ATEX Guidelines), available on http://ec.europa.eu/growth/sectors/mechanical-engineering/atex/.

51 OJ L 277, 20.10.1984 p. 12.

52 OJ L 338, 13.11.2004 p. 4.

53 OJ L 220, 15.08.2002 p. 18.

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Directive 2014/29/EU54 (*)

on simple pressure vessels

(SPVD)

(*) replacing the previous SPVD 2009/105/EC55 from 20 April 2016

In accordance with Article 3, the SPVD applies, for the pressure hazards, to simple pressure vessels manufactured in series within its scope that are incorporated into or connected to machinery.

It should be noted that the MD covers the risk of break-up during operation – see §207: comments on section 1.3.2 of Annex I.

Directive 2009/142/EC56 (*)

on appliances burning gaseous fuels

(Gas Appliances Directive, GAD)

(*) a new Regulation (EU) 2016/426 on gas appliances was approved in 2016 and will be applicable from 21.04.201857

The GAD applies to appliances burning gaseous fuels used for cooking, heating, hot water production, refrigeration, lighting or washing, including forced draught burners, and to fittings for such appliances.

In accordance with Article 3, the GAD also applies, for the hazards that it covers, to gas appliances within its scope that are incorporated into machinery.

Appliances specifically designed for use in industrial processes carried out on industrial premises are excluded from the GAD. Such appliances, and other gas appliances excluded from the scope of the GAD, are subject to the MD if they are in its scope or are incorporated into machinery.

The MD also applies to gas appliances in the scope of the GAD that have powered moving parts, for hazards that are not covered by the GAD.

Directive 2014/68/EU58 (*)

on pressure equipment

(PED)

(*) replacing the previous PED 97/23/EC59 from 19 July 2016

In accordance with Article 3, the PED is applicable, for the pressure hazards, to pressure equipment within its scope that is incorporated into or connected to machinery. If pressure equipment that has already been placed on the market is incorporated into machinery, the machinery manufacturer’s technical file must include the EC Declaration of Conformity of that pressure equipment to the PED – see §392: comments on Annex VII A 1 (a).

Pressure equipment classified as no higher than category 1 that is incorporated into machinery in the scope of the MD is excluded from the scope of the PED. The MD is thus fully applicable to such equipment.

It should be noted that the MD covers the risk of break-up during operation – see §207: comments on section 1.3.2 of Annex I.

54 OJ L 96, 29.3.2014, p. 45.

55 OJ L 264, 8.10.2009, p. 12.

56 OJ L 330, 16.12.2009, p. 10.

57 OJ L 81, 31.3.2016, p.99

58 OJ L 189, 27.6.2014, p. 164.

59 OJ L 181, 9.7.1997, p. 1.

§ 92 EU legislation that may apply to machinery, in addition to the Machinery Directive, for hazards they cover more specifically than the Machinery Directive

Regulation (EU) No 305/201160 (*)

on construction products

(CPR)

(*) replaced the previous CPD 89/106/EEC61 from 1 July 2013

The CPR sets out requirements relating to the suitability of construction products for the construction works into which they are to be incorporated.

The CPR applies, in addition to the Machinery Directive, to machinery designed to be incorporated in a permanent manner in construction works, such as, for example, powered gates, doors, windows, shutters and blinds, ventilation and air-conditioning systems.

It should be noted that application of the CPR is possible only when a harmonised technical specification is available.

Regulation (EU) 2016/162862 (*) on requirements relating to gaseous and particulate pollutant emission limits

(NRMMD)

(*) amending and repealing Directive 97/68/EC63

The NRMMD Regulation sets out type-approval requirements and emission limits for the gaseous and particulate emissions of internal combustion engines to be installed in the non-road mobile machinery that is within its scope.

Engines installed in non-road mobile machinery must bear the markings referred to in Article 32 to Regulation (EU) 2016/1628 and further specified in its Implementing Regulation (EU) 2017/656, but those Regulations shall not be mentioned in the EC Declaration of Conformity of the machinery.

Directive 2014/53/EU64 (*)

on radio equipment

(RED)

(*) replacing the previous R&TTED 1999/5/EC65 from 13 June 2016

The requirements of the RED with respect to the use of the radio frequency spectrum apply to radio equipment within its scope that is incorporated into machinery, such as, for example, certain remote control devices.

It should be noted that the safety of remote control systems for machinery is subject to the MD – see §184: comments on section 1.2.1 of Annex I.

60 OJ L 88, 4.4.2011, p. 5.

61 OJ L 40, 11.2.1989, p. 12.

62 OJ L 252, 16.9.2016, p.53

63 OJ L 59, 27.2.1998, p. 1.

64 OJ L 153, 22.5.2014, p. 62.

65 OJ L 91, 7.4.1999, p. 10.

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Directive 2000/14/EC66 as amended by Directive 2005/88/EC67

on the noise emission in the environment by equipment for use outdoors

(OND)

The OND sets out environmental noise emission requirements for machinery intended for use outdoors within its scope.68

It should be noted that the last paragraph of section 1.7.4.2 (u) of Annex I of the MD refers to other Community Directives that address noise. Where machinery is within the scope of the OND, the MD provisions concerning sound power levels do not apply – see §229 and §230: comments on section 1.5.8, and §273: comments on section 1.7.4.2 (u) of Annex I.

Directive 2011/65/EU69 (*)

on the restriction of the use of certain hazardous substances in electrical and electronic equipment

(RoHS)

(*) replaced the previous Directive 2002/95/EC70 from 3 January 2013

The RoHS Directive sets out restrictions on the use of certain hazardous substances in the electrical and electronic equipment belonging to categories 1, 2, 3, 4, 5, 6, 7 and 10 as set out in Annex I A to Directive 2002/96/EC71 (WEEE).

Certain products belonging to these categories may also be in the scope of the Machinery Directive such as, for example, categories 1 – large household appliances that are not intended for domestic use, 6 – electrical and electronic tools, 7 – powered leisure and sports equipment and 10 – automatic dispensers.

Directive 2014/30/EU72 (*)

on electromagnetic compatibility

(EMCD)

(*) replacing the previous EMCD 2004/108/EC from 20 April 2016

The EMCD applies to machinery that contains electrical or electronic parts that may generate or be affected by electromagnetic disturbance. The EMCD covers aspects of electromagnetic compatibility related to the functioning of machinery73.

However, the MD covers the immunity of machinery with respect to safety-related electromagnetic disturbance, whether transmitted by radiation or by wire – see §184: comments on section 1.2.1, and §233: comments on section 1.5.11 of Annex I.

66 OJ L 162, 3.7.2000, p. 1.

67 OJ L 344, 27.12.2005, p. 44.

68 See the Guidelines for the application of Directive 2000/14/EC, available on http://ec.europa.eu/growth/sectors/mechanical-engineering/noise-emissions/.

69 OJ L 174, 1.7.2011, p. 88.

70 OJ L 37, 13.2.2003, p. 19.

71 OJ L 37, 13.2.2003, p. 24.

72 OJ L 96, 29.3.2014, p. 79.

73 See the Guide for the EMC Directive 2004/108/EC, available on http://ec.europa.eu/growth/sectors/electrical-engineering/emc-directive/.

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Directive 2009/125/EC74 (*)

on ecodesign requirements for energy-related products

(EuP Directive)

(*) replaced the previous Directive 2005/32/EC from 20 November 2010

The EuP Directive provides a framework for the adoption of eco-design requirements for industrial products.

The implementing measures adopted in the framework of the EuP Directive may apply to machinery or to equipment to be incorporated into machinery, such as, for example, pumps.

Article 4

Market surveillance

1. Member States shall take all appropriate measures to ensure that machinery may be placed on the market and/or put into service only if it satisfies the relevant provisions of this Directive and does not endanger the health and safety of persons and, where appropriate, domestic animals or property and, where applicable, the environment, when properly installed and maintained and used for its intended purpose or under conditions which can reasonably be foreseen75.

. . .

§ 93 Market surveillance

Article 4 sets out the obligation of the Member States to ensure that the provisions of the Machinery Directive for machinery and partly completed machinery are correctly applied and that machinery placed on the market and put into service is safe. This Article was changed by Directive 2009/127/EC which amended the Machinery Directive with regard to machinery for pesticide application. The main change was to add “does not endanger and, where applicable, the environment”, otherwise the application of this Article is not affected.

The term ‘machinery’ in Article 4 (1) is used in the broad sense to refer to the product categories referred to in Article 1 (1) (a) to (f) – see §33: comments on the first paragraph of Article 2.

Basic rules for market surveillance are set out in Chapter III of the Regulation (EC) No 765/2008 setting out the requirements for accreditation and market surveillance relating to the marketing of products.76 The Regulation is directly applicable from 1st January 2010. Its provisions relating to market surveillance are complementary to those of the Machinery Directive, in other words, they apply when the Machinery Directive does not include specific provisions having the same objective77.

74 OJ L 285, 31.10.2009, p. 10.

75 Article 4(1) was amended by Directive 2009/127/EC of the European Parliament and of the Council of 21 October 2009 amending Directive 2006/42/EC with regard to machinery for pesticide application. OJ L 310, 25.11.2009, p. 29.

76 Regulation (EC) No 765/2008 of the European Parliament and of the Council setting out the requirements for accreditation and market surveillance relating to the marketing of products and repealing Regulation (EEC) No 339/93. OJ L 218, 13.8.2008, p. 30.

77 See Article 15 (2) of Regulation (EC) No 765/2008.

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The following comments relate both to the provisions of Article 4 of the Machinery Directive and to the complementary provisions included in Chapter III of the Regulation. The relevant provisions of the Regulation are summarised and references are made to the relevant Articles of the Regulation in footnotes, however readers should consult the full text of the Regulation.

The term ‘market surveillance’ designates the activities carried out and the measures taken by public authorities to ensure that the products subject to the Directive have been subject to the requisite conformity assessment procedures, that they comply with the applicable essential health and safety requirements and, for complete products, that they are safe.78 Market surveillance is carried out when or after such products are placed on the market or put into service. Market surveillance is thereby distinguished from conformity assessment, which aims to ensure the conformity of products before they are placed on the market or put into service.

§ 94 Market surveillance of machinery

The market surveillance of machinery required by Article 4 (1) includes at least the following activities:

− checking that machinery that is placed on the market or put into service bears the CE-marking and is accompanied by a correct EC Declaration of Conformity – see §103: comments on Articles 5 (1), §141: comments on Article 16, §383: comments on Annexes II 1 A, and §387: comments on Annex III;

− ensuring that machinery that is placed on the market or put into service has been subject to the appropriate conformity assessment procedure – see §127 to §130: comments on Article 12;

− checking that machinery that is placed on the market or put into service is accompanied by the necessary information, such as instructions – see §103: comments on Articles 5 (1), and §254 to §256: comments on section 1.7.4 of Annex I;

− where the machinery incorporates partly completed machinery, checking that the assembly instructions of the manufacturer of the partly completed machinery have been correctly followed by the manufacturer of the complete machinery or assembly of machinery;

− monitoring the conformity of machinery that is placed on the market or put into service to ensure that it complies with the essential health and safety requirements that are applicable and does not endanger the health and safety of persons and, where appropriate, domestic animals, property or the environment in the case of pesticides machinery – see §282: comments on EHSR 2.4 on Annex I; §103: comments on Article 5 (1), and §160: comments on General principle 2 of Annex I;

− taking appropriate action to ensure that non-compliant products are brought into conformity or withdrawn from the market – see §122 to §126: comments on Articles 11, and §142, comments on Article 17.

78 See Article 2 (17) of Regulation (EC) No 765/2008.

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The essential health and safety requirements of the Machinery Directive mainly concern the health and safety of persons, including operators and other exposed persons – see §166 and §167: comments on sections 1.1.1 (c) and (d) of Annex I. The essential health and safety requirements apply, also where appropriate, to the health and safety of domestic animals (the use of the word “domestic” has a wide definition and included animals bred for farming, and not just household pets). This may be relevant, for example, to machinery intended for use with, or liable to be in contact with farm animals, horses or pets. The essential health and safety requirements also apply, where appropriate, to the protection of property, for example, against the risks of fire or explosion – see §227 and §228: comments on sections 1.5.6 and 1.5.7 of Annex I.

Market surveillance can be carried out at any stage after the construction of the machinery is complete, as soon as the product concerned has been made available for distribution or use in the EU – see §73: comments on Article 2 (h). Machinery can be examined in the premises of manufacturers, importers, distributors, rental companies, in transit or at the external borders of the EU.

The conformity of machinery may also be checked at the user’s premises after it has been put into service, however, in that case, the market surveillance authorities must take care to distinguish the features of the machinery as it was supplied by the manufacturer from features that may result from modifications carried out by the user – see §382: comments on Annex II 1 A. This may be facilitated by examination of the relevant elements of the manufacturer’s technical file – see §392: comments on Annex VII A. The conformity of machinery manufactured by the user for his own use may also be checked after it has been put into service – see §86: comments on Article 2 (k).

If the non-conformity of machinery in use creates a risk for users, the national authorities in charge of occupational health and safety may require users to take the necessary measures to protect persons and, in case of serious risk, may forbid the use of the machinery. Such measures may be taken in the framework of national regulations implementing Directive 2009/104/EC on the use of work equipment – see §140: comments on Article 15. However, in such cases, the market surveillance authorities shall also take the necessary action on the basis of the Machinery Directive with respect to the manufacturer of the machinery concerned.

When assessing the conformity of machinery, the market surveillance authorities must take account of the state of the art including, where appropriate, the harmonised standards in force, at the time the machinery was placed on the market – see §161 and §162: comments on General Principle 3 of Annex I.

The market surveillance authorities must take into account the use of the machinery intended by the manufacturer and also reasonably foreseeable misuse – see §171 and §172: comments on sections 1.1.1 (h) and (i) of Annex I.

Article 4 (continued)

. . .

2. Member States shall take all appropriate measures to ensure that partly completed machinery can be placed on the market only if it satisfies the relevant provisions of this Directive.

. . .

§ 95 Market surveillance of partly completed machinery

Article 4 (2) requires Member States to carry out market surveillance of partly completed machinery.

Market surveillance of partly completed machinery can be carried out before the partly completed machinery has been incorporated into the final machinery or assembly of machinery. The market surveillance authorities may also carry out checks on machinery or assemblies of machinery into which partly completed machinery has been incorporated. In that case, the market surveillance of the partly completed machinery is an aspect of the market surveillance of the final machinery.

If a non-conformity is detected in the partly completed machinery after it has been incorporated, the market surveillance authorities can check in the technical file for the final machinery whether the Declaration of Incorporation for the partly completed machinery states that the essential health and safety requirement concerned has been applied and fulfilled – see §384: comments on Annex II 1 B. In that case, the market surveillance authorities should address the manufacturer of the partly completed machinery.

Market surveillance of partly completed machinery comprises the following activities:

a) ensuring that partly completed machinery that has been placed on the market has been subject to the appropriate procedure – see §131: comments on Article 13;

b) checking that partly completed machinery that has been placed on the market is accompanied by a correct Declaration of Incorporation. In particular, ensuring that the Declaration of Incorporation includes the declaration as to which essential health and safety requirements have been applied and fulfilled – see §131: comments on Article 13, and §384: comments on Annex II. 1 B;

c) checking that the manufacturer’s assembly instructions have drawn up so as to enable the manufacturer of the complete machinery to assemble the partly completed machinery correctly – see §131: comments on Article 13, and §390: comments on Annex VI;

d) monitoring the conformity of the partly completed machinery that has been placed on the market with the essential health and safety requirements that the manufacturer states have been applied and fulfilled – see §385: comments on Annex II B 4. The monitoring of partly completed machinery can be facilitated by referring to the relevant technical documentation – see §394: comments on Annex VII B;

e) taking appropriate measures to deal with partly completed machinery that fails to comply with any of the provisions referred to in (a) to (d) above. Although the Machinery Directive does not specify the measures to be taken, it is clear that the market surveillance authorities must require the manufacturer of partly completed machinery to bring his product into conformity with the provisions referred to in (a) to (d) above and, failing that, to ensure that the product is withdrawn from the market.

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Article 4 (continued)

. . .

3. Member States shall institute or appoint the competent authorities to monitor the conformity of machinery and partly completed machinery with the provisions set out in paragraphs 1 and 2.

4. Member States shall define the tasks, organisation and powers of the competent authorities referred to in paragraph 3 and shall notify the Commission and other Member States thereof and also of any subsequent amendment.

§ 96 Market surveillance authorities

The term ‘competent authorities’ designates the authority or authorities of each Member State responsible for carrying out market surveillance on its territory79. Articles 4 (3) and 4 (4) require the Member States to designate the authorities that are responsible for carrying out market surveillance and to define their tasks, organisation and powers. The Member States are free to determine how their market surveillance is organised, however the market surveillance system must fulfil certain criteria:

− The market surveillance authorities shall carry out their duties independently, impartially and without bias80.

− The Member States must provide the market surveillance authorities with adequate resources in terms of staff and budget to carry out their tasks.

− The legal powers to be given to the market surveillance authorities shall include the power to require economic operators to make available the necessary documentation and information and, where justified, to enter the premises of economic operators and take the necessary representative samples of products81.

− The Member States must ensure that the powers given to the market surveillance authorities are exercised in accordance with the principle of proportionality82.

− The Member states must take the necessary measures to ensure that the public is aware of the existence, responsibilities and identity of the national market surveillance authorities, as well as how they may be contacted83.

− The market surveillance system must be able to cover the whole range of products subject to the Machinery Directive, including machinery for professional use and machinery intended for use by consumers84. In some Member States, a single authority may cover the whole range of products. In other Member States, market surveillance for the Machinery Directive may be

79 See Article 2 (18) of Regulation (EC) No 765/2008.

80 See Article 19 (4) of Regulation (EC) No 765/2008.

81 See Article 19 (1) of Regulation (EC) No 765/2008.

82 See Article 18 (4) of Regulation (EC) No 765/2008.

83 See Article 17 (2) of Regulation (EC) No 765/2008.

84 See Article 16 (3) of Regulation (EC) No 765/2008.

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shared between, for example, the authority in charge of consumer protection and the authority responsible for occupational health and safety.

− If more than one authority is involved, the Member State must make arrangements to ensure the necessary coordination and communication between them85.

− The market surveillance authorities must have the facilities to carry out the necessary technical inspection and tests or, at least, they must have access to the necessary facilities as required86. The public authorities responsible for market surveillance may entrust certain specific tasks, such as testing or technical inspection of machinery, to competent test or inspection bodies, including private bodies. However, the public market surveillance authorities remain responsible for all market surveillance decisions and measures taken on the basis of tests or inspections carried out on their behalf by such bodies.

§ 97 The market surveillance system

The market surveillance system must include:

− a procedure for dealing with complaints about non-compliant machinery;

− a system for monitoring and acting on reports and data relating to accidents and damage to health due to machinery;

− surveys of particular categories of machinery and inspection or testing of samples;

− adequate means to verify that corrective actions have been effectively carried out;

− means to follow up scientific and technical knowledge concerning health and safety issues relating to machinery.87

Obviously, the market surveillance authorities cannot examine all of the products placed on the market, but the level of monitoring of products on the market must be sufficient to ensure that market surveillance activity is perceived by the stakeholders concerned and has a significant impact on the behaviour of the economic operators.

The market surveillance authorities shall take appropriate action when complaints or reports on accidents, incidents or damage to health due to machinery indicate that the machinery concerned does not comply with the essential health and safety requirements of the Machinery Directive.

The market surveillance authorities shall follow up decisions made by the Commission according to the safeguard clause procedure – see §122 to §126: comments on Article 11. The market surveillance authorities shall also follow up information on unsafe products notified under the RAPEX system set up under the General Product Safety Directive88.

85 See Article 18 (1) of Regulation (EC) No 765/2008.

86 See Article 19 (1) of Regulation (EC) No 765/2008.

87 See Article 18 (2) of Regulation (EC) No 765/2008.

88 Directive 2001/95/EC of the European Parliament and of the Council of 3 December 2001 on general product safety. OJ L 11, 15.1.2002, p. 4.

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In addition to such reactive action, market surveillance activity shall be organised on the basis of periodic market surveillance programmes which must be regularly reviewed and updated in order to improve their effectiveness. The market surveillance programme for machinery can either be included in a general market surveillance programme or be subject to a sector-specific programme. The market surveillance programmes must be communicated to the other Member States and to the Commission and made known publicly, including by means of electronic communications. The first such communication shall take place by 1st January 2010. Market surveillance programmes must be reviewed at least every fourth year and the results of the review shall be communicated to the other Member States and to the Commission and made available to the public89.

In order to be most effective, market surveillance activity should be based on risk assessment. Particular attention should be given to product areas where there is evidence of poor application of the provisions of the Directive or where, despite application of the Directive, the rate of accidents or damage to health due to the use of machinery remains high.

In order to optimise the use of resources, cooperation and coordination between the market surveillance authorities of the Member States is necessary – see §144: comments on Article 19. The Regulation setting out the requirements for accreditation and market surveillance relating to the marketing of products foresees specific measures to improve such cooperation as well as measures to ensure appropriate cooperation with the competent authorities of third countries90.

§ 98 The tools for market surveillance

The European Commission has introduced the Information and Communication System for Market Surveillance (ICSMS)91 which is a databased system that implements Article 23 of Regulation (EC) No 765/2008, as a key tool for market surveillance authorities. The ICSMS system’s internal section is confidential and should be used to record the results of market surveillance. In this sense, it provides a tool:

− to enable market surveillance authorities to exchange information on products being examined and thus help stop duplication of effort;

− to facilitate the cooperation between market surveillance authorities to bring defective products into compliance; and

− to provide a means to help plan and manage market surveillance campaigns and projects.

The database should be filled in when the investigation of a machine has started so other authorities know of this work and can stop any duplication of effort and to establish cooperation where it is beneficial. As the information in the investigation is obtained, the ICSMS database should be added to. Facilities exist in ICSMS to transfer this information to the necessary forms for both RAPEX and Safeguard Notifications if these are required.

89 See Article 18 (5) and (6) of Regulation (EC) No 765/2008.

90 See Articles 24, 25 and 26 of Regulation (EC) No 765/2008.

91 See http://ec.europa.eu/growth/single-market/goods/building-blocks/icsms/.

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The following sections explain the steps market surveillance can proceed and the information that should be available to assist this process.

The CE marking and the EC Declaration of Conformity

The CE marking affixed to the machinery and the manufacturer’s EC Declaration of Conformity that shall accompany the machinery are the first elements that can be checked by the market surveillance authorities – see §141: comments on Articles 16, §385: comments on Annex II 1 A, and §387: comments on Annex III.

In particular, the EC Declaration of Conformity provides essential information to enable the market surveillance authorities to carry out the necessary checks:

− the identity of manufacturer of the machinery and of his authorised representative, where appropriate;

− the person authorised to compile the technical file;

− the conformity assessment procedure that has been followed and the identity of the Notified Body involved, where appropriate;

− the other Directives that have been applied to cover certain hazards more specifically – see §89 to §92: comments on Article 3;

− the harmonised standards or other technical specifications that have been applied, where appropriate.

In order to benefit from the presumption of conformity conferred by the application of harmonised standards, manufacturers must indicate the references of the harmonised standard(s) applied in the EC Declaration of Conformity. However, it should be recalled that the application of harmonised standards remains voluntary – see §110 and §111: comments on Articles 7 (2), §114: comments on Article 7 (3) and §385: comments on Annex II 1 A.

In the case of machinery belonging to one of the categories listed in Annex IV where the manufacturer has followed the procedure for assessment of conformity with internal checks on the manufacture of machinery according to Annex VIII, the manufacturer must indicate the reference(s) of the harmonised standard(s) applied in the EC Declaration of Conformity, since the application of harmonised standards that cover all of the EHSRs applicable to the machinery is a condition for using that conformity assessment procedure – see §129: comments on Article 12 (3).

Where the reference of a harmonised standard is indicated in the EC Declaration of Conformity, the market surveillance authorities are entitled to consider that the manufacturer has applied the specifications of the standard in full. If the manufacturer has not applied all of the specifications of a harmonised standard, he may still indicate the reference of the standard in the EC Declaration of Conformity, but, in that case, he must indicate which specifications of the standard he has or has not applied.

The instructions

Examination of the instructions that must accompany the machinery may also provide important information for the purposes of market surveillance. The instructions must be provided in the official language or languages of the country of use – see §256: comments on section 1.7.4 of Annex I.

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In particular, the instructions must specify the intended use of the machinery, which must be taken into account in the course of any investigation of the conformity of the machinery – see §171: comments on section 1.1.1 (h) of Annex I.

The technical file or the relevant technical documentation

If the market surveillance authorities have a doubt as the conformity of machinery with the essential health and safety requirements, they may request communication of all or part of the manufacturer’s technical file – see §393: comments on Annex VII A 2 and 3. In the case of partly completed machinery, the market surveillance authorities may request communication of the manufacturer’s relevant technical documentation – see §394: comments on Annex VII B. Such a request can be made at any stage of the market surveillance process.

These provisions have a dual purpose: on the one hand, providing the relevant elements of the technical file or of the relevant technical documentation enables a manufacturer to explain the measures he has taken to deal with the risks associated with the machinery in order to comply with the applicable essential health and safety requirements. On the other hand, the examination of these documents helps the market surveillance authorities to complete their investigation and either dispel or confirm their doubts about the conformity of the machinery concerned. However, it is not necessary for the market surveillance authorities to request these documents if they consider that they already have enough information on which to base their decision.

The request for communication of the technical file or of the relevant technical documentation should indicate the nature of the doubt about the conformity of the machinery concerned and the parts or aspects of the machinery that are subject to investigation. Only the elements of the technical file or the relevant technical documentation that are necessary for the investigation should be requested, so as not to constitute a disproportionate burden for the manufacturer.

Failure to present the technical file for machinery, or the relevant technical documentation for partly completed machinery, in response to such a duly reasoned request may constitute grounds for doubting the conformity of the machinery or the partly completed machinery – see §393: comments on Annex VII A 3, and §394: comments on Annex VII B (b). In other words, if the manufacturer fails to respond to a duly reasoned request to supply the relevant elements of his technical file or technical documentation, the market surveillance authorities are entitled to decide what action to take on the basis of whatever other evidence is available to them.

§ 99 Documents relating to Annex IV machinery

When machinery belonging to one of the categories listed in Annex IV has been subject to one of the conformity assessment procedures involving a Notified Body, in addition to the requests for documentation mentioned in the preceding paragraph, the market surveillance authorities have the possibility to obtain certain documents from the Notified Body concerned.

EC type-examination

For machinery subject to the EC type-examination procedure set out in Annex IX, the market surveillance authorities may, on request, obtain a copy of the relevant EC type-examination certificate. This enables the authorities, from any Member State, to check that a certificate has really been issued for the machinery concerned. On

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reasoned request, the market surveillance authorities may obtain a copy of the technical file and the results of the examinations carried out by the Notified Body – see §399: comments on Annex IX 7.

Such requests may be addressed by the market surveillance authority directly to the Notified Body that carried out the EC type-examination. The Notified Body should respond to the national market surveillance authority making the request. In case of difficulties, for example, with respect to language, the market surveillance authorities may seek the assistance of the national authorities responsible for the notification of the Notified Body concerned – see §144: comments on Article 19.

Full quality assurance

In order to check that conformity assessment procedure involving the manufacturer’s full quality assurance system has been correctly applied, the market surveillance authorities can request from the manufacturer or his authorised representative communication of the relevant elements of the documentation of the manufacturer’s full quality assurance system – see §407: comments on Annex X 4.

§100 Action to deal with non-compliant machinery

Non-compliant CE marking

If a market surveillance authority discovers a non-conformity with respect to the CE-marking, the corrective action to be taken is set out in Article 17. The safeguard clause set out in Article 11 is only to be used if the action taken according to Article 17 fails to put an end to the non-conformity – see §142: comments on Article 17.

Failure to comply with the essential health and safety requirements

If a market surveillance authority discovers that machinery that has been placed on the market fails to comply with the relevant essential health and safety requirements, the authority should first require the manufacturer or his authorised representative to take the necessary corrective action to bring the machinery into conformity or to withdraw it from the market within a timeframe determined by the market surveillance authority92. Such corrective measures should be taken with respect to all items of the machinery that have the same design or construction defect and be applied throughout the EU market.

If the product concerned creates a serious risk, the market surveillance authority shall also require the manufacturer to take appropriate action with respect to machinery that has already been placed on the market or put into service such as, for example, a recall of the product93. Where the product possess a serious and immediate risk and there is not ready access or response from the manufacturer, the market surveillance authority may take action to restrict or stop the use and supply of the product urgently through contact with the supply chain and users. In this case the manufacturer should be contacted as soon as possible and asked to correct the non-compliance.

If the necessary corrective actions are not undertaken voluntarily by the manufacturer within the timeframe determined by the market surveillance authority, the Member State must take the necessary measures to ensure that the unsafe products are

92 See Article 2 (15) of Regulation (EC) No 765/2008.

93 See Article 2 (14) and Article 20 of Regulation (EC) No 765/2008.

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withdrawn from the market. Such measures must be notified to the Commission and the other Member States in accordance with the safeguard clause – see §123: comments on Article 11.

The market surveillance authorities shall also take appropriate measures to ensure users are alerted, where possible, in cooperation with the economic operators concerned, in order to prevent accidents or damage to health that might result from the defect that has been identified94.

If machinery presenting a serious risk is withdrawn from the market, whether voluntarily or by means of a restrictive measure, is or brought into conformity by voluntary corrective action, the Member State concerned must inform the other Member States and the Commission in order to enable them to check that the necessary corrective actions are taken throughout the EU – see §144: comments on Article 19. The Rapid Alert System (RAPEX) originally established under the General Product Safety Directive is now used for this purpose95.

It should be noted that when the market surveillance authorities take a compulsory measure restricting the placing on the market of machinery presenting a serious risk, the notification under the RAPEX system does not remove the obligation for the Member State concerned to notify the measure according to the safeguard clause of the Machinery Directive – see §123: comments on Article 11.

§101 Unsafe consumer products

In addition to the provisions of the Machinery Directive and the Regulation setting out the requirements for accreditation and market surveillance relating to the marketing of products, certain specific provisions of the General Product Safety Directive apply with respect to machinery intended for or likely to be used by consumers, where the Machinery Directive or the Regulation do not include equivalent provisions.96 In particular the following provisions are applicable:

− the obligation for distributors to exercise due care and cooperate with the market surveillance authorities97;

− the obligation for producers and distributors to inform the authorities about unsafe products and to cooperate with the authorities in order to prevent risks to consumers98;

− certain measures that can be taken by the market surveillance authorities with respect to unsafe products99.

§102 Controls at the external borders of the EU

In many cases, in particular for mass-produced products imported into the EU from third countries, the most effective way to carry out market surveillance is to check the

94 See Article 19 (2) of Regulation (EC) No 765/2008.

95 See Article 22 (4) of Regulation (EC) No 765/2008.

96 See Article 1 (2) (b) of Directive 2001/95/EC and Article 15 (3) of Regulation (EC) No 765/2008.

97 See Article 5 (2) of Directive 2001/95/EC.

98 See Article 5 (3) of Directive 2001/95/EC.

99 See Article 8 of Directive 2001/95/EC.

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conformity of such products at the point of entry into the EU market, before they are dispersed throughout the distribution networks of the Member States.

Articles 27 to 29 of Regulation (EC) No 765/2008 which, for this aspect, repeals and replaces Regulation (EEC) No 339/93, provide the legal framework for such controls. These provisions are fully applicable for imported machinery.

Member States must provide the authorities in charge of the control of products entering the EU market (usually, the Customs authorities) with the necessary powers and resources to enable them to carry out, on an adequate scale, appropriate checks on the characteristics of machinery before it is released for free circulation100.

The necessary cooperation and exchange of information must be organised between these authorities and the authority or authorities in charge of market surveillance for machinery101. In particular, market surveillance authorities shall provide authorities in charge of external border controls with information on product categories in which a serious risk or non-compliance has been identified102.

The authorities in charge of the external border controls shall suspend release of machinery for free circulation within the EU in the following cases:

− if complete machinery does not bear the CE marking and the other markings required by the Machinery Directive or has been affixed with the CE marking in a false or misleading manner, or is not accompanied by the EC Declaration of Conformity signed by the manufacturer or his authorised representative;

− if there is cause to believe that the machinery presents a serious risk to health and safety103.

The authorities in charge of the external border controls shall suspend release of partly completed machinery for free circulation within the EU in the following cases:

− if the partly completed machinery is not accompanied by a Declaration of Incorporation – see §384: comments on Annex II 1 B;

− if the partly completed machinery is not accompanied by assembly instructions – see §390: comments on Annex VI.

The market surveillance authorities must be immediately informed of any such suspension. They must release the product for free circulation within 3 days unless action has been initiated by the market surveillance authorities. This does not mean the product has to be investigated or tested within these 3 days, but the market surveillance authority has to decide, in this period, if they want to carry out such testing or examination and to inform the border control authority so the product is not released for free circulation. Normally, the market surveillance authority will visit to see the product in the 3-day period to make an initial assessment, but with access to modern communication tools between the authorities, a visit may not always be necessary.

100 See Article 27 (1) of Regulation (EC) No 765/2008.

101 See Article 27 (2) of Regulation (EC) No 765/2008.

102 See Article 29 (5) of Regulation (EC) No 765/2008.

103 See Article 27 (3) of Regulation (EC) No 765/2008.

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The Regulation sets out the procedures to be followed if the machinery has not been subject to the appropriate conformity assessment procedure, if it fails to comply with the applicable essential health and safety requirements, or if the machinery presents a serious risk104.

Article 5

Placing on the market and putting into service

1. Before placing machinery on the market and/or putting it into service, the manufacturer or his authorised representative shall:

(a) ensure that it satisfies the relevant essential health and safety requirements set out in Annex I;

(b) ensure that the technical file referred to in Annex VII, part A is available;

(c) provide, in particular, the necessary information, such as instructions;

(d) carry out the appropriate procedures for assessing conformity in accordance with Article 12;

(e) draw up the EC declaration of conformity in accordance with Annex II, part 1, Section A and ensure that it accompanies the machinery;

(f) affix the CE marking in accordance with Article 16.

. . .

§103 The obligations of machinery manufacturers

Article 5 (1) provides a summary of the obligations to be fulfilled by manufacturers of machinery before placing their products on the market or putting them into service – see § 78 to § 81: comments on Article 2 (i).

It should be noted that the term ‘machinery’ is used here in the broad sense. These obligations thus apply to manufacturers of machinery referred to in Article 1 (1) (a) to (f): machinery in the strict sense, interchangeable equipment, safety components, lifting accessories, chains, ropes and webbing and removable mechanical transmission devices – see §33: comments on the first paragraph of Article 2.

All or part of the obligations summarised in Article 5 (1) (a) to (f) can also be fulfilled by the manufacturer’s authorised representative – see §84 and §85: comments on Article 2 (j).

In most cases, these obligations must be fulfilled before the machinery is placed on the market in the EU – see §73: comments on Article 2 (h). However, for machinery that is not placed on the market such as, for example machinery manufactured or imported into the EU by a user for his own use, the obligations must be fulfilled before the machinery is put into service – see §80 and §81: comments on Article 2 (i).

Article 5 (1) (c) requires the manufacturer to provide the necessary information and instructions with the machinery. In this regard, it should be noted that providing the necessary information on the machinery and drafting the instructions is considered

104 See Articles 28 and 29 of Regulation (EC) No 765/2008.

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as part of the design and construction of the machinery and is subject to specific essential health and safety requirements – see §244: comments on section 1.7 of Annex I.

Article 5 (continued)

. . .

2. Before placing partly completed machinery on the market, the manufacturer or his authorised representative shall ensure that the procedure referred to in Article 13 has been completed.

. . .

§104 The obligations of manufacturers of partly completed machinery

Article 5 (2) refers to the obligations of manufacturers of partly completed machinery as defined in Article 2 – see §46: comments on Article 2 (g). The obligations of manufacturers of partly completed machinery are summarised in Article 13 – see §131: comments on Article 13.

Article 5 (continued)

. . .

3. For the purposes of the procedures referred to in Article 12, the manufacturer or his authorised representative shall have, or shall have access to, the necessary means of ensuring that the machinery satisfies the essential health and safety requirements set out in Annex I.

. . .

§105 Means of ensuring the conformity of machinery

Article 5 (3) refers to the obligation referred to in Article 5 (1) (d) to carry out the appropriate conformity assessment procedure according to Article 12.

In the case of machinery subject to the procedure for assessment of conformity with internal checks on the manufacture described in Annex VIII, the necessary verifications may be carried out by or on behalf of the manufacturer or his authorised representative. Whether the conformity assessment of the machinery is carried out by the manufacturer himself or entrusted to his authorised representative, the person carrying out the conformity assessment must have, or have access to the necessary means to verify the conformity of the machinery with the applicable health and safety requirements. The means may include, for example, access to the necessary qualified personnel who have knowledge of both the Machinery Directive and relevant standards, access to the necessary information, the competency and the equipment needed to carry out the necessary design checks, calculations, measurements, functional tests, strength tests, visual inspections and checks on information and instructions to ensure the conformity of the machinery with the relevant essential health and safety requirements.

When machinery is designed and constructed according to harmonised standards, the standards normally specify the means to be used to verify the conformity of the

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machinery with their specifications105. Access to the relevant standards is required in this case.

In the case of machinery belonging to one of the categories listed in Annex IV for which the full quality assurance procedure described in Annex X is used, the means to carry out the necessary verifications must be documented in the manufacturer’s full quality assurance system – see §403: comments on paragraph 2.2 of Annex X.

Article 5 (continued)

. . .

4. Where machinery is also the subject of other Directives relating to other aspects and providing for the affixing of the CE marking, the marking shall indicate that the machinery also conforms to the provisions of those other Directives.

However, where one or more of those Directives allow the manufacturer or his authorised representative to choose, during a transitional period, the system to be applied, the CE marking shall indicate conformity only to the provisions of those Directives applied by the manufacturer or his authorised representative. Particulars of the Directives applied, as published in the Official Journal of the European Union, shall be given on the EC declaration of conformity.

§106 CE marking according to other EU legislation

Article 5 (4) concerns the obligation referred to in Article 5 (1) (f): the affixing of the CE marking. Article 5 (4) is a reminder that other EU legislation (Regulations or Directives) providing for the affixing of the CE marking may be applicable to machinery or partly completed machinery (note that although under the Machinery Directive a CE mark must not be placed on partly completed machinery, it may carry a CE mark due to other relevant EU legislation applying such as ATEX – see §251: comments on Annex I 1.7.3 – 3rd paragraph). In that case, the manufacturer must ensure that he has fulfilled his obligations according to all of the EU legislation applicable to his product before affixing the CE marking – see §89 to §92: comments on Article 3.

Besides the CE marking of machinery as proof of their compliance with the relevant EU Directives and Regulations requiring CE-marking, other mandatory affixing and marking may be required by EU legislation106.

105 See clause 6.8 “Verification of the safety requirements and/or protective/risk reduction measures” of CEN Guide 414:2004 Safety of machinery – Rules for the drafting and presentation of safety standards.

106 See the Blue Guide on the implementation of EU products rules 2016, sections 4.5.1.7. and 4.5.2.

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Article 6

Freedom of movement

1. Member States shall not prohibit, restrict or impede the placing on the market and/or putting into service in their territory of machinery which complies with this Directive.

2. Member States shall not prohibit, restrict or impede the placing on the market of partly completed machinery where the manufacturer or his authorised representative makes a declaration of incorporation, referred to in Annex II, part 1, Section B, stating that it is to be incorporated into machinery or assembled with other partly completed machinery to form machinery.

. . .

§107 Free movement of machinery and partly completed machinery

Article 6 (1) and (2) set out obligations intended to fulfil one of the fundamental objectives of the Machinery Directive: the free movement of machinery and partly completed machinery within the single market.

In Article 6 (1), the term ‘machinery’ is used in the broad sense to designate all of the products referred to in Article 1 (1) (a) to (f) – see §33: comments on the first paragraph of Article 2.

According to the obligations set out in Article 6, the Member States may not impose any requirements or procedures for the placing on the market of machinery or partly completed machinery or the putting into service of machinery, for the hazards covered by the Machinery Directive, other than those set out in that Directive.

The obligation to allow free movement of machinery and partly completed machinery that complies with the Directive does not prevent Member States from regulating the installation and use of machinery within certain limits – see §139 and §140: comments on Article 15.

By virtue of the Agreement on the European Economic Area (EEA)107, machinery and partly completed machinery that complies with the Machinery Directive also benefits from free movement in Iceland, Liechtenstein and Norway. The same is true in Switzerland by virtue of the Mutual Recognition Agreement (MRA) with the EU108, and in Turkey, Andorra and San Marino by virtue of the Customs Union Agreements between the EU and these countries109.

107 http://www.efta.int/legal-texts/eea.

108 http://ec.europa.eu/growth/single-market/goods/international-aspects/mutual-recognition-agreements/.

109 http://ec.europa.eu/taxation_customs/customs/customs_duties/rules_origin/customs_unions/.

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Article 6 (continued)

3. At trade fairs, exhibitions, demonstrations, and such like, Member States shall not prevent the showing of machinery or partly completed machinery which does not conform to this Directive, provided that a visible sign clearly indicates that it does not conform and that it will not be made available until it has been brought into conformity. Furthermore, during demonstrations of such non-conforming machinery or partly completed machinery, adequate safety measures shall be taken to ensure the protection of persons.

§108 Trade fairs, exhibitions and demonstrations

Trade fairs, exhibitions and demonstrations provide an opportunity for machinery manufacturers, importers and distributors to promote new and innovative products. The provisions of Article 6 (3) are intended to ensure that the Machinery Directive does not constitute an obstacle to the promotion of such products – see §19: comments on Recital 17. In some cases, the companies concerned may wish to see whether their products interest potential customers before carrying out the relevant conformity assessment procedure. In other cases, the procedure may not have been completed at the time the machinery is put on display. Manufacturers, importers or distributors may also wish to exhibit products that are not intended for the EU market. Products may also be displayed with certain guards or protective devices removed in order to show their operating characteristics more clearly.

According to Article 6 (3), such practices are authorised. However, in order to provide clear information to potential customers and avoid unfair competition with exhibitors of products that are in conformity with the Machinery Directive, products that are not in conformity with the provisions of the Directive must be accompanied by a visible sign. This must clearly indicate that they are not in conformity and will not be available for supply into the EU until they have been brought into conformity. It is helpful for the organisers of Trade Fairs to remind exhibitors of their obligation in this respect.

The Machinery Directive does not specify a particular format or wording for this sign. The following wording can be suggested for machinery that the manufacturer intends to bring into conformity and place on the market in the EU:

The machinery displayed is not in conformity with the Machinery Directive 2006/42/EC.

Visitors are informed that the machinery will be made available in the European Union only once it has been brought into conformity.

The necessary precautions must be taken during exhibitions and demonstrations in order to ensure the safety of the demonstrators and the public, particularly if products are shown with guards or protective devices removed. With respect to the health and safety of demonstrators or other employees of the exhibitors, the necessary measures must be taken in accordance with the national provisions implementing the relevant EU Directives on the protection of the health and safety of workers.

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Article 7

Presumption of conformity and harmonised standards

1. Member States shall regard machinery bearing the CE marking and accompanied by the EC declaration of conformity, the content of which is set out in Annex II, part 1, Section A, as complying with the provisions of this Directive.

. . .

§109 Presumption of conformity conferred by the CE marking and the EC Declaration of Conformity

Article 7 (1) explains the role of the CE marking and the EC Declaration of Conformity as “passports” facilitating the free movement of machinery in the single market referred to in Article 6 (1).

The EC Declaration of Conformity must accompany the machinery. This implies that the EC Declaration of Conformity must be supplied with the machinery by the manufacturer when the machinery is placed on the market and it must be passed on by other economic operators, such as importers or distributors, to the user of the machinery – see §83: comments on Article 2 (i).

It should be underlined that the obligation set out in Article 7 (1) for the Member States to regard machinery bearing the CE-marking and accompanied by an EC Declaration of Conformity as complying with the Machinery Directive does not affect the duty of the Member States to carry out market surveillance to ensure that products bearing the CE-marking and accompanied by an EC Declaration of Conformity really comply with the requirements of the Machinery Directive and their duty to ensure that non-compliant products bearing the CE-marking are withdrawn from the market – see §93 and §94: comments on Articles 4 (1), §122 to §126: comments on Article 11, and §142: comments on Article 17.

Article 7 (continued)

. . .

2. Machinery manufactured in conformity with a harmonised standard, the references to which have been published in the Official Journal of the European Union, shall be presumed to comply with the essential health and safety requirements covered by such a harmonised standard.

. . .

§110 The presumption of conformity conferred by the application of harmonised standards

The reference to European standards is a key element of the “New Approach to technical harmonization and standards” that is followed in the Machinery Directive. The Directive sets out the mandatory essential health and safety requirements for machinery while detailed technical specifications for fulfilling these essential health and safety requirements are given in European harmonised standards – see §87: comments on Article 2 (l).

Once a European harmonised standard has been adopted, the European standardisation organisation communicates it to the European Commission so that

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the references of the standard can be published in the Official Journal of the European Union (OJEU).

Once the reference of a harmonised standard has been published in the OJEU, application of its specifications confers a presumption of conformity with the essential health and safety requirements covered by the standard. This presumption of conformity exists from the date on which the reference of the standard is first published in the OJEU. The presumption of conformity ceases when the standard is replaced by a new or revised standard on the “date of cessation of presumption of conformity” that is specified in the OJEU for machinery placed on the market after that date – see §114: comments on Article 7 (3).

It is important to understand that the presumption of conformity only extends to the essential health and safety requirements covered by the harmonised standard. Annex Z (in CEN standards) will indicate which essential health and safety requirements are covered. The manufacturer will need to carry out a risk assessment and compliance procedure for the risk areas associated to the relevant essential health and safety requirements. For Annex IV machinery (broad sense) the harmonised standards approach cannot be used if the standard does not cover all relevant essential health and safety requirements of the Directive.

It should be noted that, following formal objection, the references of certain standards may be published in the OJEU with a warning withdrawing the presumption of conformity for certain parts of the standard – see §121: comments on Article 10.

Application of draft European standards (identified by the prefix “prEN”) or European standards the references of which have not been published in the OJEU does not confer a presumption of conformity with the essential health and safety requirements of the Machinery Directive.

Information about the subject of the standard (the category of machinery or the aspect of machinery safety covered by the standard) can be found in the clause of the standard relating to its scope. Additional information on the essential health and safety requirements of the Machinery Directive dealt with (or not dealt with) by the standard is provided in an informative Annex “Z” to the standard, which indicates as well the supported legislation and the relevant standardisation request.

Where a standard or part of a standard is referred to by a normative reference in a European harmonised standard, the specifications of the standard or parts of the standard referred to become part of the harmonised standard and their application confers a presumption of conformity with the essential health and safety requirements they cover. This remains true, even if the standard referred to is no longer in force (unless its reference has been withdrawn from the OJEU following a formal objection – see §121: comments on Article 10). On the other hand, application of the latest version of the standard referred to also confers a presumption of conformity with the essential health and safety requirements concerned, provided its reference has been published in the OJEU.

The presumption of conformity conferred by the application of a harmonised standard is not absolute, since the conformity of the standard itself can be challenged – see §119 to §121: comments on Article 10. However, the presumption of conformity conferred by the application of a harmonised standard gives a certain legal certainty for the manufacturer, since he does not have to provide further proof of conformity with the essential health and safety requirements covered by the standard.

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Furthermore, in the case of categories of machinery listed in Annex IV, application of a harmonised standard that covers all the essential health and safety requirements that are applicable to the machinery enables the manufacturer to carry out the conformity assessment of the machinery without recourse to a Notified Body – see §129: comments on Article 12 (3).

It should be noted that, although the application of harmonised standards facilitates the risk assessment, it does not entirely dispense the machinery manufacturer from the obligation to carry out a risk assessment for the machinery – see §159: comments on General Principle 1 of Annex I.

Even when a given essential health and safety requirement is covered by a harmonised standard, a machinery manufacturer remains free to apply alternative specifications. The voluntary nature of harmonised standards is intended to prevent technical standards being an obstacle to the placing on the market of machinery incorporating innovative solutions.

However, a harmonised standard provides an indication of the state of the art at the time it was adopted. In other words, the harmonised standard indicates the level of safety which can be expected of a given type of product at that time. A machinery manufacturer who chooses to apply other technical specifications must be able to demonstrate that his alternative solution is in conformity with the EHSRs of the Machinery Directive and provides a level of safety that is at least equivalent to that afforded by application of the specifications of the harmonised standard – see §161 and §162: comments on General Principle 3 of Annex I.

When a manufacturer chooses not to apply harmonised standards or to apply only parts of a harmonised standard, he must include in the technical file the risk assessment undertaken and the steps taken to comply with the essential health and safety requirements – see §392: comments on Annex VII A 1 (a). In such a case, the reference of the harmonised standard should not be listed as such in the manufacturer’s EC Declaration of Conformity, but the Declaration may indicate which parts or clauses of a harmonised standard have been applied – see §383: comments on Annex II A 1 (7).

§111 The classification of machinery standards

Machinery standards are classified into three types, A, B and C. The purpose of this classification is to enable the authors of standards for particular categories of machinery to refer to horizontal standards providing well tried technical solutions. The horizontal A and B-type standards can also help manufacturers designing machinery for which C-type standards are not available.

The nature of the presumption of conformity conferred by application of the harmonised standards of these three types must be distinguished:

A-type standards

A-type standards specify basic concepts, terminology and design principles applicable to all categories of machinery. Application of such standards alone, although providing an essential framework for the correct application of the Machinery Directive, is not sufficient to ensure conformity with the relevant essential health and safety requirements of the Directive and therefore does not give a presumption of conformity.

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For example, the application of standard EN ISO 12100110 ensures that the risk assessment is carried out according to the requirements of General Principle 1 of Annex I, but it is not sufficient to show that the protective measures taken by the manufacture to deal with the hazards presented by the machinery comply with the relevant essential health and safety requirements of Annex I.

B-type standards

B-type standards deal with specific aspects of machinery safety or specific types of safeguard that can be used across a wide range of categories of machinery. Application of the specifications of B-type standards confers a presumption of conformity with the essential requirements of the Machinery Directive that they cover when a C-type standard or the manufacturer’s risk assessment shows that a technical solution specified by the B-type standard is adequate for the particular category or model of machinery concerned.

Application of B-type standards that give specifications for safety components that are independently placed on the market confers a presumption of conformity for the safety components concerned and for the EHSRs covered by the standards – see §42, comments on Article 2 (c).

C-type standards

C-type standards provide specifications for a given category of machinery such as, for example, mechanical presses, combine harvesters or compressors. The different types of machinery belonging to the category covered by a C-standard have a similar intended use and present similar hazards. C-type standards may refer to A or B-type standards, indicating which of the specifications of the A or B-type standard are applicable to the category of machinery concerned. When, for a given aspect of machinery safety, a C-type standard deviates from the specifications of an A or B-type standard, the specifications of the C-type standard take precedence over the specifications of the A or B-type standard.

Application of the specifications of a C-type standard confers a presumption of conformity with the essential health and safety requirements of the Machinery Directive covered by the standard provided that the manufacturer has determined in his risk assessment that the scope and the significant hazards covered by the standard correspond with his actual machinery111.

Certain C-type standards are organised as a series of several parts, Part 1 of the standard giving general specifications applicable to a family of machinery and other parts of the standard giving specifications for specific categories of machinery belonging to the family, supplementing or modifying the general specifications of Part 1. For C-type standards organised in this way, the presumption of conformity with the essential requirements of the Machinery Directive is conferred by application of the general Part 1 of the standard together with the relevant specific part of the standard.

110 EN ISO 12100:2010 Safety of machinery – General principles for design – Risk assessment and risk reduction (ISO 12100-1:2010).

111 Further practical guidance is provided by CEN ISO/TR 22100-1:2017 Safety of machinery – Relationship with ISO 12100 – Part 1: How ISO 12100 relates to type-B and type-C standards (ISO/TR 22100-1:2015)

§112 The development of harmonised standards for machinery

Harmonised standards for machinery are developed by the Technical Committees (TCs) of the European Standardisation Organisations, CEN and CENELEC. The TCs are constituted by representatives mandated by the national member organisations of CEN and CENELEC. The TCs involved in developing standards supporting the Machinery Directive include the following:

CEN

TC 10

Lifts, escalators and moving walks

TC 33

Doors, windows, shutters

TC 47

Atomising oil burners and their components – Function – Safety – Testing

TC 98

Lifting platforms

TC 114

Safety of machinery

TC 122

Ergonomics

TC 123

Lasers and photonics

TC 131

Gas burners using fans

TC 142

Woodworking machines – Safety

TC 143

Machine tools – Safety

TC 144

Tractors and machinery for agriculture and forestry

TC 145

Plastics and rubber machines

TC 146

Packaging machines – Safety

TC 147

Cranes – Safety

TC 148

Continuous handling equipment and systems – Safety

TC 149

Power-operated warehouse equipment

TC 150

Industrial trucks – safety

TC 151

Construction equipment and building material machinery – Safety

TC 153

Machinery intended for use with foodstuffs and feed

TC 168

Chains, ropes, webbing, slings and accessories – Safety

TC 169

Light and lighting

TC 182

Refrigerating systems, safety and environmental requirements

TC 186

Industrial thermo processing – Safety

TC 188

Conveyor belts

TC 192

Fire and Rescue service equipment

TC 196

Machines for underground mines – Safety

TC 197

Pumps

TC 198

Printing and paper machinery – Safety

TC 200

Tannery machines and plants – Safety

TC 202

Foundry machinery

TC 211

Acoustics

TC 213

Cartridge operated hand-held tools – Safety

TC 214

Textile machinery and accessories

TC 221

Shop fabricated metallic tanks and equipment for storage tanks and for service stations

TC 231

Mechanical vibration and shock

TC 232

Compressors, vacuum pumps and their systems

TC 255

Hand-held, non-electric power tools – Safety

TC 256

Railway applications

TC 270

Internal combustion engines

TC 271

Surface treatment equipment – Safety

TC 274

Aircraft ground support equipment

TC 310

Advanced manufacturing technologies and their applications

TC 313

Centrifuges – Safety requirements

TC 322

Equipments for making and shaping of metals – Safety requirements

TC 354

Non-type approved light motorized vehicles for the transportation of persons and goods and related facilities

TC 397

Project Committee – Baling presses – Safety requirements

TC 429

Project Committee – Food hygiene – Commercial warewashing machines – Hygiene requirements and testing

TC 433

Entertainment Technology – Machinery, equipment and installations

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CENELEC

TC 44X

Safety of machinery – electro technical aspects

TC 61

Safety of household and similar electrical appliances

TC 116

Safety of hand-held and transportable motor-operated electric tools

TC 88

Wind turbine systems

Draft standards are prepared by Working Groups (WGs) set up by the relevant TC. The WGs are made up of experts nominated by the national standardisation organisations. The draft standard (prEN) prepared by the WG is sent by the TC to the national standardisation organisations who circulate the draft to interested parties at national level for comments (public enquiry). Public enquiry is combined with a majority weighted vote of national standardisation organisations. The comments received are sent back to the TC and examined by the WG in order to improve the draft if relevant Depending on the outcome of the vote and upon TC decision it is possible to publish the standard straight after the enquiry. In case there are technical changes to be made to the draft standard after enquiry, a separate weighted majority vote by the national standardisation organisations is needed for adoption.

Many European harmonised standards are now developed within the framework of the agreements relating to cooperation between CEN and the International Standardisation Organisation (ISO) or between CENELEC and the International Electrotechnical Commission (IEC). The agreement between CEN and ISO is known as the Vienna Agreement. The agreement between CENELEC and IEC is known as the Frankfurt Agreement (former Dresden Agreement). When these agreements are applied, the draft standards may be prepared by the TCs and WGs of ISO or IEC. However, before being adopted as European harmonised standards, they are subject to the enquiry and adoption procedures of CEN or CENELEC, which are normally carried out in parallel with the ISO or IEC procedures.

The reference material on the technical cooperation between CEN and ISO as well as CENELEC and IEC is available on CEN and CENELEC website.

§113 The identification of harmonised standards

Draft European standards are identified by a reference number preceded by the prefix “prEN”, followed by the date of the draft. Such draft European standards are made publicly available at the Public Enquiry stage.

Once the standard has been adopted by CEN or CENELEC, it is identified by the same number preceded by the prefix “EN”, and followed by the date (year) of adoption. When a standard is amended or revised and the new version bears the same number, the date of adoption makes it possible to distinguish the new version of the standard from the previous version.

When a CEN standard is identical to an international standard adopted by ISO, the European and International standards have the same number and the reference of the harmonised standard has the prefix “EN ISO”. A CENELEC standard identical or based on an IEC standard has also an identical EN number. However, for both European Standardisation Organisations, the reference of the corresponding ISO or IEC standard is indicated in brackets after the title of the European standard.

The national member organisations of CEN and CENELEC must give the harmonised standard the status of a national standard without any alteration. In the

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reference of the national version of a harmonised standard, the prefix “EN” is preceded by the prefix used to identify national standards in the country concerned. Harmonised standards are published by the national standardisation organisations of the EU Member States with the following prefixes:

“ÖNORM EN” in Austria

“NBN EN” in Belgium

“БДС EN” in Bulgaria

“HRN EN” in Croatia

“CYS EN” in Cyprus

“ČSN EN” in the Czech Republic

“DS EN” in Denmark

“EVS EN” in Estonia

“SFS EN” in Finland

“NF EN” in France

“DIN EN” in Germany

“EN” in Greece

“MSZ EN” in Hungary

“IS EN” in Ireland

“UNI EN” in Italy

“LVS EN” in Latvia

“LST EN” in Lithuania

“EN” in Luxembourg

“MSA EN” in Malta

“NEN EN” in the Netherlands

“PN EN” in Poland

“NP EN” in Portugal

“SR EN” in Romania

“STN EN” in Slovakia

“SIST EN” in Slovenia

“UNE EN” in Spain

“SS EN” in Sweden

“BS EN” in the United Kingdom

The same standards are published with the following prefixes in EFTA countries:

“IST EN” in Iceland

“NS EN” in Norway

“SN EN” in Switzerland

In some cases, the date included in the reference of the national version of the harmonised standard is later than the date included in the reference of the standard published in the OJEU, due to the fact that the publication of the standard at national level may have occurred in the following year.

In the EC Declaration of Conformity of machinery, the European harmonised standards applied by the manufacturer may be identified using either the national reference, with one of the national prefixes listed above, or the reference as listed the in OJEU with the prefix “EN” only – see §383: comments on Annex II 1 A (7).

Article 7 (continued)

. . .

3. The Commission shall publish in the Official Journal of the European Union the references of the harmonised standards.

. . .

§114 Publication of the references of harmonised standards in the OJEU

Consolidated lists of harmonised standards are published in the C-series of the OJEU in the form of a Commission communication in the framework of the implementation of the Machinery Directive. The list is regularly updated when the references of new or revised standards are communicated to the European Commission by CEN and CENELEC.

CEN and CENELEC communicate the references several times a year, usually quarterly.

The list published in the OJEU includes the following 5 columns:

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Column 1 indicates the European standardisation organisation that has adopted the standard: CEN or CENELEC;

Column 2 indicates the reference of the standard, that is to say, its number, the date of its adoption by CEN or CENLEC and its title;

If the standard has been amended, the reference of the amended version of the standard is indicated. Once the references of such amended standards have been published in the OJEU, the amended version of the standard confers presumption of conformity with the relevant essential health and safety requirements of the Machinery Directive;

Column 3 indicates the date on which the reference of the standard was first published in the OJEU. This is the date from which application of the standard confers a presumption of conformity with the essential health and safety requirement it covers;

Column 4 gives the references of the superseded standard. This column is only used if there was already a harmonised standard dealing with the same subject when the new or revised standard was adopted. In most cases, the superseded standard is an earlier version of a standard that has been revised;

Column 5 indicates the date of cessation of presumption of conformity of the superseded standard. This column is only used when the reference of a superseded standard is given in the fourth column. The date of cessation of presumption of conformity is fixed by the Commission. In general, the date of cessation of presumption of conformity is the same as the date fixed by CEN or CENELEC for the withdrawal of the superseded standard by the national standardisation organisations.

The new standard confers a presumption of conformity as from the date on which its reference is published in the OJEU, while the superseded standard continues to confer a presumption of conformity until the date of cessation of presumption of conformity indicated in the fifth column. During the period between the two dates (the transition period) the specifications of either the new standard or the superseded standard confer a presumption of conformity with the essential health and safety requirements they cover.

Under the line listing of a particular standard it may be added a “warning” that either limits the presumption of conformity in some way, such as not applying it to certain sections of the standard, or pointing out that the standard does not address certain essential health and safety requirements in an appropriate manner. Such warnings have followed a formal objection. In cases of more fundamental concerns raised in a formal objection then the whole reference in the OJEU may be removed and with it the presumption of conformity.

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Article 7 (continued)

. . .

4. Member States shall take the appropriate measures to enable the social partners to have an influence at national level on the process of preparing and monitoring the harmonised standards.

§115 Participation of the social partners in standardisation

Standardisation is based on a consensus between the interested parties. The parties interested in machinery standards include, for example, machinery manufacturers, users of machinery such as employers, workers and consumers, occupational health and safety institutions, Notified Bodies, other relevant NGOs and public authorities. Rules for the participation of the interested parties are usually subject to national provisions relating to the organisation of standardisation; for example, a fee may be charged to participate depending on the individual national standardisation organisation.

Article 7 (4) sets out a specific requirement for Member States to ensure that appropriate measures are taken to enable the social partners, that is to say the representatives of employers and employees, to have an influence on the standardisation process at national level. It is up to Member States to decide what measures are appropriate and how they are put into effect.

However, societal stakeholders as defined in Annex III to the Regulation (EU) 1025/2012 and SMEs, can also participate at European level directly with the European Standardisation Organisations (Articles 5 and 6 of Regulation (EU) 1025/2012).

Article 8 112

Specific measures

1. The Commission may take any appropriate measure relating to the following:

(a) updating of the indicative list of safety components in Annex V referred to in Article 2 (c);

(b) restricting the placing on the market of machinery referred to in Article 9.

Those measures, designed to amend non-essential elements of this Directive by supplementing it, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 22 (3).

. . .

112 Article 8 was amended by Regulation (EC) No 596/2009 of the European Parliament and of the Council of 18 June 2009 adapting a number of instruments subject to the procedure referred to in Article 251 of the Treaty to Council Decision 1999/468/EC with regard to the regulatory procedure with scrutiny (PRAC) – Adaptation to the regulatory procedure with scrutiny – Part Four. OJ L 188, 18.7.2009, p.14.

§116 Measures subject to the Regulatory Committee Procedure

Article 8 (1) sets out the two cases in which the Commission can adopt measures after consulting the Machinery Committee according to the Regulatory procedure with scrutiny – see §147: comments on Article 22 (3).

− Article 8 (1) (a) enables the Commission to update the indicative list of safety components set out in Annex V, for example, by adding to the list further examples of components that correspond to the definition given in Article 2 – see §42: comments on Article 2 (c). This may be done if it appears that certain existing safety components have been omitted from the list or if new safety components are developed.

− Article 8 (1) (b) enables the Commission to adopt a measure restricting the placing on the market of machinery presenting risks due to the shortcomings of a harmonised standard, presenting the same risk as machinery subject to a justified safeguard action or at the request of a Member State – see §118: comments on Article 9.

Article 8 (continued)

. . .

2. The Commission, acting in accordance with the procedure referred to in Article 22(2), may take any appropriate measure connected with the practical application of this Directive, including measures necessary to ensure cooperation of Member States with each other and with the Commission, as provided for in Article 19(1).

§117 Measures subject to the Advisory Committee procedure

Article 8 (2) enables the Commission to take any appropriate measure connected with the practical application of the Machinery Directive after consulting the Machinery Committee according to the Advisory procedure – see §147: comments on Article 22 (2). It also provides a legal basis for Commission support for the organisation of administrative cooperation (AdCo) between the market surveillance authorities of the Member States. This has now been implemented and support such as interpretation and funding for travel and accommodation for the official representative of a member states is now given by the Commission – see §144: comments on Article 19 (1).

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Article 9113

Specific measures to deal with potentially hazardous machinery

1. When, in accordance with the procedure referred to in Article 10, the Commission considers that a harmonised standard does not entirely satisfy the essential health and safety requirements which it covers and which are set out in Annex I, the Commission may, in accordance with paragraph 3 of this Article, take measures requiring Member States to prohibit or restrict the placing on the market of machinery with technical characteristics presenting risks due to the shortcomings in the standard or to make such machinery subject to special conditions.

When, in accordance with the procedure referred to in Article 11, the Commission considers that a measure taken by a Member State is justified, the Commission may, in accordance with paragraph 3 of this Article, take measures requiring Member States to prohibit or restrict the placing on the market of machinery presenting the same risk by virtue of its technical characteristics or to make such machinery subject to special conditions.

2. Any Member State may request the Commission to examine the need for the adoption of the measures referred to in paragraph 1.

3. In the cases referred to in paragraph 1, the Commission shall consult the Member States and other interested parties, indicating the measures it intends to take in order to ensure, at Community level, a high level of protection of the health and safety of persons.114

Taking due account of the results of this consultation, it shall adopt the necessary measures.

Those measures, designed to amend non-essential elements of this Directive by supplementing it, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 22(3).

§ 118 Measures to deal with unsafe machinery presenting similar risks

The safeguard clause set out in Article 11 requiring the Member States to take appropriate measures to deal with unsafe machinery bearing the CE marking, applies to particular models of machinery. Article 9 enables the Commission to adopt measures to prohibit or restrict the placing on the market all models of machinery presenting risks due to the same technical characteristics. This article was amended by Directive 2009/127/EC which expanded the application from just persons to add “where appropriate, of domestic animals and property and, where applicable, of the environment”. The meaning of “where applicable, of the environment” restricts the

113 Article 9 (3) was amended by Regulation (EC) No 596/2009 of the European Parliament and of the Council of 18 June 2009 adapting a number of instruments subject to the procedure referred to in Article 251 of the Treaty to Council Decision 1999/468/EC with regard to the regulatory procedure with scrutiny (PRAC) – Adaptation to the regulatory procedure with scrutiny – Part Four. OJ L 188, 18.7.2009, p.14.

114 Article 9 (3) 2nd indent was amended by Directive 2009/127/EC of the European Parliament and of the Council of 21 October 2009 amending Directive 2006/42/EC with regard to machinery for pesticide application. OJ L 310, 25.11.2009, p. 29.

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application of this article to the potential or actual effect on the environment to that caused by “pesticides application machinery” and does not increase the scope in this respect to any other type of machinery.

Such measures can be adopted in the following circumstances:

Following a formal objection to a harmonised standard according to Article 10

The first circumstance is linked to the procedure set out in Article 10 for disputing a harmonised standard. When a formal objection is made against a harmonised standard, the Commission may adopt a decision withdrawing or restricting the presumption of conformity conferred by application of the standard on the grounds that certain of its specifications fail to satisfy the relevant essential health and safety requirements – see §121: comments on Article 10. Following such a decision, it may be considered necessary, in order to protect the health and safety of persons, to ensure that machinery designed according to the defective standard is withdrawn from the market or subject to certain restrictions.

Following a safeguard action according to Article 11

The second circumstance is linked to the safeguard clause procedure set out in Article 11. Following the notification of a measure taken by a Member State to prohibit or restrict the placing on the market of a particular model of unsafe machinery, the Commission adopts a decision stating whether or not it considers the measure to be justified – see §123: comments on Article 11 (3). Following such a decision, the Commission may adopt a Decision requiring all Member States to take the appropriate measures, in order to protect the health and safety of persons, to ensure that any other machinery having the same defect as the model subject to the original national measure should be withdrawn from the market or subject to certain restrictions i.e. similar to the action taken in the MS instigating the safeguard action.

At the request of the Member State

Article 9 (2) gives the Member States the possibility to initiate the process by requesting the Commission to examine the need for measures to prohibit or restrict the placing on the market of machinery presenting the same risk by virtue of its technical characteristics or to make such machinery subject to special conditions.

Before taking such measures, the Commission shall consult the interested parties. Since, the measures do not just concern a single manufacturer but may have consequences for all of the manufacturers of a given category of machinery, it is clear that organisations representing machinery manufacturers at EU level must be consulted. In general, the consultation of the interested parties is organised in the framework of the Machinery Working Group – see §148: comments on Article 22. The measure is then adopted after consultation of the Machinery Committee according to the Regulatory procedure with scrutiny – see §147: comments on Article 22 (3).

This system has been used, for example, to require Member States to prohibit the placing on the market of flail-type cutting attachments for portable hand-held brush cutters115.

115 Commission Decision of 19 January 2012 requiring Member States to prohibit the placing on the market of flail-type cutting attachments for portable hand-held brush cutters. OJ L 18, 21.1.2012, p. 5.

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Article 10

Procedure for disputing a harmonised standard

Where a Member State or the Commission considers that a harmonised standard does not entirely satisfy the essential health and safety requirements which it covers and which are set out in Annex I, the Commission or the Member State shall bring the matter before the committee set up by Directive 98/34/EC, setting out the reasons therefor. The committee shall deliver an opinion without delay. In the light of the committee’s opinion, the Commission shall decide to publish, not to publish, to publish with restriction, to maintain, to maintain with restriction or to withdraw the references to the harmonised standard concerned in the Official Journal of the European Union.

§119 Formal objections to harmonised standards

The application of harmonised standards the references of which are published in the OJEU confers a presumption of conformity with the essential health and safety requirements they cover – see §110: comments on Article 7 (2). However, according to Articles 10 and 11 the presumption of conformity can be challenged:

− Article 10 requires a Member State or the Commission to refer a harmonised standard to the Committee set up by Regulation 1025/2012116 if they have evidence that certain essential health and safety requirements covered by the standard are not adequately fulfilled by its specifications.

− If the safeguard procedure set out in Article 11 is used and the Member State concerned considers that the non-conformity of the machinery subject to the restrictive measure is due to a shortcoming in a harmonised standard applied by the manufacturer, the standard concerned is also referred to the Regulation 1025/2012 Committee – see §124: comments on Article 11 (4).

To avoid the need for such formal objections, the Member States are encouraged to follow the development of harmonised standards and to make their concerns known to CEN or CENELEC before harmonised standards are adopted. Participation in standardization by market surveillance authorities is foreseen at national level by article 7 of Regulation EU 1025/2012. The comments to draft standards are expected to be made during Enquiry stage directly by market surveillance authorities or via national mirror committees. If the information is received at a late stage of the standards development process (for example after a Formal Vote), it cannot always be integrated directly, but could be processed after the publication of the given standard, possibly resulting in an amendment or revision. By the same token, the standardisation organisations are encouraged to take due account of the concerns of the Member States when developing and adopting harmonised standards.

However, a Technical Committee needs to receive structured, concrete and adequately detailed technical and legal information in order to be able to address the concerns and develop a proper technical solution to the issue.

116 Regulation (EU) No 1025/2012 of the European Parliament and of the Council of 25 October 2012 on European standardisation (OJ L 316, 14.11.2012, p. 12) lays down procedures, among others, for objections to standards and sets up a committee to consider these. It took over this function with amendments (deletions) to Directive 98/34/EC.

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Only the Member States and the Commission have the possibility to make a formal objection against a harmonised standard. If other interested parties consider that a harmonised standard has serious shortcomings, they may draw the matter to the attention of the national authorities or the Commission and ask them to take appropriate action.

§120 The procedure for formal objections

A formal objection can be introduced when a harmonised standard has been adopted by the European Standardisation Organisation and its reference been communicated to the Commission for publication in the OJEU. A formal objection can also be introduced at any time after the publication of the reference of the harmonised standard in the OJEU.

The formal objection must be communicated by the Member State to the Commission via its Permanent Representation to the EU, indicating the reference of the standard concerned, the specifications of the standard that are considered to be defective and the grounds for the objection.

The formal objection is first discussed within the Machinery Working Group – see §148: comments on Article 22 – where the other Member States, the representatives of CEN or CENELEC and other interested parties are invited to express their opinions. The outcome of the discussion in the Machinery Working Group is reported by the Commission to the Regulation 1025/2012 Committee. This Committee is then consulted on a draft Commission Decision. The Decision is then adopted by the Commission and published in the L series of the OJEU.

§121 The outcome of a formal objection

The Commission Decision on a formal objection to a harmonised standard can take several forms:

− if the formal objection is not sustained, the Commission adopts a Decision to publish the reference of the standard in the OJEU, or to maintain the reference of the standard in the OJEU if it has already been published;

− if the formal objection is sustained, the Commission may decide not to publish the reference of the standard in the OJEU, or to withdraw the reference of the standard from the OJEU if it has already been published;

− if the shortcomings of the standard only concern certain specifications and the rest of the standard is considered adequate, the Commission may decide to publish the reference of the standard in the OJEU (or maintain the reference of the standard in the OJEU if it has already been published) with a warning restricting the presumption of conformity conferred by application of the standard.

When the reference of a harmonised standard is published in the OJEU with a warning restricting the presumption of conformity, this implies that the application of the specifications of the standard that are not subject to the restriction continue to confer a presumption of conformity with the essential health and safety requirements they cover. However, in order to comply with the essential health and safety requirements that are not fulfilled by the standard, the manufacturer must carry out a full risk assessment, choose adequate protective measures to deal with the hazards concerned and justify his choice in his technical file – see §392: comments on Annex

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VII A 1 (a). As the standard used does not carry a complete presumption of conformity, and the product concerned is listed in Annex IV then the procedure for assessment of conformity with internal checks on the manufacture of machinery, provided for in Annex VIII is not possible and either the EC type-examination procedure provided for in Annex IX, plus the internal checks on the manufacture of machinery provided for in Annex VIII, point 3, or the full quality assurance procedure provided for in Annex X will need to be used.

When the Commission adopts a Decision not to publish the reference of a standard in the OJEU, to withdraw a reference of a standard from the OJEU or to publish or to maintain the reference of a standard in the OJEU with a restriction, the Commission gives a mandate to the European Standardisation Organisation to revise the standard concerned in order to remedy the shortcomings that have been identified.

Article 11117

Safeguard clause

1. Where a Member State ascertains that machinery covered by this Directive, bearing the CE marking, accompanied by the EC declaration of conformity and used in accordance with its intended purpose or under conditions which can reasonably be foreseen, is liable to compromise the health and safety of persons and, where appropriate, domestic animals or property, it shall take all appropriate measures to withdraw such machinery from the market, to prohibit the placing on the market and/or putting into service of such machinery or to restrict free movement thereof.

. . .

§122 The safeguard clause

The safeguard clause is foreseen in paragraph (10) of Article 95 of the EC Treaty (now Article 114 of the TFEU) on which the Machinery Directive is based – see §2: comments on the citations:

“The harmonisation measures referred to above shall, in appropriate cases, include a safeguard clause authorising the Member States to take, for one or more of the non-economic reasons referred to in Article 30, provisional measures subject to a Community control procedure”.

Article 11 sets out the procedure to be followed when the market surveillance authorities of a Member State discover that the presumption of conformity conferred by the CE-marking and the EC Declaration of Conformity is not founded – see §109: comments on Article 7 (1). This Article was modified by the Directive 2009/127/EC to also apply “where applicable the environment” but only for machinery for pesticide application.

The safeguard procedure set out in Article 11 applies to machinery in the broad sense, in other words, it can be applied to any of the products listed in Article 1 (1), (a) to (f). It is not applicable to partly completed machinery.

When machinery is found not to comply with the applicable health and safety

117 Article 11 was amended by Directive 2009/127/EC of the European Parliament and of the Council of 21 October 2009 amending Directive 2006/42/EC with regard to machinery for pesticide application. OJ L 310, 25.11.2009, p. 29.

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requirements despite the presence of the CE-marking, the Member State should first contact the manufacturer, his authorised representative or the person responsible for placing the machinery on the market and require him to bring the product into conformity or withdraw it from the market within a timeframe determined by the market surveillance authority – see §78 to §84: comments on Article 2 (i) and (j), and §100: comments on Article 4.

If the product is brought into conformity or withdrawn from the market voluntarily, there is no need to take the restrictive measures referred to in Article 11 (1) and consequently there is no legal basis for recourse to the safeguard procedure. However, if the machinery concerned presents a serious risk, Regulation (EC) No 765/2008 requires the Member State concerned to inform the Commission and the other Member States of the action taken using the RAPEX system118.

In all cases where corrective action is taken by the manufacturer, it is important for the Member State concerned to inform the market surveillance authorities of the other Member States so that they can ensure that the necessary corrective measures are taken throughout the EU – see §100: comments on Article 4. This information can be communicated in the framework of the Machinery AdCo Group – see §144: comments on Article 19 and by using the Information Communication System for Market Surveillance (ICSMS) which is owned and operated by the Commission and implemented by Article 23 of Regulation (EC) No 765/2008 which foresaw the establishment of a General EU information support system. If the non-conformity subject to corrective action taken by the manufacturer results from a deficiency in the harmonised standard applied, the Member State must also take action with respect to the harmonised standard, if necessary by means of the formal objection procedure – see §119 to §121: comments on Article 10.

If voluntary measures to bring the product into conformity are not taken within the timeframe determined by the market surveillance authorities and if the non-conformity is liable to endanger the health and safety of persons or, where appropriate, domestic animals or property, or for pesticides machinery, the environment, the safeguard procedure set out in Article 11 must be followed.

Article 11 (1) describes the measures to be taken by the national market surveillance authorities. The measures may include suspending or prohibiting the placing on the market of the machinery and/or the putting into service of the machinery, or making these operations subject to certain restrictions. The form and content of the measures is a matter for the Member State concerned, but the measures must be both sufficient to protect the health and safety of persons and proportionate to the risk involved.

According to Article 21 (3) of Regulation (EC) No 765/2008, before such measures are taken, the interested parties must be given the opportunity to express their views unless this is not possible because of urgency. If measures are taken without the interested parties being heard, they must be given the opportunity to express their views as soon as possible.

According to Article 20 of the Regulation, in the case of machinery presenting a serious risk requiring rapid intervention, Member States may also order the recall of

118 See Articles 20 and 22 of Regulation (EC) No 765/2008 of the European Parliament and of the Council of 9 July 2008 setting out the requirements for accreditation and market surveillance relating to the marketing of products and repealing Regulation (EEC) No 339/93. OJ L 218, 13.8.2008, p.30.

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machinery already placed on the market, both in the supply chain and in service, in order to protect the health and safety of users.

The measure taken by the Member State according to Article 11 (1) must state the exact grounds on which it is based and be notified as soon as possible to the party concerned who shall at the same time be informed of the legal remedies available to him – see §145: comments on Article 20.

The decision taken by the Member State shall be published – see §143: comments on Article 18 (3).

Article 11 (continued)

. . .

2. The Member State shall immediately inform the Commission and the other Member States of any such measure, indicating the reasons for its decision and, in particular, whether the non-conformity is due to:

a) failure to satisfy the essential requirements referred to in Article 5(1)(a);

b) incorrect application of the harmonised standards referred to in Article 7(2);

c) shortcomings in the harmonised standards themselves referred to in Article 7(2).

3. The Commission shall enter into consultation with the parties concerned without delay.

The Commission shall consider, after this consultation, whether or not the measures taken by the Member State are justified, and it shall communicate its decision to the Member State which took the initiative, the other Member States, and the manufacturer or his authorised representative.

. . .

§123 The safeguard procedure

Article 11 (2) and (3) set out the procedure to be followed at EU level when a national measure is taken in accordance with Article 11 (1). The measure must be notified by the Member State concerned to the European Commission, indicating the reasons for the measure. The notification shall be transmitted to the Commission by the Permanent Representation of the Member State concerned. At the same time, the other Member States must be informed. The information can be communicated through the Machinery AdCo Group using the CIRCABC system – see §146: comments on Article 21. The Machinery AdCo Group has developed a special form to help Member States to transmit the necessary information. This form can be generated with much of the information filled in from the ICSMS system, completed and printed.

Note that Article 11 only applies to CE marked products that do not conform to the Machinery Directive. If a machine is found on the EU/EEA market that is not CE marked and which may be also non-compliant in other respects, the competent Member State Authority (MSA) should take appropriate action to ensure the machine is brought into compliance and CE marked or have it withdrawn from the market.

The notification should clearly indicate the essential health and safety requirements with which the machinery fails to comply and explain the nature of the risks to which these non-conformities give rise. If the market surveillance authorities have assessed

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the conformity of the machinery with reference to the specifications of a harmonised standard, the relevant clauses of the standard should also be indicated.

In order to enable the Commission to carry out its enquiry without delay, the national authorities should transmit all relevant documents with the notification. Relevant documents may include:

− photos or drawings of the machinery concerned showing the CE marking and the defects concerned;

− a copy of the EC Declaration of Conformity;

− the EC type-examination certificate or the certificate of approval of the manufacturer’s full quality assurance system (if applicable);

− the relevant elements of the manufacturer’s technical file if they are available;

− the relevant extracts from the manufacturer’s instructions;

− reports of any tests or inspections on which the measure is based;

− details of any correspondence exchanged with the parties concerned, such as the manufacturer or his authorised representative, the importer or the distributor of the machinery, or the Notified Body involved.

The Commission services then examine the notification and the supporting documents and consult the parties concerned in order to consider whether or not the measure taken by the Member State is justified. The parties concerned include the authorities of the Member State that has notified the measure, the manufacturer of the machinery concerned or his authorised representative and, where applicable, the Notified Body involved in the conformity assessment of the machinery. An opportunity is given to the parties concerned to meet the Commission services to present their observations if they so wish.

If necessary, the Commission may seek independent expert advice in order to assess the file and, in some cases, to inspect the machinery concerned or carry out tests. The Commission then adopts a Decision which is communicated to the Member State which took the initial measure, to the other Member States, and to the manufacturer or his authorised representative. The Commission’s Decision is published in the Official Journal of the European Union – see §143: comments on Article 18 (3).

If the Commission decides that the measure taken by the Member State is justified, the other Member States shall take the measures necessary to ensure the protection of the health and safety of persons with respect to the non-compliant machinery. If, on the other hand, the Commission decides that the measure taken by the Member State is not justified, the measure shall be withdrawn.

It should be noted that Decision No 768/2008 of the European Parliament and the Council of 9 July 2008 on a common framework for the marketing of products, sets out a “safeguard procedure” that is intended to become the system for all relevant “CE marking” Directives and Regulations. A number of such legislation has now been revised to follow this Decision. However, the Machinery Directive 2006/42/EC has not yet been revised and the procedure described in Article 11 must be used until the Machinery Directive is so revised and aligned to the New Legislative Framework.

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Article 11 (continued)

. . .

4. Where the measures referred to in paragraph 1 are based on a shortcoming in the harmonised standards and if the Member State which instigated the measures maintains its position, the Commission or the Member State shall initiate the procedure referred to in Article 10.

. . .

§124 Shortcomings in harmonised standards

Article 11 (4) is applicable when the non-conformity notified according to Article 11 (1) and (2) is due to a shortcoming in the harmonised standard applied by the manufacturer. In that case, in addition to the procedure set out in Article 11 (3), a formal objection must be lodged either by the Member State concerned or by the Commission, according to the procedure set out in Article 10 – see §119 to §121: comments on Article 10.

Article 11 (continued)

. . .

5. Where machinery does not conform and bears the CE marking, the competent Member State shall take appropriate action against whomsoever has affixed the marking and shall so inform the Commission. The Commission shall inform the other Member States.

. . .

§125 Action against the person who has affixed the CE marking

The provisions set out in Article 11 (1) to (4) deal with the measures to be taken with respect to products that bear the CE marking and that are liable to compromise the health and safety of persons and, where appropriate, domestic animals or property, or the environment in the case of pesticides machinery.

In addition to those measures, Article 11 (5) requires the Member State to take appropriate action with respect to the person who has affixed the CE marking on a non-compliant product and thereby taken the responsibility for placing the product on the market or putting it into service – see §141: comments on Article 16. That person may be the manufacturer his authorised representative or another person taking the responsibility for placing the product on the market who is considered as a manufacturer – see §78 to §81: comments on Article 2 (i).

The appropriate action shall be determined by the Member States according to the provisions implementing the Machinery Directive into national law. In general, the market surveillance authorities should first require the manufacturer or his authorised representative to take the measures necessary to put an end to the non-conformity. If the necessary measures are not taken within the timeframe determined by the market surveillance authorities, appropriate sanctions must be applied – see §150: comments on Article 23.

In such cases, the Member States must inform the Commission and the Commission shall inform the other Member States. For this purpose, the ICSMS system foreseen in Article 23 of Regulation (EC) No 765/2008 shall be used.

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For non-conformities relating to the CE marking or the EC Declaration of Conformity – see §142: comments on Article 17.

Article 11 (continued)

. . .

6. The Commission shall ensure that Member States are kept informed of the progress and outcome of the procedure.

§126 Information on the safeguard procedure

According to Article 11 (6), the Commission shall keep the Member States informed of the progress and outcome of the safeguard procedure. The relevant information is provided to the Member States in the framework of the Machinery AdCo Group – see §144: comments on Article 19.

The Commission’s Decision is published in the Official Journal of the European Union – see §143: comments on Article 18 (3).

Article 12

Procedures for assessing the conformity of machinery

1. The manufacturer or his authorised representative shall, in order to certify the conformity of machinery with the provisions of this Directive, apply one of the procedures for assessment of conformity described in paragraphs 2, 3 and 4.

. . .

§127 Conformity assessment of machinery

Article 12 concerns the conformity assessment procedure that must be carried out by the manufacturer of machinery or his authorised representative before placing machinery on the market and/or putting it into service – see §103: comments on Article 5 (1). The conformity assessment procedure is mandatory, however, for certain categories of machinery, the manufacturer can choose between several alternative procedures. The following paragraphs set out the conditions under which the different conformity assessment procedures can be used.

Article 12 (continued)

. . .

2. Where the machinery is not referred to in Annex IV, the manufacturer or his authorised representative shall apply the procedure for assessment of conformity with internal checks on the manufacture of machinery provided for in Annex VIII.

. . .

§128 Categories of machinery not listed in Annex IV

Article 12 (2) sets out the conformity assessment procedure to be used for all categories of machinery other than those listed in Annex IV. The procedure to be followed is the procedure for assessment of conformity with internal checks on the manufacture of machinery, sometimes referred to as “Supplier’s Declaration of

119

Conformity” or “first party attestation”119 – see §395: comments on Annex VIII. This procedure does not involve the intervention of a Notified Body. However, the manufacturer or his authorised representative is free to seek any independent advice or assistance he needs in order to carry out the conformity assessment of the machinery. He may carry out the checks, inspections and tests and inspections needed to assess the conformity of the machinery himself or entrust them to any competent body of his choice. The relevant technical reports shall be included in the technical file – see §392: comments on Annex VII A 1 (a), sixth indent.

It should be noted that there are no Notified Bodies for categories of machinery other than those listed in Annex IV. Manufacturers of non-Annex IV machinery may seek advice or assistance from Bodies that are notified for certain categories of Annex IV machinery. However, in that case, the body is not acting as a Notified Body and must not use the identification number assigned to it by the Commission on any documents relating to such activity – see §133: comments on Article 14.

Article 12 (continued)

. . .

3. Where the machinery is referred to in Annex IV and manufactured in accordance with the harmonised standards referred to in Article 7(2), and provided that those standards cover all of the relevant essential health and safety requirements, the manufacturer or his authorised representative shall apply one of the following procedures:

(a) the procedure for assessment of conformity with internal checks on the manufacture of machinery, provided for in Annex VIII;

(b) the EC type-examination procedure provided for in Annex IX, plus the internal checks on the manufacture of machinery provided for in Annex VIII, point 3;

(c) the full quality assurance procedure provided for in Annex X.

. . .

§129 Annex IV machinery designed to harmonised standards that cover all the applicable essential health and safety requirements

Article 12 (3) sets out the three alternative conformity assessment procedures that may be applied to categories of machinery listed in Annex IV designed and constructed in accordance with harmonised standards. For the procedures set out in Article 12 (3) to be applicable, the following three conditions must be fulfilled:

− the machinery concerned must be in the scope of one or more harmonised C-type standards, (exception is made for safety components independently placed on the market within the scope of one or more harmonised B-type standards- – see §111), the references of which have been published in the OJEU – see §110: comments on Article 7 (2);

119 The concept of “Suppliers Declaration of Conformity” is explained in standard EN ISO/IEC 17050-1:2010 Conformity assessment – Supplier’s Declaration of Conformity – Part 1: General requirements (ISO/IEC 17050-1:2004, corrected version 2007-06-15); however, application of this standard does not confer a presumption of conformity with the requirements of the Machinery Directive.

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− the harmonised standard or standards concerned must cover all of the essential health and safety requirements that are applicable to the machinery as determined by the risk assessment – see §159: comments on General Principle 1; Note that some harmonised standards do not cover all the EHSRs either due to a warning in the OJEU or by design, in the latter case this will be stated in Annex Z. The manufacturer must therefore check that the standard/s do cover all the applicable EHSR by checking both the most recent publication in the OJEU and Annex Z;

− the machinery must be designed and constructed fully in accordance with the harmonised standards concerned.

When these three conditions are fulfilled, the manufacturer can choose the procedure referred to in Article 12 (3) (a) or one of the alternative procedures referred to in Article 12 (3) (b) and (c).

The procedure referred to in Article 12 (3) (a) – assessment of conformity with internal checks on the manufacture of machinery – is identical to the procedure referred to in Article 12 (2) that is applicable for categories of machinery not listed in Annex IV.

The procedure referred to in Article 12 (3) (b) requires the manufacturer to submit the model of machinery to an EC type-examination by a Notified Body in order to ensure that it complies with the EHSRs that are applicable. The conformity of the machinery subsequently produced according to the model examined by the Notified Body is then assessed by the manufacturer himself by means of internal checks – see §396 to §400: comments on Annex IX, and §395: comments on Annex VIII 3.

The procedure set out in Article 12 (3) (c) requires the manufacturer to have a full quality assurance system covering the design, manufacture, final inspection and testing of machinery. The system must be assessed and approved by a Notified Body to ensure that it is adequate to ensure the design and manufacture of machinery that complies with the EHSRs that are applicable. The Notified Body must also monitor the correct application of the full quality assurance system – see §401 to §407: comments on Annex X.

The manufacturer or his authorised representative in the EU can request an EC type-examination of a model of machinery or the assessment of a full quality assurance system from any Notified Body of his choice in the EU, provided the Notified Body concerned is notified for the conformity assessment procedure and for the category of machinery concerned – see §133: comments on Article 14. However, a request for an EC type-examination for a given model of machinery or a request for the assessment of a given full quality assurance system can only be lodged with a single Notified Body – see §397: comments on Annex IX 2.1, and §402: comments on Annex X 2.1.

An EC type-examination certificate or a decision approving a full quality assurance system issued by a Notified Body is valid throughout the EU.

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Article 12 (continued)

. . .

4. Where the machinery is referred to in Annex IV and has not been manufactured in accordance with the harmonised standards referred to in Article 7(2), or only partly in accordance with such standards, or if the harmonised standards do not cover all the relevant essential health and safety requirements or if no harmonised standards exist for the machinery in question, the manufacturer or his authorised representative shall apply one of the following procedures:

(a) the EC type-examination procedure provided for in Annex IX, plus the internal checks on the manufacture of machinery provided for in Annex VIII, point 3;

(b) the full quality assurance procedure provided for in Annex X.

§130 Other Annex IV machinery

Article 12 (4) sets out the 2 conformity assessment procedures that may be applied for categories of machinery listed in Annex IV when the one or more of the three conditions for applying Article 12 (3) are not fulfilled. Consequently, the procedures referred to in Article 12 (4) apply in the following cases:

− where harmonised standards covering the type of machinery concerned are not available;

− where the harmonised standards applied by the manufacturer do not cover all the essential health and safety requirements applicable to the machinery concerned;

− where the manufacturer of the machinery concerned has not applied or has only partially applied the relevant harmonised standards.

In such cases, the procedure for assessment of conformity with internal checks on the manufacture of machinery cannot be used and, consequently, one of the two procedures involving a Notified Body must be followed. The manufacturer can still refer to specific clauses of a harmonised standard to prove compliance with one or more requirements of the Directive.

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Article 13

Procedure for partly completed machinery

1. The manufacturer of partly completed machinery or his authorised representative shall, before placing it on the market, ensure that:

(a) the relevant technical documentation described in Annex VII, part B is prepared;

(b) assembly instructions described in Annex VI are prepared;

(c) a declaration of incorporation described in Annex II, part 1, Section B has been drawn up.

2. The assembly instructions and the declaration of incorporation shall accompany the partly completed machinery until it is incorporated into the final machinery and shall then form part of the technical file for that machinery.

§131 Procedure for partly completed machinery

Article 13 (1) sets out the procedure to be followed for the placing on the market of partly completed machinery referred to in Article 1 (1) (g) – see §384 and §385: comments on Annex II 1 B, §390: comments on Annex VI, and §394: comments on Annex VII B.

Article 13 (2) aims to ensure that the assembly instructions and the Declaration of Incorporation drawn up by the manufacturer of partly completed machinery are made available to the manufacturer of the final machinery into which the partly completed machinery is incorporated. This is so they can both apply the assembly instructions and include them and the Declaration of Incorporation in the technical file for the final machinery – see §392: comments on the eighth indent of Annex VII A 1 (a).

In general, this implies that the Declaration of Incorporation and a copy of the assembly instructions must be supplied with each item of partly completed machinery. However, in cases where a manufacturer of partly completed machinery supplies a batch of identical products to an identified manufacturer of final machinery, it is not necessary for the manufacturer of the partly completed machinery to supply the Declaration of Incorporation and the assembly instructions with each item, provided he ensures that the manufacturer of the final machinery has received these documents with the first delivery of products belonging to the batch and makes it clear that the Declaration of Incorporation and the assembly instructions apply to all of the items of partly completed machinery belonging to the batch.

Where the partly completed machinery (or part of it) is subject to other EU legislation in addition to the Machinery Directive, the conformity with the other Directives or Regulations concerned must also be declared.

§132 Diagram of the procedures for the placing on the market of machinery and partly completed machinery

The following diagram summarises the procedures set out in Article 12 and 13:

 Harmonised standards are not available, the harmonised standards do not cover all the applicable EHSRs or the harmonised standards are not applied or are only partially applied.

Colour code:

Product category

Documents

Procedure

Declaration – marking

Partly completed machinery

referred to

in Article 1 (1) – (g)

Machinery:

Product referred to

in Article 1 (1) – (a) to (f)

Technical file –

Annex VII A

Instructions

Category of machinery

in Annex IV

Relevant technical documentation

Annex VII B

Assembly instructions

Annex VI

Fully designed to harmonised standards that cover all applicable EHSRs

Not fully designed to harmonised standards that cover all applicable EHSRs 

Assessment of conformity with internal checks on manufacture

Annex VIII

Full quality assurance

Annex X

EC type-examination Annex IX

+ internal checks on manufacture

Annex VIII 3

EC Declaration of Conformity

Annex II 1 A

Declaration of Incorporation

Annex II 1 B

CE marking

Article 16

Annex III

Category of machinery

not in Annex IV

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Article 14

Notified bodies

1. Member States shall notify the Commission and the other Member States of the bodies which they have appointed to carry out the assessment of conformity for placing on the market referred to in Article 12 (3) and (4), together with the specific conformity assessment procedures and categories of machinery for which these bodies have been appointed and the identification numbers assigned to them beforehand by the Commission. Member States shall notify the Commission and other Member States of any subsequent amendment.

2. The Member States shall ensure that the notified bodies are monitored regularly to check that they comply at all times with the criteria set out in Annex XI. The notified body shall provide all relevant information on request, including budgetary documents, to enable the Member States to ensure that the requirements of Annex XI are met.

3. Member States shall apply the criteria set out in Annex XI in assessing the bodies to be notified and the bodies already notified.

4. The Commission shall publish in the Official Journal of the European Union, for information, a list of the notified bodies and their identification numbers and the tasks for which they have been notified. The Commission shall ensure that this list is kept up to date.

5. Bodies meeting the assessment criteria laid down in the relevant harmonised standards, the references of which shall be published in the Official Journal of the European Union, shall be presumed to fulfil the relevant criteria.

. . .

§133 Notified Bodies

Article 14 sets out the provisions relating to Notified Bodies. Notified Bodies are independent, third-party conformity assessment bodies entrusted with the conformity assessment procedures referred to in Article 12 (3) and (4) for the categories of machinery listed in Annex IV. The term “notified” refers to the fact that such Bodies are notified by the Member States to the Commission and to the other Member States. Before a conformity assessment body is notified, it must be assigned an identification number (with 4 digits) by the Commission. A given Body has a single identification number and may be notified under one or several EU Directives.

Under the Machinery Directive, bodies can only be notified for conformity assessment of the categories of machinery listed in Annex IV. Bodies that have been notified may also provide conformity assessment services to manufacturers of other categories of machinery. However, in such cases, the bodies must make it clear to their customers that they are not acting as Notified Bodies and must not use the identification number assigned to them by the Commission on any documents relating to such activity – see §128: comments on Article 12 (2). It is important that there is no conflict of interest when they carry out work as a Notified Body, so if they undertake consultancy work involving the design of a product that is listed under Annex IV then another Notified Body should be appointed for the conformity assessment process.

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The assessment, appointment and monitoring of the Notified Bodies is the exclusive responsibility of the Member States.

The notification is carried out using the Commission’s online information system NANDO (New Approach Notified and Designated Organisations). This site lists all of the European Notified Bodies as well as third country bodies designated under formal agreements such as Mutual Recognition Agreements (MRAs), the European Economic Area Agreement (EEA) and Agreements on Conformity Assessment and Acceptance of Industrial Products (ACAAs).

When notifying a body for conformity assessment according to the Machinery Directive, the notifying authority of the Member State concerned must indicate the category of machinery for which the Body has been designated. A Notified Body may be designated to assess the conformity of one or more of the categories of machinery listed in Annex IV.

The notification must also indicate for which conformity assessment procedure or procedures the Body has been designated. A Notified Body may be designated for one or both of the following two procedures referred to in Article 12:

− the EC type-examination procedure – Article 12 (3) (b) and Article 12 (4) (a) – Annex IX;

− the full quality assurance procedure – Article 12 (3) (c) and Article 12 (4) (b) – Annex X.

Before lodging a request for conformity assessment with a Notified Body, it is therefore important to check in NANDO that the Notified Body concerned has been notified according to the Machinery Directive for the category of machinery and for the conformity assessment procedure concerned – see §129: comments on Article 12 (3).

§134 Assessment and monitoring of Notified Bodies

Article 14 (3) refers to the criteria set out in Annex XI to be used when assessing the bodies to be notified – see §408: comments on Annex XI. Member States are strongly encouraged to use accreditation as a means for assessing Notified Bodies. Regulation (EC) No 765/2008 requires each Member State to appoint a single accreditation body to evaluate whether assessment bodies are competent to carry out specific conformity assessment activities. Each national accreditation body is subject to peer evaluation organised by the European Cooperation for Accreditation (EA)120.

Article 14 (5) refers to the relevant harmonised standards that can be used to assess Notified Bodies and their laboratories. The relevant harmonised standards are EN ISO/IEC 17020, 17021 and 17025121.

120 Regulation (EC) No 765/2008, Articles 3 to 14.

121 EN ISO/IEC 17020:2012 General criteria for the operation of various types of bodies performing inspection: EN ISO/IEC 17021:2011 Conformity assessment – Requirements for bodies providing audit and certification of management systems (Revised in June 2015 as a family of five standards 17021:2015-1 to 5 – bodies have 2 years before they full supersede the 2011 version); EN ISO/IEC 17025:2005 General requirements for the competence of testing and calibration laboratories (ISO/IEC 17025:2005); EN ISO/IEC 17025:2005/AC:2006. See Commission communication in the framework of the implementation of the Regulation (EC) No 765/2008 of the European Parliament and of the

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According to Article 14 (2), the Member States must also monitor the Notified Bodies in order to ensure that they continue to fulfil the criteria set out in Annex XI. When accreditation is used for the initial assessment of a Notified Body, the accreditation is usually granted for a limited period of time. The monitoring of the Notified Body can therefore be carried out by means of periodic audits in view of renewal of the accreditation.

Article 14 (continued)

. . .

6. If a notified body finds that relevant requirements of this Directive have not been met or are no longer met by the manufacturer or that an EC type-examination certificate or the approval of a quality assurance system should not have been issued, it shall, taking account of the principle of proportionality, suspend or withdraw the certificate or the approval issued or place restrictions on it, giving detailed reasons, unless compliance with such requirements is ensured by the implementation of appropriate corrective measures by the manufacturer.

In the event of suspension or withdrawal of the certificate or the approval or of any restriction placed on it, or in cases where intervention by the competent authority may prove necessary, the notified body shall inform the competent authority pursuant to Article 4. The Member State shall inform the other Member States and the Commission without delay.

An appeal procedure shall be available.

. . .

§135 Withdrawal of certificates or decisions issued by Notified Bodies

Article 14 (6) sets out the duties of a Notified Body in the following cases:

− The Notified Body is informed that machinery placed on the market covered by an EC type-examination certificate or by a decision approving a manufacturer’s full quality assurance system fails to comply with the applicable essential health and safety requirements or is unsafe.

This may be the case, for example, if the machinery concerned is the subject of a measure notified under the safeguard procedure according to Article 11 or by a measure taken to deal with potentially hazardous machinery according to Article 9.

− The notified Body is informed that the manufacturer is failing to comply with his obligations under an approved full quality assurance system.

This may be the case, for example, following a periodic audit of the full quality assurance system or following an unannounced visit to check the proper functioning of such a system – see §406: comments on Annex X 3.

The measures to be taken by the Notified Body in such cases depend on the seriousness of the non-conformity and of the risks involved. However, if the appropriate corrective measures are not taken by the manufacturer within the

Council, Decision 768/2008/EC of the European Parliament and of the Council, Regulation (EC) No 761/2001 of the European Parliament and of the Council (Publication of titles and references of harmonised standards). OJ C 136, 16.6.2009, p. 8.

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imparted timeframe, the relevant EC type-examination certificate or Decision of approval of a full quality assurance system must be suspended or withdrawn.

When a certificate or decision of approval is suspended or withdrawn, the Notified Body must inform the market surveillance authorities in the Member State in which they are established so that any measures needed to deal with non-compliant or unsafe machinery can be taken. The national authorities shall inform the other Member States and the Commission if action is needed to deal with non-compliant or unsafe machinery outside their territory.

The third paragraph of Article 14 (6) states that an appeal procedure shall be available. A manufacturer must be able to appeal against a decision of a Notified Body to refuse to issue, to suspend, to withdraw or not to renew an EC type-examination certificate – see §399 and §400: comments on Annex IX 5 and 9. A manufacturer must also be able to appeal against a decision not to approve a full quality assurance system, to withdraw or suspend such an approval or to place restrictions on it – see §404 and §406: comments on Annex X 2.3 and 3. The manufacturer must first make a reasoned request to the Notified Body to reconsider its decision. If that fails and if the manufacturer continues to disagree with the decision, he must be able to lodge an appeal. The form of the appeal and the procedure to be followed depends on the national provisions regulating the activity of the Notified Bodies.

Article 14 (continued)

. . .

7. The Commission shall provide for the organisation of an exchange of experience between the authorities responsible for appointment, notification and monitoring of notified bodies in the Member States, and the notified bodies, in order to coordinate the uniform application of this Directive.

. . .

§136 Exchange of experience between the notifying authorities

The exchange of experience between the authorities responsible for assessing and monitoring of the Notified Bodies foreseen in Article 14 (7) is organised in the framework of the Machinery Working Group – see §148: comments on Article 22.

§137 The coordination of Notified Bodies

The exchange of experience between the Notified Bodies is organised in the framework of a European Coordination of Notified Bodies for Machinery, NB-M. The purpose of NB-M is to discuss problems arising in the course of the conformity assessment procedures and to harmonise the practice of the Notified Bodies. In some cases, Notified Bodies are represented by a national coordination group set up in their country. Participation in coordination activities is one of the criteria for the notification of bodies – see §408: comments on Annex XI.

NB-M is divided into a number of groups that cover the different categories of machinery listed in Annex IV. These are called Vertical Groups (VGs).

There are currently 13 VGs that meet as necessary to deal with the following subjects:

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VG1

Woodworking machinery

VG2

Meatworking machinery

VG3

Presses for cold-working metals

VG4

Injection or compression moulding machines

VG5

Machines for underground work

VG6

Household waste collection skips (RCVs)

VG7

Removable transmission shafts

VG8

Vehicles servicing lifts

VG9

Lifting persons devices

VG 11

Safety components

VG 12

ROPS and FOPS

VG 13

Full quality assurance

VG 14

Portable cartridge-operated fixing and other impact machinery

In addition, NB-M has a Horizontal Committee that supervises and coordinates the work of the Vertical Groups and deals with issues common to all of the Notified Bodies. The Horizontal Committee meets twice a year, under the chairmanship of an elected representative of one of the Notified Bodies. Representatives of the European Commission and of three Member States chosen by the Machinery Working Group take part in these meetings as observers.

The European Commission contributes to the functioning of NB-M by financing the technical secretariat, which prepares the work of the Group, and the administrative secretariat, which organises the meetings and manages the circulation of documents.

NB-M adopts so-called “Recommendations for Use” (RfUs) which provide agreed answers to questions that have been discussed in the Vertical Groups. In general, RfUs are established where no relevant harmonised standard is available or where the relevant harmonised standard does not provide a sufficiently precise answer to a certain question. When a relevant harmonised standard is adopted or when the harmonised standard is revised accordingly, the RfU is withdrawn. The RfUs are approved by the NB-M Horizontal Committee then communicated to the Machinery Working Group for endorsement. The RfUs that have been endorsed by the Machinery Working Group are published on the Commission’s Website EUROPA. The RfUs are not legally binding but, once they have been agreed by NB-M and have been endorsed by the Machinery Working Group, they are to be considered as an important reference for ensuring uniform application of the Machinery Directive by the NBs.

Article 14 (continued)

. . .

8. A Member State which has notified a body shall immediately withdraw its notification if it finds:

(a) that the body no longer meets the criteria set out in Annex XI; or

(b) that the body seriously fails to fulfil its responsibilities.

The Member State shall immediately inform the Commission and the other Member States accordingly.

§138 Withdrawal of notification

Article 14 (8) obliges Member States to withdraw their notification of a body which no

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longer meets the criteria listed in Annex XI or which seriously fails to fulfil its responsibilities. The obligation to withdraw a notification that is no longer justified is a consequence of the obligation for the Member States to monitor the activity of the bodies they have notified in order to ensure that they are carrying out their tasks correctly – see §134: comments on Article 14 (2).

Article 15

Installation and use of machinery

This Directive shall not affect Member States’ entitlement to lay down, in due observance of Community law, such requirements as they may deem necessary to ensure that persons, and in particular workers, are protected when using machinery, provided that this does not mean that such machinery is modified in a way not specified in this Directive.

§139 National regulations on the installation and use of machinery

The Machinery Directive applies to the design, construction, placing on the market or putting into service of machinery – see §71 to §77: comments on Article 2 (h), and §86: comments on Article 2 (k). For these aspects, the Directive ensures the total harmonisation of the regulations in force throughout the EU. In other words, the Member States may not introduce national provisions that go beyond, overlap with or contradict the provisions of the Directive.

Article 15 indicates that Member States remain free to regulate the installation and use of machinery in accordance with the relevant provisions of EU law, providing these regulations do not have the effect of restricting the free movement of machinery that complies with the provisions of the Machinery Directive – see §6: comments on Recital 3, and §107: comments on Article 6 (1).

Thus national regulations on the installation and use of machinery or their application must not lead to the modification of machinery that complies with the Machinery Directive. This presupposes that machinery placed on the market really complies with the requirements of the Directive. If users or the national authorities consider that an item of machinery placed on the market is not sufficiently safe and that the applicable essential health and safety requirements have not been correctly applied, the machinery should be reported to the market surveillance authorities, while the necessary measures are taken to ensure the safety of persons – see §100: comments on Article 4.

The following are some examples of the subjects that may be covered by national rules on the installation and use of machinery:

− the installation of machinery in certain areas, such as, for example, the installation of cranes in urban areas or the installation of wind generators in the countryside;

− the use of mobile machinery in certain areas, such as, for example, the use of off-road vehicles in areas open to the public or the use of certain types of agricultural machinery close to dwellings or public roads;

− the circulation of mobile machinery on public roads;

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− the use of machinery at certain times, such as, for example, restrictions on the use of lawnmowers during the weekend;

− the use of certain kinds of machinery by people under a certain age.

§140 National regulations on the health and safety of workers

Particular mention must be made of the national regulations implementing the provisions of the EU Directives relating to health and safety at work. These Directives are based on Article 137 of the EC Treaty (now Article 153 of the TFEU) relating to the protection of workers’ health and safety. They set out minimum requirements, which means that Member States remain free to maintain or adopt more stringent requirements if they see fit. Consequently, it is necessary to consult the national regulations in force in each Member State in order to identify the relevant obligations. The most important Directives relating to the use of machinery are:

− Directive 89/391/EEC122 on the safety and health of workers at work. This is known as the “Framework” Directive, since it sets out the basic obligations of employers and workers relating to health and safety at work and provides the framework for a series of individual Directives dealing with specific aspects of health and safety or specific hazards;

− Directive 2009/104/EC123 on the use of work equipment by workers at work. This is the second individual Directive adopted under the “Framework” Directive.

Although the concept of work equipment is broader than that of machinery, machinery for professional use constitutes an important category of work equipment. The national regulations implementing the provisions of Directive 2009/104/EC always apply to the use of machinery at work. In this respect, Directive 2009/104/EC can be considered as a measure complementary to the Machinery Directive.

According to Directive 2009/104/EC, employers are required to make available to workers work equipment that is suitable for the work to be carried out and which complies with the provisions of any relevant EU Directive which is applicable to it.124 Consequently, all new machinery made available to workers must comply with the Machinery Directive and any other EU Directives that may be applicable – see §89 to §92: comments on Article 3.

The provisions of Directive 2009/104/EC are applicable to machinery in service in workplaces. During the lifetime of the machinery, the employer must take the measures necessary to ensure that machinery in service is kept, by means of adequate maintenance, at a level such that it complies with the provisions that were applicable when it was first made available in the undertaking or establishment125.

122 Council Directive 89/391/EEC of 12 June 1989 on the introduction of measures to encourage improvements in the safety and health of workers at work. OJ L 183, 29.6.1989.

123 Directive 2009/104/EC of the European Parliament and of the Council of 16 September 2009 concerning the minimum safety and health requirements for the use of work equipment by workers at work (second individual Directive within the meaning of Article 16(1) of Directive 89/391/EEC). OJ L 260, 3.10.2009, p. 5. Directive 2009/104/EC is a codified version of Directive 89/655/EEC and amending Directives 95/63/EEC, 2001/45/EC and 2007/30/EC.

124 See Directive 2009/104/EC, Articles 4 (1) (a).

125 See Directive 2009/104/EC, Article 4 (2).

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This does not mean that the machinery must be maintained in an “as new” condition, since it is subject to wear. But the necessary maintenance must be carried out to ensure that it continues to comply with the applicable health and safety requirements. To do so, the employer must follow the manufacturer’s instructions – see § 272: comments on section 1.7.4.2 (r) of Annex I.

Thus machinery that was subject to the provisions of the Machinery Directive when it was first made available must be maintained in a state of conformity with the essential health and safety requirements of the Machinery Directive that were applied when it was first placed on the market or put into service.

This also applies whenever machinery is modified by the user during the course of its lifetime, unless the modifications are so substantial that the modified machinery must be considered as new machinery and be subject to a new conformity assessment according to the Machinery Directive – see §72: comments on Article 2 (h).

Annex I of Directive 2009/104/EC sets out minimum technical requirements applicable to work equipment in service. These minimum requirements are applicable to machinery put into service before the Machinery Directive became applicable126.They are not applicable to machinery placed on the market or put into service according to the Machinery Directive.

Directive 2009/104/EC also includes provisions relating to:

− the initial inspection of work equipment the safety of which depends on installation conditions, after installation and before being put into service;

− the inspection of such work equipment after assembly at a new site or in a new location, for example when tower cranes are moved to a new site;

− periodic and special inspections and, where appropriate, testing of work equipment exposed to conditions causing deterioration which is liable to result in dangerous situations127.

In the case of lifting machinery, the initial inspections, for which the employer is responsible, must be distinguished from the measures to check the fitness for purpose of the machinery, which are the responsibility of the machinery manufacturer – see §350 to §352: comments on section 4.1.3 of Annex I.

Other provisions of Directive 2009/104/EC deal with:

− the restriction of the use and/or the maintenance of work equipment involving a specific risk to designated workers;

− taking account of ergonomic principles;

− information, instructions and training for workers on the use of work equipment;

− consultation of workers and workers’ participation128.

In addition, Annex II of Directive 2009/104/EC sets out specific rules for the use of certain categories of work equipment, including mobile work equipment, work

126 See Directive 2009/104/EC, Article 4 (1) (a) (ii) and (b).

127 See Directive 2009/104/EC, Article 5.

128 See Directive 2009/104/EC, Articles 6 to 10.

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equipment for lifting goods and work equipment for lifting persons – see §10: comments on Recital 7.

The instructions supplied by the manufacturer with machinery constitute an essential tool to enable employers to apply the provisions implementing Directive 2009/104/EC – see §254: comments on section 1.7.4 of Annex I.

Article 16

CE marking

1. The CE conformity marking shall consist of the initials ‘CE’ as shown in Annex III.

2. The CE marking shall be affixed to the machinery visibly, legibly and indelibly in accordance with Annex III.

3. The affixing on machinery of markings, signs and inscriptions which are likely to mislead third parties as to the meaning or form of the CE marking, or both, shall be prohibited. Any other marking may be affixed to the machinery provided that the visibility, legibility and meaning of the CE marking is not thereby impaired.

§141 The CE marking

The provisions on the CE marking of machinery set out in the Machinery Directive apply together with the provisions of Regulation (EC) 765/2008 setting out the General Principles of the CE marking which apply in a complementary way. The following comments are based on Article 16 and Annex III of the Machinery Directive and on Article 2 (20) and Article 30 of Regulation (EC) 765/2008. The obligations relating to the CE marking apply to the manufacturer, his authorised representative or the person responsible for placing the machinery on the market – see §78 to §85: comments on Article 2 (i) and (j).

Regulation (EC) 765/2008 defines ‘CE marking’ as a marking by which the manufacturer indicates that the product is in conformity with the applicable requirements set out in Community harmonisation legislation providing for its affixing. By affixing or having affixed the CE marking, the manufacturer indicates that he takes responsibility for the conformity of the product.

− the CE marking consists of the initials ‘CE’ with the graphic form shown in Annex III;

− the various components of the CE marking must have substantially the same vertical dimension, which may not be less than 5 mm. The minimum dimension may be waived for small-scale machinery;

− the CE marking must be affixed to the machinery visibly, legibly and indelibly in the immediate vicinity of the name of the manufacturer or his authorised representative, using the same technique – see §250: comments on section 1.7.3 of Annex I;

− where the full quality assurance procedure referred to in Article 12 (3) (c) and 12 (4) (b) has been applied, the CE marking must be followed by the identification number of the Notified Body that has approved the manufacturer’s full quality assurance system – see §133: comments on Article 14.

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The CE marking shall be the only marking which attests the conformity of the product with the applicable requirements of the relevant EU harmonisation legislation providing for its affixing. Article 16 (3) requires the Member States to forbid the affixing on machinery of markings, signs or inscriptions which are likely to mislead third parties as to the meaning or form of the CE markings or both.

Markings which are likely to mislead third parties as to the form of the CE marking might be, for example, the letters ‘EC’ or ‘EEC’, with a graphic form similar to that shown in Annex III, or the initials ‘CE’ with a graphic form different from that shown in Annex III. Markings which are likely to mislead third parties as to the meaning of the CE marking are markings, other than the CE marking, that signify that the machinery complies with the applicable EU legislation.

The measures to be taken in cases of non-conformity of marking are set out in Article 17.

Article 17

Non-conformity of marking

1. Member States shall consider the following marking not to conform:

(a) the affixing of the CE marking pursuant to this Directive on products not covered by this Directive;

(b) the absence of the CE marking and/or the absence of the EC declaration of conformity for machinery;

(c) the affixing on machinery of a marking, other than the CE marking, which is prohibited under Article 16 (3).

2. Where a Member State ascertains that marking does not conform to the relevant provisions of this Directive, the manufacturer or his authorised representative shall be obliged to make the product conform and to put an end to the infringement under conditions fixed by that Member State.

3. Where non-conformity persists, the Member State shall take all appropriate measures to restrict or prohibit the placing on the market of the product in question or to ensure that it is withdrawn from the market in accordance with the procedure laid down in Article 11.

§142 Non conformity of marking

The safeguard clause set out in Article 11 sets out the measures to be taken when machinery bearing the CE marking is discovered to be unsafe. Article 17 sets out the measures to deal with cases of formal non-conformity with the provisions of the Machinery Directive, where there is no indication that the machinery concerned is unsafe. These measures are in line with the obligation of the Member States to ensure the correct implementation of the regime governing the CE marking and to take appropriate action in the event of improper use of the marking set out in Article 30 (6) of Regulation (CE) 765/2008.

Article 17 (1) defines the three cases that are considered to constitute non-conformity of marking. Article 17 (2) states that Member States shall take the necessary measures to require economic operators to put an end to such infringements. The nature of the measures is left to the discretion of the Member States. Such measures

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do not have to be notified to the Commission or to the other Member States. The penalties for infringements against the provisions of the Machinery Directive must include penalties for non-conformity of marking – see §150: comments on Article 23.

Article 17 (3) sets out the procedure to be followed in case the measures taken to put an end to the infringements referred to in Article 17 (1) are not effective. In that case, the safeguard procedure set out in Article 11 must be followed.

Article 18

Confidentiality

1. Without prejudice to existing national provisions and practices in the area of confidentiality, Members States shall ensure that all parties and persons concerned by the application of this Directive are required to treat as confidential information obtained in the execution of their tasks. More particularly business, professional and trade secrets shall be treated as confidential, unless the divulging of such information is necessary in order to protect the health and safety of persons.

2. The provisions of paragraph 1 shall not affect the obligations of the Member States and the notified bodies with regard to mutual exchange of information and the issuing of warnings.

3. Any decisions taken by the Member States and by the Commission in accordance with Articles 9 and 11 shall be published.

§143 Confidentiality and transparency

The parties and persons concerned by the provisions set out in Article 18 include the administrations of the Member States, the Commission and the Notified Bodies. In particular, the authorities of the Member States and the services of the Commission may require manufacturers to communicate elements of the technical file for machinery or of the relevant technical documentation for partly completed machinery which contain professional and trade secrets. The officials of the public administrations or agencies concerned and any other bodies or institutions acting on their behalf must respect the confidentiality of such information obtained or received in the course of application of the Machinery Directive. Similarly, Notified Bodies must respect the confidentiality of information obtained or received while carrying out the conformity assessment procedures for which they are responsible – see §408: comments on Annex XI 7.

Article 18 (2) indicates that the obligation of confidentiality does not prevent the transmission of information between the Member States and to the Commission in the framework of the cooperation foreseen in Article 19 (Machinery AdCo Group) or to using the internal section of ICSMS to which access is appropriately restricted. The obligation of confidentiality does not apply to the communication of information between the Notified Bodies and to the communication of information by the Notified Bodies to the Member States – see §135: comments on Article 14 (6), §399: comments on Annex IX 5 and 7, and §407: comments on Annex X 4.

The confidentiality obligation does not preclude the issuing of public warnings when this is necessary in order to protect the health and safety of persons.

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Article 18 (3) sets out a particular requirement for transparency relating to any decisions taken by the Member States and by the Commission in accordance with Articles 9 and 11. The decisions concerned include:

− the measures taken by the Commission requiring Member States to prohibit or restrict the placing on the market of potentially hazardous machinery according to Article 9 (1);

− the measures taken by the Member States to withdraw from the market, to prohibit the placing on the market and/or putting into service or to restrict the free movement of machinery that is liable to compromise the health and safety of persons and, where appropriate, domestic animals, property, or the environment for pesticide machinery, according to Article 11 (1) (the safeguard clause);

− decisions taken by the Commission on safeguard clauses according to Article 11 (3).

Article 19

Cooperation between Member States

1. Member States shall take the appropriate measures to ensure that the competent authorities referred to in Article 4(3) cooperate with each other and with the Commission and transmit to each other the information necessary to enable this Directive to be applied uniformly.

2. The Commission shall provide for the organisation of an exchange of experience between the competent authorities responsible for market surveillance in order to coordinate the uniform application of this Directive.

§ 144 Machinery AdCo Group

Article 19 (1) requires the Member States to organise cooperation between the national market surveillance authorities and to transmit to each other the necessary information. Cooperation is essential in this area since, while CE-marked machinery is able to move freely within the single market, surveillance is carried out by each of the Member States.

Article 19 (2) gives the Commission the responsibility of providing for the organisation of an exchange of experience between the market surveillance authorities.

The practical application of Article 19 is carried out in the framework of the Machinery Administrative Cooperation Group (Machinery AdCo Group). This is a forum for the exchange of information between the market surveillance authorities of the Member States and the Commission. The Machinery AdCo Group usually meets twice a year and is chaired in turn by representatives of the Member States. The meetings are restricted to the representatives of the Member States and the Commission and the proceedings and documents of the AdCo Group are confidential, since they frequently refer to specific cases under investigation. However other stakeholders may be invited to take part in AdCo meetings as experts, to an “open” section of the meeting only, to contribute on particular topics when such confidential information is not discussed.

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Where the Machinery AdCo reaches a view on the interpretation or added guidance on the Directive, this is then transmitted to the Machinery Working Group for its discussion and agreement. If approved by the Machinery Working Group, the Commission will either integrate the agreed changes in the guide or publish them on the EUROPA machinery web site.

The main activities of the Machinery AdCo Group are:

− sharing information and experience of market surveillance activity;

− promoting best practices and optimising the use of resources;

− ensuring that corrective measures to deal with non-compliant and unsafe machinery are applied in all Member States;

− providing information on the progress and outcome of the safeguard procedure and following-up safeguard clause decisions;

− following-up decisions on specific measures to deal with potentially hazardous machinery;

− planning and organising joint market surveillance projects.

Article 20

Legal remedies

Any measure taken pursuant to this Directive which restricts the placing on the market and/or putting into service of any machinery covered by this Directive shall state the exact grounds on which it is based. Such a measure shall be notified as soon as possible to the party concerned, who shall at the same time be informed of the legal remedies available to him under the laws in force in the Member State concerned and of the time limits to which such remedies are subject.

§ 145 Reasons for decisions and appeals

Article 20 applies to any measures taken by the authorities of the Member States restricting the placing on the market and/or the putting into service of machinery, whether they are taken on the basis of Article 11 (the safeguard clause), Article 9 (specific measures to deal with potentially hazardous machinery) or Article 17 (non-conformity of marking). The Member State is required to have a procedure in place by which an economic operator can have access to a legal remedy in case of dispute. There should be clear time limits that the operator has to raise such a case against a restrictive action.

Article 21

Dissemination of information

The Commission shall take the necessary measures for appropriate information concerning the implementation of this Directive to be made available.

§146 Information sources

Information relevant to the implementation of the Machinery Directive is publicly available online on the machinery pages of the Directorate-General for Internal Market, Industry, Entrepreneurship and SMEs (DG Growth) section of the Commission’s website EUROPA.

In particular, the following information is available on EUROPA:

− the legal text and the consolidated text of the Machinery Directive;

− a list of contact points in the Member States for implementation of the Directive;

− the list of references of harmonised standards for machinery;

− the list of Notified Bodies for machinery;

− the Recommendations for Use adopted by the European coordination of Notified Bodies for Machinery (NB-M) that have been endorsed by the Machinery Working Group;

− guidance documents approved by the Machinery Working Group and the present Guide to application of Directive 2006/42/EC;

− the consolidated minutes, including decisions, of all the meetings of the Machinery Working Group held since 1997.

Article 22 129

Committee

1. The Commission shall be assisted by a committee, hereinafter referred to as the ‘Committee’.

2. Where reference is made to this paragraph, Articles 3 and 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof.

3. Where reference is made to this paragraph, Articles 5a(1) to (4), and Article 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof.

§147 The Machinery Committee

Article 22 foresees the setting up of the Committee, called the Machinery Committee, which is composed of representatives of the Member States and chaired by a representative of the Commission. The Committee adopts its own rules of procedure on the basis of standard rules published in the OJEU. The European Parliament is informed of the agendas of the meetings of the Committee and of any draft measures that are submitted to it and receives the results of voting and summary records of the meetings.

129 Article 22 was amended by Regulation (EC) No 596/2009 of the European Parliament and of the Council of 18 June 2009 adapting a number of instruments subject to the procedure referred to in Article 251 of the Treaty to Council Decision 1999/468/EC with regard to the regulatory procedure with scrutiny (PRAC) – Adaptation to the regulatory procedure with scrutiny – Part Four. OJ L 188, 18.7.2009, p.14.

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The Machinery Committee has two distinct roles:

− an advisory role

The advisory role of the Machinery Committee, set out in Article 8 (2), is to advise the Commission on any appropriate measure connected with the practical application of the Machinery Directive, including measures necessary to ensure cooperation of Member States with each other and with the Commission as provided for in Article 19 (1). The measures concerned cannot involve the amendment of the Directive or the adoption of Decisions supplementing the provisions of the Directive. Therefore, these measures consist mainly in providing guidance on the correct and uniform application of the provisions of the Directive.

− a regulatory role

The regulatory role of the Machinery Committee is to give its opinion on measures proposed by the Commission, which amend or supplement the provisions of the Directive. According to Article 8 (1) (a) and (b), only two subjects can be the subject of such measures:

a) updating of the indicative list of safety components in Annex V – see §42: comments on Article 2 (c);

b) restriction of the placing on the market of potentially hazardous machinery – see §118: comments on Article 9.

The opinion of the Machinery Committee is expressed by means of votes of the representatives of the Member States within the Committee, weighted as for votes of the Council according to Article 205 of the EC Treaty (now Article 238 of the TFEU).

Before such measures are adopted by the Commission, they are submitted to the European Parliament and the Council for scrutiny. The European Parliament or the Council may oppose the draft measures proposed by the Commission on the grounds that they exceed the implementing powers provided for in the Directive, that they are not compatible with the aim or the content of the Directive or do not respect the principles of subsidiarity or proportionality. In case of such opposition, the Commission can submit an amended draft or make a legislative proposal. If there is no opposition from the European Parliament and the Council within three months, the Commission adopts the measure.

§148 The Machinery Working Group

The Machinery Working Group is set up by the Machinery Committee in order to allow observers from industry, users (workers and consumers representation organisations) standardisation and the Notified Bodies to take part in the discussion of problems relating to the practical application of the Machinery Directive. In practice, the Machinery Working Group is the most frequently used forum to discuss the application of the Directive at EU level. Like the Machinery Committee, the Machinery Working Group is chaired by a representative of the Commission and composed of representatives of the Member States. Representatives of EFTA countries, candidate countries and countries with formal agreements with the EU are also present as observers.

Associations of machinery manufacturers at European level participate as observers and are invited to attend meetings in order to present information and views on specific issues that are under discussion. Representatives of the European

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standardisation organisations are also present to provide information and to respond to the questions raised by the Member States relating to standards. The Notified Bodies are represented by the European Coordination of Notified Bodies for Machinery (NB-M) which reports on the work of the Coordination, takes note of the opinion of the Machinery Working Group on the Recommendations for Use submitted to the Working Group for endorsement and submits questions to the Working Group relating to the interpretation of the Directive. Trades unions and representatives of consumer protection organisations are also invited to express the views of the final users of machinery.

The topics most frequently discussed by the Machinery Working Group are:

− clarification of the scope of the Directive and the conformity assessment procedures with respect to particular categories of products;

− concerns relating to the development of harmonised standards for machinery;

− opinions on formal objections against harmonised standards – see §120: comments on Article 10.

The Machinery Working Group meets twice or three times a year in Brussels. Working documents for the meetings of the Machinery Working Group are circulated to members of the Group on the Machinery Directive section of the Commission online information system CIRCABC. Organisations representing machinery stakeholder at European level have access to these documents. Other stakeholders can request the documents from their respective representative organisations. Care should be taken not to take the positions expressed in working documents or discussion papers as representing the views of the Commission or of the Machinery Working Group.

The minutes of meetings of the Machinery Working Group are published on the machinery pages of the Commission’s website EUROPA, once they have been corrected and approved at the following meeting.

§149 Diagram of institutions dealing with the Machinery Directive

The following diagram indicates the roles of the different institutions, entities and groups involved in proposing, adopting, transposing, applying and enforcing the Machinery Directive:

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Article 23

Penalties

Member States shall lay down the rules on penalties applicable to infringements of the national provisions adopted pursuant to this Directive and shall take all measures necessary to ensure that they are implemented. The penalties provided for must be effective, proportionate and dissuasive. Member States shall notify those provisions to the Commission by 29 June 2008 and shall notify it without delay of any subsequent amendment affecting them.

§150 Penalties for infringements against the provisions of the Directive

The national provisions implementing the Machinery Directive must be legally binding and infringements against those provisions must therefore be sanctioned by appropriate penalties.

The possible infringements may include the following:

− failure to apply the applicable conformity assessment procedure for machinery – see §127 to §130: comments on Articles 12;

− failure to apply the procedure for partly completed machinery – see §131: comments on Article 13;

− non-conformity of marking – see §142: comments on Article 17;

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− failure of machinery to comply with the essential health and safety requirements set out in Annex I;

− missing or incomplete technical file – see §103: comments on Article 5, and §391 to §393: comments on Annex VII A;

− missing or incomplete instructions (including the necessary translation) – see §103: comments on Article 5, and §254 to §256: comments on section 1.7.4 of Annex I;

− failure to comply with the measures foreseen in Article 11 (safeguard clause) and Article 9 (specific measures to deal with potentially hazardous machinery).

It is up to each Member State to fix the type and the level of the penalties for such infringements. Article 23 states that the penalties must be effective, proportionate and dissuasive, in line with the Jurisprudence of the European Court of Justice.

Article 24

Amendment of Directive 95/16/EC

Directive 95/16/EC is hereby amended as follows:

1. in Article 1, paragraphs 2 and 3 shall be replaced by the following:

2. ‘For the purposes of this Directive, “lift” shall mean a lifting appliance serving specific levels, having a carrier moving along guides which are rigid and inclined at an angle of more than 15 degrees to the horizontal, intended for the transport of:

— persons,

— persons and goods,

— goods alone if the carrier is accessible, that is to say a person may enter it without difficulty, and fitted with controls situated inside the carrier or within reach of a person inside the carrier.

Lifting appliances moving along a fixed course even where they do not move along guides which are rigid shall be considered as lifts falling within the scope of this Directive.

A “carrier” means a part of the lift by which persons and/or goods are supported in order to be lifted or lowered.

3. This Directive shall not apply to:

— lifting appliances whose speed is not greater than 0,15 m/s,

— construction site hoists,

— cableways, including funicular railways,

— lifts specially designed and constructed for military or police purposes,

— lifting appliances from which work can be carried out,

— mine winding gear,

— lifting appliances intended for lifting performers during artistic performances,

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— lifting appliances fitted in means of transport,

— lifting appliances connected to machinery and intended exclusively for access to workstations including maintenance and inspection points on the machinery,

— rack and pinion trains,

— escalators and mechanical walkways.’;

2. in Annex I, point 1.2 shall be replaced by the following:

1.2. ‘Carrier

The carrier of each lift must be a car. This car must be designed and constructed to offer the space and strength corresponding to the maximum number of persons and the rated load of the lift set by the installer.

Where the lift is intended for the transport of persons, and where its dimensions permit, the car must be designed and constructed in such a way that its structural features do not obstruct or impede access and use by disabled persons and so as to allow any appropriate adjustments intended to facilitate its use by them.’

§151 The borderline between the Machinery Directive and the Lifts Directive

Article 24 of Directive 2006/42/EC introduces an amendment to the Lifts Directive 95/16/EC (replaced by Directive 2014/33/EU from 20 April 2016) with the purpose of better defining the borderline with the Machinery Directive – see §28: comments on Recital 27.

On the one hand, Article 24 (1) modifies the definition of ‘lift’ given in Article 1 (2) of the Lifts Directive, replacing the term ‘car’ with the term ‘carrier’. This implies that the nature of the carrier is not a criterion for application of the Lifts Directive. At the same time, Article 24 (2) modifies the essential health and safety requirement set out in section 1.2 of Annex I to the Lifts Directive in order to specify that the carrier of lifts subject to that Directive must be a car. It should also be noted that section 3.1 of Annex I to the Lifts Directive requires lift cars to be completely enclosed.

On the other hand, Article 24 (1) modifies the list of exclusions set out in Article 1 (3) of the Lifts Directive, adding the exclusion of lifting appliances whose speed is not greater than 0,15 m/s. Consequently, low-speed lifts are subject to the Machinery Directive – see §344: comments on section 4.1.2.8 and §377: comments on section 6.4 of Annex I.

With respect to the modified list of exclusions from the Lifts Directive, the following items should also be noted:

Construction site hoists are excluded from the scope of the Lifts Directive. They are no longer excluded from the scope of Directive 2006/42/EC and are thus subject to the Machinery Directive as from 29th December 2009 – see §8: comments on Recital 5.

The following are excluded from the Lifts Directive and are subject to the Machinery Directive:

− lifting appliances from which work can be carried out;

− lifting appliances fitted in means of transport;

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− lifting appliances connected to machinery and intended exclusively for access to workstations including maintenance and inspection points on the machinery;

− escalators and mechanical walkways.

Cableways are all excluded from the scope of the Lifts Directive. In accordance with Article 3, while the Machinery Directive is not applicable to cableways designed to carry persons that are covered by the Cableways Directive 2000/9/EC, it does apply to certain cableways that are outside or excluded from the scope of the Cableways Directive – see §90: comments on Article 3.

The following are excluded from both the Lifts Directive and the Machinery Directive:

− lifts specially designed and constructed for military or police purposes – see §59: comments on Article 1 (2) (g);

− mine winding gear – see §61: comments on Article 1 (2) (i);

− lifting appliances intended for lifting performers during artistic performances – see §62: comments on Article 1 (2) (j);

− rack and pinion trains on rail networks – §57: comments on the fifth indent of Article 1 (2) (e).

Article 25

Repeal

Directive 98/37/EC is hereby repealed as from 29 December 2009. 130

References made to the repealed Directive shall be construed as being made to this Directive and should be read in accordance with the correlation table in Annex XII.

§152 Repeal of Directive 98/37/EC

Directive 2006/42/EC replaced Directive 98/37/EC. Directive 98/37/EC was repealed on 29th December 2009, at which date the provisions of Directive 2006/42/EC became applicable.

The second paragraph of Article 25 means that from 29th December 2009, references to the Machinery Directive in other EU legislation remain valid and shall be understood as references to Directive 2006/42/EC. Where such references are made to specific provisions of the Directive, the references shall be read as referring to the equivalent provisions indicated in the correlation table given in Annex XII. Such references are updated when the legislation concerned is revised.

130 Subject to a corrigendum published in OJ L 76, 16.3.2007, p. 35.

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Article 26

Transposition

1. Member States shall adopt and publish the provisions necessary to comply with this Directive by 29 June 2008 at the latest. They shall forthwith inform the Commission thereof.

They shall apply those provisions with effect from 29 December 2009.

When Member States adopt those provisions, they shall contain a reference to this Directive or shall be accompanied by such reference on the occasion of their official publication. Member States shall determine how such reference is to be made.

2. Member States shall communicate to the Commission the text of the provisions of national law which they adopt in the field covered by this Directive, together with a table showing how the provisions of this Directive correspond to the national provisions adopted.

§153 Transposition and application of the provisions of the Directive

EU Directives are addressed to the Member States who are thereby instructed to adopt the necessary provisions transposing them into national law. It is these national provisions that create binding obligations for economic operators. According to Article 288 of the TFEU (former Article 249 EC), the Directive is binding as to the result to be achieved but leaves to the national authorities the choice of form and methods. However, since the Machinery Directive is based on Article 95 of the EC Treaty (now Article 114 of the TFEU) that foresees measures to harmonise provisions laid down by law, regulation or administrative action in Member States which have as their object the establishment and functioning of the internal market, the latitude given to the Member States is, in practice, rather limited. In particular, the essential health and safety requirements for the design and construction of machinery and the conformity assessment procedures applicable must be the same in all the Member States.

The Member States were given 2 years following the entry into force of the Directive to adopt the necessary provisions. These provisions become applicable eighteen months later, on 29th December 2009. Until that date, Directive 98/37/EC continued to apply.

The references of the texts transposing the provisions of the Directive into the national law of the Member States, that have been communicated to the Commission according to the obligation set out in Article 26 (2), are presented on the EUR-Lex website131.

131 http://eur-lex.europa.eu/.

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Article 27

Derogation

Until 29 June 2011 Member States may allow the placing on the market and the putting into service of portable cartridge operated fixing and other impact machinery which are in conformity with the national provisions in force upon adoption of this Directive.

§154 Transition period for portable cartridge operated fixing and other impact machinery

As a general rule, since manufacturers have a period of three and a half years between the entry into force of Directive 2006/42/EC and the application of its provisions during which to adapt their products where necessary, it was not considered necessary to foresee a transition period. However, by way of derogation to the general rule, Article 27 foresees a transition period of eighteen months for portable cartridge operated fixing machinery and other portable cartridge operated impact machinery during which Member States may allow the placing on the market of products that comply with the national provisions in force previously. These national provisions are either those implementing the Convention of 1st July 1969 on the Reciprocal Recognition of Proofmarks on Small Arms (the CIP convention), in the case of Member States that are signatories to that Convention, or, in other Member States, existing national regulations – see §9: comments on Recital 6.

It should be noted that the transition period was a facility open to Member States, not an obligation. Consequently, portable cartridge operated fixing machinery and other portable cartridge operated impact machinery that complied with the Machinery Directive benefited for free movement in the EU from 29th December 2009. Such machinery that complied with the national provisions in force previously could only be placed on the market in those Member States that allow this. As from 29 June 2011, all such machinery must comply with the Machinery Directive.

Article 28

Entry into force

This Directive shall enter into force on the 20th day following its publication in the Official Journal of the European Union.

§ 155 Date of entry into force of the Directive

Article 28 sets out the date of entry into force of Directive 2006/42/EC. Since the Directive was published in the OJEU on 9th June 2006, it entered into force on 29th June 2006. The date of entry into force is the date at which the Directive acquires a legal existence and should not be confused with the date of application of the provisions of the Directive which is 29th December 2009 – see §153: comments on Article 26 (1).

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Article 29

Addressees

This Directive is addressed to the Member States.

Done at Strasbourg, 17 May 2006.

For the European Parliament

The President

J. BORRELL FONTELLES

For the Council

The President

H. WINKLER

§ 156 Addressees and signatories of the Directive

The Directive is addressed to the Member States, since the transposition of the provisions of the Directive into national law is necessary in order to create binding legal obligations for the economic operators.

The Directive is signed by the Presidents of the European Parliament and of the Council since it was adopted by these Institutions according to the co-decision procedure foreseen in Article 251 of the EC Treaty (now referred to as the ordinary legislative procedure in Article 294 of the TFEU) – see §2: comments on the citations.

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ANNEX I

Essential health and safety requirements relating to the design and construction of machinery

GENERAL PRINCIPLES

§157 The General Principles

The essential health and safety requirements (EHSRs) set out in Annex I are introduced by four General Principles. The first one, dealing with risk assessment, explains a basic requirement of Annex I to identify the hazards and assess the risks associated with machinery in order to identify and apply the relevant EHSRs. The other General Principles are essential for understanding the status and the implications of the EHSRs.

These General Principles must be taken into account when applying each of the EHSRs to the design and construction of machinery.

GENERAL PRINCIPLES

1. The manufacturer of machinery or his authorised representative must ensure that a risk assessment is carried out in order to determine the health and safety requirements which apply to the machinery. The machinery must then be designed and constructed taking into account the results of the risk assessment.

By the iterative process of risk assessment and risk reduction referred to above, the manufacturer or his authorised representative shall:

— determine the limits of the machinery, which include the intended use and any reasonably foreseeable misuse thereof,

— identify the hazards that can be generated by the machinery and the associated hazardous situations,

— estimate the risks, taking into account the severity of the possible injury or damage to health and the probability of its occurrence,

— evaluate the risks, with a view to determining whether risk reduction is required, in accordance with the objective of this Directive,

— eliminate the hazards or reduce the risks associated with these hazards by application of protective measures, in the order of priority established in section 1.1.2 (b).

. . .

§158 Risk assessment

According to General Principle 2, the EHSRs are only applicable when the corresponding hazard exists for the machinery in question. In order to identify these hazards, taking into account all phases of the foreseeable lifetime of the machinery, the manufacturer or his authorised representative must ensure that a risk assessment is carried out according to the iterative process described in General Principle 1. For the terms ‘hazard’ and ‘risk’ – see §164: comments on section 1.1.1 (a), and §168: comments on section 1.1.1 (e).

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The risk assessment may be carried out by the manufacturer himself, by his authorised representative or by another person acting on their behalf. If the risk assessment is carried out on behalf of the manufacturer by another person, the manufacturer remains responsible for the risk assessment and the implementation of the necessary protective measures during the design and construction of machinery – see §78 to §81: comments on Article 2 (i), and §83 and §84: comments on Article 2 (j).

The second sentence of the first paragraph of General Principle 1 states that the machinery must then be designed and constructed taking into account the results of the risk assessment. Risk assessment is described as an iterative process because each risk reduction measure envisaged to deal with a particular hazard must be evaluated to see if it is adequate and does not generate new hazards. If this is not the case, the process must be carried out anew. This implies that the risk assessment process must be carried out in parallel with the design process of the machinery.

The last indent of the second paragraph underlines that the risk reduction measures to deal with the identified hazards are to be given an order of priority, according to the principles of safety integration – see §174: comments on section 1.1.2 (b).

The risk assessment and its outcome must be documented in the Technical file for machinery – see §392: comments on Annex VII A 1 (a).

Standard EN ISO 12100 (A-type standard) explains the general principles for risk assessment of machinery132.

§159 Risk assessment and harmonised standards

The process of risk assessment is facilitated by the application of harmonised standards, since C-type standards for machinery identify the significant hazards that are generally associated with the category of machinery concerned and specify protective measures to deal with them. However, the application of harmonised standards does not entirely dispense the machinery manufacturer from the obligation to carry out a risk assessment.

A manufacturer who applies the specifications of a C-type standard must ensure that the harmonised standard is appropriate to the particular machinery concerned and covers all of the risks it presents. As a starting point, Annex Z and the entry of the reference in the OJEU should be checked to ensure that the standard’s presumption of conformity does not exclude any essential health and safety requirements. If the machinery concerned presents hazards that are not covered by the harmonised standard, a full risk assessment is required for those hazards and appropriate protective measures must be taken to deal with them.

Furthermore, where harmonised standards specify several alternative solutions without defining criteria for choice between them, the choice of the appropriate solution for the machinery concerned must be based on a specific risk assessment. This is particularly important when applying B-type standards – see §111: comments on Article 7 (2).

132 EN ISO 12100: 2010 Safety of machinery – General principles for design. Risk assessment and risk reduction (ISO 12100-1:2010).

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GENERAL PRINCIPLES (continued).

. . .

2. The obligations laid down by the essential health and safety requirements only apply when the corresponding hazard exists for the machinery in question when it is used under the conditions foreseen by the manufacturer or his authorised representative or in foreseeable abnormal situations. In any event, the principles of safety integration referred to in section 1.1.2 and the obligations concerning marking of machinery and instructions referred to in sections 1.7.3 and 1.7.4 apply.

. . .

§160 The applicability of the essential health and safety requirements

General Principle 2 must be borne in mind when reading each of the EHSRs set out in Annex I. The EHSRs are usually expressed without qualification. However, they are only applicable when they are relevant and necessary. In other words, an EHSR applies when the hazard concerned is present on the particular model of machinery concerned. The first sentence of General Principle 2 also underlines that, when identifying the hazards for a given model of machinery, not just the intended conditions of use but also foreseeable abnormal situations must be taken into account. Foreseeable abnormal situations are those arising from reasonably foreseeable misuse – see §172: comments on section 1.1.1 (i).

The second sentence sets out an exception to General Principle 2, since the requirements set out in sections 1.1.2, 1.7.3 and 1.7.4 are applicable to all machinery.

GENERAL PRINCIPLES (continued)

. . .

3. The essential health and safety requirements laid down in this Annex are mandatory; However, taking into account the state of the art, it may not be possible to meet the objectives set by them. In that event, the machinery must, as far as possible, be designed and constructed with the purpose of approaching these objectives.

. . .

§161 The state of the art

General Principle 3 is critical for a correct understanding of how to apply the essential health and safety requirements (EHSRs). It first recalls that the EHSRs, when they are applicable to a given model of machinery, are legally binding. This is clear from the terms of Article 5 (a) setting out the obligations of machinery manufacturers. In this respect, it is important to distinguish the EHSRs of Annex I from the specifications of harmonised standards, the application of which is voluntary – see §110: comments on Article 7 (2).

The EHSRs set out in Annex I are usually expressed without qualification. The second sentence of General Principle 3 recognises that it may not always be possible to satisfy certain EHSRs fully, given the current state of the art. In such

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cases, the machinery manufacturer must strive to fulfil the objectives set out in the EHSRs to the greatest extent possible.

The notion of “the state of the art” is not defined as such in the Machinery Directive. However, it is clear from Recital 14 (see §16: comments) that the notion of ‘the state of the art’ includes both a technical and an economic aspect. In order to correspond to the state of the art, the technical solutions adopted to fulfil the EHSRs must employ the most effective technical means that are available at the time for a cost which is reasonable taking account of the total cost of the category of machinery concerned and the seriousness of the harm the risk reduction is required to address. For example the cost of compliance will be more relevant for the risk of minor fully recoverable injuries, but to reduce the risk of a fatal injury the cost “barrier” will be extremely high, when an adequate technical solution that already exists is not applied, for risks leading to a fatal injury.

Manufacturers of machinery cannot be expected to use solutions that are still at the research stage or technical means that are not generally available on the market. On the other hand, they must take account of technical progress and adopt the most effective technical solutions that are appropriate to the machinery concerned when they become available for a reasonable cost.

“The state of the art” is thus a dynamic concept: the state of the art evolves when more effective technical means become available or when their relative cost diminishes. Thus a technical solution that is considered to satisfy the EHSRs of the Directive at a given time may be considered inadequate at a later time, if the state of the art has evolved.

A machinery manufacturer can only take account of the state of the art at the time the machinery is constructed. If an evolution of the state of the art makes it possible to approach the objectives set out in the EHSRs more closely, a manufacturer producing a series of machines according to the same design must upgrade his design accordingly (while taking account of the time necessary for the redesign and the corresponding changes in the production process).

§162 Harmonised standards and the state of the art

Harmonised standards provide technical specifications that enable machinery manufacturers to comply with the EHSRs. Since harmonised standards are developed and adopted on the basis of a consensus between the interested parties, their specifications provide a good indication of the state of the art at the time they are adopted. The evolution of the state of the art is reflected in later amendments or revisions of harmonised standards. The evolution of the state of the art may mean a standard becomes outdated and is in need of a revision; the revision cycle (normally 5 years) should address this aspect, but in some cases the standard’s presumption of conformity may need to be withdrawn or limited – see §119: comments on Article 10.

In this respect, the level of safety afforded by the application of a harmonised standard provides a benchmark that must be taken into account by all manufacturers of the category of machinery covered by the standard, including those who choose to employ alternative technical solutions. A manufacturer who chooses alternative solutions must be able to demonstrate that these solutions are in conformity with the EHSRs of the Machinery Directive, taking account of the current state of the art. Consequently, such alternative solutions must provide a level of safety that it is at

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least equivalent to that afforded by application of the specifications of the relevant harmonised standard – see §110: comments on Article 7 (2).

When harmonised standards are not available, other technical documents may provide useful indications for applying the EHSRs of the Machinery Directive. Such documents include, for example, international standards, national standards, draft European standards, the Recommendations for Use issued by the European Coordination of Notified Bodies – see §137: comments on Article 14 (7) – or guidelines issued by professional organisations. However, application of such technical documents does not confer a presumption of conformity with the EHSRs of the Machinery Directive – see §383: comments on Annex II 1 A (8).

GENERAL PRINCIPLES (continued)133

. . .

4. This Annex is organised in several parts. The first one has a general scope and is applicable to all kinds of machinery. The other parts refer to certain kinds of more specific hazards. Nevertheless, it is essential to examine the whole of this Annex in order to be sure of meeting all the relevant essential requirements. When machinery is being designed, the requirements of the general part and the requirements of one or more of the other parts shall be taken into account, depending on the results of the risk assessment carried out in accordance with point 1 of these General Principles. Essential health and safety requirements for the protection of the environment are applicable only to the machinery referred to in section 2.4.

§163 The structure of Annex I

General principle 4 explains the structure of Annex I. The EHSRs set out in Part 1 of Annex I must be taken into account by manufacturers of all categories of machinery. With the exception of sections 1.1.2, 1.7.3 and 1.7.4 which are always applicable, the EHSRs set out in the other sections of Part 1 are applicable when the manufacturer’s risk assessment shows that the hazard concerned is present.

Parts 2 to 6 of Annex I deal with the following specific hazards:

Part 2 hazards specific to certain categories of machinery:

− foodstuffs machinery,

− machinery for cosmetics or pharmaceutical products,

− hand-held and hand-guided machinery,

− portable fixing machinery and other portable impact machinery,

− machinery for working wood and material with similar characteristics,

− machinery for pesticide application;

Part 3 hazards due to the mobility of machinery;

Part 4 hazards due to lifting operations;

133 General principle 4 was amended by Directive 2009/127/EC of the European Parliament and of the Council of 21 October 2009 amending Directive 2006/42/EC with regard to machinery for pesticide application. OJ L 310, 25.11.2009, p. 29.

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Part 5 hazards specific to machinery intended for underground work;

Part 6 hazards due to the lifting of persons.

The relevance of the EHSRs set out in each of these parts depends on whether a given model of machinery belongs to one or more of the categories of machinery concerned by Parts 2 or 5 or whether the manufacturer’s risk assessment show that the machinery presents one or more of the specific hazards referred to in Parts 3, 4 and 6 – see §160: comments on General Principle 2. For example, a mobile elevating work platform is subject to requirements set out in Parts 1, 3, 4, and 6. A hand-held circular saw for woodworking is subject to requirements set out in Parts 1 and 2.

In some cases, the EHSRs set out in Parts 2 to 6 are supplementary to EHSRs set out in the other parts of Annex I dealing with the same type of hazard. This is indicated in the comments on the sections concerned.

1. ESSENTIAL HEALTH AND SAFETY REQUIREMENTS

1.1 GENERAL REMARKS

1.1.1 Definitions

For the purpose of this Annex:

(a) ‘hazard’ means a potential source of injury or damage to health;

. . .

§164 Hazard

The term ‘hazard’ is used in the context of risk assessment with a meaning which may be different from everyday usage. In the context of risk assessment, ‘hazard’ refers to a potential source of harm. The presence of a hazard is an inherent feature of the machinery and is independent of whether or not any injury or damage to health is actually likely to occur. For example, the presence in the machinery of parts at a high temperature is a potential source of injuries, such as burns, or of damage to health, such as heat stress-related illness; the presence in the machinery of sharp blades is a potential source of injuries such as cuts or amputation. During the phase of hazard identification, a hazard must be considered to be present, even if the part of the machinery presenting the hazard is inaccessible.

Hazards can be identified by their physical origin (for example, mechanical hazard, electrical hazard) or by the nature of the potential injury or damage to health (for example, cutting hazard, crushing hazard, repetitive strain hazard, or electric shock hazard).

General Principle 1 requires the manufacturer to identify the hazards that are inherent to the machinery or that can be generated by its use, and the associated hazardous situations. A hazardous situation is a circumstance, an event or a sequence of events in which a person is exposed to a hazard. Hazardous situations can range in duration from a sudden event to a circumstance that is permanently present during use of the machinery.

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1.1.1 Definitions (continued)

. . .

(b) ‘danger zone’ means any zone within and/or around machinery in which a person is subject to a risk to his health or safety;

. . .

§165 Danger zone

The concept of ‘danger zone’ makes it possible to locate the places where persons may be exposed to a hazard. In the case of risks involving contact with moving parts of the machinery, for example, the danger zone is limited to the proximity of the hazardous parts. In the case of other risks, such as, for example, the risk of being hit by objects ejected from the machinery or the risk of exposure to noise emissions or emissions of hazardous substances from the machinery, the danger zone may include substantial areas in the environment of the machinery.

One of the most effective ways to prevent risks is to design machinery so as to avoid the need for persons to enter danger zones – see §189: comments on section 1.2.2, and §239: comments on section 1.6.1.

1.1.1 Definitions (continued)

. . .

(c) ‘exposed person’ means any person wholly or partially in a danger zone;

. . .

§166 Exposed person

The definition of the term ‘exposed person’ is very broad. Operators are one category of potentially exposed person – see §167: comments on section 1.1.1 (d). However, persons who do not have any direct involvement with the machinery may be present in a danger zone, particularly if the danger zones include areas in the environment of the machinery. In the case of machinery for professional use, such persons may be, for example, other employees of the company where the machinery is used or bystanders. In the case of machinery used on construction sites, on public roads or in urban areas, potentially exposed persons may include members of the public in the street or in buildings nearby. In the case of machinery such as agricultural machinery or machinery intended for use by consumers in the home or in the garden, potentially exposed persons may be family members including children. The EHSRs aim to prevent risks for all exposed persons. Consequently, the manufacturer’s risk assessment must include an assessment of the likelihood of operators and of any other persons being in a danger zone.

1.1.1 Definitions (continued)

. . .

(d) ‘operator’ means the person or persons installing, operating, adjusting, maintaining, cleaning, repairing or moving machinery;

. . .

§167 Operator

The definition of ‘operator’ gives the term a very broad sense. In the Machinery Directive, the term is used to designate all persons with specific tasks involving the machinery and is not limited to production operators. Operators include all the different persons dealing with the machinery in the various phases of its lifetime – see §173: comments on section 1.1.2 (a). In the case of machinery intended for use at the workplace, the operators may be professionals who may or may not have been specially trained. In the case of machinery designed for use by consumers, the operators using the machinery are non-professional and must be assumed not to have been specially trained – see §259: comments on section 1.7.4.1 (d). It should be noted that certain kinds of machinery are placed on the market for both professional use and for use by consumers.

1.1.1 Definitions (continued)

. . .

(e) ‘risk’ means a combination of the probability and the degree of an injury or damage to health that can arise in a hazardous situation;

. . .

§168 Risk

Like the term ‘hazard’, the term ‘risk’ is used in the Machinery Directive with a more precise sense than in everyday use. The existence of a risk depends on the hazards generated by the machinery and also on the interface between the machinery and the operators and other exposed persons. A hazard may be present on machinery, but if no person is liable to be exposed to that hazard, there is no risk.

Risks may be characterised by reference to the hazard or hazardous situation concerned (such as, for example, a risk due to contact with moving parts, a risk due to contact with hot surfaces, a risk due to noise emissions or emissions of hazardous substances); risks may also be characterised by reference to their possible consequences (such as, for example, a crushing risk, a cutting risk, a risk of being burnt, a risk of loss of hearing).

The third step of the process of risk assessment is to estimate the risks, taking into account the severity of the possible injury or damage to health and the probability of its occurrence – see §158: comments on General Principle 1. The estimation of the risk is based on a combination of these two factors. The most serious risks involve a combination of a high probability of occurrence and the possibility of fatal or severe injury or damage to health. However, a low probability of occurrence may still result in a serious risk if fatal or severe injuries or damage to health may result. Risks must therefore be evaluated on a case-by-case basis, taking account of the fact that risks may be different in the phases of the lifetime of the machinery, depending on the operations concerned and the state of the machinery during each phase – see §173: comments on section 1.1.2 (a).

Market surveillance authorities (MSAs) should use risk assessment to determine the level of appropriate action to take to deal with the risk and to inform other MSAs of high risk machinery on the EU market using the Rapid Alert System (RAPEX). A risk

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assessment procedure134 has been developed to assist in this process as well as a guideline on how the system should be used. This system was developed for consumer products but it is also applicable to industrial machinery. However, at the moment it is under review mainly to expand its scope to deal with Directives and Regulations where the risk is not primarily with respect to health and safety of persons.

1.1.1 Definitions (continued)

. . .

(f) ‘guard’ means a part of the machinery used specifically to provide protection by means of a physical barrier;

. . .

§169 Guard

The term ‘guard’ is used for parts of the machinery specifically designed to fulfil a protective function. Other parts of the machinery that fulfil a primarily operational function, such as, for example, the frame of the machinery, may also fulfil a protective function but are not referred to as guards.

Guards are defined as providing protection by means of a physical barrier such as, for example, a casing, a shield, a cover, a screen, a door, an enclosure or a fence. The term ‘physical barrier’ implies that a guard is constituted by a solid material such as, for example, steel or plastic, to be chosen according to the protection required. The materials used may be continuous or perforated and may be rigid or flexible.

Guards are one of the means that can be used to prevent access to danger zones in or around machinery. In many cases, the guard acts as a barrier in both directions in order to protect against two or more risks simultaneously. For example, a guard may be fitted both to prevent persons entering a danger zone and also to prevent ejected objects or fluids, noise emissions, radiation or hazardous substances from reaching persons in the environment of the machinery.

The Machinery Directive distinguishes three main kinds of guards: fixed guards, interlocking moveable guards and adjustable guards restricting access – see §217: comments on section 1.4.2 of Annex I.

When placed independently on the market, guards are considered as safety components – see §42: comments on Article 2 (c) and §389: comments on Annex V (1) (3) and (7).

1.1.1 Definitions (continued)

. . .

(g) ‘protective device’ means a device (other than a guard) which reduces the risk, either alone or in conjunction with a guard;

. . .

§170 Protective devices

Protective devices are distinguished from guards since they do not constitute a physical barrier between the exposed person and the danger zone but reduce risks by preventing exposure to the hazard by other means. Protective devices include, for example, two-hand control devices, sensitive protective equipment such as pressure-sensitive mats and sensitive edges, trip bars and trip wires, and opto-electronic protective devices such as light curtains, laser scanners or camera-based safeguarding systems – see §221: comments on section 1.4.3 of Annex I.

When placed independently on the market, protective devices are considered as safety components – see §42: comments on Article 2 (c) and §389: comments on Annex V (2) and (7).

1.1.1 Definitions (continued)

. . .

(h) ‘intended use’ means the use of machinery in accordance with the information provided in the instructions for use;

. . .

§171 Intended use

The first step of the risk assessment process described in General Principle 1 is to determine the limits of the machinery, which include the intended use of the machinery. Machinery is not necessarily safe for all possible uses: for example, the manufacturer of machinery intended for working metal has usually not designed the machinery for safely working wood and vice versa; for example, the manufacturer of a mobile elevating work platform usually has not designed the machine to be safely used as a crane. The manufacturer’s risk assessment and the design and construction of the machinery must therefore be based on specified use or uses. The specification of the intended use of the machinery must cover, where appropriate, the different operating modes and phases of use of the machinery – see §173: comments on section 1.1.2 (a).

In particular, the parameters on which the safe use of the machinery depends and their limits must be precisely specified. Such parameters include, for example, the maximum load for lifting machinery; the maximum slope on which mobile machinery can be used without loss of stability; the maximum wind-speed in which machinery can be safely used outdoors; the maximum dimensions of workpieces and the type of material that can be safely processed by a machine tool.

The intended use of the machinery is the use defined and described in the manufacturer’s instructions – see §263: comments on section 1.7.4.2 (g).

1.1.1 Definitions (continued)

. . .

(i) ‘reasonably foreseeable misuse’ means the use of machinery in a way not intended in the instructions for use, but which may result from readily predictable human behaviour.

§172 Reasonably foreseeable misuse

The first step of the risk assessment process described in General Principle 1 also requires the manufacturer to take account of reasonably foreseeable misuse of machinery. The machinery manufacturer cannot be expected to take account of all possible misuse of the machinery. However, certain kinds of misuse, whether intentional or unintentional, are predictable on the basis of experience of past use of the same type of machinery or of similar machinery, accident investigations and knowledge about human behaviour – see §173: comments on sections 1.1.2 (a), §175: comments on section 1.1.2 (c), and §263: comments on section 1.7.4.2 (h).

The “A” type standard EN ISO 12100:2010 gives the following examples of the kinds of misuse or readily predictable human behaviour that may have to be taken into account:

− loss of control of the machine by the operator;

− reflex behaviour of a person in case of malfunction, incident or failure during the use of the machine;

− behaviour resulting from lack of concentration or carelessness;

− behaviour resulting from taking the line of least resistance in carrying out a task;

− behaviour resulting from pressures to keep machinery running in all circumstances;

− the behaviour of certain persons such as children.

Such behaviour can result in a range of misuse situations, such as, for example, using a crane or a MEWP without deploying the stabilisers; leaving the door open on an earthmoving truck in hot weather thereby defeating the air filtering and noise control equipment; two people operating a press designed for use by a single person.

Particular attention must be given to factors that may lead to the removal, disabling or defeating of guards and protective devices – see §216: comments on section 1.4.1.

1.1.2 Principles of safety integration

(a) Machinery must be designed and constructed so that it is fitted for its function, and can be operated, adjusted and maintained without putting persons at risk when these operations are carried out under the conditions foreseen but also taking into account any reasonably foreseeable misuse thereof.

The aim of measures taken must be to eliminate any risk throughout the foreseeable lifetime of the machinery including the phases of transport, assembly, dismantling, disabling and scrapping.

. . .

§173 Principles of safety integration

Section 1.1.2, setting out the principles of safety integration, sometimes referred to as safety by design, is a key section of Annex I. Section 1.1.2 sets out a basic methodology for designing and constructing safe machinery which is fundamental to

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the approach of the Machinery Directive135. General Principle 2 states that this EHSR is applicable to all machinery. When applying the other EHSRs, the principles of safety integration set out in section 1.1.2 must always be followed.

Section 1.1.2 (a) first states that machinery must be fitted for its function. The Machinery Directive is primarily concerned with safety and does not contain any specific requirements relating to the performance of machinery. It is generally considered that the performance of machinery is a matter to be left to the market and that users will select machinery with performance characteristics appropriate to their needs. However, the aptitude of machinery to fulfil its function correctly does affect safety in so far as inadequate functioning of the machinery may lead to hazardous situations or be conducive to misuse.

Section 1.1.2 (a) then sets out the general objective that machinery must be designed and constructed so that it can be operated, adjusted and maintained without putting persons at risk. The term ‘persons’ covers both operators and any other exposed persons – see §166 and §167: comments on sections 1.1.1 (c) and (d). In order to achieve this objective, the manufacturer must consider both the intended conditions of use, but also any reasonably foreseeable misuse of the machinery – see §172: comments on section 1.1.1 (i).

The second paragraph of section 1.1.2 (a) sets out the objective of preventing risks throughout the foreseeable lifetime of the machinery, including the phases of transport, assembly, dismantling, disabling and scrapping. On the one hand, this requirement implies that safety related components and assemblies must be sufficiently strong and durable – see §207: comments on section 1.3.2, §339 to §341: comments on sections 4.1.2.3, 4.1.2.4, 4.1.2.5, and §369: comments on section 6.1.1 – and that adequate instructions must be given for the maintenance and replacement of components subject to fatigue and wear – see §272: comments on section 1.7.4.2 (r). On the other hand, this paragraph requires the manufacturer to address not only the risks generated during operation, setting and maintenance of the machinery but also during the other phases of its lifetime:

− transport

Measures to prevent the risks associated with the transport of machinery include, for example:

− the design of machinery to facilitate its handling – see §180: comments on section 1.1.5;

− measures to ensure the stability of the machinery during transport – see §206: comments on sections 1.3.1, and comments on section 4.1.2.1;

− measures to ensure adequate mechanical strength during transport – see §338: comments on section 4.1.2.3;

− providing instructions for safe transport – see §269 and §270: comments on sections 1.7.4.2 (o) and (p).

135 EN ISO 12100-1:2003 + A1:2009 – Safety of machinery – Basic concepts, general principles for design – Part 1: Basic terminology, methodology (ISO 12100-1:2003); EN ISO 12100-2:2003 + A1:2009 – Safety of machinery – Basic concepts, general principles for design – Part 2: Technical principles (ISO 12100-2:2003).

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Such measures are particularly important for machinery intended to be transported between successive sites during its lifetime.

− assembly and dismantling

Design of machinery to facilitate assembly and dismantling is also particularly important in the case of machinery intended for temporary installation on successive sites during its lifetime. The measures to be taken include, for example:

− preventing errors of fitting – see §225: comments on section 1.5.4;

− providing adequate instructions, including guide markings on the machine – see §264 and §269: comments on sections 1.7.4.2 (i) and (o).

− disabling and scrapping

The Machinery Directive does not include requirements relating to the disposal, recycling or reuse of machinery components or materials when machinery is scrapped.

The measures referred to in the second paragraph to prevent risks during the disabling and scrapping of the machinery at the end of its lifetime are those that can be taken by the machinery manufacturer. Such measures may include, for example, ensuring that parts containing hazardous substances are suitably and indelibly marked, ensuring that hazardous substances contained in the machinery can be safely evacuated and ensuring that any stored energy can be safely dissipated when the machinery is disabled, in order to avoid hazards during scrapping – see §178: comments on section 1.1.3.

1.1.2 Principles of safety integration (continued)

. . .

(b) In selecting the most appropriate methods, the manufacturer or his authorised representative must apply the following principles, in the order given:

— eliminate or reduce risks as far as possible (inherently safe machinery design and construction),

— take the necessary protective measures in relation to risks that cannot be eliminated,

— inform users of the residual risks due to any shortcomings of the protective measures adopted, indicate whether any particular training is required and specify any need to provide personal protective equipment.

. . .

§174 The 3-step method

Section 1.1.2 (b) sets out the approach that must be adopted when determining the measures to be taken to deal with the risks that have been identified and assessed by means of the risk assessment described in General Principle 1. This hierarchy of measures explained below is a one of the most important requirements of the Directive. The three successive steps are put in an order of priority, often referred to as the 3-step method:

 Step 1 = first priority – Inherently safe design measures

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 Step 2 = second priority – Technical protective measures

 Step 3 = third priority – Information for users

This order of priority must be adhered to when selecting measures to deal with a given risk in order to satisfy the corresponding EHSR. Consequently, the manufacturer must exhaust all the possible inherently safe design measures before resorting to protective measures. Similarly, he must exhaust the possible protective measures before relying on warnings and instructions to operators. Application of the 3-step method must also take due account of the state of the art – see §161: comments on General Principle 3.

− Step 1 = first priority

The first priority is given to inherently safe design measures because they are more effective than protective measures or warnings. Some examples of inherently safe design measures are, for example:

− eliminating the hazard altogether, for example, replacing flammable hydraulic fluid with a non-flammable type, removing risk of falls by having maintenance points easily accessible at ground level rather than at height. – see §178: comments on section 1.1.3;

− designing the control system and control devices in order to ensure safe functioning – see §184 to §185: comments on sections 1.2, and §297 and §298: comments on section 3.3;

− ensuring the inherent stability of machinery by its shape and the distribution of masses – see §206: comments on sections 1.3.1;

− ensuring that accessible parts of the machinery do not have sharp edges or rough surfaces – see §209: comments on section 1.3.4;

− ensuring sufficient distance between moving and fixed parts of the machine to avoid the risk of crushing – see §212: comments on section 1.3.7;

− placing the operator so they have all round direct vision of danger areas;

− avoiding accessible surfaces with extreme temperatures – see §226: comments on section 1.5.5;

− reducing emissions of noise, vibrations, radiation or hazardous substances at source – see §229: comments on section 1.5.8, §231: comments on section 1.5.9, §232: comments on section 1.5.10, and §235: comments on section 1.5.13;

− reducing, where possible, the speed and the power of moving parts or the travel speed of the machinery itself;

− locating hazardous parts of machinery in inaccessible places – see §212: comments on section 1.3.7;

− locating adjustment and maintenance points outside danger zones – see §239: comments on section 1.6.1 of Annex I.

− Step 2 = second priority

When it is not possible to eliminate hazards or sufficiently reduce risks by inherently safe design measures, the second priority is given to technical protective measures

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to prevent persons from being exposed to the hazards. Some examples of technical protective measures are, for example:

− guards: fixed guards, interlocking moveable guards with guard locking where necessary or adjustable guards restricting access – see §218 to §220: comments on sections 1.4.2.1 to 1.4.1.3;

− protective devices – see §221: comments on section 1.4.3;

− insulation of live electrical parts – see §222: comments on section 1.5.1;

− enclosure of sources of noise – see §229: comments on section 1.5.8;

− damping of vibrations – see §231: comments on section 1.5.9;

− containment or evacuation of hazardous substances – see §235: comments on section 1.5.13;

− devices to compensate the lack of direct visibility – see §294: comments on section 3.2.1;

− protective structures against the risk of rolling or tipping over or the risk of falling objects – see §315 and §316: comments on sections 3.4.3 and 3.4.4;

− stabilisers – see §335: comments on sections 4.1.2.1.

− Step 3 = third priority

Finally, for the residual risks that cannot be adequately reduced by inherently safe design measures or by technical protective measures, information must be given to exposed persons, in the form of warnings, signs and information on the machinery, and to users in the instructions so that the necessary precautions and measures can be taken by the users136. Some examples of such warnings and instructions are:

− Information or warnings on the machinery in the form of symbols or pictograms – see §245: comments on section 1.7.1;

− warning acoustic or light signals – see §248: comments on section 1.7.1.2;

− indicating of the mass of machinery or parts thereof which must be handled with lifting equipment during the different phases of its foreseeable lifetime – see comments on section – see §253: comments on section 1.7.3;

− warning against the use of machinery by certain persons such as, for example, young people under a certain age or height – see §263: comments on section 1.7.4.2 (g);

− information relating to the safe assembly and installation of the machinery – see §264: comments on section 1.7.4.2 (i);

− specifying the need to provide the necessary information and training to operators – see §266: comments on section 1.7.4.2 (k).

− information on the complementary protective measures to be taken in the workplace – see §267: comments on section 1.7.4.2 (l);

136 Such measures are subject to the national provisions implementing Directive 89/391/EEC as amended on the introduction of measures to encourage improvements in the safety and health of workers at work (the “Framework” Directive) and to the individual Directives adopted within this framework – see §140, comments on Article 15.

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− specifying the need to provide the appropriate personal protective equipment to operators and ensure that it is used – see §267: comments on section 1.7.4.2 (m)137.

Providing warnings and instructions for use is considered as an integral part of the design and construction of the machinery. However, the fact that this third step is the last in the order of priority given in section 1.1.2 (b) means that warnings and instructions must not be a substitute for inherently safe design measures and technical protective measures when these are possible, taking into account the state of the art.

1.1.2 Principles of safety integration (continued)

. . .

(c) When designing and constructing machinery and when drafting the instructions, the manufacturer or his authorised representative must envisage not only the intended use of the machinery but also any reasonably foreseeable misuse thereof.

The machinery must be designed and constructed in such a way as to prevent abnormal use if such use would engender a risk. Where appropriate, the instructions must draw the user’s attention to ways — which experience has shown might occur — in which the machinery should not be used.

. . .

§175 Preventing abnormal use

Section 1.1.2 (c) follows logically from section 1.1.2 (a). Since the machinery manufacturer must envisage both the intended use of the machinery and also reasonably foreseeable misuse – see §172: comments on section 1.1.1 (i) – measures must also be taken to prevent foreseeable abnormal use that would engender a risk. These measures must be chosen according to the order of priority set out in section 1.1.2 (b). Thus the manufacturer must as far as possible prevent foreseeable abnormal use by technical means. Example of such means include, for example:

− providing means for restricting the operation of the machinery or of certain control devices to authorised persons – see §204: comments on section 1.2.5, and §297: comments on section 3.3;

− designing machinery to prevent errors of fitting – see §225: comments on section 1.5.4;

− fitting devices to prevent the travel of mobile machinery when the driver is not at the controls – see §304: comments on section 3.3.2;

− fitting devices to prevent the operation of machinery unless stabilisers are in position – see §335: comments on section 4.1.2.1;

− fitting devices to prevent the overloading of lifting machinery – see §354: comments on sections 4.2.2, and §370: comments on section 6.1.2.

137 The provision of personal protective equipment at the workplace is subject to the national provisions implementing Council Directive 89/656/EEC on the minimum health and safety requirements for the use by workers of personal protective equipment at the workplace.

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Where there remains a residual risk of foreseeable misuse that cannot be entirely prevented by such technical means, appropriate warnings must be given on the machinery – see §249: comments on section 1.7.2 – and in the instructions – see §263: comments on section 1.7.4.2 (h).

1.1.2 Principles of safety integration (continued)

. . .

(d) Machinery must be designed and constructed to take account of the constraints to which the operator is subject as a result of the necessary or foreseeable use of personal protective equipment.

. . .

§176 Constraints due to the use of PPE

Section 1.1.2 (d) deals with a particular aspect of the intended use of machinery. Machinery operators may be required to wear or carry personal protective equipment (PPE) to deal with residual hazards generated by the machinery itself, such as, for example, hearing protectors to protect against noise emissions or eye protectors to protect against the risk of projections of hazardous substances or objects. They may also be required to use PPE to protect against hazards that are not generated by the machinery but which are present in the environment in which the machinery is used. For example, machinery operators may have to wear protective footwear to protect their feet against shocks and sharp objects on the construction site or in the workplace where the machinery is used. Machinery operators may have to wear protective gloves, clothing and footwear if the machinery is used in cold or hot atmospheres or in adverse weather conditions.

The design and construction of the machinery and, in particular, the design, positioning and dimensions of the control devices, must take account of the constraints to which the operator is likely to be subject due to such use of PPE. For example, on machinery designed to be used in cold conditions, the spacing, size and design of foot-pedals should be such as to accommodate the wearing of large boots – see §300: comments on section 3.3.1.

1.1.2 Principles of safety integration (continued)

. . .

(e) Machinery must be supplied with all the special equipment and accessories essential to enable it to be adjusted, maintained and used safely.

§177 Special equipment and accessories

Section 1.1.2 (e) does not require machinery manufacturers to supply standard tools and equipment required for adjustment and maintenance operations (screwdrivers, spanners, wrenches, hoists and the like) that may be used with different kinds of machinery. However, if the safe adjustment, maintenance or use of the machinery requires the use of equipment or accessories that are specific to machinery concerned, such equipment or accessories must be made available by the machinery manufacturer with the machinery. Such special equipment may include, for example, devices for the removal of parts of the machinery for cleaning purposes or devices for feeding or loading and unloading workpieces.

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1.1.3 Materials and products

The materials used to construct machinery or products used or created during its use must not endanger persons’ safety or health. In particular, where fluids are used, machinery must be designed and constructed to prevent risks due to filling, use, recovery or draining.

§178 Materials and products used

The requirement set out in section 1.1.3 deals with several kinds of risk:

a) Risks due to materials or products used to construct the machinery such as, for example, metals, plastics, textiles or paints.

Attention must be given to risks for the health and safety of operators or other exposed persons due to contact with these materials or, for example, due to hazardous substances that may be emitted by these materials when they heat up, are disturbed or are subject to wear. As far as possible, these risks must be prevented by the choice of innocuous materials for the construction of the machinery.

b) Risks due to materials or products used by the machinery such as fuels, lubricants, hydraulic fluids, chemicals, battery electrolyte, water, steam, compressed air and so on.

Such risks can be eliminated or reduced by designing the machinery to use innocuous materials or products or by substituting hazardous materials or products with less hazardous ones. The manufacturer’s instructions must specify the appropriate materials or products to be used with the machinery. Where risks remain, protective measures must be taken to protect operators against exposure to hazardous materials or products used by the machinery, for example, by ensuring that they are inaccessible or adequately contained. Where necessary, appropriate warnings must be given on the machinery and in the instructions.

The second sentence of section 1.1.3 underlines particular aspects that must be considered when fluids are used. The measures to be taken to prevent risks due to filling, use, recovery or draining of fluids include, for example, the appropriate location and design of tanks and reservoirs and of their filling and draining points and the fitting of a retention tray under hydraulic equipment if leaks cannot be entirely prevented. When tanks are pressurised, they must be provided with means of reducing them to a safe pressure and of checking the pressure prior to the opening of filling or draining points.

c) Risks due to materials or products worked, processed or transformed by the machinery, such as metals, rubber, plastics, wood, foodstuffs, cosmetics and so on.

The manufacturer of the machinery must take account of the materials to be worked by the machinery and take measures to prevent risks due to hazards such as, for example, sharp edges, splinters, ejected fragments or hot or cold materials.

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d) Risks due to materials or products created during the use of the machinery. Such materials may either be the intended products of the machinery or by-products or waste such as, for example, chips, shavings, fumes or dust.

It should be noted that the reference in section 1.1.3 to “risks due to … products created during the use” of the machinery does not concern the product safety of products produced by machinery.

Certain aspects of the risks mentioned in (a) to (d) above are subject to specific EHSRs – see §208: comments on section 1.3.3 on risks due to falling or ejected objects, §226: comments on section 1.5.5 on extreme temperatures, §227: comments on section 1.5.6 on the risk of fire, § 228: comments on section 1.5.7 on the risk of explosion, and §235: comments on section 1.5.13 on emissions of hazardous materials and substances.

1.1.4 Lighting

Machinery must be supplied with integral lighting suitable for the operations concerned where the absence thereof is likely to cause a risk despite ambient lighting of normal intensity.

Machinery must be designed and constructed so that there is no area of shadow likely to cause nuisance, that there is no irritating dazzle and that there are no dangerous stroboscopic effects on moving parts due to the lighting.

Internal parts requiring frequent inspection and adjustment, and maintenance areas must be provided with appropriate lighting.

§179 Integral lighting

The machinery manufacturer is entitled to assume that the ambient lighting in the place of use is of normal intensity. Normal intensity can be judged, for example, by taking into account the levels for indoor and outdoor workplaces indicated in standards EN 12464, parts 1 and 2138.

The first paragraph of section 1.1.4 requires the manufacturer to provide lighting integral to the machinery when normal ambient lighting is likely to be inadequate to ensure safe operation of the machinery. Such lighting may be necessary, for example, at work stations that are likely to be in the shade or in enclosed or covered work stations or cabs. Such lighting may also be necessary where the visual tasks of the operators require a higher level of luminance than is likely to be provided by the ambient lighting. The third paragraph of section 1.1.4 adds the requirement for integral lighting for internal parts to which access is frequently required for inspection, adjustment and maintenance purposes.

The second paragraph of section 1.1.4 concerns the design of the integral lighting, to ensure that it does not generate other hazards.

Specifications for integral lighting are given in standard EN 1837139.

138 EN 12464-1:2002 2011 Light and lighting – Lighting of work places – Part 1: Indoor work places; EN 12464-2:2014 Lighting of work places – Part 2: Outdoor work places.

139 EN 1837:1999+A1:2009 Safety of machinery – Integral lighting of machines.

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1.1.5 Design of machinery to facilitate its handling

Machinery, or each component part thereof, must:

— be capable of being handled and transported safely,

— be packaged or designed so that it can be stored safely and without damage.

During the transportation of the machinery and/or its component parts, there must be no possibility of sudden movements or of hazards due to instability as long as the machinery and/or its component parts are handled in accordance with the instructions.

Where the weight, size or shape of machinery or its various component parts prevents them from being moved by hand, the machinery or each component part must:

— either be fitted with attachments for lifting gear, or

— be designed so that it can be fitted with such attachments, or

— be shaped in such a way that standard lifting gear can easily be attached.

Where machinery or one of its component parts is to be moved by hand, it must:

— either be easily moveable, or

— be equipped for picking up and moving safely.

Special arrangements must be made for the handling of tools and/or machinery parts which, even if lightweight, could be hazardous.

§180 Handling of machinery and parts of machinery

The requirements set out in section 1.1.5 are to be applied in the light of an analysis of the different phases of the lifetime of the machinery concerned – see §173: comments on section 1.1.2 (a).

Section 1.1.5 applies to ‘machinery or each component part thereof’. This does not mean that all parts of machinery must be designed for safe handling, but only those parts of the machinery, or the machinery itself, which may have to be handled separately.

Portable hand-held and/or hand guided machinery is subject to specific requirements – see §278: comments on section 2.2.1.

Handling of machinery or parts of machinery is frequently carried out during phases other than normal operation such as, for example, transport, loading and unloading, assembly, installation, dismantling, setting or maintenance. A hand-held power tool intended for consumer use, for example, must be packaged so that it can be safely transported, stored during distribution and carried home by the consumer. A machine tool, for example, must be packaged for transport to the user’s premises and designed and constructed so that it can be safely loaded, transported, unloaded and moved to the place of installation. Heavy parts of machinery such as, for example the mould of an injection moulding machine or the die of a metal working press, may need to be changed frequently, depending on the work to be carried out.

Machinery intended to be installed on successive sites during its lifetime, such as, for example, tower cranes, must be designed so that their elements can be safely handled during assembly and disassembly and safely loaded and attached on the means of transport between installation sites. Special attention should be given to

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parts that may become unstable during transport, for example, on a lorry travelling on uneven ground. Loading instructions are required and, in some cases, extra equipment may be needed ensure stability during transport, such as, for example, a transport support frame.

The third and fourth paragraphs of section 1.1.5 distinguish machinery or component parts that cannot be safely moved by hand from machinery or parts that can be safely moved by hand. When evaluating whether machinery or parts of machinery fall into one or other category, account should be taken of national regulations implementing the provisions of Directive 90/269/EEC140 and of the criteria given in the relevant harmonised standards141.

When designing machinery or parts of machinery to be safely moved or lifted by hand, sharp edges must be avoided. Particular attention must be given to the required posture of the operator142.

1.1.6 Ergonomics

Under the intended conditions of use, the discomfort, fatigue and physical and psychological stress faced by the operator must be reduced to the minimum possible, taking into account ergonomic principles such as:

− allowing for the variability of the operator’s physical dimensions, strength and stamina,

− providing enough space for movements of the parts of the operator’s body,

− avoiding a machine-determined work rate,

− avoiding monitoring that requires lengthy concentration,

− adapting the man/machinery interface to the foreseeable characteristics of the operators.

§181 Ergonomic principles

The requirements set out in section 1.1.6 refer to ergonomics. The discipline of ergonomics can be defined as follows:

“Ergonomics (or the study of human factors) is the scientific discipline concerned with the understanding of interactions among human and other elements of a system, and the profession that applies theory, principles, data and methods to design in order to optimize human well-being and overall system performance”143.

140 Council Directive 90/269/EEC of 29 May 1990 on the minimum health and safety requirements for the manual handling of loads where there is a risk particularly of back injury to workers (fourth individual Directive within the meaning of Article 16 (1) of Directive 89/391/EEC). OJ L 156, 21.6.1990, p. 9.

141 EN 1005-2:2003+A1:2008 Safety of machinery – Human physical performance – Part 2: Manual handling of machinery and component parts of machinery.

142 EN 1005-4: 2005+A1: 2008 Safety of machinery – Human physical performance – Part 4: Evaluation of working postures and movements in relation to machinery.

143 EN ISO 6385: 2004 Ergonomic principles in the design of work systems (ISO6385:2004).

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The ergonomic aspects referred to in section 1.1.6 can be distinguished into two groups. The first group includes ergonomic factors that have to be taken into account when designing machinery. Five factors are listed in the indents of section 1.1.6, however it should be underlined that this list is not exhaustive but is intended to draw the attention of manufacturers to certain important aspects of ergonomic principles.

The second group, listed in the first sentence of section 1.1.6, includes negative effects that can be caused by these factors. Good design reduces the negative effects of these factors on persons whereas inadequate design is likely to give rise to discomfort, fatigue or physical or psychological stress. These effects may, in turn, give rise to musculoskeletal disorders and other ill-health effects, for example. They also can be a factor that makes injury accidents more likely.

The following diagram illustrates requirements set out in section 1.1.6:

Ergonomic factors Possible negative consequences

Guidance on the practical application of ergonomic principles to the design and construction of machinery is given in a family of harmonised standards developed by CEN TC 122 Ergonomics. The relationship between these standards and the ergonomic factors listed above is presented in a separate table and in series of information sheets.

In addition to the general requirement set out in section 1.1.6, ergonomic principles must also be taken into account when applying the essential health and safety requirements (EHSRs) set out in a number of other sections of Annex I to the

Operators

variability

Space of

movements

Work rate

Concentration

Man/machinery

interface

Allowing for the variability

of the operators:

 physical dimension

 strength

 stamina

Providing enough space for movements of the parts of the operator`s body:

 posture

 dynamic

Avoiding a machine-determined work rate:

 pace

 speed

Avoiding monitoring that requires lengthy concentration:

 vigilance

 mental operations (number, complexity)

Adapting the man/machine interfaces to the foreseeable characteristics of the operators:

 visual

 auditory

 sensitivity

 sensory

Physical

stress

Psychological

stress

Discomfort

Fatigue

Stressors, loads

Negative effects

Under the intended condition of use of the machinery, the discomfort, fatigue, and physical and psychological stress faced by the operator must be reduced.

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Machinery Directive 2006/42/EC. For example, the following EHSRs include important ergonomic aspects:

EHSRs applicable to all machinery:

− Lighting (section 1.1.4),

− Handling of machinery or parts of machinery (section 1.1.5),

− Operating positions (sections 1.1.7 and 1.1.8),

− Control devices (section 1.2.2),

− Extreme temperatures (section 1.5.5),

− Noise (section 1.5.8),

− Vibrations (section 1.5.9),

− Radiation (section 1.5.10),

− Emissions of hazardous materials and substances (section 1.5.13),

− Risk of tripping, slipping and falling (section 1.5.15),

− Machinery maintenance (section 1.6.1),

− Access to operating positions and servicing points (section 1.6.2),

− Operator intervention (section 1.6.4),

− Information (section 1.7);

Supplementary EHSRs for portable hand-held and/or hand guided machinery:

− General requirements (section 2.2.1),

− Instructions – vibrations (section 2.2.1.1);

Supplementary EHSRs for the mobility of machinery:

− Driving positions (section 3.2.1),

− Seating (section 3.2.2),

− Positions for other persons (section 3.2.3),

− Control devices (section 3.3.1),

− Starting/moving (section 3.3.2),

− Movement of pedestrian controlled machinery (section 3.3.4),

− Means of access (section 3.4.5),

− Signs, signals and warnings (section 3.6.1),

− Instructions – vibrations (section 3.6.3.1);

Supplementary EHSRs for lifting operations:

− Movement of loads during handling (section 4.1.2.7),

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− Access to the carrier (sections 4.1.2.8.2),

− Control of movements (section 4.2.1);

Supplementary EHSRs for the lifting of persons:

− Control devices (section 6.2),

− Access to the carrier (section 6.4.3).

A guidance document on the application of essential health and safety requirements on ergonomics, as approved by the Machinery Working Group, is available on EUROPA website for machinery144 and to be noted that it is in process to be revised and updated.

1.1.7 Operating positions

The operating position must be designed and constructed in such a way as to avoid any risk due to exhaust gases and/or lack of oxygen.

If the machinery is intended to be used in a hazardous environment presenting risks to the health and safety of the operator or if the machinery itself gives rise to a hazardous environment, adequate means must be provided to ensure that the operator has good working conditions and is protected against any foreseeable hazards.

Where appropriate, the operating position must be fitted with an adequate cabin designed, constructed and/or equipped to fulfil the above requirements. The exit must allow rapid evacuation. Moreover, when applicable, an emergency exit must be provided in a direction which is different from the usual exit.

§182 Operating positions in hazardous environments

Operating positions are the places on or at the machinery where operators, as defined in section 1.1.1 (d), carry out their tasks. The manufacturer’s instructions must describe the workstation(s) likely to be occupied by operators – see §262: comments on section 1.7.4.2 (f).

The requirement set out in the first paragraph of section 1.1.7 applies mainly to machinery with internal combustion engines. This requirement implies, firstly, that the emission of hazardous exhaust gases must be reduced as far as possible. For example, in the case of machinery designed to be used in enclosed spaces, appropriate systems for the extraction or filtering of exhaust gases must be fitted. Secondly, where there remains a risk of exposure to hazardous exhaust gases, means must be provided to ensure that operators do not inhale such gases and are provided with an adequate supply of breathable air.

The second paragraph of section 1.1.7 is more general and requires operators to be protected against any risks due to the foreseeable use of the machinery in a hazardous environment. Such risks may include, for example, exposure to hot and cold atmospheres, to risks due to noise, radiation, humidity, adverse weather conditions or atmospheres polluted by hazardous substances. This section also covers the risk of electric shock due to overhead lines in the operating area (e.g. agricultural spray machines working under such lines). The manufacturer must

144 http://ec.europa.eu/growth/sectors/mechanical-engineering/machinery/

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therefore take account of the intended and foreseeable conditions of use of the machinery. For example, if the machinery is placed on the market in a country with a mild climate, it might not be necessary to provide protection against extremely cold weather, whereas protection against dust or heat might be needed. Special consideration needs to be given to machinery that generates hazardous substances, such as dust, fume or toxic aerosols, by its very operation; examples are machinery for rock crushing and screening, machinery for grain handling, agricultural spray machinery and paint spray booths.

The third paragraph of section 1.1.7 refers to one of the means that can be used to ensure that operating positions are protected. ‘Cabin’ in this paragraph is a generic term for an enclosed operating position such as, for example, a cab on mobile machinery or an enclosed control panel on fixed industrial machinery. In order to fulfil the requirements set out in the first two paragraphs of section 1.1.7, the cabin or enclosure must be provided with the necessary means of purifying and conditioning the air entering the enclosure and preventing inward leaks, for example, by maintaining a positive pressure differential with the outside atmosphere. As well as ensuring protection against hazardous environments, such enclosures can also be designed and constructed to protect operators against exposure to noise emissions – see §229: comments on section 1.5.8. On some mobile machinery, the cab may include a structure to protect against the risk of rolling or tipping over or the risk due to falling objects or both – see §315 and §316: comments on sections 3.4.3 and 3.4.4.

It should be noted that operator’s cabins which are an integrated part of a building (e.g. for concrete batching plant or asphalt mixing plant) are not covered by the Machinery Directive, being subject to national regulations, unless they are provided by the manufacturer as part of machinery when placed on the market. However, the control panels provided by the manufacturer shall comply with the Machinery Directive.

1.1.8 Seating

Where appropriate and where the working conditions so permit, work stations constituting an integral part of the machinery must be designed for the installation of seats.

If the operator is intended to sit during operation and the operating position is an integral part of the machinery, the seat must be provided with the machinery.

The operator’s seat must enable him to maintain a stable position. Furthermore, the seat and its distance from the control devices must be capable of being adapted to the operator.

If the machinery is subject to vibrations, the seat must be designed and constructed in such a way as to reduce the vibrations transmitted to the operator to the lowest level that is reasonably possible. The seat mountings must withstand all stresses to which they can be subjected. Where there is no floor beneath the feet of the operator, footrests covered with a slip-resistant material must be provided.

§183 Seating and the provision of seats

The requirement set out in section 1.1.8 deals with a specific aspect of the interface between the operator and the machinery that can be a source both of discomfort, fatigue and damage to health if badly designed – see §181: comments on section 1.1.6.

The first paragraph of section 1.1.8 requires machinery to be designed to enable seats to be installed, ‘where appropriate and where the working conditions so permit’. Machinery manufacturers must therefore consider whether operators are likely to be more comfortable and to carry out all or part of their tasks more easily and efficiently when seated145. Where this is the case, the work station, in other words, the place at the machinery where the operators are to be seated, must be designed so that the necessary seats can be installed. This implies paying attention, in particular, to the height of the work surfaces, to the location and design of the control devices and the other parts of the machinery to which the operators must have access and to the space provided for the seat itself and for the operators upper and lower limbs.

The second paragraph of section 1.1.8 is applicable when the operator is intended to sit during operation and the operating position is an integral part of the machinery, in other words, when the operator’s seat is not to be installed on the floor next to the machinery but on part of the machinery itself. In that case, the seat must be provided with the machinery.

The second and third paragraphs of section 1.1.8 set out requirements for the seat. The seat must be designed to enable the operator to maintain a stable position taking account of the foreseeable conditions of use including, in particular, foreseeable movements of the machinery.

The relevant parameters of the seat itself such as the height, width, depth and angle of the seat, the position of the backrest and, where appropriate, the position of the arm and footrests, must be adjustable to take account of the variability of operators’ physical dimensions. The position of the seat relative to the position of the control devices, including foot-pedals, to be used by the operator must also be adjustable. This can be achieved by allowing for adjustment of the position of the seat, of the control devices or both146.

For machinery where the seated operator may be exposed to vibration due to the functioning of the machinery itself or due to the movement of the machinery on uneven ground, the provision of a seat with an appropriate damped suspension system is one way to reduce the risk of exposure of seated operators to whole body vibration – see §231: comments on section 1.5.9147.

145 EN 1005-4: 2005+A1:2008 Safety of machinery – Human physical performance – Part 4: Evaluation of working postures and movements in relation to machinery.

146 See EN ISO 14738:2008 Safety of machinery – Anthropometric requirements for the design of workstations at machinery (ISO 14738:2002, including Cor 1:2003 and Cor 2:2005).

147 See, for example, EN ISO 7096:2008 Earth-moving machinery – Laboratory evaluation of operator seat vibration (ISO 7096:2000).

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1.2 CONTROL SYSTEMS

1.2.1 Safety and reliability of control systems

Control systems must be designed and constructed in such a way as to prevent hazardous situations from arising. Above all, they must be designed and constructed in such a way that:

− they can withstand the intended operating stresses and external influences,

− a fault in the hardware or the software of the control system does not lead to hazardous situations,

− errors in the control system logic do not lead to hazardous situations,

− reasonably foreseeable human error during operation does not lead to hazardous situations.

Particular attention must be given to the following points:

− the machinery must not start unexpectedly,

− the parameters of the machinery must not change in an uncontrolled way, where such change may lead to hazardous situations,

− the machinery must not be prevented from stopping if the stop command has already been given,

− no moving part of the machinery or piece held by the machinery must fall or be ejected,

− automatic or manual stopping of the moving parts, whatever they may be, must be unimpeded,

− the protective devices must remain fully effective or give a stop command,

− the safety-related parts of the control system must apply in a coherent way to the whole of an assembly of machinery and/or partly completed machinery.

For cable-less control, an automatic stop must be activated when correct control signals are not received, including loss of communication.

§184 Safety and reliability of control systems

The control system of machinery is the system which responds to input signals from parts of the machinery, from operators, from external control equipment or any combination of these and generates corresponding output signals to the machinery actuators, causing the machine to perform in the intended manner. Control systems can use different technologies or combinations of technologies such as, for example, mechanical, hydraulic, pneumatic, electric, or electronic technologies. The use of electronic control systems that are programmable have been and are now much more common since the Directive came into force.

The design and construction of the control system in order to ensure safe and reliable functioning of the machinery are key factors in ensuring the safety of the machinery as a whole. Operators must be able to ensure that the machinery functions safely and as expected at all times.

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The requirements set out in section 1.2.1 apply to all parts of the control system that, in the event of a fault or a failure, can lead to hazards due to unintended or unexpected behaviour of the machinery. They are of particular importance for the design and construction of the parts of the control system related to safety functions such as, for example, the parts of the control system related to interlocking and guard-locking devices for guards, to protective devices or to emergency stop controls, since a failure of safety related parts of the control system is liable to give rise to a hazardous situation when the corresponding safety function is next required to operate. Certain safety functions may also be operational functions, such as, for example, a two-hand start control device.

The first paragraph of section 1.2.1 and its 4 indents set out the basic requirements for the reliability and safety of control systems. The second paragraph of section 1.2.1 and its 7 indents describe the main hazardous events and situations that must be avoided.

According to the first indent of the first paragraph of section 1.2.1, control systems must be able to withstand intended operating stresses and external influences, taking into account foreseeable abnormal situations – see §160: comments on General Principle 2, and §175: comments on section 1.1.2 (c). The control system must thus be able to withstand the mechanical effects generated by operation of the machinery itself or by its environment such as, for example, shocks, vibrations, and abrasion. Control systems must be able to withstand the effects of the internal and external conditions under which the machinery is intended to function such as, for example, humidity, extreme temperatures, corrosive atmospheres and dust. The correct functioning of control systems must not be affected by electromagnetic radiation, whether generated by parts of the machinery itself or by external elements in the conditions in which the machinery is intended to be used – see §233: comments on section 1.5.11.

The second and third indents of the first paragraph of section 1.2.1 deal with the behaviour of the control system in case of a fault or error in the hardware or software. These requirements take account of the possibility of faults occurring in the control system due, for example, to the failure of a mechanical, hydraulic, pneumatic or electrical component or to an error in the software of a programmable system. Control systems must be designed and constructed so that, if such faults or errors occur, they do not lead to hazardous situations such as those described in the second paragraph of section 1.2.1 – see also §205: comments on section 1.2.6.

The hazardous functions of the machinery can be brought under control, for example, by stopping the function, removing power from the function or preventing the hazardous action of the function. If the relevant functions of the machinery are able to continue despite the occurrence of a fault or a failure, for example, by means of a redundant architecture, there must be a means of detecting the fault or failure so that the necessary action can be taken to achieve or maintain a safe state.

The means to be used to fulfil this requirement depend on the type of control system, on the part of the control system concerned and on the risks that could arise in case of its failure.

The concepts that can be used include:

− The exclusion or reduction of the probability of faults or failures which may affect the safety function by recourse to particularly reliable components and

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by applying well-tried safety principles, such as, for example, the principle of the positive mechanical action of a component on another component;

− The use of standard components with a check on the safety functions at suitable intervals by the control system;

− The redundancy of parts of the control system such that a single fault or failure does not lead to the loss of the safety function. Technical diversity of the redundant elements can be used to avoid common cause failures;

− Automatic monitoring to ensure that faults or failures are detected and that the necessary protective measures are initiated to prevent the risk concerned. The protective measures may include the stopping of the hazardous process, preventing the re-start of this process or the triggering of an alarm.

These concepts can be applied in different combinations.

The level of performance required for a given safety related part of the control system depends on the level of the risk for which the safety function is intended and is to be determined on the basis of the manufacturer’s risk assessment. C-type standards for particular categories of machinery provide guidance on the level of performance required for the different safety related parts of the control system.

The achievement of the required level of performance for safety related parts of control systems must be validated, taking account both of the hardware and software aspects of such systems.

Specifications for the design of safety-related parts of control systems are given in standards EN ISO 13849-1148 and standard EN 62061149.

The fourth indent of the first paragraph of section 1.2.1 deals with reasonably foreseeable human error during operation. In order to satisfy this requirement, control systems must, as far as possible, be designed with error tolerance. This involves measures such as the detection of errors and providing appropriate feedback to the operator to facilitate the correction of errors.

General principles for human interaction with machinery to minimise operator errors are given in standard EN 894-1150.

The third paragraph of section 1.2.1 covers a particular hazard associated with cable-less control systems, such as, for example, remote control systems using radio, optical or sonar signals: incorrect signals or loss of communication between the control devices and the machinery to be controlled. It should be noted that section 3.3 provides supplementary requirements for remote control systems for mobile machinery.

1.2.2 Control devices

148 EN ISO 13849-1:2008 Safety of machinery – Safety-related parts of control systems – Part 1: General principles for design (ISO 13849-1:2006).

149 EN 62061:2005+A2:2015 Safety of machinery – Functional safety of safety-related electrical, electronic and programmable electronic control systems (IEC 62061:2005+A2:2015).

150 EN 894-1:1997+A1:2008 Safety of machinery – Ergonomic requirements for the design of displays and control actuators – Part 1: General principles for human interactions with displays and control actuators.

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. . .

§185 Control devices

Control devices are parts of the control system which detect input signals given by the operators, usually by means of hand or foot pressure. There are many different kinds of control devices including, for example, push-buttons, levers, switches, knobs, sliders, joy-sticks, hand wheels, pedals, keyboards and tactile screens. Control devices may be located on the machinery itself or, in the case of remote controls, may be located at a distance from the machinery and be linked to the machinery, for example, by means of wires, or by means of radio, optical or sonar signals.

Application of the requirements set out in section 1.2.2 requires particular attention to ergonomic principles, since control devices are at the interface between the machinery and the operators – see §181: comments on section 1.1.6.

Specifications relating to the requirements set out in the following paragraphs of section 1.2.2 are given in the standards of the EN 894 series151 and the standards of the EN 61310 series152.

In addition to the general requirements for control devices set out in section 1.2.2, the following sections of Annex I provide supplementary requirements for control devices for certain categories of machinery or for certain risks:

− portable hand-held and/or hand-guided machinery – sections 2.2.1 and 2.2.2.1;

− mobility of machinery – section 3.3;

− lifting operations – section 4.2.1;

− machinery for underground work – section 5.3;

− machinery for lifting persons – sections 6.2 and 6.4.2.

1.2.2 Control devices (continued)

. . .

Control devices must be:

− clearly visible and identifiable, using pictograms where appropriate,

. . .

151 EN 894-1:1997+A1:2008 Safety of machinery – Ergonomic requirements for the design of displays and control actuators – Part 1: General principles for human interactions with displays and control actuators; EN 894-2:1997+A1:2008 Safety of machinery – Ergonomics requirements for the design of displays and control actuators – Part 2: Displays; EN 894-3:2000+A1:2008 Safety of machinery – Ergonomics requirements for the design of displays and control actuators – Part 3: Control actuators.

152 EN 61310-1:2008 Safety of machinery – Indication, marking and actuation – Part 1: Requirements for visual, acoustic and tactile signals (IEC 61310-1:2007); EN 61310-2:2008 Safety of machinery – Indication, marking and actuation – Part 2: Requirements for marking (IEC 61310-2:2007); EN 61310-3:2008 Safety of machinery – Indication, marking and actuation – Part 3: Requirements for the location and operation of actuators (IEC 61310-3:2007).

§186 Identification of control devices

The first indent of section 1.2.2 on the visibility and clear identification of control devices, aims to enable operators to use the devices without hesitation and avoid unintended commands due to operators confusing one control device with another. Since operators are often liable to perform different tasks and use several different machines in the course of their activity, it is important for manufacturers to identify control devices using, as far as possible, standardised colours, shapes and pictograms so that operators are not surprised when they change tasks or move from one machine to another. If the function of a control device is obvious from its standard shape and location such as, for example, a steering wheel or handlebars on mobile machinery, additional means of identification are not required.

If the controls are identified by means of written or verbal information, this information is subject to the language requirements relating to information and warnings on the machinery – see §245: comments on section 1.7.1.

1.2.2 Control devices (continued)

. . .

− positioned in such a way as to be safely operated without hesitation or loss of time and without ambiguity,

. . .

§187 Positioning of control devices

The second indent of section 1.2.2 requires manufacturers to take account of ergonomic principles when positioning control devices on the machinery, to ensure that the devices are clearly visible to operators and that they can be reached and used efficiently and safely, without the need to adopt awkward postures.

The positioning of the control devices must take account of the tasks to be carried out by the operators and of the corresponding operating modes, of the position and characteristics of work stations or operating positions, of whether operators are likely to be standing or seated and of the need for operators to observe certain parts of the machinery while using the control devices.

The layout of control devices should also take account of the position of the parts of the machinery affected by its use, following commonly accepted conventions. For example, a device controlling parts of the machinery to the right of the operator should be positioned on the right of the operating position; a device controlling an upward movement should be positioned above a button controlling a downward movement and so on.

Where control devices have to be operated in a given sequence, they should be arranged in that sequence. Devices controlling related functions should be grouped together and devices controlling unrelated functions should be clearly separated.

The control devices that are likely to be used most frequently or that need to be used continuously should be positioned within the central area of the operator’s field of vision and within the immediate reach envelope where they can be reached without bending. Where necessary, this may require the provision of means of adjusting the position of the control devices to accommodate the variation of the body dimensions of operators.

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1.2.2 Control devices (continued)

. . .

− designed in such a way that the movement of the control device is consistent with its effect,

. . .

§188 Movement of control devices

The requirement set out in the third indent of section 1.2.2 deals with two principles for the design of control devices which are to ensure conformity with the expectations of users and to comply with common practice in order to avoid hazardous situations and errors. The requirement applies to the movements of control devices such as, for example, levers or hand wheels.

Wherever possible, the direction of movement of such devices should be consistent with the direction of the movement controlled by their use. In the case of control devices controlling other parameters, the direction of movement of the device should correspond to commonly accepted conventions such as, for example, the convention that turning a device clockwise increases the value of the parameter concerned and turning the device anti-clockwise reduces it.

Particular attention should be given to the design of control devices in machinery where the operating position is able to rotate with respect to the rest of the machinery, with the result that the direction of certain movements controlled by the control devices is inverted.

1.2.2 Control devices (continued)

. . .

− located outside the danger zones, except where necessary for certain control devices such as an emergency stop or a teach pendant,

− positioned in such a way that their operation cannot cause additional risk,

. . .

§189 Location of and positioning of control devices

The location and positioning of control devices outside the danger zones, required by the fourth and fifth indents of section 1.2.2, is one of the ways of avoiding the exposure of operators to hazards – see §165: comments on section 1.1.1 (b). This requirement must be applied taking account not only of areas where there is a risk of direct contact with hazardous elements of the machinery but also of areas where there may be risks due to ejected objects or emissions from the machinery. Ways to fulfil these requirements include, for example, locating the control devices at a sufficient distance from moving parts – see §212: comments on section 1.3.7 – or locating control devices behind a screen or inside an adequate cabin – see §182: comments on section 1.1.7.

Where it is necessary to derogate from this general rule, for example, in cases where control devices have to be provided within a danger zone for setting or maintenance purposes, the requirement set out in the fourth indent can be fulfilled by providing a setting or maintenance mode, the selection of which triggers particular protective

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measures such as, for example, low speed and/or incremental movement – see §204: comments on section 1.2.5. The provision of emergency stop devices within danger zones is also an exception to the general rule – see §202: comments on section 1.2.4.3.

1.2.2 Control devices (continued)

. . .

− designed or protected in such a way that the desired effect, where a hazard is involved, can only be achieved by a deliberate action,

. . .

§190 Preventing inadvertent operation of control devices

The requirement set out in the sixth indent of section 1.2.2 aims to avoid inadvertent operation of control devices. Inadvertent operation can result from various causes, such as, for example, accidental contact between a part of the operator’s body or of his or her clothing and a control device, unintentional operation of two adjacent control devices (for example, pushing two buttons or levers with one hand or two pedals with one foot), a control device being caught on an obstacle in the environment of the machinery or use of a control device as a hand hold for access to the operating position – see §317: comments on section 3.4.5.

Such risks must be assessed for the different phases of the foreseeable lifetime of the machinery, taking account of the operators’ tasks and the corresponding operation modes, and must be prevented by appropriate design measures. Such measures include, for example:

− designing the control devices with sufficient resistance to avoid inadvertent operation by slight pressure;

− positioning the control devices in a recess or surrounding them with a collar;

− positioning and/or guarding control devices, to prevent contact with parts of the operator’s body or clothing and to prevent them from being caught on obstacles in the environment of the machinery;

− fitting control devices, the operation of which requires two independent actions;

− fitting control devices with a lock.

Where there is a risk arising from an operator falling onto or being pressed against the controls, then means to prevent dangerous movement of the machine should be taken. A number of fatal accidents have occurred with a variety of machinery such as MEWPs; loader cranes; and interchangeable digging equipment. If such a risk cannot be eliminated by the controls’ location and mode of operation, then other means must be taken such as designing the controls with a trip feature when excessive pressure is used or fitting other trip devices.

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1.2.2 Control devices (continued)

. . .

− made in such a way as to withstand foreseeable forces; particular attention must be paid to emergency stop devices liable to be subjected to considerable forces.

. . .

§191 Strength of control devices

The requirement set out in the seventh indent of section 1.2.2 concerns the mechanical strength of control devices. Breakage of control devices can result in a hazardous situation due to the inability to control the function concerned. Such a breakage can also itself result in injury.

In applying this requirement, the foreseeable conditions of use during the different phases of the foreseeable lifetime of the machinery and the different tasks and operating modes involved must be taken into account – see §207: comments on section 1.3.2. This is particularly important for emergency stop devices which have to be operated rapidly and are often designed to be hit – see §202: comments on section 1.2.4.3.

1.2.2 Control devices (continued)

. . .

Where a control device is designed and constructed to perform several different actions, namely where there is no one-to-one correspondence, the action to be performed must be clearly displayed and subject to confirmation, where necessary.

. . .

§192 Control devices to perform different actions

The requirement set out in the second paragraph of section 1.2.2 applies where a single control device is able to control several different functions.

For example, certain control devices may perform different actions depending on the operating or control mode selected. Control devices may perform different actions depending on the interchangeable equipment fitted to the machinery. Certain joy-stick type control devices can control different actions by means of fore and aft movements, side to side movements and twisting movements, and the effects of the different movements of the joy-stick can be varied using top buttons or trigger switches incorporated in the device.

Use of such control devices can facilitate the control of certain categories of machinery by reducing the number and amplitude of the necessary hand and arm movements. However, it is particularly important when designing such devices to ensure that the effects of the various movements of the device are clearly identified and that the devices are designed to avoid confusion between the different actions that can be performed. Where necessary to avoid confusion, two separate actions must be necessary to control a given function.

The requirement set out in the second paragraph of section 1.2.2 also applies to so-called numerically controlled machinery or machinery with a programmable electronic control system, where the input signals are given by means of a keyboard or tactile

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screen. One way to avoid errors is for the software to indicate the action to be performed and require confirmation by the operator before the output signal is sent to the machinery actuators.

1.2.2 Control devices (continued)

. . .

Control devices must be so arranged that their layout, travel and resistance to operation are compatible with the action to be performed, taking account of ergonomic principles.

. . .

§193 Control devices and ergonomic principles

The requirement set out in the third paragraph of section 1.2.2 implies that the characteristics of control devices must take account of the various parameters of the operators’ tasks, including, for example:

− the accuracy required in positioning the control device;

− the speed of setting required;

− the force required to operate the device.

Attention must be paid to the visibility of the control devices and to the ability of operators to reach and use them efficiently and safely in all task situations and operating modes, without having to adopt awkward postures. The layout of control devices, the travel distance of the moving parts of the devices and the force required to operate the devices must take account of the nature of the action to be performed, of the functional anatomy of the human hand or foot and the body dimensions of the operator population. In the case of control devices used frequently or continuously, the design of the devices must avoid repetitive movements involving awkward postures or excessive hand span that may contribute to musculoskeletal disorders.

Where hold-to-run control devices are required, they must be designed to reduce the constraints for operators as far as possible – see §301: comments on section 3.3.1, §353: comments on section 4.2.1, and §371: comments on section 6.2.

The space between control devices must be sufficient to reduce the risk of unintentional operation, without thereby demanding unnecessary movements. Particular attention should be given to whether operators are likely to use PPE such as protective gloves or protective footwear – see §176: comments on section 1.1.2 (d).

The arrangement and layout of control devices must also take account of human capacities for information processing, with respect to attention, perception and cognition.

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1.2.2 Control devices (continued)

. . .

Machinery must be fitted with indicators as required for safe operation. The operator must be able to read them from the control position.

. . .

§194 Indicators and displays

The requirement set out in the fourth paragraph of section 1.2.2 requires machinery to be fitted with the necessary indicators to enable operators to carry out their various tasks. These include, for example, indicators to inform operators on the value of the relevant parameters of the machinery (such as, for example, the speed, load, temperature or pressure of parts of the machinery) and on the effects of their action on the control devices, when this is not obvious.

Indicators may also provide warnings to operators when the relevant parameters exceed the safe range of values. Such indicators may be associated with limiting devices that trigger certain actions when safe parameters are exceeded. The indicators may also be used in combination with a specific mode of operation such as low speed or incremental operation.

Commonly used indicators include digital displays and screens, analogical displays such as dials and gauges, as well as tactile and auditory indicators. Indicators can be an integral part of the control devices themselves or independent. If they are independent, they must be designed and positioned so that they can be easily read and understood by the operators from the control position when using the related control devices. In particular, indicators must be designed to facilitate the rapid detection of abnormal behaviour of the machinery.

Indicators and displays are subject to the requirements set out in sections 1.7.1, 1.7.1.1, and 1.7.1.2 relating to information and warnings on the machinery, information devices and warning devices. In particular, any written or verbal information provided by indicators or displays is subject to the language requirements set out in section 1.7.1 – see §245 to §248: comments on sections 1.7.1, 1.7.1.1 and 1.7.1.2.

1.2.2 Control devices (continued)

. . .

From each control position, the operator must be able to ensure that no-one is in the danger zones, or the control system must be designed and constructed in such a way that starting is prevented while someone is in the danger zone.

If neither of these possibilities is applicable, before the machinery starts, an acoustic and/or visual warning signal must be given. The exposed persons must have time to leave the danger zone or prevent the machinery starting up.

. . .

§195 Visibility of danger zones during starting

In accordance with section 1.1.2 (b), the first measure should be the elimination or reduction of the risk, for example, by designing the machinery so that persons do not need to enter the danger zones of the machinery – see §239: comments on section

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1.6.1 – or by fitting guards and/or protective devices to detect the presence of persons in the danger zone and prevent starting as long as persons are present. But such measures are not always possible.

If there is a risk that persons may enter the danger zones, the requirement set out in the fifth and sixth paragraphs of section 1.2.2 aim to enable the operator to ensure that no-one is in the danger zones of the machinery before starting the machinery. The persons concerned may be other production operators or other exposed persons such as maintenance operators. In the case of danger zones in the environment of the machinery, the possible exposed persons may include bystanders – see §165: comments on section 1.1.1 (b).

If it is not possible to design the machinery so that the operator controlling the start of the machinery has adequate direct vision of the danger zones from the control position, indirect vision aids can be provided, such as, for example, mirrors or closed circuit television (CCTV).

In this respect, it should be noted that supplementary requirements relating to visibility from the driving position of mobile machinery are set out in section 3.2.1.

Where it is not possible to ensure effective direct or indirect visibility of the danger zones from the control positions, for example due to the extent of the danger zone on a long field conveyor, the starting of the machinery must be preceded by an acoustic or visual warning signal (or both) with sufficient time between the warning signal and the start or movement of the machinery to allow any exposed persons to leave the danger zones or, if that is not possible, exposed persons must have means to prevent the machinery from starting, such as, for example, an emergency stop control in the danger zone – see §202: comments on section 1.2.4.3.

Specifications for acoustic and visual warning signals are given in standard EN 981153.

When maintenance operations may be carried out in danger zones of machinery, specific means must be provided for preventing the unexpected start of the machinery or parts of the machinery – see §241: comments on section 1.6.3.

1.2.2 Control devices (continued)

. . .

If necessary, means must be provided to ensure that the machinery can be controlled only from control positions located in one or more predetermined zones or locations.

. . .

§196 Location of control positions

The requirement set out in the seventh paragraph of section 1.2.2 aims to ensure that the position from which the operator controls the operation of the machinery is outside the danger zones of the machinery and located, as far as possible, so that the operator can ensure that other persons are not exposed to risks.

Particular attention should be given to this requirement when considering the use of moveable control devices such as pendant controls or remote controls. The risk

153 EN 981:1996+A1:2008 Safety of machinery – System of auditory and visual danger and information signals.

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assessment must take account of the risk that the operator may control the machinery from a hazardous position, such as, for example, a zone where there is a risk of being crushed or hit by falling or ejected objects.

1.2.2 Control devices (continued)

. . .

Where there is more than one control position, the control system must be designed in such a way that the use of one of them precludes the use of the others, except for stop controls and emergency stops.

. . .

§197 Multiple control positions

The requirements set out in the eighth paragraph of section 1.2.2 concerns machinery provided with two or more control positions intended to be used in turn, either by a single operator or by two or more operators, to carry out different tasks or control the machinery during different phases of its operation. In order to avoid confusion or contradictory commands, the control devices at each control position must be linked to the control system in such a way that the use of one control position precludes the use of the others, except for stop controls and emergency stops.

1.2.2 Control devices (continued)

. . .

When machinery has two or more operating positions, each position must be provided with all the required control devices without the operators hindering or putting each other into a hazardous situation.

§198 Multiple operating positions

The last paragraph of section 1.2.2 applies to machinery provided with two or more operating positions that can be used simultaneously. This is typically the case for assemblies of machinery where different constituent units of the assembly have their own operating position – see §38: comments on the fourth indent of Article 2 (a). The overall control system of such an assembly and the attribution of control functions to the different operating positions must be designed so that commands given at one operating position do not hinder or create a hazardous situation for operators at other operating positions. Particular precautions must be taken if the operation of one element of the assembly automatically starts the operation of another element – see §199: comments on section 1.2.3.

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1.2.3 Starting

It must be possible to start machinery only by voluntary actuation of a control device provided for the purpose.

The same requirement applies:

− when restarting the machinery after a stoppage, whatever the cause,

− when effecting a significant change in the operating conditions.

However, the restarting of the machinery or a change in operating conditions may be effected by voluntary actuation of a device other than the control device provided for the purpose, on condition that this does not lead to a hazardous situation.

For machinery functioning in automatic mode, the starting of the machinery, restarting after a stoppage, or a change in operating conditions may be possible without intervention, provided this does not lead to a hazardous situation.

Where machinery has several starting control devices and the operators can therefore put each other in danger, additional devices must be fitted to rule out such risks. If safety requires that starting and/or stopping must be performed in a specific sequence, there must be devices which ensure that these operations are performed in the correct order.

§199 Control of starting

The requirements set out in section 1.2.3 aim to prevent unintended or unexpected starting, which are common causes of serious accidents involving machinery.

The basic requirement set out in the first paragraph of section 1.2.3 is that machinery shall only start when the operator gives a start command by using a specific start control device. This requirement applies to the initial start of machinery at the beginning of a period of operation.

According to the second paragraph of section 1.2.3, this basic requirement also applies when restarting the machinery after a stoppage or when effecting a significant change in the operating conditions such as, for example, the adjustment of the speed of the machinery.

Thus, for example, as a general rule, starting must not be initiated by the closing of an interlocking moveable guard, by the release of a stop control or by the release of an emergency stop control – see §200 to §202: comments on section 1.2.4.

However, according to the third paragraph of section 1.2.3, the requirement for a specific start or restart control device does not apply to restarting or changing the operating conditions if the use of another device than the specific start control device does not lead to a hazardous situation.

Thus, for example, it is exceptionally possible to control the initiation of certain functions of machinery by the closure of an interlocked guard (control guard) or by the withdrawal of a person or the detected part of a person from the sensing field of a protective device. This feature can be useful for ergonomic reasons, in order to avoid the need for repeated action on the start control device on machinery with a short work cycle. However, these exceptional solutions can only be applied if the

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machinery is designed and constructed with adequate compensatory protective measures to prevent the risk of unintended or unexpected starting.

Specifications for the exceptional recourse to control guards or of protective devices used for cycle initiation are given in standard EN ISO 12100154.

The fourth paragraph of section 1.2.3 permits a second exception to the general rule set out in the first paragraph, in cases where the starting of the machinery, the restarting after a stoppage or after a change in operating conditions is triggered automatically, provided that this does not lead to a hazardous situation. This requirement implies that automatic starting and restarting must be possible only when the necessary means to protect persons against the risks associated with the automatically controlled functions are in place and operating correctly.

The requirements set out in the fifth paragraph of section 1.2.3 are supplementary to the requirements set out in the eighth and ninth paragraphs of section 1.2.2.

Machinery may be fitted with several start control devices because it is provided with several control positions intended to be used at different times or for different tasks. In such cases, the control system must be designed to ensure that only one start control can be used at a time, in accordance with the eighth paragraph of section 1.2.2.

Several start control devices may also be provided on machinery, especially assemblies of machinery, having several operating positions for different constituent units. In that case the overall control system of the assembly must be designed to ensure that use of one of the start control devices does not give rise to a hazardous situation for the other operators. Similarly, the overall control system must be designed to ensure that elements of the machinery that must be started or stopped in a given order can only be started or stopped in that order and that incorrect start or stop control signals are ineffective.

Specifications for preventing unexpected start-up of machinery are given in standard EN 1037155.

It should be noted that, in addition to the general requirements relating to starting set out in section 1.2.3, supplementary requirements for starting relating to the mobility of machinery are set out in section 3.3.2.

154 EN ISO 12100:2010 Safety of machinery – General principles for design. Risk assessment and risk reduction (ISO 12100:2010) – see clauses 5.2.5.3 and 5.3.2.5.

155 EN 1037:1995+A1:2008 Safety of machinery – Prevention of unexpected start-up.

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1.2.4 Stopping

1.2.4.1 Normal stop

Machinery must be fitted with a control device whereby the machinery can be brought safely to a complete stop.

Each workstation must be fitted with a control device to stop some or all of the functions of the machinery, depending on the existing hazards, so that the machinery is rendered safe.

The machinery’s stop control must have priority over the start controls.

Once the machinery or its hazardous functions have stopped, the energy supply to the actuators concerned must be cut off.

§200 Normal stop control devices

The requirement set out in section 1.2.4.1 aims to ensure that operators can stop machinery safely at all times. Apart from the need to stop the machinery safely for operational reasons, it is also essential for operators to be able to stop machinery in case of malfunctioning that might lead to a hazardous situation.

The second paragraph applies to machinery with two or more workstations. In some cases, a single operator may control the whole of the machinery from different control positions, depending on his tasks and on the phase of operation. In other cases, different parts of the machinery may be controlled by different operators. The stop control device provided at each workstation may stop all of the machinery or only a part of the machinery where this can be done without risk – see §203: comments on section 1.2.4.4. If necessary, the stop control device shall stop the relevant parts of the complex machinery in a sequential procedure – see §199: comments on section 1.2.3.

The requirement set out in the third paragraph of section 1.2.4.1 is a requirement for the design of the control system that is particularly important in the case of machinery with several workstations, since it prevents a start command given by one operator from overriding a stop command given by another operator. It also aims to ensure that a stop command can be given, even in case of a failure of the start control in the sense of a maintained start command.

The requirement, set out in the last paragraph of section 1.2.4.1, that, once the machinery or its hazardous functions have stopped, the energy supply to the actuators concerned must be cut off, aims to prevent the risk of unintended starting following a stop command that might be caused by a fault or failure in the control system. This means that stopping can either be achieved by immediate removal of power to the machine actuators, or with power available to the machine actuators to achieve the stop and then removal of power once the stop has been achieved.

It should be noted that, in addition to the general requirements for stopping set out in section 1.2.4.1, supplementary requirements for stopping for the travelling function of mobile machinery are set out in section 3.3.3.

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1.2.4.2 Operational stop

Where, for operational reasons, a stop control that does not cut off the energy supply to the actuators is required, the stop condition must be monitored and maintained.