Source: http://www.industry-finder.com/machinery-directive/guide-application-machinery-directive-2006-42-ce-july-2017-citations-recitals
Timestamp: 2019-04-20 05:18:50+00:00

Document:
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.
OJ C 154 E, 29.5.2001, p. 164.
OJ C 311, 7.11.2001, p. 1.
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.
(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).
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).
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).
Directive 91/368/EEC 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/EEC 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/EEC introduced harmonised provisions relating to the CEmarking.
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.
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.
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.
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.
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.
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.
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.
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.
OJ L 256, 13.9.1991, p. 51.
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 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).
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 Directive – see §388: comments on Annex IV, item 17.
(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).
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).
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.
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.
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.
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.
The eleventh recital indicates that the procedure for disputing a harmonised standard (known as a formal objection) and the safeguard procedure for dealing with noncompliant and dangerous products are different procedures that are set out in distinct Articles of the Directive – see §119 to §121: comments on Articles 10, and §122 to §126: comments on Article 11.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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 nonbinding status.
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/EC.
(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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Member States should provide for penalties applicable to infringements of the provisions of this Directive. Those penalties should be effective, proportionate and dissuasive.
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 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).
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.
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 lawmaking,(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.
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.
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.
 OJ L 183, 29.6.1989, p. 9.
 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. OJ L 207, 27.7.1998, p.1.
 OJ L 198, 22.7.1991, p. 16.
 OJ L 175, 19.7.1993, p. 12.
 OJ L 220, 31.8.1993, p. 1.
 See guidance on Interchangeable equipment for lifting persons and equipment used with machinery designed for lifting goods for the purpose of lifting persons.
 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.

References: §51
 §280
 §388
 §154
 §140
 §388
 §53
 §93
 §102
 §118
 §122
 §126
 §144
 §119
 §121
 §122
 §126
 §86
 §139
 §140
 §118
 §147
 §161
 §162
 §259
 §46
 §131
 §385
 §394
 §103
 §163
 §87
 §110
 §127
 §130
 §141
 §141
 §250
 §387
 §158
 §159
 §103
 §383
 §391
 §393
 §135
 §145
 §153
 §151
 §153
 §116
 §147