Proposal for a DIRECTIVE OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on machinery and amending Directive 95/16/EC

(presented by the Commission)

EXPLANATORY MEMORANDUM

1. BACKGROUND/EXISTING LEGISLATION

Council Directive 89/392/EEC [1] of 14 June 1989 on the approximation of the laws of the Member States relating to machinery, more generally known as the Machinery Directive, entered into force on 1 January 1993 and has been fully applicable since 1 January 1995. It was amended by Council Directives 91/368/EEC [2], 93/44/EEC [3] and 93/68/EEC [4]. All of these Directives have been fully applicable since 1 January 1997.

[1] OJ L 183, 29.6.1989, p. 9.

[2] OJ L 198, 22.7.1991, p. 16.

[3] OJ L 175, 19.7.1993, p. 12.

[4] OJ L 220, 30.8.1993, p. 1.

These texts were consolidated by Directive 98/37/EC [5] 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.

[5] OJ L 207, 23.7.1998, p. 1.

2. REASONS AND OBJECTIVES

Anxious to demonstrate greater efficiency and transparency to the outside world, the Commission undertook to eliminate excessive red tape and to simplify the implementation of legislative texts.

With this in mind, the Commission, supported by the Council, considered it necessary to seek the views of a number of individuals not directly involved in the drafting and administration of directives. In September 1994, it therefore set up a high-level group of independent experts from various backgrounds (industry, trade unions, universities, the judiciary and the civil service) who were asked to assess the impact of Community and national legislation on competitiveness and employment and to make recommendations to the Commission. This group was chaired by Dr Bernhard Molitor and drew up general proposals which were applicable to all of the directives. It also considered a number of individual directives, including the Machinery Directive.

This proposal for a Directive has been prepared on the basis of those proposals and of the Commission's comments on the report issued by the group of independent experts [6] (18 general proposals and 12 relating to the Machinery Directive). It also takes account of the experience gained in the practical application of the amended Directive 89/392/EEC.

[6] Document SEC(95) 2121, 29.11.1995 (not published in the OJ).

This proposal for a Directive amends Directive 98/37/EC. Given the scope and number of these amendments, and in order to make the text more comprehensible, it is presented as a recast directive rather than a directive amending Directive 98/37/EC.

The various parts which have been amended are underlined. The Commission wishes to emphasise that only these underlined sections form part of the recasting proposal.

3. LEGAL BASIS

This proposal for a revision of the Machinery Directive is based on Article 95 of the Treaty which sets out the principles for the establishment of the internal market. The Machinery Directive ensures the free movement of machinery falling within its scope and which satisfies the essential requirements laid down in it in respect of safety, health and consumer protection.

The principles of the New Approach, set out in the Council Resolution of 7 May 1985, apply. The draft spells out the essential health and safety requirements with which the machinery must comply before being placed on the market and/or put into service, as well as the conformity assessment procedures applicable. While the Directive details the objectives to be attained, the European standardisation bodies, i.e. CEN, CENELEC and ETSI, are responsible for the practical means of fulfilling these essential requirements.

This proposal for a Directive is of relevance for the European Economic Area (EEA).

4. IMPORTANCE OF THE SECTOR COVERED BY THE DIRECTIVE

Although there are no statistics relating to the area covered by the Directive, it is possible to use as a basis statistics covering the engineering industry, which includes machinery, mechanical apparatus and components.

With a production of around EUR 300 billion in 1998 (EUR 314 billion if EFTA members are included), the engineering sector makes up approximately 8% of the Union's industry.

As a producer of the capital goods needed in agriculture, mining, the construction industry, transport and all other industrial sectors, the engineering sector plays a key role for the economy as a whole. The competitiveness of the other sectors of the economy is therefore heavily reliant on equipment and installations provided by the engineering industry.

In terms of production volume, the European Union leads the world in this sector together with the United States, and is ahead of Japan. The sector employs over 2.2 million engineers, technicians and workers, mostly highly skilled, in the 15 Member States.

The European Union is by far the largest exporter of machinery and mechanical equipment, totalling EUR 113 billion; it is followed by the United States (EUR 66 billion) and Japan (EUR 57 billion). Of all the industrial sectors, it is the engineering sector that generates the European Union's largest trade surplus.

With annual sales of EUR 227 billion, the European Union's engineering market is second in the world, after the United States, in terms of consumption.

5. THE TEXT MUST BE ACCESSIBLE AND EASY TO APPLY

In addition to the Molitor report which advocated, among other things, a better definition of various concepts, the Commission has endeavoured to clarify the procedures described by the Directive. To this end, it has explained the conformity assessment and market surveillance procedures so as to avoid differing interpretations of these procedures.

6. PROPORTIONALITY

This proposal contains two major changes to the scope.

The first concerns the inclusion of portable cartridge-operated devices, such as fixing tools, stunning pistols, marking guns etc, where the cartridge is not direct-acting. At present, these are excluded from the Directive because they are regarded as firearms, even though they fully comply with the definition set out in the Directive. It therefore seems expedient to include them so that they can benefit from freedom of movement within the European Union. Appliances in which the cartridge is direct-acting can be considered as firearms and naturally remain outside the scope of the Directive.

The second proposal concerns construction site hoists intended for lifting persons or persons and goods. At the moment there is no European legislation in this area. Construction site hoists intended for lifting persons or persons and goods are explicitly excluded from the Machinery Directive 98/37/EC and the Lifts Directive 95/16/EC [7], although they can in fact be treated in the same way as other appliances for the lifting of persons under this Directive. There is no reason to make an exception for them, and it is altogether logical that they be included.

[7] OJ L 213, 7.9.1995, p. 1.

All the parties concerned, especially industry and workers' representatives, have readily accepted Directive 98/37/EC. It has led to an improvement in the safety of machinery placed on the market since its application. It is considered as being suited to market demands and observes the principles of subsidiarity and proportionality as Community texts are required to do.

7. FOLLOW-UP TO THE MOLITOR REPORT

The general proposals in the report of the Molitor Group have been taken into consideration, in particular:

- Proposal 6, which sets out the criteria to be met by each legislative proposal (clear and understandable provisions, consistency with existing Community legislation, etc.). The proposed text meets all of these criteria;

- Proposal 8 requires that all parties concerned be consulted before a proposal is drawn up. The preliminary draft has been the subject of numerous discussions in which all the parties concerned (Member States, consumers, enterprises, workers) have been associated.

The specific proposals put forward by the Group which are germane to the Machinery Directive are set out below:

- the first proposal concerns the definition of machinery. This proposal has been followed, the definition of machinery covered by the Directive has been improved and the machines to be excluded have been clearly identified;

- the second proposal, with regard to placing on the market, has been taken into account. The concepts of "placing on the market", "putting into service", "manufacturer" and "authorised representative" have also been clarified so as to avoid divergent interpretations by economic operators. As for placing on the market, it has been made quite clear that this refers to the moment when the machine is first made available on the territory of the European Union;

- the third proposal, namely that the Directive should apply only to complete ready-for-use machines, has been followed. The definition of partly completed machinery (formerly called subassemblies), which must be allowed to move freely within the European Union, has been clarified. Such machines are not subject to all of the Directive's provisions but only to the following two requirements:

- a declaration of incorporation in its present form;

- assembly instructions, which must be part of the technical file of the complete machine.

By the same token, components are not included in the text of the Directive.

- The fourth proposal concerns the CE marking and calls for the uncertainties surrounding the affixing of this marking to be removed. The Commission ascertained that other marks were being used to indicate conformity with the essential health and safety requirements, in some cases applying conformity assessment procedures which differed from those required by the Directive. It was not possible to improve on this point in this text. There appears to be a need for a proposal which applies equally to all the New Approach directives, as simply improving the text of the Machinery Directive would not satisfactorily resolve this problem.

- The fifth proposal relates to the market for second-hand machinery. The text of the Directive makes it very clear that it refers only to the making available for the first time in the territory of the Union; the use of second-hand machinery falls within the scope of Directive 89/655/EEC [8], as amended by Directive 95/63/EC [9].

[8] OJ L 393, 30.12.1989, p. 13.

[9] OJ L 335, 30.12.1995, p. 28.

- The sixth proposal refers to the overlap with Directive 73/23/EEC [10], as amended, on electrical equipment designed for use within certain voltage limits (known as the Low-Voltage Directive) and has received considerable attention because of the numerous difficulties it has caused for the application of the existing Directive. The text has been made more explicit in order to avoid the danger of overlapping.

[10] OJ L 77, 26.3.1973, p. 29, as last amended by Directive 93/68/EEC.

- The seventh proposal concerns the relationship with Directive 92/59/EEC [11] on general product safety (GPS), which is currently being revised. The provisions of the GPS Directive do not apply to products covered by the New Approach directives in as much as those directives contain specific provisions having the same objectives and same presentation as the GPS Directive. For instance, this proposal does not include an early warning system for dangerous products which need to be withdrawn rapidly from the Community market. It is necessary, therefore, in the case of products intended for consumers, that the Community system for the rapid exchange of information and, where appropriate, the necessary emergency measures should apply as provided for in the GPS Directive. Claims against products must be settled under the safeguard clauses described in the various directives applicable.

[11] OJ L 228, 11.8.1992, p. 24.

- The eighth proposal concerns the list of machines for which more stringent conformity assessment needs to be applied. Although the number of machines has been reduced in this proposal, it has not been possible, in view of the major hazards presented by the machines in question, to futher shorten this list. Moreover, the various conformity assessment procedures have been brought into line with the procedures described in Decision 93/465/EEC [12] concerning modules.

[12] OJ L 220, 30.8.1993, p. 23.

- Secondly, a full quality assurance procedure has been added to the various existing possibilities, in order that the industry is no longer obliged to submit every new machine for examination by a notified body. This procedure, which may be used at the manufacturer's discretion, seems particularly interesting for those who manufacture machines individually or in very small numbers.

- It has not been possible to follow up the ninth proposal relating to machines manufactured in accordance with harmonised standards, for the reasons set out in the Commission's comments to the proposals, which are quoted below: "In the case of compliance with the harmonised standards, the procedure has already been simplified in that the manufacturer will not have to demonstrate how the means used meet the essential requirements. However, this does not imply that the declaration of conformity suffices. In particular, the declaration and the technical file serve different objectives - one signifies the responsibility of the manufacturer who places the product on the market, while the other provides the results of the tests conducted, applying the standards. Consequently, the declaration of conformity cannot be considered a substitute for the technical file. Finally, the approach proposed would conflict with the global approach to certification followed since 1990 and applied to all the New Approach directives since then."

- The tenth proposal, concerning languages, has been carefully examined and clearer provisions have been included in Annex I, point 1.10.1. It became clear, however, that a translation alone was not sufficient to guarantee manufacturers' rights, because they are only "responsible" for the original notice(s).

- The eleventh proposal concerns guides for users of the Directive. The Commission had proposed a new structure for Annex I "Essential health and safety requirements" based on the hazards posed by machinery (general requirements plus specific requirements for the various categories of equipment). This new presentation would have made it easier to apply this Annex. This proposal was rejected both by the Member States and by the representatives of industry, who preferred to keep the existing structure (based on the different categories of machinery). The Commission intends to prepare guides (in the form of comments) for the use of each category of machinery. The social partners concerned will naturally be involved in this drafting exercise.

- The twelfth and last proposal concerns harmonised standards. The Commission would point out that, while agreeing that harmonised standards must form complete sets and be relevant in market and commercial terms, European standardisation is a private-sector process over which it has only limited influence. It also points out that the social partners as a whole, and industry in particular, are extremely closely involved in the choices made by the various technical standardisation committees.

A majority of Member States would like to see a tightening-up of the rules on market surveillance so as to allow a genuine circulation of information. The amendments thus seek to strengthen cooperation between Member States in order to provide a clear legal basis for exchanges of information and to ensure observance of professional secrecy where this proves necessary.

The Commission is currently examining the need for a supplementary proposal on this matter.

In conclusion, the purpose of the work that has gone into the revision of the Machinery Directive has been to simplify its application and make it easier to interpret, on the basis of the experience acquired since its entry into force in the Member States and of the conclusions of the Molitor report. Economic operators need a stable legal framework that is conducive to the development of the internal market, in order to manage their present and future activities more effectively.

8. CONTENT OF THE DIRECTIVE

As this Directive is a recast of Directive 98/37/EC, which has been applied in its entirety since 1 January 1997 and partially since 1 January 1993, this chapter indicates only the major amendments to the text.

Articles

Article 1 has been very substantially amended to take account of comments to the effect that not all of the products referred to in the Directive are machines in the strict sense of the word. The new definition takes account of this aspect and clearly identifies partly completed machinery, to which the Directive does not apply in its entirety.

A number of definitions have been added to make it easier to interpret the text. In the case of safety components, it was decided to present an exhaustive list of machinery rather than a definition (the text of Directive 98/37/EC contains such a definition and it has given rise to many problems of interpretation). In order to take account of technological development, the Machinery Committee set up by the Directive will have the powers to amend this list.

A number of machines which were not in Directive 98/37/EC have been included within the scope of the Directive:

- devices for the lifting of persons with reduced mobility;

- construction site hoists intended for lifting persons or persons and goods;

- cartridge-operated fixing devices.

This latter category is the subject of a convention signed by 13 states [13], including eight Member States, under the auspices of the Permanent International Commission for the Proof of Small Arms (CIP) [14]. This Convention requires all products placed on the market by one of the signatory countries to be examined by an authorised body and to be stamped. Member States will have to ensure that there is compatibility between the Convention and the obligations arising from this Directive.

[13] Germany, Austria, Belgium, Chile, Spain, Finland, France, United Kingdom, Hungary, Italy, Russian Federation, Czech Republic, Slovakia.

[14] Permanent Office of the Permanent International Commission, 45 rue Fond des Tawes, 4000 Liège, Belgium.

In accordance with Council Decision 1999/468/EC of 28 June 1999 [15] laying down the procedures for the exercise of implementing powers conferred on the Commission, the Machinery Committee set up by the Directive has been divided into two distinct parts, one using the regulatory procedure to work on clearly defined tasks, the other playing an advisory role on all matters raised by the implementation and practical application of the Directive.

[15] OJ L 184, 17.7.1999, p. 23.

The possibility of prohibiting potentially dangerous machinery has been introduced; the Member State must ascertain this fact, take precautionary measures and inform the Commission and the other Member States thereof. After scrutiny, prohibitive Community measures may be taken by the Machinery Committee set up by the Directive (under the regulatory procedure).

The procedures for disputing harmonised standards and the safeguard clauses are set out in separate articles.

As regards the conformity assessment of machinery referred to in the Directive, the distinction between machinery as a whole and machines which present more serious hazards (quoted in Annex IV) has been maintained. For the first category only conformity assessment with internal inspection (Annex VII) applies; for the more hazardous machines, the manufacturer or his authorised representative may choose to apply either adequacy in respect of harmonised standards (Annex IX), EC type-examination of the machine (Annex X) or full quality assurance (Annex XI). It should be noted that it is no longer possible, in cases where a machine is manufactured in accordance with harmonised standards, to lodge the technical file with a notified body which takes receipt without examining it. Moreover, a simplified procedure has been introduced for machinery which is referred to by the Directive but which presents no inherent risk to safety and health (Annex VIII).

Partly completed machinery, which is almost a machine but which cannot itself perform a specific application, is required to meet only two obligations, namely to bear a declaration of incorporation (Annex II, part B) and to be accompanied by assembly instructions (Annex V).

In order to ensure that the laws, regulations and administrative provisions existing in the various Member States relating to the installation and use of machinery are transparent, Member States are now required to inform all parties concerned and the Commission of all existing and future provisions which they intend to apply.

Article 17 deals specifically with non-conforming markings and describes the obligations arising from the affixing of the CE marking on a machine that is not covered by the Directive or the absence of CE marking for a machine that is so covered.

To ensure total consistency between the scope of this Directive and of Directive 95/16/EC on lifts, an Article amending the latter Directive has been added (Article 24).

Two articles (Articles 18 and 19) have been introduced, the first to describe the necessary cooperation between Member States, and the second to ensure the necessary confidentiality in exchanges of information relating to the application of the Directive.

Annex I - Essential health and safety requirements

The essential health and safety requirements set out in Annex I have not been fundamentally changed; the numbering of the various points has been maintained wherever possible. Many of the changes to the original text concern the drafting, and the most important changes are set out below:

- a number of requirements contained in the existing text for machinery involving a hazard due to its moving parts or for lifting machinery have been extended to cover all machinery. This involves in particular:

- sudden movement during handling (point 1.1.6);

- certain provisions relating to more than one control station;

- the requirement for the operating and/or driving position to be protected against external pollution (point 1.5.1);

- the requirement to provide seating, in particular where machinery is subject to vibrations (point 1.5.2);

- hazards due to lightning (point 1.6.3).

- the parts dealing with instructions (point 1.10 et seq) have been made easier to understand;

- a warning about specific hazards has been added to each of these chapters to draw attention to the fact that the machinery in question must comply with all of the essential health and safety requirements laid down in the Annex;

- specific points have been added to take account of new machinery included within the scope of the Directive.

The essential health and safety requirements are set out by category of machinery, and are supplemented by the following requirements for specific categories:

- agri-foodstuffs machinery and machinery intended for use in the cosmetic and pharmaceutical industries;

- portable hand-held and/or hand-guided machinery;

- portable cartridge-operated fixing devices;

- machinery for working wood and analogous materials;

- machinery presenting hazards due to moving parts;

- machinery presenting hazards due to lifting operations;

- machinery used in underground workings;

- machinery presenting hazards due to an operation involving the lifting or moving of persons;

- machinery designed for lifting persons with reduced mobility;

- construction site hoists intended for lifting persons or persons and goods.

When designing a machine, the manufacturer is required to ascertain from Annex I all of the essential health and safety requirements which he must apply. A wording of Annex I based on hazards and laying a general rule for each hazard, followed by specific cases for the various categories of machinery, would probably have simplified the manufacturer's task.

The Commission intends to prepare explanatory guides for each category of machinery in collaboration with the enterprises concerned.

Annex II - Declarations

The contents of the declarations described in Annex II have been amended to take account of the incorporation of safety components into machinery. There are now only two types of declaration: the EC conformity declaration for all machinery and the declaration of incorporation for partly completed machinery.

Annex IV - Categories of potentially hazardous machinery

The list in Annex IV of machinery regarded as most hazardous has been amended to take account of the difficulties of interpreting the existing list, in particular for points 1.1 to 1.4 and 4. Points 14 and 15 have been widened to cover all "removable mechanical transmission devices" instead of being limited to "detachable transmission shafts with universal joints".

Portable cartridge-operated fixing devices have been added to this list of machinery; some machines, on the other hand, have been withdrawn: machines for the manufacture of pyrotechnics, logic units which ensure the safety functions of bimanual controls, roll-over protection structures (ROPS) and falling-object protective structures (FOPS).

Annexes V and VIII on partly completed machinery and intrinsically safe machinery

A specific annex setting out the assembly instructions for partly completed machinery has been added (Annex V). The same goes for the conformity assessment of a machine not exhibiting any intrinsic health and safety hazard (Annex VIII).

Annexes VI, VII, IX, X and XI on conformity assessment

The content of these annexes, which corresponds to the modules set out in Decision 93/465/EEC (Annexes VI, VII, X and XI), has been maintained, although the wording has been changed to make them easier to use.

The technical file which is included in a number of modules is now the subject of a separate annex (Annex VI) so as to avoid this text having to be copied several times.

Annex IX on the adequacy of a machine in respect of harmonised standards has been added to take account of the practice in the 1989 Directive, which was drafted before the modules were adopted. This procedure is a major simplification for manufacturers who have elected to manufacture their machinery in accordance with harmonised standards; deleting it would put firms at a serious disadvantage and would inevitably mean an increase in the cost of applying the Directive.

In Annex IX (adequacy in respect of harmonised standards) and Annex X (EC type-examination), it has been specified that the notified body must keep its technical file for 15 years. This detail does not appear in the modules.

Annex XI on full quality assurance has been amended relative to the corresponding module to make it clear that the manufacturer must, for each of the machines he manufactures, possess a technical file so as to be able to respond to any reasoned request from a Member State which might consider that the machinery in question is defective.

Annex XII - Minimum criteria for notification of bodies

Annex XII, setting out the minimum criteria, reproduces the text of the existing Directive.

9. CONSISTENCY WITH OTHER COMMUNITY POLICIES

There does not appear to be any inconsistency between the Machinery Directive and other Community policies, in particular the directives on the use of machinery (Directive 89/655/EEC as amended).

10. EXTERNAL CONSULTATIONS

Over a period of nearly three years, numerous parties were consulted at meetings of the Working Party set up by the Machinery Committee created by Article 6 of this Directive. All parties concerned, both at Member State level and from European federations of manufacturers and trade unions, had an opportunity to express their opinions and make comments. These consultations helped to identify a number of approaches and to overcome difficulties of implementing the existing Directive.

The final version of the proposal for a revised Machinery Directive is the culmination of three successive drafts, each of which has been submitted to the Working Party. It incorporates as far as possible the criticisms, remarks and comments made both by Member States and by European industrial federations and trade unions, in particular the Advisory Committee on Safety, Hygiene and Health Protection at the Workplace.

11. EVALUATION

The assessment of the impact of recasting the Directive on the European economy and on small and medium-sized enterprises in particular is based on a study carried out by an outside body [16] at the Commission's request.

[16] Study of the impact of revising the Machinery Directive (98/37/EC) - Contract No ETD/00/502945 (available on request from the information service of DG Enterprise).

Carrying out a proper cost-benefit analysis of the draft recast of the Directive for every specific situation is virtually impossible, given the variety of possible situations. Nevertheless, from the conversations with manufacturers and users it has been possible to gather opinions based on their actual experience of the implementation of the existing Directive.

There were a number of reasons for the recasting:

- to improve the legal certainty of the text by providing those responsible for observing and ensuring observance of the Directive with a clearer, more detailed text from which earlier ambiguities had been removed, and providing an answer to the divergent interpretations of the existing text;

- to amend and clarify the scope;

- to maintain the highest possible level of health and safety.

The following conclusions can be drawn from the study.

The Machinery Directive covers a vast number of categories of products. Moreover, there are one hundred or more essential safety requirements. A reading of the new guide published by the Commission in 1999 reveals the number and diversity of technical, legal and practical issues which the Directive raises.

Overall, opinions on the proposed revision are positive. All those consulted agree that the revision of the Directive has improved a number of points whose interpretation had caused uncertainty.

In terms of safety at work, all the experts consulted agree that the revision represents significant progress.

As regards the resulting financial and administrative burden on manufacturers and users, the representatives from industry who were consulted feel that the balance is positive. The savings resulting from the additional level of detail in the new text offset any expenditure generated by a few points of detail.

Certain points require specific clarification.

(a) Interpreting the previous text Those consulted took the view that this objective had been attained. The reformulation of certain requirements was particularly appreciated, as was the definition of the terminology used in the recast version. Safety components The list of safety components in the revised version is restrictive; it will be the task of the committee set up by the Directive to update this list. The fact that the list in the existing text was open gave rise to differences of opinion as to its scope. These differences were a serious handicap for industry. Tying in with the Low-Voltage Directive Another crucial point of interpretation, which was the subject of endless discussions between representatives of the engineering industry and of the electrical and electronics industries, particularly under the heading of standardisation, was the type of electrical equipment to be included in the Machinery Directive. The revised version contains a detailed list of products excluded from the Machinery Directive. This measure has no impact on manufacturers, but undeniably improves the organisation of standardisation work.

(b) Amending the scope The revised version proposes the inclusion of new products into the Directive. Portable cartridge-operated fixing devices

These devices were excluded from the Directive as firearms. They were not allowed to bear the CE marking like competing products which operated using different processes. This revision has been warmly welcomed by the profession. Construction site hoists intended for lifting persons or persons and goods The revised version brings construction site hoists intended for lifting persons or persons and goods back into the Directive, thus filling the legal vacuum which meant that they were not covered by any of the European directives in force. This inclusion also satisfies a request from the industry, which wanted to benefit from the effects of free movement. Motors The formal exclusion of motors, which are already covered by a number of more specific Directives, removes the administrative uncertainty which was troubling manufacturers. It reduces costs by removing the disruption to trade.

(c) Partly completed machinery The existing Directive includes subassemblies. They enjoy the right of free movement provided they are accompanied by a special declaration. However, the concept of subassemblies was open to interpretation and was used in some cases to cover the most elementary components. The revised version now makes it clear that it refers only to machinery that is virtually complete. It requires the purchaser to submit a declaration of incorporation and assembly instructions. Many manufacturers of partly completed machinery already produce these assembly instructions; those who have not done this in the past consider, nevertheless, that the costs involved are lower than the costs resulting from claims against their third-party liability. However, those questioned in industry stressed the importance of a reasonable interpretation of this requirement. The assembly notice should not become an instruction manual on the scale of that required for completed machinery. The cost of this measure is acceptable within the scope and limits of this compromise.

(d) Revision of the essential requirements This point looks only at the small number of essential requirements to which the parties consulted gave particular emphasis.

Controls In the revised version each work station must be equipped with the necessary manual controls. This requirement is neutral provided that it refers to the manual controls necessary for each workstation. It appears disproportionate if it involves duplicating all of the control functions at each work station. As far as controls for mobile machinery are concerned, the revised version calls for the means to be put in place to prevent unauthorised use. This measure could result in the modification of some equipment (system allowing only authorised persons to start up the machine). As long as this is indeed the meaning of this requirement, it is not disproportionate to the increased safety that will result. There is a new requirement for remote controls. This corresponds to the state of the art in this area, provided that it is interpreted in a reasonable manner. Cabs The revised version requires the installation of a cab in every case where the working environment poses a health hazard. The very broad wording of this requirement raises the problem of how to reconcile the obligations of the manufacturer with those of the user. An artificial transfer of responsibility from the user to the manufacturer may result from an excessively strict interpretation of this text, possibly leading to disproportionate additional costs. Lightning The revised version provides that preventive measures must be taken against lightning where the machine is installed outside. This requirement may well prove costly if it is applied indiscriminately to all types of machinery. Machinery intended for the cosmetics industry The Directive extends the hygiene requirements to cover this type of machinery which was previously implicitly included. This looks unlikely to give rise to any additional costs, because manufacturers have already incorporated these requirements.

(e) Administrative procedures and the formal aspects of the Directive Under the terms of the Directive, equipment falling within Annex IV and meeting harmonised standards will require the intervention of a notified body to confirm its conformity on the basis of the technical file or on the basis of the product. The manufacturers concerned regret that the procedure involving the deposition of the technical file without examination has been taken away

On the other hand, the introduction of a quality assurance procedure for machinery subject to EC type-examination represents a very appreciable easing of the financial and administrative burden on manufacturers of single machines or ofmachinery in small quantities. It was virtually impossible to amortise the cost of EC type-examination for each launch of a different model. Quality assurance spreads the costs over the whole production.

Some representatives from the industry were afraid that certain new requirements might be interpreted in an overly strict manner which might go beyond the letter and the spirit of the revised version. Such unwarranted interpretations could generate disproportionate costs. A reasonable reading of the text is an essential precondition for the success of the revised version. To this extent, the revised version constitutes a balanced whole in terms of both safety and the administrative and financial burdens. This text should be favourably received by the economic and social partners, given that it does not introduce a ny radical changes to the existing situation.

2001/0004 (COD)

Proposal for a DIRECTIVE OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on machinery and amending Directive 95/16/EC

(Text with EEA relevance)

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 [17],

[17] OJ C

Having regard to the opinion of the Economic and Social Committee [18]

[18] OJ C

Acting in accordance with the procedure laid down in Article 251 of the Treaty [19],

[19] OJ C

Whereas:

(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 [20] codified Directive 89/392/EEC [21]. Since further substantial amendments are to be made to Directive 98/37/EC, it should be recast in the interests of clarity.

[20] OJ L 207, 23.7.1998, p. 1, Directive amended by Directive 98/79/EC (OJ L 331, 7.12.1998, p. 1).

[21] OJ L 183, 29.6.1989, p. 9.

(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.

(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.

(4) The maintenance or improvement of the level of safety attained in the Member States constitutes one of the essential aims of this Directive. However, unnecessary constraints imposed on undertakings for certain types of machinery should be reduced: machines for the manufacture of pyrotechnics, the main hazard of which is covered by Directive 94/9/EC of the European Parliament and of the Council of 23 March 1994 on the approximation of the laws of the Member States concerning equipment and protective systems intended for use in potentially explosive atmospheres [22], roll-over protection structures and falling-object protective structures, which are covered by the declaration of the manufacturer of the complete machinery and logic units which ensure the safety functions of bimanual controls, which are now an integral part of the machinery placed on the market.

[22] OJ L 100, 19.4.1994, p. 1.

(5) 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.

(6) The mandatory provisions governing construction site hoists intended for lifting persons or persons and goods and portable cartridge-operated devices intended for industrial or technical use, 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 construction site hoists intended for lifting persons or persons and goods, and portable cartridge-operated fixing devices, from the scope of this Directive, since the latter are excluded from the scope of Council Directive 91/477/EEC of 18 June 1991 on control of the acquisition and possession of weapons [23].

[23] OJ L 256, 13.9.1991, p. 51.

(7) Construction site hoists intended for lifting persons or persons and goods, which are but one specific example of devices for lifting persons, should be covered by this Directive. However, the health and safety requirements laid down by this Directive cannot, in view of their specific use, apply to theatre elevators, that is to say devices for lifting persons which are permanently or temporarily installed in auditoria and which permit the movement of persons from the stage to adjacent locations and vice versa.

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

(9) In the context of this 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.

(10) 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.

(11) 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 manufacturing process. The same will apply where a machine is used normally to provide a service to a consumer.

(12) Although the body of provisions of this Directive may not apply to partly completed machinery, it is nevertheless important that their free movement be guaranteed where they are specifically stated to be intended for incorporation into or assembled with other machinery to form a machine covered by this Directive.

(13) For trade fairs, exhibitions, etc., it must 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.

(14) 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 harmonised at Community level are drawn up by private-law bodies and must retain their non-binding status.

(15) 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, which is 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 [24] and takes account of the nature of the verification required for such machinery.

[24] OJ L 220, 30.8.1993, p. 23.

(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.

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

(18) 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.

(19) The manufacturer or his authorised representative should also be obliged to carry out a risk analysis 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.

(20) 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 physically produced, 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.

(21) 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.

(22) In accordance with Article 2 of Council Decision 1999/468/EC of 28 June 1999 laying down the procedures for the exercise of implementing powers conferred on the Commission [25], measures for the implementation of this Directive should be adopted by use of the advisory procedure provided for in Article 3 of that Decision or by use of the regulatory procedure provided for in Article 5 of that Decision, as appropriate.

[25] OJ L 184, 17.7.1999, p. 23.

(23) Member States should provide for penalties applicable to infringements of the provision of this Directive. The penalties should be effective, proportionate and dissuasive.

(24) The application of this Directive to a number of machines intended for lifting persons, particularly persons with limited mobility, is conducive to a better definition of the products covered by this Directive in relation to 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 [26]. A redefinition of the scope of that Directive was deemed necessary and the Directive should be amended accordingly.

[26] OJ L 213, 7.9.1995, p. 1.

(25) In accordance with the principle of proportionality, it is necessary and appropriate, in order to implement the fundamental objection of improving the safety of machinery put on the market, to lay down the essential health and safety requirements in relation to its design and manufacture. The Directive confines itself to the minimum required in order to ahieve those objectives, in accordance with Article 5 of the Treaty,

HAVE ADOPTED THIS DIRECTIVE:

Article 1 Scope

1. This Directive applies to:

(a) the products defined in points (a) to (i) of the second paragraph of Article 2;

(b) vehicles designed and built to carry out work other than just the transport of persons and used in airports and in the mineral extraction industry.

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

(a) components, including safety components, or equipment, including interchangeable equipment, intended to be used as spare parts to replace identical components or equipment supplied by the manufacturer of the original machinery or by a third party in accordance with the manufacturer's instructions;

(b) specific equipment for use in fairgrounds and 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) firearms;

(e) means of transport, including trailers;

(f) mobile offshore units and machinery covered by this Directive installed on board such units;

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

(h) mine winding gear;

(i) theatre elevators for persons;

(j) products falling into the following areas:

(i) household appliances,

(ii) audio and video equipment,

(iii) information technology equipment,

(iv) office machinery and equipment,

(v) circuit-breakers and switches;

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

(i) switch gear and control gear,

(ii) transformers;

(l) motors of all types;

(m) industrial sites taken as a whole, such as petrochemical plants or heat or power stations;

(n) medical devices.

Article 2 Definitions

For the purposes of this Directive, "machinery" means the products defined in points (a) to (h) of this Article, and the vehicles referred to in point (b) of Article 1(1).

The following definitions shall apply:

(a) "machinery stricto sensu":

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

(ii) machinery referred to in (i), missing only the components to connect it on site or to sources of energy and motion,

(iii) machinery referred to in (i), ready to be installed and able to function as it stands only if mounted on a vehicle or installed in a building or a structure,

(iv) lifting apparatus whose only power source is directly applied manual effort;

(b) "assembly of machinery" means an assembly of machinery and/or of partly completed machinery which, in order to achieve the same end, are arranged and controlled so that they function as an integral whole;

(c) "interchangeable equipment" means a device which, after the placing 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 spare part or a tool;

(d) "safety component" means a component included in the list below which is independently placed on the market in order to be installed on machinery already in use or on second-hand machinery:

(i) components referred to in points 19 and 20 of Annex IV,

(ii) safety logic units for an emergency stop or movable guard control circuit,

(iii) solenoid valves controlling dangerous movements of machinery,

(iv) smoke and dust extraction systems for machinery,

(v) guards and protection devices and their locking mechanisms for machinery,

(vi) control devices for calling lifting appliances and anti-fall devices for hoists,

(vii) devices for preventing lifting appliances from colliding,

(viii) safety belts and seat harnesses,

(ix) non-return valves for installation on hydraulic circuits,

(x) guards for removable mechanical transmission devices;

(e) "lifting accessory" means a component or equipment not attached to the lifting machinery, allowing the load to be held, and placed between the machinery and the load or on the load itself, or constituting an integral part of the load; slings and their components are also regarded as lifting accessories;

(f) "removable mechanical transmission device" means a removable component for transmitting power between a self-propelled machine or a tractor and another machine by joining them at the first fixed bearing. At least one of these two machines must be mobile;

(g) "guard for a removable mechanical transmission device" means a device protecting persons exposed from the risk of being dragged along by a removable transmission mechanical device;

(h) "portable cartridge-operated device" means a portable device intended for industrial or technical use making use of an explosive charge in the form of a cartridge, for the purposes of:

(i) fixing a metal part in a material, or

(ii) slaughtering animals, or

(iii) marking an object by cold engraving, or

(iv) crimping cables;

(i) "partly completed machinery" means an assembly, fitted or intended to be fitted with a drive system, of linked parts or mechanical components which are almost a machine but which cannot themselves perform a specific application. Partly completed machinery is intended to be incorporated into or assembled with one or more machines or other partly completed machinery, thereby forming a single machine to which this Directive applies;

(j) "placing on the market" means making available for the first time in the Community machinery intended for an end user, whether for reward or free of charge;

(k) "manufacturer" means any natural or legal person who designs or manufactures machinery covered by this Directive, with a view to placing it on the market, under his own name or trademark.The manufacturer may also be:

(i) any natural or legal person who designs or manufactures a machine covered by this Directive, or who has such a machine designed or manufactured, for his own use,

(ii) any natural or legal person who, when a machine covered by this Directive is placed on the market or put into service, is responsible for its conformity to this Directive;

(l) "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;

(m) "putting into service" means the first use, for its intended purpose, in the Community, of a machine covered by this Directive. Machinery which, prior to its first use, does not require any installation or adjustment by the manufacturer or by a third party designated by him is considered to have been put into service when it is placed on the market;

(n) "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), adopted 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 [27].

[27] OJ L 204, 21.7.1998, p. 37, as amended by Directive 98/48/EC (OJ L 217, 5.8.1998, p. 18).

Article 3 Specific Directives

1. To the extent that, for a machine, the risks referred to in this Directive are covered more specifically by other Community Directives, this Directive shall not apply, or shall cause to apply, in the case of such machinery and of such risks on the implementation of those Directives.

2. In the case of machinery intended to be used by a consumer, as regards the provisions intended to protect health and safety which are not covered either by this Directive or by other specific Community texts, the provisions of Council Directive 92/59/EEC [28] shall apply.

[28] OJ L 228, 11.8.1992, p. 24.

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 does not endanger the health and safety of persons and, where appropriate, domestic animals or property, when properly installed and maintained and used for its intended purpose or under conditions which can reasonably be foreseen.

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 the Directive.

3. Member States shall institute or appoint the competent authorities to monitor the conformity of 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.

Article 5 Placing on the market

1. Before placing a machine on the market and/or putting it into service, the manufacturer or his authorised representative must ensure that:

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

(b) the conformity assessment procedures referred to in Article 12 have been completed.

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

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

4. Where machinery is also the subject of other Community Directives relating to other aspects and providing for the affixing of the CE marking, the latter 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 Communities, must be given on the EC declaration of conformity which accompanies the machine.

Article 6 Freedom of movement

1. Member States may 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 in respect of the risks which it covers.

2. Member States may 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 B, stating that it is to be incorporated into machinery or assembled with other partly completed machinery to form a machine.

3. At trade fairs, exhibitions, demonstrations, etc., Member States shall not prevent the showing of machines which do not conform to this Directive, provided that a visible sign clearly indicates that they do not conform and that they are not available until they have been brought into conformity by the manufacturer or his authorised representative. Furthermore, during demonstrations of such non-conforming machinery, adequate safety measures shall be taken to ensure the protection of persons.

Article 7 Presumption of conformity

1. Member States shall consider that machinery bearing the CE marking and accompanied by the EC declaration of conformity, the contents of which are set out in Annex II, part A, comply with the provisions of this Directive.

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

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

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.

Article 8 Specific measures

1. The Commission may, acting in accordance with the procedure referred to in Article 22(3), take any appropriate measure to implement the provisions relating to the following points:

(a) updating of the list of safety components referred to in point (d) of the second paragraph of Article 2;

(b) arrangements for cooperation between Member States provided for in Article 19;

(c) updating of the list of machinery referred to in Annex I, point 3.4.2. for which a rollover protective structure is obligatory;

(d) updating of the list of machinery referred to in Annex I, point 1.6.11.2 for which information on non-ionising radiation must be supplied;

(e) prohibition of the placing on the market of machinery referred to in Article 9.

2. The Commission may, acting in accordance with the procedure referred to in Article 22(2), take any appropriate measure connected with the implementation and practical application of this Directive.

Article 9 Specific measures to deal with categories of potentially hazardous machinery

Where a Member State considers, with regard to a given category of machinery that it is necessary, in order to protect safety and health, to prohibit or restrict its placing on the market or make it subject to special conditions, it shall take or envisage all necessary and justified transitional measures. It shall then inform the Commission and the other Member States thereof, indicating its reasons.

The Commission shall consult the Member States and other interested parties, indicating to them the measures it intends to take at Community level. The Commission shall adopt, if the national measures are justified and if Community action can ensure a high level of protection of the health and safety of its citizens, the Community measures necessary under the procedure referred to in Article 22(3).Article 10 Procedure for disputing a harmonised standard

Where a Member State or the Commission considers that a harmonised standard referred to in Article 7(2) 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 instituted 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 not to publish, to publish with restriction, to maintain or to withdraw the references to the harmonised standard concerned in the Official Journal of the European Communities.

Article 11 "Product" safeguard clause

1. Where a Member State ascertains that machinery, 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 or to restrict free movement thereof.

The Member State shall immediately inform the Commission 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);

(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) .

2. The Commission shall enter into consultation with the parties concerned without delay. Where the Commission considers, after this consultation, that the measure is justified, it shall immediately so inform the Member State which took the initiative and the other Member States. Where the Commission considers, after this consultation, that the measure is not justified, it shall immediately so inform the Member State which took the initiative and the manufacturer or his authorised representative. Where the decision referred to in paragraph 1 is based on a shortcoming in the harmonised standards, the Commission shall refer the matter to the committee instituted by Directive 98/34/EC if the Member State at the origin of the decision maintains its position, and the Commission or the Member State shall initiate the procedure referred to in Article 10.

3. 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 and the other Member States.

4. The Commission shall ensure that Member States are kept informed of the progress and outcome of the procedure.

Article 12 Procedures for the conformity assessment of machinery

1. Following the risk analysis described in Annex I, point 1.1.2, the manufacturer or his authorised representative shall apply one of the procedures for the assessment of conformity described in paragraphs 2 to 5.

2. Where the risk analysis enables the conclusion to be drawn that the Directive has no relevance, the manufacturer or his authorised representative shall apply the simplified procedure described in Annex VIII.

3. Where the risk analysis does not enable the conclusion to be drawn that the Directive has no relevance and the machinery is not referred to in Annex IV, the manufacturer or his authorised representative shall, in order to certify its conformity with the provisions of this Directive, apply the procedure for assessment of conformity with internal checks on the manufacture provided for in Annex VII.

4. Where the risk analysis does not enable the conclusion to be drawn that the Directive has no relevance and 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 risks, the manufacturer or his authorised representative shall, in order to certify its conformity with the provisions of this Directive, apply one of the following procedures:

(a) the procedure for adaptation to harmonised standards provided for in Annex IX;

(b) the EC type-examination procedure provided for in Annex X;

(c) the full quality assurance procedure provided for in Annex XI.

5. Where the risk analysis does not enable the conclusion to be drawn that the Directive has no relevance and 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 no harmonised standards exist for the machinery in question, the manufacturer or his authorised representative shall, in order to certify its conformity with the provisions of this Directive, apply one of the following procedures:

(a) the EC type-examination procedure provided for in Annex X;

(c) the full quality assurance procedure provided for in Annex XI.

Article 13 Procedure for partly completed machinery

The manufacturer of partly completed machinery or his authorised representative must, before placing it on the market:

(a) draw up a declaration of incorporation described in Annex II, part B, which must accompany the partly completed machinery until it is incorporated into a complete machine and shall then form part of the technical file for that machine,

(b) prepare a notice of assembly described in Annex V.

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(4) and (5), together with the specific tasks which these bodies have been appointed to carry out and the identification numbers assigned to them beforehand by the Commission.

2. The Commission shall publish in the Official Journal of the European Communities, 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.

3. Member States shall apply the criteria referred to in Annex XII in assessing the bodies to be notified. 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 Communities pursuant to this Directive, shall be presumed to fulfil those criteria.

4. A Member State which has designated a body must withdraw its notification if it finds:

(a) that the body no longer meets the criteria referred to in Annex XII, or

(b) that certificates have repeatedly been issued to models of machinery which do not satisfy the essential health and safety requirements set out in Annex I.

It shall immediately inform the Commission and the other Member States accordingly.

Article 15 Installation and use of machinery

1. 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.

2. Member States shall take whatever measures they deem necessary to ensure that their laws, regulations and administrative provisions relating to the installation and/or use of machinery are brought to the attention of the parties concerned. They shall inform the Commission thereof.

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 distinctly and visibly in accordance with point 1.9 of Annex I.

3. The affixing on machinery of markings which are likely to mislead third parties as to the meaning or form of the CE marking 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.

Article 17 Non-conformity of marking

Member States shall consider the following marking not to conform:

(a) the affixing of the CE marking pursuant to this Directive on machinery not covered by this Directive;

(b) the absence of the CE marking and/or 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.

Where a Member State ascertains that marking does not conform, the manufacturer or his authorised representative shall be obliged to make the machinery conform to the relevant provisions of this Directive and put an end to the infringement under conditions fixed by that Member State.

Where non-conformity persists, the Member State shall take all appropriate measures to restrict or prohibit the placing on the market of the machinery in question or to ensure that it is withdrawn from the market in accordance with the procedure laid down in Article 11.

Article 18 Confidentiality

Without prejudice to existing national provisions and practices in the area of confidentiality, Member States shall ensure that all parties concerned by the application of this Directive are bound to treat as confidential the information obtained in the execution of their tasks which is covered by professional secrecy, unless the divulging of such information is necessary in order to protect the health and safety of persons.

The provisions of the first subparagraph shall not affect the obligations of the Member States and the notified bodies with regard to mutual information and the issuing of warnings, nor the obligations to provide information incumbent on the persons concerned under criminal law.

The decisions taken by the Member States and by the Commission under Articles 9 and 11 must be published.

Article 19 Cooperation between Member States

Member States shall take the appropriate measures to ensure that the competent authorities referred to in Article 4(3) cooperate with each other and transmit to each other the information necessary to enable this Directive to be applied uniformly.

Article 20 Right of defence

Any measure taken pursuant to this Directive which restricts the placing on the market and/or putting into service of a machine 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.

Article 21 Dissemination of information

The Commission will take the necessary measures for appropriate information concerning the implementation of this Directive to be made available.

Article 22 Committee

1. The Commission shall be assisted by a committee, hereinafter called the "Machinery Committee", composed of representatives of the Member States and chaired by the representative of the Commission.

2. Where reference is made to this paragraph, the advisory procedure laid down in Article 3 of Decision 1999/468/EC shall apply, in compliance with Article 7 and Article 8 thereof.

3. Where reference is made to this paragraph, the regulatory procedure laid down in Article 5 of Decision 1999/468/EC shall apply, in compliance with Article 7 and Article 8 thereof.

The period provided for in Article 5(6) of Decision 1999/468/EC shall be three months.

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 the date specified in the first subparagraph of Article 26(1) at the latest and shall notify it without delay of any subsequent amendment affecting them.

Article 24 Amendment of Directive 95/16/EC

Directive 95/16/EC is amended as follows:

(1) In Article 1, paragraphs 2 and 3 are replaced by the following:

"2. For the purposes of this Directive, 'lift' shall mean an appliance serving specific levels, having a load support 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.

Appliances moving along a fixed course even where they do not move along guides which are rigid shall fall within the scope of this Directive.

3. This Directive shall not apply to:

- hoists for persons or for persons and goods, whose speed is not greater than 0.15 m/s,

- cableways, including funicular railways,

- lifts specially designed and constructed for military or police purposes,

- platforms intended for raising/lowering persons and from which work can be carried out,

- mine winding gear,

- theatre elevators for persons,

- lifts fitted in means of transport,

- lifts connected to machinery and intended exclusively for access to the workstation,

- appliances for persons with limited mobility, the load support of which moves along the inclined plain of a staircase,

- escalators and mechanical walkways."

(2) In Annex I, point 1.2 is replaced by the following:

"1.2. Load support

The load support 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 their access."

Article 25 Repeal

Directive 98/37/EC is repealed.

References in Community acts to the repealed Directive shall be construed as references to this Directive and shall be read in accordance with the correlation table in Annex XIII.

Article 26 Implementation

1. Member States shall adopt and publish before 30 June 2004 the laws, regulations and administrative provisions necessary to comply with this Directive. They shall forthwith inform the Commission thereof.

They shall apply those provisions with effect from 1 January 2006.

When Member States adopt those provisions, they shall contain a reference to this Directive or be accompanied by such a 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.

Article 27 Entry into force

This Directive shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Communities.

Article 28 Addressees

This Directive is addressed to the Member States.

Done at Brussels,

For the European Parliament For the Council

The President The President

ANNEX I ESSENTIAL HEALTH AND SAFETY REQUIREMENTS RELATING TO THE DESIGN AND CONSTRUCTION OF MACHINES

PRELIMINARY OBSERVATIONS

1. The manufacturer of a machine or his authorised representative is under an obligation to assess the hazards in order to identify all of those which apply to his machine; he must then design and construct it taking account of his assessment.

2. The obligations laid down by the essential health and safety requirements apply only 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 but also in foreseeable abnormal situations. In any event, the principle of safety integration (requirement 1.1.2) and the obligations of marking and supplying instructions (requirements 1.9 and 1.10.2) apply to all machinery with the exception of machinery referred to in Article 12, paragraph 2 which present no risks.

3. The essential health and safety requirements laid down in this Annex are mandatory. However, taking into account the state of the art and prohibitive economic imperatives, it may not be possible to meet the objectives set by them. In this case, the machinery must as far as possible be designed and constructed with the purpose of approaching those objectives.

4. The essential health and safety requirements have been grouped according to the categories of machinery. Nevertheless, it is essential to take account of the whole of this Annex in order to be able to meet all the relevant essential requirements. Machinery presents a series of hazards which may be covered under more than one heading of this Annex.

1. ESSENTIAL HEALTH AND SAFETY REQUIREMENTS

1.1. General remarks

1.1.1. Definitions

For the purpose of this Annex:

(1) 'danger zone' means any zone within and/or around machinery in which an exposed person is subject to a risk to his health or safety;

(2) 'exposed person' means any person wholly or partially in a danger zone;

(3) 'operator' means the person or persons given the task of installing, operating, adjusting, maintaining, cleaning, repairing or moving machinery;

(4) 'hazardous situation' means any situation in which a person is exposed to one or more risks;

(5) 'risk' means a combination of the probability and the degree of an injury or damage to health that can arise in a hazardous situation;

(6) 'guard' means a part of a machine used specifically to provide protection by means of a physical barrier;

(7) 'protective device' means a device (other than a guard) which eliminates a potential danger or reduces the risk to an acceptable level, alone or in conjunction with a guard.

1.1.2. Principles of safety integration

a) Machinery must be so constructed that it is fitted for its function, and can be adjusted and maintained without putting persons at risk when these operations are carried out under the conditions foreseen by the manufacturer but also in foreseeable abnormal situations. The aim of measures taken must be to eliminate any risk of accident throughout the foreseeable lifetime of the machinery, including the phases of assembly, dismantling, disabling and scrapping .

b) In selecting the most appropriate methods, the manufacturer 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.

c) When designing and constructing machinery, and when drafting the instructions, the manufacturer or his authorised representative must envisage not only the normal use of the machinery but also uses of it which could reasonably be expected. The machinery must be so designed and constructed 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.

d) Machinery must be so designed and constructed as 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.

e) Machinery must be supplied with all the essential special equipment and accessories to enable it to be adjusted, maintained and used without risk.

1.1.3. Ergonomics

Under the intended conditions of use, the discomfort, fatigue and psychological stress faced by the operator must be reduced to the minimum possible taking ergonomic principles into account.

1.1.4. Materials and products

The materials used to construct machinery or products used and created during its use must not endanger exposed persons' safety or health.

In particular, where fluids are used, machinery must be designed and constructed for use without risks due to filling, use, recovery or draining.

1.1.5. Lighting

Machinery must be supplied with integral lighting suitable for the operations concerned where its lack is likely to cause a hazard despite ambient lighting of normal intensity.

Machinery must be so designed and constructed 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 due to the lighting provided by the manufacturer.

The essential requirement described in section 3.1.2 also applies to fixed machinery intended for use outside and for which night work is foreseen.

Internal parts requiring frequent inspection, and adjustment and maintenance areas, must be provided with appropriate lighting.

1.1.6. Design of machinery to facilitate its handling

Machinery or each component part thereof must:

- be capable of being handled safely,

- be packaged or designed so that it can be stored safely and without damage.

During the transportation of the machine and/or its parts, there must be no possibility of sudden movements or of hazards due to instability as long as the machine and/or its parts are handled in accordance with the instructions of the manufacturer or of his authorised representative.

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

- 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 movable, or

- be equipped for picking up and moving in complete safety.

Special arrangements must be made for the handling of tools and/or machinery parts, even if lightweight, which could be hazardous.

1.2. Controls

1.2.1. Safety and reliability of control systems

Control systems must be designed and constructed so that they are safe and reliable, in a way that will prevent a hazardous situation arising. Above all they must be designed and constructed in such a way that:

- they can withstand the rigours of normal use and external factors,

- human error during operation does not lead to hazardous situations.

1.2.2. Manual controls

Manual controls must be:

- clearly visible and identifiable; the use of pictograms is recommended,

- positioned for safe operation without hesitation or loss of time, and without ambiguity,

- designed so that the movement of the manual control is consistent with its effect,

- located outside the danger zones, except where necessary for certain controls, such as the emergency stop and the console for training of robots,

- positioned so that their operation cannot cause additional risk,

- designed or protected so that the desired effect, where a risk is involved, cannot occur without an intentional operation,

- made so as to withstand foreseeable strain; particular attention must be paid to emergency stop devices liable to be subjected to considerable strain.

Where a manual control 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.

Manual controls 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.

Machinery must be fitted with indicators as required for safe operation. The operator must be able to read them from the control position.

From each control position the operator must be able to ensure that there are no persons in the danger zones.

If this is impossible, the control system must be designed and constructed so that, whenever the machinery is about to start, an acoustic and/or visual warning signal is given which leaves enough time for the exposed person to leave the danger zone or prevent the machinery starting up.

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.

1.2.3. Starting

It must be possible to start machinery only by voluntary actuation of a manual control 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 manual control provided for the purpose, unless this would lead to a hazardous situation.

As an exception to the above requirements, for automated plant functioning in automatic mode, the starting of the machinery, or restarting after a stoppage, or a change in operating conditions must be possible without intervention, provided this does not lead to a hazardous situation for the operator and/or exposed persons.

1.2.4. Stopping device

1.2.4.1. Normal stopping

Each machine must be fitted with a manual control whereby the machine can be brought safely to a complete stop.

Each workstation must be fitted with a manual control to stop some or all of the moving parts of the machinery, depending on the type of risk, so that the machinery is rendered safe.

The machinery's stop control must have priority over the start controls.

Once the machinery or its dangerous parts have stopped, the energy supply to the actuators concerned must be cut off.

1.2.4.2. Emergency stop

Each machine must be fitted with one or more emergency stop devices to enable actual or impending danger to be averted.

The following exceptions apply:

- machines in which an emergency stop device would not lessen the risk, either because it would not reduce the stopping time or because it would not enable the special measures required to deal with the risk to be taken,

- hand-held portable machines and hand-guided machines.

This device must:

- have clearly identifiable, clearly visible and quickly accessible manual controls,

- stop the hazardous process as quickly as possible, without creating additional risks,

- where necessary, trigger or permit the triggering of certain safeguard movements.

Once active operation of the emergency stop control has ceased following a stop command, that command must be sustained by engagement of the emergency stop device until that engagement is specifically overridden; it must not be possible to engage the device without triggering a stop command; it must be possible to disengage the device only by an appropriate operation, and disengaging the device must not restart the machinery but only permit restarting.

1.2.4.3. Complex installations

In the case of machinery or parts of machinery designed to work together, the machinery must be so designed and constructed that the stop controls, including emergency stop devices, can stop not only the machinery itself but also all equipment upstream and/or downstream if its continued operation can be dangerous.

1.2.5. Control or operating mode selector

The control mode selected must override all other control or operating modes with the exception of the emergency stop.

If machinery has been designed and built to allow its use in several control or operating modes presenting different safety levels, it must be fitted with a mode selector which can be locked in each position. Each position of the selector must correspond to a single operating or control mode.

The selector may be replaced by another selection method which restricts the use of certain functions of the machinery to certain categories of operator.

If, for certain operations, the machinery must be able to operate with its protection devices neutralised, the control or operating mode selector must simultaneously:

- disable the automatic control mode,

- permit movements only by manual controls requiring sustained action,

- permit the operation of dangerous moving parts only in enhanced safety conditions while preventing hazards from linked sequences,

- prevent any movement liable to pose a danger by acting voluntarily or involuntarily on the machine's internal sensors and any uncontrolled movement.

In addition, the operator must be able to control operation of the parts he is working on from the adjustment point.

1.2.6. Failure of the power supply

The interruption, re-establishment after an interruption or fluctuation in whatever manner of the power supply to the machinery must not lead to dangerous situations.

1.2.7. Control circuit failure

A fault in the control circuit logic, or failure of or damage to the control circuit must not lead to dangerous situations.

1.2.8. Software

Any interactive software between the operator and the command or control system of a machine must be user-friendly.

1.3. Protection against mechanical hazards

1.3.1. Stability

Machinery and its components and fittings must be so designed and constructed that they are stable enough for use without risk of overturning, falling or unexpected movement.

This requirement also applies during transportation, assembly, dismantling, scrapping and any other action involving the machinery.

If the shape of the machinery itself or its intended installation does not offer sufficient stability, appropriate means of anchorage must be incorporated and indicated in the instructions.

1.3.2. Risk of break-up during operation

The various parts of machinery and their linkages must be able to withstand the stresses to which they are subject when used.

The durability of the materials used must be adequate for the nature of the workplace.

The manufacturer or his authorised representative must indicate in the instructions the type and frequency of inspections and maintenance required for safety reasons. He must, where appropriate, indicate the parts subject to wear and the criteria for replacement.

Where a risk of rupture or disintegration remains despite the measures taken, the moving parts must be mounted and positioned in such a way that in case of rupture their fragments will be contained and prevented from reaching workstations.

Both rigid and flexible pipes carrying fluids, particularly those under high pressure, must be able to withstand the foreseen internal and external stresses and must be firmly attached and/or protected against all manner of external stresses and strains; precautions must be taken to ensure that no risk is posed by a rupture.

Where the material to be processed is fed to the tool automatically, the following conditions must be fulfilled to avoid risks to the exposed persons:

- when the workpiece comes into contact with the tool, the latter must have attained its normal working conditions,

- when the tool starts and/or stops (intentionally or accidentally) the feed movement and the tool movement must be coordinated.

1.3.3. Risks due to falling or ejected objects

Precautions must be taken to prevent risks from falling or ejected objects.

1.3.4. Risks due to surfaces, edges or angles

In so far as their purpose allows, accessible parts of the machinery must have no sharp edges, no sharp angles, and no rough surfaces likely to cause injury.

1.3.5. Risks related to combined machinery

Where the machinery is intended to carry out several different operations with the manual removal of the piece between each operation (combined machinery), it must be designed and constructed in such a way as to enable each element to be used separately without the other elements constituting a danger or risk for the exposed person.

For this purpose, it must be possible to start and stop separately any elements that are not protected.

1.3.6. Risks relating to variations in the rotational speed of tools

When the machinery performs operations under different conditions of use, it must be designed and constructed in such a way that selection and adjustment of these conditions can be carried out safely and reliably.

1.3.7. Prevention of risks related to moving parts

The moving parts of machinery must be designed, built and laid out in such a way as to prevent risk of contact which could lead to accidents or, where risks persist, fitted with guards or protective devices.

All necessary steps must be taken to prevent accidental blockage of moving parts involved in the work. In cases where, despite the precautions taken, a blockage is likely to occur, specific protection devices or tools must be provided to enable the equipment to be safely unblocked.

The instructions and possibly a sign on the machinery should indicate these specific protection devices.

1.3.8. Choice of protection against risks caused by moving parts

Guards or protection devices used to protect against the risks caused by moving parts must be selected on the basis of the type of risk. The following guidelines must be used to help make the choice.

1.3.8.1. Moving transmission parts

Guards designed to protect exposed persons against the risks associated with moving transmission parts must be:

- either fixed guards as referred to in section 1.4.2.1,

- or movable guards of type A as referred to in section 1.4.2.2,

Movable guards should be used where frequent access is foreseen.

1.3.8.2. Moving parts directly involved in the work process

Guards or protection devices designed to protect exposed persons against the risks associated with moving parts directly involved in the process must be:

- either fixed guards as referred to in section 1.4.2.1,

- or movable guards of type B as referred to in section 1.4.2.2,

- or protection devices as referred to in section 1.4.3.

However, when certain moving parts directly involved in the process cannot be made completely or partially inaccessible during operation owing to operations requiring nearby operator intervention, where technically possible such parts must be fitted with:

- fixed guards, preventing access to those sections of the parts that are not used in the work,

- adjustable guards as referred to in section 1.4.2.3.

1.3.9. Uncontrolled movements

When a part of a machine has been stopped, any drift away from the stopping position, for whatever reason other than action at the controls, must be such that it is not a hazard to exposed persons.

1.4. Required characteristics of guards and protection devices

1.4.1. General requirements

Guards and protection devices must:

- be of robust construction,

- be securely held in place,

- not give rise to any additional risk,

- not be easy to by-pass or render non-operational,

- be unable to remain in place without their fixings,

- be located at an adequate distance from the danger zone,

- cause minimum obstruction to the view of the production process,

- enable essential work to be carried out on installation and/or replacement of tools and also for maintenance by restricting access only to the area where the work has to be done, if possible without the guard or protection device having to be dismantled.

1.4.2. Special requirements for guards

1.4.2.1. Fixed guards

They must be fixed by systems that can be opened only with tools. Their fixing systems must remain attached to the guards when removed.

1.4.2.2. Movable guards

A. Type A movable guards must:

- as far as possible remain attached to the machinery when open,

- be associated with a locking device:

- to prevent moving parts starting up as long as these parts can be accessed,

- and to give a stop command whenever they are no longer closed.

B. Type B movable guards must:

- as far as possible remain fixed to the machinery when open,

- be so designed and constructed that:

- they can be adjusted only by means of an intentional action,

- the absence or failure of one of their components prevents starting or stops the moving parts,

- protection against any risk of ejection is provided by means of an appropriate barrier.

- be associated with an interlocking device preventing:

- moving parts from starting up while they are within the operator's reach,

- the exposed p