EN Official Journal of the European Union L 157/24

DIRECTIVE 2006/42/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL

of 17 May 2006

on machinery, and amending Directive 95/16/EC (recast)

(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 (1),

Having regard to the opinion of the European Economic and Social Committee (2),

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

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 (4) codified Directive 89/392/EEC (5). Now that new substantial amendments are being made to Directive 98/37/EC, it is desirable, in order to clarify matters, that that Directive should be recast.

(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) 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.

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

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

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

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

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

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

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

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

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

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

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

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

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

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

(19) In view of the nature of the risks involved in the use of machinery covered by this Directive, procedures for assessing conformity to the essential health and safety requirements should be established. These procedures should be devised in the light of the extent of the danger inherent in such machinery. Consequently, each category of machinery should have its appropriate procedure in conformity with Council Decision 93/465/EEC of 22 July 1993 concerning the modules for the various phases of the conformity assessment procedures and the rules for the affixing and use of the CE conformity marking, which are intended to be used in the technical harmonisation directives (9), taking account of the nature of the verification required for such machinery.

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

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

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

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

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

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

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

(27) The application of this Directive to a number of machines intended for lifting persons requires a better delimitation of the products covered by this Directive with respect to those covered by Directive 95/16/EC of the European Parliament and of the Council of 29 June 1995 on the approximation of the laws of the Member States relating to lifts (10). A redefinition of the scope of the latter Directive is thus deemed necessary. Directive 95/16/EC should therefore be amended accordingly.

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

(29) In accordance with point 34 of the Interinstitutional Agreement on better law-making (11), Member States are encouraged to draw up, for themselves and in the interests of the Community, their own tables illustrating, as far as possible, the correlation between this Directive and the transposition measures, and to make them public.

(30) The measures necessary for the implementation of this Directive should be adopted in accordance with Council Decision 1999/468/EC of 28 June 1999 laying down the procedures for the exercise of implementing powers conferred on the Commission (12),

HAS ADOPTED THIS DIRECTIVE:

Article 1

Scope

1. This Directive applies to the following products:

(a) machinery;

(b) interchangeable equipment;

(c) safety components;

(d) lifting accessories;

(e) chains, ropes and webbing;

(f) removable mechanical transmission devices;

(g) partly completed machinery.

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

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

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

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

(d) weapons, including firearms;

(e) the following means of transport: — agricultural and forestry tractors for the risks covered by Directive 2003/37/EC, with the exclusion of machinery mounted on these vehicles, — motor vehicles and their trailers covered by Council Directive 70/156/EEC of 6 February 1970 on the approximation of the laws of the Member States relating to the type-approval of motor vehicles and their trailers (13), with the exclusion of machinery mounted on these vehicles, — vehicles covered by Directive 2002/24/EC of the European Parliament and of the Council of 18 March 2002 relating to the type-approval of two or three-wheel motor vehicles (14), with the exclusion of machinery mounted on these vehicles, — motor vehicles exclusively intended for competition, and — means of transport by air, on water and on rail networks with the exclusion of machinery mounted on these means of transport;

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

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

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

(i) mine winding gear;

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

(k) electrical and electronic products falling within the following areas, insofar as they are covered by Council Directive 73/23/EEC of 19 February 1973 on the harmonisation of the laws of Member States relating to electrical equipment designed for use within certain voltage limits (15): — household appliances intended for domestic use, — audio and video equipment, — information technology equipment, — ordinary office machinery, — low-voltage switchgear and control gear, — electric motors;

(l) the following types of high-voltage electrical equipment: — switch gear and control gear, — transformers.

Article 2

Definitions

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

The following definitions shall apply:

(a) ‘machinery’ means: — an assembly, fitted with or intended to be fitted with a drive system other than directly applied human or animal effort, consisting of linked parts or components, at least one of which moves, and which are joined together for a specific application, — an assembly referred to in the first indent, missing only the components to connect it on site or to sources of energy and motion, — an assembly referred to in the first and second indents, ready to be installed and able to function as it stands only if mounted on a means of transport, or installed in a building or a structure, — assemblies of machinery referred to in the first, second and third indents or partly completed machinery referred to in point (g) which, in order to achieve the same end, are arranged and controlled so that they function as an integral whole, — an assembly of linked parts or components, at least one of which moves and which are joined together, intended for lifting loads and whose only power source is directly applied human effort;

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

(c) ‘safety component’ means a component: — which serves to fulfil a safety function, — which is independently placed on the market, — the failure and/or malfunction of which endangers the safety of persons, and — which is not necessary in order for the machinery to function, or for which normal components may be substituted in order for the machinery to function. An indicative list of safety components is set out in Annex V, which may be updated in accordance with Article 8(1)(a);

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

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

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

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

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

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

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

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

(l) ‘harmonised standard’ means a non-binding technical specification adopted by a standardisation body, namely the European Committee for Standardisation (CEN), the European Committee for Electrotechnical Standardisation (CENELEC) or the European Telecommunications Standards Institute (ETSI), on the basis of a remit issued by the Commission in accordance with the procedures laid down in Directive 98/34/EC of the European Parliament and of the Council of 22 June 1998 laying down a procedure for the provision of information in the field of technical standards and regulations and of rules on Information Society services (16).

Article 3

Specific Directives

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

Article 4

Market surveillance

1. Member States shall take all appropriate measures to ensure that machinery may be placed on the market and/or put into service only if it satisfies the relevant provisions of this Directive and does not endanger the health and safety of persons and, where appropriate, domestic animals or property, 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 this Directive.

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

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

Article 5

Placing on the market and putting into service

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

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

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

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

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

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

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

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

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

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

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

Article 6

Freedom of movement

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

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

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

Article 7

Presumption of conformity and harmonised standards

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

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

3. The Commission shall publish in the Official Journal of the European Union 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, acting in accordance with the procedure referred to in Article 22(3), may take any appropriate measure to implement the provisions relating to the following points:

(a) updating of the indicative list of safety components in Annex V referred to in point (c) in Article 2;

(b) restriction of the placing on the market of machinery referred to in Article 9.

2. The Commission, acting in accordance with the procedure referred to in Article 22(2), may take any appropriate measure connected with the implementation and practical application of this Directive, including measures necessary to ensure cooperation of Member States with each other and with the Commission, as provided for in Article 19(1).

Article 9

Specific measures to deal with potentially hazardous machinery

1. When, in accordance with the procedure referred to in Article 10, the Commission considers that a harmonised standard does not entirely satisfy the essential health and safety requirements which it covers and which are set out in Annex I, the Commission may, in accordance with paragraph 3 of this Article, take measures requiring Member States to prohibit or restrict the placing on the market of machinery with technical characteristics presenting risks due to the shortcomings in the standard or to make such machinery subject to special conditions.

When, in accordance with the procedure referred to in Article 11, the Commission considers that a measure taken by a Member State is justified, the Commission may, in accordance with paragraph 3 of this Article, take measures requiring Member States to prohibit or restrict the placing on the market of machinery presenting the same risk by virtue of its technical characteristics or to make such machinery subject to special conditions.

2. Any Member State may request the Commission to examine the need for the adoption of the measures referred to in paragraph 1.

3. In the cases referred to in paragraph 1, the Commission shall consult the Member States and other interested parties indicating the measures it intends to take, in order to ensure, at Community level, a high level of protection of the health and safety of persons.

Taking due account of the results of this consultation, it shall adopt the necessary measures in accordance with 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 does not entirely satisfy the essential health and safety requirements which it covers and which are set out in Annex I, the Commission or the Member State shall bring the matter before the committee set up by Directive 98/34/EC, setting out the reasons therefor. The committee shall deliver an opinion without delay. In the light of the committee's opinion, the Commission shall decide to publish, not to publish, to publish with restriction, to maintain, to maintain with restriction or to withdraw the references to the harmonised standard concerned in the Official Journal of the European Union.

Article 11

Safeguard clause

1. Where a Member State ascertains that machinery covered by this Directive, bearing the CE marking, accompanied by the EC declaration of conformity and used in accordance with its intended purpose or under conditions which can reasonably be foreseen, is liable to compromise the health and safety of persons and, where appropriate, domestic animals or property, it shall take all appropriate measures to withdraw such machinery from the market, to prohibit the placing on the market and/or putting into service of such machinery or to restrict free movement thereof.

2. The Member State shall immediately inform the Commission and the other Member States of any such measure, indicating the reasons for its decision and, in particular, whether the non-conformity is due to:

(a) failure to satisfy the essential requirements referred to in Article 5(1)(a);

(b) incorrect application of the harmonised standards referred to in Article 7(2);

(c) shortcomings in the harmonised standards themselves referred to in Article 7(2).

3. The Commission shall enter into consultation with the parties concerned without delay.

The Commission shall consider, after this consultation, whether or not the measures taken by the Member State are justified, and it shall communicate its decision to the Member State which took the initiative, the other Member States, and the manufacturer or his authorised representative.

4. Where the measures referred to in paragraph 1 are based on a shortcoming in the harmonised standards and if the Member State which instigated the measures maintains its position, the Commission or the Member State shall initiate the procedure referred to in Article 10.

5. Where machinery does not conform and bears the CE marking, the competent Member State shall take appropriate action against whomsoever has affixed the marking and shall so inform the Commission. The Commission shall inform the other Member States.

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

Article 12

Procedures for assessing the conformity of machinery

1. The manufacturer or his authorised representative shall, in order to certify the conformity of machinery with the provisions of this Directive, apply one of the procedures for assessment of conformity described in paragraphs 2, 3 and 4.

2. Where the machinery is not referred to in Annex IV, the manufacturer or his authorised representative shall apply the procedure for assessment of conformity with internal checks on the manufacture of machinery provided for in Annex VIII.

3. Where the machinery is referred to in Annex IV and manufactured in accordance with the harmonised standards referred to in Article 7(2), and provided that those standards cover all of the relevant essential health and safety requirements, the manufacturer or his authorised representative shall apply one of the following procedures:

(a) the procedure for assessment of conformity with internal checks on the manufacture of machinery, provided for in Annex VIII;

(b) the EC type-examination procedure provided for in Annex IX, plus the internal checks on the manufacture of machinery provided for in Annex VIII, point 3;

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

4. Where the machinery is referred to in Annex IV and has not been manufactured in accordance with the harmonised standards referred to in Article 7(2), or only partly in accordance with such standards, or if the harmonised standards do not cover all the relevant essential health and safety requirements or if no harmonised standards exist for the machinery in question, the manufacturer or his authorised representative shall apply one of the following procedures:

(a) the EC type-examination procedure provided for in Annex IX, plus the internal checks on the manufacture of machinery provided for in Annex VIII, point 3;

(b) the full quality assurance procedure provided for in Annex X.

Article 13

Procedure for partly completed machinery

1. The manufacturer of partly completed machinery or his authorised representative shall, before placing it on the market, ensure that:

(a) the relevant technical documentation described in Annex VII, part B is prepared;

(b) assembly instructions described in Annex VI are prepared;

(c) a declaration of incorporation described in Annex II, part 1, Section B has been drawn up.

2. The assembly instructions and the declaration of incorporation shall accompany the partly completed machinery until it is incorporated into the final machinery and shall then form part of the technical file for that machinery.

Article 14

Notified bodies

1. Member States shall notify the Commission and the other Member States of the bodies which they have appointed to carry out the assessment of conformity for placing on the market referred to in Article 12(3) and (4), together with the specific conformity assessment procedures and categories of machinery for which these bodies have been appointed and the identification numbers assigned to them beforehand by the Commission. Member States shall notify the Commission and other Member States of any subsequent amendment.

2. The Member States shall ensure that the notified bodies are monitored regularly to check that they comply at all times with the criteria set out in Annex XI. The notified body shall provide all relevant information on request, including budgetary documents, to enable the Member States to ensure that the requirements of Annex XI are met.

3. Member States shall apply the criteria set out in Annex XI in assessing the bodies to be notified and the bodies already notified.

4. The Commission shall publish in the Official Journal of the European Union, for information, a list of the notified bodies and their identification numbers and the tasks for which they have been notified. The Commission shall ensure that this list is kept up to date.

5. Bodies meeting the assessment criteria laid down in the relevant harmonised standards, the references of which shall be published in the Official Journal of the European Union, shall be presumed to fulfil the relevant criteria.

6. If a notified body finds that relevant requirements of this Directive have not been met or are no longer met by the manufacturer or that an EC type-examination certificate or the approval of a quality assurance system should not have been issued, it shall, taking account of the principle of proportionality, suspend or withdraw the certificate or the approval issued or place restrictions on it, giving detailed reasons, unless compliance with such requirements is ensured by the implementation of appropriate corrective measures by the manufacturer. In the event of suspension or withdrawal of the certificate or the approval or of any restriction placed on it, or in cases where intervention by the competent authority may prove necessary, the notified body shall inform the competent authority pursuant to Article 4. The Member State shall inform the other Member States and the Commission without delay. An appeal procedure shall be available.

7. The Commission shall provide for the organisation of an exchange of experience between the authorities responsible for appointment, notification and monitoring of notified bodies in the Member States, and the notified bodies, in order to coordinate the uniform application of this Directive.

8. A Member State which has notified a body shall immediately withdraw its notification if it finds:

(a) that the body no longer meets the criteria set out in Annex XI; or

(b) that the body seriously fails to fulfil its responsibilities.

The Member State shall immediately inform the Commission and the other Member States accordingly.

Article 15

Installation and use of machinery

This Directive shall not affect Member States' entitlement to lay down, in due observance of Community law, such requirements as they may deem necessary to ensure that persons, and in particular workers, are protected when using machinery, provided that this does not mean that such machinery is modified in a way not specified in this Directive.

Article 16

CE marking

1. The CE conformity marking shall consist of the initials ‘CE’ as shown in Annex III.

2. The CE marking shall be affixed to the machinery visibly, legibly and indelibly in accordance with Annex III.

3. The affixing on machinery of markings, signs and inscriptions which are likely to mislead third parties as to the meaning or form of the CE marking, or both, shall be prohibited. Any other marking may be affixed to the machinery provided that the visibility, legibility and meaning of the CE marking is not thereby impaired.

Article 17

Non-conformity of marking

1. Member States shall consider the following marking not to conform:

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

(b) the absence of the CE marking and/or the absence of the EC declaration of conformity for machinery;

(c) the affixing on machinery of a marking, other than the CE marking, which is prohibited under Article 16(3).

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

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

Article 18

Confidentiality

1. Without prejudice to existing national provisions and practices in the area of confidentiality, Members States shall ensure that all parties and persons concerned by the application of this Directive are required to treat as confidential information obtained in the execution of their tasks. More particularly business, professional and trade secrets shall be treated as confidential, unless the divulging of such information is necessary in order to protect the health and safety of persons.

2. The provisions of paragraph 1 shall not affect the obligations of the Member States and the notified bodies with regard to mutual exchange of information and the issuing of warnings.

3. Any decisions taken by the Member States and by the Commission in accordance with Articles 9 and 11 shall be published.

Article 19

Cooperation between Member States

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

2. The Commission shall provide for the organisation of an exchange of experience between the competent authorities responsible for market surveillance in order to coordinate the uniform application of this Directive.

Article 20

Legal remedies

Any measure taken pursuant to this Directive which restricts the placing on the market and/or putting into service of any machinery covered by this Directive shall state the exact grounds on which it is based. Such a measure shall be notified as soon as possible to the party concerned, who shall at the same time be informed of the legal remedies available to him under the laws in force in the Member State concerned and of the time limits to which such remedies are subject.

Article 21

Dissemination of information

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

Article 22

Committee

1. The Commission shall be assisted by a committee, hereinafter referred to as the ‘Committee’.

2. Where reference is made to this paragraph, Articles 3 and 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof.

3. Where reference is made to this paragraph, Articles 5 and 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof.

The period laid down in Article 5(6) of Decision 1999/468/EC shall be set at three months.

4. The Committee shall adopt its rules of procedure.

Article 23

Penalties

Member States shall lay down the rules on penalties applicable to infringements of the national provisions adopted pursuant to this Directive and shall take all measures necessary to ensure that they are implemented. The penalties provided for must be effective, proportionate and dissuasive. Member States shall notify those provisions to the Commission by 29 June 2008 and shall notify it without delay of any subsequent amendment affecting them.

Article 24

Amendment of Directive 95/16/EC

Directive 95/16/EC is hereby amended as follows:

1. in Article 1, paragraphs 2 and 3 shall be replaced by the following: 2. ‘For the purposes of this Directive, “lift” shall mean a lifting appliance serving specific levels, having a carrier moving along guides which are rigid and inclined at an angle of more than 15 degrees to the horizontal, intended for the transport of: — persons, — persons and goods, — goods alone if the carrier is accessible, that is to say a person may enter it without difficulty, and fitted with controls situated inside the carrier or within reach of a person inside the carrier. Lifting appliances moving along a fixed course even where they do not move along guides which are rigid shall be considered as lifts falling within the scope of this Directive. A “carrier” means a part of the lift by which persons and/or goods are supported in order to be lifted or lowered. 3. This Directive shall not apply to: — lifting appliances whose speed is not greater than 0,15 m/s, — construction site hoists, — cableways, including funicular railways, — lifts specially designed and constructed for military or police purposes, — lifting appliances from which work can be carried out, — mine winding gear, — lifting appliances intended for lifting performers during artistic performances, — lifting appliances fitted in means of transport, — lifting appliances connected to machinery and intended exclusively for access to workstations including maintenance and inspection points on the machinery, — rack and pinion trains, — escalators and mechanical walkways.’;

2. in Annex I, point 1.2 shall be replaced by the following: 1.2. ‘Carrier The carrier of each lift must be a car. This car must be designed and constructed to offer the space and strength corresponding to the maximum number of persons and the rated load of the lift set by the installer. Where the lift is intended for the transport of persons, and where its dimensions permit, the car must be designed and constructed in such a way that its structural features do not obstruct or impede access and use by disabled persons and so as to allow any appropriate adjustments intended to facilitate its use by them.’

Article 25

Repeal

Directive 98/37/EC is hereby repealed.

References made to the repealed Directive shall be construed as being made to this Directive and should be read in accordance with the correlation table in Annex XII.

Article 26

Transposition

1. Member States shall adopt and publish the provisions necessary to comply with this Directive by 29 June 2008 at the latest. They shall forthwith inform the Commission thereof.

They shall apply those provisions with effect from 29 December 2009.

When Member States adopt those provisions, they shall contain a reference to this Directive or shall be accompanied by such reference on the occasion of their official publication. Member States shall determine how such reference is to be made.

2. Member States shall communicate to the Commission the text of the provisions of national law which they adopt in the field covered by this Directive, together with a table showing how the provisions of this Directive correspond to the national provisions adopted.

Article 27

Derogation

Until 29 June 2011 Member States may allow the placing on the market and the putting into service of portable cartridge-operated fixing and other impact machinery which are in conformity with the national provisions in force upon adoption of this Directive.

Article 28

Entry into force

This Directive shall enter into force on the 20th day following its publication in the Official Journal of the European Union.

Article 29

Addressees

This Directive is addressed to the Member States.

Done at Strasbourg, 17 May 2006. For the European Parliament The President J. BORRELL FONTELLES For the Council The President H. WINKLER

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

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

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

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

(5) Council Directive 89/392/EEC of 14 June 1989 on the approximation of the laws of the Member States relating to machinery (OJ L 183, 29.6.1989, p. 9).

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

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

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

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

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

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

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

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

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

(15) OJ L 77, 26.3.1973, p. 29. Directive as amended by Directive 93/68/EEC (OJ L 220, 30.8.1993, p. 1).

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

ANNEX I

Essential health and safety requirements relating to the the design and construction of machinery

GENERAL PRINCIPLES

1. The manufacturer of machinery or his authorised representative must ensure that a risk assessment is carried out in order to determine the health and safety requirements which apply to the machinery. The machinery must then be designed and constructed taking into account the results of the risk assessment. By the iterative process of risk assessment and risk reduction referred to above, the manufacturer or his authorised representative shall: — determine the limits of the machinery, which include the intended use and any reasonably foreseeable misuse thereof, — identify the hazards that can be generated by the machinery and the associated hazardous situations, — estimate the risks, taking into account the severity of the possible injury or damage to health and the probability of its occurrence, — evaluate the risks, with a view to determining whether risk reduction is required, in accordance with the objective of this Directive, — eliminate the hazards or reduce the risks associated with these hazards by application of protective measures, in the order of priority established in section 1.1.2(b).

2. The obligations laid down by the essential health and safety requirements only apply when the corresponding hazard exists for the machinery in question when it is used under the conditions foreseen by the manufacturer or his authorised representative or in foreseeable abnormal situations. In any event, the principles of safety integration referred to in section 1.1.2 and the obligations concerning marking of machinery and instructions referred to in sections 1.7.3 and 1.7.4 apply.

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

4. This Annex is organised in several parts. The first one has a general scope and is applicable to all kinds of machinery. The other parts refer to certain kinds of more specific hazards. Nevertheless, it is essential to examine the whole of this Annex in order to be sure of meeting all the relevant essential requirements. When machinery is being designed, the requirements of the general part and the requirements of one or more of the other parts shall be taken into account, depending on the results of the risk assessment carried out in accordance with point 1 of these General Principles.

1. ESSENTIAL HEALTH AND SAFETY REQUIREMENTS

1.1. GENERAL REMARKS

1.1.1. Definitions

For the purpose of this Annex:

(a) ‘hazard’ means a potential source of injury or damage to health;

(b) ‘danger zone’ means any zone within and/or around machinery in which a person is subject to a risk to his health or safety;

(c) ‘exposed person’ means any person wholly or partially in a danger zone;

(d) ‘operator’ means the person or persons installing, operating, adjusting, maintaining, cleaning, repairing or moving machinery;

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

(f) ‘guard’ means a part of the machinery used specifically to provide protection by means of a physical barrier;

(g) ‘protective device’ means a device (other than a guard) which reduces the risk, either alone or in conjunction with a guard;

(h) ‘intended use’ means the use of machinery in accordance with the information provided in the instructions for use;

(i) ‘reasonably foreseeable misuse’ means the use of machinery in a way not intended in the instructions for use, but which may result from readily predictable human behaviour.

1.1.2. Principles of safety integration

(a) Machinery must be designed and constructed so that it is fitted for its function, and can be operated, adjusted and maintained without putting persons at risk when these operations are carried out under the conditions foreseen but also taking into account any reasonably foreseeable misuse thereof. The aim of measures taken must be to eliminate any risk throughout the foreseeable lifetime of the machinery including the phases of transport, assembly, dismantling, disabling and scrapping.

(b) In selecting the most appropriate methods, the manufacturer or his authorised representative must apply the following principles, in the order given: — eliminate or reduce risks as far as possible (inherently safe machinery design and construction), — take the necessary protective measures in relation to risks that cannot be eliminated, — inform users of the residual risks due to any shortcomings of the protective measures adopted, indicate whether any particular training is required and specify any need to provide personal protective equipment.

(c) When designing and constructing machinery and when drafting the instructions, the manufacturer or his authorised representative must envisage not only the intended use of the machinery but also any reasonably foreseeable misuse thereof. The machinery must be designed and constructed in such a way as to prevent abnormal use if such use would engender a risk. Where appropriate, the instructions must draw the user's attention to ways — which experience has shown might occur — in which the machinery should not be used.

(d) Machinery must be designed and constructed to take account of the constraints to which the operator is subject as a result of the necessary or foreseeable use of personal protective equipment.

(e) Machinery must be supplied with all the special equipment and accessories essential to enable it to be adjusted, maintained and used safely.

1.1.3. Materials and products

The materials used to construct machinery or products used or created during its use must not endanger persons' safety or health. In particular, where fluids are used, machinery must be designed and constructed to prevent risks due to filling, use, recovery or draining.

1.1.4. Lighting

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

Machinery must be designed and constructed so that there is no area of shadow likely to cause nuisance, that there is no irritating dazzle and that there are no dangerous stroboscopic effects on moving parts due to the lighting.

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

1.1.5. Design of machinery to facilitate its handling

Machinery, or each component part thereof, must:

— be capable of being handled and transported safely,

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

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

Where the weight, size or shape of machinery or its various component parts prevents them from being moved by hand, the machinery or each component part must:

— either be fitted with attachments for lifting gear, or

— be designed so that it can be fitted with such attachments, or

— be shaped in such a way that standard lifting gear can easily be attached.

Where machinery or one of its component parts is to be moved by hand, it must:

— either be easily moveable, or

— be equipped for picking up and moving safely.

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

1.1.6. Ergonomics

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

— allowing for the variability of the operator's physical dimensions, strength and stamina,

— providing enough space for movements of the parts of the operator's body,

— avoiding a machine-determined work rate,

— avoiding monitoring that requires lengthy concentration,

— adapting the man/machinery interface to the foreseeable characteristics of the operators.

1.1.7. Operating positions

The operating position must be designed and constructed in such a way as to avoid any risk due to exhaust gases and/or lack of oxygen.

If the machinery is intended to be used in a hazardous environment presenting risks to the health and safety of the operator or if the machinery itself gives rise to a hazardous environment, adequate means must be provided to ensure that the operator has good working conditions and is protected against any foreseeable hazards.

Where appropriate, the operating position must be fitted with an adequate cabin designed, constructed and/or equipped to fulfil the above requirements. The exit must allow rapid evacuation. Moreover, when applicable, an emergency exit must be provided in a direction which is different from the usual exit.

1.1.8. Seating

Where appropriate and where the working conditions so permit, work stations constituting an integral part of the machinery must be designed for the installation of seats.

If the operator is intended to sit during operation and the operating position is an integral part of the machinery, the seat must be provided with the machinery.

The operator's seat must enable him to maintain a stable position. Furthermore, the seat and its distance from the control devices must be capable of being adapted to the operator.

If the machinery is subject to vibrations, the seat must be designed and constructed in such a way as to reduce the vibrations transmitted to the operator to the lowest level that is reasonably possible. The seat mountings must withstand all stresses to which they can be subjected. Where there is no floor beneath the feet of the operator, footrests covered with a slip-resistant material must be provided.

1.2. CONTROL SYSTEMS

1.2.1. Safety and reliability of control systems

Control systems must be designed and constructed in such a way as to prevent hazardous situations from arising. Above all, they must be designed and constructed in such a way that:

— they can withstand the intended operating stresses and external influences,

— a fault in the hardware or the software of the control system does not lead to hazardous situations,

— errors in the control system logic do not lead to hazardous situations,

— reasonably foreseeable human error during operation does not lead to hazardous situations.

Particular attention must be given to the following points:

— the machinery must not start unexpectedly,

— the parameters of the machinery must not change in an uncontrolled way, where such change may lead to hazardous situations,

— the machinery must not be prevented from stopping if the stop command has already been given,

— no moving part of the machinery or piece held by the machinery must fall or be ejected,

— automatic or manual stopping of the moving parts, whatever they may be, must be unimpeded,

— the protective devices must remain fully effective or give a stop command,

— the safety-related parts of the control system must apply in a coherent way to the whole of an assembly of machinery and/or partly completed machinery.

For cable-less control, an automatic stop must be activated when correct control signals are not received, including loss of communication.

1.2.2. Control devices

Control devices must be:

— clearly visible and identifiable, using pictograms where appropriate,

— positioned in such a way as to be safely operated without hesitation or loss of time and without ambiguity,

— designed in such a way that the movement of the control device is consistent with its effect,

— located outside the danger zones, except where necessary for certain control devices such as an emergency stop or a teach pendant,

— positioned in such a way that their operation cannot cause additional risk,

— designed or protected in such a way that the desired effect, where a hazard is involved, can only be achieved by a deliberate action,

— made in such a way as to withstand foreseeable forces; particular attention must be paid to emergency stop devices liable to be subjected to considerable forces.

Where a control device is designed and constructed to perform several different actions, namely where there is no one-to-one correspondence, the action to be performed must be clearly displayed and subject to confirmation, where necessary.

Control devices must be so arranged that their layout, travel and resistance to operation are compatible with the action to be performed, taking account of ergonomic principles.

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 no-one is in the danger zones, or the control system must be designed and constructed in such a way that starting is prevented while someone is in the danger zone.

If neither of these possibilities is applicable, before the machinery starts, an acoustic and/or visual warning signal must be given. The exposed persons must have time to leave the danger zone or prevent the machinery starting up.

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.

Where there is more than one control position, the control system must be designed in such a way that the use of one of them precludes the use of the others, except for stop controls and emergency stops.

When machinery has two or more operating positions, each position must be provided with all the required control devices without the operators hindering or putting each other into a hazardous situation.

1.2.3. Starting

It must be possible to start machinery only by voluntary actuation of a control device provided for the purpose.

The same requirement applies:

— when restarting the machinery after a stoppage, whatever the cause,

— when effecting a significant change in the operating conditions.

However, the restarting of the machinery or a change in operating conditions may be effected by voluntary actuation of a device other than the control device provided for the purpose, on condition that this does not lead to a hazardous situation.

For machinery functioning in automatic mode, the starting of the machinery, restarting after a stoppage, or a change in operating conditions may be possible without intervention, provided this does not lead to a hazardous situation.

Where machinery has several starting control devices and the operators can therefore put each other in danger, additional devices must be fitted to rule out such risks. If safety requires that starting and/or stopping must be performed in a specific sequence, there must be devices which ensure that these operations are performed in the correct order.

1.2.4. Stopping

1.2.4.1. Normal stop

Machinery must be fitted with a control device whereby the machinery can be brought safely to a complete stop.

Each workstation must be fitted with a control device to stop some or all of the functions of the machinery, depending on the existing hazards, so that the machinery is rendered safe.

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

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

1.2.4.2. Operational stop

Where, for operational reasons, a stop control that does not cut off the energy supply to the actuators is required, the stop condition must be monitored and maintained.

1.2.4.3. Emergency stop

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

The following exceptions apply:

— machinery 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,

— portable hand-held and/or hand-guided machinery.

The device must:

— have clearly identifiable, clearly visible and quickly accessible control devices,

— 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 device 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.

The emergency stop function must be available and operational at all times, regardless of the operating mode.

Emergency stop devices must be a back-up to other safeguarding measures and not a substitute for them.

1.2.4.4. Assembly of machinery

In the case of machinery or parts of machinery designed to work together, the machinery must be designed and constructed in such a way that the stop controls, including the emergency stop devices, can stop not only the machinery itself but also all related equipment, if its continued operation may be dangerous.

1.2.5. Selection of control or operating modes

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

If machinery has been designed and constructed to allow its use in several control or operating modes requiring different protective measures and/or work procedures, it must be fitted with a mode selector which can be locked in each position. Each position of the selector must be clearly identifiable and 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 a guard displaced or removed and/or a protective device disabled, the control or operating mode selector must simultaneously:

— disable all other control or operating modes,

— permit operation of hazardous functions only by control devices requiring sustained action,

— permit the operation of hazardous functions only in reduced risk conditions while preventing hazards from linked sequences,

— prevent any operation of hazardous functions by voluntary or involuntary action on the machine's sensors.

If these four conditions cannot be fulfilled simultaneously, the control or operating mode selector must activate other protective measures designed and constructed to ensure a safe intervention zone.

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

Particular attention must be given to the following points:

— the machinery must not start unexpectedly,

— the parameters of the machinery must not change in an uncontrolled way when such change can lead to hazardous situations,

— the machinery must not be prevented from stopping if the command has already been given,

— no moving part of the machinery or piece held by the machinery must fall or be ejected,

— automatic or manual stopping of the moving parts, whatever they may be, must be unimpeded,

— the protective devices must remain fully effective or give a stop command.

1.3. PROTECTION AGAINST MECHANICAL HAZARDS

1.3.1. Risk of loss of stability

Machinery and its components and fittings must be stable enough to avoid overturning, falling or uncontrolled movements during transportation, assembly, dismantling 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 working environment foreseen by the manufacturer or his authorised representative, in particular as regards the phenomena of fatigue, ageing, corrosion and abrasion.

The instructions must indicate the type and frequency of inspections and maintenance required for safety reasons. They 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 parts concerned must be mounted, positioned and/or guarded in such a way that any fragments will be contained, preventing hazardous situations.

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 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 persons:

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

— 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

Insofar 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 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 risk for exposed persons.

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

1.3.6. Risks related to variations in operating conditions

Where 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. Risks related to moving parts

The moving parts of machinery must be designed and constructed in such a way as to prevent risks of contact which could lead to accidents or must, where risks persist, be 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, the necessary specific protective devices and tools must, when appropriate, be provided to enable the equipment to be safely unblocked.

The instructions and, where possible, a sign on the machinery shall identify these specific protective devices and how they are to be used.

1.3.8. Choice of protection against risks arising from moving parts

Guards or protective devices designed to protect against risks arising from moving parts must be selected on the basis of the type of risk. The following guidelines must be used to help to make the choice.

1.3.8.1. Moving transmission parts

Guards designed to protect persons against the hazards generated by moving transmission parts must be:

— either fixed guards as referred to in section 1.4.2.1, or

— interlocking movable guards as referred to in section 1.4.2.2.

Interlocking movable guards should be used where frequent access is envisaged.

1.3.8.2. Moving parts involved in the process

Guards or protective devices designed to protect persons against the hazards generated by moving parts involved in the process must be:

— either fixed guards as referred to in section 1.4.2.1, or

— interlocking movable guards as referred to in section 1.4.2.2, or

— protective devices as referred to in section 1.4.3, or

— a combination of the above.

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

— fixed guards or interlocking movable guards preventing access to those sections of the parts that are not used in the work, and

— adjustable guards as referred to in section 1.4.2.3 restricting access to those sections of the moving parts where access is necessary.

1.3.9. Risks of uncontrolled movements

When a part of the machinery has been stopped, any drift away from the stopping position, for whatever reason other than action on the control devices, must be prevented or must be such that it does not present a hazard.

1.4. REQUIRED CHARACTERISTICS OF GUARDS AND PROTECTIVE DEVICES

1.4.1. General requirements

Guards and protective devices must:

— be of robust construction,

— be securely held in place,

— not give rise to any additional hazard,

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

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

— cause minimum obstruction to the view of the production process, and

— enable essential work to be carried out on the installation and/or replacement of tools and for maintenance purposes by restricting access exclusively to the area where the work has to be done, if possible without the guard having to be removed or the protective device having to be disabled.

In addition, guards must, where possible, protect against the ejection or falling of materials or objects and against emissions generated by the machinery.

1.4.2. Special requirements for guards

1.4.2.1. Fixed guards

Fixed guards must be fixed by systems that can be opened or removed only with tools.

Their fixing systems must remain attached to the guards or to the machinery when the guards are removed.

Where possible, guards must be incapable of remaining in place without their fixings.

1.4.2.2. Interlocking movable guards

Interlocking movable guards must:

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

— be designed and constructed in such a way that they can be adjusted only by means of an intentional action.

Interlocking movable guards must be associated with an interlocking device that:

— prevents the start of hazardous machinery functions until they are closed and

— gives a stop command whenever they are no longer closed.

Where it is possible for an operator to reach the danger zone before the risk due to the hazardous machinery functions has ceased, movable guards must be associated with a guard locking device in addition to an interlocking device that:

— prevents the start of hazardous machinery functions until the guard is closed and locked, and

— keeps the guard closed and locked until the risk of injury from the hazardous machinery functions has ceased.

Interlocking movable guards must be designed in such a way that the absence or failure of one of their components prevents starting or stops the hazardous machinery functions.

1.4.2.3. Adjustable guards restricting access

Adjustable guards restricting access to those areas of the moving parts strictly necessary for the work must be:

— adjustable manually or automatically, depending on the type of work involved, and

— readily adjustable without the use of tools.

1.4.3. Special requirements for protective devices

Protective devices must be designed and incorporated into the control system in such a way that:

— moving parts cannot start up while they are within the operator's reach,

— persons cannot reach moving parts while the parts are moving, and

— the absence or failure of one of their components prevents starting or stops the moving parts.

Protective devices must be adjustable only by means of an intentional action.

1.5. RISKS DUE TO OTHER HAZARDS

1.5.1. Electricity supply

Where machinery has an electricity supply, it must be designed, constructed and equipped in such a way that all hazards of an electrical nature are or can be prevented.

The safety objectives set out in Directive 73/23/EEC shall apply to machinery. However, the obligations concerning conformity assessment and the placing on the market and/or putting into service of machinery with regard to electrical hazards are governed solely by this Directive.

1.5.2. Static electricity

Machinery must be designed and constructed to prevent or limit the build-up of potentially dangerous electrostatic charges and/or be fitted with a discharging system.

1.5.3. Energy supply other than electricity

Where machinery is powered by source of energy other than electricity, it must be so designed, constructed and equipped as to avoid all potential risks associated with such sources of energy.

1.5.4. Errors of fitting

Errors likely to be made when fitting or refitting certain parts which could be a source of risk must be made impossible by the design and construction of such parts or, failing this, by information given on the parts themselves and/or their housings. The same information must be given on moving parts and/or their housings where the direction of movement needs to be known in order to avoid a risk.

Where necessary, the instructions must give further information on these risks.

Where a faulty connection can be the source of risk, incorrect connections must be made impossible by design or, failing this, by information given on the elements to be connected and, where appropriate, on the means of connection.

1.5.5. Extreme temperatures

Steps must be taken to eliminate any risk of injury arising from contact with or proximity to machinery parts or materials at high or very low temperatures.

The necessary steps must also be taken to avoid or protect against the risk of hot or very cold material being ejected.

1.5.6. Fire

Machinery must be designed and constructed in such a way as to avoid any risk of fire or overheating posed by the machinery itself or by gases, liquids, dust, vapours or other substances produced or used by the machinery.

1.5.7. Explosion

Machinery must be designed and constructed in such a way as to avoid any risk of explosion posed by the machinery itself or by gases, liquids, dust, vapours or other substances produced or used by the machinery.

Machinery must comply, as far as the risk of explosion due to its use in a potentially explosive atmosphere is concerned, with the provisions of the specific Community Directives.

1.5.8. Noise

Machinery must be designed and constructed in such a way that risks resulting from the emission of airborne noise are reduced to the lowest level, taking account of technical progress and the availability of means of reducing noise, in particular at source.

The level of noise emission may be assessed with reference to comparative emission data for similar machinery.

1.5.9. Vibrations

Machinery must be designed and constructed in such a way that risks resulting from vibrations produced by the machinery are reduced to the lowest level, taking account of technical progress and the availability of means of reducing vibration, in particular at source.

The level of vibration emission may be assessed with reference to comparative emission data for similar machinery.

1.5.10. Radiation

Undesirable radiation emissions from the machinery must be eliminated or be reduced to levels that do not have adverse effects on persons.

Any functional ionising radiation emissions must be limited to the lowest level which is sufficient for the proper functioning of the machinery during setting, operation and cleaning. Where a risk exists, the necessary protective measures must be taken.

Any functional non-ionising radiation emissions during setting, operation and cleaning must be limited to levels that do not have adverse effects on persons.

1.5.11. External radiation

Machinery must be designed and constructed in such a way that external radiation does not interfere with its operation.

1.5.12. Laser radiation

Where laser equipment is used, the following should be taken into account:

— laser equipment on machinery must be designed and constructed in such a way as to prevent any accidental radiation,

— laser equipment on machinery must be protected in such a way that effective radiation, radiation produced by reflection or diffusion and secondary radiation do not damage health,

— optical equipment for the observation or adjustment of laser equipment on machinery must be such that no health risk is created by laser radiation.

1.5.13. Emissions of hazardous materials and substances

Machinery must be designed and constructed in such a way that risks of inhalation, ingestion, contact with the skin, eyes and mucous membranes and penetration through the skin of hazardous materials and substances which it produces can be avoided.

Where a hazard cannot be eliminated, the machinery must be so equipped that hazardous materials and substances can be contained, evacuated, precipitated by water spraying, filtered or treated by another equally effective method.

Where the process is not totally enclosed during normal operation of the machinery, the devices for containment and/or evacuation must be situated in such a way as to have the maximum effect.

1.5.14. Risk of being trapped in a machine

Machinery must be designed, constructed or fitted with a means of preventing a person from being enclosed within it or, if that is impossible, with a means of summoning help.

1.5.15. Risk of slipping, tripping or falling

Parts of the machinery where persons are liable to move about or stand must be designed and constructed in such a way as to prevent persons slipping, tripping or falling on or off these parts.

Where appropriate, these parts must be fitted with handholds that are fixed relative to the user and that enable them to maintain their stability.

1.5.16. Lightning

Machinery in need of protection against the effects of lightning while being used must be fitted with a system for conducting the resultant electrical charge to earth.

1.6. MAINTENANCE

1.6.1. Machinery maintenance

Adjustment and maintenance points must be located outside danger zones. It must be possible to carry out adjustment, maintenance, repair, cleaning and servicing operations while machinery is at a standstill.

If one or more of the above conditions cannot be satisfied for technical reasons, measures must be taken to ensure that these operations can be carried out safely (see section 1.2.5).

In the case of automated machinery and, where necessary, other machinery, a connecting device for mounting diagnostic fault-finding equipment must be provided.

Automated machinery components which have to be changed frequently must be capable of being removed and replaced easily and safely. Access to the components must enable these tasks to be carried out with the necessary technical means in accordance with a specified operating method.

1.6.2. Access to operating positions and servicing points

Machinery must be designed and constructed in such a way as to allow access in safety to all areas where intervention is necessary during operation, adjustment and maintenance of the machinery.

1.6.3. Isolation of energy sources

Machinery must be fitted with means to isolate it from all energy sources. Such isolators must be clearly identified. They must be capable of being locked if reconnection could endanger persons. Isolators must also be capable of being locked where an operator is unable, from any of the points to which he has access, to check that the energy is still cut off.

In the case of machinery capable of being plugged into an electricity supply, removal of the plug is sufficient, provided that the operator can check from any of the points to which he has access that the plug remains removed.

After the energy is cut off, it must be possible to dissipate normally any energy remaining or stored in the circuits of the machinery without risk to persons.

As an exception to the requirement laid down in the previous paragraphs, certain circuits may remain connected to their energy sources in order, for example, to hold parts, to protect information, to light interiors, etc. In this case, special steps must be taken to ensure operator safety.

1.6.4. Operator intervention

Machinery must be so designed, constructed and equipped that the need for operator intervention is limited. If operator intervention cannot be avoided, it must be possible to carry it out easily and safely.

1.6.5. Cleaning of internal parts

The machinery must be designed and constructed in such a way that it is possible to clean internal parts which have contained dangerous substances or preparations without entering them; any necessary unblocking must also be possible from the outside. If it is impossible to avoid entering the machinery, it must be designed and constructed in such a way as to allow cleaning to take place safely.

1.7. INFORMATION

1.7.1. Information and warnings on the machinery

Information and warnings on the machinery should preferably be provided in the form of readily understandable symbols or pictograms. Any written or verbal information and warnings must be expressed in an official Community language or languages, which may be determined in accordance with the Treaty by the Member State in which the machinery is placed on the market and/or put into service and may be accompanied, on request, by versions in any other official Community language or languages understood by the operators.

1.7.1.1. Information and information devices

The information needed to control machinery must be provided in a form that is unambiguous and easily understood. It must not be excessive to the extent of overloading the operator.

Visual display units or any other interactive means of communication between the operator and the machine must be easily understood and easy to use.

1.7.1.2. Warning devices

Where the health and safety of persons may be endangered by a fault in the operation of unsupervised machinery, the machinery must be equipped in such a way as to give an appropriate acoustic or light signal as a warning.

Where machinery is equipped with warning devices these must be unambiguous and easily perceived. The operator must have facilities to check the operation of such warning devices at all times.

The requirements of the specific Community Directives concerning colours and safety signals must be complied with.

1.7.2. Warning of residual risks

Where risks remain despite the inherent safe design measures, safeguarding and complementary protective measures adopted, the necessary warnings, including warning devices, must be provided.

1.7.3. Marking of machinery

All machinery must be marked visibly, legibly and indelibly with the following minimum particulars:

— the business name and full address of the manufacturer and, where applicable, his authorised representative,

— designation of the machinery,

— the CE Marking (see Annex III),

— designation of series or type,

— serial number, if any,

— the year of construction, that is the year in which the manufacturing process is completed.

It is prohibited to pre-date or post-date the machinery when affixing the CE marking.

Furthermore, machinery designed and constructed for use in a potentially explosive atmosphere must be marked accordingly.

Machinery must also bear full information relevant to its type and essential for safe use. Such information is subject to the requirements set out in section 1.7.1.

Where a machine part must be handled during use with lifting equipment, its mass must be indicated legibly, indelibly and unambiguously.

1.7.4. Instructions

All machinery must be accompanied by instructions in the official Community language or languages of the Member State in which it is placed on the market and/or put into service.

The instructions accompanying the machinery must be either ‘Original instructions’ or a ‘Translation of the original instructions’, in which case the translation must be accompanied by the original instructions.

By way of exception, the maintenance instructions intended for use by specialised personnel mandated by the manufacturer or his authorised representative may be supplied in only one Community language which the specialised personnel understand.

The instructions must be drafted in accordance with the principles set out below.

1.7.4.1. General principles for the drafting of instructions

(a) The instructions must be drafted in one or more official Community languages. The words ‘Original instructions’ must appear on the language version(s) verified by the manufacturer or his authorised representative.

(b) Where no ‘Original instructions’ exist in the official language(s) of the country where the machinery is to be used, a translation into that/those language(s) must be provided by the manufacturer or his authorised representative or by the person bringing the machinery into the language area in question. The translations must bear the words ‘Translation of the original instructions’.

(c) The contents of the instructions must cover not only the intended use of the machinery but also take into account any reasonably foreseeable misuse thereof.

(d) In the case of machinery intended for use by non-professional operators, the wording and layout of the instructions for use must take into account the level of general education and acumen that can reasonably be expected from such operators.

1.7.4.2. Contents of the instructions

Each instruction manual must contain, where applicable, at least the following information:

(a) the business name and full address of the manufacturer and of his authorised representative;

(b) the designation of the machinery as marked on the machinery itself, except for the serial number (see section 1.7.3);

(c) the EC declaration of conformity, or a document setting out the contents of the EC declaration of conformity, showing the particulars of the machinery, not necessarily including the serial number and the signature;

(d) a general description of the machinery;

(e) the drawings, diagrams, descriptions and explanations necessary for the use, maintenance and repair of the machinery and for checking its correct functioning;

(f) a description of the workstation(s) likely to be occupied by operators;

(g) a description of the intended use of the machinery;

(h) warnings concerning ways in which the machinery must not be used that experience has shown might occur;

(i) assembly, installation and connection instructions, including drawings, diagrams and the means of attachment and the designation of the chassis or installation on which the machinery is to be mounted;

(j) instructions relating to installation and assembly for reducing noise or vibration;

(k) instructions for the putting into service and use of the machinery and, if necessary, instructions for the training of operators;

(l) information about the residual risks that remain despite the inherent safe design measures, safeguarding and complementary protective measures adopted;

(m) instructions on the protective measures to be taken by the user, including, where appropriate, the personal protective equipment to be provided;

(n) the essential characteristics of tools which may be fitted to the machinery;

(o) the conditions in which the machinery meets the requirement of stability during use, transportation, assembly, dismantling when out of service, testing or foreseeable breakdowns;

(p) instructions with a view to ensuring that transport, handling and storage operations can be made safely, giving the mass of the machinery and of its various parts where these are regularly to be transported separately;

(q) the operating method to be followed in the event of accident or breakdown; if a blockage is likely to occur, the operating method to be followed so as to enable the equipment to be safely unblocked;

(r) the description of the adjustment and maintenance operations that should be carried out by the user and the preventive maintenance measures that should be observed;

(s) instructions designed to enable adjustment and maintenance to be carried out safely, including the protective measures that should be taken during these operations;

(t) the specifications of the spare parts to be used, when these affect the health and safety of operators;

(u) the following information on airborne noise emissions: — the A-weighted emission sound pressure level at workstations, where this exceeds 70 dB(A); where this level does not exceed 70 dB(A), this fact must be indicated, — the peak C-weighted instantaneous sound pressure value at workstations, where this exceeds 63 Pa (130 dB in relation to 20 μPa), — the A-weighted sound power level emitted by the machinery, where the A-weighted emission sound pressure level at workstations exceeds 80 dB(A). These values must be either those actually measured for the machinery in question or those established on the basis of measurements taken for technically comparable machinery which is representative of the machinery to be produced. In the case of very large machinery, instead of the A-weighted sound power level, the A-weighted emission sound pressure levels at specified positions around the machinery may be indicated. Where the harmonised standards are not applied, sound levels must be measured using the most appropriate method for the machinery. Whenever sound emission values are indicated the uncertainties surrounding these values must be specified. The operating conditions of the machinery during measurement and the measuring methods used must be described. Where the workstation(s) are undefined or cannot be defined, A-weighted sound pressure levels must be measured at a distance of 1 metre from the surface of the machinery and at a height of 1,6 metres from the floor or access platform. The position and value of the maximum sound pressure must be indicated. Where specific Community Directives lay down other requirements for the measurement of sound pressure levels or sound power levels, those Directives must be applied and the corresponding provisions of this section shall not apply;

(v) where machinery is likely to emit non-ionising radiation which may cause harm to persons, in particular persons with active or non-active implantable medical devices, information concerning the radiation emitted for the operator and exposed persons.

1.7.4.3. Sales literature

Sales literature describing the machinery must not contradict the instructions as regards health and safety aspects. Sales literature describing the performance characteristics of machinery must contain the same information on emissions as is contained in the instructions.

2. SUPPLEMENTARY ESSENTIAL HEALTH AND SAFETY REQUIREMENTS FOR CERTAIN CATEGORIES OF MACHINERY

Foodstuffs machinery, machinery for cosmetics or pharmaceutical products, hand-held and/or hand-guided machinery, portable fixing and other impact machinery, machinery for working wood and material with similar physical characteristics must meet all the essential health and safety requirements described in this chapter (see General Principles, point 4).

2.1. FOODSTUFFS MACHINERY AND MACHINERY FOR COSMETICS OR PHARMACEUTICAL PRODUCTS

2.1.1. General

Machinery intended for use with foodstuffs or with cosmetics or pharmaceutical products must be designed and constructed in such a way as to avoid any risk of infection, sickness or contagion.

The following requirements must be observed:

(a) materials in contact with, or intended to come into contact with, foodstuffs or cosmetics or pharmaceutical products must satisfy the conditions set down in the relevant Directives. The machinery must be designed and constructed in such a way that these materials can be cleaned before each use. Where this is not possible disposable parts must be used;

(b) all surfaces in contact with foodstuffs or cosmetics or pharmaceutical products, other than surfaces of disposable parts, must: — be smooth and have neither ridges nor crevices which could harbour organic materials. The same applies to their joinings, — be designed and constructed in such a way as to reduce the projections, edges and recesses of assemblies to a minimum, — be easily cleaned and disinfected, where necessary after removing easily dismantled parts; the inside surfaces must have curves with a radius sufficient to allow thorough cleaning;

(c) it must be possible for liquids, gases and aerosols deriving from foodstuffs, cosmetics or pharmaceutical products as well as from cleaning, disinfecting and rinsing fluids to be completely discharged from the machinery (if possible, in a ‘cleaning’ position);

(d) machinery must be designed and constructed in such a way as to prevent any substances or living creatures, in particular insects, from entering, or any organic matter from accumulating in, areas that cannot be cleaned;

(e) machinery must be designed and constructed in such a way that no ancillary substances hazardous to health, including the lubricants used, can come into contact with foodstuffs, cosmetics or pharmaceutical products. Where necessary, machinery must be designed and constructed in such a way that continuing compliance with this requirement can be checked.

2.1.2. Instructions

The instructions for foodstuffs machinery and machinery for use with cosmetics or pharmaceutical products must indicate recommended products and methods for cleaning, disinfecting and rinsing, not only for easily accessible areas but also for areas to which access is impossible or inadvisable.

2.2. PORTABLE HAND-HELD AND/OR HAND-GUIDED MACHINERY

2.2.1. General

Portable hand-held and/or hand-guided machinery must:

— depending on the type of machinery, have a supporting surface of sufficient size and have a sufficient number of handles and supports of an appropriate size, arranged in such a way as to ensure the stability of the machinery under the intended operating conditions,

— except where technically impossible, or where there is an independent control device, in the case of handles which cannot be released in complete safety, be fitted with manual start and stop control devices arranged in such a way that the operator can operate them without releasing the handles,

— present no risks of accidental starting and/or continued operation after the operator has released the handles. Equivalent steps must be taken if this requirement is not technically feasible,

— permit, where necessary, visual observation of the danger zone and of the action of the tool with the material being processed.

The handles of portable machinery must be designed and constructed in such a way as to make starting and stopping straightforward.

2.2.1.1. Instructions

The instructions must give the following information concerning vibrations transmitted by portable hand-held and hand-guided machinery:

— the vibration total value to which the hand-arm system is subjected, if it exceeds 2,5 m/s2. Where this value does not exceed 2,5 m/s2, this must be mentioned,

— the uncertainty of measurement.

These values must be either those actually measured for the machinery in question or those established on the basis of measurements taken for technically comparable machinery which is representative of the machinery to be produced.

If harmonised standards are not applied, the vibration data must be measured using the most appropriate measurement code for the machinery.

The operating conditions during measurement and th