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 and property and, where applicable, the environment, when properly installed and maintained and used for its intended purpose or under reasonably foreseeable conditions.
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 may take any appropriate measure relating to the following:
(a) updating the indicative list of safety components in Annex V referred to in Article 2(c);
(b) restricting the placing on the market of machinery referred to in Article 9.
Those measures, designed to amend non-essential elements of this Directive by supplementing it, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 22(3).
2. The Commission, acting in accordance with the advisory procedure referred to in Article 22(2), may take any appropriate measure connected with the practical application of this Directive, including measures necessary to ensure cooperation of Member States with each other and with the Commission, as provided for in Article 19(1).
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.
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 and, where appropriate, of domestic animals and property and, where applicable, of the environment.
Taking due account of the results of this consultation, it shall adopt the necessary measures.
Those measures, designed to amend non-essential elements of this Directive by supplementing it, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 22(3).
Article 10
Procedure for disputing a harmonised standard
Where a 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 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 reasonably foreseeable conditions, is liable to endanger the health or safety of persons or, where appropriate, domestic animals or property or, where applicable, the environment, 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 the free movement thereof.
2. The Member State shall immediately inform the Commission and the other 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 are justified, and it shall communicate its decision to the 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 which instigated the measures maintains its position, the Commission or the shall initiate the procedure referred to in Article 10.
5. Where machinery does not conform and bears the CE marking, the competent 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 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 shall inform the other 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.
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 shall immediately inform the Commission and the other 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 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, Article 5a(1) to (4) and Article 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof.
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:
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.";
Annex I, point 1.2 shall be replaced by the following:
1.2. "Carrier
