Guide to application of machinery directive - § 382 to § 386 - ANNEX II Declarations

 

ANNEX II

Declarations

1.    CONTENT

A.   EC DECLARATION OF CONFORMITY OF THE MACHINERY

This declaration and translations thereof must be drawn up under the same conditions as the instructions (see Annex I, section 1.7.4.1(a) and (b)), and must be typewritten or else handwritten in capital letters.

This declaration relates exclusively to the machinery in the state in which it was placed on the market, and excludes components which are added and/or operations carried out subsequently by the final user.

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§382   The EC Declaration of Conformity of machinery

Annex II 1 A concerns the EC Declaration of Conformity that must be drawn up by the manufacturer of machinery or his authorised representative in the EU and that must accompany the machinery until it reaches the user – see §103: comments on Article 5 (1), and §109: comments on Article 7 (1). The EC Declaration of Conformity is a legal statement by the manufacturer or his authorised representative attesting that the machinery concerned complies with all of the relevant provisions of the Machinery Directive.

The requirement set out in the first paragraph of Annex II 1 A, that the declaration and translations thereof must be drawn up under the same conditions as the instructions, entails that the EC Declaration of conformity must be drafted in one or more official EU languages. Where no original EC Declaration of conformity exists in the official language(s) of the country where the machinery is to be used, a translation into that or those languages 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 word "Translation"see §246: comments on section 1.7.1, §255: comments on section 1.7.4, and §257: comments on sections 1.7.4.1 (a) and (b) of Annex I.

The EC Declaration of Conformity must be typewritten (printed) or handwritten in capital letters. It must either be included in the instruction manual or provided separately, in which case a document setting out the contents of the EC Declaration of Conformity must be included in the instruction manual – see §149: comments on section 1.7.4.2 (c) of Annex I.

The second paragraph of Annex II 1 A underlines that the EC Declaration of Conformity relates only to the machinery as it has been designed, constructed and placed on the market by the manufacturer. If the manufacturer authorises another economic operator such as an importer or a distributor to modify machinery before it is supplied to the final user, the manufacturer remains legally responsible for the machinery as supplied. However the manufacturer is not legally responsible for any additions or modifications made to the machinery without his authorisation by other economic operators or by the final user. This must be taken into account when machinery in use is examined by the market surveillance authorities – see §94: comments on Article 4 (1).

 

Annex II 1 A (continued)

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The EC declaration of conformity must contain the following particulars:

1.    business name and full address of the manufacturer and, where appropriate, his authorised representative;

2.    name and address of the person authorised to compile the technical file, who must be established in the Community;

3.    description and identification of the machinery, including generic denomination, function, model, type, serial number and commercial name;

4.    a sentence expressly declaring that the machinery fulfils all the relevant provisions of this Directive and where appropriate, a similar sentence declaring the conformity with other Directives and/or relevant provisions with which the machinery complies. These references must be those of the texts published in the Official Journal of the European Union;

5.    where appropriate, the name, address and identification number of the notified body which carried out the EC type-examination referred to in Annex IX and the number of the EC type-examination certificate;

6.    where appropriate, the name, address and identification number of the notified body which approved the full quality assurance system referred to in Annex X;

7.    where appropriate, a reference to the harmonised standards used, as referred to in Article 7(2);

8.    where appropriate, the reference to other technical standards and specifications        used;

9.    the place and date of the declaration;

10. the identity and signature of the person empowered to draw up the declaration on behalf of the manufacturer or his authorised representative.

            . . .

§383   The content of the EC Declaration of Conformity

The following comments refer to the numbered paragraphs in Annex II 1 A:

  1. The manufacturer's business name and full address must be the same as those marked on the machinery – see §250: comments on section 1.7.3 of Annex I. Where the manufacturer has chosen to mandate an authorised representative in the EU to carry out all or part of his obligations set out in Article 5 – see §84 and §85: comments on Article 2 (j) – the particulars of the authorised representative must also be indicated in the EC Declaration of Conformity.
  2. The person authorised to compile the technical file is a natural or legal person established in the EU who has been entrusted by the manufacturer with the task of assembling and making available the relevant elements of the technical file in response to a duly reasoned request from the market surveillance authorities of one of the Member States – see §98: comments on Articles 4 (3) and (4), and §393: comments on Annex VII A 2 and 3.

The person authorised to compile the technical file is not, as such, responsible for the design, construction or conformity assessment of the machinery, for drawing up the documents included in the technical file, for affixing the CE marking or for drawing up and signing the EC Declaration of Conformity.

All machinery manufacturers must indicate the name and address of the person authorised to compile the technical file.

For manufacturers established in the EU, the person authorised to compile the technical file may be the manufacturer himself, his authorised representative, a contact person belonging to the manufacturer's staff (who can be the same as the signatory of the EC Declaration of Conformity) or another natural or legal person established in the EU to whom the manufacturer entrusts this task.

For manufacturers established outside the EU, the person authorised to compile the technical file may be any natural or legal person established in the EU who is entrusted with the task of assembling and making available the technical file in response to a duly reasoned request. If a manufacturer established outside the EU has chosen to mandate an authorised representative in the EU to carry out all or part of the obligations set out in Article 5 – see §84 and §85: comments on Article 2 (j) – the authorised representative in the EU can also be the person authorised to compile the technical file.

  1. The particulars required for the description and identification of the machinery are essentially the same as those to be marked on the machinery – see §250: comments on section 1.7.3 of Annex I. However, in the EC Declaration of Conformity the particulars of the machinery must be given in full. The purpose of this information is to enable both the user and the market surveillance authorities to identify the machinery covered by the declaration without ambiguity.

As a general rule, the serial number of the machinery covered by the EC Declaration of Conformity shall be indicated. In the case of machinery produced in large series, it is possible to draw up a single EC Declaration of Conformity covering a range of serial numbers or batches, in which case the range covered by the declaration must be specified and a new EC Declaration of Conformity must be issued for each new range of serial numbers or batches. In any case, the necessary identification must be provided to ensure the link between each item of machinery and the EC Declaration of Conformity that applies to it.

  1. The sentence declaring that the machinery fulfils all the relevant provisions of the Machinery Directive is the key element of the EC Declaration of Conformity. In this sentence, the manufacturer or his authorised representative attests that the machinery concerned complies with all of the applicable EHSRs of Annex I to the Machinery Directive and that the appropriate conformity assessment procedure has been carried out.

Where the machinery concerned is subject to other EU legislation in addition to the Machinery Directive, the conformity with the other Directives or Regulations concerned must also be declared – see §91 and §92: comments on Article 3. The manufacturer may draw up a single EC Declaration of Conformity for these other Directives or Regulations, provided that the declaration contains all the information required by each Directive. This may not be possible in all cases since certain Directives specify a particular format for the Declaration of Conformity – see §89: comments on Article 3.

  1. For machinery belonging to one of the categories listed in Annex IV, where the manufacturer has chosen to follow the EC type-examination procedure, the particulars of the Notified Body which carried out the EC type-examination and the number of the EC type-examination certificate are to be indicated  – see §129 and §130: comments on Articles 12 (3) and (4). The name, address and four-figure identification number of the Notified Body to be indicated can be checked in the NANDO database – see §133: comments on Article 14.
  2. For machinery belonging to one of the categories listed in Annex IV, where the manufacturer has chosen to follow the full quality assurance procedure, the particulars of the Notified Body which approved the manufacturer's full quality assurance system are to be indicated - see §129 and §130: comments on Articles 12 (3) and (4). The name, address and four-figure identification number of the Notified Body to be indicated can be checked in the NANDO database – see §133: comments on Article 14.
  3. In order to benefit from the presumption of conformity conferred by the application of harmonised standards that cover all the relevant essential health and safety requirements, manufacturers must indicate the references of the harmonised standard(s) applied in the EC Declaration of Conformity – see §110 and §111: comments on Articles 7 (2), and §114: comments on Article 7 (3). However, it should be recalled that the application of harmonised standards remains voluntary – see §110: comments on Article 7 (2).

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

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

  1. Where harmonised standards have not been used, the manufacturer may indicate the references of other technical documents used to design and construct the machinery. It should be borne in mind that the application of such documents does not confer a presumption of conformity – see §162: comments on General Principle 3 of Annex I.
  2. The indication of the place and date of the declaration are customary requirements for a signed legal document. The place to be indicated is usually the town where the premises of the manufacturer or his authorised representative are established. Since the EC Declaration of Conformity must be drawn up before the machinery is placed on the market or put into service – see §103: comments on Article 5 (1) - the date indicated in the EC Declaration of Conformity must be no later than the placing on the market of the machinery, or in the case of machinery for the manufacturer's own use, no later than the putting into service of the machinery.
  3. The identity of the person empowered by the manufacturer or his authorised representative to draw up the EC Declaration of Conformity must be indicated adjacent to his or her signature. The identity of the person is understood as comprising his or her name and position.

The EC Declaration of Conformity can be signed by the Managing Director of the Company concerned or by another representative of the Company to whom this responsibility has been delegated. The EC Declaration of Conformity shall be signed and kept by the manufacturer or his authorised representative – see §386: comments on Annex II 2. The signature can be reproduced on the copies of the Declaration of Conformity that accompany the machinery.

ANNEX II

1. CONTENT (continued)

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B.    DECLARATION OF INCORPORATION OF PARTLY COMPLETED MACHINERY

This declaration and translations thereof must be drawn up under the same conditions as the instructions (see Annex 1, section 1.7.4.1(a) and (b)), and must be typewritten or else handwritten in capital letters.

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§384   The Declaration of Incorporation of partly completed machinery

Annex II 1 B concerns the Declaration of Incorporation that must be drawn up by the manufacturer of partly completed machinery or his authorised representative in the EU and that must accompany the partly completed machinery until it reaches the manufacturer of the final machinery into which it is to be incorporated - see §104: comments on Article 5 (2), and §131: comments on Article 13. The Declaration of Incorporation shall then form part of the Technical file for the final machinery – see §392: comments on Annex VII A 1 (a).

The Declaration of Incorporation is a legal statement by the manufacturer of the partly completed machinery or his authorised representative with the following main purposes:

  • to inform the manufacturer of the final machinery which of the applicable EHSRs of Annex I to the Machinery have been applied and fulfilled and, where appropriate, to declare the conformity of the partly completed machinery with the provisions of other applicable EU legislation;
  • to undertake to transmit, in response to a reasoned request by the national authorities, relevant information on the partly completed machinery;
  • to indicate that the partly completed machinery must not be put into service until the final machinery into which it is to be incorporated has been declared in conformity with the relevant provisions of the Machinery Directive.

The comments relating to the first paragraph of Annex II 1 A also apply to the first paragraph of Annex II 1 B.

Annex II 1 B (continued)

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The declaration of incorporation must contain the following particulars:

1.    business name and full address of the manufacturer of the partly completed machinery and, where appropriate, his authorised representative;

2.    name and address of the person authorised to compile the relevant technical documentation, who must be established in the Community;

3.    description and identification of the partly completed machinery including generic denomination, function, model, type, serial number and commercial name;

4.    a sentence declaring which essential requirements of this Directive are applied and fulfilled and that the relevant technical documentation is compiled in accordance with part B of Annex VII, and, where appropriate, a sentence declaring the conformity of the partly completed machinery with other relevant Directives. These references must be those of the texts published in the Official Journal of the European Union;

5.    an undertaking to transmit, in response to a reasoned request by the national authorities, relevant information on the partly completed machinery. This shall include the method of transmission and shall be without prejudice to the intellectual property rights of the manufacturer of the partly completed machinery;

6.    a statement that the partly completed machinery must not be put into service until the final machinery into which it is to be incorporated has been declared in conformity with the provisions of this Directive, where appropriate;

7.    the place and date of the declaration;

8.    the identity and signature of the person empowered to draw up the declaration on behalf of the manufacturer or his authorised representative.

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§385   The content of the Declaration of Incorporation

The following comments refer to the numbered paragraphs in Annex II 1 B:

  1. The comments on paragraph 1 of Annex II 1 A apply.
  2. With respect to the person authorised to compile the technical documentation, the comments on paragraph 2 of Annex II 1 A relating to the person authorised to compile the technical file apply.
  3. The comments on paragraph 3 of Annex II 1 A apply.
  4. The Machinery Directive does not determine which of the applicable EHSRs must be applied and fulfilled by the manufacturer of partly completed machinery. The following considerations may be taken into account when deciding whether or not to apply and fulfil certain EHSRs:
  • it may not be possible for the manufacturer of the partly completed machinery to fully assess certain risks which depend on the way the partly completely machinery is incorporated into the final machinery;
  • the manufacturer of the partly completed machinery may agree with a manufacturer of final machinery on a 'division of tasks' whereby the application and fulfilment of certain EHSRs is left to the manufacturer of the final machinery. This type of agreement will not be possible for partly complete machinery placed on the market and sold through the distribution chain. It is suggested that in this case all EHSRs are applied other than those EHSRs that cannot be fully applied prior to its combination into a final machine in scope of the Machinery Directive.

In the sentence required by paragraph 4 of Annex II 1 B, the manufacturer of partly completed machinery must indicate in the Declaration of Incorporation precisely which of the applicable EHSRs have been applied and fulfilled. If a given EHSR has been fulfilled for certain parts or aspects of the partly completed machinery and not for others, this shall be indicated. The Assembly instructions for the partly completed machinery must indicate the need to deal with the EHSRs that are not fulfilled or only partly fulfilled – see §390: comments on Annex VI. The manufacturer of the partly completed machinery must also state that he has compiled the Relevant Technical Documentation showing how those EHSRs have been applied – see §394: comments on Annex VII B.

Where the partly completed machinery (or part of it) is subject to other EU legislation in addition to the Machinery Directive, the conformity with the other Directives or Regulations concerned must also be declared – see §91 and §92: comments on Article 3. Where those Directives or Regulations foresee an EC Declaration of Conformity, an EC Declaration of Conformity according to those texts must be drawn up for the partly completed machinery. Such Declarations of Conformity are to be included in the Technical file for the final machinery – see §392: comments on Annex VII A 1 (a).

5.   The undertaking required by paragraph 5 of Annex II 1 B concerns the obligation of the manufacturer of partly completed machinery to present any information relevant to health and safety and, in particular, the relevant technical documentation, in response to a duly reasoned request from the market surveillance authorities of one of the Member States – see §394: comments on Annex VII B.

Since the Declaration of Incorporation of the partly completed machinery is to form part of the Technical file for the final machinery – see §392: comments on Annex VII A 1 (a) – the manufacturer of the final machinery thereby has in his possession an undertaking by his supplier to transmit the relevant technical documentation to the market surveillance authorities in response to a duly reasoned request.

The intellectual property rights of the manufacturer of the partly completed machinery are protected by the fact that the market surveillance authorities are bound to treat as confidential information obtained in the execution of their tasks – see §143: comments on Article 18 (1).

6.   The statement required by paragraph 6 takes account of the fact that partly completed machinery cannot be considered safe until:

-           any EHSRs applicable to the partly completed machinery, not fulfilled by the manufacturer of the partly completed machinery, have been fulfilled;

-           any risks arising from the incorporation of the partly completed machinery into the final machinery have been assessed and the necessary protective measures have been taken to deal with them.

7.   The comments on paragraph 9 of Annex II 1 A apply.

8.   The comments on paragraph 10 of Annex II 1 A apply.

Annex II (continued)

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2.    CUSTODY

The manufacturer of machinery or his authorised representative shall keep the original EC declaration of conformity for a period of at least 10 years from the last date of manufacture of the machinery.

The manufacturer of partly completed machinery or his authorised representative shall keep the original declaration of incorporation for a period of at least 10 years from the last date of manufacture of the partly completed machinery.

§386   Custody of the EC Declaration of Conformity and the Declaration of Incorporation

The period of custody of ten years from the last date of manufacture set out in Annex II 2 for the EC Declaration of Conformity and the Declaration of Incorporation is to enable the market surveillance authorities to verify these documents if necessary – see §98: comments on Article 4 (3) and (4).