Annex II : Declarations of CONFORMITY OF THE MACHINERY, DECLARATION OF INCORPORATION - machinery directive 2006/42/EC

The text in RED color is the amended or added text in comparison with the former 98/37/EC machinery directive.


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.

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.

Comment :

New requirements have been added:

2) an authorized person that compile the technical file must be established in the community in order to provide this documentation to the authorities must be designed.

3) requirements in terms of identification have been added.

4) references to directives are required. References to national legislation and national technical specifications contained in the 98/37/EC Machinery Directive have been removed.

6) This is a new requirement induced by this new Annex and the certification process associated with it.

When the full quality assurance procedure is applied, the CE marking of machinery must be immediately followed by the identification number of the notified body. See whereas 22 and Annex I, paragraph 1.7.3.

9) the place and date of the declaration were not requirements of the previous Machinery Directive 98/37/EC

The EC declaration of conformity applies now to machines and safety components. The requirements of 98/37/EC Directive on safety components (formerly C of Annex II "content of the EC declaration of conformity for safety components placed separately on the market").

Original comment :

Des nouvelles exigences ont été ajoutées :

2) une personne autorisée à constituer le dossier technique doit être établie dans la communauté afin de pouvoir fournir ce dossier aux autorités.

3) des exigences en termes d’identification ont été ajoutées.

4) les références aux directives sont exigées. Les références à la législation nationale et aux spécifications techniques nationales qui figuraient dans  la directive machines 98/37/CE ont été supprimées.

6) il s’agit d’une nouvelle exigence induite par l’introduction de cette annexe et de la procédure de certification qui y est associée.

Lorsque la procédure d’assurance qualité complète est appliquée, le marquage CE des machines doit être immédiatement suivi du numéro d’identification de l’organisme notifié. Voir considérant 22 et annexe I paragraphe 1.7.3.

9) le lieu et la date de la déclaration n’étaient pas des exigences de la précédent directive machines 98/37/CE

La déclaration CE de conformité concerne désormais les machines et les composants de sécurité. Les exigences de la directive 98/37/CE relatives aux composants de sécurité (anciennement C de l’annexe II « contenu de la déclaration CE de conformité pour les composants de sécurité mis isolément sur le marché »).

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.

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.

Comment :

This chapter is new due to the introduction of PARTLY COMPLETED MACHINERY in 2006/42/EC Directive.

The requirements are substantially similar to those described above for the machine.

Points 1, 2 and 3 are identical. Points 7 and 8 correspond to numbers 9 and 10 described for machines.

Items 4, 5 and 6 are specific to PARTLY COMPLETED MACHINERY.

Original comment :

Ce chapitre est nouveau du fait de l’introduction des quasi machines dans la directive 2006/42/CE.

Les exigences sont quasi similaires à celle décrites ci-avant pour la machine.

Les points 1, 2 et 3 sont identiques. Les points 7 et 8 correspondent respectivement à la numérotation 9 et 10 pour les machines.

Les points 4, 5 et 6  sont spécifiques aux quasi-machines.

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.

Comment :

This section is new and fixed the time duration to keep the official document.

Original comment :

Ce chapitre est nouveau et fixe la durée de conservation des déclarations.