Guide to application of the directive 89/686/EEC on Personal Protective Equipment - Annex VI
1.10 Annex VI
MODEL EC DECLARATION OF CONFORMITY
The manufacturer or his authorized representative established in Community (1)
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declares that the new PPE described hereafter (2)
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is in conformity with the provisions of Council Directive 89/686/EEC and, where such is
the case, with the national standard transposing harmonized standard No ........... (for the
PPE referred to in article 8 (3))
is identical to the PPE which is the subject of EC certificate of conformity No................................
issued by (3)(4)
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is subject to the procedure set out in article 11 point A or point B (4) of Directive 89/686/EEC
under the supervision of the notified body(3)
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Done at ................................, on ................................
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Signature (5)
(1) Business name and full address; authorized representatives must also give the business name and address of the manufacturer.
(2) Description of the PPE (make, type, serial number, etc.).
(3) Name and address of the approved body.
(4) Delete whichever is inapplicable.
(5) Name and position of the person empowered to sign n behalf of the manufacturer or his authorized representative.
The EC Declaration of Conformity must be drawn up by the manufacturer or the authorised representative established within the Community in one of the official languages of the Community when the PPE is placed on the market. The EC Declaration of Conformity is issued under the sole responsibility of the manufacturer or authorised representative established within the Community.
The EC Declaration of Conformity must be made available to the surveillance authority upon request. Its essential objective is to enable public authorities to ensure that PPE placed on the market conform to the BHSRs of the Directive. It is not required that PPE are accompanied by the EC Declaration of Conformity.
It is generally recognised that the market surveillance authority of a Member State can request a translation of the EC Declaration of Conformity into its official language.
For Category I PPE, the EC Declaration of Conformity must ensure that the PPE satisfies the BHSRs of the Directive.
For Category II and III PPE, the EC Declaration of Conformity must additionally ensure that the PPE is in conformity with the type/model for which an EC-Type Examination Certificate has been issued. The name, address and identification number of the Notified Body which issued the certificate are to be included in the EC Declaration of Conformity.
For Category III PPE, the address and identification number of the Notified Body involved in the quality control for the final product set out in Article 11 A+B of the Directive must also be included in addition to the above.
The EC Declaration of Conformity must be made available to the market surveillance authority upon request. It is generally recognised that the market surveillance authority of a Member State can request a translation of the EC declaration of conformity into its official language. It is not required the PPE is accompanied by the EC declaration of conformity.
The EC declaration of conformity must be kept for at least ten years from the last date of manufacture of the PPE.
Remark:
Annex VI contains in its 3rd paragraph a printing error. The reference to article 8(3) is wrongly cited. In fact the reference must read: "(for the PPE referred to in article 8(2))".




