4.4 EU適合宣言

Union harmonisation legislation imposes an obligation on the manufacturer to draw up and sign an EU Declaration of Conformity before placing a product on the market (221). The manufacturer or his authorised representative established within the Union must draw up and sign an EU Declaration of Conformity as part of the conformity assessment procedure provided for in the Union harmonisation legislation. The EU declaration of conformity is the document that states that the product satisfies all the relevant requirements of the applicable legislation.

By drawing up and signing the EU Declaration of Conformity, the manufacturer assumes responsibility for the compliance of the product.

Just as it is the case for the technical documentation (222), the EU Declaration of Conformity must be kept for ten years from the date of placing the product on the market, unless the legislation provides for any other duration (223). This is the responsibility of the manufacturer or the authorised representative established within the Union. For imported products, the importer must take on this responsibility for the Declaration of Conformity (224).

The EU Declaration of Conformity must be kept up to date (225). The EU Declaration of Conformity is specific to each individual product, even if they are manufactured in series. In practice, the same version of the EU Declaration of conformity may be applicable to many individual products which are manufactured in series. However, as soon as any of the elements of the EU declaration of conformity changes, the version of the EU declaration of conformity will have to be updated for products placed on the market after that change. Such changes may for example be changes in the legislation, changes in the versions of the harmonised standards or changes in the contact details of the manufacturer or authorised representative.

The contents of the EU Declaration of Conformity either refer to the model declaration contained in Annex III of Decision No 768/2008/EC or a model declaration directly annexed to the sectoral Union harmonisation legislation at stake. The standard EN ISO/IEC 17050-1 has been drawn up with the objective of providing the general criteria for the declaration of conformity, and it can also be used as a guidance document provided it is in line with the applicable Union harmonisation legislation. The declaration may take the form of a document, a label or equivalent, and must contain sufficient information to enable all products covered by it to be traced back to it.

The model declaration of Decision No 768/2008/EC contains:

1.A number identifying the product. This number does not need to be unique to each product. It could refer to a product, batch, type or a serial number (226). This is left to the discretion of the manufacturer (227).

2.The name and address of the manufacturer or the authorised representative issuing the declaration.

3.A statement that the declaration is issued under the sole responsibility of the manufacturer.

4.The identification of the product allowing traceability. This is basically any relevant information supplementary to point 1 describing the product and allowing for its traceability. It may where relevant for the identification of the product contain an image, but unless specified as a requirement in the Union harmonisation legislation this is left to the discretion of the manufacturer.

5.All relevant Union harmonisation legislation complied with the referenced standards or other technical specifications (such as national technical standards and specifications) in a precise, complete and clearly defined way; this implies that the version and/or date of the relevant standard is specified.

6.The name and identification number of the notified body or bodies when they have been involved in the conformity assessment procedure (228) (229) and the reference to the relevant certificate(s), if applicable.

7.All supplementary information that may be required (for example grade, category), if applicable.

8.The date of issue of the declaration; signature and title or an equivalent marking of authorised person (230) (231); this could be any date after the completion of the conformity assessment

Where several pieces of Union harmonisation legislation apply to a product, the manufacturer or the authorised representative has to provide a single declaration of conformity in respect of all such Union acts (232). In order to reduce the administrative burden on economic operators and facilitate its adaptation to the modification of one of the applicable Union acts, the single declaration may be a dossier made up of relevant individual Declarations of conformity (233).

The EU declaration of conformity must be made available to the surveillance authority upon request. Moreover, Union harmonisation legislation relating to machinery, equipment in potentially explosive atmospheres, radio equipment, measuring instruments, recreational craft, lifts, high-speed and conventional rail systems and constituents of the European Air Traffic Management network require products to be accompanied by the EU declaration of conformity.

The EU declaration of conformity must be translated into the language or languages required by the Member State in which the product is placed or made available on the market (234). Union harmonisation legislation does not necessarily specify who has the obligation to translate. Logically, this should be the manufacturer or another economic operator making the product available. The EU declaration of conformity must be signed by the manufacturer or his authorised representative. If a translation of the EU declaration of conformity has been produced by another economic operator and is not signed by the manufacturer, a copy of the original EU declaration of conformity signed by the manufacturer must also be provided together with the translated version.