EC DECLARATION OF CONFORMITY

What is it and what does it represent?

The EU Declaration of conformity is the document that certifies that the product meets the essential requirements of the applicable legislation.

When preparing and signing the EU Declaration of conformity, the manufacturer (or their authorised representative established in the EU), takes responsibility for the conformity of the product.

The EU Declaration of conformity must be issued prior to placing the product on the market.

The EU Declaration of conformity must be translated into the language or languages required by the Member State on whose market the product is placed or made available. If not specified, the Declaration of conformity must be issued in one of the official languages of the European Union.

Under the regulation of construction products (Reg. EC 305/2011), the Declaration of conformity is called declaration of performance. Directive 2006/42/EC on machinery provides that the placing on the market of “partly completed machinery” is accompanied by a declaration of incorporation, which is different from the EU Declaration of conformity.

Contents of the EC Declaration of Conformity

Annex III to Decision No. 768/2008/EC proposes a model of the Declaration of conformity based on ISO/IEC 17050-1. The Declaration may take the form of a document, a label or any other equivalent element, and must contain enough information to allow the traceability of all products covered by the declaration concerned.

Thus, the content proposed in the decision identified above is the following:

  • A product identification number. This number does not need to be unique for each product.

 

It may refer to a product, type, batch or serial number. This choice is left to the discretion of the manufacturer;

  • Name and address of the manufacturer and of its representative issuing the declaration;
  • A statement attesting that the Declaration of conformity is issued under the sole responsibility of the manufacturer;
  • The identification of the product that allows its traceability. It essentially contains any relevant information complementary to section 1 describing the product and enabling its traceability. When appropriate for the product identification, it can contain an image but, unless this is specified as a requirement in the legislation of harmonisation of the Union, the choice is left to the manufacturer;
  • All relevant harmonisation legislation of the Union with which the Declaration is in compliance; the standards or other technical specifications (such as national technical standards or specifications) referenced in a precise, complete and clear manner; this requires the specification of the version and/or date of the standard concerned;
  • The name and identification number of the notified body involved in the conformity assessment procedure;
  • Any further information that may be required (for example, the class, the category), if applicable;
  • The date of issue of the Declaration; the signature and position or an equivalent marking of the authorised person; it can be any date after the conclusion of the conformity assessment