5.4. EC declaration of conformity

•   The manufacturer or the authorised representative established within the Community must draw up an EC declaration of conformity as part of the conformity assessment procedure provided for in the New Approach directives.
• The EC declaration of conformity should contain all relevant information to identify the directives according to which it is issued, as well as the manufacturer, the authorised representative, the notified body if applicable, the product, and where appropriate a reference to harmonised standards or other normative documents established within the Community.
• In some cases the importer or the person responsible for placing on the market must take on this responsibility (99).

New Approach directives impose an obligation on the manufacturer, or the authorised
representative established within the Community, to draw up an EC declaration of conformity
when the product is placed on the market. Depending on the procedure, the EC declaration of conformity must either
ensure that the product satisfies the essential requirements of the applicable directives,
or that the product is in conformity with the type for which a type-examination certificate has been issued and
satisfies the essential requirements of the applicable directives (101).
The EC declaration of conformity must be kept for at least ten years from the last date of manufacture
of the product, unless the directive expressly provides for any other duration (102).
This is the responsibility of the manufacturer or the authorised representative

The contents of the EC declaration of conformity are laid down, directive by directive, in accordance with the
products concerned. The standard EN 45014 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 in view of New Approach directives.
According to the standard the declaration may take the form of a document, a label or equivalent, and should contain
sufficient information to enable all products covered by it to be traced back to it.
As a minimum the following information should be provided:

• the name and address of the manufacturer or the authorised representative issuing the declaration;
• the identification of the product (name, type or model number)
• and any relevant supplementary information, such as
• lot,
• batch or
• serial number,
• sources and numbers of items.
• all relevant provisions complied with the referenced standards or other normative documents                                                                                                (such as national technical standards and specifications) in a precise, complete and clearly defined way;
• all supplementary information that may be required (for example grade, category), if applicable;
• the date of issue of the declaration;
• signature and title or an equivalent marking of authorised person (103); and
• the statement that the declaration is issued under the sole responsibility of the manufacturer and,
• if applicable, the authorised representative.

Other useful information to be included in the EC declaration of conformity is the name, address and identification
number of the notified body when it has been involved in the conformity assessment procedure, as well as the name and
address of the person who keeps the technical documentation.
Where several New Approach directives apply to a product, the manufacturer or the authorised representative can,
basically, merge all the declarations into a single document. However, this is not possible if the directive provides for a
specific form of the EC declaration of conformity (such as the Directive relating to personal protective equipment).
Consequently, the EC declaration should also provide information on whether or not it covers only one directive.
In such a case the declaration should include a reference to other directives in order to verify whether the manufacturer
has followed all the Community legislation, or which legislation has been chosen during the transitional period.
The EC declaration of conformity must be made available to the surveillance authority immediately upon request.
Moreover, Directives relating to machinery, gas appliances, potentially explosive atmospheres, recreational craft, lifts
and high-speed rail systems require that products are accompanied by the EC declaration of conformity.
The EC declaration of conformity must be drawn up in one of the official languages of the Community.
If the Community directives contain no further provisions concerning the language of the declaration, the requirements of the
Member States to use a specific language must be assessed according to Articles 28 and 30 of the EC Treaty
on a case by case basis. However, for products, which are required to be accompanied by the declaration of conformity,
it has to be in the official language of the country of use.
In these situations a translation should be provided by the manufacturer, the authorised representative or the distributor.
Additionally, a copy of the declaration in the original language should be supplied.