Directive 94/9/EC: Guidelines on the application
13. EUROPEAN HARMONISED STANDARDS
Directive 94/9/EC provides manufacturers with the option of complying with its requirements by designing and manufacturing directly in accordance with the Essential Health and Safety Requirements, or to harmonised standards which are developed specifically to allow a presumption of conformity with those requirements. In other words, in the case of a challenge, the responsible national authorities will have to prove that the equipment is not in conformity with the Essential Health and Safety Requirements of the Directive.
The presumption of conformity is conferred, in regulatory terms, only by the use of the national standards transposing a harmonised standard the reference of which is published in the OJEU. Where the relevant national standardisation body has not transposed the standard, use of the original harmonised standard or of a transposed standard in another Member of the EU confers the same presumption of conformity. However, such transposition must have taken place into the national standards collection of at least one of the Member States of the European Community.
Industry and many Notified Bodies are involved in the development of these standards and it is likely that these standards will be the preferred option for demonstrating compliance once they become available.
Voluntary harmonised standards are the only documents the application of which provides for presumption of conformity. Manufacturers may also decide to use existing European, national and other technical standards and specifications regarded as important or relevant to cover the relevant essential health and safety requirements, together with additional controls addressing those other requirements not already covered.
Standards are amended and updated in response to new technical knowledge. During the process of updating, a manufacturer may continue to use a current harmonised standard to claim full compliance with the Directive, even though it is clear that the standard will change in time.
13.1. European Harmonised Standards published in the Official Journal
By way of information, a reference list of European Harmonised Standards can be found on the European Commission's website.
European standards for ATEX are available from the European Standardisation Organisations:
- CEN: avenue Marnix 17, B-1000 Bruxelles; tel. (32-2) 550 08 11; fax (32-2) 550 08 19 ( http://www.cen.eu)
- CENELEC: avenue Marnix 17, B-1000 Brussels; tel. (32-2) 519 68 71; fax (32-2) 519 69 19 ( http://www.cenelec.org)
National transpositions of Harmonised Standards are available from the national standardisation bodies.
National transpositions of harmonised standards are available from the national standardisation bodies.
13.2. Standardisation Programme
Two standardisation programmes addressed to the European standardisation bodies. Each one is the subject of a standardisation mandate drawn up by the European Commission.
The European Commission has granted a mandate to CEN/CENELEC to produce European standards. The mandate covers the standardisation work necessary for the optimum functioning of the Directive in both the electrical and mechanical field.
The mandate requires intensive co-operation between CEN and CENELEC to carry out the following work:
- To review and, where appropriate, modify existing standards with a view to aligning them with the Essential Health and Safety Requirements of the Directive.
- To establish the new standards required, giving priority to horizontal standards, which apply to broad ranges of products, rather than to specific products, with the need for them to be demonstrated on a case-by-case basis.
To carry out their mandate CEN established a technical committee CEN/TC 305 "Potentially explosive atmospheres - explosion prevention and protection". Several Working Groups carry out the detailed work.
To carry out their mandate CENELEC allocated the work to TC 31 "Electrical Apparatus for Explosive Atmospheres", and its sub-committees. These Committees have been working in the potentially explosive atmosphere field for a considerable number of years and have produced a series of Standards under the Old Approach Directive.
- CENELEC and CEN are responsible for the preparation of standards of the electrical and non-electrical sectors of industry respectively. They have the responsibility to ensure that:
there is uniform interpretation of the New Approach Directive for potentially explosive atmospheres, and other relevant directives;
- safety requirements for the electrical and non-electrical sectors are compatible where they overlap, and the levels of safety sought are equivalent;
- the preparation of standards in the future by one of the organisations satisfactorily reflects the needs of the other, and vice versa.