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Mutual Recognition of Conformity Assessment

Proposed European Community Agreements with third countries relating to third party testing, certification, or marking 
 
Introduction

The European Commission was mandated by the General Affairs Council to negotiate agreements on the mutual recognition of conformity assessment with several third countries. The mutual recognition agreements (MRAs) are confined to sectors (covered by New and Old Approach EC Directives, as well as non-harmonised national legislation) which require independent testing and / or certification and / or marking by a third-party.

The scope of the negotiations is restricted to reaching an agreement only in respect of accepting designated conformity assessment bodies (CABs) in third countries as being competent to test / certify / mark in accordance with Community legislative requirements and for nominated bodies in the Community to test / certify / mark to the legislative requirements of the third country. The scope does not, therefore, extend to the mutual recognition of products for sale in the Community, which have been tested / certified / marked to the third country requirements, or vice versa. Nor does it extend to products that are not independently tested / certified / marked.

The scope of the MRAs is, therefore, limited. For example, in the case of machinery it is only machinery which is submitted for type-examination that is able to be tested to Community requirements by an approved third country body. In a similar manner, bodies in the Community are able to test machinery to be exported to the third country which requires independent testing according to the third country requirements.

Initial negotiations

Discussion with Member States takes place in a Technical Group under the Article 133 Committee in Brussels and we co-ordinated the UK's input to these negotiations. The sectors vary depending upon the particular interests of both the European Community and the third country. The initial negotiations have concentrated on harmonised areas because of the existence of Community-wide harmonised legislation, rather than the non-harmonised areas where the differing legislation in Member States makes it difficult to reach an agreement at Community level with third countries.

We are supportive of the benefit of such agreements. Their effect is to give easier access (to the Single Market) to certain other countries on the basis of one-stop testing and certification, provided that EU producers are given equal access in return.

Progress

The Community has signed individual mutual recognition agreements (MRAs) with Australia, New Zealand, Canada, the United States of America, Israel, Japan and Switzerland.  See below in the information section on where to find further information on the sectors covered by the MRAs.

The text of the Agreements have been published in the Official Journal - OJ L229 of 17.08.98 for Australia & New Zealand, L280 of 16.10.98 for Canada, L31 of 04.02.99 for USA, L263 of 09.10.99 for Israel, L284 of 29.10.01 for Japan and OJ L114 of 30.04.02 for Switzerland.

The Commission has signed an agreement with the US in the area of marine equipment, which unlike other MRAs, is based on regulatory equivalence of both parties for mutually agreed product areas. Equipment approved by one party to mutually agreed standards is fully acceptable for use on ships of the other party. This agreement was published in the Official Journal OJ L150 of 30.04.04 and L185 of 24.05.04.

Community obligations under the sectoral annex for Electrical Safety of the MRA with the US have been suspended (Official Journal OJ L23 of 28.01.2003).

Next steps

The Agreements with United States and Canada contain transition periods for confidence building, as specified in the Sectoral Annexes of the Agreements. The Agreements with Australia, New Zealand, Switzerland and Japan do not have transition periods. In practice, however, the Agreements, with the exception of the pharmaceutical sector, which does not rely on the appointment of conformity assessment bodies, become operational when proposed conformity assessment bodies for the specified Sectoral Annexes are confirmed by the individual Joint Committees, established for effective functioning of the Agreement. In the pharmaceutical sector, the Annex would become operational only when regulatory systems are confirmed as equivalent by both parties.

A Joint Committee may establish Joint Sectoral Committees for the effective functioning of the Sectoral Annexes. Once an agreement is in place, it is intended that further sectors can be added as and when appropriate.

The Commission has placed a list of CABs agreed to participate for the purposes of the MRA on its website given below in the information section.

Protocols on European Conformity Assessment (PECAs)

The Commission is negotiating with Bulgaria and Romania with a view to reaching agreement on Protocols relating to European conformity assessment. These are similar to the above mentioned mutual recognition agreements but, unlike the mutual recognition agreements, they are based on the countries concerned adopting EC legislation, with a view to joining the EU, and will permit mutual recognition of third party conformity assessment to the relevant EC requirements by both parties.

Further information can be found on the European Commission website.

Information

Further information on Mutual Recognition Agreements as well as PECAs can be found from the European Commission website.

Contact

Ajay Gohil, Department for Innovation, Universities and Skills, Bay 410, Kingsgate House, 66-74 Victoria Street, London SW1E 6SW
Tel: 0203 300 8630
E-mail: STRD2@dius.gsi.gov.uk