EU–United States of America mutual recognition agreement (MRA)

SUMMARY OF:

Agreement on mutual recognition between the European Community and the United States of America

Decision 1999/78/EC concluding the Agreement on Mutual Recognition between the European Community and the United States of America

WHAT IS THE AIM OF THE AGREEMENT AND THE DECISION?

The mutual recognition agreement (MRA)* aims to promote trade in goods between the EU and the US by removing technical barriers.

Under the bilateral agreement EU governments approved on 22 June 1998, the EU and the US accept the conformity assessment* results carried out for specified industrial products.

The decision adopts the MRA with the US on behalf of the EU.

KEY POINTS

The agreement covers the following sectors:

telecommunications equipment;
electromagnetic compatibility*;
electrical safety;
recreational craft;
pharmaceutical good manufacturing practices (GMPs);
medical devices.

The agreement, which has been updated several times:

enables EU companies to have their products — which must comply with US requirements — tested and certified in the EU and then they can export them to the US market and vice versa;
liststhe legislation, regulations and administrative rules the agreement covers for each sector;
requires the parties to the agreement to exchange information on implementation of those rules;
lays down the conditions for reciprocal acceptance of conformity assessment results;
lists the various national conformity assessment bodies* for each sector;
requires the EU and US authorities to audit, inspect and monitor the conformity assessment bodies they designate to ensure they carry out their work correctly;
provides for the suspension of a designated conformity assessment body;
establishes a joint committee of EU and US representatives to deal with any issues that might arise under the agreement.

FROM WHEN DOES THE AGREEMENT APPLY?

It has applied since 1 December 1998.

BACKGROUND

In their resolution of 21 December 1989, EU governments agreed the principles of MRAs. On 21 September 1992, they authorised the European Commission to negotiate mutual recognition agreements on behalf of the EU with certain non-EU countries.

For more information, see:

Mutual recognition agreements (European Commission).

KEY TERMS

Mutual recognition agreement: an international agreement where 2 or more countries recognise each other’s conformity assessment results.

Conformity assessment: the procedure in which a product, before it can be marketed, is tested, inspected and certified to ensure it complies with the relevant legislation.

Electromagnetic compatibility: the interaction of electrical and electronic equipment with its electromagnetic environment, and with other equipment. All electronic devices have the potential to emit electromagnetic fields.

Conformity assessment bodies: these assess whether a product meets the relevant regulatory or legislative requirements.

MAIN DOCUMENTS

Agreement on mutual recognition between the European Community and the United States of America (OJ L 31, 4.2.1999, pp. 3-80)

Successive amendments to the agreement have been incorporated in the original text. This consolidated version is of documentary value only.

Council Decision 1999/78/EC of 22 June 1998 on the conclusion of an Agreement on Mutual Recognition between the European Community and the United States of America (OJ L 31, 4.2.1999, pp. 1-2)

See consolidated version.