European Commission - Enterprise and Industry

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Mutual Recognition Agreements (MRAs)



CABs designated under MRA
The objective of MRAs is to promote trade in goods between the European Union and third countries by facilitating market access. They are bilateral agreements, and aim to benefit industry by providing easier access to conformity assessment

For a list of designating authorities, see Notifying authorities

For further information and background documents, see the web site: Mutual Recognition Agreements

LTA: For further information and background documents see
. Australia
CABs from Australia
EU CABs
OJ L 229 of 17/08/1998
OJ L 359 of 29/12/2012

. Canada
CABs from Canada
EU CABs
OJ L 280 of 16/10/1998

. Israel
Information on the EU-Israel MRA on Good Laboratory Practice
Information on the EU-Israel ACAA on Pharmaceutical Products

. Japan
CABs from Japan
EU CABs
OJ L 284 of 29/10/2001

. New Zealand
CABs from New Zealand
EU CABs
OJ L 229 of 17/08/1998
OJ L 356 of 22/12/2012

. Switzerland (*)
CABs from Switzerland
EU CABs
OJ L 114 of 30/04/2002
OJ L 386 of 29/12/2006

. United States
CABs from United States
EU CABs
OJ L 31 of 4/02/1999

(*) Switzerland is listed for Directive 2008/57/EC by virtue of Decision 1/2013 and the EU-Switzerland Land Transport Agreement - LTA

Conformity assessment and designation of Conformity Assessment Bodies (CABs)
MRAs lay down the conditions under which the EU and the third country concerned will accept test reports, certificates and marks of conformity issued by the conformity assessment bodies (CABs) of the other party to the agreement, in conformity with the legislation of the other party. MRAs include the finalisation of relevant lists of designated laboratories, inspection bodies and conformity assessment bodies in both the EU and the third country. [Links to existing lists are provided on this website.] Designation of CABs represents a core function in the operation of the MRA. EU Member States are enabled to designate CABs that will assess and certify products, in specified sectors, which are exported to the third country signatory of an MRA with the EU. The legislation of reference comprises the regulations and technical requirements of the third country. Similarly, third country signatories can designate CABs that in practice will operate as Notified Bodies in the context of the EU internal market.

Designation of CABs by EU Member States
Designation enables European CABs to conduct assessments, in line with the legislation in a non-member country, on products to be placed on the market in that country. It will basically take the form of indicating the details (address, etc.) of the body, the country in question and its legislation, and the detailed technical qualifications - as requested by the third country - on the basis of which the designation is made. An identification number is not assigned to an EU CAB, which may nevertheless already possess identification number as an EU notified body.

Procedure:
The applicant CAB requests designation from its national designating authority, which in turn communicates the dossier to the European Commission (DG ENTR.C.1).

Designation of CABs by non-EU countries
Designation in this case enables non-EU CABs to assess, in line with EU directives and in accordance with the provisions of the MRA, products to be placed on the EU market. In certain sectors these CABs receive identification numbers (which will feature next to the CE marking where a CAB intervenes during the production phase). Such designation takes place according to the relevant terms of the MRA - broadly on the basis of the same criteria as for Notified Bodies. In certain sectors, according to the terms of the MRA Framework Agreement and the relevant Sectoral Annexes, these CABs will be performing the same tasks as the EU Notified Bodies. In this case, and in line with the European Commission procedures applicable for Notified bodies, they will be included in the data base of Notified Bodies.

Procedure:
The non-EU CAB applies to its own designating authority, which in turn sends the application to the European Commission (DG TRADE.G.3).

For further information and background documents, see the web site:mra