The Conformity Assessment (Mutual Recognition Agreements) Regulations 2019

Explanatory Note

(This note is not part of the Regulations)

These Regulations implement the following agreements between the European Union and third countries (“the mutual recognition agreements”)—

(a)

the Agreement on mutual recognition in relation to conformity assessment, certificates and markings between the European Community and Australia;

(b)

the Agreement on mutual recognition in relation to conformity assessment between the European Community and New Zealand;

(c)

the Protocol on the mutual acceptance of the results of conformity assessment, which is part of the Comprehensive Economic and Trade Agreement (CETA) between Canada, of the one part, and the European Union and its Member States, of the other part;

(d)

the Protocol on the mutual recognition of the compliance and enforcement programme regarding good manufacturing practices for pharmaceutical products, which is part of the Comprehensive Economic and Trade Agreement (CETA) between Canada, of the one part, and the European Union and its Member States, of the other part;

(e)

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

(f)

the Agreement on mutual recognition between the European Community and Japan;

(g)

the Agreement between the European Community and the Swiss Confederation on mutual recognition in relation to conformity assessment (“the Swiss agreement”);

(h)

the Agreement between the European Community and the United States of America on the Mutual Recognition of Certificates of Conformity for Marine Equipment;

(i)

Decision No. 1/2006 of the EC-Turkey Association Council of 15 May 2006 on the implementation of Article 9 of Decision No. 1/95 of the EC-Turkey Association Council on implementing the final phase of the Customs Union (“the Turkish agreement”);

(j)

Annex 2-B to the Free Trade Agreement between the European Union and its Member States, of the one part, and the Republic of Korea, of the other part;

(k)

the Protocol to the Euro-Mediterranean Agreement establishing an association between the European Communities and their Member States, of the one part, and the State of Israel, of the other part, on Conformity Assessment and Acceptance of Industrial Products (CAA) (“the Israeli agreement”).

The mutual recognition agreements require member States to accept attestations of conformity issued by third countries in respect of certain products, processes or services. A third country's attestation of conformity confirms that the product, process or service concerned complies with the requirements of European Union law which apply to that product, process or service and which are referred to in the mutual recognition agreement concerned. Regulation 3(2) of these Regulations requires the United Kingdom to accept such attestations of conformity.

Article 1(2) of the Swiss agreement also requires member States to accept an attestation of conformity issued by Switzerland, where the attestation confirms that Switzerland has complied with the requirements of Swiss law which are equivalent to the requirements of European Union law in respect of a product, process or service. Regulation 3(4) of these Regulations provides that the United Kingdom must accept such attestations of conformity.

Article 2(3) of the Turkish agreement requires member States to accept an attestation of conformity issued by Turkey in respect of a product, in cases where the Customs Union Joint Committee has adopted a statement confirming that Turkey has put into force the European Union law in respect of that product. Regulation 3(6) of these Regulations implements that requirement.

Article 5(3) of the Israeli agreement requires member States to accept an attestation of conformity issued by Israel in respect of a product, in cases where Israel has complied with provisions of Israeli law which align with any provision of European Union law in respect of that product which has been specified in a notification under the Annex to the Israeli agreement. Regulation 3(8) of these Regulations implements that requirement.

Regulation 4 of these Regulations implements the provisions in the Swiss agreement that allow a Swiss manufacturer to appoint an authorised representative who is established in the European Union or in Switzerland.

Regulation 5 of these Regulations makes similar provision in relation to authorised representatives who are established in Turkey.

An impact assessment has not been published for this instrument as it has no or no significant impact on the private, public and voluntary sectors.