The Conformity Assessment (Mutual Recognition Agreements) Regulations 2019

Citation and commencement

1.  These Regulations may be cited as the Conformity Assessment (Mutual Recognition Agreements) Regulations 2019 and come into force on 22nd March 2019.

Interpretation

2.  In these Regulations—

(a) “attestation of conformity” means, in relation to a product, process or service, any of the following—

(i) the results of any conformity assessment carried out in respect of the product, process or service;

(ii) a report, certificate, authorisation, decision or a mark of conformity relating to such an assessment;

(iii) a declaration of conformity;

(iv) the confirmation (within the meaning given by Article 1(1)(f) of the Japanese agreement) of manufacturing facilities;

(b) “conformity assessment” means systematic examination to determine the extent to which a product, process or service fulfils specified requirements;

(c) “Israeli agreement” means the agreement mentioned in sub-paragraph (e)(xi);

(d) “Japanese agreement” means the agreement mentioned in sub-paragraph (e)(vi);

(e) “mutual recognition agreement” means—

(i) the Agreement on mutual recognition in relation to conformity assessment, certificates and markings between the European Community and Australia(1);

(ii) the Agreement on mutual recognition in relation to conformity assessment between the European Community and New Zealand(2);

(iii) 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(3);

(iv) 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(4);

(v) the Agreement on mutual recognition between the European Community and the United States of America(5);

(vi) the Agreement on mutual recognition between the European Community and Japan(6);

(vii) the Agreement between the European Community and the Swiss Confederation on mutual recognition in relation to conformity assessment(7);

(viii) the Agreement between the European Community and the United States of America on the Mutual Recognition of Certificates of Conformity for Marine Equipment(8);

(ix) 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(9);

(x) 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(10); or

(xi) 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)(11);

(f) “Swiss agreement” means the agreement mentioned in sub-paragraph (e)(vii);

(g) “Turkish agreement” means the decision mentioned in sub-paragraph (e)(ix).

Recognition of conformity assessments etc.

3.—(1) Subject to paragraph (10), paragraph (2) applies where, pursuant to a mutual recognition agreement, member States are required to recognise or accept an attestation of conformity with the relevant European Union law in respect of a product, process or service (a “mutually recognised attestation of conformity”).

(2) Where this paragraph applies, the mutually recognised attestation of conformity is to be treated as if it were an attestation of conformity issued under the updated relevant European Union law by a person authorised or required to issue such attestations in respect of the product, process or service.

(3) Subject to paragraph (10), paragraph (4) applies where, pursuant to Article 1(2) of the Swiss agreement, member States are required to accept an attestation of conformity with the relevant Swiss law in respect of a product, process or service (a “Swiss enhanced attestation of conformity”).

(4) Where this paragraph applies—

(a) compliance with requirements of the updated relevant Swiss law in respect of the product, process or service is to be treated as compliance with the equivalent requirements of the updated relevant European Union law; and

(b) the Swiss enhanced attestation of conformity is to be treated as if it were an attestation of conformity issued under the updated relevant European Union law by a person authorised or required to issue such attestations in respect of the product, process or service.

(5) Subject to paragraph (10), paragraph (6) applies where, pursuant to Article 2(3) of the Turkish agreement, member States are required to accept an attestation of conformity with the relevant Turkish law in respect of a product (a “Turkish enhanced attestation of conformity”).

(6) Where this paragraph applies—

(a) compliance with requirements of the updated relevant Turkish law in respect of the product is to be treated as compliance with the equivalent requirements of the updated relevant European Union law; and

(b) the Turkish enhanced attestation of conformity is to be treated as if it were an attestation of conformity issued under the updated relevant European Union law by a person authorised or required to issue such attestations in respect of the product.

(7) Subject to paragraph (10), paragraph (8) applies where, pursuant to Article 5(3) of the Israeli agreement, member States are required to accept an attestation of conformity with the relevant Israeli law in respect of a product (an “Israeli enhanced attestation of conformity”).

(8) Where this paragraph applies—

(a) compliance with requirements of the relevant Israeli law in respect of the product is to be treated as compliance with the equivalent requirements of the relevant European Union law; and

(b) the Israeli enhanced attestation of conformity is to be treated as if it were an attestation of conformity issued under the relevant European Union law by a person authorised or required to issue such attestations in respect of the product.

(9) In this regulation—

(a) “relevant European Union law”, in respect of a mutual recognition agreement as it relates to a product, process or service, means the European Union law in respect of that product, process or service which is specified, or otherwise referred to, in or under the mutual recognition agreement;

(b) “relevant Israeli law”, in respect of a product, means any provision of Israeli law in respect of that product which is specified in a notification under the Annex to the Israeli agreement;

(c) “relevant Swiss law”, in respect of a product, process or service, means the Swiss law in respect of that product, process or service which is specified in the Swiss agreement;

(d) “relevant Turkish law”, in respect of a product, means any provision of Turkish law that reproduces the effect of any provision of relevant European Union law in respect of that product (as specified in a statement adopted as mentioned in Article 1(1) of the Turkish agreement);

(e) “updated relevant European Union law”, in respect of a mutual recognition agreement as it relates to a product, process or service, means the relevant European Union law as amended or re-enacted (with or without modifications) before the day on which these Regulations are made (whether or not those amendments or re-enactments are specified, or otherwise referred to, in or under the mutual recognition agreement as it had effect immediately before that day);

(f) “updated relevant Swiss law”, in respect of a product, process or service, means the relevant Swiss law as amended or re-enacted (with or without modifications) before the day on which these Regulations are made (whether or not those amendments or re-enactments are specified in the Swiss agreement as it had effect immediately before that day);

(g) “updated relevant Turkish law”, in respect of a product, means any provision of Turkish law that reproduces the effect of any updated relevant European Union law in respect of that product.

(10) Any provision made by paragraph (2), (4), (6) or (8) (a “default provision”) does not apply in respect of a product, process or service at any time if, at that time, there is sector specific provision in force.

(11) In paragraph (10), “sector specific provision”, means provision in respect of the product, process or service, which is of similar effect to the default provision in question.

Recognition of authorised representatives established in Switzerland

4.—(1) This regulation applies in respect of the product sectors listed in Chapters 2, 4 to 9, 11, 16, 17, 19 and 20 of Annex 1 to the Swiss agreement (“the specified product sectors”).

(2) Any person established in Switzerland is to be treated as established in a member State for the purpose of determining whether that person is, or is eligible to be appointed as, the authorised representative of a manufacturer.

(3) In paragraph (2), “authorised representative” means a person who has received a written mandate from a manufacturer to perform specified tasks on the manufacturer’s behalf pursuant to the updated relevant European Union law or the updated relevant Swiss law in respect of the specified product sector concerned.

(4) In paragraph (3), “updated relevant European Union law” and “updated relevant Swiss law” have the meanings given in regulation 3(9).

Recognition of authorised representatives established in Turkey

5.—(1) This regulation applies where a statement, adopted as mentioned in Article 1(1) of the Turkish agreement, recommends implementation of the principle of mutual recognition of the rights of authorised representatives in respect of any product to which the statement relates (“the relevant product”).

(2) Any person established in Turkey is to be treated as established in a member State for the purpose of determining whether that person is, or is eligible to be appointed as, the authorised representative of a manufacturer.

(3) In this regulation, “authorised representative” means a person who has received a written mandate from a manufacturer to perform specified tasks on the manufacturer’s behalf in accordance with the updated relevant European Union law or the updated relevant Turkish law in respect of the relevant product concerned.

(4) In paragraph (3), “updated relevant European Union law” and “updated relevant Turkish law” have the meanings given in regulation 3(9).

Kelly Tolhurst

Parliamentary Under Secretary of State

Department for Business, Energy and Industrial Strategy

28th February 2019