Regulation 2 InterpretationI1
United Kingdom
In these Regulations—
“attestation of conformity” means, in relation to a product, process or service, any of the following—
the results of any conformity assessment carried out in respect of the product, process or service;
a report, certificate, authorisation, decision or a mark of conformity relating to such an assessment;
a declaration of conformity;
the confirmation (within the meaning given by Article 1(1)(f) of the Japanese agreement) of manufacturing facilities;
“conformity assessment” means systematic examination to determine the extent to which a product, process or service fulfils specified requirements;
“Israeli agreement” means the agreement mentioned in sub-paragraph (e)(xi);
“Japanese agreement” means the agreement mentioned in sub-paragraph (e)(vi);
“mutual recognition agreement” means—
the Agreement on mutual recognition in relation to conformity assessment, certificates and markings between the European Community and Australia M1;
the Agreement on mutual recognition in relation to conformity assessment between the European Community and New Zealand M2;
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 M3;
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 M4;
the Agreement on mutual recognition between the European Community and the United States of America M5;
the Agreement on mutual recognition between the European Community and Japan M6;
the Agreement between the European Community and the Swiss Confederation on mutual recognition in relation to conformity assessment M7;
the Agreement between the European Community and the United States of America on the Mutual Recognition of Certificates of Conformity for Marine Equipment M8;
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 M9;
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 M10; or
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) M11;
“Swiss agreement” means the agreement mentioned in sub-paragraph (e)(vii);
“Turkish agreement” means the decision mentioned in sub-paragraph (e)(ix).
Annotations
Marginal citations
- M1
OJ No. L 229, 17.8.1998, p. 3. This agreement was amended by the Agreement between the European Union and Australia amending the Agreement on mutual recognition in relation to conformity assessment, certificates and markings between the European Community and Australia (OJ No. L 359, 29.12.2012, p. 2). There are other amendments but they are not relevant.
- M2
OJ No. L 229, 17.8.1998, p. 62. This agreement was amended by the Agreement between the European Union and New Zealand amending the Agreement on mutual recognition in relation to conformity assessment between the European Community and New Zealand (OJ No. L 356, 22.12.2012, p. 2).
- M3
OJ No. L 11, 14.1.2017, p. 567. There are no relevant amendments to this protocol.
- M4
OJ No. L 11, 14.1.2017, p. 581. There are no relevant amendments to this protocol.
- M5
OJ No. L 31, 4.2.1999, p. 3. This agreement was amended by: (i) Decision No. 16/2002 of 16 April 2002 of the Joint Committee established under the Agreement on mutual recognition between the European Community and the United States of America on amending the Sectoral Annex on Medical Devices (OJ No. L 302, 6.11.2002, p. 30); and (ii) Decision No. 1/2017 of 1 March 2017 of the Joint Committee established under Article 14 of the Agreement on Mutual Recognition between the European Community and the United States of America, amending the Sectoral Annex for Pharmaceutical Good Manufacturing Practices (GMPs) [2017/382] (OJ No. L 58, 4.3.2017, p. 36). There are other amendments but they are not relevant.
- M6
OJ No. L 284, 29.10.2001, p. 3. There are no relevant amendments to this agreement.
- M7
OJ No. L 114, 30.4.2002, p. 369. This agreement was amended by: (i) Decision No. 2/2002 of 8 January 2003 of the Committee established under the Agreement between the European Community and the Swiss Confederation on mutual recognition in relation to conformity assessment on the modification of the Annex 1 of the Agreement (OJ No. L 68, 12.3.2003, p. 1); (ii) Decision No. 2/2005 of 30 March 2005 of the Committee established under the Agreement on Mutual Recognition between the EC and the Swiss Confederation on amending Chapter 3 of Annex 1 (OJ No. L 110, 30.4.2005, p. 78); (iii) the Agreement revising the Agreement between the European Community and the Swiss Confederation on mutual recognition in relation to conformity assessment (OJ No. L 386, 29.12.2006, p. 51); (iv) Decision No. 1/2006 of 29 September 2006 of the Committee established under the Agreement on Mutual Recognition between the European Community and the Swiss Confederation on amending Chapter 11 of Annex 1 (OJ No. L 325, 24.11.2006, p. 22); (v) Decision No. 1/2008 of 12 March 2008 of the Committee established under the Agreement between the European Community and the Swiss Confederation on Mutual Recognition in relation to Conformity Assessment on the inclusion in Annex 1 of a new Chapter 16 on construction products (OJ No. L 282, 25.10.2008, p. 22); (vi) Decision No. 1/2009 of 21 December 2009 of the Committee established under the Agreement between the European Community and the Swiss Confederation on mutual recognition in relation to conformity assessment on the inclusion in Annex 1 of a new Chapter 17 on lifts and on the amendment of Chapter 1 on Machinery (OJ No. L 147, 12.6.2010, p. 11); (vii) Decision No. 1/2010 of the Committee established under the Agreement between the European Community and the Swiss Confederation on mutual recognition in relation to conformity assessment of 18 October 2010 on the amendment of Chapter 12 on Motor vehicles of Annex 1 and on the inclusion in Annex 1 of a new Chapter 18 on Biocidal products (OJ No. L 46, 19.2.2011, p. 51); (viii) Decision No. 1/2011 of the Committee established under the Agreement between the European Community and the Swiss Confederation on mutual recognition in relation to conformity assessment of 20 December 2011 on the inclusion in Annex 1 of a new Chapter 19 on cableway installations and the update of legal references listed in Annex 1 (OJ No. L 80, 20.3.2012, p. 31); (ix) Decision No. 1/2012 of the Committee established under the Agreement between the European Community and the Swiss Confederation on mutual recognition in relation to conformity assessment of 17 December 2012 on the inclusion in Annex 1 of a new Chapter 20 on explosives for civil use, the amendment of Chapter 3 on toys and the update of legal references listed in Annex 1 (OJ No. L 136, 23.5.2013, p. 17); (x) Decision No. 1/2014 of the Committee established under the Agreement between the European Community and the Swiss Confederation on mutual recognition in relation to conformity assessment of 1 April 2014 on the amendment of Chapter 6 on pressure vessels, Chapter 16 on construction products and the update of legal references listed in Annex 1 (OJ No. L 182, 21.6.2014, p. 61); (xi) Decision No. 1/2015 of the Committee established under the Agreement between the European Community and the Swiss Confederation on mutual recognition in relation to conformity assessment of 14 April 2015 on the amendment of Chapter 16 on construction products, Chapter 18 on biocidal products and the update of legal references listed in Annex 1 [2015/1058] (OJ No. L 171, 2.7.2015, p. 25); (xii) Decision No. 1/2017 of the Committee established under the Agreement between the European Community and the Swiss Confederation on mutual recognition in relation to conformity assessment of 28 July 2017 on the amendment of Chapter 4 on medical devices, Chapter 6 on pressure vessels, Chapter 7 on radio equipment and telecommunication terminal equipment, Chapter 8 on equipment and protective systems intended for use in potentially explosive atmosphere, Chapter 9 on electrical equipment and electromagnetic compatibility, Chapter 11 on measuring instruments, Chapter 15 on medicinal products, GMP inspection and batch certification, Chapter 17 on lifts, and Chapter 20 on explosives for civil use, and the update of legal references listed in Annex 1 [2017/2118] (OJ No. L 323, 7.12.2017, p. 51); and (xiii) Decision No. 2/2017 of the Committee established under the Agreement between the European Community and the Swiss Confederation on mutual recognition in relation to conformity assessment of 22 December 2017 on the amendment of Chapter 2 on personal protective equipment, Chapter 4 on medical devices, Chapter 5 on gas appliances and boilers and Chapter 19 on Cableway installations [2018/403] (OJ No. L 72, 15.3.2018, p. 24). There are other amendments but they are not relevant.
- M8
OJ No. L 150, 30.4.2004, p. 46. This agreement was amended by Decision No. 1/2018 of 18 February 2019 of the Joint Committee established by the Agreement between the European Community and the United States of America on the mutual recognition of certificates of conformity for marine equipment amending Annexes 1, 2 and 3.
- M9
OJ No. L 271, 30.9.2006, p. 58.
- M10
OJ No. L 127, 14.5.2011, p. 1134. There are no relevant amendments.
- M11
OJ No. L 1, 4.1.2013, p. 2.
Commencement
- I1
Reg. 2 in force at 22.3.2019, see reg. 1