Regulation (EC) No 765/2008 of the European Parliament and of the CouncilShow full title

CHAPTER I U.K. GENERAL PROVISIONS

Article 1 U.K. Subject matter and scope

1. This Regulation lays down rules on the organisation and operation of accreditation of conformity assessment bodies performing conformity assessment activities.

2. This Regulation provides a framework for the market surveillance of products to ensure that those products fulfil requirements providing a high level of protection of public interests, such as health and safety in general, health and safety at the workplace, the protection of consumers, protection of the environment and security.

3. This Regulation provides a framework for controls on products [F1 entering the market of Great Britain].

[F2 4. This Regulation provides the requirements as to the form of the UK marking.]

Textual Amendments

F1 Words in Art. 1(3) substituted (31.12.2020) by The Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/696), reg. 1, Sch. 33 para. 2(a) (as amended by S.I. 2020/1460, reg. 1(4), Sch. 3 para. 22(2)); 2020 c. 1, Sch. 5 para. 1(1)

F2 Art. 1(4) substituted (31.12.2020) by The Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/696), reg. 1, Sch. 33 para. 2(b); 2020 c. 1, Sch. 5 para. 1(1)

Article 2 U.K. Definitions

For the purposes of this Regulation the following definitions F3 ... apply:

1.

‘making available on the market’ [F4 means] any supply of a product for distribution, consumption or use on the [F5 market of Great Britain] in the course of a commercial activity, whether in return for payment or free of charge [F6 and related expressions must be construed accordingly];

2.

‘placing on the market’ [F4 means] the first making available of a product on the [F7 market of Great Britain ][F8 and related expressions must be construed accordingly];

3.

‘manufacturer’ [F4 means] any natural or legal person who manufactures a product or has a product designed or manufactured, and markets that product under his name or trademark;

4.

[F9 “authorised representative” means a person who—

(a)

is established in the United Kingdom; and

(b)

has received a written mandate from a manufacturer to act on that manufacturer's behalf in relation to specified task with regard to the manufacturer's obligation under any relevant enactment;]

5.

[F10 “importer” means any person established in the United Kingdom who places a product from a country outside of the United Kingdom on the market;]

6.

‘distributor’ [F11 means] any natural or legal person in the supply chain, other than the manufacturer or the importer, who makes a product available on the market;

7.

‘economic operators’ [F12 means] the manufacturer, the authorised representative, the importer and the distributor;

8.

F13 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

9.

F13 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

10.

[F14 “accreditation” means an attestation by a national accreditation body conveying formal recognition that a conformity assessment body is competent to carry out a specific conformity assessment activity;]

11.

[F15 “UK national accreditation body” means the body appointed by the Secretary of State in accordance with Article 4;]

12.

‘conformity assessment’ [F16 means] the process demonstrating whether specified requirements relating to a product, process, service, system, person or body have been fulfilled;

13.

‘conformity assessment body’ [F16 means] a body that performs conformity assessment activities including calibration, testing, certification and inspection;

14.

‘recall’ [F16 means] any measure aimed at achieving the return of a product that has already been made available to the end user;

15.

‘withdrawal’ [F16 means] any measure aimed at preventing a product in the supply chain from being made available on the market;

16.

F17 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

17.

‘market surveillance’ [F18 means] the activities carried out and measures taken by public authorities to ensure that products comply with the requirements set out in [F19 any relevant enactment] and do not endanger health, safety or any other aspect of public interest protection;

18.

[F20 “market surveillance authority” means an authority responsible for carrying out market surveillance in the United Kingdom;]

19.

[F21 “the free circulation procedure” means the procedure set out in Schedule 1 to the Taxation (Cross-border Trade) Act 2018;]

20.

[F22 “conformity marking” means a marking, such as the UK marking, by which the manufacturer indicates that a product is in conformity with the applicable requirements of any enactment providing for the affixing such a marking;]

21.

[F23 “relevant enactment” means any [F24 assimilated] law, as it applies in Great Britain, derived from an EU instrument harmonising the conditions for the marketing of products in the EU;]

22.

[F25 “UK marking” means the marking in the form set out in Annex 2.]

Textual Amendments

F3 Word in Art. 2 omitted (31.12.2020) by virtue of The Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/696), reg. 1, Sch. 33 para. 3(a); 2020 c. 1, Sch. 5 para. 1(1)

F4 Word in art. 2(1)-(3) substituted (31.12.2020) by The Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/696), reg. 1, Sch. 33 para. 3(b); 2020 c. 1, Sch. 5 para. 1(1)

F5 Word in Art. 2(1) substituted (31.12.2020) by The Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/696), reg. 1, Sch. 33 para. 3(c)(i) (as substituted by S.I. 2020/1460, reg. 1(4), Sch. 3 para. 22(3)(a)); 2020 c. 1, Sch. 5 para. 1(1)

F6 Words in Art. 2(1) inserted (31.12.2020) by The Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/696), reg. 1, Sch. 33 para. 3(c)(ii); 2020 c. 1, Sch. 5 para. 1(1)

F7 Word in Art. 2(2) substituted (31.12.2020) by The Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/696), reg. 1, Sch. 33 para. 3(d)(i) (as substituted by S.I. 2020/1460, reg. 1(4), Sch. 3 para. 22(3)(b)); 2020 c. 1, Sch. 5 para. 1(1)

F8 Words in Art. 2(2) inserted (31.12.2020) by The Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/696), reg. 1, Sch. 33 para. 3(d)(ii); 2020 c. 1, Sch. 5 para. 1(1)

F9 Art. 2(4) substituted (31.12.2020) by The Product Safety and Metrology etc. (Amendment etc.) (UK(NI) Indication) (EU Exit) Regulations 2020 (S.I. 2020/1460), reg. 1(2), Sch. 5 para. 1(5)

F10 Art. 2(5) substituted (31.12.2020) by The Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/696), reg. 1, Sch. 33 para. 3(f); 2020 c. 1, Sch. 5 para. 1(1)

F11 Word in Art. 2(6) substituted (31.12.2020) by The Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/696), reg. 1, Sch. 33 para. 3(b); 2020 c. 1, Sch. 5 para. 1(1)

F12 Word in Art. 2(7) substituted (31.12.2020) by The Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/696), reg. 1, Sch. 33 para. 3(b); 2020 c. 1, Sch. 5 para. 1(1)

F13 Art. 2(8)(9) omitted (31.12.2020) by virtue of The Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/696), reg. 1, Sch. 33 para. 3(g); 2020 c. 1, Sch. 5 para. 1(1)

F14 Art. 2(10) substituted (31.12.2020) by The Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/696), reg. 1, Sch. 33 para. 3(h); 2020 c. 1, Sch. 5 para. 1(1)

F15 Art. 2(11) substituted (31.12.2020) by The Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/696), reg. 1, Sch. 33 para. 3(i); 2020 c. 1, Sch. 5 para. 1(1)

F16 Word in art. 2(12)-(15) substituted (31.12.2020) by The Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/696), reg. 1, Sch. 33 para. 3(b); 2020 c. 1, Sch. 5 para. 1(1)

F17 Art. 2(16) omitted (31.12.2020) by virtue of The Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/696), reg. 1, Sch. 33 para. 3(j); 2020 c. 1, Sch. 5 para. 1(1)

F18 Word in Art. 2(17) substituted (31.12.2020) by The Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/696), reg. 1, Sch. 33 para. 3(b); 2020 c. 1, Sch. 5 para. 1(1)

F19 Words in Art. 2(17) substituted (31.12.2020) by The Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/696), reg. 1, Sch. 33 para. 3(k); 2020 c. 1, Sch. 5 para. 1(1)

F20 Art. 2(18) substituted (31.12.2020) by The Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/696), reg. 1, Sch. 33 para. 3(l); 2020 c. 1, Sch. 5 para. 1(1)

F21 Art. 2(19) substituted (31.12.2020) by The Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/696), reg. 1, Sch. 33 para. 3(m); 2020 c. 1, Sch. 5 para. 1(1)

F22 Art. 2(20) substituted (31.12.2020) by The Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/696), reg. 1, Sch. 33 para. 3(n); 2020 c. 1, Sch. 5 para. 1(1)

F23 Art. 2(21) substituted (31.12.2020) by The Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/696), reg. 1, Sch. 33 para. 3(o) (as amended by S.I. 2020/1460, reg. 1(4), Sch. 3 para. 22(3)(c)); 2020 c. 1, Sch. 5 para. 1(1)

F24 Word in Art. 2(21) substituted (27.2.2025) by The Retained EU Law (Revocation and Reform) Act 2023 (Consequential Amendments) Regulations 2025 (S.I. 2025/82), reg. 1(2), Sch. 6 para. 17

F25 Art. 2(22) inserted (31.12.2020) by The Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/696), reg. 1, Sch. 33 para. 3(p); 2020 c. 1, Sch. 5 para. 1(1)