Regulation (EU) 2016/425 of the European Parliament and of the CouncilShow full title

[F1 Article 7A U.K. Designated standard

1. Subject to paragraphs 6 and 7, in this Regulation, a “designated standard” means a technical specification which is—

(a) adopted by a recognised standardisation body [F2 or an international standardising body], for repeated or continuous application, with which compliance is not compulsory; and

(b) designated by the Secretary of State, by publishing the reference to the standard and maintaining that publication in a manner the Secretary of State considers appropriate.

2. For the purposes of paragraph 1, “technical specification” means a document that prescribes technical requirements to be fulfilled by a product, process, service or system and which lays down one or more of the following—

(a) the characteristics required of a product, including—

(i) levels of quality, performance, interoperability, environmental protection, health, safety or dimensions; and

(ii) the requirements applicable to the product as regards the name under which the product is sold, terminology, symbols, testing and test methods, packaging, marking or labelling and conformity assessment procedures;

(b) production methods and processes relating to the product, where these have an effect on the characteristics of the product.

3. For the purposes of this Article, a “recognised standardisation body” means any one of the following organisations—

(a) the European Committee for Standardisation (CEN);

(b) the European Committee for Electrotechnical Standardisation (Cenelec);

(c) the European Telecommunications Standards Institute (ETSI);

(d) the British Standards Institution (BSI).

[F3 3A. In this Article “international standardising body” has the same meaning as it has for the purposes of the Agreement on Technical Barriers to Trade, part of Annex 1A to the agreement establishing the World Trade Organisation signed at Marrakesh on 15 April 1994 (as modified from time to time).]

4. When considering whether the manner of publication of a reference is appropriate in accordance with paragraph 1(b), the Secretary of State must have regard to whether the publication will draw the standard to the attention of any person who may have an interest in the standard.

5. Before publishing the reference to a technical specification adopted by the British Standards Institution, the Secretary of State must have regard to whether the technical specification is consistent with [F4 such] technical specifications adopted by the other recognised standardisation bodies [F5 or by international standardising bodies as the Secretary of State considers to be relevant].

6. The Secretary of State may remove from publication the reference to a standard which has been published in accordance with paragraph 1(b).

7. Where the Secretary of State removes the reference to a standard from publication, that standard is no longer a designated standard.

8. In this Article, a reference to a “product” is a reference to PPE to which this Regulation applies.

9. The Secretary of State may, by regulations, amend paragraph 3 to reflect any changes in the name or structure of the recognised standardisation bodies.

10. Regulations made under paragraph 9 must be made by statutory instrument, subject to annulment in pursuance of a resolution of either House of Parliament.]

Textual Amendments

F1 Art. 7A inserted (31.12.2020) by The Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/696), reg. 1, Sch. 35 para. 3(7); 2020 c. 1, Sch. 5 para. 1(1)

F2 Words in Art. 7A(1)(a) inserted (31.12.2020) by European Union (Future Relationship) Act 2020 (c. 29), s. 40(7), Sch. 4 para. 23(a); S.I. 2020/1662, reg. 2(ee)

F3 Art. 7A(3A) inserted (31.12.2020) by European Union (Future Relationship) Act 2020 (c. 29), s. 40(7), Sch. 4 para. 23(b); S.I. 2020/1662, reg. 2(ee)

F4 Word in Art. 7A(5) inserted (31.12.2020) by European Union (Future Relationship) Act 2020 (c. 29), s. 40(7), Sch. 4 para. 23(c)(i); S.I. 2020/1662, reg. 2(ee)

F5 Words in Art. 7A(5) inserted (31.12.2020) by European Union (Future Relationship) Act 2020 (c. 29), s. 40(7), Sch. 4 para. 23(c)(ii); S.I. 2020/1662, reg. 2(ee)