The Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019

Insertion of regulation 12A

9.  After regulation 12 insert—

“Obligations which are met by complying with obligations in the Directive

12A.— (1) In this regulation—

(a) any reference to an Article or an Annex is a reference to an Article of or an Annex to the Directive;

(b) “CE marking” means the marking referred to in Article 16(1);

(c) “harmonised standard” means a harmonised standard within the meaning of Article 2(l), the reference to which has been published in the Official Journal of the European Union.

(2) Subject to paragraphs (6) and (7), paragraph (3) applies where, before placing machinery on the market or putting machinery into service, the responsible person—

(a) ensures that the machinery satisfies the essential health and safety requirements set out in Annex I;

(b) ensures that the technical file referred to in Annex VII, part A is available to the enforcement authorities on request;

(c) provides the necessary information, referred to in Article 5(1)(c);

(d) carries out the appropriate procedures for assessing conformity in accordance with Article 12;

(e) ensures that the technical file, necessary information and records and correspondence relating to the conformity assessment procedures are prepared in or translated into English;

(f) draws up the EC declaration of conformity in accordance with Annex II, part I, Section A and ensure that it accompanies the machinery;

(h) ensures that the EC declaration of conformity is prepared in or translated into English; and

(i) affixes the CE marking in accordance with Article 16.

(3) Where this paragraph applies—

(a) the requirements of regulation 7(2)(a), (b), (c), (e)(i) and (f) are to be treated as being satisfied;

(b) regulations 7(2)(e)(ii), 15 and 21 apply subject to the modifications in paragraph (8);

(c) Part 8 of Schedule 2 does not apply.

(4) Subject to paragraphs (6) and (7) paragraph (5) applies where, before placing partly completed machinery on the market, the responsible person ensures that—

(a) the relevant technical documentation referred to in Annex VII part B is prepared in or translated into English;

(b) the assembly instructions referred to in Annex VI are prepared in or translated into English; and

(c) a declaration of incorporation referred to in Annex II part 1, Section B has been drawn up in or translated into English.

(5) Where this paragraph applies the requirements of regulation 8(1) are to be treated as being satisfied.

(6) This paragraph applies to machinery listed in Annex IV where there is no designated standard or part of a designated standard which corresponds exactly to a harmonised standard or part of a harmonised standard referred to in Article 7(2).

(7) Where paragraph (6) applies, paragraph (2)(d) is to be read as requiring the responsible person to have carried out the conformity assessment procedure in Article 12(4).

(8) The modifications referred to in paragraph (3)(b) are that—

(a) any reference to “declaration of conformity” is to be read as a reference to the EU declaration of conformity;

(b) any reference to “UK marking” is to be read as a reference to the CE marking.”.