The Personal Protective Equipment (Enforcement) Regulations 2018

[F1 Obligations which are met by complying with obligations in Regulation 2016/425 (pre-exit) E+W+S

2A.— (1) In this regulation, “harmonised standard” has the meaning in Article 3(10) of Regulation 2016/425 (pre-exit).

(2) Paragraph (3) applies where before placing PPE on the market, the manufacturer—

(a) ensures that the PPE has been designed and manufactured in accordance with the applicable essential health and safety requirements set out in Annex II of Regulation 2016/425 (pre-exit);

(b) carries out the applicable conformity assessment procedure referred to in Article 19 of Regulation 2016/425 (pre-exit), or has it carried out;

(c) draws up the technical documentation referred to in Annex III of Regulation 2016/425 (pre-exit);

(d) ensures that the technical documentation and other records and correspondence relating to the conformity assessment procedures are prepared in, or translated into, English;

(e) affixes a CE marking in accordance with Articles 16 and 17(1) to (4) of Regulation 2016/425 (pre-exit);

(f) draws up an EU declaration of conformity, in accordance with Article 15 of Regulation 2016/425 (pre-exit); and

(g) ensures that the EU declaration of conformity is prepared in, or translated into, English.

(3) Where this paragraph applies—

(a) the requirements of Articles 8(1) and (2), 15, 16, 17 and 19 are to be treated as being satisfied;

(b) Articles 8(3), (4), (7) and (8), 9(2) and regulation 7(1) apply, subject to the modifications in paragraph (8);

(c) Article 41 does not apply.

(4) Paragraph (5) applies, where before placing PPE on the market, the importer ensures that—

(a) the applicable conformity assessment procedure referred to in Article 19 of Regulation 2016/425 (pre-exit) has been carried out;

(b) the manufacturer has drawn up the technical documentation referred to in Annex III of Regulation 2016/425 (pre-exit); and

(c) the PPE bears the CE marking in accordance with Articles 16 and 17(1) to (4) of Regulation 2016/425 (pre-exit).

(5) Where this paragraph applies—

(a) the requirements in Article 10(2), to ensure that—

(i) the appropriate conformity assessment procedure referred to in Article 19 has been carried out;

(ii) the manufacturer has drawn up the technical documentation;

(iii) the PPE bears the UK marking,

are to be treated as being satisfied; and

(b) the second subparagraph of Article 10(2), Article 10(4), (5) and (8), and regulation 7(1) apply, subject to the modifications in paragraph (8).

(6) Paragraph (7) applies where, before placing PPE on the market, a distributor ensures that the PPE bears the CE marking in accordance with Articles 16 and 17(1) to (4) of Regulation 2016/425 (pre-exit).

(7) Where this paragraph applies—

(a) the requirement for the distributor to verify that the PPE bears the UK marking, referred to in Article 11(2), is to be treated as being satisfied; and

(b) (excluding the requirement mentioned in sub-paragraph (a)), Article 11(2), 11(3) and regulation 7(1) apply, subject to the modifications in paragraph (8).

(8) The modifications referred to in subparagraphs (3)(b), (5)(b) and (7)(b) are that—

(a) any reference to a “declaration of conformity” is to be read as a reference to an EU declaration of conformity, referred to in Article 15 of Regulation 2016/425 (pre-exit);

(b) any reference to point 1.4 of Annex II is to be read as a reference to point 1.4 of Annex II of Regulation 2016/425 (pre-exit);

(c) any reference to “essential health and safety requirements” is to be read as a reference to the essential health and safety requirements referred to in Annex II of Regulation 2016/425 (pre-exit);

(d) any reference to “designated standard” is to be read as a reference to a harmonised standard;

(e) any reference to “technical documentation” is a reference to the technical documentation referred to in Annex III of Regulation 2016/425 (pre-exit);

(f) in regulation 7(1), any reference to a numbered Article is to be read as a reference to the equivalent Article of Regulation 2016/425 (pre-exit).]

Textual Amendments

F1 Regs. 2A, 2B inserted (E.W.S.) (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. 1(4) (as amended by S.I. 2020/676, regs. 1(1), 2, 3); 2020 c. 1, Sch. 5 para. 1(1)