The Product Safety and Metrology etc. (Amendment etc.) (UK(NI) Indication) (EU Exit) Regulations 2020

24.—(1) Schedule 35 (personal protective equipment) is amended as follows. U.K.

(2) In paragraph 1(4), in the inserted text, after the inserted regulation 2B, insert—

“Expiry of regulations 2A and 2B

2C.— (1) Subject to paragraph (2), regulation 2A ceases to have effect at the end of the period of 12 months beginning with IP completion day.

(2) Notwithstanding the expiry of regulation 2A—

(a) any PPE which was placed on the market pursuant to regulation 2A may continue to be made available on the market on or after the expiry of regulation 2A;

(b) any obligation to which a person was subject under regulation 2A in respect of PPE placed on the market pursuant to regulation 2A continues to have effect after the expiry of regulation 2A, in respect of that PPE.

(3) Subject to paragraph (4), regulation 2B ceases to have effect at the end of the period of 12 months beginning with IP completion day.

(4) Where a conformity assessment procedure has been completed pursuant to regulation 2B in relation to a product prior to the expiry of regulation 2B, regulation 2B continues to apply in respect of that product where—

(a) the manufacturer arranges for the EU-Type examination certificate and any annexes to that certificate to be transferred to an approved body;

(b) the approved body referred to in sub-paragraph (a) accepts responsibility for the EU-Type examination certificate; and

(c) the approved body issues a Type-examination certificate relying, or relying in part, on any examinations or tests undertaken prior to the issue of the EU-Type examination certificate.

(5) In paragraph (4) “EU-Type examination certificate” means a certificate issued after the conformity assessment procedure referred to in regulation 2B(1)(b) has been carried out in relation to that PPE, in accordance with Article 19(b) or (c) of Regulation 2016/425 (pre-exit).

Qualifying Northern Ireland Goods

2D.— (1) In this regulation—

“EU Regulation 2016/425 (Northern Ireland)” means Regulation (EU) No. 2016/425 of March 2016 of March 2016 of the European Parliament and of the Council on personal protective equipment, repealing Council Directive 89/686/EEC, as it has effect by virtue of the Protocol on Ireland/Northern Ireland in the EU withdrawal agreement;

“applicable conformity assessment procedure” means the conformity assessment procedure applicable to the PPE in accordance with Article 19 of EU Regulation 2016/245 (Northern Ireland);

“CE marking” has the meaning given to it in Article 3(18) of EU Regulation 2016/425 (Northern Ireland);

“qualifying Northern Ireland goods” has the meaning given to it in regulations made under section 8C(6) of the European Union (Withdrawal) Act 2018;

“technical documentation” means the documentation referred to in Annex III of Regulation 2016/425 (Northern Ireland).

(2) Where paragraph (3) applies—

(a) PPE is to be treated as being in conformity with the essential safety requirements within the meaning given in EU Regulation 2016/425; and

(b) each relevant economic operator is to be treated as having complied or as complying with the obligations imposed on them under Chapter II of EU Regulation 2016/425.

(3) This paragraph applies where—

(a) PPE is—

(i) in conformity with the essential requirements within the meaning given in EU Regulation 2016/245 (Northern Ireland); and

(ii) qualifying Northern Ireland goods; and

(b) each relevant economic operator has complied or is complying with the obligations imposed on them under Chapter II of EU Regulation 2016/425 (Northern Ireland); and

(c) an importer has complied with the obligations set out in paragraph (4).

(4) The obligations referred to in paragraph (3)(c) are that, before placing the PPE on the market, the importer—

(a) complies with Article 10(3) of EU Regulation 2016/425;

(b) ensures that—

(i) the applicable conformity assessment procedure has been carried out in relation to the PPE;

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

(iii) the PPE bears the CE marking.”.

(3) Omit paragraph 2(5), (6), (8), (11) and (13).

(4) For paragraph 3(4)(a) substitute—

“(a) in points (2) and (3) for “Union market” substitute “ market of Great Britain ”;”.

(5) In paragraph 3(4)(c) for the substituted definition of “ importer ” substitute—

“importer” means a person who—

(a) is established in the United Kingdom and places PPE from a country outside of the United Kingdom on the market; or

(b) is established in Northern Ireland and places PPE on the market that has been supplied to them for distribution, consumption or use in the course of a commercial activity, whether in return for payment or free of charge, from an EEA state;”.

(6) In paragraph 3(16) before paragraph (a) insert—

“(aa) before paragraph 1 insert—

“A1.   Paragraph 1 is subject to paragraph 1A.”;

(ab) after paragraph 1 insert—

“1A.   For a period of 24 months beginning with IP completion day, paragraph 1 does not apply where the UK marking is affixed to—

(a) a label affixed to the PPE; or

(b) a document accompanying the PPE.”;”.

Commencement Information

I1 Sch. 3 para. 24 in force at 31.12.2020 immediately before IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1(4)