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

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Insertion of regulations 38A and 38BE+W+S

This section has no associated Explanatory Memorandum

24.  After regulation 38 insert—

Obligations which are met by complying with obligations in the Directive

38A.(1) In this regulation—

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

(b)CE marking” has the meaning given to it in Article 2(17);

(c)harmonised standard” has the meaning given to it in Article 2(9).

(2) Subject to paragraphs (6) and (7), paragraph (3) applies where, before placing a category A vessel on the market, the manufacturer—

(a)ensures that the vessel has been designed and manufactured in accordance with the essential safety requirements set out in Annex I;

(b)ensures that the relevant conformity assessment procedures that apply to that vessel in accordance with Article 13(1) and (2) have been carried out;

(c)draws up the technical documentation referred to in Annex II;

(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 and the inscriptions, in accordance with Articles 15 and 16(1) to (4);

(f)draws up an EU declaration of conformity, in accordance with Article 14; 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 regulations 4(1), 5, 6(1) to (3) and (5) are to be treated as being satisfied;

(b)regulations 2(5)(a), 6(4), 8, 9(2), 16(2) and 38 apply subject to the modifications in paragraph (10);

(c)Part 3 does not apply; and

(d)regulation 62 does not apply.

(4) Subject to paragraphs (6) and (7), paragraph (5) applies where, before placing a category A vessel on the market, the importer ensures that—

(a)the relevant conformity assessment procedures that apply to that vessel in accordance with Article 13(1) and (2) have been carried out;

(b)the manufacturer has drawn up the technical documentation referred to in Annex II; and

(c)the vessel bears the CE marking and inscriptions referred to in point 1 of Annex III.

(5) Where this paragraph applies—

(a)the requirements of regulation 18(a) to (c) are to be treated as being satisfied; and

(b)regulations 2(5)(a), 19(1), 23 and 26 apply subject to the modifications in paragraph (10).

(6) This paragraph applies 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 12.

(7) Where paragraph (6) applies, paragraphs (2)(b) and (4)(a) are to be treated as requiring the manufacturer to have carried out—

(a)the conformity assessment procedure set out in Article 13(1)(b); and

(b)the relevant conformity assessment procedure that applies to that product in accordance with Article 13(2).

(8) Paragraph (9) applies where, before making a category A vessel available on the market, a distributor ensures that the vessel bears the CE marking and inscriptions referred to in point 1 of Annex III.

(9) Where this paragraph applies—

(a)regulation 29(a)(i) is to be treated as being satisfied; and

(b)regulations 2(5)(a), 30(1) and 32 apply subject to the modifications in paragraph (10).

(10) The modifications referred to in paragraphs (3)(b), (5)(b) and (9)(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;

(c)any reference to “essential safety requirements” is to be read as a reference to the essential safety requirements referred to in Annex I;

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

(e)any reference to “relevant conformity assessment procedure” is to be read as a reference to the conformity assessment procedures that apply to the vessel in accordance with Article 13(1) and (2);

(f)any reference to “technical documentation” is a reference to the technical documentation referred to in Annex II.

Conformity assessment procedure obligation which is met by complying with the Directive

38B.(1) In this regulation—

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

(b)harmonised standard” has the meaning given to it in Article 2(9).

(2) Subject to paragraphs (4) and (5), paragraph (3) applies where, prior to the manufacture of a category A vessel, the manufacturer ensures that the conformity assessment procedure that applies to that vessel in accordance with Article 13(1) has been carried out.

(3) Where this paragraph applies—

(a)regulation 40 is to be treated as being satisfied;

(b)any reference to “relevant conformity assessment procedure” in regulations 5(b), 6(1), 18(a), 38(b) and 43(c) is to be read as including the conformity assessment procedure referred to in Article 13(1); and

(c)any reference to “technical documentation” in regulations 5(a), 8, 18(b) and 26(b) is to be read as including the technical documentation relating to the design of the vessel referred to in Annex II.

(4) This paragraph applies 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 12.

(5) Where paragraph (4) applies, paragraph (2) is to be treated as requiring the manufacturer to have carried out the conformity assessment procedure set out in Article 13(1)(b).

[F1Expiry of regulations 38A and 38B

38C.(1) Subject to paragraph (2), regulation 38A ceases to have effect at the end of the period of 12 months beginning with IP completion day.

(2) Notwithstanding the expiry of regulation 38A—

(a)any vessel which was placed on the market pursuant to regulation 38A may continue to be made available on the market after the expiry of regulation 38A;

(b)any obligation to which a person was subject under regulation 38A in respect of a vessel placed on the market pursuant to regulation 38A continues to have effect after the expiry of regulation 38A, in respect of that vessel.

(3) Subject to paragraph (4), regulation 38B 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 38B in relation to a vessel prior to the expiry of regulation 38B, regulation 38B continues to apply in respect of that vessel where—

(a)the manufacturer arranges for the EU-Type examination certificate and any annexes 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 an EU-Type examination has been carried out in accordance with a conformity assessment procedure set out in point 1 of Annex II of the Directive.

Qualifying Northern Ireland Goods

38D.(1) Where paragraph (2) applies, a vessel is to be treated as being in conformity with Part 2.

(2) This paragraph applies where—

(a)a vessel—

(i)is in conformity with Part 2, as that Part applies in Northern Ireland; and

(ii)is qualifying Northern Ireland goods; and

(b)an importer has complied with the obligations set out in paragraph (3).

(3) The obligations referred to in paragraph (2)(b) are that, before placing the vessel on the market, the importer—

(a)complies with regulation 21;

(b)ensures that—

(i)the relevant conformity assessment procedure has been carried out in relation to the vessel, in accordance with Part 3, as that Part applies in Northern Ireland;

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

(iii)the vessel bears the CE marking.

(4) In this regulation—

CE marking” has the meaning given to it in regulation 2(1), as it applies in 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 paragraph 2(2)(c) of Part 1 of Schedule 2 to these Regulations, as that Schedule applies in Northern Ireland. ].

Textual Amendments

Commencement Information

I1Sch. 21 para. 24 in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1

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