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

Insertion of regulation 39A and Part 2AE+W+S

27.  After regulation 39 insert—

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

39A.—(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” has the meaning given to it in Article 3(16);

(c)“harmonised standard” has the meaning given to it in Article 3(8);

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

(a)ensures that the toy has been designed and manufactured in accordance with the requirements set out in—

(i)in Article 10 (essential safety requirements); and

(ii)Annex II (particular safety requirements);

(b)carries out the safety assessment in accordance with Article 18;

(c)ensures that the relevant conformity assessment procedure has been carried out in accordance with Article 19;

(d)in cases where the manufacturer considers that Article 19(3) applies, ensures that the provisions of Article 20 are complied with;

(e)draws up the technical documentation in accordance with Article 21(1);

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

(g)affixes the CE marking in accordance with Articles 16 and 17;

(h)draws up an EC declaration of conformity, in accordance with Article 15; and

(i)ensures that the EC declaration of conformity is prepared in or translated into English.

(3) Where this paragraph applies—

(a)the requirements of regulations 10 to 15, 16(1) to (2), 17(1) to (4) and 18, are to be treated as being satisfied;

(b)regulations 16(4) to (5), 17(5) and (10), 21, 22, 39 and 44 are to be read subject to the modifications in paragraph (10);

(c)regulations 42 to 44 do not apply; and

(d)regulation 52 does not apply.

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

(a)the relevant conformity assessment procedure that applies to that toy has been carried out in accordance with Article 19;

(b)the manufacturer has drawn up the technical documentation in accordance with Article 21(1); and

(c)the toy bears the CE marking affixed in accordance with Articles 16 and 17.

(5) Where this paragraph applies—

(a)the requirements in regulation 26(a)(i) to (iii) are to be treated as being satisfied; and

(b)regulations 26(1), 28 and 30 to 32 are to be read 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.

(7) Where paragraph (6) applies paragraphs (2)(c) and (4)(a) are to be treated as requiring the manufacturer to carry out the conformity assessment procedure referred to in Article 19(3).

(8) Paragraph (9) applies where before making a toy available on the market, a distributor ensures that the manufacturer has affixed the CE marking in accordance with Articles 16 and 17.

(9) Where this paragraph applies—

(a)regulation 33(3)(a)(i) is to be treated as being satisfied;

(b)regulation 33(2), 34, 35 and 37 are to be read 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 EC 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 requirements set out in—

(i)in Article 10 (essential safety requirements); and

(ii)Annex II (particular safety requirements);

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

(e)any reference to “applicable conformity assessment procedure” is to be read as a reference to the applicable conformity assessment procedures referred to in Article 19;

(f)any reference to “technical documentation” is a reference to the technical documentation referred to in Article 21(1);

(g)any reference to “authorised representative” is a reference to a person appointed in accordance with Article 5; and

(h)any reference to “Type examination” is a reference to “EC-type examination”.

[F1Expiry of regulation 39A

39AA.—(1) Subject to paragraph (2), regulation 39A ceases to have effect at the end of the period of 12 months beginning with IP completion day.

(2) Notwithstanding the expiry of regulation 39A—

(a)any toy which was placed on the market pursuant to regulation 39A may continue to be made available on the market on or after the expiry of regulation 39A;

(b)any obligation to which a person was subject under regulation 39A in respect of a toy placed on the market pursuant to regulation 39A continues to have effect after the expiry of regulation 39A, in respect of that toy.

Qualifying Northern Ireland Goods

39AB.—(1) Where paragraph (2) applies—

(a)a toy is to be treated as being in conformity with the essential safety requirements; and

(b)each relevant economic operator is to be treated as having complied or as complying with the obligations imposed on them under Part 2.

(2) This paragraph applies where—

(a)a toy is—

(i)in conformity with the essential safety requirements, within the meaning of regulation 3 as it applies in Northern Ireland; and

(ii)qualifying Northern Ireland goods;

(b)each relevant economic operator has complied or is complying with the obligations imposed on them under Part 2, as that Part applies in Northern Ireland; and

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

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

(a)complies with regulation 27;

(b)ensures that—

(i)the applicable conformity assessment procedure has been carried out;

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

(iii)the toy bears the CE marking.

(4) In this regulation—

“applicable conformity assessment procedure” means the conformity assessment procedure applicable to the toy under regulation 15, as it applies in Northern Ireland;

“CE marking” has the meaning given to it in regulation 3, 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 technical documentation that a manufacturer has to draw up in accordance with regulation 17, as it applies in Northern Ireland.]

PART 2AE+W+SPowers and duties of the Secretary of State in relation to toys

Power to amend Schedules 1, 2 and 5

39B.—(1) The Secretary of State may by regulations amend the provision of the Schedules referred to in paragraph (2) where the Secretary of State considers it necessary to do so in order to take technical progress and scientific developments into account.

(2) The provisions referred to in paragraph (1) are—

(a)any provision in Schedule 1;

(b)points 11 and 13 of Part 3 of Schedule 2; and

(c)any provision of Schedule 5.

(3) The power to make regulations made under paragraph (1) includes power—

(a)to make different provisions for different cases; and

(b)to make such supplemental, consequential and transitional provisions as the Secretary of State considers appropriate.

(4) Regulations made under this regulation are to be made by statutory instrument subject to annulment in pursuance of a resolution of either House of Parliament.

Power to amend Appendix C to Schedule 2

39C.—(1) The Secretary of State may by regulations amend Appendix C to Schedule 2 to add specific values for chemicals used in toys intended for use by children under 36 months or in other toys intended to be placed in the mouth.

(2) Regulations made under paragraph (1) may—

(a)make different provisions for different cases; and

(b)make such supplemental, consequential and transitional provisions as the Secretary of State considers appropriate.

(3) Regulations made under this regulation are to be made by statutory instrument subject to annulment in pursuance of a resolution of either House of Parliament.

Powers to amend Appendix A to Schedule 2

39D.—(1) Where the conditions set out in paragraph (3)(a) and (b) are met, the Secretary of State may by regulations amend Appendix A to Schedule 2 to allow substances or mixtures classified as carcinogenic, mutagenic or toxic for reproduction of the categories laid down in Section 4 of Appendix B of Schedule 2 to be used in toys, in components of toys or micro-structurally distinct parts of toys.

(2) Where the conditions set out in paragraphs (3)(a), (b) and (c) are met, the Secretary of State may by regulations amend Appendix A to Schedule 2 to allow substances or mixtures classified as carcinogenic, mutagenic or toxic for reproduction of the categories laid down Section 3 of Appendix B of Schedule 2 to be used in toys, in components of toys or micro-structurally distinct parts of toys.

(3) The conditions referred to in paragraphs (1) and (2) are—

(a)the Secretary of State considers that there is sufficient scientific evidence to demonstrate that the use of substances or mixtures that are classified as carcinogenic, mutagenic or toxic for reproduction of the categories laid down in Section 5 of Appendix B to Schedule 2 are safe for use in toys, particularly in view of exposure;

(b)the substance or mixture is not prohibited for use in consumer articles by Regulation (EC) 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) establishing a European Chemicals Agency, amending Directive 19999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/105/EC and 2000/21/EC.

(c)there are no suitable alternative substances or mixtures available, as documented in an analysis of alternatives; and

(4) Regulations made under paragraph (1) or (2) may—

(a)make different provisions for different cases; and

(b)make such supplemental, consequential and transitional provisions as the Secretary of State considers appropriate.

(5) Regulations made under this regulation are to be made by statutory instrument subject to annulment in pursuance of a resolution of either House of Parliament.

(6) The Secretary of State must—

(a)carry out a review of regulations made under paragraph (1) or (2);

(b)set out the conclusions of the review in a report; and

(c)publish the report.

(7) A review to which paragraph (6) refers must be made—

(a)as soon as any safety concerns arise; and

(b)at intervals not exceeding five years beginning with the date regulations made under paragraph (1) or (2) come into force.

Duty of the Secretary of State to evaluate use of hazardous substances

39E.—(1) The Secretary of State must—

(a)evaluate the occurrence of hazardous substances of materials in toys;

(b)set out the conclusions of the evaluation in a report; and

(c)publish the report.

(2) During the evaluation the Secretary of State must consult—

(a)any enforcement authority which is not the Secretary of State; and

(b)any person that the Secretary of State considers appropriate.

(3) The first report must be published before the end of the period of five years beginning on [F2IP completion day].

(4) Subsequent reports are to be published at intervals not exceeding five years.”.