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

Insertion of regulation 32A

19.  After regulation 32 insert—

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

32A.— (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(19);

(c) “Module B” means the conformity assessment procedure set out in point 1 of Annex II;

(d) “EU-type examination certificate” means an EU-type examination certificate issued in accordance with Module B;

(e) “harmonised standard” has the meaning given to it in Article 2(11).

(2) Paragraph (3) applies where, before placing a non-automatic weighing instrument on the market, the manufacturer—

(a) ensures that the non-automatic weighing instrument has been designed and manufactured in accordance with the essential requirements set out in Annex I;

(b) ensures that the relevant conformity assessment procedures that apply to that non-automatic weighing instrument in accordance with Article 13 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 the CE marking and the supplementary metrology marking, in accordance with Articles 16 and 17(1) to (5);

(f) affixes the inscriptions provided for in points 1 or 2 of Annex III in accordance with Article 6(5);

(g) affixes where required in accordance with Article 6(5) the restrictive use symbol as provided for in Article 18 and in point 3 of Annex III;

(h) draws up an EU declaration of conformity, in accordance with Article 14; and

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

(3) Where this paragraph applies—

(a) the requirements of regulations 6, 9(3) and (4), 41 and 45(2) are to be treated as being satisfied;

(b) regulations 7, 8(2), 44, 63(1)(a) to (e), 67, 68 and 71 apply subject to the modifications in paragraph (8); and

(c) Regulations 34 to 36 do not apply.

(4) Paragraph (5) applies where, before placing a regulated non-automatic weighing instrument on the market, the importer ensures that—

(a) the relevant conformity assessment procedure referred to in Article 13 has been carried out;

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

(c) the non-automatic weighing instrument bears the CE marking and supplementary metrology marking in accordance with Articles 16 and 17(1) to (5).

(5) Where this paragraph applies—

(a) the requirements of regulation 16(2)(a) to (c) are to be treated as being satisfied; and

(b) regulations 23, 63(1)(a) to (e), 67 and 68 apply subject to the modifications in paragraph (8).

(6) Paragraph (7) applies where, before making a regulated non-automatic weighing instrument available on the market, a distributor ensures that the non-automatic weighing instrument bears the CE marking and the inscriptions referred to in point 1 of Annex III.

(7) Where this paragraph applies—

(a) regulation 27(1) is to be treated as being satisfied; and

(b) regulations 28(1), 28(2), 29, 63(1)(a), 63(1)(b), 67, 68 and 71 apply subject to the modifications in paragraph (8).

(8) The modifications referred to in sub-paragraphs (3)(b), (5)(b) and (7)(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 “designated standard” is to be read as a reference to a harmonised standard;

(d) any reference to “relevant conformity assessment procedure” is to be read as a reference to the relevant conformity assessment procedures referred to in Article 13;

(e) any reference to “technical documentation” is to be read as a reference to the technical documentation referred to in Annex II;

(f) any reference to “type examination certificate” is to be read as a reference to an EU-type examination certificate;

(g) any reference to “M marking” is to be read as a reference to the supplementary metrology marking;

(h) any reference to “approved body” is to be read as a reference to the body that undertook any conformity assessment procedure in accordance with Article 13;

(i) any reference to “authorised mark” includes the CE marking and the supplementary metrology marking.

Conformity assessment procedure obligations that are met by complying with the Directive

32B.— (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) “EU-type examination certificate” means an EU-type examination certificate issued in accordance with the conformity assessment procedure set out in point 1 of Annex II (Module B);

(c) any reference to “the first stage of the conformity assessment procedure” is a reference to one or both of the following—

(i) all examinations and tests which are not gravity dependent and which are included in the conformity assessment procedures set out in points 2 to 5 of Annex II;

(ii) the examinations and tests included in the conformity assessment procedures set out in points 2 to 5 of Annex II that may be carried out at the manufacturer’s works or any other location where—

(aa) the transport of the instrument to its place of use requires dismantling of the instrument; or

(bb) the putting into service of the instrument in its place of use requires assembly of the instrument or other technical installation work that is likely to affect the instrument’s performance.

(2) Paragraph (3) applies where, prior to the manufacture of a non-automatic weighing instrument the manufacturer has ensured that the conformity assessment procedure as set out in point 1 of Annex II (Module B) has been carried out.

(3) Where this paragraph applies—

(a) the reference in regulation 36(a) to “Module B as set out in point 1 of Schedule 7” is to be read as a reference to the conformity assessment procedure as set out in point 1 of Annex II (Module B); and

(b) regulations 6(b) and (c), 7, 16(2)(a) and (b), 63(1)(e), 67(2)(b), 68(4)(b) and paragraph 1 of Schedule 1 apply subject to the modifications in paragraph (6).

(4) Paragraph (5) applies where—

(a) in accordance with point 7.1 of Annex II, the procedures set out in points 2 to 5 of that Annex may be carried out in two stages; and

(b) the first stage of the conformity assessment procedure is carried out in accordance with any of the following points of Annex II—

(i) point 2 (Module D);

(ii) point 3 (Module D1);

(iii) point 4 (Module F); or

(iv) point 5 (Module F1).

(5) Where this paragraph applies—

(a) the reference in regulation 36(1)(a)(i) to “Module D as set out in point of Schedule 7” is to be read as including the first stage of the conformity assessment procedure as set out in point 2 of Annex II (Module D);

(b) the reference in regulation 36(1)(a)(ii) to “Module F as set out in point 4 of Schedule 7” is to be read as including the first stage of the conformity assessment procedure as set out in point 4 of Annex II (Module F);

(c) the reference in regulation 36(3)(a) to “Module D1 as set out in point 3 of Schedule 7” is to be read as including the first stage of the conformity assessment procedure as set out in point 3 of Annex II (Module D1);

(d) the reference in regulation 36(3)(b) to “Module F1 as set out in point 5 of Schedule 7” is to be read as including the first stage of the conformity assessment procedure as set out in point 5 of Annex II (Module F1);

(e) regulations 6(b) and (c), 7, 16(2)(a) and (b), 45(6) and (7), 63(1)(c) and (e) and 67(1)(c) apply subject to the modifications in paragraph (6).

(6) The modifications referred to in paragraphs (3)(b) and (5)(e) are that—

(a) any reference to “relevant conformity assessment procedure” is to be read as including—

(i) where paragraph (3) applies, the conformity assessment procedure set out in point 1 of Annex II;

(ii) where paragraph (5) applies, the relevant first stage conformity assessment procedure;

(b) any reference to “type examination” is to be read as a reference to the EU-Type examination certificate;

(c) any reference to “technical documentation” is to be read as including the technical documentation required by points 1 to 5 of Annex II (as applicable);

(d) any reference to “approved body” is to be read as including the body which undertook the first stage conformity assessment procedure.”.