The Product Safety and Metrology etc. (Amendment) Regulations 2024
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Change 1
21 Amendment to the Personal Protective Equipment (Enforcement) Regulations 2018 and Regulation (EU) 2016/425
(1) The Personal Protective Equipment (Enforcement) Regulations 2018 are amended as follows. (2) In regulation 1(2), in the definition of “Regulation 2016/425 (pre-exit)” omit “, as it had effect immediately before IP completion day”. (3) In regulation 2, omit paragraph (5). (4) For regulation 2C substitute— Further use of UK marking 2C (1) In this regulation “harmonised standard” has the meaning given to it 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); and (d) ensures that the technical documentation and other records and correspondence relating to the conformity assessment procedures are prepared in, or translated into, English. (3) Where this paragraph applies— (a) Article 8(1) and the first subparagraph of Article 8(2) are to be treated as being satisfied; (b) Articles 14, 17(3), 18 and 19 do not apply; (c) the following provisions of Article 8 apply subject to the modifications in paragraph (4)— (i) Article 8(2), second subparagraph; (ii) Article 8(3); (iii) Article 8(4); (iv) Article 8(7); (d) Articles 9, 10(2), (5) and (8), 11(2) and (3), 15, 17 and 41 and Annex IX apply subject to the modifications in paragraph (4). (4) The modifications referred to in paragraph (3)(c) and (d) are that— (a) 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); (b) any reference to “designated standard” is to be read as a reference to a harmonised standard; (c) any reference to “technical documentation” is to be read as a reference to the technical documentation referred to in Annex III of Regulation 2016/425 (pre-exit); (d) 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); (e) any reference to “appropriate conformity assessment procedure” or “appropriate procedure” is to be read as a reference to the conformity assessment procedure applicable to the PPE in accordance with Article 19 of Regulation 2016/425 (pre-exit); (f) in Article 15 the references to “enactment” are to be read as including Regulation 2016/425 (pre-exit); (g) Article 17(4) is to be read as if the words beginning with “and” and ending with “body” were omitted; (h) in Annex IX— (i) in paragraph 5 the reference to “relevant statutory requirements” is to be read as including Regulation 2016/425 (pre-exit); (ii) paragraph 7 is to be read as requiring the manufacturer to include the details set out in paragraph 7 of Annex IX to Regulation 2016/425 (pre-exit). . (5) In Article 47 of Regulation (EU) 2016/425 of the European Parliament and of the Council on personal protective equipment and repealing Council Directive 89/686/EEC, omit paragraphs (4) to (6).
21 Amendment to the Personal Protective Equipment (Enforcement) Regulations 2018 and Regulation (EU) 2016/425
(1) The Personal Protective Equipment (Enforcement) Regulations 2018 are amended as follows. (2) In regulation 1(2), in the definition of “Regulation 2016/425 (pre-exit)” omit “, as it had effect immediately before IP completion day”. (3) In regulation 2, omit paragraph (5). (4) For regulation 2C substitute— Further use of UK marking 2C (1) In this regulation “harmonised standard” has the meaning given to it 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); and (d) ensures that the technical documentation and other records and correspondence relating to the conformity assessment procedures are prepared in, or translated into, English. (3) Where this paragraph applies— (a) Article 8(1) and the first subparagraph of Article 8(2) are to be treated as being satisfied; (b) Articles 14, 17(3), 18 and 19 do not apply; (c) the following provisions of Article 8 apply subject to the modifications in paragraph (4)— (i) Article 8(2), second subparagraph; (ii) Article 8(3); (iii) Article 8(4); (iv) Article 8(7); (d) Articles 9, 10(2), (5) and (8), 11(2) and (3), 15, 17 and 41 and Annex IX apply subject to the modifications in paragraph (4). (4) The modifications referred to in paragraph (3)(c) and (d) are that— (a) 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); (b) any reference to “designated standard” is to be read as a reference to a harmonised standard; (c) any reference to “technical documentation” is to be read as a reference to the technical documentation referred to in Annex III of Regulation 2016/425 (pre-exit); (d) 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); (e) any reference to “appropriate conformity assessment procedure” or “appropriate procedure” is to be read as a reference to the conformity assessment procedure applicable to the PPE in accordance with Article 19 of Regulation 2016/425 (pre-exit); (f) in Article 15 the references to “enactment” are to be read as including Regulation 2016/425 (pre-exit); (g) Article 17(4) is to be read as if the words beginning with “and” and ending with “body” were omitted; (h) in Annex IX— (i) in paragraph 5 the reference to “relevant statutory requirements” is to be read as including Regulation 2016/425 (pre-exit); (ii) paragraph 7 is to be read as requiring the manufacturer to include the details set out in paragraph 7 of Annex IX to Regulation 2016/425 (pre-exit). . (5) In Article 47 of Regulation (EU) 2016/425 of the European Parliament and of the Council on personal protective equipment and repealing Council Directive 89/686/EEC, omit paragraphs (4) to (6).
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