The Product Safety and Metrology etc. (Amendment) Regulations 2024

Type Statutory-Instrument
Publication 2024-05-23
State In force
Department King's Printer of Acts of Parliament
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(36B) (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(18). (2) Subject to paragraphs (4) and (5), paragraph (3) applies where, before placing radio equipment on the market, the manufacturer— (a) ensures that the radio equipment has been designed and manufactured in accordance with the essential requirements set out in Article 3; (b) ensures that the conformity assessment procedure that applies to that radio equipment in accordance with Article 17 has been carried out; (c) draws up the technical documentation in accordance with Article 21; and (d) ensures that the technical documentation and other records and correspondence relating to the conformity assessment procedure are prepared in or translated into English. (3) Where this paragraph applies— (a) regulations 7, 9 and 45 are to be treated as being satisfied; (b) except for regulations 42, 43 and 44(1) to (3), Part 3 does not apply; (c) regulations 2(2)(a), 11, 17, 20, 21(a) and (c), 22, 25, 28, 32, 33, 39, 42, 44 and 63 apply subject to the modifications in paragraph (6); (d) regulation 10 and Schedule 6 apply subject to the modifications in paragraphs (6) and (7); (e) Schedule 7 applies subject to the modification in paragraph (7). (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 17. (5) Where paragraph (4) applies, paragraph (2)(b) is to be treated as requiring the manufacturer, when assessing the compliance with the essential requirements set out in Article 3(2) and (3), to ensure either of the conformity assessment procedures set out in Article 17(4) is carried out. (6) The modifications referred to in paragraph (3)(c) and (d) are that— (a) any reference to the “essential requirements” is to be read as a reference to the essential requirements set out in Article 3; (b) any reference to “designated standard” is to be read as a reference to a harmonised standard; (c) any reference to “relevant conformity assessment procedure” is to be read as a reference to the conformity assessment procedure that applies to that radio equipment in accordance with Article 17; (d) any reference to “technical documentation” is to be read as a reference to the technical documentation referred to in Annex V. (7) The modifications referred to in paragraph (3)(d) and (e) are that— (a) in regulation 10 the references to “enactment” are to be read as including the Directive; (b) in Schedule 6 any reference to “approved body” is to be read as a reference to the conformity assessment body that undertook the relevant conformity assessment procedure in accordance with Article 17; (c) in Schedules 6 and 7 the references to “relevant statutory requirements” are to be read as including the Directive.

  • (5) In regulation 76A, omit paragraphs (4) to (6).
  • (6) In paragraph 7 of Schedule 6 for “notified” substitute “approved”.

Amendment to the Personal Protective Equipment (Enforcement) Regulations 2018 and Regulation (EU) 2016/425

21

  • (1) The Personal Protective Equipment (Enforcement) Regulations 201829 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—

(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/EEC30, omit paragraphs (4) to (6).

Amendment to the Gas Appliances (Enforcement) and Miscellaneous Amendments Regulations 2018 and Regulation (EU) 2016/426

22

  • (1) The Gas Appliances (Enforcement) and Miscellaneous Amendments Regulations 201831 are amended as follows.
  • (2) For regulation 2C substitute—

(2C) (1) In this regulation “harmonised standard” has the meaning given to it in Article 2(23) of Regulation 2016/426 (pre-exit). (2) Paragraph (3) applies where, before placing an appliance or fitting on the market or using an appliance for their own purposes, the manufacturer— (a) ensures that the appliance or fitting has been designed and manufactured in accordance with the essential requirements set out in Annex I to Regulation 2016/426 (pre-exit); (b) carries out the applicable conformity assessment procedure referred to in Article 14 of Regulation 2016/426 (pre-exit) or has it carried out; (c) draws up the technical documentation referred to in Annex III to Regulation 2016/426 (pre-exit); and (d) ensures that the technical documentation and other records and correspondence relating to the conformity assessment procedure are prepared in or translated into English. (3) Where this paragraph applies— (a) Article 7(1) and the first subparagraph of Article 7(2) are to be treated as being satisfied; (b) Articles 13, 14 and 17(3) do not apply; (c) the following provisions of Article 7 apply subject to the modifications in paragraph (4)— (i) Article 7(2), second subparagraph; (ii) Article 7(3); (iii) Article 7(4); (d) Articles 8, 9(2), (4), (5) and (8), 10(2) and (3), 15(1) to (4), 17(4) and 40(1) and Annex V 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 requirements” is to be read as a reference to the essential requirements set out in Annex I to Regulation 2016/426 (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 to Regulation 2016/426 (pre-exit); (d) in Article 7(2), in the second subparagraph the reference to “procedure referred to in the first subparagraph” is to be read as a reference to the applicable conformity assessment procedure referred to in Article 14 of Regulation 2016/426 (pre-exit); (e) any reference to “appropriate conformity assessment procedure” is to be read as a reference to the applicable conformity assessment procedure referred to in Article 14 of Regulation 2016/426 (pre-exit); (f) Article 17(4) is to be read as if the words beginning with “and” and ending with “paragraph 3” were omitted; (g) in Annex 5 the reference to “relevant statutory requirements” is to be read as including Regulation 2016/426 (pre-exit); (h) in paragraph 7 of Annex 5, the reference to “approved body” is to be read as a reference to the conformity assessment body that undertook the conformity assessment procedure in accordance with Article 14 of Regulation 2016/426 (pre-exit).

Transitional provisions

23

  • (1) In this regulation—
  • (a) “enactment” means any enactment amended by regulations 2 to 22;
  • (b) “product” means any product regulated by any enactment;
  • (c) “made available on the market” in relation to a product means supplied to the market of Great Britain in the course of a commercial activity, whether in return for payment or free of charge;
  • (d) “placed on the market” in relation to a product means made available on the market for the first time;
  • (e) “put into service” in relation to a product means used for its intended purpose in Great Britain for the first time.
  • (2) Paragraph (3) applies where a product—
  • (a) was placed on the market or put into service before the commencement of these Regulations; and
  • (b) was in conformity with all enactments applicable to it when it was placed on the market or put into service.
  • (3) Where this paragraph applies—
  • (a) nothing in these Regulations prevents the product from being made available on the market or put into service after the commencement of these Regulations; and
  • (b) any obligation relating to the product to which any person was subject under any enactment immediately before the commencement of these Regulations continues to apply after the commencement of these Regulations.

Signed

Kevin Hollinrake — Minister for Enterprise, Markets and Small Business — Department for Business and Trade — 23rd May 2024

Explanatory note

(This note is not part of the Regulations)

Explanatory Note

These Regulations revoke and replace provisions of the following legislation as they apply in Great Britain (England and Wales and Scotland):

The Noise Emission in the Environment by Equipment for use Outdoors Regulations 2001;

The Supply of Machinery (Safety) Regulations 2008;

The Aerosol Dispensers Regulations 2009;

The Ecodesign for Energy-Related Products Regulations 2010;

The Toys (Safety) Regulations 2011;

The Restriction of the Use of Certain Hazardous Substances in Electrical and Electronic Equipment Regulations 2012;

The Explosives Regulations 2014;

The Pyrotechnic Articles (Safety) Regulations 2015;

The Electromagnetic Compatibility Regulations 2016;

The Simple Pressure Vessels (Safety) Regulations 2016;

The Lifts Regulations 2016;

The Electrical Equipment (Safety) Regulations 2016;

The Pressure Equipment (Safety) Regulations 2016;

The Equipment and Protective Systems Intended for Use in Potentially Explosive Atmospheres Regulations 2016;

The Non-automatic Weighing Instruments Regulations 2016;

The Measuring Instruments Regulations 2016;

The Recreational Craft Regulations 2017;

The Radio Equipment Regulations 2017;

The Personal Protective Equipment (Enforcement) Regulations 2018 and Regulation (EU) 2016/425; and

The Gas Appliances (Enforcement) and Miscellaneous Amendments Regulations 2018 and Regulation (EU) 2016/426.

They also revoke a provision of the Measuring Container Bottles (EEC Requirements) Regulations 1977.

This legislation relates to consumer safety, environmental protection and health and safety and sets out the requirements that products must meet in order to be placed on the market in Great Britain. It is secondary retained EU law within the meaning of section 11(2) of the Retained EU Law (Revocation and Reform) Act 2023 (c. 28).

The amendments made to each of these pieces of legislation revoke provision that sets out the expiry of provisions which themselves allow obligations in the legislation as it applies in Great Britain to be met by complying with requirements of the corresponding EU law. With the exception of the Measuring Container Bottles (EEC Requirements) Regulations 1977, they replace this provision with provision allowing relevant economic operators to meet any conformity assessment or testing requirements in the legislation as it applies in Great Britain by complying with the corresponding EU conformity assessment or testing requirements.

The Regulations also revoke certain transitional measures which are no longer necessary. The Regulations also amend the definition of some of the EU instruments referred to in the Regulations amended, to remove reference to “IP completion day”. In one case the Regulations replace the definition of the EU instrument so that it refers to the EU instrument as last amended in 2023.

Regulation 23 provides that where a product was in conformity with the Regulations that these Regulations amend when it was first supplied to the market of Great Britain, the changes made by these Regulations do not prevent any further supply of the product and that an obligation to which a person was subject in relation to a product prior to the changes made by these Regulation, continues to apply after the commencement of these Regulations.

A full impact assessment of the effect that this instrument will have on the costs of business, the voluntary sector and the public sector is available from the Trade and Investment Negotiations - Goods Team, Department for Business and Trade, Old Admiralty Building, London SW1A 2AY and is also published with the Explanatory Memorandum alongside this Regulations on www.legislation.gov.uk

Footnotes

2

The term “relevant national authority” is defined in section 21(1) of the Retained EU Law (Revocation and Reform) Act 2023.

3

S.I. 1977/932; they were made under section 2(2) of the European Communities Act 1972 and are accordingly saved by virtue of section 2(1) of the European Union (Withdrawal) Act 2018; they were amended in respect of England and Wales and Scotland by S.I. 2019/696, S.I. 2021/1273 and S.I. 2022/1393; there are other amending instruments but none is relevant.

4

S.I. 2001/1701; they were made under section 2(2) of the European Communities Act 1972 (c. 68) and are accordingly saved by virtue of section 2(1) of the European Union (Withdrawal) Act 2018; they were amended in respect of England and Wales and Scotland by S.I. 2019/696, S.I. 2021/1273 and S.I. 2022/1393; there are other amending instruments but none is relevant.

5

S.I. 2008/1597; they were made under section 2(2) of the European Communities Act 1972 and are accordingly saved by virtue of section 2(1) of the European Union (Withdrawal) Act 2018; they were amended in respect of England and Wales and Scotland by S.I. 2019/696, S.I. 2021/1273 and S.I. 2022/1393; there are other amending instruments but none is relevant.

6

S.I. 2009/2824; they were made in part under section 2(2) of the European Communities Act 1972 and are accordingly saved by virtue of section 2(1) of the European Union (Withdrawal) Act 2018; they were amended in respect of England and Wales and Scotland by S.I. 2019/696, S.I. 2021/1273 and S.I. 2022/1393; there are other amending instruments but none is relevant.

7

S.I. 2010/2617; they were made in part under section 2(2) of the European Communities Act 1972 and are accordingly saved by virtue of section 2(1) of the European Union (Withdrawal) Act 2018; they were amended in respect of England and Wales and Scotland by S.I. 2019/539 and S.I. 2022/1393; there are other amending instruments but none is relevant.

8

EUR 813/2013.

9

EUR 2016/426, as amended by S.I. 2021/1273 and S.I. 2022/1393.

10

S.I. 2011/1881; they were made in part under section 2(2) of the European Communities Act 1972 and are accordingly saved by virtue of section 2(1) of the European Union (Withdrawal) Act 2018; they were amended in respect of England and Wales and Scotland by S.I. 2019/696, S.I. 2021/1273, S.I. 2022/1393 and S.I. 2022/659.

11

S.I. 2012/3032; they were made under section 2(2) of the European Communities Act 1972 and are accordingly saved by virtue of section 2(1) of the European Union (Withdrawal) Act 2018 (c. 16); in regulation 2 the definition of “the Directive” was amended by S.I. 2018/942 and 2020/1647; regulation 34A was inserted in respect of England and Wales and Scotland by S.I. 2019/188; regulation 34B was inserted in respect of England and Wales and Scotland by S.I. 2020/1647 and was amended by S.I. 2022/1393; there are other amending instruments but none is relevant.

12

OJ L 174, 1.7.2011, p. 88.

14

S.I. 2014/1638; they were made in part under section 2(2) of the European Communities Act 1972 and are accordingly saved by virtue of section 2(1) of the European Union (Withdrawal) Act 2018; they were amended in respect of England and Wales and Scotland by S.I. 2016/315, S.I. 2019/696, S.I. 2021/1273 and S.I. 2022/1393; there are other amending instruments but none is relevant.

15

S.I. 2015/1553; they were made in part under section 2(2) of the European Communities Act 1972 and are accordingly saved by virtue of section 2(1) of the European Union (Withdrawal) Act 2018; they were amended in respect of England and Wales and Scotland by S.I. 2019/696, S.I. 2021/1273 and S.I. 2022/1393; there are other amending instruments but none is relevant.

16

OJ L 396, 30.12.2006, p. 1. Annex II was substituted by Commission Regulation (EU) 2020/878.

17

S.I. 2016/1091; they were made in part under section 2(2) of the European Communities Act 1972 and are accordingly saved by virtue of section 2(1) of the European Union (Withdrawal) Act 2018; they were amended in respect of England and Wales and Scotland by S.I. 2019/696, S.I. 2021/1273 and S.I. 2022/1393.

18

S.I. 2016/1092; they were made in part under section 2(2) of the European Communities Act 1972 and are accordingly saved by virtue of section 2(1) of the European Union (Withdrawal) Act 2018 (c. 16); they were amended in respect of England and Wales and Scotland by S.I. 2019/696, S.I. 2021/1273 and S.I. 2022/1393; there are other amending instruments but none is relevant.

19

S.I. 2016/1093; they were made in part under section 2(2) of the European Communities Act 1972 and are accordingly saved by virtue of section 2(1) of the European Union (Withdrawal) Act 2018; they were amended in respect of England and Wales and Scotland by S.I. 2019/696, S.I. 2021/1273 and S.I. 2022/1393; there are other amending instruments but none is relevant.

20

S.I. 2016/1101; they were made in part under section 2(2) of the European Communities Act 1972 and are accordingly saved by virtue of section 2(1) of the European Union (Withdrawal) Act 2018; they were amended in respect of England and Wales and Scotland by S.I. 2019/696, S.I. 2021/1273 and S.I. 2022/1393; there are other amending instruments but none is relevant.

21

S.I. 2016/1105; they were made in part under section 2(2) of the European Communities Act 1972 and are accordingly saved by virtue of section 2(1) of the European Union (Withdrawal) Act 2018; they were amended in respect of England and Wales and Scotland by S.I. 2019/696, S.I. 2021/1273 and S.I. 2022/1393; there are other amending instruments but none is relevant.

22

S.I. 2016/1107; they were made in part under section 2(2) of the European Communities Act 1972 and are accordingly saved by virtue of section 2(1) of the European Union (Withdrawal) Act 2018; they were amended in respect of England and Wales and Scotland by S.I. 2019/696, S.I. 2021/1273 and S.I. 2022/1393; there are other amending instruments but none is relevant.

23

S.I. 2016/1152; they were made in part under section 2(2) of the European Communities Act 1972 and are accordingly saved by virtue of section 2(1) of the European Union (Withdrawal) Act 2018; they were amended in respect of England and Wales and Scotland by S.I. 2019/696, S.I. 2021/1273 and S.I. 2022/1393; there are other amending instruments but none is relevant.

24

S.I. 2016/1153; they were made in part under section 2(2) of the European Communities Act 1972 and are accordingly saved by virtue of section 2(1) of the European Union (Withdrawal) Act 2018; they were amended in respect of England and Wales and Scotland by S.I. 2019/696, S.I. 2021/1273 and S.I. 2022/1393; there are other amending instruments but none is relevant.

25

S.I. 2017/737; they were made in part under section 2(2) of the European Communities Act 1972 and are accordingly saved by virtue of section 2(1) of the European Union (Withdrawal) Act 2018; they were amended in respect of England and Wales and Scotland by S.I. 2019/696, S.I. 2021/1273 and S.I. 2022/1393; there are other amending instruments but none is relevant.

26

OJ L 2018, 13.8.2008, p. 82-128.

27

S.I. 2017/1206; they were made in part under section 2(2) of the European Communities Act 1972 and are accordingly saved by virtue of section 2(1) of the European Union (Withdrawal) Act 2018; they were amended in respect of England and Wales and Scotland by S.I. 2019/696, S.I. 2021/1273 and S.I. 2022/1393; there are other amending instruments but none is relevant.

28

OJ L 153, 22.5.2014, p.62, as amended by Regulation (EU) 2018/1139, Directive (EU) 2022/2380 and Commission Delegated Regulation (EU) 2023/1717.

29

S.I. 2018/390; they were made in part under section 2(2) of the European Communities Act 1972 and are accordingly saved by virtue of section 2(1) of the European Union (Withdrawal) Act 2018; they were amended in respect of England and Wales and Scotland by S.I. 2019/696, S.I. 2021/1273 and S.I. 2022/1393; there are other amending instruments but none is relevant.

30

EUR 2016/425, as amended by S.I. 2019/696, S.I. 2021/1273 and S.I. 2022/1393.

31

S.I. 2018/389; they were made in part under section 2(2) of the European Communities Act 1972 and are accordingly saved by virtue of section 2(1) of the European Union (Withdrawal) Act 2018; they were amended in respect of England and Wales and Scotland by S.I. 2019/696, S.I. 2021/1273 and S.I. 2022/1393; there are other amending instruments but none is relevant.

32

EUR 2016/429, as amended by S.I. 2021/1273 and S.I. 2022/1393.

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