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

(1) Where the Secretary of State considers it necessary to do so to take technical progress into account, the Secretary of State may by regulations amend— (a) point (k) of Article 2(1) (nanomaterials); (b) paragraphs 1, 2 and 6 to 12 of Article 13 (notification) to add requirements; or (c) paragraphs 3, 4 and 11 to 13 of Article 16 (nanomaterials) to add requirements. (2) The Secretary of State may by regulations amend paragraph 3 of Article 2(2) to reflect any changes in the name or structure of the recognised standardisation bodies. (3) Where the conditions in paragraph 4 are met, the Secretary of State may by regulations amend Article 16(1) to extend the provisions of Article 16 to nanomaterials used as colourants, UV-filters or preservatives that are regulated under Article 14. (4) The conditions referred to in paragraph 3 are that the Secretary of State considers that it is necessary to do so in view of— (a) safety concerns raised by a competent authority; or (b) scientific or technical evidence that there are safety concerns relating to colourants, UV filters or preservatives regulated under Article 14. (5) The Secretary of State may amend Article 14(1)(c) to extend its scope to hair colouring products. (1) The Secretary of State may by regulations amend— (a) Annex 1 where the Secretary of State considers there is sufficient scientific evidence that it is necessary to do so to ensure the safety of cosmetic products; (b) Annexes 2 to 6 where the Secretary of State considers that there is sufficient scientific evidence that there is a potential risk to human health arising from the use of a substance in a cosmetic product; (c) Annexes 2 or 3 where the Secretary of State considers that there is insufficient data to be able to determine whether there is a potential risk to human health; (d) Annexes 3 to 6 and 8 where the Secretary of State considers that there is sufficient scientific evidence that it is necessary to do so to take technical progress into account; (e) Annex 4 to extend its scope to hair colouring products. (f) Annex 2 to add a substance classified as a CMR substance of category 1A, 1B or 2 under Regulation (EC) No 1272/2008; (g) Annexes 3 to 6— (i) to allow a substance classified as a CMR substance of category 2 under Regulation (EC) No 1272/2008 to be used in cosmetic products where the Secretary of State considers that there is sufficient scientific evidence that the substance is safe for use in cosmetic products; (ii) to allow a substance classified as a CMR substance of category 1A or 1B under Regulation (EC) No 1272/2008 to be used in cosmetic products where the conditions in point (h) are met; (iii) to make provision as to labelling in order to implement Article 15(2); (h) the conditions referred to in point (g)(ii) are that— (i) the CMR substance complies with the food safety requirements as defined in Regulation (EC) No 178/2002 of the European Parliament and of the Council of January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety; (ii) an analysis of alternative substances has been undertaken and concluded that there are no suitable alternative substances available; (iii) an application to the Secretary of State is made for a particular use of the product category with a known exposure; (iv) the Secretary of State considers that there is sufficient scientific evidence that the CMR substance has been evaluated and found safe for use in cosmetic products; and (v) the evaluation referred to in point (iv) took into account exposure to the product and overall exposure to the CMR substance from other sources, particularly for vulnerable population groups (1) Regulations made under Articles 30 or 31 may— (a) make different provisions for different cases; and (b) make such supplementary, transitional, transitory, consequential or saving provision as the Secretary of State considers appropriate. (3) Regulations made under Articles 30 or 31 are to be made by statutory instrument subject to annulment in pursuance of a resolution of either House of Parliament. (1) The Secretary of State must establish and operate a database containing information relating to cosmetic products which have been made available on the market. (2) The Secretary of State must publish guidance to enable undertakings to comply with the requirements in Annex 1. (3) Before publishing guidance referred to in paragraph 1, the Secretary of State must— (a) consult such persons as the Secretary of State considers have an interest in the guidance; (b) consider how the guidance can be made accessible to business with fewer than 250 members of staff. (4) The Secretary of State must publish the reference to a glossary of common ingredient names and the glossary must be easily accessible and free to use .

Amendment to the Preamble to Annexes 2 to 6

28

In paragraph 2, after “1907/2006” insert “ of the European Parliament and of the Council on the Registration, Evaluation, Authorisation and Restrictions of Chemicals establishing a European Chemicals Agency, amending Directive 1999/45/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, 93/67/EEC, 93/105/EC and 2000/21/EC ”.

PART 3 — Amendment of the Cosmetic Products Enforcement Regulations 2013

29

The Cosmetic Products Enforcement Regulations 2013 are amended in accordance with paragraphs 30 to 40.

Amendment to regulation 2

30

In regulation 2 (interpretation)—

• (a) in the definition of “the EU Cosmetics Regulation” omit “EU”;

• (b) in the definition of “officer” omit “EU”;

• (c) omit paragraph (2);

• (d) in paragraph (3) omit “EU” in both places in which it occurs.

Amendment to regulation 3

31

In regulation 3 (revocation and savings)—

• (a) in paragraph (2)(a) after “apply” insert “ subject to the modification in paragraph 3, ”;

• (b) in paragraph (2)(b) omit “EU”;

• (c) after paragraph (2)(b) insert—

(c) enforcement authorities must keep information received under regulations 17 or 19 of the 2008 Regulations until 11th July 2020; (d) a responsible person under those Regulations must keep the information collected under regulation 16 of those Regulations until 11th July 2020.

• (d) after paragraph (2) insert—

(3) The modification referred to in paragraph (2)(a) is that any reference to “EEA” is to be read as including the United Kingdom.

Insertion of regulation 3A

32

After regulation 3, insert—

(3A) (1) In this regulation— - “pre-exit period” means the period beginning with 11 July 2013 and ending immediately before IP completion day; - “product” means a cosmetic product to which these Regulations apply. (2) Subject to paragraph (3), where a product was made available on the market during the pre-exit period, despite the amendments made by Schedule 34 to the Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019 — (a) any obligation to which a person was subject and was enforced under these Regulations as they had effect immediately before IP completion day, continues to have effect as it did immediately before IP completion day, in relation to that product; and (b) enforcement authorities continue to be under an obligation to enforce the obligations referred to in paragraph (a). (3) Paragraph (2) does not apply to— (a) any obligation of any competent authority to inform the European Commission or the member States of any matter; or (b) any obligation to take action outside of the United Kingdom in respect of that product.

Amendment to regulation 4

33

In regulation 4 (competent authority)—

• (a) in paragraph (1)—

• (i) omit “Subject to paragraph (2)”; and

• (ii) omit “EU”;

• (b) omit paragraph (2);

• (c) in paragraph (3) omit “Notwithstanding paragraph (2),”.

Amendment to regulations 5 to 8 and 10

34

In regulations 5 to 8 and 10 each place in which it occurs and in the heading to regulation 8 omit “EU”.

Omission of regulation 9

35

Omit regulation 9.

Amendment to regulation 10

36

In regulation 10 (notification to the Secretary of State) omit the words from “,which is required” to “member States”.

Amendment to regulation 11

37

In regulation 11 for “regulation 9” substitute “ Article 27(2) of the Cosmetics Regulation ”.

Amendment to regulations 12 to 15, 17, 19 to 21

38

In regulations 12 to 15, 17 and 19 to 21 in each place in which it occurs omit “EU”.

Amendment to regulation 26

39

In regulation 26 in paragraphs (1) and (3) after “these Regulations” insert “ and the Cosmetic Regulation ”.

Amendment to Schedule 3

40

In Schedule 3 (sampling and testing) omit “EU” in each place in which it occurs.

PART 4 — Amendment to EU tertiary legislation

Amendment to Commission Regulation (EU) No 655/2013

41

Commission Regulation (EU) No 655/2013 of 10 July 2013 laying down common criteria for the justification of claims used in relation to cosmetic products is amended in accordance with paragraphs 42 and 43.

Amendment to Article 2

42

In Article 2—

• (a) in the first place in which it occurs, after “1223/2009” insert “of the European Parliament and of the Council of 30 November 2009 on cosmetic products (recast);

• (b) in the second place in which it occurs for “Regulation (EC) No 1223/2009” substitute “ that Regulation ”.

Amendment to the Annex

43

In the Annex—

• (a) in paragraph 1(1) for “within the Union” substitute “ within the meaning of regulation 4 of the Cosmetic Products Enforcement Regulations 2013 or under Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30 November 2009 on cosmetic products (recast) (as it has effect in EU law) ”;

• (b) in paragraph 6(3) for “relevant Member States” substitute “ the United Kingdom or relevant parts of the United Kingdom ”.

SCHEDULE 35 — Amendment of Regulation (EU) 2016/425 and the Personal Protective Equipment (Enforcement) Regulations 2018

PART 1 — Amendment of subordinate legislation

Amendment of the Personal Protective Equipment (Enforcement) Regulations 2018

1

• (1) The Personal Protective Equipment (Enforcement) Regulations 2018 are amended as follows.

• (2) In regulation 1—

• (a) in paragraph (2), at the appropriate place, insert the following definition—

• “Regulation 2016/425 (pre-exit)” means Regulation (EU) 2016/425 of the European Parliament and of the Council on personal protective equipment and repealing Council Directive 89/686/EEC, as it had effect immediately before IP completion day;
• ...

• (b) in paragraph (3)—

• (i) after “In these Regulations”, insert “ (unless otherwise stated) ”;

• (ii) in sub-paragraph (a), omit “unless otherwise stated”;

• (iii) in sub-paragraph (b), after “paragraph of an Article” in both places insert “ , Chapter ”;

• (c) in paragraph (4), after “EU Regulation 2016/425” in the second place it occurs, insert “ unless otherwise stated ”.

• (3) In regulation 2—

• (a) at the beginning of paragraph (4) insert “ Subject to the modifications made in paragraph (4A), ”

• (b) after paragraph (4), insert—

(4A) The modifications referred to in paragraph (4) are as follows— (a) any reference to “Community” is to be read as including the United Kingdom; (b) any reference to “Member State” is to be read as including the United Kingdom; (c) in Schedule 7— (i) in paragraph 5— (aa) omit from “The Commission” to “conducted”; (bb) before “file shall be held” insert “ manufacturer's technical ”; (ii) in paragraph 6, omit from “An inspection body” to the end; (d) in Schedule 10, in paragraph 2, omit from “with a view” to “the Commission

• (c) in paragraph (5), at the end, insert “ of Regulation 2016/425 (pre-exit) or a declaration of conformity set out in paragraphs 7 or 8 of Annex IX ”;

• (d) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

• (e) in paragraph (6), for “(4) and (5)” substitute “ (4) to (5) ”.

• (4) After regulation 2, insert—

(2A) (1) In this regulation, “harmonised standard” has the meaning 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); (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 in accordance with Articles 16 and 17(1) to (4) of Regulation 2016/425 (pre-exit); (f) draws up an EU declaration of conformity, in accordance with Article 15 of Regulation 2016/425 (pre-exit); 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 Articles 8(1) and (2), 15, 16, 17 and 19 are to be treated as being satisfied; (b) Articles 8(3), (4), (7) and (8), 9(2) and regulation 7(1) apply, subject to the modifications in paragraph (8); (c) Article 41 does not apply. (4) Paragraph (5) applies, where before placing PPE on the market, the importer ensures that— (a) the applicable conformity assessment procedure referred to in Article 19 of Regulation 2016/425 (pre-exit) has been carried out; (b) the manufacturer has drawn up the technical documentation referred to in Annex III of Regulation 2016/425 (pre-exit); and (c) the PPE bears the CE marking in accordance with Articles 16 and 17(1) to (4) of Regulation 2016/425 (pre-exit). (5) Where this paragraph applies— (a) the requirements in Article 10(2), to ensure that— (i) the appropriate conformity assessment procedure referred to in Article 19 has been carried out; (ii) the manufacturer has drawn up the technical documentation; (iii) the PPE bears the UK marking, are to be treated as being satisfied; and (b) the second subparagraph of Article 10(2), Article 10(4), (5) and (8), and regulation 7(1) apply, subject to the modifications in paragraph (8). (6) Paragraph (7) applies where, before placing PPE on the market, a distributor ensures that the PPE bears the CE marking in accordance with Articles 16 and 17(1) to (4) of Regulation 2016/425 (pre-exit). (7) Where this paragraph applies— (a) the requirement for the distributor to verify that the PPE bears the UK marking, referred to in Article 11(2), is to be treated as being satisfied; and (b) (excluding the requirement mentioned in sub-paragraph (a)), Article 11(2), 11(3) and regulation 7(1) apply, subject to the modifications in paragraph (8). (8) The modifications referred to in subparagraphs (3)(b), (5)(b) and (7)(b) are that— (a) any reference to a “declaration of conformity” is to be read as a reference to an EU declaration of conformity, referred to in Article 15 of Regulation 2016/425 (pre-exit); (b) 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); (c) 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); (d) any reference to “designated standard” is to be read as a reference to a harmonised standard; (e) any reference to “technical documentation” is a reference to the technical documentation referred to in Annex III of Regulation 2016/425 (pre-exit); (f) in regulation 7(1), any reference to a numbered Article is to be read as a reference to the equivalent Article of Regulation 2016/425 (pre-exit). (2B) (1) Paragraph (2) applies where— (a) PPE is classified under Article 18 of Regulation 2016/425 (pre-exit) as falling within risk category II or risk category III, as set out in Annex I to Regulation 2016/425 (pre-exit); and (b) prior to manufacture of that PPE, the manufacturer ensures that the conformity assessment procedure set out in Annex V to Regulation 2016/425 (pre-exit), and referred to in Article 19(b) and (c) of Regulation 2016/425 (pre-exit) as EU type-examination, has been carried out in accordance with Article 19(b) or (c). (2) Where this paragraph applies— (a) the requirement in Article 19(b) or (c) to follow the conformity assessment procedure referred to in those provisions as type-examination, and set out in Annex V, is to be treated as being satisfied; (b) any reference to “conformity assessment procedure” in Articles 8(2) and 10(2) is to be read as including the conformity assessment procedure referred to in Article 19(b) and (c) of Regulation 2016/425 (pre-exit) as EU type-examination; (c) any reference to “technical documentation” in Articles 8(2), 8(3), 10(2) and 10(8) is to be read as including the technical documentation relating to the design of the PPE as referred to in Annex V to Regulation 2016/425 (pre-exit). (2C) (1) Subject to paragraph (2), regulation 2A ceases to have effect at the end of the period of 12 months beginning with IP completion day. (2) Notwithstanding the expiry of regulation 2A— (a) any PPE which was placed on the market pursuant to regulation 2A may continue to be made available on the market on or after the expiry of regulation 2A; (b) any obligation to which a person was subject under regulation 2A in respect of PPE placed on the market pursuant to regulation 2A continues to have effect after the expiry of regulation 2A, in respect of that PPE. (3) Subject to paragraph (4), regulation 2B 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 2B in relation to a product prior to the expiry of regulation 2B, regulation 2B continues to apply in respect of that product where— (a) the manufacturer arranges for the EU-Type examination certificate and any annexes to that certificate 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 the conformity assessment procedure referred to in regulation 2B(1)(b) has been carried out in relation to that PPE, in accordance with Article 19(b) or (c) of Regulation 2016/425 (pre-exit). (2D) (1) In this regulation— - “EU Regulation 2016/425 (Northern Ireland)” means Regulation (EU) No. 2016/425 of March 2016 of March 2016 of the European Parliament and of the Council on personal protective equipment, repealing Council Directive 89/686/EEC, as it has effect by virtue of the Protocol on Ireland/Northern Ireland in the EU withdrawal agreement; - “applicable conformity assessment procedure” means the conformity assessment procedure applicable to the PPE in accordance with Article 19 of EU Regulation 2016/245 (Northern Ireland); - “CE marking” has the meaning given to it in Article 3(18) of EU Regulation 2016/425 (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 Annex III of Regulation 2016/425 (Northern Ireland). (2) Where paragraph (3) applies— (a) PPE is to be treated as being in conformity with the essential safety requirements within the meaning given in EU Regulation 2016/425; and (b) each relevant economic operator is to be treated as having complied or as complying with the obligations imposed on them under Chapter II of EU Regulation 2016/425. (3) This paragraph applies where— (a) PPE is— (i) in conformity with the essential requirements within the meaning given in EU Regulation 2016/245 (Northern Ireland); and (ii) qualifying Northern Ireland goods; and (b) each relevant economic operator has complied or is complying with the obligations imposed on them under Chapter II of EU Regulation 2016/425 (Northern Ireland); and (c) an importer has complied with the obligations set out in paragraph (4). (4) The obligations referred to in paragraph (3)(c) are that, before placing the PPE on the market, the importer— (a) complies with Article 10(3) of EU Regulation 2016/425; (b) ensures that— (i) the applicable conformity assessment procedure has been carried out in relation to the PPE; (ii) the manufacturer has drawn up the technical documentation; and (iii) the PPE bears the CE marking.

• (5) In regulation 6, for the words from “or other matter within its knowledge” to the end, substitute “ in accordance with Chapter 6 ”.

• (6) In regulation 7(1), in both places, for “CE” substitute “ UK ”.

• (7) In regulation 12(1), omit “at national level”.

• (8) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

• (9) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Consequential amendments to subordinate legislation

2

• (1) The following consequential amendments are made to subordinate legislation.

• (2) In the Personal Protective Equipment at Work Regulations 1992 , in regulation 4(5)(b), omit “(OJ No L81, 31.3.2016, p51)”.

• (3) In the Control of Lead at Work Regulations 2002 , in regulation 6(11), omit “(OJ No L81, 31.3.2016, p51)”.

• (4) In the Control of Substances Hazardous to Health Regulations 2002 , in regulation 7(12), omit “(OJ No L81, 31.3.2016, p51)”.

• (5) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

• (6) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

• (7) In the Control of Noise at Work Regulations 2005 , in regulation 7(5), omit “(OJ No L81, 31.3.2016, p51)”.

• (8) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

• (9) In Schedule 5B to the REACH Enforcement Regulations 2008 , in paragraph 5, omit “(OJ No L81, 31.3.2016, p51)”.

• (10) In the Control of Asbestos Regulations 2012 , in regulation 11(6), omit “(OJ No L81, 31.3.2016, p51)”.

• (11) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

• (12) In the Ionising Radiations Regulations 2017 , in regulation 10(3), omit “(OJ No L81, 31.3.2016, p51)”.

• (13) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

PART 2 — Amendment of retained direct EU legislation

Amendment of Regulation (EU) 2016/425

3

• (1) Regulation (EU) 2016/425 of the European Parliament and of the Council on personal protective equipment and repealing Council Directive 89/686/EEC is amended as follows.

• (2) In Article 1—

• (a) for “on the free movement of” substitute “ concerning ”;

• (b) for “Union” substitute “ United Kingdom ”.

• (3) In Article 2(2)(d), for “Member States” substitute “ the United Kingdom ”.

• (4) In Article 3—

• (a) in points (2) and (3) for “Union market” substitute “ market of Great Britain ”;

• (b) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

• (c) for point (6), substitute—

(6) importer” means a person who— (a) is established in the United Kingdom and places PPE from a country outside of the United Kingdom on the market; or (b) is established in Northern Ireland and places PPE on the market that has been supplied to them for distribution, consumption or use in the course of a commercial activity, whether in return for payment or free of charge, from an EEA state;

• (d) omit points (10) to (12), and (17) and (18);

• (e) at the end, insert—

(19) ‘approved body’ has the meaning given in Article 20; (20) ‘designated standard’ has the meaning given in Article 7A; (21) ‘enforcement authority’ means a person enforcing this Regulation under regulation 4 of the Personal Protective Equipment (Enforcement) Regulations 2018 (S.I. 2018/390); (22) ‘UK Marking’ means the marking in the form set out in Annex 2 of Regulation (EC) 765/2008 of the European Parliament and of the Council setting out the requirements for accreditation and market surveillance relating to the marketing of products, and repealing Regulation (EEC) 339/93; (23) ‘UK national accreditation body’ means the body appointed by the Secretary of State in accordance with Article 4 of Regulation (EC) 765/2008 of the European Parliament and of the Council setting out the requirements for accreditation and market surveillance relating to the marketing of products, and repealing Regulation (EEC) 339/93; (24) ‘Regulation 2016/425 (pre-exit)’ means Regulation (EU) 2016/425 of the European Parliament and of the Council on personal protective equipment and repealing Council Directive 89/686/EEC, as it had effect immediately before IP completion day; (25) In this Regulation, references to “the market surveillance authority” are to be construed in accordance with regulation 3 of the Personal Protective Equipment (Enforcement) Regulations 2018.

• (5) Omit Article 6.

• (6) In Article 7—

• (a) for the heading, substitute— “ Making available, putting into service and exhibition at trade fairs, etc ”;

• (b) in paragraph 1, for “Member States shall not impede” substitute “ Nothing in this Regulation impedes ”;

• (c) in paragraph 2, for “Member States shall not prevent” substitute “ nothing in this Regulation prevents ”.

• (7) After Article 7, insert—

(1) Subject to paragraphs 6 and 7, in this Regulation, a “designated standard” means a technical specification which is— (a) adopted by a recognised standardisation body, for repeated or continuous application, with which compliance is not compulsory; and (b) designated by the Secretary of State, by publishing the reference to the standard and maintaining that publication in a manner the Secretary of State considers appropriate. (2) For the purposes of paragraph 1, “technical specification” means a document that prescribes technical requirements to be fulfilled by a product, process, service or system and which lays down one or more of the following— (a) the characteristics required of a product, including— (i) levels of quality, performance, interoperability, environmental protection, health, safety or dimensions; and (ii) the requirements applicable to the product as regards the name under which the product is sold, terminology, symbols, testing and test methods, packaging, marking or labelling and conformity assessment procedures; (b) production methods and processes relating to the product, where these have an effect on the characteristics of the product. (3) For the purposes of this Article, a “recognised standardisation body” means any one of the following organisations— (a) the European Committee for Standardisation (CEN); (b) the European Committee for Electrotechnical Standardisation (Cenelec); (c) the European Telecommunications Standards Institute (ETSI); (d) the British Standards Institution (BSI). (4) When considering whether the manner of publication of a reference is appropriate in accordance with paragraph 1(b), the Secretary of State must have regard to whether the publication will draw the standard to the attention of any person who may have an interest in the standard. (5) Before publishing the reference to a technical specification adopted by the British Standards Institution, the Secretary of State must have regard to whether the technical specification is consistent with technical specifications adopted by the other recognised standardisation bodies. (6) The Secretary of State may remove from publication the reference to a standard which has been published in accordance with paragraph 1(b). (7) Where the Secretary of State removes the reference to a standard from publication, that standard is no longer a designated standard. (8) In this Article, a reference to a “product” is a reference to PPE to which this Regulation applies. (9) The Secretary of State may, by regulations, amend paragraph 3 to reflect any changes in the name or structure of the recognised standardisation bodies. (10) Regulations made under paragraph 9 must be made by statutory instrument, subject to annulment in pursuance of a resolution of either House of Parliament.

• (8) In Article 8—

• (a) in paragraph 2, in the second subparagraph (beginning “Where compliance of”)—

• (i) omit “EU”;

• (ii) for “CE” substitute “ UK ”;

• (b) in paragraph 3, omit “EU”;

• (c) in paragraph 4, for “harmonised” substitute “ designated ”;

• (d) in paragraph 6, for “market surveillance authorities” substitute “ the market surveillance authority ”;

• (e) in paragraph 7, for the words from “in a language” to the end, substitute “ and that they are clear, legible and in easily understandable English ”;

• (f) in paragraph 8, omit “EU” in both places;

• (g) in paragraph 9, for the words from “competent national authorities” to “on the market”, substitute “ enforcement authority ”;

• (h) in paragraph 10, for “a competent national authority” substitute “ the enforcement authority ”.

• (9) In Article 9—

• (a) in paragraph 1, after “appoint” insert “ a person established in the United Kingdom as their ”, and omit “an”;

• (b) in paragraph 2—

• (i) in point (a)—

• (aa) omit “EU” and “national”;

• (bb) for “authorities” substitute “ authority ”;

• (ii) in point (b), for “a competent national authority” substitute “ the enforcement authority ”;

• (iii) in point (c), for “competent national authorities” substitute “ enforcement authority ”.

• (10) In Article 10—

• (a) in paragraph 2—

• (i) in the first subparagraph (beginning “Before placing PPE”), for “CE” substitute “ UK ”;

• (ii) in the second subparagraph (beginning “Where an importer”), for “authorities” substitute “ authority ”;

• (b) in paragraph 3—

• (i) omit the words from “or, where” to the end of the first sentence;

• (ii) for “authorities” substitute “ authority ”;

• (iii) after “and market surveillance authorities” insert—

The obligation set out in this paragraph 3 to indicate information on the PPE does not apply where— (a) either— (i) it is not possible to indicate that information on the PPE, or (ii) the importer has imported the PPE from an EEA state or Switzerland and places it on the market within the period of 24 months beginning with IP completion day, and (b) before placing the PPE on the market, the importer sets out the information referred to in this paragraph 3 on the packaging of the PPE or in a document accompanying the PPE.

• (c) in paragraph 4, for the words from “in a language which” to the end, substitute “ and that they are clear, legible and in easily understandable English ”;

• (d) in paragraph 7, for the words from “competent national authorities” to “available on the market” substitute “ enforcement authority ”;

• (e) in paragraph 8—

• (i) omit “EU”;

• (ii) for “authorities” in the first place it occurs, substitute “ authority ”;

• (iii) for “those authorities” substitute “ that authority ”;

• (f) in paragraph 9, for “a competent national authority” substitute “ the enforcement authority ”.

• (11) In Article 11—

• (a) in paragraph 2—

• (i) in the first subparagraph (beginning “Before making PPE”)—

• (aa) for “CE” substitute “ UK ”;

• (bb) for the words from “in a language which” to “available on the market” substitute “ and that they are clear, legible and in easily understandable English ”;

• (ii) in the second subparagraph (beginning “Where a distributor”), for “authorities” at the end, substitute “ authority ”;

• (b) in paragraph 4, for the words from “competent national authorities” to “on the market” substitute “ enforcement authority ”;

• (c) in paragraph 5, for “a competent national authority” substitute “ the enforcement authority ”.

• (12) In Article 13, (in the first sentence), for “authorities” substitute “ authority ”.

• (13) For Article 14, substitute—

(1) PPE which is in conformity with a designated standard or part thereof shall be presumed to be in conformity with the essential health and safety requirements set out in Annex II covered by that standard or part thereof. (2) The presumption in paragraph 1 is rebuttable.

• (14) In Article 15—

• (a) in the heading, and in paragraphs 1, 2 and 4, omit “EU”;

• (b) in paragraph 2, for the words from “translated into the language” to the end, substitute “ in English ”;

• (c) for paragraph 3, substitute—

(3) Where PPE is subject to more than one enactment requiring a declaration of conformity, the manufacturer must draw up a single declaration of conformity which identifies each enactment by its title.

• (15) In Article 16, and in the heading to that Article, for “CE” substitute “ UK ”.

• (16) In Article 17—

• (aa) before paragraph 1 insert—

(A1) Paragraph 1 is subject to paragraph 1A.

• (ab) after paragraph 1 insert—

(1A) For a period of 24 months beginning with IP completion day, paragraph 1 does not apply where the UK marking is affixed to— (a) a label affixed to the PPE; or (b) a document accompanying the PPE.

• (a) in paragraphs 1 to 4, and in the heading, for “CE” substitute “ UK ”;

• (b) in paragraph 3, for “notified”, in both places, substitute “ approved ”;

• (c) in paragraph 4, for “notified” substitute “ approved ”;

• (d) omit paragraph 5.

• (17) In Article 19(b) and (c), omit “EU”.

• (18) In the heading to Chapter V for “Notification” substitute “ Approval ”.

• (19) For Article 20, substitute—

(1) An approved body is a conformity assessment body which— (a) has been approved by the Secretary of State pursuant to the procedure set out in Article 21 (approval of conformity assessment bodies); or (b) immediately before IP completion day was a notified body in respect of which the Secretary of State had taken no action under Article 30 of Regulation 2016/425 (pre-exit), to suspend or withdraw the body's status as a notified body. (2) Paragraph 1 has effect subject to Article 30 (restriction, suspension or withdrawal of approval). (3) In this Chapter— - “notified body” means a body which— 1. the Secretary of State had, before IP completion day, notified to the European Commission and the member States of the European Union in accordance with Article 20 of Regulation 2016/425 (pre-exit); and 2. in respect of which no objections had been raised, as referred to in Article 28(5) of Regulation 2016/425 (pre-exit); - “approved body requirements” means the requirements set out in Article 24.

• (20) For Article 21, substitute—

(1) The Secretary of State may approve only those conformity assessment bodies that qualify for approval. (2) A conformity assessment body qualifies for approval if the first and second conditions below are met. (3) The first condition is that the conformity assessment body has applied to the Secretary of State to become an approved body and that application is accompanied by— (a) a description of— (i) the conformity assessment activities that the conformity assessment body intends to carry out; (ii) the conformity assessment procedure in respect of which the conformity assessment body claims to be competent; (iii) the category of PPE in respect of which the conformity assessment body claims to be competent; and (b) either— (i) an accreditation certificate; or (ii) the documentary evidence necessary for the Secretary of State to verify, recognise and regularly monitor the conformity assessment body's compliance with the approved body requirements. (4) The second condition is that the Secretary of State is satisfied that the conformity assessment body meets the approved body requirements. (5) For the purposes of paragraph 4, the Secretary of State may accept an accreditation certificate provided in accordance with paragraph 3(b), as sufficient evidence that the conformity assessment body meets the approved body requirements. (6) When deciding whether to approve a conformity assessment body that qualifies for approval, the Secretary of State may— (a) have regard to any other matter which appears to the Secretary of State to be relevant; and (b) set conditions that the conformity assessment body must meet. (7) For the purposes of this Article, “accreditation certificate” means a certificate issued by the UK national accreditation body, attesting that a conformity assessment body meets the approved body requirements.

• (21) For Article 22, substitute—

The Secretary of State may authorise the UK national accreditation body to carry out the following activities on behalf of the Secretary of State— (a) assessing whether a conformity assessment body meets the approved body requirements; (b) monitoring approved bodies in accordance with Article 23; and (c) compiling and maintaining the register of approved bodies, in accordance with Article 29.

• (22) For Article 23 substitute—

The Secretary of State must monitor each approved body with a view to verifying that the body— (a) continues to meet— (i) the approved body requirements; and (ii) any conditions set by the Secretary of State under Article 21(6)(b); and (b) carries out its functions in accordance with this Regulation.

• (23) In Article 24—

• (a) for the heading, substitute— “ Approved body requirements ”;

• (b) in paragraph 1, for “notification” substitute “ approval ”;

• (c) in paragraph 2, for “under the national law of a Member State” substitute “ in the United Kingdom ”;

• (d) in paragraphs 4 (in the second subparagraph), and 7(a), for “notified” substitute “ approved ”;

• (e) in paragraph 6—

• (i) for “notified”, in the first two places where it occurs, substitute “ approved ”;

• (ii) in point (b), for “a notified body” substitute “ an approved body ”;

• (f) in paragraph 7(c)—

• (i) for “harmonised” substitute “ designated ”;

• (ii) for “Union harmonisation legislation and of national legislation” substitute “ this Regulation and any other relevant United Kingdom legislation ”;

• (g) in paragraph 9, for “liability is assumed by the Member State in accordance with national law, or the Member State itself” substitute “ the Secretary of State ”;

• (h) in paragraph 10—

• (i) for “national” substitute “ United Kingdom ”;

• (ii) for “competent authorities of the Member State in which its activities are carried out” substitute “ enforcement authority ”;

• (i) in paragraph 11—

• (i) for “the notified” substitute “ any approved ”;

• (ii) for “under Article 36” substitute “ by the Secretary of State ”.

• (24) For Article 25, substitute —

(1) Where a conformity assessment body demonstrates its conformity with the criteria laid down in a designated standard (or part of such a standard), the Secretary of State must presume that the conformity assessment body meets the approved body requirements covered by that standard (or the part of that standard). (2) The presumption in paragraph 1 is rebuttable.

• (25) For Article 26, substitute—

(1) An approved body may subcontract specific conformity assessment activities, or use a subsidiary to carry out such activities provided— (a) the body is satisfied that the subcontractor or subsidiary meets the approved body requirements; (b) the body has informed the Secretary of State that it is satisfied that the subcontractor or subsidiary meets those requirements; and (c) the economic operator for whom the activities are to be carried out has consented to the activities being carried out by that person. (2) The approved body which subcontracts specific conformity assessment activities or uses a subsidiary to carry out such activities remains responsible for the proper performance of those activities (irrespective of where the subcontractor or subsidiary is established). (3) Where an approved body subcontracts, or uses a subsidiary to carry out, a specific conformity assessment activity, the approved body must, for a period of 10 years beginning on the day on which the activity is first carried out, keep available for inspection by the Secretary of State all relevant documentation concerning— (a) the assessment of the qualifications of the subcontractor or the subsidiary; and (b) the conformity assessment activity carried out by the subcontractor or subsidiary. (4) In this Article, “subsidiary” has the meaning given to it by section 1159 of the Companies Act 2006 .

• (26) Omit Articles 27 and 28.

• (27) For Article 29, substitute—

(1) The Secretary of State must— (a) assign an approved body identification number to each approved body; and (b) compile and maintain a register of— (i) approved bodies; (ii) their approved body identification numbers; (iii) the activities for which they have been approved; and (iv) any restrictions on those activities. (2) The register referred to in paragraph 1 must be made publicly available.

• (28) For Article 30, substitute—

(1) Where the Secretary of State determines that an approved body— (a) no longer meets an approved body requirement, or (b) is failing to fulfil its obligations under these Regulations, other than a condition referred to in Article 21(6)(b), the Secretary of State must restrict, suspend or withdraw the body's status as an approved body under Article 21. (2) Where the Secretary of State determines that an approved body no longer meets a condition referred to in Article 21(6)(b), the Secretary of State may restrict, suspend or withdraw the body's status as an approved body under Article 21. (3) In deciding what action to take under paragraph 1 or 2, the Secretary of State must have regard to the seriousness of the non-compliance. (4) Before taking action under paragraph 1 or 2, the Secretary of State must— (a) give notice in writing to the approved body of the proposed action and the reasons for it; (b) give the approved body an opportunity to make representations to the Secretary of State regarding the proposed action within a reasonable period from the date of the notice; and (c) consider any such representations made by the approved body. (5) Where the Secretary of State has taken action in respect of an approved body under paragraph 1 or 2, or where an approved body has ceased its activity, the approved body must, at the request of the Secretary of State— (a) transfer its files relating to the activities it has undertaken as an approved body to another approved body or to the Secretary of State; or (b) keep its files relating to the activities it has undertaken as an approved body available for inspection by the Secretary of State and market surveillance authority for a period of 10 years from the date they were created. (6) The activities undertaken as an approved body referred to in paragraph 5 include any activities that the body has undertaken as a notified body.

• (29) Omit Article 31.

• (30) In Article 32—

• (a) in the heading, and in paragraph 5, for “notified” substitute “ approved ”;

• (b) in paragraph 1, for “Notified” substitute “ Approved ”;

• (c) after paragraph 1 insert—

(1A) Subject to the terms of its appointment an approved body must carry out the conformity assessment activities and procedures, in respect of which— (a) the body's approval was given under Article 21; or (b) the body's notification as a notified body was made.

• (d) in paragraphs 3 and 4, for “a notified” substitute “ an approved ”;

• (e) in paragraph 3 for “harmonised” substitute “ designated ”.

• (31) In Article 33—

• (a) for “Notified” substitute “ Approved ”; and

• (b) in the heading, for “notified” substitute “ approved ”.

• (32) In Article 34—

• (a) in the heading, for “notified” substitute “ approved ”;

• (b) in paragraph 1—

• (i) for—

• (aa) “Notified” substitute “Approved”;

• (bb) “notifying authority” substitute “Secretary of State”;

• (ii) in point (b), for “notification” substitute “ their approval ”;

• (iii) in point (c), for “market surveillance authorities” substitute “ the market surveillance authority ”;

• (iv) in point (d), for “notification” substitute “ approval ”;

• (c) in paragraph 2—

• (i) for “Notified” in the first place it occurs, substitute “ Approved ”;

• (ii) for “the other bodies notified” substitute “ other approved bodies ”.

• (33) Omit Article 35 and 36.

• (34) For the heading to Chapter VI, substitute— “ MARKET SURVEILLANCE AND CONTROL OF PPE ENTERING THE UNITED KINGDOM MARKET ”.

• (35) In Article 37—

• (a) for the heading, substitute— “ Market surveillance and control of PPE entering the United Kingdom market ”;

• (b) for “Article 15(3) and Articles 16 to 29” substitute “ Articles 15(3), 16 to 22 and 26 to 29 ”.

• (36) In Article 38—

• (a) in the heading, omit “at national level”;

• (b) in paragraph 1—

• (i) in the first subparagraph (beginning “Where the market”)—

• (aa) for “authorities of one Member State have” substitute “ authority has ”;

• (bb) for “they” substitute “ the authority ”;

• (cc) in the last sentence, for “authorities” substitute “ authority ”,

• (ii) in the second subparagraph (beginning “Where, in the course of the evaluation”)—

• (aa) for “authorities find” substitute “ authority finds ”;

• (bb) for “they” in both places, substitute “ the authority ”;

• (iii) in the third subparagraph (beginning “The market surveillance authorities”)—

• (aa) for “authorities”, substitute “ authority ”;

• (bb) for “notified” substitute “ approved ”;

• (c) omit paragraph 2;

• (d) in paragraph 3, omit “throughout the Union”;

• (e) in paragraph 4—

• (i) in the first subparagraph (beginning “Where the relevant”)—

• (aa) for “authorities”, substitute “ authority ”;

• (bb) omit “provisional”;

• (cc) for “their national market” substitute “ the market ”;

• (ii) omit the second subparagraph (beginning “The market surveillance authorities shall”);

• (f) omit paragraphs 5 to 8.

• (37) Omit Article 39.

• (38) In Article 40—

• (a) in paragraph 1, for “a Member State” substitute “ the enforcement authority ”;

• (b) in paragraph 2, omit “throughout the Union”;

• (c) omit paragraphs 3 to 5.

• (39) In Article 41—

• (a) in paragraph 1—

• (i) in the first sentence, for “a Member State” substitute “ the enforcement authority ”;

• (ii) in points (a) and (b), for “CE” substitute “ UK ”;

• (iii) in point (c), for “notified” substitute “ approved ”;

• (iv) in point (d), omit “EU”;

• (b) in paragraph 2, for “Member State concerned” substitute “ enforcement authority ”.

• (40) For Article 42 substitute—

(1) In order to take into account technical progress and knowledge or new scientific evidence with respect to the category of a specific risk, the Secretary of State may, by regulations, amend Annex I by reclassifying the risk from one category to another. (2) Regulations made under paragraph 1 must be made by statutory instrument, subject to annulment in pursuance of a resolution of either House of Parliament. (3) Any power to make regulations under this Article includes power to make— (a) different provision for different purposes; (b) consequential, supplementary, transitional or transitory provision or savings.

• (41) Omit Articles 43 to 46.

• (42) For Article 47, substitute—

(1) In this Article, “pre-exit period” means the period beginning with 21 April 2018 and ending immediately before IP completion day. (2) Subject to paragraph 3, where PPE was made available on the market during the pre-exit period, despite the amendments made by Schedule 35 of the Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019 , any obligation to which a person was subject under Regulation 2016/425 (pre-exit), continues to have effect as it did immediately before IP completion day, in relation to that PPE. (3) Paragraph 2 does not apply to— (a) any obligation of the enforcement authority to inform the European Commission or the member States of any matter, or (b) any obligation to take action outside of the United Kingdom in relation to that PPE. (4) Where during the pre-exit period— (a) PPE has not been placed on the market; and (b) a manufacturer has taken any action under Article 8(2) of Regulation 2016/425 (pre-exit) with respect to carrying out the applicable conformity assessment procedure referred to in Article 19 of that Regulation, that action has effect as if it had been done under Article 8(2) of this Regulation (with respect to carrying out the applicable conformity assessment procedure referred to in Article 19 of this Regulation).

• (43) Omit Article 48.

• (44) After Article 48, omit—

• (a) the words “This Regulation shall be binding” to the end;

• (b) “Done at Strasbourg, 9 March 2016”;

• (c) the signatory text.

• (45) In Annex II (Essential Health and Safety Requirements)—

• (a) in paragraph 1.4—

• (i) in point (i), for “Union harmonisation” substitute “ relevant United Kingdom ”;

• (ii) in point (j), for “notified” substitute “ approved ”;

• (iii) in point (k), for “harmonised” substitute “ designated ”;

• (iv) in point (l), omit “EU”;

• (v) in the sentence after point (l), (beginning “The information referred”), omit “EU”.

• (b) in paragraph 2.12—

• (i) in the first subparagraph, (beginning “Where PPE bears”)—

• (aa) omit “harmonised”;

• (bb) for the words from “a language easily” to the end, substitute “ English ”;

• (c) in paragraph 3.5, for “by Directive 2003/10/EC of the European Parliament and of the Council” substitute “ in the Control of Noise at Work Regulations 2005 (S.I. 2005/1643) and the Control of Noise at Work Regulations (Northern Ireland) 2006 (S.R. 2006 No.1) ” .

• (46) In Annex III—

• (a) in point (f), for “harmonised” in both places, substitute “ designated ”;

• (b) in point (g), for “harmonised” substitute “ designated ”.

• (47) In Annex IV—

• (a) in the heading to paragraph 4—

• (i) for “CE” substitute “ UK ”;

• (ii) omit “EU”;

• (b) in paragraph 4.1, for “CE” substitute “ UK ”;

• (c) in paragraph 4.2, omit “EU”, in each place it occurs.

• (48) In Annex V—

• (a) in the heading, and in the headings to paragraphs 3, 4, 6 and 7, omit “EU”;

• (b) in paragraph 1, for “a notified” substitute “ an approved ”;

• (c) in paragraphs 1, 2, 3, 6.2, 6.3, 7.7, and 9, omit “EU”;

• (d) in paragraphs 7.2, 7.4, 7.5, 7.6, and 8, omit “EU”, in each place it occurs;

• (e) in paragraphs 4, 6.1, 6.2, 6.4, 7.2 and 7.7, for “notified” substitute “ approved ”;

• (f) in paragraph 3, 5, 7.1, 7.4, 7.5, 7.6 and 8, for “notified”, in each place it occurs, substitute “ approved ”;

• (g) in paragraph 4, for “harmonised”, in each place it occurs, substitute “ designated ”;

• (h) in paragraph 5, for “notifying authorities” substitute “ Secretary of State ”;

• (i) in paragraphs 6.1 and 6.4, for “an EU” substitute “ a ”;

• (j) in paragraph 6.2(e) and 7.6(b), for “harmonised” substitute “ designated ”;

• (k) in paragraph 8—

• (i) in the first subparagraph (beginning “Each notified body shall inform its notifying”), for “its notifying authority”, in both places, substitute “ the Secretary of State ”;

• (ii) in the third subparagraph (beginning “The Commission”)—

• (aa) for “The Commission, the Member States”, substitute “ The Secretary of State ”;

• (bb) for “On a reasoned request, the Commission and the Member States may” substitute “ The Secretary of State may on request ”.

• (49) In Annex VI—

• (a) in paragraphs 1 and 2, and in the heading to paragraph 3, omit “EU”;

• (b) in paragraph 3, omit “EU”, in each place it occurs;

• (c) in paragraph 3.1 and in the heading to paragraph 3, for “CE” substitute “ UK ”;

• (50) In Annex VII—

• (a) in paragraphs 1, 2, 4.1, 4.2, 4.3, 4.4, 4.6 and 6.1, and in the heading to paragraph 6, omit “EU”;

• (b) in paragraph 3, in each place it occurs—

• (i) for “notified” substitute “ approved ”;

• (ii) omit “EU”;

• (c) in paragraphs 4.1, 4.2, 4.3, 4.4, 4.6, 5.1 and 6.1, for “notified” substitute “ approved ”;

• (d) in paragraph 4.3, for “harmonised” substitute “ designated ”;

• (e) in paragraph 4.6, for “notifying authority” substitute “ Secretary of State ”;

• (f) in paragraph 5.3, for “notified”, in both places, substitute “ approved ”;

• (g) in the heading to paragraph 6, and in paragraph 6.1, for “CE” substitute “ UK ”;

• (h) in paragraph 6.2, omit “EU”, in each place it occurs.

• (51) In Annex VIII—

• (a) in paragraphs 1, 3.2, 3.6 and 5.1, and in the heading to paragraph 5, omit “EU”;

• (b) in paragraphs 3.1 and 5.2, omit “EU”, in each place it occurs;

• (c) in paragraphs 3.3, 4.2, 4.3, 5.1 and 6, and in the heading to paragraph 4, for “notified” substitute “ approved ”;

• (d) in paragraphs 3.1, 3.5, 3.6, 4.4 and 7, for “notified”, in each place it occurs, substitute “ approved ”;

• (e) in paragraph 3.3, for “harmonised” substitute “ designated ”;

• (f) in the heading to paragraph 5, and in paragraph 5.1, for “CE” substitute “ UK ”;

• (g) in paragraph 5.2—

• (i) in the first subparagraph (beginning “The manufacturer shall”), for “national authorities” substitute “ enforcement authority ”;

• (ii) in the second subparagraph (beginning “A copy of”), for “relevant authorities” substitute “ enforcement authority ”;

• (h) in paragraph 6, for “national authorities” substitute “ enforcement authority ”;

• (i) in paragraph 7, for “its notifying authority”, in both places, substitute “ the Secretary of State ”.

• (52) In Annex IX—

• (a) in the heading, omit “EU”;

• (b) in paragraph 5, for “Union harmonisation legislation” substitute “ statutory requirements ”;

• (c) in paragraph 6, for “harmonised” substitute “ designated ”;

• (d) in paragraphs 7 and 8, for “notified” substitute “ approved ”;

• (e) in paragraph 7, omit “EU” in both places it occurs.

SCHEDULE 36 — Amendment of Regulation (EU) 2016/426 and the Gas Appliances (Enforcement) and Miscellaneous Amendments Regulations 2018

PART 1 — Amendment of subordinate legislation

Amendment of the Gas Appliances (Enforcement) and Miscellaneous Amendments Regulations 2018

1

• (1) The Gas Appliances (Enforcement) and Miscellaneous Amendments Regulations 2018 are amended as follows.

• (2) In regulation 1—

• (a) in paragraph (2), at the appropriate place, insert—

Regulation 2016/426 (pre-exit)” means Regulation (EU) 2016/426 of the European Parliament and of the Council on appliances burning gaseous fuels and repealing Directive 2009/142/EC as it had effect immediately before IP completion day;

• (b) in paragraph (3)—

• (i) after “In these Regulations”, insert “ (unless otherwise stated) ”;

• (ii) in sub-paragraph (a), omit “unless otherwise stated”;

• (iii) in sub-paragraph (b), after “paragraph of an Article” in both places insert “ , Chapter ”;

• (c) in paragraph (4), after “EU Regulation 2016/426” in the second place it occurs, insert “ unless otherwise stated ”.

• (3) In regulation 2—

• (a) in paragraph (4), for “The” substitute “ Subject to the modifications made in paragraph (4A), the ”;

• (b) after paragraph (4), insert—

(4A) The modifications referred to in paragraph (4) are as follows— (a) any reference to the “Community” is to be read as including the United Kingdom; (b) any reference to “member State” is to be read as though the United Kingdom were a member State; (c) regulation 10(6) is to be read as if the words from “and, on request made by it” to the end were omitted; (d) regulation 13(2) is to be read as if sub-paragraph (b) were omitted; (e) regulation 15(2) is to be read as if sub-paragraph (b) were omitted.

• (4) After regulation 2, insert—

(2A) (1) In this regulation, “harmonised standard” has the meaning given 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); (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 provided for in Annex IV of Regulation 2016/426 (pre-exit), in accordance with Articles 16, 17(1) to (4) and 18 of Regulation 2016/426 (pre-exit); (f) draws up an EU declaration of conformity, in accordance with Article 15 of Regulation 2016/426 (pre-exit); 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 Articles 7(1) and (2) and 14 to 18 are to be treated as being satisfied; (b) the requirement in Article 7(5) to ensure that appliances and fittings bear inscriptions, is to be treated as being satisfied; (c) Articles 7(3), (4) and (7), 8(2) and point 1.7 of Annex I (referred to in Article 7(7)) and regulations 7(1) and 8(3)(a) apply subject to the modifications in paragraph (8); and (d) Article 40 does not apply. (4) Paragraph (5) applies where before placing an appliance or fitting on the market, the importer ensures that— (a) the applicable conformity assessment procedure referred to in Article 14 of Regulation 2016/426 (pre-exit) has been carried out; (b) the manufacturer has drawn up the technical documentation referred to in Annex III of Regulation 2016/426 (pre-exit); and (c) the appliance or fitting bears the CE marking in accordance with Articles 16 and 17(1) to (4) of Regulation 2016/426 (pre-exit). (5) Where this paragraph applies— (a) the requirements in the first or second subparagraph of Article 9(2), as applicable, to ensure that— (i) the appropriate conformity assessment procedure referred to in Article 14 has been carried out; (ii) the manufacturer has drawn up the technical documentation; and (iii) the appliance or fitting bears the UK marking, are to be treated as being satisfied; (b) the third subparagraph of Article 9(2), Article 9(5) and (8), and regulations 7(1) and 8(3)(b) apply subject to the modifications in paragraph (8); and (c) in relation to fittings, the second subparagraph of Article 9(2) (other than those requirements treated as being satisfied), point 1.7 of Annex I (referred to in that subparagraph) and the second subparagraph of Article 9(4) also apply subject to the modifications in paragraph (8). (6) Paragraph (7) applies where, before placing an appliance or fitting on the market, a distributor ensures that the appliance or fitting bears the CE marking in accordance with Articles 16 and 17(1) to (4) of Regulation 2016/426 (pre-exit). (7) Where this paragraph applies— (a) the requirement in the first or second subparagraph of Article 10(2), as applicable, for the distributor to verify that the appliance or fitting bears the UK marking, is to be treated as being satisfied; (b) the third subparagraph of Article 10(2), Article 10(3) and regulation 7(1) apply subject to the modifications in paragraph (8); and (c) in relation to fittings, the second subparagraph of Article 10(2) (other than that requirement treated as being satisfied) and point 1.7 of Annex I (referred to in that subparagraph) also apply subject to the modifications in paragraph (8). (8) The modifications referred to in paragraphs (3)(c), (5)(b) and (c), and (7)(b) and (c) are that— (a) any reference to a “declaration of conformity” is to be read as a reference to an EU declaration of conformity, referred to in Article 15 of Regulation 2016/426 (pre-exit); (b) any reference to “essential requirements” is to be read as a reference to the essential requirements set out in Annex I of Regulation 2016/426 (pre-exit); (c) any reference to “designated standard” is to be read as a reference to a harmonised standard; (d) any reference to “technical documentation” is a reference to the technical documentation referred to in Annex III to Regulation 2016/426 (pre-exit); (e) in regulations 7(1) and 8(3), any reference to a numbered Article is to be read as a reference to the equivalent Article of Regulation 2016/426 (pre-exit). (2B) (1) Paragraph (2) applies where, before placing an appliance or fitting on the market the manufacturer ensures that its conformity with Regulation 2016/426 (pre-exit) has been assessed by means of the conformity assessment procedure set out in point 1 of Annex III to Regulation 2016/426 (pre-exit) and referred to in Article 14(2) of Regulation 2016/426 (pre-exit) as EU type-examination, in accordance with that Article. (2) Where this paragraph applies— (a) the requirement in Article 14(2) that the conformity of appliances and fittings with Regulation EU 2016/426 be assessed by means of the type-examination set out in point 1 of Annex III is to be treated as being satisfied; (b) any reference to “conformity assessment procedure” in Articles 7(2) and 9(2) (first and second subparagraphs) is to be read as including the conformity assessment procedure referred to in Article 14(2) of Regulation 2016/426 (pre-exit) as EU type-examination; (c) any reference to “technical documentation” in Articles 7(2), 7(3), 9(2) (first and second subparagraphs) and 9(8) is to be read as including the technical documentation relating to the design of the appliance or fitting as referred to in point 1 of Annex III to Regulation 2016/426 (pre-exit). (2C) (1) Subject to paragraph (2), regulation 2A ceases to have effect at the end of the period of 12 months beginning with IP completion day. (2) Notwithstanding the expiry of regulation 2A— (a) any appliance or fitting which was placed on the market pursuant to regulation 2A may continue to be made available on the market on or after the expiry of regulation 2A; (b) any obligation to which a person was subject under regulation 2A in respect of any appliance or fitting placed on the market pursuant to regulation 2A continues to have effect after the expiry of regulation 2A, in respect of that appliance or fitting. (3) Subject to paragraph (4), regulation 2B 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 2B in relation to a product prior to the expiry of regulation 2B, regulation 2B continues to apply in respect of that product 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 the conformity assessment procedure referred to in regulation 2B(1) has been carried out in relation to that appliance or fitting, in accordance with Article 14(2) of Regulation 2019/426 (pre-exit). (2D) (1) In this regulation— - “EU Regulation 2016/426 (Northern Ireland)” means Regulation (EU) No. 2016/426 of the European Parliament and of the Council on appliances burning gaseous fuels, repealing Council Directive 2009/142/EC, as it has effect by virtue of the Protocol on Ireland/ Northern Ireland in the EU withdrawal agreement; - “applicable conformity assessment procedure” means the conformity assessment procedure applicable to the appliance or fitting in accordance with Article 14 of EU Regulation 2016/426 (Northern Ireland); - “CE marking” has the meaning given to it in Article 2(31) of EU Regulation 2016/426 (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 Annex III of Regulation 2016/426 (Northern Ireland). (2) Where paragraph (3) applies— (a) an appliance or fitting is to be treated as being in conformity with the essential safety requirements within the meaning given in EU Regulation 2016/426; and (b) each relevant economic operator is to be treated as having complied or as complying with the obligations imposed on them under Chapter II of EU Regulation 2016/426. (3) This paragraph applies where— (a) the appliance or fitting is— (i) in conformity with the essential requirements within the meaning given in EU Regulation 2016/246 (Northern Ireland); and (ii) qualifying Northern Ireland goods; and (b) each relevant economic operator has complied or is complying with the obligations imposed on them under Chapter II of EU Regulation 2016/426 (Northern Ireland); and (c) an importer has complied with the obligations set out in paragraph (4). (4) The obligations referred to in paragraph (4)(c) are that, before placing the appliance or fitting on the market, the importer— (a) complies with Article 9(3) of EU Regulation 2016/426; (b) ensures that— (i) the applicable conformity assessment procedure has been carried out in relation to the appliance or fitting; (ii) the manufacturer has drawn up the technical documentation; and (iii) the appliance or fitting bears the CE marking.

• (5) In regulation 6, for the words from “or other matter within its knowledge” to the end, substitute “ in accordance with Chapter 5 ”.

• (6) In regulation 7(1)(e), for “CE” substitute “ UK ”.

• (7) In regulation 8(3), omit “EU” in both places in which it occurs.

• (8) In regulation 12(1), omit “at national level”.

PART 2 — Amendment of retained direct EU legislation

Amendment of Regulation (EU) 2016/426

2

• (1) Regulation (EU) 2016/426 of the European Parliament and of the Council on appliances burning gaseous fuels and repealing Directive 2009/142/EC is amended as follows.

• (2) In Article 1—

• (a) in paragraph 2(b), for “Member States in their communication pursuant to” substitute “ the Secretary of State under”;

• (b) in paragraph 4, for “acts of Union harmonisation legislation” substitute “ enactments ”;

• (c) in paragraph 5, for “a measure adopted pursuant to Article 15 of Directive 2009/125/EC” substitute “ an implementing measure within the meaning given in the Ecodesign for Energy-Related Products Regulations 2010 ”;

• (d) omit paragraph 6.

• (3) In Article 2—

• (a) in points (14) and (15) for “Union market” substitute “ market of Great Britain ”;

• (aa) in point (16) for “the Union” substitute “ Great Britain ”;

• (b) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

• (c) for point (19), substitute—

(19) “importer” means a person who— (a) is established in the United Kingdom and places an appliance or fitting from a country outside of the United Kingdom on the market; or (b) is established in Northern Ireland and places an appliance or fitting on the market that has been supplied to them for distribution, consumption or use in the course of a commercial activity, whether in return for payment or free of charge, from an EEA state;

• (d) omit points (23) to (25), and (30) to (31);

• (e) after point (31), insert—

(32) ‘approved body’ has the meaning given in Article 19; (33) ‘designated standard’ has the meaning given in Article 6A; (34) ‘enforcement authority’ means a person enforcing this Regulation under regulation 4 of the Gas Appliances (Enforcement) and Miscellaneous Amendments Regulations 2018 (S.I. 2018/389); (35) ‘UK marking’ means the marking in the form set out in Annex 2 of Regulation (EC) 765/2008 of the European Parliament and of the Council setting out the requirements for accreditation and market surveillance relating to the marketing of products and repealing Regulation (EEC) 339/93; (36) ‘UK national accreditation body’ means the body appointed by the Secretary of State in accordance with Article 4 of Regulation (EC) 765/2008 of the European Parliament and of the Council setting out the requirements for accreditation and market surveillance relating to the marketing of products and repealing Regulation (EEC) 339/93; (37) ‘Regulation 2016/426 (pre-exit)’ means Regulation (EU) 2016/426 of the European Parliament and of the Council on appliances burning gaseous fuels and repealing Directive 2009/142/EC, as it had effect immediately before IP completion day; (38) In this Regulation, references to “the market surveillance authority” are to be construed in accordance with regulation 3 of the Gas Appliances (Enforcement) and Miscellaneous Amendments Regulations 2018.

• (4) Omit Article 3(3).

• (5) For Article 4, substitute—

(1) The Secretary of State must publish information, in accordance with Annex II, about the types of gas and corresponding supply pressures of gaseous fuels used in the United Kingdom. (2) The information that is published under paragraph 1, may be— (a) published in such form and manner as the Secretary of State considers appropriate; (b) reviewed by the Secretary of State at any time, and if it is revised following such a review, the Secretary of State must publish revised information as soon as reasonably practicable following that review. (3) Where the Secretary of State considers it necessary to do so to take account of any technical developments with regard to gas supply conditions, the Secretary of State may by regulations amend the content of the information regarding gas supply conditions as set out in Annex II. (4) Before making regulations under this Article, the Secretary of State must consult such persons as the Secretary of State considers appropriate. (5) Where regulations are made under this Article, the Secretary of State must, as soon as reasonably practicable after those regulations come into force, publish revised information in accordance with Annex II as amended by those regulations. (6) Regulations made under this Article may— (a) make different provisions for different cases; and (b) make such supplemental, consequential and transitional provisions as the Secretary of State considers appropriate. (7) Regulations made under this Article are to be made by statutory instrument subject to annulment in pursuance of a resolution of either House of Parliament.

• (6) In Article 6—

• (a) for the heading, substitute— “ Making available, putting into service and exhibition at trade fairs, etc ”;

• (b) in paragraphs 1 and 2—

• (i) for “Member States shall not” substitute “ Nothing in this Regulation prohibits, restricts or impedes ”;

• (ii) omit “prohibit, restrict or impede”;

• (c) in paragraph 3, for “Members States shall not prevent” substitute “ nothing in this Regulation prevents ”.

• (7) After Article 6, insert—

(1) Subject to paragraphs 6 and 7, in this Regulation a “designated standard” means a technical specification which is— (a) adopted by a recognised standardisation body, for repeated or continuous application, with which compliance is not compulsory; and (b) designated by the Secretary of State, by publishing the reference to the standard and maintaining that publication in a manner the Secretary of State considers appropriate. (2) For the purposes of paragraph 1, “technical specification” means a document that prescribes technical requirements to be fulfilled by a product, process, service or system and which lays down one or more of the following— (a) the characteristics required of a product, including— (i) levels of quality, performance, interoperability, environmental protection, health, safety or dimensions, and (ii) the requirements applicable to the product as regards the name under which the product is sold, terminology, symbols, testing and test methods, packaging, marking or labelling and conformity assessment procedures; and (b) production methods and processes relating to the product, where these have an effect on the characteristics of the product. (3) For the purposes of this Article, a “recognised standardisation body” means any one of the following organisations— (a) the European Committee for Standardisation (CEN); (b) the European Committee for Electrotechnical Standardisation (Cenelec); (c) the European Telecommunications Standards Institute (ETSI); (d) the British Standards Institution (BSI). (4) When considering whether the manner of publication of a reference is appropriate in accordance with paragraph 1(b), the Secretary of State must have regard to whether the publication will draw the standard to the attention of any person who may have an interest in the standard. (5) Before publishing the reference to a technical specification adopted by the British Standards Institution, the Secretary of State must have regard to whether the technical specification is consistent with technical specifications adopted by the other recognised standardisation bodies. (6) The Secretary of State may remove from publication the reference to a standard which has been published in accordance with paragraph 1(b). (7) Where the Secretary of State removes the reference to a standard from publication, that standard is no longer a designated standard. (8) In this Article, a reference to a “product” is a reference to an appliance or fitting to which this Regulation applies. (9) The Secretary of State may, by regulations, amend paragraph 3 to reflect any changes in the name or structure of the recognised standardisation bodies. (10) Regulations made under paragraph 9 must be made by statutory instrument, subject to annulment in pursuance of a resolution of either House of Parliament.

• (8) In Article 7—

• (a) in paragraph 2, in the second subparagraph (beginning “Where compliance of”)—

• (i) for “an EU” substitute “ a ”;

• (ii) for “CE” substitute “ UK ”;

• (b) in paragraph 3, omit “EU”;

• (c) in paragraph 4, for “harmonised” substitute “ designated ”;

• (d) in paragraph 6, in the first and second subparagraphs, for “market surveillance authorities” substitute “ market surveillance authority ”;

• (e) in paragraph 7—

• (i) in the first and second subparagraphs, for the words from “in a language which” to the end, substitute “ that are clear, legible and in easily understandable English ”;

• (ii) in the second and third subparagraphs, omit “EU”;

• (f) in paragraph 8, for the words from “competent national authorities” to “available on the market”, substitute “ enforcement authority ”;

• (g) in paragraph 9, for “a competent national authority” substitute “ the enforcement authority ”.

• (9) In Article 8—

• (a) in paragraph 1, after “appoint” insert “ a person established in the United Kingdom as their ”, and omit “an”;

• (b) in paragraph 2—

• (i) in point (a)—

• (aa) omit “EU”;

• (bb) for “national market surveillance authorities” substitute “ the market surveillance authority ”;

• (ii) in point (b), for “a competent national authority” substitute “ the enforcement authority ”;

• (iii) in point (c), for “competent national authorities” substitute “ enforcement authority ”.

• (10) In Article 9—

• (a) in paragraph 2—

• (i) in the first and second subparagraphs, for “CE” substitute “ UK ”;

• (ii) in the second subparagraph omit “EU”;

• (iii) in the third subparagraph (beginning “Where an importer”), for “authorities” substitute “ authority ”;

• (b) in paragraph 3—

• (i) in the first and second subparagraphs—

• (aa) omit the words from “or, where” to the end of the first sentence;

• (bb) for “authorities” substitute “ authority ”;

• (ii) after the second subparagraph insert—

The obligation set out in the first and second subparagraphs of this paragraph 3 to indicate information on the appliance or fitting does not apply where— (a) either— (i) it is not possible to indicate that information on the appliance or fitting, or (ii) the importer has imported the appliance or fitting from an EEA state or Switzerland and places it on the market within the period of 24 months beginning with IP completion day, and (b) before placing the appliance or fitting on the market, the importer sets out the information referred to in the first and second subparagraphs on the packaging of the appliance or fitting or in a document accompanying the appliance or fitting.

• (c) in paragraph 4—

• (i) in the first and second subparagraphs, for the words from “in a language which” to the end, substitute “ that are clear, legible and in easily understandable English ”;

• (ii) in the second subparagraph omit “EU”;

• (d) in paragraph 7, for the words from “competent national authorities” to “available on the market” substitute “ enforcement authority ”;

• (e) in paragraph 8—

• (i) omit “EU”;

• (ii) for “authorities” in the first place it occurs, substitute “ authority ”;

• (iii) for “those authorities” substitute “ that authority ”;

• (f) in paragraph 9, for “a competent national authority” substitute “ the enforcement authority ”.

• (11) In Article 10—

• (a) in paragraph 2—

• (i) in the first subparagraph (beginning “Before making an appliance”)—

• (aa) for “CE” substitute “ UK ”;

• (bb) for the words from “in a language which” to “made available on the market” substitute “ that are clear, legible and in easily understandable English ”;

• (ii) in the second subparagraph (beginning “Before making a fitting”)—

• (aa) for “CE” substitute “ UK ”;

• (bb) omit “EU”;

• (cc) for the words from “in a language which” to “Member State concerned” substitute “ that are clear, legible and in easily understandable English ”;

• (iii) in the third subparagraph (beginning “Where a distributor”), for “authorities” at the end, substitute “ authority ”;

• (b) in paragraph 4, for the words from “competent national authorities” to “on the market” substitute “ enforcement authority ”;

• (c) in paragraph 5, for “a competent national authority” substitute “ the enforcement authority ”.

• (12) In Article 12 (in the first sentence), for “authorities” substitute “ authority ”.

• (13) For Article 13, substitute—

(1) Appliances and fittings which are in conformity with a designated standard or part thereof shall be presumed to be in conformity with the essential requirements set out in Annex I covered by that standard or part thereof. (2) The presumption in paragraph 1 is rebuttable.

• (14) In Article 14—

• (a) in paragraph 2, omit “EU”;

• (b) in paragraph 4—

• (i) for the words from “an official language of the Member State” to “established” to the end, substitute “ English ”;

• (ii) for “that body” substitute “ the approved body ”.

• (15) In Article 15—

• (a) in the heading, and in paragraphs 1, 5 and 6, omit “EU”;

• (b) in paragraph 2—

• (i) omit “EU”;

• (ii) for the words from “translated into the language” to the end, substitute “ prepared in or translated into English ”;

• (c) in paragraph 3—

• (i) omit “EU” in both places;

• (ii) for the words from “a language which” to the end, substitute “ English ”;

• (d) for paragraph 4, substitute—

(4) Where an appliance or a fitting is subject to more than one enactment requiring a declaration of conformity, the manufacturer must draw up a single declaration of conformity which identifies each enactment by its title.

• (16) In Article 16, and in the heading to that Article, for “CE” substitute “ UK ”.

• (17) In Article 17—

• (aa) before paragraph 1 insert——

(A1) Paragraph 1 is subject to paragraph (1A).

• (ab) after paragraph 1 insert—

(1A) For a period of 24 months beginning with IP completion day, paragraph 1 does not apply where the UK marking is affixed visibly, legibly and indelibly to— (a) a label affixed to the appliance and fitting or their data plate; or (b) a document accompanying the appliance and fitting or their data plate.

• (a) in the heading, and in paragraphs 1, 2 and 4, for “CE” substitute “ UK ”;

• (b) in paragraph 3—

• (i) for “CE”, in both places, substitute “ UK ”,

• (ii) for “notified”, in both places, substitute “ approved ”;

• (c) omit paragraph 5.

• (18) In the heading to Chapter IV for “Notification of Conformity Assessment Bodies” substitute “ Approval of Conformity Assessment Bodies ”.

• (19) For Article 19, substitute—

(1) An approved body is a conformity assessment body which— (a) has been approved by the Secretary of State pursuant to the procedure set out in Article 20 (approval of conformity assessment bodies); or (b) immediately before IP completion day was a notified body in respect of which the Secretary of State had taken no action under Article 29 (changes to notifications) of Regulation 2016/426 (pre-exit), to suspend or withdraw the body's status as a notified body. (2) Paragraph 1 has effect subject to Article 29 (restriction, suspension or withdrawal of approval). (3) In this Chapter— - “notified body” means a body— 1. which the Secretary of State had, before IP completion day, notified to the European Commission and the member States of the European Union in accordance with Article 19 of Regulation 2016/426 (pre-exit); and 2. in respect of which no objections had been raised, as referred to in Article 27(5) of Regulation 2016/426 (pre-exit); - “approved body requirements” means the requirements set out in Article 23.

• (20) For Article 20 substitute—

(1) The Secretary of State may approve only those conformity assessment bodies that qualify for approval. (2) A conformity assessment body qualifies for approval if the first and second conditions below are met. (3) The first condition is that the conformity assessment body has applied to the Secretary of State to become an approved body and that application is accompanied by— (a) a description of— (i) the conformity assessment activities that the conformity assessment body intends to carry out; (ii) the conformity assessment procedure in respect of which the conformity assessment body claims to be competent; and (iii) the category of appliance or fitting in respect of which the conformity assessment body claims to be competent; and (b) either— (i) an accreditation certificate; or (ii) the documentary evidence necessary for the Secretary of State to verify, recognise and regularly monitor the conformity assessment body's compliance with the approved body requirements. (4) The second condition is that the Secretary of State is satisfied that the conformity assessment body meets the approved body requirements. (5) For the purposes of paragraph 4, the Secretary of State may accept an accreditation certificate provided in accordance with paragraph 3(b)(i), as sufficient evidence that the conformity assessment body meets the approved body requirements. (6) When deciding whether to approve a conformity assessment body that qualifies for approval, the Secretary of State may— (a) have regard to any other matter which appears to the Secretary of State to be relevant; and (b) set conditions that the conformity assessment body must meet. (7) For the purposes of this Article, “accreditation certificate” means a certificate issued by the UK national accreditation body, attesting that a conformity assessment body meets the approved body requirements.

• (21) For Article 21 substitute—

The Secretary of State may authorise the UK national accreditation body to carry out the following activities on behalf of the Secretary of State— (a) assessing whether a conformity assessment body meets the approved body requirements; (b) monitoring approved bodies in accordance with Article 22; and (c) compiling and maintaining the register of approved bodies, in accordance with Article 28.

• (22) For Article 22 substitute—