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

Type Statutory-Instrument

Publication 2019-03-27

Last updated 2020-12-31

State In force

Department King's Printer of Acts of Parliament

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(c) the UK marking and the inscriptions have been affixed in accordance with regulation 6(1)(b) to (d);

Amendment to regulation 20

14

In regulation 20 (requirements which must be satisfied before an importer places a category B vessel on the market), in paragraph (a) for “the sound engineering practice in a Member State” substitute “ sound engineering practice ”.

Amendment to regulation 21

15

In regulation 21 (information identifying importer)—

(a) in paragraph (1) omit the words from “or, where” to “vessel”;

(b) after paragraph (1) insert—

(1A) Paragraph (1) does not apply where— (a) either— (i) it is not possible to set out the information referred to in paragraph (1) on the vessel, or (ii) the importer has imported the vessel 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 vessel on the market, the importer sets out the information referred to in paragraph (1) in a document accompanying the vessel.

(c) in paragraph (2) for “competent national authority in the Member State in which it is to be made available to such end-users” substitute “ enforcing authority ”.

Amendment to regulation 22

16

For regulation 22 (instructions and safety information) substitute—

(22) When placing a vessel on the market, an importer must ensure that the vessel is accompanied by instructions and safety information that are clear, legible and in easily understandable English.

Amendment to regulation 25

17

In regulation 25 (duty of importer to take action in respect of vessels placed on the market which are considered not to be in conformity), in paragraph (2) omit “and the competent national authorities of any other Member State in which the importer made the vessel available on the market,”.

Amendment to regulation 26

18

In regulation 26 (retention by importer of technical documentation and EU declaration of conformity), in the heading to that regulation and in paragraph (a), omit “EU”.

Amendment to regulation 29

19

Regulation 29 (requirements which must be satisfied before a distributor makes available on the market a category A vessel), paragraph (a) is amended as follows—

(a) in subparagraph (i) for “CE” substitute “ UK ”; and

(b) for subparagraph (ii) substitute—

(ii) is accompanied by instructions and safety information that are clear, legible and in easily understandable English;

Amendment to regulation 31

20

In regulation 31 (requirements which must be satisfied before a distributor makes a category B vessel available on the market)—

(a) for paragraph (1)(a)(ii) substitute—

(ii) is accompanied by instructions and safety information that are clear, legible and in easily understandable English;

; and

(b) omit paragraph (2).

Amendment to regulation 33

21

In regulation 33 (duty for distributor to take action), in paragraph (2) omit “and the competent national authorities of any other Member States in which the distributor made the vessel available on the market”.

Omission of regulation 36

22

Omit regulation 36 (translation of EU declaration of conformity).

Amendment to regulation 38

23

In regulation 38 (improper use of CE marking) in the heading and in each place in which it occurs, for “CE” substitute “ UK ”.

Insertion of regulations 38A and 38B

24

After regulation 38 insert—

(38A) (1) In this regulation— (a) any reference to an Article or an Annex is a reference to an Article or an Annex of the Directive; (b) “CE marking” has the meaning given to it in Article 2(17); (c) “harmonised standard” has the meaning given to it in Article 2(9). (2) Subject to paragraphs (6) and (7), paragraph (3) applies where, before placing a category A vessel on the market, the manufacturer— (a) ensures that the vessel has been designed and manufactured in accordance with the essential safety requirements set out in Annex I; (b) ensures that the relevant conformity assessment procedures that apply to that vessel in accordance with Article 13(1) and (2) have been carried out; (c) draws up the technical documentation referred to in Annex II; (d) ensures that the technical documentation and other records and correspondence relating to the conformity assessment procedures are prepared in or translated into English; (e) affixes a CE marking and the inscriptions, in accordance with Articles 15 and 16(1) to (4); (f) draws up an EU declaration of conformity, in accordance with Article 14; 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 regulations 4(1), 5, 6(1) to (3) and (5) are to be treated as being satisfied; (b) regulations 2(5)(a), 6(4), 8, 9(2), 16(2) and 38 apply subject to the modifications in paragraph (10); (c) Part 3 does not apply; and (d) regulation 62 does not apply. (4) Subject to paragraphs (6) and (7), paragraph (5) applies where, before placing a category A vessel on the market, the importer ensures that— (a) the relevant conformity assessment procedures that apply to that vessel in accordance with Article 13(1) and (2) have been carried out; (b) the manufacturer has drawn up the technical documentation referred to in Annex II; and (c) the vessel bears the CE marking and inscriptions referred to in point 1 of Annex III. (5) Where this paragraph applies— (a) the requirements of regulation 18(a) to (c) are to be treated as being satisfied; and (b) regulations 2(5)(a), 19(1), 23 and 26 apply subject to the modifications in paragraph (10). (6) This paragraph applies where there is no designated standard or part of a designated standard which corresponds exactly to a harmonised standard or part of a harmonised standard referred to in Article 12. (7) Where paragraph (6) applies, paragraphs (2)(b) and (4)(a) are to be treated as requiring the manufacturer to have carried out— (a) the conformity assessment procedure set out in Article 13(1)(b); and (b) the relevant conformity assessment procedure that applies to that product in accordance with Article 13(2). (8) Paragraph (9) applies where, before making a category A vessel available on the market, a distributor ensures that the vessel bears the CE marking and inscriptions referred to in point 1 of Annex III. (9) Where this paragraph applies— (a) regulation 29(a)(i) is to be treated as being satisfied; and (b) regulations 2(5)(a), 30(1) and 32 apply subject to the modifications in paragraph (10). (10) The modifications referred to in paragraphs (3)(b), (5)(b) and (9)(b) are that— (a) any reference to “declaration of conformity” is to be read as a reference to the EU declaration of conformity; (b) any reference to “UK marking” is to be read as a reference to the CE marking; (c) any reference to “essential safety requirements” is to be read as a reference to the essential safety requirements referred to in Annex I; (d) any reference to “designated standard” is to be read as a reference to a harmonised standard; (e) any reference to “relevant conformity assessment procedure” is to be read as a reference to the conformity assessment procedures that apply to the vessel in accordance with Article 13(1) and (2); (f) any reference to “technical documentation” is a reference to the technical documentation referred to in Annex II. (38B) (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(9). (2) Subject to paragraphs (4) and (5), paragraph (3) applies where, prior to the manufacture of a category A vessel, the manufacturer ensures that the conformity assessment procedure that applies to that vessel in accordance with Article 13(1) has been carried out. (3) Where this paragraph applies— (a) regulation 40 is to be treated as being satisfied; (b) any reference to “relevant conformity assessment procedure” in regulations 5(b), 6(1), 18(a), 38(b) and 43(c) is to be read as including the conformity assessment procedure referred to in Article 13(1); and (c) any reference to “technical documentation” in regulations 5(a), 8, 18(b) and 26(b) is to be read as including the technical documentation relating to the design of the vessel referred to in Annex II. (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 12. (5) Where paragraph (4) applies, paragraph (2) is to be treated as requiring the manufacturer to have carried out the conformity assessment procedure set out in Article 13(1)(b). (38C) (1) Subject to paragraph (2), regulation 38A ceases to have effect at the end of the period of 12 months beginning with IP completion day. (2) Notwithstanding the expiry of regulation 38A— (a) any vessel which was placed on the market pursuant to regulation 38A may continue to be made available on the market after the expiry of regulation 38A; (b) any obligation to which a person was subject under regulation 38A in respect of a vessel placed on the market pursuant to regulation 38A continues to have effect after the expiry of regulation 38A, in respect of that vessel. (3) Subject to paragraph (4), regulation 38B 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 38B in relation to a vessel prior to the expiry of regulation 38B, regulation 38B continues to apply in respect of that vessel 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 an EU-Type examination has been carried out in accordance with a conformity assessment procedure set out in point 1 of Annex II of the Directive. (38D) (1) Where paragraph (2) applies, a vessel is to be treated as being in conformity with Part 2. (2) This paragraph applies where— (a) a vessel— (i) is in conformity with Part 2, as that Part applies in Northern Ireland; and (ii) is qualifying Northern Ireland goods; and (b) an importer has complied with the obligations set out in paragraph (3). (3) The obligations referred to in paragraph (2)(b) are that, before placing the vessel on the market, the importer— (a) complies with regulation 21; (b) ensures that— (i) the relevant conformity assessment procedure has been carried out in relation to the vessel, in accordance with Part 3, as that Part applies in Northern Ireland; (ii) the manufacturer has drawn up the technical documentation; and (iii) the vessel bears the CE marking. (4) In this regulation— - “CE marking” has the meaning given to it in regulation 2(1), as it applies in Northern Ireland; - “qualifying Northern Ireland goods” has the meaning given to it in regulations made under section 8C(6) of the European Union (Withdrawal) Act 2018; - “technical documentation” means the documentation referred to in paragraph 2(2)(c) of Part 1 of Schedule 2 to these Regulations, as that Schedule applies in Northern Ireland.

Amendment to regulation 39

25

In regulation 39 (presumption of conformity of category A vessels), in paragraph (1)—

(a) for “harmonised” substitute “ designated ”;

(b) omit “the reference to which has been published in the Official Journal”.

Amendment to regulation 40

26

In regulation 40 (conformity assessment procedures prior to manufacturer)—

(a) in paragraphs (1) and (4) for “an EU-type”, substitute “ a Type ”;

(b) in paragraphs (2) and (3) for “harmonised” substitute “ designated ”.

Amendment to regulation 42

27

In regulation 42 (records and correspondence language requirements)—

(a) for “an official language of the Member State in which the notified body is established” substitute “ English ”;

(b) for “that body” substitute “ the approved body ”.

Amendment to regulation 43

28

In regulation 43 (EU declaration of conformity)—

(a) in the heading for “EU declaration” substitute “ Declaration ”;

(b) omit “EU”.

Amendment to regulation 44

29

In regulation 44 (identification number)—

(a) for paragraph (1) substitute—

(1) The UK marking must be followed by the identification number of the approved body involved in the relevant conformity assessment procedure pursuant to regulation 41.

(b) in paragraph (2) for “notified” in each place it in which it occurs, substitute “ approved ”.

Amendment to Part 4

30

For Part 4, substitute—

(45) (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 regulation 46 (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 regulation 51(1) or (2) as they had effect immediately before IP completion day to suspend or withdraw the body's status as a notified body. (2) Paragraph (1) has effect subject to regulation 49 (restriction, suspension or withdrawal of approval). (3) In this Part— - “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 17 of the Directive; and 2. in respect of which no objections had been raised, as referred to in regulation 45(1)(b), as it had effect immediately beforeIP completion day; - “approved body requirements” means the requirements set out in Part 1 of Schedule 4. (46) (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 vessels 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 regulation “accreditation certificate” means a certificate, issued by the UK national accreditation body, attesting that a conformity assessment body meets the approved body requirements. (47) (1) Where a conformity assessment body demonstrates its conformity with the criteria laid down in a designated standard (or part of such standard), the Secretary of State is to presume that the conformity assessment body meets the approved body requirements covered by that standard (or that part of that standard). (2) The presumption in paragraph (1) is rebuttable. (48) The Secretary of State must monitor each approved body with a view to verifying that the body— (a) continues to meet the approved body requirements; (b) meets any conditions set— (i) in accordance with regulation 46(6)(b); or (ii) in the case of an approved body which was a notified body immediately before IP completion day, in accordance with regulation 46(6)(b), as it applied immediately before IP completion day; and (c) carries out its functions in accordance with these Regulations. (49) (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 regulation 48(b), the Secretary of State must restrict, suspend or withdraw the body's status as an approved body under regulation 45 (approved bodies). (2) Where the Secretary of State determines that an approved body no longer meets a condition referred to in regulation 48(b), the Secretary of State may restrict, suspend or withdraw the body's status as an approved body under regulation 45. (3) In deciding what action is required 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 the Secretary of State and market surveillance authorities 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. (50) (1) Subject to the terms of its appointment, an approved body must carry out the conformity assessment activities and procedures— (a) in respect of which the body's approval was given under regulation 46; or (b) in respect of which the body's notification as a notified body was made. (2) Where an approved body carries out a conformity assessment procedure, it must do so in accordance with Part 2 of Schedule 4. (3) An approved body must make provision for a manufacturer to be able to make an appeal against a refusal by the approved body— (a) to issue a Type examination certificate referred to in Schedule 2; or (b) to affix, or cause to be affixed, the body's identification number pursuant to regulation 44 (identification number). (51) (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 regulation “subsidiary” has the meaning given to it in section 1159 of the Companies Act 2006 . (52) (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. (53) 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 regulation 48; and (c) compiling and maintaining the register of approved bodies, in accordance with regulation 52.

Amendment to regulation 57

31

In regulation 57 omit paragraph (c).

Amendment to regulation 59

32

Regulation 59 (enforcement action in respect of vessels which are not in conformity) is amended as follows—

(a) in paragraph (2) for “notified” substitute “ approved ”;

(b) omit paragraphs (4) and (7);

(d) in paragraph (8)(f)(ii) for “harmonised” substitute “ designated ”; and

(e) in paragraph (10) omit “throughout the EU”.

Omission of regulation 60

33

Omit regulation 60 (EU safeguard procedure).

Amendment to regulation 61

34

In regulation 61 (enforcement action in respect of vessels which are in conformity, but which present a risk)—

(a) omit paragraph (3); and

(b) in paragraph (4) for “notices referred to in paragraphs (2) and (3)” substitute “ notice referred to in paragraph (2) ”.

Amendment to regulation 62

35

Regulation 62 (enforcement action in respect of formal non-compliance) is amended as follows—

(a) in paragraphs (1)(a)(i), (1)(a)(ii), (1)(a)(iv) and (1)(b)(i) for “CE” substitute “ UK ” in each place in which it occurs;

(b) in paragraphs (1)(a)(ii), (1)(a)(iv), (1)(b)(i) omit “EU” in each place in which it occurs;

(d) in paragraphs (1)(a)(iii)(aa) and (bb) for “notified” substitute “ approved ”;

(e) in paragraph (4) omit “or 60(3) (the EU safeguard procedure)”.

Amendment to regulation 76

36

In regulation 76 (transitional provisions) in paragraph (1) for “another” substitute “ a ”.

Transitional provision in relation to EU Exit

37

After regulation 76 insert—

(76A) (1) In this regulation— - “pre-exit period” means the period beginning with the commencement date and ending immediately before IP completion day; - “product” means a vessel 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 21 to the Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019 , any obligation to which a person was subject 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. (3) Paragraph (2) does not apply to— (a) any obligation of any enforcing 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. (4) Where during the pre-exit period— (a) a product has not been placed on the market; and (b) a manufacturer has taken any action under regulations 40 or 41 as they had effect immediately before IP completion day in relation to that product that action has effect as if it had been done under regulations 40 or 41 as they have effect on and after IP completion day.

Amendment to regulation 77

38

(1) Regulation 77 (revocations and savings) is amended as follows.

(2) In paragraph (2) before “as if” insert “ subject to the modifications in paragraph (2A). ”.

(3) After paragraph (2) insert—

(2A) The modifications referred to in paragraph (2) are as follows— (a) in the 1991 Regulations— (i) any reference to “the Community” is to be read as including the United Kingdom; (ii) any reference to “member State” is to be read as including the United Kingdom; (iii) in regulation 11 (EC type-examination certificate)— (aa) in paragraph (6)(a), for “the Commission, any other approved body or any other member State” substitute “ or any other United Kingdom approved body ”; (bb) in paragraph (8), omit “, with a view to this information being passed by him to the Commission and the other member States”; (iv) in regulation 17 (Functions of approved bodies in course of EC Surveillance)— (aa) paragraph (2) is to be read as if “or elsewhere” were omitted; (bb) paragraph (3) is to be read as if “, the Commission, any other approved body or any other member State” were omitted; (v) paragraph 6 of Schedule 5 (enforcement), is to be read as if “, with a view to this information being passed by him to the Commission” were omitted; (b) in the Simple Pressure Vessels (Safety) (Amendment) Regulations 1994, in regulation 5 (transitional provisions in respect of marking arrangements)— (i) any reference to “the Community” is to be read as including the United Kingdom; and (ii) paragraph (3) is to be read as if the following paragraph were substituted— (3) In the event of such election, to demonstrate compliance with the marking arrangements in force on 31 December 1994, the manufacturer or his authorised representative established in the Community, shall apply the principal Regulations (as amended by these Regulations)— (a) as if the amendments made by regulation 4(f) and (k) had not come into force; and (b) read subject to the modifications made by regulation 77(2A)(a) of the Simple Pressure Vessels (Safety) Regulations 2016 .

Amendment to Schedule 1

39

In Schedule 1, in paragraph 21(2) for “a notified” in each place in which it occurs substitute “ an approved ”.

Amendment to Schedule 2

40

Schedule 2 (conformity assessment procedures) is amended as follows—

(a) in the heading, omit “EU-”;

(b) in paragraphs 1, 7(1), 8(3) to (5), 11(2) and 15(2) for “a notified” substitute “ an approved ”;

(c) in all places in which it occurs (other than those referred to in sub-paragraph (b)) for “notified” substitute “ approved ”;

(d) in paragraph 6(1) and (3) for “an EU-Type” substitute “ a Type ”;

(e) in all places in which it occurs (other than the paragraphs referred to in sub-paragraph (d)) for “EU-Type” substitute “ Type ”;

(f) in paragraphs 2(2)(e)(i), 3(1)(c)(iv) and (v) and 16(2) for “harmonised” substitute “ designated ”;

(g) in paragraph 3(c)(iv) omit “, the references to which have been published in the Official Journal”;

(h) in paragraph 8(3) for “Commission, the member States” substitute “ Secretary of State ”;

(i) in paragraph 8(4), for “Commission and the member States” substitute “ Secretary of State ”;

(j) in paragraph 12(3) for “Member State in which the test is performed” substitute “ Secretary of State ”;

(k) in paragraphs 12(9) and 16(6) omit “other Member States and the Commission,”;

(l) for the headings to paragraphs 13, 17 and 20 substitute— “ UK marking and declaration of conformity ”;

(m) in paragraphs 13, 17 and 20—

(i) for “CE” substitute “ UK ”; and

(ii) for “EU declaration” substitute “ declaration ” in each place in which it occurs; and

(n) in paragraph 18 for “the Directive” substitute “ these Regulations ”.

Amendment to Schedule 3

41

Schedule 3 (EU Declaration of conformity) is amended as follows—

(a) omit “EU” in each place in which it occurs;

(b) for “declaration” in the first place in which it occurs substitute “ Declaration ”;

(d) in paragraph 6, for “harmonised” substitute “ designated ”; and

(e) in paragraph 7 for “notified” substitute “ approved ”.

Amendments to Schedule 4

42

Schedule 4 (notified bodies) is amended as follows—

(a) in paragraphs 8(b), 17, 18, 19, 20, 21, 24, 26, 27, 28 and 29 for “a notified” substitute “ an approved ”;

(b) in all places in which it occurs (other than the paragraphs referred to in subparagraph (a)) for “notified” substitute “ approved ”;

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

(ii) omit “the relevant Directives and of”;

(d) in paragraphs 16 and 29 for “under the Directive” substitute “ by the Secretary of State ”;

(e) in paragraph 21 for “harmonised” substitute “ designated ”; and

(f) in paragraph 26(b) omit “(notification)”.

SCHEDULE 22 — Amendment of the Lifts Regulations 2016

Introduction

1

The Lifts Regulations 2016 are amended in accordance with paragraphs 2 to 44.

Amendment to regulation 2

2

(1) Regulation 2 (interpretation) is amended as follows.

(2) In paragraph (1)—

(a) omit the definition of “accreditation”;

(b) omit the definition of “accreditation certificate”;

“approved body” has the meaning given to it in regulation 51 (approved bodies);

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

(e) omit the definition of “CE marking”;

(f) omit the definition of “competent national authority”;

(g) after the definition of “conformity assessment body” insert—

“declaration of conformity” means a declaration of conformity required to be drawn up in accordance with— (a) in relation to lifts, regulation 8(1)(a) (declaration of conformity and UK marking: installer); and (b) in relation to safety components for lifts, regulation 17(1)(a) (declaration of conformity and UK marking: manufacturer);

(h) after the definition of the “Department” insert—

“designated standard” has the meaning given to it in regulation 2A;

(i) in the definition of “the Directive” at the end insert “ (as it has effect immediately before IP completion day ”);

(j) omit the definition of “European Commission”;

(k) omit the definition of “EU declaration of conformity”;

(l) omit the definition of “harmonised standard”;

(m) for definition of “importer” substitute—

“importer” means a person who— (a) is established in the United Kingdom and places a safety component for lifts from a country outside of the United Kingdom on the market; or (b) is established in Northern Ireland and places a safety component for lifts 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;

(n) in the definition of “make available on the market” for “EU market” substitute “market of Great Britain”;

(o) omit the definition of “national accreditation body”;

(p) omit the definition of “notified body requirements”;

(q) omit the definition of “Official Journal”;

(r) in the definition of “place on the market” for “EU market” substitute “market of Great Britain” in both places in which it occurs;

(s) in the definition of “safety component for lifts” omit the words after “Schedule 3”;

(t) after the definition of “technical specification” insert—

“UK marking” means the marking in the form set out in Annex 2 of RAMS; “UK national accreditation body” means the body appointed by the Secretary of State in accordance with Article 4 of RAMS;

(3) After paragraph (1) insert—

(1A) Schedules 11 to 19 reproduce the provisions of Annexes IV to XII to the Directive (respectively) with amendments to correct deficiencies in retained EU law. (1B) A reference to any provision of Schedules 11 to 19 is a reference to the equivalent provision of the relevant Annex to the Directive as set out in the relevant Schedule.

(4) Omit paragraphs (3) and (5).

Insertion of regulation 2A

3

After regulation 2 insert—

(2A) (1) Subject to paragraphs (6) and (7), in these Regulations 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), a “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 regulation 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 regulation, a reference to a “product” is a reference to a lift or a safety component for lifts to which these Regulations apply. (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) are to be made by statutory instrument. (11) A statutory instrument containing regulations made under paragraph (9) is subject to annulment in pursuance of a resolution of either House of Parliament.

Amendment to regulation 5

4

In regulation 5 (lifts where risks are wholly or partly covered by other EU law) and in the heading to that regulation for “EU law” substitute “ enactments ”.

Amendment to regulation 7

5

In regulation 7 (technical documentation and conformity assessment)—

(a) in paragraph (b)(i) for “Annex IV to the Directive (as amended from time to time)” substitute “ Schedule 11 ”;

(b) in paragraph (b)(ii) for “Annex XI to the Directive (as amended from time to time)” substitute “ Schedule 18 ”;

Amendment to regulation 8

6

(1) Regulation 8 (EU declaration of conformity and CE marking) is amended as follows.

(2) In the heading to that regulation—

(a) for “EU declaration” substitute “ Declaration ”; and

(b) for “CE” substitute “ UK ”.

(3) In paragraph (1)—

(a) in sub-paragraph (a) omit “EU”; and

(b) in sub-paragraph (c) for “CE”, in both places it occurs, substitute “ UK ”.

(4) In paragraph (2) omit “EU”.

(5) For paragraph (3) substitute—

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

Amendment to regulation 9

7

In regulation 9 (retention of technical documentation and EU declaration of conformity) and in the heading to that regulation omit “EU”.

Amendment to regulation 10

8

In regulation 10 (labelling and instructions)—

(a) for paragraph (2) substitute—

(2) the information referred to in paragraph (1) must be clear, legible and in easily understandable English.

; and

(b) omit paragraph (3).

Amendment to regulation 12

9

In regulation 12 (duty to take action in respect of lifts placed on the market which are considered not to be in conformity) in paragraph (2), omit the words from “, and” to “market,”.

Amendment to regulation 16

10

In regulation 16 (technical documentation and conformity assessment) in paragraph (b)—

(a) in sub-paragraph (i) for “Annex IV to the Directive (as amended from time to time)” substitute “ Schedule 11 ”; and

(b) in sub-paragraph (ii) for “Annex VII to the Directive (as amended from time to time)” substitute “ Schedule 14 ”.

Amendment to regulation 17

11

(1) Regulation 17 (EU declaration of conformity and CE marking) is amended as follows.

(2) In the heading to that regulation—

(a) for “EU declaration” substitute “ Declaration ”; and

(b) for “CE” substitute “ UK ”.

(3) In paragraph (1)—

(a) in sub-paragraph (a) omit “EU”; and

(b) in sub-paragraph (c) for “CE”, in both places it occurs, substitute “ UK ”.

(4) In paragraph (2) omit “EU”.

(5) For paragraph (3) substitute—

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

Amendment to regulation 18

12

In regulation 18 (retention of technical documents and EU declaration of conformity) and in the heading to that regulation omit “EU”.

Amendment to regulation 19

13

In regulation 19 (labelling and instructions)—

(a) for paragraph (2) substitute—

(2) The information referred to in paragraph (1) must be clear, legible and in easily understandable English.

; and

(b) omit paragraph (4).

Amendment to regulation 20

14

In regulation 20 (compliance procedures for series production) in paragraph 2(b)—

(a) for “harmonised” substitute “ designated ”; and

(b) omit “EU”.

Amendment to regulation 22

15

In regulation 22 (duty to take action in respect of safety components for lifts placed on the market which are considered not to be in conformity) in paragraph (2) omit the words from “, and” to “market,”.

Amendment to regulation 24

16

In regulation 24 (appointment of authorised representatives)—

(a) in paragraph (1) after “a person” insert “ established in the United Kingdom ”;

(b) omit “EU” in each place it occurs; and

Amendment to regulation 26

17

In regulation 26 (requirements which must be satisfied before an importer places a safety component for lifts on the market) in paragraph (1)(c)—

(a) in paragraph (i) for “CE” substitute “ UK ”; and

(b) in paragraph (ii), omit “EU”.

Amendment to regulation 28

18

In regulation 28 (information identifying importer)—

(a) in paragraph (2) for “competent national authority” to the end substitute “ market surveillance authority ”;

(b) for paragraph (3) substitute—

(3) Paragraph (1) does not apply where— (a) either— (i) it is not possible to set out the information specified in paragraph (1) on the safety component for lifts; or (ii) the importer has imported the safety component 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 safety component for lifts on the market, the importer sets out the information specified in paragraph (1)— (i) on the packaging; or (ii) in a document accompanying the safety component for lifts.

Amendment to regulation 29

19

In regulation 29 (instructions)—

(a) for paragraph (1) substitute—

(1) When placing a safety component for lifts on the market, an importer must ensure that it is accompanied by the instructions referred to in paragraph 7 of Schedule 1 and that they are clear, legible and in easily understandable English.

; and

(b) omit paragraph (2).

Amendment to regulation 33

20

In regulation 33 (retention of technical documentation and EU declaration of conformity) and in the heading to that regulation omit “EU”.

Amendment to regulation 37

21

In regulation 37 (requirements which must be satisfied before a distributor makes a safety component for lifts available on the market)—

(a) in paragraph (1)(a)—

(i) in paragraph (i) for “CE” substitute “ UK ”;

(ii) in paragraph (ii) omit “EU”; and

(iii) for paragraph (iii) substitute—

(iii) is accompanied by the instructions referred to in paragraph 7 of Schedule 1 and that they are clear, legible and in easily understandable English;

; and

(b) omit paragraph (2).

Amendment to regulation 40

22

In regulation 40 (duty to take action in respect of safety components for lifts made available on the market which are not in conformity with Part 2) in paragraph (2) omit the words from “, and” to “market,”.

Amendment to regulation 43

23

Omit regulation 43 (translation of declaration of conformity).

Amendment to regulation 45

24

In regulation 45 (prohibition on improper use of CE marking), in each place it occurs and in the heading to that regulation, for “CE” substitute “ UK ”.

Insertion of regulations 45A and 45B

25

After regulation 45 insert—

(45A) (1) In this regulation— (a) any reference to an Article or an Annex is a reference to an Article of or an Annex to the Directive; (b) “CE marking” has the meaning given to it in Article 2(21); (c) “harmonised standard” has the meaning given to it in Article 2(13). (2) Paragraph (3) applies where, before placing a lift on the market, the installer— (a) ensures that the lift has been designed, manufactured, installed and tested in accordance with the essential health and safety requirements set out in Annex I; (b) ensures that the conformity assessment procedure that applies to that lift in accordance with Article 16 has been carried out; (c) draws up the technical documentation referred to in Article 7(2); (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 other markings, in accordance with Articles 18 and 19(1) to (5); (f) draws up an EU declaration of conformity, in accordance with Article 17; 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 regulations 6, 7, 8(1) and 8(3) are to be treated as being satisfied; (b) regulations 2(2)(a), 8(2), 9, 24(2), 24(3) and 45 apply subject to the modifications in paragraph (10); (c) Part 3 does not apply; and (d) regulation 68 does not apply. (4) Paragraph (5) applies where, before placing a safety component for lifts on the market, the manufacturer— (a) ensures that the safety component has been designed and manufactured in accordance with Article 5(2); (b) ensures that the conformity assessment procedure that applies to that safety component in accordance with Article 15 has been carried out; (c) ensures that the relevant technical documentation referred to in Article 8(2) is drawn up; (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 other markings, in accordance with Articles 18 and 19(1) to (5); (f) draws up an EU declaration of conformity, in accordance with Article 17; and (g) ensures that the EU declaration of conformity is prepared in or translated into English. (5) Where this paragraph applies— (a) the requirements of regulations 15, 16, 17(1) and (17)(3) are to be treated as being satisfied; (b) regulations 2(2)(a), 17(2), 18, 20(2), 24(2), 24(3) and 45 apply subject to the modifications in paragraph (10); (c) Part 3 does not apply; and (d) regulation 68 does not apply. (6) Paragraph (7) applies where, before placing a safety component for lifts on the market, the importer ensures that— (a) the conformity assessment procedure that applies to that lift in accordance with Article 15 has been carried out; (b) the manufacturer has drawn up the relevant technical documentation referred to in Article 8(2); and (c) the safety component for lifts— (i) bears the CE marking; and (ii) is accompanied by the EU declaration of conformity drawn up in accordance with Article 17. (7) Where this paragraph applies— (a) the requirements of regulation 26(1)(a) to (c)(i) are to be treated as being satisfied; (b) any requirement of regulation 26(1)(c)(ii), insofar as it relates to the declaration of conformity, is to be treated as being satisfied; and (c) regulations 2(2)(a), 27(1), 30 and 33 apply subject to the modifications in paragraph (10). (8) Paragraph (9) applies where, before making a safety component for lifts available on the market, a distributor ensures that the safety component for lifts— (a) bears the CE marking; and (b) is accompanied by an EU declaration of conformity drawn up in accordance with Article 17. (9) Where this paragraph applies— (a) the requirements of regulations 37(1)(a)(i) are to be treated as being satisfied; (b) any requirement of regulation 37(1)(a)(ii), insofar as it relates to the declaration of conformity, is to be treated as being satisfied; and (c) regulations 2(2)(a), 38(1) and 39 apply subject to the modifications in paragraph (10). (10) The modifications referred to in paragraphs (3)(b), (5)(b), (7)(c) and 9(c) are that— (a) any reference to “declaration of conformity” is to be read as a reference to the EU declaration of conformity; (b) any reference to “UK marking” is to be read as a reference to the CE marking; (c) any reference to “essential health and safety requirements” is to be read as a reference to the essential health and safety requirements referred to in Annex I; (d) any reference to “designated standard” is to be read as a reference to a harmonised standard; (e) any reference to “relevant conformity assessment procedure” is to be read as a reference to the conformity assessment procedure that applies to the lift or the safety component for the lift in accordance with Article 15 or Article 16, as the case may be; (f) any reference to “technical documentation” is a reference to the relevant technical documentation set out in Annexes IV to XII. (45B) (1) In this regulation, any reference to an Article or an Annex is a reference to an Article of or an Annex to the Directive. (2) Paragraph (3) applies where, prior to the manufacture of a safety component, the manufacturer ensures that the conformity assessment procedure set out in Annex IV, Part A and referred to in Article 15(a) and (b) as EU-type examination, has been carried out in relation to a model of the safety component in accordance with Article 15(a) or (b). (3) Where this paragraph applies— (a) the requirement in regulation 48(a) or (b) to submit the model of the safety component for the conformity assessment procedure referred to in that regulation as Type examination is to be treated as being satisfied; (b) any reference to “relevant conformity assessment procedure” in regulations 16(a), 17(1), 26(1)(a), 45(1)(b) and 49(b) is to be read as including the conformity assessment procedure referred to in Article 15(a) or (b) as EU-type examination; and; (c) any reference to “technical documentation” in regulations 16(b), 18, 26(1)(b) and 33(b) is to be read as including the technical documentation relating to the design of the safety component referred to in Annex IV, Part A. (4) Paragraph (5) applies where, a lift is designed and manufactured in accordance with a model lift that has undergone the conformity assessment procedure set out in Annex IV, Part B, referred to in Article 16(1)(a) as EU-type examination. (5) Where this paragraph applies— (a) the condition in regulation 47(1)(a) that the lift is designed and manufactured in accordance with a model lift which has undergone a Type examination set out in Part B of Schedule 11, is to be treated as being satisfied; (b) any reference to “relevant conformity assessment procedure” in regulations 7(a), 8(1), 45(1)(b) and 49(b) is to be read as including the conformity assessment procedure set out in Annex IV, Part B and referred to in Article 16(1)(a) as EU-type examination; and (c) any reference to “technical documentation” in regulations 7(b) and 9 is to be read as including the technical documentation relating to the design of the lift referred to in Annex IV, Part B. (45C) (1) Subject to paragraph (2), regulation 45A ceases to have effect at the end of the period of 12 months beginning with IP completion day. (2) Notwithstanding the expiry of regulation 38A— (a) any safety component for lifts which was placed on the market pursuant to regulation 45A may continue to be made available on the market on or after the expiry of regulation 45A; (b) any obligation to which a person was subject under regulation 45A in respect of a lift or safety component for lifts placed on the market pursuant to regulation 45A continues to have effect after the expiry of regulation 45A, in respect of that lift or safety component for lifts. (3) Subject to paragraph (4), regulation 45B 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 45B in relation to a lift or a safety component for lifts prior to the expiry of regulation 45B, regulation 45B continues to apply in respect of that lift or safety component for lifts 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— (a) in relation to a safety component for lifts, the conformity assessment procedure set out in Annex IV, Part A of the Directive and referred to in Article 15(a) and (b) of the Directive as EU-type examination, has been carried out in relation to a model of the safety component for lifts in accordance with Article 15(a) or (b) of the Directive; or (b) in relation to a lift that is designed and manufactured in accordance with a model, the conformity assessment procedure set out in Annex IV, Part B of the Directive, referred to in Article 16(1)(a) of the Directive as an EU-type examination has been carried out in relation to a model. (45D) (1) Where paragraph (2) applies a safety component for lifts is to be treated as being in conformity with Part 2. (2) This paragraph applies where— (a) a safety component for lifts— (i) is in conformity with Part 2, as that Part applies in Northern Ireland; and (ii) is qualifying Northern Ireland goods; and (b) an importer has complied with the obligations set out in paragraph (3). (3) The obligations referred to in paragraph (2)(b) are that, before placing the safety component for lifts on the market, the importer— (a) complies with regulation 28; (b) ensures that— (i) the relevant conformity assessment procedure has been carried out in accordance with Part 3, as that Part applies in Northern Ireland; (ii) the manufacturer has drawn up the technical documentation; and (iii) the safety component bears the CE marking. (4) In this regulation— - “CE marking” has the meaning given to it in regulation 2(1), as it applies in Northern Ireland; - “qualifying Northern Ireland goods” has the meaning given to it in regulations made under section 8C(6) of the European Union (Withdrawal) Act 2018; - “technical documentation” means the documentation a manufacturer must draw up in accordance with regulation 16(b), as it applies in Northern Ireland.

Amendment of regulation 46

26

In paragraph (1) of regulation 46 (presumption of conformity)—

(a) for “harmonised” substitute “ designated ”; and

(b) omit the words from “the reference” to “Journal”.

Amendment to regulation 47

27

(1) Regulation 47 (conformity assessment procedures for lifts) is amended as follows.

(2) In paragraph (1)(a)—

(a) for “EU-type” substitute “ Type ”;

(b) for “Annex IV to the Directive (as amended from time to time)” substitute “ Schedule 11 ”;

(d) in paragraph (ii) for “Annex X to the Directive (as amended from time to time)” substitute “ Schedule 17 ”; and

(e) in paragraph (iii) for “Annex XII to the Directive (as amended from time to time)” substitute “ Schedule 19 ”.

(3) In paragraph (1)(b)—

(a) for “Annex XI to the Directive (as amended from time to time)” substitute “ Schedule 18 ”;

(b) in paragraph (i) for “Annex V to the Directive (as amended from time to time)” substitute “ Schedule 12 ”;

(d) in paragraph (iii) for “Annex XII to the Directive (as amended from time to time)” substitute “ Schedule 19 ”.

(4) In paragraph (1)(c) for “Annex VIII to the Directive (as amended from time to time)” substitute “ Schedule 15 ”.

(5) In paragraph (1)(d) for “Annex XI to the Directive (as amended from time to time)” substitute “ Schedule 18 ”.

Amendment to regulation 48

28

Regulation 48 (conformity assessment procedures for safety components for lifts) is amended as follows—

(a) for “EU type” substitute “ Type ” in both places it occurs;

(b) in paragraph (a)—

(i) for “Annex IV to the Directive (as amended from time to time)” substitute “ Schedule 11 ”; and

(ii) for “Annex IX to the Directive (as amended from time to time)” substitute “ Schedule 16 ”;

(i) for “Annex IV to the Directive (as amended from time to time)” substitute “ Schedule 11 ”; and

(ii) for “Annex VI to the Directive (as amended from time to time)” substitute “ Schedule 13 ”;

(d) in paragraph (c) for “Annex VII to the Directive (as amended from time to time)” substitute “ Schedule 14 ”.

Amendment to regulation 49

29

In regulation 49 (EU declaration of conformity)—

(a) in the heading for “EU declaration” substitute “ Declaration ”;

(b) omit “EU” in both places it occurs; and

(c) in paragraph (b) for “Annexes V to XII to the Directive (as amended from time to time)” substitute “ Schedules 12 to 19 ”.

Amendment to regulation 50

30

(1) Regulation 50 (CE marking) is amended as follows.

(2) In the heading to that regulation for “CE” substitute “ UK ”.

(3) For paragraph (1) substitute—

(1) The UK marking must be affixed visibly, legibly, and indelibly— (a) to the lift carrier; (b) to the safety component for lifts; or (c) where paragraph (1A) applies, to— (i) a label affixed to the lift carrier or the safety component; or (ii) to a document accompanying the lift or the safety component.

(3A) After paragraph (1) insert—

(1A) For a period of 24 months beginning with IP completion day, the UK marking may be affixed to— (a) a label affixed to the lift carrier or the safety component; or (b) to a document accompanying the lift or the safety component.

(3B) In the following paragraphs, for “CE” substitute “ UK ”

(a) paragraph (2) (twice);

(b) paragraph (3); and

(3C) In paragraph (2) after “Where” insert “ paragraph (1A) does not apply and ”;

(3D) In paragraph (3) for “on a” substitute “ in respect of a ”.

(4) For “notified”, in each place it occurs, substitute “ approved ”.

(5) In paragraph (3)—

(a) in sub-paragraph (a) for “Annex V to the Directive (as amended from time to time)” substitute “ Schedule 12 ”;

(b) in sub-paragraph (b) for “Annex VIII to the Directive (as amended from time to time)” substitute “ Schedule 15 ”; and

(c) in sub-paragraph (c) for “Annexes X, XI or XII to the Directive (as amended from time to time)” substitute “ Schedules 17, 18 or 19 ”.

(6) In paragraph (4)—

(ia) for “on a safety” substitute “ in respect of a safety ”;

(a) in sub-paragraph (a) for “Annex VI to the Directive (as amended from time to time)” substitute “ Schedule 13 ”;

(b) in sub-paragraph (b) for “Annex VII to the Directive (as amended from time to time)” substitute “ Schedule 14 ”; and

Amendment to Part 4

31

For Part 4, substitute—

(51) (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 regulation 52 (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 regulation 57(1) or (2) as they had effect immediately before IP completion day to suspend or withdraw the body's status as a notified body. (2) Paragraph (1) has effect subject to regulation 55 (restriction, suspension or withdrawal of approval). (3) In this Part— - “notified body” means a body— 1. which the Secretary of State had before IP completion day notified to the European Commission and the member State of the European Union, in accordance with Article 20 of the Directive; and 2. in respect of which no objections had been raised, as referred to in regulation 51(1)(b), as it had effect immediately before IP completion day; and - “approved body requirements” means the requirements set out in Schedule 4. (52) (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 relevant conformity assessment procedure in respect of which the conformity assessment body claims to be competent; (iii) the product in respect of which the conformity assessment body claims to be competent, where “product” has the meaning given to it in Regulation 2A(8); 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 regulation “accreditation certificate” means a certificate, issued by the UK national accreditation body, attesting that a conformity assessment body meets the approved body requirements. (53) (1) Where a conformity assessment body demonstrates its conformity with the criteria laid down in a designated standard (or part of such standard), the Secretary of State is to presume that the conformity assessment body meets the approved body requirements covered by that standard (or that part of that standard). (2) The presumption in paragraph (1) is rebuttable. (54) The Secretary of State must monitor each approved body with a view to verifying that the body— (a) continues to meet the approved body requirements; (b) meets any conditions set— (i) in accordance with regulation 52(6)(b); or (ii) in the case of an approved body which was a notified body immediately before IP completion day, in accordance with regulation 52(6)(b) as it applied immediately before IP completion day; and (c) carries out its functions in accordance with these Regulations. (55) the Secretary of State must restrict, suspend or withdraw the body's status as an approved body under regulation 51 (approved bodies). (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 regulation 54(b), (2) Where the Secretary of State determines that an approved body no longer meets a condition referred to in regulation 54(b), the Secretary of State may restrict, suspend or withdraw the body's status as an approved body under regulation 51. (3) In deciding what action is required 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 the Secretary of State and market surveillance authorities 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. (56) (1) Subject to the terms of its appointment, an approved body must carry out the conformity assessment activities and procedures— (a) in respect of which the body's approval was given under regulation 51; or (b) in respect of which the body's notification as a notified body was made. (2) Where an approved body carries out a conformity assessment procedure, it must do so in accordance with Schedule 6. (3) An approved body must make provision for a manufacturer to be able to make an appeal against a refusal by the approved body— (a) to issue a Type-examination certificate referred to in Schedule 11; or (b) to affix, or cause to be affixed, the body's identification number pursuant to regulation 50. (57) (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 regulation “subsidiary” has the meaning given to it in section 1159 of the Companies Act 2006 . (58) (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 notification 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. (59) 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 regulation 54; and (c) compiling and maintaining the register of approved bodies, in accordance with regulation 58.

Amendment to regulation 63

32

In regulation 63 (exercise of enforcement powers) omit paragraph (c).

Amendment to regulation 65

33

In regulation 65 (enforcement action in respect of lifts and safety components for lifts which are not in conformity and which present a risk)—

(a) in paragraph (2) for “notified” substitute “ approved ”;

(b) omit paragraphs (4) and (7);

Amendment to regulation 66

34

Omit regulation 66 (EU safeguard procedure).

Amendment to regulation 67

35

In regulation 67 (enforcement action in respect of lifts and safety components for lifts which are in conformity but present a risk)—

(a) omit paragraph (3);

(b) in paragraph (4) for “notices referred to paragraphs (2) and (3)” substitute “ notice referred to in paragraph (2) ”.

Amendment to regulation 68

36

Regulation 68 (enforcement action in respect of formal non-compliance) is amended as follows—

(a) for “CE”, in each place it occurs, substitute “ UK ”;

(b) in paragraph (1)(b)—

(i) for “a notified” substitute “ an approved ”; and

(ii) for “the notified” substitute “ the approved ”;

Amendment to regulation 82

37

In regulation 82 (transitional provisions) at the end insert—

(3) In paragraphs (4), (5) and (6)— - “pre-exit period” means the period beginning with the commencement date and ending immediately before IP completion day; - “product” means a lift or a safety component to lifts to which these Regulations apply. (4) Subject to paragraph (5), where a product was made available on the market during the pre-exit period, despite the amendments made by Schedule 22 to the Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019 , any obligation to which a person was subject 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. (5) Paragraph (4) does not apply to— (a) any obligation of any enforcing 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. (6) Where during the pre-exit period— (a) a product has not been placed on the market; and (b) a manufacturer has taken any action under regulations 47 or 48 as they had effect immediately before IP completion day in relation to that product, that action has effect as if it had been done under regulations 47 or 48 as they have effect on and after IP completion day.

Amendment to regulation 83

38

In regulation 83 (consequential revocations, savings and amendments)—

(a) in paragraph (2) for “The” substitute “ Subject to the modifications made in paragraph (3A), the ”;

(b) in paragraph (3) after “effect” insert “ , subject to the modifications made in paragraph (3A), ”;

(3A) The modifications referred to in paragraphs (2) and (3) are as follows— (a) any reference to the “Community” is to be read as including the United Kingdom; (b) any reference to a “member State” is to be read as including the United Kingdom; (c) in regulation 11(3) omit paragraph (a); (d) in Schedule 5 in Part A and in Part B— (i) in paragraph (5) omit the words from “The Commission” to “carried out.”; and (ii) in paragraph (7) omit the words after “issued”; (e) in Schedules 7, 8, 11,12 and 13— (i) in paragraph (5), for “national” substitute “ enforcement ”; and (iv) in paragraph (6) omit “and withdrawn”; (f) in paragraph (6) of Schedule 15, omit “with a view to this information being passed by him to the Commission”.

Amendment to Schedule 1

39

(1) Schedule 1 (essential health and safety requirements) is amended as follows.

(2) In paragraph 1(2), for “the Directive” substitute “ this Schedule ”.

(3) In the italic heading before paragraph 2, for “Directive 2006/42/EC” substitute “ the Supply of Machinery (Safety) Regulations 2008/1597 ”.

(4) In paragraph 2—

(a) for “Annex 1 to Directive 2006/42/EC of the European Parliament and of the Council” substitute “Schedule 2 to the Supply of Machinery (Safety) Regulations 2008/1597; and

(b) for “1.1.2 of Annex I to Directive 2006/43/EC” substitute “ paragraph 1.1.2 of Schedule 2 to the Supply of Machinery (Safety) Regulations 2008/1597 ”.

(4A) In paragraph 3(4) for “member States” substitute “ the Secretary of State ”.

(5) In paragraph (6)(1) for “1.7.3 of Annex I to Directive 2006/42/EC” substitute “ paragraph 1.7.3 of Schedule 2 to the Supply of Machinery (Safety) Regulations 2008/1597 ”.

Amendment to Schedule 3

40

In Schedule 3, in the heading omit the words “referred to in Article 1(1) of the Directive”.

Amendment to Schedule 4

41

In Schedule 4—

(a) in the heading for “Notified” substitute “ Approved ”;

(b) in paragraph 5 for “notified” substitute “ approved ”;

(d) in paragraph 9(b) for “a notified” substitute “ an approved ”;

(e) in paragraph 11(a) for “notified” substitute “ approved ”; and

(f) in paragraph 17 for “the Coordination Group of Notified Bodies for Lifts established under the Directive” substitute “ any coordination group of approved bodies for lifts established by the Secretary of State ”.

Amendment to Schedule 5

42

(1) Schedule 5 (EU declaration of conformity) is amended as follows.

(2) In the heading omit “EU”.

(3) For “notified”, in each place it occurs, substitute “ approved ”.

(4) In the heading of Part 1, omit “EU”.

(5) In paragraph (1)—

(a) omit “EU”;

(b) in sub-paragraph (f) for “the relevant Union harmonisation legislation” substitute “ relevant enactments ”;

(i) for “EU-type”, in both places it occurs, substitute “ Type ”; and

(ii) for “Annex IV to the Directive (as amended from time to time)” substitute “ Schedule 11 ”;

(d) in sub-paragraph (i) for “Annex VIII to the Directive (as amended from time to time)” substitute “ Schedule 15 ”;

(e) in sub-paragraph (j) for “Annex V to the Directive (as amended from time to time)” substitute “ Schedule 12 ”; and

(f) in sub-paragraph (k) for “Annex X, XI or XII to the Directive (as amended from time to time)” substitute “ Schedules 17, 18 or 19 ”.

(6) In the heading of Part 2, omit “EU”.

(7) In paragraph (2)—

(a) omit “EU”;

(b) in sub-paragraph (i)—

(i) for “EU-type”, in both place it occurs, substitute “ Type ”; and

(ii) for “Annex IV and Annex VI to the Directive (as amended from time to time)” substitute “ Schedule 11 and Schedule 13 ”;

(d) in sub-paragraph (k) for “Annex VI or VII to the Directive (as amended from time to time)” substitute “ Schedule 13 or 14 ”.

Amendment to Schedule 6

43

Schedule 6 (operational obligations of notified bodies) is amended as follows—

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

(b) for “A notified”, in each place it occurs, substitute “ An approved ”;

(d) in paragraph 12 for “notified under the Directive” substitute “ approved by the Secretary of State ”; and

(e) in paragraph (13) for the words “the Coordination Group of Notified Approved Bodies for Lifts established under the Directive” substitute “ any coordination group of approved bodies for lifts established by the Secretary of State ”.

New Schedules 11 to 19

44

After Schedule 10 (Compliance, withdrawal and recall notices) insert—

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