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

“private importer” means a person who— (a) is established in the United Kingdom; and (b) imports in the course of a non-commercial activity a watercraft from a country outside of the United Kingdom into the United Kingdom with the intention of putting it into service for the person's own use;

• (t) in the definition of “putting into service” for “EU market” substitute “market of Great Britain”;

• (u) after the definition of “technical documentation” insert—

“technical specification” means a document that prescribes technical requirements to be fulfilled by a product; “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) Omit paragraphs (4) 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) The Secretary of State may by regulations amend paragraph (3) to reflect any changes in the name or structure of the recognised standardisation bodies. (9) Regulations made under paragraph (8) are to be made by statutory instrument. (10) A statutory instrument containing regulations made under paragraph (8) is subject to annulment in pursuance of a resolution of either House of Parliament.

Amendment to regulation 4

4

In regulation 4(1)(g) omit “EU”.

Amendment to regulation 7

5

In regulation 7 (making available and putting into service)—

• (a) omit paragraph (1)(c)(ii);

• (b) in paragraph (2)—

• (i) in sub-paragraph (a) omit “either Directive 97/68/EC or”;

• (ii) in sub-paragraph (b) omit “either the Directive or”.

Substitution of regulation 10

6

For regulation 10 (EU declaration of conformity and CE marking) substitute—

(10) (1) Where the conformity of a product with the essential requirements has been demonstrated by a relevant conformity assessment procedure, the manufacturer must, before placing the product on the market— (a) draw up a declaration of conformity in accordance with regulation 53; and (b) affix the UK marking ... in accordance with regulation 54. (2) The declaration of conformity must follow the format set out in Schedule 4. (3) But where a declaration of conformity relates to a partly-completed watercraft, the declaration must follow the format set out in Schedule 3. (4) The manufacturer must keep the declaration of conformity up to date. (5) Where a product 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 11

7

In regulation 11 (duty of manufacturers to retain technical documentation and EU declaration of conformity) and in the heading to that regulation omit “EU”.

Amendment to regulation 12

8

In regulation 12 (compliance procedures for series production), in paragraph (2)(b)—

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

• (b) omit “EU”.

Amendment to regulation 15

9

In regulation 15 (instructions and safety information)—

• (a) in paragraph (1) for “a language which can be easily understood by consumers and other end-users in the Member State in which the product is to be made available” substitute “ English ”;

• (b) omit paragraph (2).

Amendment to regulation 16

10

In regulation 16 (duty to take action in respect of product placed on the market which is considered not to be in conformity), in paragraph (2) omit “and the competent national authorities in any Member State in which the manufacturer has made the product available on the market”.

Amendment to regulation 19

11

In regulation 19 (requirements that must be satisfied before an importer places a product on the market)—

• (a) in paragraph (1)—

• (i) in sub-paragraph (a) after “assessment” insert “ procedure ”;

• (ii) in sub-paragraph (c)(i) for “CE” substitute “ UK ”;

• (b) in paragraph (2)(a) omit “EU”.

Amendment to regulation 21

12

In regulation 21, for paragraph (2) substitute—

(2) Paragraph (1) does not apply where— (a) either— (i) in the case of a component, it is not possible to indicate the information specified in paragraph (1) on the component, or (ii) the importer has imported the product from an EEA state and places it on the market within the period of 24 months beginning with IP completion day, and (b) before placing the product on the market, the importer indicates the information specified in paragraph (1)— (i) in the case of component, in a document accompanying the product or on the packaging; or (ii) in all other cases, in a document accompanying the product.

Amendment to regulation 22

13

In regulation 22 (instructions and safety information)—

• (a) in paragraph (1) for “a language which can be easily understood by consumers and other end-users in the Member State in which the product is to be made available” substitute “ English ”;

• (b) omit paragraph (2).

Amendment to regulation 24

14

In regulation 24 (duty to take action in respect of product placed on the market which is considered not to be in conformity), in paragraph (2) omit “and the competent national authorities of any other Member State in which the importer has made the product available on the market”.

Amendment to regulation 25

15

In regulation 25 (duty of importers to retain technical documentation and EU declaration of conformity) and in the heading to that regulation omit “EU”.

Amendment to regulation 28

16

In regulation 28 (making available on the market), in paragraph (1)(a)—

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

• (b) in paragraph (iii) for “a language that can be easily understood by consumers and other end-users in the Member State in which the product is to be made available on the market” substitute “ English ”.

Amendment to regulation 29

17

In regulation 29 (duty not to make available a product on the market where a distributor suspects that it is not in conformity), in paragraph (2) omit “and the competent national authorities of other Member States in which the distributor has made the product available on the market”.

Amendment to regulation 31

18

In regulation 31 (duty to take action in respect of watercraft placed on the market which is considered not to be in conformity), in paragraph (2) omit “and the competent national authorities of any other Member State in which the distributor has made the product available on the market”.

Omission of regulation 35

19

Omit regulation 35 (translation of EU declaration of conformity).

Amendment to regulation 36

20

In regulation 36 (private importers)—

• (a) in paragraph (1)(b)—

• (i) in paragraph (ii) for “(EU declaration of conformity and CE marking)” substitute “ (declaration of conformity and UK marking) ”;

• (ii) in paragraph (iii) omit “EU”;

• (b) in paragraph (4) for “notified” substitute “ approved ”.

Amendment to regulation 39

21

In regulation 39 (authorised representatives)—

• (a) in paragraph (1) for “EU” substitute “ United Kingdom ”;

• (b) in paragraph (3)(a)—

• (i) in paragraph (i) omit “EU”;

• (ii) omit “and competent national authorities”;

• (c) in paragraph (3)(c) for “competent national authorities” substitute “ enforcing authority ”.

Amendment to regulation 40

22

In regulation 40 (prohibition on improper use of CE marking) in each place in which it occurs, and in the heading to that regulation, for “CE” substitute “ UK ”.

Insertion of regulations 40A and 40B

23

After regulation 40 insert—

(40A) (1) In this regulation— (a) any reference to an Article or an Annex is a reference to an Article of or Annex to the Directive; (b) “CE marking” has the meaning given in Article 3(28); (c) “harmonised standard” has the meaning given in Article 3(20). (2) For the purposes of this regulation, references to the requirements set out in Article 4(1) and Annex I are to be read as if they include a requirement that the owner's manuals referred to in point 2.5 of Part A of Annex I and point 4 of Part B of that Annex must be in English (instead of in a language or languages which can be easily understood by consumers and other end-users, as determined by the member State concerned). (3) Where a product meets the requirements set out in Article 4(1) and Annex I— (a) the requirements of regulation 6(a) and (b) are to be treated as being satisfied; (b) regulation 2(2)(a) applies subject to the modification set out in paragraph (15)(c). (4) Subject to paragraphs (8) and (9), paragraph (5) applies where, before placing a product on the market, the manufacturer— (a) ensures that the product has been designed and manufactured in accordance with the requirements set out in Article 4(1) and Annex I; (b) draws up the technical documentation in accordance with Article 25; (c) carries out the conformity assessment procedure applicable to the product in accordance with Articles 19 to 22 and 24 or has it carried out; (d) ensures that the technical documentation and any other records and correspondence relating to the conformity assessment procedures are prepared in or translated into English; (e) affixes a CE marking to the product in accordance with Articles 16 to 18; (f) draws up an EU declaration of conformity in accordance with Article 15; 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 8, 9 and 10(1), (2), (3) and (5) are to be treated as being satisfied; (b) regulations 10(4), 11, 12(2), 39(3) and 40 apply subject to the modifications set out in paragraph (15); (c) Part 3 (except for regulations 43(2) and (3) and 48) does not apply; (d) regulation 71 does not apply. (6) Subject to paragraphs (8) and (9), paragraph (7) applies where, before placing a product on the market, the importer ensures that— (a) the conformity assessment procedure applicable to the product in accordance with Articles 19 to 22 and 24 has been carried out; (b) the manufacturer has drawn up the technical documentation in accordance with Article 25; and (c) the product bears the CE marking in accordance with Articles 16 to 18. (7) Where this paragraph applies— (a) the requirements of regulation 19(1)(a), (b) and (c)(i) are to be treated as being satisfied; (b) regulations 18, 19(2), 20, 23 and 25 apply subject to the modifications set out in paragraph (15). (8) This paragraph applies where there is no designated standard or part of a designated standard that corresponds exactly to a harmonised standard or part of a harmonised standard referred to in Article 14. (9) Where paragraph (8) applies, paragraphs (4)(c) and (6)(a) of this regulation are to be read as requiring— (a) in respect of products referred to in Article 20(1)(b)(i), one of the conformity assessment procedures (combination of procedures) referred to in the second indent of Article 20(1)(b)(i); (b) in respect of exhaust emissions for products referred to in points (d) and (e) of Article 2(1), one of the conformity assessment procedures (or combinations of procedures) referred to in Article 21(b); (c) in respect of noise emissions for products referred to in Article 22(1)— (i) the conformity assessment procedure referred to in Article 22(1)(b); or (ii) where applicable in accordance with Article 22(1)(c), one of the conformity assessment procedures referred to in Article 22(1)(c); (d) in respect of noise emissions for products referred to in Article 22(2), the conformity assessment procedure referred to in Article 22(2)(b). (10) Paragraph (11) applies where, before making a product available on the market, the distributor ensures that the product bears the CE marking in accordance with Articles 16 to 18. (11) Where this paragraph applies— (a) the requirement of regulation 28(1)(a)(i) is to be treated as being satisfied; (b) regulations 19(2) (which contains the definition of “required documents” for the purposes of regulation 28), 29 and 30 apply subject to the modifications set out in paragraph (15). (12) Paragraph (13) applies where the private importer— (a) ensures before putting a product into service that the product has been designed and manufactured in accordance with the requirements set out in Article 4(1) and Annex I; and (b) ensures that the name and postal address of the notified body that carried out the conformity assessment procedure applicable to the product in accordance with Articles 19 to 22 and 24 is marked on the product. (13) Where this paragraph applies, the requirements of regulation 36(1)(a) and 36(4) are to be treated as being satisfied. (14) Where, before placing a product on the market or putting a product into service, a person applies the procedure referred to in Article 23 to the product, the requirements of regulation 43 are to be treated as being satisfied. (15) The modifications referred to in paragraphs (3)(b), (5)(b), (7)(b) and (11)(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 “designated standard” is to be read as a reference to a harmonised standard; (c) any reference to “essential requirements” is to be read as a reference to the requirements set out in Article 4(1) and Annex I (as modified by paragraph (2)); (d) any reference to “UK marking” is to be read as a reference to the CE marking; (e) any reference to “relevant conformity assessment procedure” is to be read as a reference to the conformity assessment procedures that apply to the product in accordance with Articles 19 to 22 and 24; (f) any reference to “technical documentation” is a reference to the technical documentation referred to in Article 25. (40B) (1) In this regulation any reference to an Article or an Annex is a reference to an Article of or Annex to the Directive. (2) Paragraph (3) applies where— (a) Articles 20 or 21 provide that the conformity assessment procedure referred to as Module B in those Articles may be carried out in relation to a product; and (b) prior to the manufacture of a product, the manufacturer ensures that— (i) the product has been designed in accordance with the essential requirements set out in Annex I to the Directive; (ii) the conformity assessment procedure referred to as Module B in Articles 20 and 21 has been carried out in relation to that product, in accordance with those Articles and with Article 24(1). (3) Where this paragraph applies— (a) the requirement in regulation 42 to apply the conformity assessment procedure referred to in regulations 44 and 45 as Module B is to be treated as being satisfied in relation to that product; (b) any reference to “relevant conformity assessment procedure” in regulations 9, 10(1), 19(1)(a), 36(4), 40(1)(b) and 53(b) is to be read as including the conformity assessment procedure referred to in Articles 20, 21 and 24 as Module B; and (c) any reference to “technical documentation” in regulations 9(b), 11, 19(1)(b), 25(b) and 36(3) is to be read as including the technical documentation relating to the design of the product referred to in Article 25 of the Directive; (d) the reference to “approved body” in regulation 36(4) is to be read as the body that undertook the conformity assessment procedure referred to as Module B in Articles 20 or 21. (40C) (1) Subject to paragraph (2), regulation 40A ceases to have effect at the end of the period of 12 months beginning with IP completion day. (2) Notwithstanding the expiry of regulation 40A— (a) any product which was placed on the market pursuant to regulation 40A may continue to be made available on the market on or after the expiry of regulation 40A; (b) any obligation to which a person was subject under regulation 40A in respect of a product placed on the market pursuant to regulation 40A continues to have effect after the expiry of regulation 40A, in respect of that product. (3) Subject to paragraph (4), regulation 40B 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 40B in relation to a product prior to the expiry of regulation 40B, regulation 40B 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 as Module B in Articles 20 and 21 of the Directive has been carried out in relation to that product, in accordance with Article 24(1) of the Directive. (40D) (1) Where paragraph (2) applies a product is to be treated as being in conformity with Part 2. (2) This paragraph applies where— (a) a product— (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 product 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 product; (ii) the manufacturer has drawn up the technical documentation; and (iii) the product 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; - “relevant conformity assessment procedure” has the meaning given to it in regulation 2(1), as it applies in Northern Ireland; - “technical documentation” has the meaning given to it in regulation 2(1), as it applies in Northern Ireland.

Amendment to regulation 41

24

In regulation 41 (presumption of conformity), in paragraph (1)—

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

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

Amendment to regulation 42

25

In regulation 42 (applicable conformity assessment procedures), for “Annex II of Decision 768/2008” substitute “ Schedule 15 ”.

Amendment to regulation 44

26

• (1) Regulation 44 (design and construction) is amended as follows.

• (2) In paragraph (1)—

• (a) for “Annex II to Decision 768/2008/EC” substitute “ Schedule 15 ”;

• (b) in sub-paragraph (a) for “(EU-type examination)” in both places in which it occurs substitute “ (type examination) ”;

• (c) in sub-paragraph (b)—

• (i) for “EU type-examination” in each place in which it occurs substitute “ type examination ”;

• (ii) for “harmonised” in both places in which it occurs substitute “ designated ”;

• (d) in sub-paragraph (c)(iii) for “EU- type examination” substitute “ type examination ”.

• (3) In paragraphs (2) and (3) for “Annex II to Decision 768/2008/EC” substitute “ Schedule 15 ”.

• (4) In paragraph (2)(c) for “EU type-examination” substitute “ type examination ”.

• (5) In paragraph (3)(a) for “(EU type-examination)” substitute “ (type examination) ”.

Amendment to regulation 45

27

Regulation 45 (exhaust emissions) is amended as follows—

• (a) for “Annex II to Decision 768/2008/EC” substitute “ Schedule 15 ”;

• (b) in paragraphs (a) and (b) for “harmonised” substitute “ designated ”;

• (c) in paragraph (a)(i) for “(EU-type examination)” substitute “ (type examination) ”;

• (d) in paragraph (b)(i) for “(the EU-type examination)” substitute “ (type examination) ”.

Amendment to regulation 46

28

In regulation 46 (noise emissions: recreational craft)—

• (a) in paragraph (1) for “Annex II to Decision 768/2008/EC” substitute “ Schedule 15 ”;

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

Amendment to regulation 47

29

In regulation 47 (noise emissions: personal watercraft)—

• (a) in paragraph (1) for “Annex II to Decision 768/2008/EC” substitute “ Schedule 15 ”;

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

Omission of regulation 49

30

Omit regulation 49 (conformity assessments carried out under Module B (EU-type examination)).

Amendment to regulation 50

31

In regulation 50 (conformity assessments carried out under Module A1 (internal production control plus supervised product testing))—

• (a) in paragraph (1) for “of Annex II to Decision 768/2008/EC” substitute “ as set out in Schedule 15 ”;

• (b) omit paragraph (2).

Amendment to regulation 51

32

In regulation 51 (conformity assessments carried out under Module F (conformity to type based on product verification)), for “of Annex II to Decision 768/2008/EC” substitute “ as set out in Schedule 15 ”.

Amendment to regulation 52

33

In regulation 52 (conformity assessments carried out under Module C (conformity to type based on internal production control))—

• (a) in paragraph (1)—

• (i) in sub-paragraph (a) for “of Annex II of Decision 768/2008/EC” substitute “ set out in Schedule 15 ”;

• (ii) in sub-paragraph (c) for “of Annex II to Decision 768/2008/EC” substitute “ set out in Schedule 15 ”;

• (b) in paragraph (2)—

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

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

Amendment to regulation 53

34

In regulation 53 (EU declaration of conformity)—

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

• (b) omit “EU”;

• (c) in paragraph (b) after “assessment” insert “ procedure ”.

Amendment to regulation 54

35

In regulation 54 (CE marking)—

• (a) for the heading substitute “ UK marking ”;

• (b) for paragraph (1) substitute—

(1) The UK marking must be affixed visibly, legibly and indelibly— (a) to the product; or (b) where paragraph (1A) applies, to— (i) a label affixed to the product; or (ii) a document accompanying the product.

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

• (bb) 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 product; or (b) a document accompanying the product.

• (bc) in paragraph (2)—

• (i) after “Where” insert “ paragraph (1A) does not apply and ”;

• (ii) for “CE” substitute “ UK ” (twice);

• (iii) for “paragraph (1)” substitute “ paragraph (1)(a) ”;

• (bd) in paragraph (3)—

• (i) at the beginning insert “ Except where paragraph (3A) applies ”;

• (ii) for “CE” substitute “ UK ” (twice);

• (be) after paragraph (3) insert—

(3A) For a period of 24 months beginning with IP completion day, the UK marking may be affixed to— (a) a label affixed to the watercraft or propulsion engine; or (b) a document accompanying the watercraft or propulsion engine.

• (bf) in paragraph (4) for “CE” substitute “ UK ”;

• (c) in paragraph (4)(a) for “Annex II of Decision 768/2008” substitute “ Schedule 15 ”;

• (d) in paragraph (5) for “notified” in each place in which it occurs substitute “ approved ”.

Substitution of Part 4

36

For Part 4 substitute—

(55) (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 56 (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 61(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 59 (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 26 of the Directive; and 2. in respect of which no objections had been raised, as referred to in regulation 55(b), as it had effect immediately before IP completion day; - “approved body requirements” means the requirements set out in Schedule 11. (56) (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 the 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; 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. (8) 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. (57) (1) Where a conformity assessment body demonstrates its conformity with the criteria set out 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 the standard). (2) The presumption in paragraph (1) is rebuttable. (58) 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 condition set— (i) in accordance with regulation 56(6)(b); or (ii) in the case of an approved body that was a notified body immediately before IP completion day, in accordance with regulation 56(6)(b) as it applied immediately before IP completion day; and (c) carries out its functions in accordance with these Regulations. (59) (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 58(b), the Secretary of State must restrict, suspend or withdraw the body's status as an approved body under regulation 55 (approved bodies). (2) With the consent of the approved body or where the Secretary of State determines that an approved body no longer meets a condition referred to in regulation 58(b), the Secretary of State may restrict, suspend or withdraw the body's status as an approved body under regulation 55. (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) 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 activities, the approved body must— (a) at the request of the Secretary of State, 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) in the absence of a request under sub-paragraph (a), keep its files relating to the activities it has undertaken as an approved body available for inspection by the Secretary of State and the market surveillance authorities for a period of 10 years from the date they were created. (5) The activities undertaken as an approved body referred to in paragraph (4) include any activities that the body has undertaken as a notified body. (60) (1) Where the Secretary of State proposes to restrict, suspend or withdraw a body's status as an approved body in accordance with regulation 59 (restriction, suspension or withdrawal of approval), the Secretary of State must give notice in writing to the approved body that its approval will be restricted, suspended or withdrawn. (2) A notice provided in accordance with paragraph (1) must— (a) state the date on which the notice is issued; (b) state the reasons why the approval is being restricted, suspended or withdrawn; (c) state the date on which the restriction, suspension or withdrawal of the approval is to take effect; (d) where an approval is being restricted or suspended, state what the effect of that restriction or suspension is on the approved body; (e) inform the approved body of its right to make written representations to the Secretary of State against the proposal within 14 days of the date of the notice. (3) Where an approved body submits written representations to the Secretary of State within 14 days of the notice in accordance with paragraph (2)(e), the Secretary of State must respond to the representations within 21 days of the date on which the representations are received, stating whether, having considered the representations, the notice issued under paragraph (1) will be modified or withdrawn. (61) When an approved body carries out a relevant conformity assessment procedure, Schedule 12 (operational requirements of approved bodies) has effect. (62) (1) Where an approved body subcontracts specific tasks connected with conformity assessment, or has such tasks carried out by a subsidiary, the tasks are to be treated as having been carried out by an approved body for the purposes of regulations 44 to 47 only where the conditions in paragraphs (2) and (3) are satisfied. (2) The approved body must— (a) ensure that the subcontractor or subsidiary meets the approved body requirements; and (b) inform the Secretary of State accordingly. (3) The approved body must have obtained the agreement of the client economic operator to the use of a subcontractor or subsidiary. (4) Where an approved body subcontracts specific tasks connected with conformity assessment, or has such tasks carried out by a subsidiary, the approved body must, for a period of 10 years beginning on the day on which the tasks are carried out, keep at the disposal of the Secretary of State the documentation concerning— (a) the assessment of the qualifications of the subcontractor or subsidiary; and (b) the conformity assessment activities carried out by the subcontractor or subsidiary. (5) When monitoring an approved body in accordance with regulation 58 (monitoring of approved bodies), the Secretary of State must treat the approved body as responsible for the tasks performed by a subcontractor or subsidiary, wherever the subcontractor or subsidiary is established. (6) In this regulation “subsidiary” has the meaning given to it in section 1159 of the Companies Act 2006 . (63) (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. (64) 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 58; (c) compiling and maintaining the register of approved bodies in accordance with regulation 63.

Amendment to regulation 69

37

In regulation 69 (enforcement action in respect of products that are not in conformity and which present a risk)—

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

• (b) omit paragraphs (4) and (7);

• (c) in paragraph (8)—

• (i) for “notices referred to in paragraphs (6) and (7)” substitute “ notice referred to in paragraph (6) ”;

• (ii) in sub-paragraph (f)(ii) for “a harmonised standards referred to in regulation 41 (presumption of conformity) which confer” substitute “ a designated standard referred to in regulation 41 (presumption of conformity) which confers ”.

Omission of regulation 70

38

Omit regulation 70 (EU safeguard procedure).

Amendment to regulation 71

39

In regulation 71 (enforcement action in respect of formal non-compliance), in paragraph (1)—

• (a) in sub-paragraph (a), for “CE” substitute “ UK ” in each place in which it occurs;

• (b) in sub-paragraph (b) omit “EU”.

Insertion of Part 5A

40

After regulation 83 insert—

(83A) (1) The Secretary of State may by regulations amend any of the provisions specified in paragraph (2) where the Secretary of State considers it necessary to do so in order to take into account technical progress and new scientific evidence. (2) The provisions referred to in paragraph (1) are— (a) in Schedule 1— (i) points 2.3, 2.4, 2.5 and Section 3 of Part B; (ii) Section 3 of Part C; (b) Schedule 7; (c) Schedule 9. (3) The Secretary of State may by regulations amend Schedule 5 where the Secretary of State considers it necessary to do so in order to take into account technical progress, the adequacy of ensuring equivalent conformity and new scientific evidence. (4) Regulations made under this regulation may— (a) make different provisions for different cases; and (b) make such supplemental, consequential and transitional provisions as the Secretary of State considers appropriate. (5) Regulations made under this regulation are to be made by statutory instrument subject to annulment in pursuance of a resolution of either House of Parliament. (83B) (1) Where one or both of the conditions in paragraph (2) is met, the Secretary of State may by regulations make provision about— (a) detailed procedures for the operation of regulations 50 to 52 and paragraph 2 of Module B (as set out in Schedule 15), taking into account the specific conformity assessment needs of the products covered by these Regulations; (b) the application of the watercraft design categories set out in point 1 of Part A of Schedule 1, including on the use of weather terminology and measurement scales used in those categories; (c) the information on the builder's plate set out in point 2.2 of Part A of Schedule 1; (d) the application of the Regulations on navigation lights set out in point 5.7 of Part A of Schedule 1; (e) arrangements for discharge prevention, in particular as regards operation of holding tanks, set out in point 5.8 of Part A of Schedule 1; (f) the installation and testing of gas appliances and permanently installed gas systems on watercraft, as referenced in point 5.5 of Part A of Schedule 1. (2) The conditions referred to in paragraph (1) are that the Secretary of State considers it necessary to make such provision in order to— (a) take into account the progress of technical knowledge; and (b) ensure that these Regulations are applied in a uniform manner. (3) Before making regulations under this regulation, the Secretary of State must consult such persons as the Secretary of State considers appropriate. (4) Regulations made under this regulation may— (a) make different provisions for different cases; and (b) make such supplemental, consequential and transitional provisions as the Secretary of State considers appropriate. (5) Regulations made under this regulation are to be made by statutory instrument subject to annulment in pursuance of a resolution of either House of Parliament.

Transitional provision in relation to EU Exit

41

After regulation 89 insert—

(89A) (1) In this regulation, “pre-exit period” means the period beginning on the commencement date and ending immediately before IP completion day. (2) Subject to paragraph (3), where a product was made available on the market or put into service during the pre-exit period, despite the amendments made by Schedule 28 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 a member State of any matter; or (b) any obligation to take action outside of the market in respect of the product. (4) Where during the pre-exit period— (a) a product has not been placed on the market; and (b) the manufacturer has taken any action under regulation 42 or a person has taken action under regulation 43(2) or (3), as those provisions had effect immediately before IP completion day in relation to that product, that action has effect as if it had been done under regulation 42 or 43 as they have effect on and after IP completion day. (5) Where during the pre-exit period— (a) a product has not been placed on the market or put into service; and (b) the private importer or a person to whom regulation 43(2) applies, has taken any action under Schedule 5 as it had effect immediately before IP completion day in relation to that product, that action has effect as if it had been done under Schedule 5 as it has effect on and after IP completion day.

Amendment to regulation 90

42

• (1) Regulation 90 (revocations and savings) is amended as follows.

• (2) After paragraph (1) insert—

(1A) For the purposes of paragraph (1), the Recreational Craft Regulations 1996 have effect with the following modifications— (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 Schedule 7 (EC type-examination (module B))— (i) in paragraph 7 omit “and withdrawn”; (ii) omit paragraph 8; (d) in Schedules 9 (production quality assurance (module D)) and 12 (full quality assurance (module H))— (i) in paragraph 5, for “national” substitute “ enforcement ”; and (ii) in paragraph 6 omit “and withdrawn”; (e) in Schedule 15 (enforcement), in paragraph 2 omit “with a view to this information being passed by the Secretary of State to the Commission”.

• (3) After paragraph (2) insert—

(3) “For the purposes of paragraph (2), the Recreational Craft Regulations 2004 have effect with the following modifications— (a) any reference to “the Community” or “the European Union” 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 Schedule 7 (EC type-examination)— (i) in paragraph 7 omit “and withdrawn”; (ii) omit paragraph 8; (d) in Schedules 9 (production quality assurance), 12 (full quality assurance) and 15 (product quality assurance (module E))— (i) in paragraph 5, for “national” substitute “ enforcement ”; and (ii) in paragraph 6 omit “and withdrawn; (e) in Schedule 17 (enforcement), in paragraph 2 omit “with a view to this information being passed by the Secretary of State to the Commission”.

Amendment to Schedule 1

43

• (1) Schedule 1 (essential requirements) is amended as follows.

• (2) In Part A (essential requirements for the design and construction of products referred to in Article 2(1))—

• (a) in the Explanatory Notes to Section 1 (Watercraft Design Categories), in the final paragraph, for “Annex” substitute “ Schedule ”;

• (b) in paragraph 2.1—

• (i) in paragraph (2) for “the national authority of the Member State” substitute “ or on behalf of the Secretary of State ”;

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

• (c) for paragraph 2.2—

• (i) for paragraph (b) substitute—

(b) UK marking, as provided for in regulation 54;

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

• (d) in paragraph 2.5 for “in accordance with Article 7(7) and Article 9(4)” substitute “ including the instructions and safety information referred to in regulations 15 and 22 ”.

• (3) In Part B (essential requirements for exhaust emissions from propulsion engines)—

• (a) for paragraph 1.1(d) substitute—

(d) UK marking, as provided for in regulation 54.

• (b) in paragraphs 2.3 and 2.5—

• (i) for “Notified” substitute “ Approved ”;

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

• (c) in paragraph 4—

• (i) for “a language or languages which can be easily understood by consumers and other end-users, as determined by the Member State in which the engine is to be marketed” substitute “ English ”;

• (ii) in sub-paragraph (b) for “harmonised” substitute “ designated ”.

Amendment to Schedule 3

44

Schedule 3 (declaration by the manufacturer or the importer of the partly completed watercraft (Article 6(2)) is amended as follows—

• (a) for “established in the Union referred to in Article 6(2)” substitute “ established in the United Kingdom referred to in regulation 7(1)(b) ”;

• (b) in paragraph (b) for “established in the Union” substitute “ established in the United Kingdom ”;

• (c) in paragraph (d)—

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

• (ii) for “this Directive” substitute “ these Regulations ”.

Amendment to Schedule 4

45

Schedule 4 (EU declaration of conformity No xxxxx) is amended as follows—

• (a) in the heading omit “EU”;

• (b) in paragraph 3 for “Article 19(3) or (4) of Directive 2013/53/EU” substitute “ regulation 43(2) or (3) of the Recreational Craft Regulations 2017 (S.I. 2017/737, “the Regulations”) ”;

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

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

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

• (f) in paragraph 9—

• (i) omit “EU” in both places in which it occurs;

• (ii) for “points (b) and (c) of Article 6(4)” substitute “ regulation 7(1)(c)(iii) ”;

• (iii) for “this Directive” substitute “ the Regulations ” in both places in which it occurs;

• (iv) omit sub-paragraph (a)(ii);

• (v) for “Article 55(2)” substitute “ regulation 89(2) ”.

Amendment to Schedule 5

46

• (1) Schedule 5 (equivalent conformity based on post-construction assessment (module PCA)) is amended as follows.

• (2) For “this Directive” substitute “ these Regulations ” in each place in which it occurs.

• (3) In paragraph 1, for “Article 19(2), (3) or (4) substitute “ regulation 43(1), (2) or (3) ”.

• (4) In paragraph 2—

• (a) for “a notified” substitute “ an approved ”;

• (b) for “the notified” in both places in which it occurs substitute “ the approved ”;

• (c) for “relevant national authorities” substitute “ enforcing authority ”.

• (5) In paragraph 3—

• (a) for “notified” in each place in which it occurs substitute “ approved ”;

• (b) for “national authorities” substitute “ enforcing authority ”;

• (c) for “CE” substitute “ UK ”;

• (d) for “Annex I” substitute “ Schedule 1 ”;

• (e) for “the national authority of the Member State” substitute “ or on behalf of the Secretary of State ”.

• (6) In paragraph 4—

• (a) for the heading substitute “ UK marking and declaration of conformity ”;

• (b) in sub-paragraph 1—

• (i) for “CE” substitute “ UK ”;

• (ii) for “notified” in both places in which it occurs substitute “ approved ”;

• (c) in sub-paragraph 2—

• (i) for “an EU” substitute “ a ”;

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

• (iii) for “the EU” substitute “ the ”;

• (iv) for “relevant authorities” substitute “ enforcing authority ”;

• (d) in sub-paragraph 3, for “Annex I” in both places in which it occurs substitute “ Schedule 1 ”.

• (7) In paragraph 5 for “notified” substitute “ approved ”.

Amendment to Schedule 6

47

Schedule 6 (supplementary requirements when internal production control plus supervised production tests set out in module A1 is used (Article 24(2))) is amended as follows—

• (a) for “Annex I” substitute “ Schedule 1 ” in each place in which it occurs;

• (b) for “a notified” in both places in which it occurs substitute “ an approved ”;

• (c) for “Annex VII” substitute “ Schedule 7 ”.

Amendment to Schedule 7

48

In Schedule 7 (conformity of production assessment for exhaust and noise emissions) in paragraph 1, for “notified” substitute “ approved ”.

Amendment to Schedule 8

49

Schedule 8 (supplementary procedure to be applied under conformity to type based on internal production control (module C)) is amended as follows—

• (a) for “Article 24(5)” substitute “ regulation 52 ”;

• (b) for “Annex I” in both places in which it occurs substitute “ Schedule 1 ”;

• (c) for “this Directive” substitute “ these Regulations ”;

• (d) for “Annex VII” substitute “ Schedule 7 ”.

Amendment to Schedule 9

50

Schedule 9 is amended as follows—

• (a) omit “referred to in Article 7(2) and Article 25”;

• (b) for “Article 14” in both places in which it occurs substitute “ regulation 41 ”;

• (c) for “Annex I” in each place in which it occurs substitute “ Schedule 1 ”.

Amendment to Schedule 10

51

Schedule 10 (EU-type examination) is omitted.

Amendment to Schedule 11

52

Schedule 11 (requirements of notified bodies) is amended as follows—

• (a) for the heading substitute “ Requirements of approved bodies ”;

• (b) in paragraph 11(c) for “a notified” substitute “ an approved ”;

• (c) in each place in which it occurs (other than that referred to in sub-paragraph (b)), for “notified” substitute “ approved ”.

Amendment to Schedule 12

53

Schedule 12 (operational requirements of notified bodies) is amended as follows—

• (a) for the heading substitute “ Operational requirements of approved bodies ”;

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

• (c) in paragraph 3 for “the Directive” substitute “ these Regulations ”;

• (d) in paragraphs 4 and 5 for “a notified” substitute “ an approved ”;

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

• (f) in paragraphs 6 and 9 for “notified” substitute “ approved ”;

• (g) in paragraphs 7(1), 7(2), 8, 9 and 10 for “A notified” substitute “ An approved ”;

• (h) in paragraph 7—

• (i) for “notification” in both places in which it occurs substitute “ approval ”;

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

• (i) in paragraph 10 for “any notified body coordination group established under the Directive” substitute “ any approved body coordination group established by the Secretary of State ”.

Insertion of Schedule 15

54

After Schedule 14 insert—