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

“importer” means a person who— (a) is established in the United Kingdom and places pressure equipment or an assembly from a country outside of the United Kingdom on the market; or (b) is established in Northern Ireland and places pressure equipment or an assembly 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;

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

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

• (o) omit the definition of “Official Journal”;

• (p) in the definition of “place on the market” for “EU market” substitute “market of Great Britain”;

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

“UK marking” means the marking in the form set out in Annex 2 of RAMS;

• (3) Omit paragraphs (5) and (7).

Insertion of paragraph 2A

3

After regulation 2 (interpretation) 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; or (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 publication 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 standardisation organisations. (6) The Secretary of State may remove from publication the reference to a standard that 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 product to which these Regulations apply. (9) The Secretary of State may be 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 8

4

In regulation 8 (requirement for pressure equipment and assemblies to comply with sound engineering practice)—

• (a) in paragraph (2)(a) for “the sound engineering practice of a Member State” substitute “ sound engineering practice ”; and

• (b) for paragraph (3) substitute—

(3) Pressure equipment and assemblies to which this regulation applies must not bear the UK marking referred to in regulation 49 unless required to do so by other applicable UK legislation.

Insertion of Regulation 8A

5

After regulation 8 insert—

(8A) (1) Where the condition in paragraph (2) is met, the Secretary of State may by regulations make provision that pressure equipment or assemblies referred to in regulation 8 are to satisfy the essential requirements in Schedule 2. (2) The condition referred to in paragraph (1) is that the Secretary of State considers that the provision is required to mitigate the effects of very serious safety concerns. (3) Regulations made under paragraph (1)— (a) are to be made by statutory instrument subject to annulment in pursuance of a resolution of either House of Parliament; and (b) include power— (i) to make different provision for different cases; and (ii) to make such supplemental, consequential and transitional provision as the Secretary of State considers appropriate.

Amendment to regulation 10

6

In regulation 10 (technical documentation and conformity assessment)—

• (a) in paragraph (2) for “Annex III to the Directive (as amended from time to time)”, substitute “ Schedule 1A to these Regulations ”; and

• (b) for “EU-type” in each place where it occurs, substitute “ Type ”.

Amendment to regulation 11

7

In regulation 11 (EU declaration of conformity and CE marking)—

• (a) in the heading—

• (i) for “EU declaration”, substitute “ Declaration ”; and

• (ii) for “CE” substitute “ UK ”;

• (b) in paragraph (1)(a), omit “EU”;

• (c) in paragraph (1)(b), for “CE” substitute “ UK ”;

• (ca) in paragraph (1)(c), for “notified” substitute “ approved ”;

• (d) in paragraph (3), omit “EU”;

• (e) for paragraph (4), substitute—

(4) Where pressure equipment or an assembly 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 12

8

In regulation 12 (duty to keep technical documentation and EU declaration of conformity) and in the heading omit “EU”.

Amendment to regulation 13

9

In regulation 13 (labelling of pressure equipment and assemblies), for paragraph (3) substitute—

(3) The details set out in paragraph (1)(b) must be clear, legible and in easily understandable English.

Amendment to regulation 14

10

In regulation 14 (instructions and safety information)—

• (a) in paragraphs (1) and (3), for “in a language which can be easily understood by consumers and other users” substitute “ that are clear, legible and in easily understandable English ”;

• (b) omit paragraphs (4) and (5).

Amendment to regulation 15

11

In regulation 15 (compliance procedures for series production), in paragraph (2)(b)—

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

• (b) omit “EU”.

Amendment to regulation 17

12

In regulation 17 (duty to take action in respect of pressure equipment or assemblies 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 manufacturer made the pressure equipment or assembly available on the market,”.

Amendment to regulation 19

13

In regulation 19 (manufacturer's authorised representatives), in paragraph (2)(a), omit “EU”.

Amendment to regulation 21

14

In regulation 21 (requirements which must be satisfied before an importer places pressure equipment or assemblies on the market), in paragraph (1)(c)(i), for “CE” substitute “ UK ”.

Amendment to regulation 23

15

In regulation 23 (information identifying importer)—

• (a) in paragraph (2), omit from “in the member State” to the end of the paragraph; and

• (b) for paragraph (3) substitute—

(3) 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 pressure equipment or assembly, or (ii) the importer has imported the pressure equipment or assembly 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 pressure equipment or assembly on the market, the importer sets out the information referred to in paragraph (1) on the packaging of the pressure equipment or assembly or in a document accompanying the pressure equipment or assembly.

Amendment to regulation 24

16

In regulation 24 (instructions and safety information)—

• (a) in paragraphs (1) and (3), for “in a language which can be easily understood by consumers and other users”, substitute “ that are clear, legible and in easily understandable English ”; and

• (b) omit paragraph (4).

Amendment to regulation 27

17

In regulation 27 (duty to take action in respect of pressure equipment or assemblies placed on the market considered not to be in conformity), in paragraph (2), omit “of any other member State in which the importer made the pressure equipment or assembly available on the market”.

Amendment to regulation 28

18

In regulation 28 (retention of technical documentation and EU declaration of conformity), in the heading and in paragraph (a), omit “EU”.

Amendment to regulation 29

19

In regulation 29 (provision of information and cooperation), in paragraph (3)(b), for “must be in a language which can be easily understood by the enforcing authority”, substitute “ must be clear, legible and in easily understandable English ”.

Amendment to regulation 31

20

In regulation 31 (requirements which must be satisfied before a distributor makes pressure equipment or assemblies available on the market)—

• (a) in paragraphs (1)(a)(i) and (2)(d) for “CE”, substitute “ UK ”;

• (b) for paragraph (1)(a)(iii), substitute “ is accompanied by instructions and safety information that are clear, legible and in easily understandable English ”;

• (c) omit paragraph (3).

Amendment to regulation 34

21

In regulation 34 (duty to take action in respect of pressure equipment made available on the market which are not in conformity), in paragraph (2), omit “of the member States in which the distributor has made the pressure equipment or assembly available on the market”.

Amendment to regulation 35

22

In regulation 35 (provision of information and cooperation), in paragraph (2)(b), for “must be in a language which can clearly be understood by the enforcing authority”, substitute “ must be clear, legible and in easily understandable English ”.

Amendment to regulation 37

23

In regulation 37 (translation of EU declaration of conformity)—

• (a) in the heading to that regulation, and in paragraph (1), omit “EU”;

• (b) in paragraph (1), for “prepared in, or translated into, the language required by the member State in which it is to be made available on the market” substitute “ in English ”; and

• (c) omit paragraph (2).

Amendment to regulation 39

24

In regulation 39 (prohibition on improper use of CE marking), and in its heading, for “CE” substitute “ UK ” in every place in which it occurs.

Insertion of regulations 39A and 39B

25

After regulation 39 (prohibition on improper use of CE marking), insert—

(39A) (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(31); and (c) “pressure equipment and assemblies” means the pressure equipment and assemblies referred to in Article 4(1) and (2). (2) Paragraph (3) applies where, before placing pressure equipment or an assembly on the market, the manufacturer— (a) ensures that the pressure equipment or assembly has been manufactured in accordance with the essential safety requirements set out in Annex I; (b) ensures that the relevant conformity assessment procedures referred to in Article 14 have been carried out; (c) draws up the technical documentation referred to in Annex III; (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 identification number of the notified body (where that body is involved in the product control phase) in accordance with Articles 18 and 19(1) to (4); (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 9(1), 10 and 11(1) are to be treated as being satisfied; (b) regulations 2(2)(a), 11(3), 12, 15(2), 19(2) and 39 apply subject to the modifications in paragraph (8); and (c) Part 3 does not apply; (d) regulation 74 does not apply. (4) Paragraph (5) applies where, before placing pressure equipment or an assembly on the market, the importer ensures that— (a) the relevant conformity assessment procedure referred to in Article 14 has been carried out; (b) the manufacturer has drawn up the technical documentation referred to in Annex III; and (c) the pressure equipment or assembly bears the CE marking and any notified body identification number. (5) Where this paragraph applies— (a) the requirements of regulation 21(1)(a) to (c) are to be treated as being satisfied; and (b) regulations 2(2)(a), 22(1), 25 and 28 apply subject to the modifications in paragraph (8). (6) Paragraph (7) applies where, before making pressure equipment or an assembly available on the market, a distributor ensures that the pressure equipment or assembly bears the CE marking. (7) Where this paragraph applies— (a) regulation 31(1)(a)(i) is to be treated as being satisfied; and (b) regulations 2(2)(a) and 33(1) apply subject to the modifications in paragraph (8). (8) The modifications referred to in sub-paragraphs (3)(b), (5)(b) and (7)(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 within the meaning of Article 2(24); and (e) any reference to “relevant conformity assessment procedure” is to be read as a reference to the relevant conformity assessment procedures referred to in Article 14. (39B) (1) In this regulation any reference to an Article or an Annex is a reference to an Article or an Annex of the Directive. (2) Paragraph (3) applies where, prior to the manufacture of pressure equipment or an assembly, the manufacturer ensures that the conformity assessment procedure that applies to that pressure equipment or assembly in accordance with Article 14(2), referred to as Module B and set out in Annex III, has been carried out. (3) Where this paragraph applies— (a) the requirement in regulation 42 to follow the conformity assessment procedure referred to in that regulation as Module B is to be treated as being satisfied; (b) any reference to “relevant conformity assessment procedure” in regulations 10(1)(c), 11(1), 21(1)(a), 39(1)(b) and 48(b) is to be read as including the conformity assessment procedure referred to in Article 14(2), referred to as Module B and set out in Annex III; and (c) any reference to “technical documentation” in regulations 10(1)(d), 21(1)(b) and 28(b) is to be read as including the technical documentation relating to the design of the pressure equipment or assembly referred to as Module B as set out in Annex III. (39C) (1) Subject to paragraph (2), regulation 39A ceases to have effect at the end of the period of 12 months beginning with IP completion day. (2) Notwithstanding the expiry of regulation 39A— (a) any pressure equipment or assembly which was placed on the market pursuant to regulation 39A may continue to be made available on the market on or after the expiry of regulation 39A; (b) any obligation to which a person was subject under regulation 39A in respect of any pressure equipment or assembly placed on the market pursuant to regulation 39A continues to have effect after the expiry of regulation 39A, in respect of that equipment or assembly. (3) Subject to paragraph (4), regulation 39B 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 39B in relation to a pressure equipment or an assembly prior to the expiry of regulation 39B, regulation 39B continues to apply in respect of that pressure equipment or assembly 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 referred to in the Directive as Module B and set out in Annex III of the Directive, has been carried out. (39D) (1) Where paragraph (2) applies any pressure equipment or assembly is to be treated as being in conformity with Part 2. (2) This paragraph applies where— (a) any pressure equipment or assembly— (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 pressure equipment or assembly on the market, the importer— (a) complies with regulation 23; (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 pressure equipment or assembly 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” has the meaning given to it in regulation 2(1), as it applies in Northern Ireland.

Amendment to regulation 40

26

In regulation 40 (presumption of conformity)—

• (a) in paragraph (1)—

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

• (ii) omit “the reference to which has been published in the Official Journal”;

• (b) omit paragraph (2);

• (c) for paragraph (3) substitute—

(3) The presumption in paragraph (1) is rebuttable.

Amendment to regulation 42

27

In regulation 42 (conformity assessment procedures), in paragraph (1) for “Annex III to the Directive (as amended from time to time)”, substitute “ Schedule 1A to these Regulations ”.

Insertion of regulation 42A

28

After regulation 42 insert—

(42A) (1) Where in order to mitigate the effects of very serious safety concerns the Secretary of State considers that an item or family of pressure equipment are to be subject to different categories of modules, the Secretary of State may by regulations make such provision. (2) Regulations made under paragraph (1)— (a) are to be made by statutory instrument subject to annulment in pursuance of a resolution of either House of Parliament; and (b) include power— (i) to make different provision for different cases; and (ii) to make such supplemental, consequential and transitional provision as the Secretary of State considers appropriate.

Amendment to regulation 43

29

In regulation 43, in paragraph (4), for “Annex III to the Directive (as amended from time to time)”, substitute “ Schedule 1A to these Regulations ”.

Amendment to regulation 45

30

In regulation 45 (conformity assessment procedures), in paragraph (a), for “CE”, substitute “ UK ”.

Amendment to regulation 47

31

For regulation 47 (conformity assessment procedures), substitute—

(47) The records and correspondence relating to conformity assessment must be clear, legible and in easily understandable English.

Amendment to regulation 48

32

In regulation 48 (EU declaration of conformity)—

• (a) in the heading and in the opening words of the regulation, omit “EU”; and

• (b) in paragraph (b), for “Annex III to the Directive (as amended from time to time)”, substitute “ Schedule 1A to these Regulations ”.

Amendment to regulation 49

33

In regulation 49 (CE marking)—

• (a) in the heading and in each place in which it occurs, for “CE” substitute “ UK ”;

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

• (c) in paragraph (1)(b) for “dataplate.” substitute “ data plate; or ”;

• (d) after paragraph (1)(b) insert—

(c) where paragraph (1A) applies— (i) a label affixed to the pressure equipment or assembly; or (ii) to a document accompanying the pressure equipment or assembly.

• (e) 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 pressure equipment or assembly; or (b) to a document accompanying the pressure equipment or assembly.

• (f) in paragraph (3) after “Where” insert “ paragraph (1A) does not apply and ”.

Omission of regulation 50

34

Omit regulation 50 (European approval for materials).

Substitution of Part 4

35

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 54 (approval of conformity assessment bodies); or (b) immediately before IP completion day was a notified body in respect of which the Secretary of State has taken no action under regulation 62(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 60 (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 as a notified body, 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; - “approved body requirements” means the requirements set out in Schedule 4; - “product” means pressure equipment or assemblies; - “accreditation certificate” means a certificate, issued by the UK national accreditation body, attesting that a conformity assessment body meets the approved body requirements. (52) (1) A recognised third party organisation is a conformity assessment body which— (a) has been approved by the Secretary of State to be a recognised third party organisation, under regulation 54 (approval of conformity assessment bodies); or (b) immediately before IP completion day— (i) was a conformity assessment body which the Secretary of State had before IP completion day notified to the European Commission and the member States of the European Union as a recognised third party organisation, in accordance with Article 20 of the Directive; (ii) in respect of which no objections had been raised, as referred to in regulation 52(1)(b), as it had effect immediately before IP completion day; and (iii) in respect of which the Secretary of State had taken no action under regulation 62(1) or (2), as they had effect immediately before IP completion day to suspend or withdraw the body's status as a recognised third party organisation. (2) Paragraph (1) has effect subject to regulation 60 (restriction, suspension or withdrawal of approval). (53) (1) A user inspectorate is a conformity assessment body which— (a) has been approved as a user inspectorate by the Secretary of State under regulation 54 (approval of conformity assessment bodies); or (b) immediately before IP completion day— (i) was a conformity assessment body which the Secretary of State had before IP completion day notified to the European Commission and the member States of the European Union as a user inspectorate, in accordance with Article 20 of the Directive; (ii) in respect of which no objections had been raised, as referred to in regulation 53(1)(b), as it had effect immediately before IP completion day; and (iii) in respect of which the Secretary of State had taken no action under regulation 62(1) or (2), as they had effect immediately before IP completion day, to suspend or withdraw the body's status as a recognised third party organisation. (2) Paragraph (1) has effect subject to regulation 61 (restriction, suspension or withdrawal of approval (user inspectorates)). (54) (1) The Secretary of State may approve only those conformity assessment bodies which— (a) qualify for approval as an approved body in accordance with regulation 55; (b) qualify for approval as a recognised third party organisation in accordance with regulation 56; or (c) qualify for approval as a user inspectorate in accordance with regulation 57. (2) 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. (55) (1) A conformity assessment body qualifies for approval as an approved body if the first and second conditions below are met. (2) 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 products 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. (3) The second condition is that the Secretary of State is satisfied that the conformity assessment body meets the approved body requirements. (4) For the purposes of paragraph (3), the Secretary of State may accept an accreditation certificate, provided in accordance with paragraph (2)(b), as sufficient evidence that the conformity assessment body meets the approved body requirements. (56) (1) A conformity assessment body qualifies for approval as a recognised third party organisation if the conditions in paragraphs (2), (3) and (4) are met. (2) The first condition is that the conformity assessment body has applied to the Secretary of State to become a recognised third party organisation 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 products 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. (3) The second condition is that the Secretary of State is satisfied that the conformity assessment body meets the approved body requirements. (4) The third condition is that the conformity assessment body must carry out approvals of only those activities referred to in paragraphs 21 and 22 of Schedule 2 (permanent joining and non-destructive tests). (5) For the purposes of paragraph (3), the Secretary of State may accept an accreditation certificate, provided in accordance with paragraph (2)(b), as sufficient evidence that the conformity assessment body meets the approved body requirements. (57) (1) A conformity assessment body qualifies for approval as a user inspectorate if the conditions in paragraphs (2) to (7) are met. (2) The conformity assessment body must apply to the Secretary of State to become a user inspectorate and that application must be 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 products 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 user inspectorate requirements. (3) The Secretary of State must be satisfied that the conformity assessment body meets the user inspectorate requirements. (4) The conformity assessment procedures which a user inspectorate may carry out are modules A2, C2, F and G, set out in Part 2, Part 4, Part 9 and Part 10 of Schedule 1A respectively. (5) The group of which the user inspectorate is part must apply a common safety policy as regards the technical specifications for the design, manufacture, inspection, maintenance and use of products. (6) The user inspectorate must act exclusively for the group of which it is part. (7) Where the conformity of a product has been assessed by a user inspectorate, that product may only be used in establishments operated by the group of which the user inspectorate is part. (8) For the purposes of paragraph (3), the Secretary of State may accept an accreditation certificate, provided in accordance with paragraph (2)(b), as sufficient evidence that the conformity assessment body meets the user inspectorate requirements. (58) (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 or the user inspectorate requirements (as the case may be) covered by that standard (or part of that standard). (2) The presumption in paragraph (1) is rebuttable. (59) The Secretary of State must monitor each approved body, recognised third party organisation and user inspectorate with a view to verifying that the body— (a) continues to meet the approved body requirements or user inspectorate requirements, as applicable; (b) meets any conditions set— (i) in accordance with regulation 54(2)(b), or (ii) in the case of— (aa) an approved body which was a notified body immediately before IP completion day; (bb) a recognised third party organisation falling within regulation 52(1)(b); or (cc) a user inspectorate falling within regulations 53(1)(b); in accordance with regulation 55(2)(b) as it applied immediately before IP completion day; and (c) carries out its functions in accordance with these Regulations. (60) (1) Where the Secretary of State determines that an approved body or a recognised third party organisation— (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 59(b), the Secretary of State must restrict, suspend or withdraw the body's status as an approved body or a recognised third party organisation under regulation 51 or 52 (as the case may be). (2) Where the Secretary of State determines that an approved body or a recognised third party organisation no longer meets a condition referred to in regulation 59(b), the Secretary of State may restrict, suspend or withdraw the body's status as an approved body or a recognised third party organisation under regulation 51 or 52 (as the case may be). (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 or recognised third party organisation of the proposed action and the reasons for it; (b) give the approved body or recognised third party organisation 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 or recognised third party organisation. (5) Where the Secretary of State has taken action in respect of an approved body or recognised third party organisation under paragraph (1) or (2), or where an approved body or recognised third party organisation has ceased its activity, the approved body or recognised third party organisation must, at the request of the Secretary of State— (a) transfer its files relating to the activities it has undertaken as an approved body or recognised third party organisation to another approved body or recognised third party organisation or to the Secretary of State, or (b) keep its files relating to the activities it has undertaken as an approved body or recognised third party organisation 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 by an approved body referred to in paragraph (5) include any activities that the body has undertaken as a notified body. (61) (1) Where the Secretary of State determines that a user inspectorate— (a) no longer meets a user inspectorate requirement, or (b) is failing to fulfil its obligations under these Regulations, other than a condition referred to in regulation 59(b), the Secretary of State must restrict, suspend or withdraw the body's status as a user inspectorate under regulation 53. (2) Where the Secretary of State determines that a user inspectorate no longer meets a condition referred to in regulation 59(b), the Secretary of State may restrict, suspend or withdraw the body's status as a user inspectorate under regulation 53. (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 user inspectorate of the proposed action and the reasons for it; (b) give the user inspectorate 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 user inspectorate. (5) Where the Secretary of State has taken action in respect of a user inspectorate under paragraph (1) or (2), or where a user inspectorate has ceased its activity, the user inspectorate must at the request of the Secretary of State— (a) transfer its files relating to the activities it has undertaken as a user inspectorate to an approved body, a recognised third party organisation or to the Secretary of State, or (b) keep its files relating to the activities it has undertaken as a user inspectorate available for the Secretary of State and market surveillance authorities for a period of 10 years from the date they were created. (62) (1) Subject to the terms of its appointment, an approved body, recognised third party organisation or user inspectorate must carry out the conformity assessment activities and procedures— (a) in respect of which the body's approval was given under regulation 55, 56 or 57 (as the case may be); or (b) in respect of which the body's notification to the European Commission was made as a notified body, a recognised third party organisation or a user inspectorate (as the case may be). (2) Where an approved body carries out a conformity assessment procedure, it must do so in accordance with Schedule 6. (3) An approved conformity assessment 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 1A, or (b) to affix, or cause to be affixed, the body's identification number pursuant to regulation 49 (UK marking), where applicable. (63) (1) An approved body, recognised third party organisation or user inspectorate may subcontract specific conformity assessment activities, or use a subsidiary to carry out such activities provided— (a) the body, organisation or inspectorate is satisfied that the subcontractor or subsidiary meets the approved body requirements or user inspectorate requirements, as applicable; (b) the body, organisation or inspectorate has informed the Secretary of State that it is satisfied that the subcontractor or subsidiary meet 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, recognised third party organisation or user inspectorate 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, recognised third party organisation or user inspectorate subcontracts, or uses a subsidiary to carry out, a specific conformity assessment activity, the body, organisation or inspectorate 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 documents 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 . (64) (1) The Secretary of State must— (a) assign— (i) an approved body identification number to each approved body; (ii) a recognised third party organisation identification number to each third party organisation; (iii) a user inspectorate identification number to each user inspectorate; and (b) compile and maintain a register of— (i) approved bodies, recognised third party organisations and user inspectorates; (ii) their 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. (65) The Secretary of State may authorise the United Kingdom Accreditation Service 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 or user inspectorate requirements (as applicable); (b) monitoring approved bodies, recognised third party organisations and user inspectorates in accordance with regulation 59; and (c) compiling and maintaining the register of approved bodies, recognised third party organisations and user inspectorates, in accordance with regulation 64.

Amendment to regulation 69

36

In regulation 69 (exercise of enforcement powers) omit paragraph (c).

Amendment to regulation 71

37

In regulation 71 (enforcement action in respect of pressure equipment or assemblies which are not in conformity and which present risk)—

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

• (b) omit paragraphs (3), (4) and (7);

• (c) in paragraph (8), for “notices in paragraphs (6) and (7)”, substitute “ notice in paragraph (6) ”; and

• (d) in paragraph (8)(f)(ii) for “harmonised” substitute “ designated ”.

Omission of regulation 72

38

Omit regulation 72 (EU safeguard procedure).

Amendment to regulation 73

39

In regulation 73 (pressure equipment or assemblies which are in conformity, but 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 74

40

In regulation 74 (enforcement action in cases of formal non-compliance)—

• (a) in paragraphs (1)(a) and (1)(c)(ii) for “CE” substitute “ UK ” in each place in which it occurs;

• (aa) in paragraph (1)(b)—

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

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

• (b) in paragraph (1)(c) omit “EU” in each place in which it occurs; and

• (c) in paragraph (4) omit “, 72 (EU safeguard procedure)”.

Insertion of regulation 88A

41

After regulation 88 (transitional provisions) insert—

(88A) (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 on or after IP completion day. (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 24 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 regulation 42 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 regulation 42 as it had effect on and after IP completion day.

Amendment to regulation 90

42

In regulation 90 (revocations, amendments and savings)—

• (a) in paragraph (1) after “paragraph (2)” insert “ and (2A) ”;

• (b) for paragraph (2), substitute—

(2) Subject to the modifications made in paragraph (2A), the Regulations referred to in paragraph (1) continue to apply, as if they had not been revoked, to pressure equipment or assemblies placed on the market before the commencement date. (2A) The modifications referred to in paragraph (2) are that in the 1999 Regulations— (a) references to “the Community” shall be read as including the United Kingdom; (b) references to a “member State” shall be read as including the United Kingdom; and (c) in Schedule 8 (enforcement), in paragraph 6, omit “with a view to this information being passed by him to the Commission”.

Amendment to Schedule 1

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In Schedule 1 (excluded pressure equipment and assemblies), paragraph 1—

• (a) for sub-paragraphs (c) to (d) substitute—

(c) simple pressure vessels to which the Simple Pressure Vessel (Safety) Regulations 2016 apply; (d) aerosol dispensers to which the Aerosol Dispensers Regulations 2009 apply;

• (b) for paragraph (f) substitute—

(f) for equipment classified as no higher than category I in accordance with Schedule 1B to these Regulations and, to which, one of the following applies— (i) the Supply of Machinery (Safety) Regulations 2008 ; (ii) the Lift Regulations 2016 ; (iii) the Electrical Equipment (Safety) Regulations 2016 ; (iv) the Medical Devices Regulations 2002 ; (v) Regulation 2016/426 of the European Parliament and of the Council of 9 March on appliances burning gaseous fuels; (vi) the Equipment and Protective Systems Intended for Use in Potentially Explosive Atmospheres Regulations 2016 .

• (c) for paragraph (g) substitute—

(g) products connected with the production of trade in arms, munitions and war material;

• (d) for sub-paragraph (s) substitute—

(s) equipment covered by— (i) the Carriage of Dangerous Goods and Use of Transportable Pressure Equipment Regulations 2009 ; and (ii) equipment covered by the International Maritime Dangerous Goods Code and the Convention on International Civil Aviation .

Insertion of Schedule 1A and 1B

44

After Schedule 1 insert—

SCHEDULE 1A (1) Internal production control is the conformity assessment procedure whereby the manufacturer fulfils the obligations laid down in paragraphs 2, 3 and 4 and ensures and declares on their sole responsibility that the pressure equipment concerned satisfy the requirements of these Regulations. (2) (1) The manufacturer shall establish the technical documentation. (2) The technical documentation shall— (a) make it possible to assess the conformity of the pressure equipment, or the assembly, to the relevant requirements; (b) include an adequate analysis and assessment of the risk; (c) specify the applicable requirements and contain, where applicable— (i) a general description; (ii) the conceptual design and manufacturing drawings and diagrams of components, sub-assemblies, circuits, and all other relevant parts, to component level; (iii) descriptions and explanations necessary for an understanding of those drawings and diagrams and the operation of the pressure equipment; (iv) a list of the designated standards; (v) results of design calculations made, examinations carried out and the results of any other relevant calculation or examination; (vi) test reports; (vii) manufacture; and (viii) operation, of the pressure equipment or assembly. (3) The technical documentation must be kept at the disposal of the national authorities for 10 years after the pressure equipment, or assembly, has been placed on the market. (3) The manufacturer shall take all measures necessary so that the manufacturing process and its monitoring ensure compliance of the manufactured pressure equipment with the technical documentation referred to in paragraph 2 and the requirements of these Regulations. (4) The manufacturer shall— (a) affix the UK marking to each individual piece of pressure equipment, or assembly, that satisfies the applicable requirements of these Regulations; (b) draw up a written declaration of conformity for the pressure equipment, or assembly, which identifies the pressure equipment, or assembly, for which it has been drawn up; (c) make a copy of the declaration of conformity available, to the relevant authorities, on request; and (d) keep a copy of the declaration of conformity at the disposal of the national authorities for 10 years after the pressure equipment, or assembly, has been placed on the market. (5) The manufacturer's obligations set out in paragraph 4 may be fulfilled by their authorised representative, on their behalf and under their responsibility, provided that they are specified in the mandate.