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

(46) (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 47 (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 regulations 52(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 50 (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 22 of the Directive; and 2. in respect of which no objections had been raised, as referred to in regulation 46(1)(b) as it had effect immediately before IP completion day; - “approved body requirements” means the requirements set out in Schedule 8. (47) (1) The Secretary of State may approve only those conformity assessment bodies that qualify for approval. (2) A conformity assessment body qualifies for approval if the first and second conditions below are met. (3) The first condition is that the conformity assessment body has applied to the Secretary of State to become an approved body and that application is accompanied by— (a) a description of— (i) the conformity assessment activities that the conformity assessment body intends to carry out; (ii) the conformity assessment procedure in respect of which the conformity assessment body claims to be competent; (iii) the radio equipment in respect of which the conformity assessment body claims to be competent; and (b) either— (i) an accreditation certificate; or (ii) the documentary evidence necessary for the Secretary of State to verify, recognise and regularly monitor the conformity assessment body's compliance with the approved body requirements. (4) The second condition is that the Secretary of State is satisfied that the conformity assessment body meets the approved body requirements. (5) For the purposes of paragraph (4), the Secretary of State may accept an accreditation certificate, provided in accordance with paragraph (3)(b), as sufficient evidence that the conformity assessment body meets the approved body requirements. (6) When deciding whether to approve a conformity assessment body that qualifies for approval, the Secretary of State may— (a) have regard to any other matter which appears to the Secretary of State to be relevant; and (b) set conditions that the conformity assessment body must meet. (7) For the purposes of this regulation “accreditation certificate” means a certificate, issued by the UK national accreditation body, attesting that a conformity assessment body meets the approved body requirements. (48) (1) Where a conformity assessment body demonstrates its conformity with the criteria laid down in a designated standard (or part of such standard), the Secretary of State is to presume that the conformity assessment body meets the approved body requirements covered by that standard (or that part of that standard). (2) The presumption in paragraph (1) is rebuttable. (49) The Secretary of State must monitor each approved body with a view to verifying that the body— (a) continues to meet the approved body requirements; (b) meets any conditions set— (i) in accordance with regulation 47(6)(b); or (ii) in the case of an approved body which was a notified body immediately before IP completion day, in accordance with regulation 47(6)(b), as it applied immediately beforeIP completion day; and (c) carries out its functions in accordance with these Regulations. (50) the Secretary of State must restrict, suspend or withdraw the body's status as an approved body under regulation 46 (approved bodies). (1) Where the Secretary of State determines that an approved body— (a) no longer meets an approved body requirement, or (b) is failing to fulfil its obligations under these Regulations, other than a condition referred to in regulation 49(b), (2) Where the Secretary of State determines that an approved body no longer meets a condition referred to in regulation 49(b), the Secretary of State may restrict, suspend or withdraw the body's status as an approved body under regulation 46. (3) In deciding what action is required under paragraph (1) or (2), the Secretary of State must have regard to the seriousness of the non-compliance. (4) Before taking action under paragraph (1) or (2), the Secretary of State must— (a) give notice in writing to the approved body of the proposed action and the reasons for it; (b) give the approved body an opportunity to make representations to the Secretary of State regarding the proposed action within a reasonable period from the date of the notice; and (c) consider any such representations made by the approved body. (5) Where the Secretary of State has taken action in respect of an approved body under paragraph (1) or (2), or where an approved body has ceased its activity, the approved body must, at the request of the Secretary of State— (a) transfer its files relating to the activities it has undertaken as an approved body to another approved body or to the Secretary of State; or (b) keep its files relating to the activities it has undertaken as an approved body available for the Secretary of State and market surveillance authorities for a period of 10 years from the date they were created. (6) The activities undertaken as an approved body referred to in paragraph (5) include any activities that the body has undertaken as a notified body. (51) (1) Subject to the terms of its appointment, an approved body must carry out the conformity assessment activities and procedures— (a) in respect of which the body's approval was given under regulation 47; or (b) in respect of which body's notification as a notified body was made. (2) Where an approved body carries out a conformity assessment procedure, it must do so in accordance with Schedule 9. (3) An approved body must make provision for a manufacturer to be able to make an appeal against a refusal by the approved body— (a) to issue a Type-examination certificate referred to in Schedule 3; or (b) to affix, or cause to be affixed, the body's identification number pursuant to regulation 44(5) (UK marking). (52) (1) An approved body may subcontract specific conformity assessment activities, or use a subsidiary to carry out such activities provided— (a) the body is satisfied that the subcontractor or subsidiary meets the approved body requirements; (b) the body has informed the Secretary of State that it is satisfied that the subcontractor or subsidiary meets those requirements; and (c) the economic operator for whom the activities are to be carried out has consented to the activities being carried out by that person. (2) The approved body which subcontracts specific conformity assessment activities or uses a subsidiary to carry out such activities remains responsible for the proper performance of those activities (irrespective of where the subcontractor or subsidiary is established). (3) Where an approved body subcontracts, or uses a subsidiary to carry out, a specific conformity assessment activity, the approved body must, for a period of 10 years beginning on the day on which the activity is first carried out, keep available for inspection by the Secretary of State all relevant documentation concerning— (a) the assessment of the qualifications of the subcontractor or the subsidiary; and (b) the conformity assessment activity carried out by the subcontractor or subsidiary. (4) In this regulation, “subsidiary” has the meaning given to it in section 1159 of the Companies Act 2006 . (53) (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. (54) 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 49; and (c) compiling and maintaining the register of approved bodies, in accordance with regulation 53.

Amendment to regulation 57

37

In regulation 57 (enforcement powers) each place where it occurs, for “CE” substitute “ UK ”.

Amendment to regulation 58

38

In regulation 58 (exercise of enforcement powers), omit sub- paragraph (c).

Amendment to regulation 60

39

In regulation 60 (enforcement action in respect of radio equipment which is not in conformity and which presents a risk)—

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

• (b) in paragraph (8), for “notifications under paragraphs (6) and (7), substitute “ notification under paragraph (6) ”; and

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

Amendment to regulation 61

40

Omit regulation 61 (EU safeguard procedure).

Amendment to regulation 62

41

In regulation 62 (enforcement action in respect of radio equipment which is in conformity, but which presents a risk)—

• (a) omit paragraph (3); and

• (b) in paragraph (4), for “notifications referred to in paragraphs (2) and (3)” substitute “ notification referred to in paragraph (2) ”.

Amendment to regulation 63

42

In regulation 63 (enforcement action in respect of formal non-compliance)—

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

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

• (c) in paragraphs (1)(c) and (1)(c)(ii), in each place in which it occurs omit “EU”.

Amendment to regulation 77

43

• (1) Regulation 77 (transitional provisions), is amended as follows.

• (2) In paragraph (a), for from “Directive” to the end of the paragraph substitute “ the Radio Equipment and Telecommunications Terminal Equipment Regulations 2000 ”.

Transitional provision in relation to EU Exit

44

After regulation 76 insert—

(76A) (1) In this regulation— - “pre-exit period” means the period beginning with the commencement date and ending immediately before IP completion day; - “product” means radio equipment to which these Regulations apply. (2) Subject to paragraph (3), where a product was made available on the market during the pre-exit period, despite the amendments made by Schedule 29 of 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 market 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 41 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 41 as it has effect on and after IP completion day.

Amendment to regulation 78

45

• (1) Regulation 78 (revocations and savings) is amended as follows.

• (2) For paragraph (2) substitute—

(2) The Regulations referred to in paragraph (1) continue to apply, as if they had not been revoked, to any equipment placed on the market in accordance with those Regulations before the commencement date, subject to the modifications made in paragraph (2A).

• (3) Before paragraph (3), insert—

(2A) The modifications referred to in paragraph (2) are as follows— (a) references to the Community are to be read as including the United Kingdom; (b) except where “Member State” first appears in regulation 14 (notified bodies), references to Member State are to be read as including the United Kingdom; (c) the references to European Union and EEA State in regulation 14 are both to be read as including the United Kingdom; (d) regulation 18A (duty of enforcement authority to inform Secretary of State of action taken), is to be read without the words “, with a view to this information being passed by her to the Commission.”; (e) Schedule 5 applies as if paragraph 6 were omitted.

Amendment to Schedule 1

46

In Schedule 1 (radio equipment outside the scope of these regulations), for paragraph 2 substitute “ Marine equipment falling within the Merchant Shipping (Marine Equipment) Regulations 2016 ”.

Amendment to Schedule 2

47

In Schedule 2 (conformity assessment module A), in paragraph 4—

• (a) in the heading, and in subparagraphs (2) and (3), in each place where it occurs, omit “EU”; and

• (b) in the heading, and in subparagraph (1) in each place where it occurs, for “CE” substitute “ UK ”.

Amendment to Schedule 3

48

In Schedule 3 (conformity assessment modules B and C)—

• (a) in the first, second and fifth headings, and in paragraphs 1 and 2, for “EU-Type” substitute “ Type ”;

• (b) in paragraphs 6(1) and (4), for “an EU-Type” substitute “ a Type ”;

• (c) in each place in which it occurs in paragraphs, 3, 6(2), 6(3), 7(2) 8(1), 8(3), 9, 11, 12, and 13(1), for “EU-type” substitute “ Type ”;

• (d) in each place in which it occurs in paragraphs 3(1), 3(2)(b), 4, 5, 6(1), 6(4), 7, and 8, for “notified” substitute “ approved ”;

• (e) in paragraphs 3(2)(d) and 8(3) for “harmonised” substitute “ designated ”;

• (f) in both places in which it occurs in paragraph 8(1) for “its notifying authority” substitute “ the Secretary of State ”;

• (g) in paragraph 8(3)—

• (i) in the first place in which it occurs, for “Member States” substitute “ Secretary of State and the other approved bodies ”;

• (ii) for “Member States, the European Commission” in the second sentence substitute “ Secretary of State ”;

• (iii) for “Member States and the European Commission” in the third sentence substitute “ Secretary of State ”; and

• (iv) omit “the references of which have been published in the Official Journal”;

• (h) in paragraph 9 for “national” substitute “ enforcing ”;

• (i) in paragraph 13—

• (i) in the heading and in each place in which it occurs in sub-paragraph (1), for “CE” substitute “ UK ”; and

• (ii) in the heading and in each place in which it occurs in sub-paragraphs (2) and (3), omit “EU”.

Amendment to Schedule 4

49

In Schedule 4 (conformity assessment module H)—

• (a) in each place in which it occurs in paragraphs 3(1), 3(1)(d), 3(3), 3(9), 4(2), 4(3), 4(4), 5(1), 6, 7(1) and 7(2), as well as the heading to paragraph 4, for “notified” substitute “ approved ”;

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

• (c) in paragraph 5—

• (i) in the heading and in each place in which it occurs in paragraph (1), for “CE” substitute “ UK ”;

• (ii) in the heading and in both places in which it occurs in sub-paragraph (2), omit “EU”; and

• (iii) in sub-paragraph (2) in both places in which it occurs for “national” and for “relevant” substitute “ enforcing ”;

• (d) in paragraph 6, for “national” substitute “ enforcing ”; and

• (e) in paragraph 7(1) in both places in which it occurs for “its notifying authority” substitute “ the Secretary of State ”.

Amendment to Schedule 5

50

In Schedule 5 (contents of technical documentation), in paragraph 1—

• (a) in subparagraph (d)—

• (i) in each place in which it occurs, for “harmonised” substitute “ designated ”; and

• (ii) omit “the references of which have been published in the Official Journal”;

• (b) in subparagraph (e), omit “EU”;

• (c) in subparagraph (f)—

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

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

• (d) in subparagraph (i), for “in at least one Member” substitute “ without infringement of requirements ”.

Amendment to Schedule 6

51

In Schedule 6 (EU declaration of conformity)—

• (a) in the heading and in paragraph 8 omit “EU”;

• (b) in the heading and subheading, for “declaration” substitute “ Declaration ”;

• (c) in paragraph 5, for from “Union harmonisation legislation:” to “where applicable” substitute “ statutory requirements ”;

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

• (e) in paragraph 7, for “EU-type” substitute “ Type ”.

Amendments to Schedule 7

52

In Schedule 7 (simplified EU declaration of conformity)—

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

• (b) in paragraph 2, for “Directive 2014/53/EU” substitute “ the relevant statutory requirements ”.

Amendment to Schedule 8

53

In Schedule 8 (notified body requirements)—

• (a) in the heading and in paragraphs 5, 8, 9(c), 11(a) and 17, for “notified” substitute “ approved ”;

• (b) in paragraph 11(c)—

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

• (ii) omit “, the Directive”;

• (c) in paragraph 11(d) for “EU-type” substitute “ Type ”;

• (d) in paragraph 14 omit “and must satisfy the Secretary of State that it has”; and

• (e) in paragraph 17, for “under the Directive” substitute “ by the Secretary of State ”.

Amendment to Schedule 9

54

In Schedule 9 (operational obligations of notified bodies)—

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

• (i) in the heading;

• (ii) in each place in which it occurs in paragraphs 7 and 9; and

• (iii) in the second place in which it occurs in paragraphs 12 and 13;

• (b) for “a notified” substitute “ an approved ” in each place in which it occurs in paragraphs 1, 2, 5, 6, 8, 10, 11, 12, 13 and 14;

• (c) in all places in which it occurs in paragraphs 5, 8, 10 and 11, and in the first place in which it occurs in paragraph 6, for “an Eu-type” substitute “ a Type ”;

• (d) in paragraph 6 in the second place in which it occurs and in all places in which it occurs in paragraphs 7 and 9 for “EU-Type” substitute “ Type ”;

• (e) in paragraph 5, for “harmonised” substitute “ designated ”;

• (f) in paragraph 10(b)—

• (i) in the first place in which it occurs for “notification” substitute “ approval ”;

• (ii) in the second place in which it occurs for “notification” substitute “ approval of conformity assessment bodies ”

• (g) in paragraph 10(c), omit “or a competent national body of another Member State”;

• (h) in paragraph 12, for “the Directive” substitute “ these Regulations ”; and

• (i) in paragraph 13, for “under the Directive” substitute “ by the Secretary of State ”.

PART 2 — Amendment of Commission Implementing Regulation (EU) 2017/1354

55

Commission Implementing Regulation (EU) 2017/1354 specifying how to present the information provided for in Article 10(10) of Directive 2014/53/EU of the European Parliament and of the Council is amended in accordance with paragraphs 56 to 62.

56

In Article 1 and in both places in which it occurs in Article 2 for “Article 10(10) of Directive 2014/53/EU” substitute “ regulation 14 of the Radio Equipment Regulations 2017 ”.

57

In Article 1 for “at least one Member State” substitute “ the United Kingdom ”.

58

In Article 2—

• (a) in paragraph 1(a) after “Annex I” insert “ , followed by the abbreviation “UK” ”;

• (b) in paragraph 1(b)—

• (i) after “Requirements in” insert “ the UK ”;

• (ii) omit from “, in a language” to the end;

• (c) in paragraph 2 for the words from “a language” to the end substitute—“English, the geographical areas in the United Kingdom where such restrictions or requirements exist, as well as the types of restrictions or requirements applicable”.

]59

Omit Article 3.

60

After Article 3 omit—

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

• (b) “Done at Brussels, 20 July 2017”;

• (c) the signatory text.

61

In Annex I—

• (a) omit paragraph 3;

• (b) omit paragraph 5.

62

Omit Annex II.

SCHEDULE 30 — Amendment of the Identification and Traceability of Explosives Regulations (Northern Ireland) 2013

Introduction

1

The Identification and Traceability of Explosives Regulations (Northern Ireland) 2013 are amended as follows.

Amendment to regulation 5

2

In regulation 5—

• (a) in paragraph (3)—

• (i) in the opening words for “that is not an EEA State” substitute “ other than the United Kingdom ”,

• (ii) in sub-paragraph (a) for “an EEA State” substitute “ the United Kingdom ”,

• (iii) in sub-paragraph (b) for “an EEA State” substitute “ the United Kingdom ”,

• (iv) in sub-paragraph (c) for “either Great Britain or an EEA State other than the United Kingdom” substitute “ Great Britain ”;

• (b) in paragraph (4)(b) omit “or an EEA State other than the United Kingdom”;

• (c) in paragraph (5)—

• (i) at the end of sub-paragraph (a) omit “and”,

• (ii) for sub-paragraph (b) substitute—

(b) the importer must at the time of its application provide the Secretary of State with the details of any site code previously attributed to those explosives; and (c) the Secretary of State must attribute the code (which may be the same as the code previously attributed to the explosives) and inform the importer accordingly.

• (d) for paragraph (6) substitute—

(6) Where this paragraph applies, the manufacturer must apply to the Health and Safety Executive for the Health and Safety Executive to attribute a code for the site where the explosives are manufactured.

Amendment to Schedule 1

3

In Schedule 1, for paragraph 1(a)(ii)(aa) substitute—

(aa) two letters identifying Northern Ireland, Great Britain or the EEA state (place of production or import);

SCHEDULE 31 — Amendment of the Making Available on the Market and Supervision of Transfers of Explosives Regulations (Northern Ireland) 2016

Introduction

1

The Making Available on the Market and Supervision of Transfers of Explosives Regulations (Northern Ireland) 2016 are amended as follows.

Amendment to regulation 2

2

• (1) Regulation 2 (interpretation) is amended as follows—

• (2) In paragraph (1)—

• (a) omit the definition of “accreditation”;

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

• (c) after the definition of “the 1993 Regulations” insert—

“approved body” has the meaning given to it in regulation 35 (approved bodies);

• (d) for the definition of “authorised representative” substitute—

“authorised representative” means— (a) a person who— (i) immediately before exit day was established in the United Kingdom or an EEA state; and was appointed by a manufacturer by written mandate to perform specified tasks for that manufacturer, in accordance with regulation 12, as it had effect immediately before exit day; and (ii) on or after exit day continues to be so established and appointed by the manufacturer to perform those tasks; or (b) a person who, on or after exit day is appointed in accordance with regulation 12;

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

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

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

“declaration of conformity” means a declaration of conformity required to be drawn up in accordance with regulation 7;

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

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

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

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

• (k) omit the definition of “harmonised standard”;

• (l) for the definition of “importer” substitute—

“importer”, in relation to civil explosives, means any person who— (a) is established in the United Kingdom; and (b) places a civil explosive from a country outside the United Kingdom on the market;

• (m) in the definition of “making available on the market” for “an EEA state” substitute “ the United Kingdom ”;

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

• (o) in the definition of “place on the market”—

• (i) after “means” insert “ , apart from in regulation 45A, ”;

• (ii) for “on the market in an EEA state” substitute “ on the United Kingdom market ”;

• (p) for the definition of “relevant authority” substitute—

“relevant authority” means any public authority which has a function under these Regulations or a function under another enactment in relation to the security or traceability of civil explosives;

and

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

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

• (3) Omit paragraph (3).

Insertion of regulation 2A

3

After regulation 2 insert—

(2A) (1) Subject to paragraphs (6) and (7), “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; (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 of Standardisation (CEN); (b) the European Committee for Electrotechnical Standardisation (Cenlec); (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 a reference to a technical specification adopted by the British Standards Institution, the Secretary of State must have regard to whether the technical specification is consistent with technical specifications adopted by the other recognised standardisation bodies. (6) The Secretary of State may remove from publication the reference to a standard which has been published in accordance with paragraph (1)(b). (7) Where the Secretary of State removes the reference to a standard from publication, that standard is no longer a designated standard. (8) In this regulation, a reference to a “product” is a reference to a civil explosive. (9) The Department may by regulations amend the list of recognised standardisation bodies in paragraph (3) to reflect any changes in the name or structure of those bodies made by the Secretary of State. (10) Regulations made under paragraph (9) are subject to negative resolution.

Amendment to regulation 4

4

• (1) Regulation 4 (authorisation to transfer civil explosives) is amended as follows.

• (2) In paragraph (1) omit “for the place where the transfer will terminate”.

• (3) In paragraph (2) for “relevant authority” substitute “ relevant competent authority ”.

• (4) In paragraph (5), in both places where it appears, for “the area of the EEA States” substitute “ the United Kingdom ”.

• (5) After paragraph (7) insert—

(7A) A recipient competent authority document issued under this regulation may be granted for such period as the competent authority determines and may be revoked by notice in writing by that authority on grounds of safety or security.

• (6) For paragraph (8) substitute—

(8) In this regulation— (a) “competent authority” means the Chief Constable; (b) “recipient competent authority document” means a document issued in accordance with this regulation by the competent authority; and (c) “relevant competent authority” means— (i) in respect of a transfer or part of a transfer which takes place within Northern Ireland, the Chief Constable; and (ii) in respect of a transfer or part of a transfer which takes place in Great Britain, the body which discharges in Great Britain similar functions to those discharged by the Chief Constable under these Regulations in relation to Northern Ireland.

• (7) After paragraph (8) insert—

(9) A transfer document issued under the Directive, which was valid immediately before exit day is deemed to be a valid recipient competent authority document for the purposes of this regulation after exit day, until such time as it expires or is withdrawn by a relevant competent authority.

Amendment to regulation 6

5

Regulation 6 (technical documentation and conformity assessment) is amended as follows—

• (a) in paragraph (b)(i)—

• (i) for “32(a)” substitute “ 32(2)(a) ”;

• (ii) for “point 3(c) of Module B of Annex III to the Directive (as amended from time to time)” substitute “ paragraph 2(2)(c) of Part 1 (Module B) of Schedule 5 ”;

• (b) in paragraph (b)(ii)—

• (i) for “32(b)” substitute “ 32(2)(b) ”;

• (ii) for “point 2 of Module G of Annex III to the Directive (as amended from time to time)” substitute “ paragraph 46 of Part 6 (Module G) of Schedule 5 ”.

Amendment to regulation 7

6

Regulation 7 (EU declaration of conformity and CE marking) is amended as follows—

• (a) in the heading to that regulation—

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

• (ii) for “CE” substitute “ UK ”;

• (b) in paragraph (1)(a) omit “(EU declaration of conformity)”;

• (c) in paragraph (1)(b)—

• (i) for “CE” substitute “ UK ”;

• (ii) omit “(CE marking)”;

• (d) for paragraph (3) substitute—

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

Amendment to regulation 8

7

In regulation 8 (retention of technical documentation and EU declaration of conformity) and in the heading to that regulation omit “EU”.

Amendment to regulation 9

8

In regulation 9 (compliance procedures for series production), in paragraph (2)(b)—

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

• (b) omit “EU”.

Amendment to regulation 10

9

In regulation 10 (traceability of certain civil explosives excluded from the scope of regulations 4, 5 and 6 of the Identification and Traceability of Explosives Regulations (Northern Ireland) 2013 (ITOER (NI) 2013)) for paragraph (4) substitute—

(4) For a civil explosive that is to be made available on the market in Northern Ireland the contact details referred to in paragraph (1) must be provided in English.

Amendment to regulation 11

10

For regulation 11 (instructions and safety information), substitute—

(11) (1) When placing a civil explosive on the market, a manufacturer must ensure that it is accompanied by instructions and safety information that are clear, legible and in easily understandable English. (2) Any labelling on the civil explosive must be clear, legible and in easily understandable English.

Amendment to regulation 12

11

Regulation 12 (appointment of authorised representative by written mandate) is amended as follows—

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

• (b) in paragraph (2)(a) omit “EU”.

Amendment to regulation 14

12

In regulation 14 (requirements which must be satisfied before an importer places a civil explosive on the market), in paragraph (1)(c)(i) for “CE” substitute “ UK ”.

Amendment to regulation 16

13

In regulation 16 (information identifying importer)—

• (a) after paragraph (1) insert—

(1A) Paragraph (1) does not apply where the importer has imported the civil explosive from an EEA state or Switzerland and places it on the market within the period of eighteen months beginning with exit day, and before placing the civil explosive on the market, the importer sets out the information referred to in paragraph (1) in a document accompanying the civil explosive.

• (b) in paragraph (2) for “the market surveillance authority in the EEA State in which the civil explosive is to be made available to such end-users” substitute “ a relevant authority ”.

Amendment to regulation 17

14

For regulation 17 (instructions and safety information) substitute—

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

Amendment to regulation 18

15

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

Amendment to regulation 19

16

In regulation 19 (duty to take action in respect of civil explosives placed on the market which are considered not to be in conformity), in paragraph (2) for “competent national authorities of any EEA State in which the manufacturer or importer made the civil explosive available on the market,” substitute “ market surveillance authority ”.

Amendment to regulation 20

17

In regulation 20 (provision of information and cooperation)—

• (a) in each place where it occurs, for “a competent national authority” substitute “ the market surveillance authority ”; and

• (b) in paragraph (1)(b) for “in a language which can be easily understood by the authority” substitute “ in clear, legible and in easily understandable English ”.

Amendment to regulation 22

18

In regulation 22 (requirements which must be satisfied before a distributor makes a civil explosive available on the market), paragraph (1)(a) is amended as follows—

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

• (b) for sub-paragraph (iii) substitute—

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

Amendment to regulation 24

19

In regulation 24 (duty to take action in respect of civil explosives made available on the market which are not in conformity), in paragraph (2) for “competent national authorities of any EEA State in which the distributor has made the civil explosive available on the market,” substitute “ market surveillance authority ”.

Amendment to regulation 25

20

In regulation 25 (provision of information and cooperation), in each place in which it occurs for “a competent national authority” substitute “ the enforcing authority ”.

Revocation of regulation 28

21

Omit regulation 28 (translation of declaration of conformity).

Amendment to regulation 30

22

In regulation 30 (prohibition on improper use of CE marking), in the heading and in each place in which it occurs, for “CE” substitute “ UK ”.

Insertion of regulation 30A

23

After regulation 30 insert—

(30A) (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(24); (c) “harmonised standard” has the meaning given to it in Article 2(16). (2) Subject to paragraphs (6) and (7), paragraph (3) applies where, before placing a civil explosive on the market, the manufacturer— (a) ensures that the civil explosive has been designed and manufactured in accordance with the essential safety requirements set out in Annex II; (b) ensures that the relevant conformity assessment procedures that apply to that civil explosive in accordance with Article 20 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, in accordance with Articles 22 and 23(1) to (5); (f) draws up an EU declaration of conformity, in accordance with Article 21; 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 5, 6, 7(1) and 7(3) are to be treated as being satisfied; (b) regulations 7(2), 8, 9(2), 12(2) and 30 apply subject to the modifications in paragraph (10); and (c) Schedule 2 paragraph 12 does not apply. (4) Subject to paragraphs (6) and (7), paragraph (5) applies where, before placing a civil explosive on the market, the importer ensures that— (a) the relevant conformity assessment procedures that apply to that explosive in accordance with Article 20 have been carried out; (b) the manufacturer has drawn up the technical documentation referred to in Annex III; and (c) the civil explosive bears the CE marking referred to in Article 23. (5) Where this paragraph applies— (a) the requirements of regulation 14(1)(a) to (c) are to be treated as being satisfied; and (b) regulations 13, 15(1), 18 and 26 apply subject to the modifications in paragraph (10). (6) This paragraph applies where there is no designated standard or part of a designated standard which corresponds exactly to a harmonised standard or part of a harmonised standard referred to in Article 19. (7) Where paragraph (6) applies paragraphs (2)(b) and (4)(a) are to be treated as requiring the manufacturer to carry out one of the conformity assessment procedures set out in Article 20. (8) Paragraph (9) applies where, before making a civil explosive available on the market, a distributor ensures that the civil explosive bears the CE marking referred to in Article 23. (9) Where this paragraph applies— (a) regulation 22(1)(a)(i) is to be treated as being satisfied; and (b) regulations 23(1) and 26 apply subject to the modifications in paragraph (10). (10) The modifications referred to in sub-paragraphs (3)(b), (5)(b) and (9)(b) are that— (a) any reference to “declaration of conformity” is to be read as a reference to the EU declaration of conformity; (b) any reference to “UK marking” is to be read as a reference to the CE marking; (c) any reference to “essential safety requirements” is to be read as a reference to the essential safety requirements referred to in Annex II; (d) any reference to “designated standard” is to be read as a reference to a harmonised standard; (e) any reference to “relevant conformity assessment procedure” is to be read as a reference to the relevant conformity assessment procedures referred to in Article 20; (f) any reference to “technical documentation” is a reference to the technical documentation referred to in Annex III. (30B) (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 a civil explosive, the manufacturer ensures that the conformity assessment procedure that applies to that explosive in accordance with Article 20(a) has been carried out. (3) Where this paragraph applies— (a) any reference to “relevant conformity assessment procedure” in regulations 6(a), 7(1), 14(1)(a), 30(1)(b), 33(b) and 34(3) are to be read as including the conformity assessment procedure referred to in Article 20(a) of the Directive; and; (b) any reference to “technical documentation” in regulations 6(b), 8, 14(1)(b), 18(b), and in Schedule 2 Part 1 paragraph 12(1)(d) and Schedule 5 is to be read as including the technical documentation relating to the design of the civil explosive referred to in Annex III.

Amendment to regulation 31

24

In regulation 31 (presumption of conformity), paragraph (1) is amended as follows—

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

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

Amendment to regulation 32

25

For regulation 32 (conformity assessment procedures) substitute—

(32) (1) Assessment of conformity of a civil explosive is carried out by an approved body in accordance with the procedures set out in Schedule 5. (2) For the assessment of conformity of a civil explosive, the manufacturer must follow one of the following procedures set out in Schedule 5— (a) in Part 1 of Schedule 5, Type examination carried out by an approved body (Module B), and, at the choice of the manufacturer, one of the following procedures— (i) in Part 2 of Schedule 5, conformity to type based on internal production control plus supervised product checks at random intervals (Module C2); (ii) in Part 3 of Schedule 5, conformity to type based on quality assurance of the production process (Module D); (iii) in Part 4 of Schedule 5, conformity to type based on product quality assurance (Module E); (iv) in Part 5 of Schedule 5, conformity to type based on product verification (Module F); (b) in Part 6 of Schedule 5, conformity based on unit verification (Module G).

Amendment to regulation 33

26

Regulation 33 (EU declaration of conformity) is amended as follows—

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

• (b) in the opening words omit “EU”;

• (c) in paragraph (b) for “Annex III to the Directive (as amended from time to time)” substitute “ Schedule 5 ”;

• (d) in paragraph (c) for “Annex IV to the Directive (as amended from time to time)” substitute “ Schedule 6 ”.

Amendment to regulation 34

27

Regulation 34 (CE marking) is amended as follows—

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

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

• (c) in paragraph (2) for “CE” in both places it appears, substitute “ UK ”;

• (d) in paragraph (3)—

• (i) for “CE” substitute “ UK ”;

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

• (e) in paragraph (4) for “notified” in each place it appears, substitute “ approved ”;

• (f) in paragraph (5) for “CE” substitute “ UK ”.

Amendment to Part 3, Sub-Part C

28

For Part 3, Sub-Part C (NOTIFICATION OF CONFORMITY ASSESSMENT BODIES) substitute—

(35) (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 36 (approval of conformity assessment bodies); or (b) immediately before exit day was a notified body in respect of which the Secretary of State had taken no action under regulation 41(1) or (2) as they had effect immediately before exit day to suspend or withdraw the body's status as a notified body. (2) Paragraph (1) has effect subject to regulation 39 (restriction, suspension or withdrawal of approval). (3) In this Sub-Part— - “notified body” means a body— 1. which the Secretary of State had before exit day notified to the European Commission and to the other EEA states, in accordance with Article 24 of the Directive; and 2. in respect of which no objections had been raised, as referred to in regulation 35(1)(b), as it had effect immediately before exit day; - “approved body requirements” means the requirements set out in Schedule 3. (36) (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 condition are met. (3) The first condition is that the conformity assessment body has applied to the Secretary of State to become an approved body and that application is accompanied by— (a) a description of— (i) the conformity assessment activities that the conformity assessment body intends to carry out; (ii) the conformity assessment procedure in respect of which the conformity assessment body claims to be competent; (iii) the civil explosives in respect of which the conformity assessment body claims to be competent; and (b) either— (i) an accreditation certificate; or (ii) the documentary evidence necessary for the Secretary of State to verify, recognise and regularly monitor the conformity assessment body's compliance with the approved body requirements. (4) The second condition is that the Secretary of State is satisfied that the conformity assessment body meets the approved body requirements. (5) For the purposes of paragraph (4), the Secretary of State may accept an accreditation certificate, provided in accordance with paragraph (3)(b), as sufficient evidence that the conformity assessment body meets the approved body requirements. (6) When deciding whether to approve a conformity assessment body that qualifies for approval, the Secretary of State may— (a) have regard to any other matter which appears to the Secretary of State to be relevant; and (b) set conditions that the conformity assessment body must meet. (7) For the purposes of this regulation, “accreditation certificate” means a certificate, issued by the UK national accreditation body, attesting that a conformity assessment body meets the approved body requirements. (37) (1) Where a conformity assessment body demonstrates its conformity with the criteria laid down in a designated standard (or part of such standard), the Secretary of State is to presume that the conformity assessment body meets the approved body requirements covered by that standard (or part of that standard). (2) The presumption in paragraph (1) is rebuttable. (38) The Secretary of State must monitor each approved body with a view to verifying that the body— (a) continues to meet the approved body requirements; (b) meets any conditions set— (i) in accordance with regulation 36(6)(b); or (ii) in the case of an approved body which was a notified body immediately before exit day, in accordance with conditions set under regulation 36(6)(b) as it applied immediately before exit day; and (c) carries out its functions in accordance with these Regulations. (39) the Secretary of State must restrict, suspend or withdraw the body's status as an approved body under regulation 35 (approved bodies). (1) Where the Secretary of State determines that an approved body— (a) no longer meets an approved body requirement; or (b) is failing to fulfil its obligations under these Regulations, other than a condition referred to in regulation 38(b), (2) Where the Secretary of State determines that an approved body no longer meets a condition referred to in regulation 38(b), the Secretary of State may restrict, suspend or withdraw the body's status as an approved body under regulation 35. (3) In deciding what action is required under paragraph (1) or (2), the Secretary of State must have regard to the seriousness of the non-compliance. (4) Before taking action under paragraph (1) or (2), the Secretary of State must— (a) give notice in writing to the approved body of the proposed action and the reasons for it; (b) give the approved body an opportunity to make representations to the Secretary of State regarding the proposed action within a reasonable period from the date of the notice; and (c) consider any such representations. (5) Where the Secretary of State has taken action in respect of an approved body under paragraph (1) or (2), or where an approved body has ceased its activity, the approved body must, at the request of the Secretary of State— (a) transfer its files relating to the activities it has undertaken as an approved body to another approved body or to the Secretary of State; or (b) keep its files relating to the activities it has undertaken as an approved body available for the Secretary of State and market surveillance authority for a period of 10 years from the date they were created. (6) The activities undertaken as an approved body referred to in paragraph (5) include any activities that the body has undertaken as a notified body. (40) (1) Subject to the terms of its appointment, an approved body must carry out the conformity assessment activities and procedures— (a) in respect of which the body's approval was given under regulation 36; or (b) in respect of which the body's notification as a notified body was made. (2) Where an approved body carries out a conformity assessment procedure, it must do so in accordance with Schedule 4 (operational obligations of approved bodies). (3) An approved body must make provision for a manufacturer to be able to make an appeal against a refusal by the approved body— (a) to issue a Type examination certificate referred to in Schedule 5 (conformity assessment procedures); or (b) to affix, or cause to be affixed, the body's identification number pursuant to regulation 34 (UK marking). (41) (1) An approved body may subcontract specific conformity assessment activities or use a subsidiary to carry out such activities provided— (a) the body is satisfied that the subcontractor or subsidiary meets the approved body requirements; (b) the body has informed the Secretary of State that it is satisfied that the subcontractor or subsidiary meets those requirements; and (c) the economic operator for whom the activities are to be carried out has consented to the activities being carried out by that person. (2) The approved body which subcontracts specific conformity assessment activities or uses a subsidiary to carry out such activities remains responsible for the proper performance of those activities (irrespective of where the subcontractor or subsidiary is established). (3) Where an approved body subcontracts, or uses a subsidiary to carry out, a specific conformity assessment activity, the approved body must, for a period of 10 years beginning on the day on which the activity is first carried out, keep available for inspection by the Secretary of State all relevant documentation concerning— (a) the assessment of the qualifications of the subcontractor or the subsidiary; and (b) the conformity assessment activity carried out by the subcontractor or subsidiary. (4) In this regulation “subsidiary” has the meaning given to it in section 1159 of the Companies Act 2006 . (42) (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. (43) 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 38; and (c) compiling and maintaining the register of approved bodies, in accordance with regulation 42.

Transitional provision in relation to EU Exit

29

After regulation 45 (transitional provisions) insert—

(45A) (1) In this regulation— - “pre-exit period” means the period beginning with 20th April 2016 and ending immediately before exit day; - “product” means a civil explosive to which these Regulations apply. (2) Subject to paragraph (3), where a product was made available on the market during the pre-exit period, despite the amendments made by Schedule 31 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 exit day, continues to have effect as it did immediately before exit 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 market 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 6 as it had effect immediately before exit day in relation to that product, that action has effect as if it had been done under regulation 6 as it had effect on and after exit day.

Amendment to Schedule 1

30

In Schedule 1 at the beginning omit “(This Schedule reproduces, with minor modifications, the provision of Annex II to the Directive)”.

Amendments to Schedule 2

31

Schedule 2 is amended as follows—

• (a) in paragraph 2 for “the Directive” substitute “ these Regulations ”;

• (b) omit paragraph 4(c);

• (c) in paragraph 9(2) for “notified body” substitute “ approved body ”;

• (d) omit paragraph 9(4);

• (e) omit paragraph 9(7);

• (f) in paragraph 9(8)—

• (i) for “The notices in sub-paragraphs (6) and (7)” substitute “ The notice in sub-paragraph (6) ”;

• (ii) in head (f)(ii) for “harmonised” substitute “ designated ”;

• (g) in paragraph 9(10) for “competent national authority” substitute “ relevant authority ”;

• (h) omit paragraph 10 (EU safeguarding procedures);

• (i) omit paragraph 11(3);

• (j) in paragraph 11(4) for “The notices referred to in sub-paragraphs (2) and (3)” substitute “ The notice referred to in sub-paragraph (2) ”;

• (k) in paragraph 12—

• (i) in sub-paragraphs (1)(a), (1)(b) and (1)(c), for “CE marking” substitute “ UK marking ” in each place it appears;

• (ii) in sub-paragraph (1)(b) for “a notified body” substitute “ an approved body ”;

• (iii) in sub-paragraph (1)(b) “the notified body” substitute “the approved body”; and

• (iv) in sub-paragraph (1)(c) for “EU declaration of conformity” substitute “ declaration of conformity ” in each place it appears.

Amendment to Schedule 3

32

Schedule 3 is amended as follows—

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

• (b) in paragraph 8 for “notified” substitute “ approved ”;

• (c) in paragraph 11(c)—

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

• (ii) omit “and of the Directive”;

• (d) in paragraph 17—

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

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

Amendments to Schedule 4

33

Schedule 4 is amended as follows—

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

• (b) in paragraph 1, for “A notified” substitute “ An approved ”;

• (c) in paragraph 2, for “A notified” substitute “ An approved ”;

• (d) in paragraph 3, for “A notified” substitute “ An approved ”;

• (e) in paragraph 4, for “A notified” substitute “ An approved ”;

• (f) in paragraph 5—

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

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

• (g) in paragraph 6, for “a notified” substitute “ an approved ”;

• (h) in paragraph 7, for “notified” substitute “ approved ” in both places it appears;

• (i) in paragraph 8, for “a notified” substitute “ an approved ”;

• (j) in paragraph 9, for “notified” substitute “ approved ”;

• (k) in paragraph 10—

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

• (ii) in sub-paragraph (b)—

• (aa) for “notification” in the first place it appears substitute “ approval ”;

• (bb) in the second place it appears omit “(notification)”;

• (iii) in sub-paragraph (d) for “notification” substitute “ approval ”;

• (l) in paragraph 11, for “A notified” substitute “ An approved ”;

• (m) in paragraph 12—

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

• (ii) for “notified under the Directive” substitute “ approved under these Regulations ”;

• (n) in paragraph 13—

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

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

• (iii) for “under the Directive” substitute “ by the Secretary of State ”.

Insertion of Schedule 5 and Schedule 6

34

After Schedule 4 insert—