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[F1PART 13U.K.SUB-PART A: MAKING AVAILABLE ON THE MARKET – OBLIGATIONS OF ECONOMIC OPERATORS, SUB-PART B: CONFORMITY ASSESSMENT BODIES, SUB-PART C: NOTIFICATION OF CONFORMITY ASSESSMENT BODIES

Textual Amendments

F1Pt. 13 (regs. 39-77) substituted for Pt. 13 (regs. 39-42) (and therefore original regs. 43, 44 renumbered as new regs. 78, 79, new reg. 80 substituted for original reg. 45 and original regs. 46-49 renumbered as new regs. 81-84) (20.4.2016) by The Explosives Regulations 2014 (Amendment) Regulations 2016 (S.I. 2016/315), regs. 1, 7, 8, 9 (with regs. 2(1), 15)

SUB-PART A: MAKING AVAILABLE ON THE MARKET – OBLIGATIONS OF ECONOMIC OPERATORSU.K.MANUFACTURERSU.K.

Design and manufacture in accordance with essential safety requirementsU.K.

39.  Before placing a civil explosive on the market or using it for their own purposes, a manufacturer must ensure that it has been designed and manufactured in accordance with the essential safety requirements.

Technical documentation and conformity assessmentU.K.

40.  Before placing a civil explosive on the market, or using it for their own purposes, a manufacturer must, in respect of that civil explosive—

(a)have a relevant conformity assessment procedure carried out; and

(b)draw up the technical documentation referred to —

(i)for a civil explosive in respect of which the conformity assessment procedure in regulation [F266(2)(a)] is being carried out, in [F3paragraph 2(2)(c) of Part 1 (Module B) of Schedule 17];

(ii)for a civil explosive in respect of which the conformity assessment procedure in regulation [F466(2)(b)] is being carried out, in [F5paragraph 46 of Part 6 (Module G) of Schedule 17].

Textual Amendments

[F6Declaration] of conformity and [F7UK] markingU.K.

41.—(1) Where the conformity of a civil explosive with the essential safety requirements has been demonstrated by a relevant conformity assessment procedure, the manufacturer must, before placing the civil explosive on the market or using it for their own purposes—

(a)draw up a declaration of conformity in accordance with regulation 67 F8...; and

(b)affix the [F9UK] marking in accordance with regulation 68 F10....

(2) The manufacturer must keep the EU declaration of conformity up to date.

(3) [F11Where 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.]

Textual Amendments

Retention of technical documentation and F12... declaration of conformityU.K.

42.  A manufacturer must keep the technical documentation and the F12... declaration of conformity drawn up in respect of a civil explosive for a period of 10 years beginning on the day on which the civil explosive is placed on the market.

Textual Amendments

Compliance procedures for series productionU.K.

43.—(1) A manufacturer of civil explosives which are manufactured by series production must ensure that, before placing such a civil explosive on the market, procedures are in place to ensure that any civil explosive so manufactured will be in conformity with this Part.

(2) In doing so, the manufacturer must take adequate account of —

(a)any change in the design or characteristics of the civil explosive; and

(b)any change in a [F13designated] standard or in another technical specification by reference to which the F14... declaration of conformity was drawn up.

Textual Amendments

Traceability of certain civil explosives excluded from the scope of regulations 33, 34 and 36U.K.

44.—(1) A manufacturer of a civil explosive which is excluded from the scope of regulations 33, 34 and 36 by virtue of regulation 3(15), must, before placing such a civil explosive on the market—

(a)ensure that it bears a type, batch or serial number or other element allowing its identification, and

(b)indicate on the civil explosive—

(i)any of—

(aa)the manufacturer’s name;

(ab)registered trade name; or

(ac)trade mark; and

(ii)a single postal address at which they can be contacted.

(2) Where the small size, shape or design of the civil explosive does not allow the information specified in paragraph (1)(a) to be indicated on it, the manufacturer must ensure that such information is indicated on its packaging or in a document accompanying the civil explosive.

(3) Where it is not possible to indicate the information specified in paragraph (1)(b) on the civil explosive, the manufacturer must indicate that information on the packaging or in a document accompanying the civil explosive.

[F15(4) For a civil explosive that is to be made available on the market in Great Britain the contact details referred to in paragraph (1) must be provided in English.]

Textual Amendments

[F16Instructions and safety informationU.K.

45.—(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.]

Textual Amendments

AUTHORISED REPRESENTATIVESU.K.

Appointment of authorised representative by written mandateU.K.

46.—(1) A manufacturer may, by written mandate, appoint a person [F17established in the United Kingdom] as their authorised representative to perform specified tasks on the manufacturer’s behalf.

(2) The mandate must allow the authorised representative to do at least the following in relation to a civil explosive covered by the mandate—

(a)perform the manufacturer’s obligations under regulation 42 (retention of technical documentation and F18... declaration of conformity); and

(b)perform the manufacturer’s obligations under regulation 54 (provision of information and cooperation).

(3) A manufacturer must not delegate the performance of their functions under regulation 39 (design and manufacture in accordance with essential safety requirements) and regulation 40 (technical documentation and conformity assessment) to an authorised representative.

(4) An authorised representative must comply with all the duties imposed on the manufacturer in relation to each obligation under this Part that the authorised representative is appointed by the manufacturer to perform and, accordingly—

(a)as far as those duties are concerned, references in this Part (except in this regulation) to the manufacturer are to be taken as including a reference to the authorised representative; and

(b)if the authorised representative contravenes or fails to comply with any of those duties, the authorised representative may be proceeded against as though the authorised representative were the manufacturer.

(5) A manufacturer who has appointed an authorised representative to perform on their behalf an obligation under this Part remains responsible for the proper performance of that obligation.

Textual Amendments

IMPORTERSU.K.

Prohibition on placing on the market civil explosives which are not in conformityU.K.

47.  An importer must not place a civil explosive on the market unless it is in conformity with the essential safety requirements.

Requirements which must be satisfied before an importer places a civil explosive on the marketU.K.

48.—(1) Before placing a civil explosive on the market, an importer must ensure that—

(a)a relevant conformity assessment procedure has been carried out by the manufacturer;

(b)the manufacturer has drawn up the technical documentation;

(c)the civil explosive—

(i)bears the [F19UK] marking; and

(ii)is accompanied by the required documents; and

(d)the manufacturer has complied with the requirements, where applicable, set out in regulation 44 (traceability of certain civil explosives excluded from the scope of regulations 33, 34 and 36) to the extent not already covered by sub-paragraph (c)(ii).

(2) In paragraph (1)(c)(ii), “required documents” means any documents that are required to be provided with the civil explosive pursuant to—

(a)regulation 44(2) and (3); and

(b)regulation 45.

Textual Amendments

Prohibition on placing on the market civil explosives considered not to be in conformity with the essential safety requirementsU.K.

49.—(1) Where an importer considers, or has reason to believe, that a civil explosive is not in conformity with the essential safety requirements, the importer must not place the civil explosive on the market.

(2) Where the civil explosive presents a risk, the importer must inform the manufacturer and the market surveillance authority of that risk.

Information identifying importerU.K.

50.—(1) Before placing a civil explosive on the market, an importer must indicate on the civil explosive—

(a)any of—

(i)the name;

(ii)registered trade name; or

(iii)registered trade mark of the importer; and

(b)a postal address at which the importer can be contacted.

[F20(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 [F21seven years] beginning with IP completion 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.]

(2) The information specified in paragraph (1) must be in a language which can be easily understood by end-users and [F22a relevant authority].

(3) Where it is not possible to indicate the information specified in paragraph (1) on the civil explosive, the importer must indicate that information—

(a)on the packaging; or

(b)in a document accompanying the civil explosive.

Textual Amendments

Modifications etc. (not altering text)

[F23Instructions and safety informationU.K.

51.  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.]

Textual Amendments

Retention of technical documentation and F24... declaration of conformityU.K.

52.  An importer must, for a period of 10 years beginning on the day on which the civil explosive is placed on the market—

(a)keep a copy of the F25... declaration of conformity at the disposal of the market surveillance authority; and

(b)ensure that the technical documentation can be made available to that authority, upon request.

Textual Amendments

MANUFACTURERS AND IMPORTERSU.K.

Duty to take action in respect of civil explosives placed on the market which are considered not to be in conformityU.K.

53.—(1) A manufacturer or importer who considers, or has reason to believe, that a civil explosive which they have placed on the market is not in conformity with this Part must immediately take the corrective measures necessary to—

(a)bring the civil explosive into conformity;

(b)withdraw the civil explosive; or

(c)recall the civil explosive.

(2) Where the civil explosive presents a risk, the manufacturer or importer must immediately inform the market surveillance authorityF26... of the risk, giving details of—

(a)the respect in which the civil explosive is considered not to be in conformity with this Part; and

(b)any corrective measures taken.

Textual Amendments

Provision of information and cooperationU.K.

54.—(1) A manufacturer or importer must, further to a reasoned request from the market surveillance authority, provide the authority with the information and documentation necessary to demonstrate that the civil explosive is in conformity with this Part—

(a)in paper or electronic form; and

[F27(b)in clear, legible and easily understandable English.]

(2) A manufacturer or importer must, at the request of the market surveillance authority, cooperate with the authority on any action taken to—

(a)evaluate a civil explosive in accordance with paragraph 8 of Schedule 12 (evaluation of civil explosive presenting a risk);

(b)eliminate the risks posed by a civil explosive which the manufacturer or importer has placed on the market.

Textual Amendments

DISTRIBUTORSU.K.

Duty to act with due careU.K.

55.  When making a civil explosive available on the market, a distributor must act with due care to ensure that it is in conformity with this Part.

Requirements which must be satisfied before a distributor makes a civil explosive available on the marketU.K.

56.—(1) Before making a civil explosive available on the market, the distributor must verify that—

(a)the civil explosive—

(i)bears the [F28UK] marking;

(ii)is accompanied by the required documents;

[F29(iii)is accompanied by instructions and safety information that are clear, legible and in easily understandable English;]

(b)the manufacturer has complied with the requirements, where applicable, set out in regulation 44 (traceability of certain civil explosives excluded from the scope of regulations 33, 34 and 36) to the extent not already covered by sub-paragraph (a)(ii); and

(c)the importer has complied with the requirements set out in regulation 50 (information identifying importer) to the extent not already covered by sub-paragraph (a)(ii).

(2) In paragraph (1)(a)(ii), “required documents” means the documents that are required to be provided with the civil explosive pursuant to—

(a)regulation 44(2) and (3); and

(b)regulation 50(3).

Textual Amendments

Prohibition on making available on the market where civil explosive considered not to be in conformity with the essential safety requirementsU.K.

57.—(1) Where a distributor considers, or has reason to believe, that a civil explosive is not in conformity with the essential safety requirements, the distributor must not make the civil explosive available on the market.

(2) Where the civil explosive presents a risk, the distributor must inform the following persons of the risk—

(a)the manufacturer or the importer; and

(b)the market surveillance authority.

Duty to take action in respect of civil explosives made available on the market which are not in conformityU.K.

58.—(1) A distributor who considers, or has reason to believe, that a civil explosive which the distributor has made available on the market is not in conformity with this Part must make sure that the necessary corrective measures are taken to—

(a)bring that civil explosive into conformity;

(b)withdraw the civil explosive; or

(c)recall the civil explosive.

(2) Where the civil explosive presents a risk, the distributor must immediately inform the market surveillance authorityF30... of that risk, giving details of—

(a)the respect in which the civil explosive is considered not to be in conformity with this Part; and

(b)any corrective measures taken.

Textual Amendments

Provision of information and cooperationU.K.

59.—(1) A distributor must, further to a reasoned request from the enforcing authority, provide the authority with the information and documentation, in paper or electronic form, necessary to demonstrate that the civil explosive is in conformity with this Part.

(2) A distributor must, at the request of the enforcing authority, cooperate with the authority on any action taken to—

(a)evaluate a civil explosive in accordance with paragraph 8 of Schedule 12 (evaluation of civil explosives presenting a risk); and

(b)eliminate the risks posed by a civil explosive which the distributor has made available on the market.

IMPORTERS AND DISTRIBUTORSU.K.

Storage and transportU.K.

60.  Each importer and distributor must ensure that, while a civil explosive is their responsibility, its storage or transport conditions do not jeopardise its conformity with the essential safety requirements.

Cases in which obligations of manufacturers apply to importers and distributorsU.K.

61.  An economic operator (“A”) who would, but for this regulation, be considered an importer or distributor, is to be considered a manufacturer for the purposes of this Part and is subject to the obligations of a manufacturer under this Part, where A—

(a)places a civil explosive on the market under A’s own name or trademark; or

(b)modifies a civil explosive already placed on the market in such a way that it may affect whether the civil explosive is in conformity with this Part.

ALL ECONOMIC OPERATORSU.K.

Translation of declaration of conformityU.K.

F3162.  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Textual Amendments

Identification of economic operatorsU.K.

63.—(1) This regulation applies in relation to civil explosives excluded from the scope of regulations 33, 34 and 36 by virtue of regulation 3(15).

(2) An economic operator (“E”) who receives a request from the market surveillance authority before the end of the relevant period, must, within such period as the authority may specify, identify to the market surveillance authority—

(a)any economic operator who has supplied E with a civil explosive to which this regulation applies; and

(b)any economic operator to whom E has supplied a civil explosive to which this regulation applies.

(3) The relevant period is—

(a)for information under paragraph (2)(a), a period of 10 years beginning on the day on which E was supplied with the civil explosive;

(b)for information under paragraph (2)(b), a period of 10 years beginning on the day on which E supplied the civil explosive.

Prohibition on improper use of [F32UK] markingU.K.

64.—(1) An economic operator must not affix the [F33UK] marking to a civil explosive unless—

(a)that economic operator is the manufacturer; and

(b)the conformity of the civil explosive with the essential safety requirements has been demonstrated by a relevant conformity assessment procedure.

(2) An economic operator must not affix to a civil explosive a marking (other than the [F33UK] marking) which purports to attest that the civil explosive is in conformity with the essential safety requirements.

(3) An economic operator must not affix to a civil explosive a marking, sign or inscription which is likely to mislead any other person as to the meaning or form of the [F33UK] marking.

(4) An economic operator must not affix to a civil explosive any other marking if the visibility, legibility and meaning of the [F33UK] marking would be impaired as a result.

Textual Amendments

[F34Obligations which are met by complying with obligations in the DirectiveU.K.

64A.—(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 39, 40, 41(1) and 41(3) are to be treated as being satisfied;

(b)regulations 41(2), 42, 43(2), 46(2) and 64 apply subject to the modifications in paragraph (10); and

(c)Schedule 12 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 48(1)(a) to (c) are to be treated as being satisfied; and

(b)regulations 47, 49(1), 52 and 60 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 56(1)(a)(i) is to be treated as being satisfied; and

(b)regulations 57(1) and 60 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.

Textual Amendments

Conformity assessment procedure obligation which is met by complying with the DirectiveU.K.

64B.—(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 40(a), 41(1), 48(1)(a), 64(1)(b), 67(b) and 68(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 40(b), 42, 48(1)(b), 52(b), and in paragraph 12(1)(d) of Part 1 of Schedule 12 and Schedule 17 is to be read as including the technical documentation relating to the design of the civil explosive referred to in Annex III.

Textual Amendments

Expiry of regulations 64A and 64BU.K.

64C.—(1) Subject to paragraph (2), regulation 64A ceases to have effect at the end of the period of [F35four years] beginning with IP completion day.

(2) Notwithstanding the expiry of regulation 64A—

(a)any civil explosive which was placed on the market pursuant to regulation 64A may continue to be made available on the market on or after the expiry of regulation 64A;

(b)any obligation to which a person was subject under regulation 64A in respect of a civil explosive placed on the market pursuant to regulation 64A continues to have effect after the expiry of regulation 64A, in respect of that civil explosive.

(3) Subject to paragraph (4), regulation 64B ceases to have effect at the end of the period of [F36four years] beginning with IP completion day.

(4) Where a conformity assessment procedure has been completed pursuant to regulation 64B in relation to a civil explosive prior to the expiry of regulation 64B, regulation 64B continues to apply in respect of that civil explosive where—

(a)the manufacturer arranges for the EU-Type examination certificate and any annexes to be transferred to an approved body;

(b)the approved body referred to in sub-paragraph (a) accepts responsibility for the EU-Type examination certificate; and

(c)the approved body issues a Type-examination certificate relying, or relying in part, on any examinations or tests undertaken prior to the issue of the EU-Type examination certificate.

(5) In paragraph (4) “EU-Type examination certificate” means a certificate issued after an EU-Type examination has been carried out in accordance with a conformity assessment procedure set out in point 1 of Annex III of the Directive.

Textual Amendments

Qualifying Northern Ireland GoodsU.K.

64D.—(1) In this regulation—

“the 2016 Regulations” means the Making Available on the Market and Supervision of Transfers of Explosives Regulations (Northern Ireland) 2016;

“CE marking” has the meaning given to it in regulation 2(1) of the 2016 Regulations;

“qualifying Northern Ireland goods” has the meaning given to it in regulations made under section 8C(6) of the European Union (Withdrawal) Act 2018;

“relevant conformity assessment procedure” has the meaning given to it in regulation 2(1) of the 2016 Regulations;

“technical documentation” has the meaning given to it in regulation 2(1) of the 2016 Regulations.

(2) Where paragraph (3) applies, a civil explosive is to be treated as being in conformity with Part 13 Sub-Part A.

(3) This paragraph applies where—

(a)a civil explosive—

(i)is in conformity with Part 3 Sub-Part A of the 2016 Regulations;

(ii)is qualifying Northern Ireland goods; and

(b)an importer has met the obligations set out in paragraph (4).

(4) The obligations referred to in paragraph (3)(b) are that, before placing the civil explosive on the market, the importer—

(a)complies with regulation 50;

(b)ensures that—

(i)the relevant conformity assessment procedure has been carried out in in relation to the civil explosive;

(ii)the manufacturer has drawn up the technical documentation; and

(iii)the civil explosive bears the CE marking.]

Textual Amendments

SUB-PART B: CONFORMITY ASSESSMENTU.K.

Presumption of conformityU.K.

65.—(1) A civil explosive which is in conformity with a [F37designated] standard, or part of such a standard, F38... is to be presumed to be in conformity with the essential safety requirements covered by that standard, or that part of that standard.

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

Textual Amendments

[F39Conformity assessment proceduresU.K.

66.—(1) Assessment of conformity of a civil explosive is carried out by an approved body in accordance with the procedures set out in Schedule 17.

(2) For the assessment of conformity of a civil explosive, the manufacturer must follow one of the following procedures set out in Schedule 17—

(a)in Part 1 of Schedule 17, 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 17, conformity to type based on internal production control plus supervised product checks at random intervals (Module C2);

(ii)in Part 3 of Schedule 17, conformity to type based on quality assurance of the production process (Module D);

(iii)in Part 4 of Schedule 17, conformity to type based on product quality assurance (Module E);

(iv)in Part 5 of Schedule 17, conformity to type based on product verification (Module F);

(b)in Part 6 of Schedule 17, conformity based on unit verification (Module G).]

Textual Amendments

[F40Declaration] of conformityU.K.

67.  The F41... declaration of conformity for a civil explosive must—

(a)state that the fulfilment of the essential safety requirements has been demonstrated in respect of the civil explosive;

(b)contain the elements specified in [F42Schedule 17,] for the relevant conformity assessment procedure followed in respect of the civil explosive; and

(c)have the model structure set out in [F43Schedule 18.]

Textual Amendments

[F44UK] markingU.K.

68.—(1) [F45The UK marking must be affixed visibly, legibly and indelibly—

(a)to the civil explosive; or

(b)where paragraph (1A) applies, to—

(i)a label affixed to the civil explosive; or

(ii)the accompanying documents.]

[F46(1A) For a period of [F47seven years] beginning with IP completion day, the UK marking may be affixed to—

(a)a label affixed to the civil explosive; or

(b)the accompanying documents.]

(2) Where [F48paragraph (1A) does not apply and] it is not possible or warranted, on account of the nature of the civil explosive, to affix the [F49UK] marking in accordance with paragraph (1), the [F49UK] marking must be affixed to—

(a)the packaging; and

(b)the accompanying documents.

(3) The [F50UK] marking must be followed by the identification number of the [F51approved] body which carried out the relevant conformity assessment procedure for the civil explosive, where that body is involved in the production control phase.

(4) The identification number of the [F52approved] body must be affixed—

(a)by the [F52approved] body itself; or

(b)under the instructions of the [F52approved] body, by the manufacturer or the manufacturer’s authorised representative.

(5) In the case of a civil explosive—

(a)manufactured for the manufacturer’s own use;

(b)transported and delivered unpackaged or in a mobile explosives manufacturing unit for its direct unloading into the blast-hole; or

(c)manufactured at the blasting site which is loaded immediately after being produced,

the [F53UK] marking must be affixed to the accompanying documents.

Textual Amendments

F45Reg. 68(1) substituted (31.12.2020) by S.I. 2019/696, Sch. 16 para. 27(b) (as substituted by The Product Safety and Metrology etc. (Amendment etc.) (UK(NI) Indication) (EU Exit) Regulations 2020 (S.I. 2020/1460), reg. 1(4), Sch. 3 para. 10(5)(a))

F46Reg. 68(1A) inserted by S.I. 2019/696, Sch. 16 para. 27(ba) (as inserted by The Product Safety and Metrology etc. (Amendment etc.) (UK(NI) Indication) (EU Exit) Regulations 2020 (S.I. 2020/1460), reg. 1(4), Sch. 3 para. 10(5)(b))

[F54SUB-PART C: Approval of Conformity Assessment Bodies U.K.

Textual Amendments

F54Pt. 13 Sub-Pt. C substituted (31.12.2020) by The Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/696), reg. 1, Sch. 16 para. 28 (with Sch. 16 para. 29) (as amended by S.I. 2020/676, regs. 1(1), 2, The Product Safety and Metrology (Amendment) (EU Exit) Regulations 2020 (S.I. 2020/852), regs. 2(2), 4(2), Sch. 1 para. 1(f)(iii)(iv)); 2020 c. 1, Sch. 5 para. 1(1)

Approved bodiesU.K.

69.—(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 70 (approval of conformity assessment bodies); or

(b)immediately before IP completion day was a notified body in respect of which the Secretary of State had taken no action under regulation 75(1) or (2) as they had effect before IP completion day to suspend or withdraw the body's status as a notified body.

(2) Paragraph (1) has effect subject to regulation 73 (restriction, suspension or withdrawal of approval).

(3) In this Sub-Part—

“notified body” means a body—

(a)

which the Secretary of State had before IP completion day notified to the European Commission and to the other EEA states, in accordance with Article 24 of the Directive; and

(b)

in respect of which no objections had been raised, as referred to in regulation 69(1)(b);

“approved body requirements” means the requirements set out in Schedule 15.

Approval of conformity assessment bodiesU.K.

70.—(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 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.

Presumption of conformity of approved bodiesU.K.

71.—(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.

MonitoringU.K.

72.  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 70(6)(b); or

(ii)in the case of an approved body which was a notified body immediately before IP completion day, in accordance with conditions set under regulation 70(6)(b) as it applied immediately before IP completion day; and

(c)carries out its functions in accordance with these Regulations.

Restriction, suspension or withdrawal of approvalU.K.

73.—(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 72(b),

the Secretary of State must restrict, suspend or withdraw the body's status as an approved body under regulation 69 (approved bodies).

(2) Where the Secretary of State determines that an approved body no longer meets a condition referred to in regulation 72(b), the Secretary of State may restrict, suspend or withdraw the body's status as an approved body under regulation 69.

(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 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.

Operational matters in relation to approved bodiesU.K.

74.—(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 70; 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 16 (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 17 (conformity assessment procedures); or

(b)to affix, or cause to be affixed, the body's identification number pursuant to regulation 68 (UK marking).

Subsidiaries and contractorsU.K.

75.—(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 .

Register of approved bodiesU.K.

76.—(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.

UK national accreditation bodyU.K.

77.  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 72; and

(c)compiling and maintaining the register of approved bodies, in accordance with regulation 76.]]