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

(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

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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

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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

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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

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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

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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

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After Schedule 4 insert—

SCHEDULE 5 (1) (1) Type examination (Module B) is a conformity assessment procedure in which an approved body examines the technical design of an explosive and verifies and attests that the technical design of the explosive meets the requirements of these Regulations that apply to it. (2) Type examination must be carried out as an assessment of the adequacy of the technical design of the explosive through— (a) examination of the technical documentation and supporting evidence referred to in paragraph 2; and (b) examination of a specimen of the production envisaged which is representative of the complete product (combination of production type and design type). (2) (1) A manufacturer must lodge an application for Type examination (Module B) with an approved body of the manufacturer's choice. (2) The application must include— (a) the name and address of the manufacturer and, if the application is lodged by the authorised representative, the name and address of the authorised representative; (b) a written declaration that the same application has not been lodged with any other approved body; (c) the technical documentation; (d) the specimens representative of the production envisaged, and any further specimens requested by the approved body if needed for carrying out the test programme; (e) the supporting evidence for the adequacy of the technical design solution; this supporting evidence must— (i) mention any documents that have been used, in particular where the relevant designated standards have not been applied in full; (ii) include, where necessary, the results of tests carried out in accordance with other relevant technical specifications by the appropriate laboratory of the manufacturer, or by another testing laboratory on the manufacturer's behalf and under the manufacturer's responsibility. (3) The technical documentation referred to in paragraph 2(2)(c) must— (a) make it possible to assess the explosive's conformity with the applicable requirements of these Regulations and must include an adequate analysis and assessment of any risks; (b) specify the applicable requirements and cover, as far as relevant for the assessment, the design, manufacture and operation of the explosive; (c) contain, wherever applicable, at least the following elements— (i) a general description of the explosive; (ii) conceptual design and manufacturing drawings and schemes of components, sub-assemblies and circuits; (iii) descriptions and explanations necessary for the understanding of those drawings and schemes and the operation of the explosive; (iv) a list of the designated standards applied in full or in part (where applicable specifying the parts which have been applied); (v) where designated standards have not been applied, descriptions of the solutions adopted to meet the essential safety requirements, including a list of other relevant technical specifications applied to meet the essential safety requirements; (vi) the results of design calculations made and examinations carried out; (vii) test reports. (4) (1) The approved body must examine the technical documentation and supporting evidence in respect of an explosive to assess the adequacy of the technical design of the explosive. (2) For each of the specimens examined, the approved body must— (a) verify that the specimen— (i) has been manufactured in conformity with the technical documentation; (ii) identifies the elements which have been designed in accordance with the applicable provisions of the relevant designated standards, as well as the elements which have been designed in accordance with other relevant technical specifications; (b) carry out appropriate examinations and tests, or have them carried out, to check whether, where the manufacturer has chosen to apply the solutions in the relevant designated standards, these have been applied correctly; (c) carry out, or arrange the carrying out of, appropriate examinations and tests to check whether, where the solutions in the relevant designated standards have not been applied, the solutions adopted by the manufacturer applying other relevant technical specifications meet the corresponding essential safety requirements; (d) agree with the manufacturer on a location where the examinations and tests will be carried out. (5) The approved body must draw up an evaluation report that records the activities undertaken in accordance with paragraph 4 and their outcomes and, without prejudice to the approved body's obligations in relation to the Secretary of State, the approved body may disclose the content of that report, in full or in part, only with the agreement of the manufacturer. (6) (1) Where the type meets the applicable requirements of these Regulations, the approved body must issue a Type examination certificate to the manufacturer, which must contain— (a) the name and address of the manufacturer; (b) the conclusions of the examination; (c) the conditions (if any) for its validity; (d) the necessary data for the identification of the approved type; (e) all relevant information to allow the conformity of manufactured explosives with the examined type to be evaluated and to allow for in-service control. (2) The Type examination certificate referred to in sub-paragraph (1)— (a) may have one or more annexes attached; (b) must be accompanied by the descriptions and drawings necessary for identification of the approved type. (3) Where the type does not satisfy the applicable requirements of these Regulations, the approved body must refuse to issue a Type examination certificate and must inform the applicant accordingly, giving detailed reasons for its refusal. (7) An approved body must keep itself apprised of any changes in the generally acknowledged state of the art which indicate that the approved type may no longer comply with the applicable requirements of these Regulations, and must determine whether such changes require further investigation and, if so, the approved body must inform the manufacturer accordingly. (8) A manufacturer must inform the approved body that holds the technical documentation relating to the Type examination certificate of all modifications to the approved type that may affect the conformity of the explosive with the essential safety requirements or the conditions for validity of that certificate; such modifications require additional approval in the form of an addition to the original Type examination certificate. (9) (1) Each approved body must inform the Secretary of State of all Type examination certificates and any additions thereto which it has issued or withdrawn, and must, periodically or upon request, make available to the Secretary of State the list of such certificates and any additions thereto refused, suspended or otherwise restricted. (2) Each approved body must inform the other approved bodies of all Type examination certificates and any additions thereto which it has refused, withdrawn, suspended or otherwise restricted, and must, upon request, inform the other approved bodies of such certificates and additions thereto which it has issued. (3) The other approved bodies and the Secretary of State may obtain from the approved body a copy of— (a) the Type examination certificates and additions thereto; (b) the technical documentation and the results of the examinations carried out by the approved body. (4) An approved body must keep a copy of the Type examination certificate, its annexes and additions, as well as the file containing the technical documentation including the documentation submitted by the manufacturer, until the expiry of the validity of that certificate. (5) A manufacturer must keep a copy of the Type examination certificate, its annexes and additions together with the technical documentation at the disposal of the relevant authority for 10 years beginning on the day on which the explosive has been placed on the market. (10) A manufacturer's authorised representative (if any) may lodge the application referred to in paragraph 2 and fulfil the obligations set out in paragraphs 8 and 9(5), provided that they are specified in the mandate by which they were appointed under regulation 12. (11) Conformity to type based on internal production control plus supervised product checks at random intervals (Module C2) is the part of a conformity assessment procedure whereby the manufacturer fulfils the obligations laid down in paragraphs 12 to 14, and it is solely the manufacturer's responsibility to ensure and declare that the explosives concerned are in conformity with the type described in the Type examination certificate and satisfy the requirements of these Regulations that apply to them. (12) A manufacturer must take all measures necessary so that the manufacturing process and its monitoring ensure conformity of the manufactured explosives with the type described in the Type examination certificate and with the requirements of these Regulations that apply to them. (13) (1) The approved body chosen by the manufacturer must carry out product checks or have them carried out at random intervals determined by that body, in order to verify the quality of the internal checks on the explosive, taking into account, amongst other things, the technological complexity of the explosives and the quantity of production. (2) The approved body must ensure that— (a) it takes an adequate sample of the final product on site before its placing on the market; and (b) the sample is examined and appropriate tests as identified by the relevant parts of the designated standards, or equivalent tests set out in other relevant technical specifications, are carried out to check the conformity of the explosive with the type described in the Type examination certificate and with the relevant requirements of these Regulations. (3) Where a sample does not conform to the acceptable quality level, the approved body must take appropriate measures. (4) The acceptance sampling procedure to be applied is intended to determine whether the manufacturing process of the explosive performs within acceptable limits, with a view to ensuring conformity of the explosive. (5) The manufacturer must, under the responsibility of the approved body, affix the approved body's identification number during the manufacturing process. (14) (1) A manufacturer must affix the UK marking to each individual explosive that is in conformity with the type described in the Type examination certificate and which satisfies the applicable requirements of these Regulations. (2) A manufacturer must draw up a written declaration of conformity for each explosive type and keep it at the disposal of the relevant authority for 10 years beginning on the day on which the explosive has been placed on the market; the declaration of conformity must identify the explosive type for which it has been drawn up. (3) A copy of the declaration of conformity must be made available to the relevant authority upon request. (15) A manufacturer's obligations set out in paragraph 14 may be fulfilled by the manufacturer's authorised representative (if any), on the manufacturer's behalf and under the manufacturer's responsibility, provided that they are specified in the mandate by which they were appointed under regulation 12. (16) Conformity to type based on quality assurance of the production process (Module D) is a conformity assessment procedure whereby the manufacturer fulfils the obligations laid down in paragraphs 17 and 23, and it is solely the manufacturer's responsibility to ensure and declare that the explosives concerned are in conformity with the type described in the Type examination certificate and satisfy the requirements of these Regulations that apply to them. (17) A manufacturer must operate an approved quality system for production, final product inspection and testing of the explosives specified in paragraph 18, and which is subject to surveillance as specified in paragraph 22. (18) (1) A manufacturer must lodge an application for assessment of the manufacturer's quality system with an approved body of the manufacturer's choice. (2) The application must include— (a) the name and address of the manufacturer and, if the application is lodged by the authorised representative, the name and address of the authorised representative; (b) a written declaration that the same application has not been lodged with any other approved body; (c) all relevant information for the explosive category envisaged; (d) the documentation concerning the quality system; (e) the technical documentation of the approved type and a copy of the Type examination certificate. (19) (1) The quality system must ensure that the explosives are in conformity with the type described in the Type examination certificate and comply with the requirements of these Regulations that apply to them. (2) All the elements, requirements and provisions adopted by the manufacturer must be documented in a systematic and orderly manner in the form of written policies, procedures and instructions. (3) The quality system documentation must permit a consistent interpretation of the quality programmes, plans, manuals and records and must, in particular, contain an adequate description of— (a) the quality objectives and the organisational structure, responsibilities and powers of the management with regard to product quality; (b) the corresponding manufacturing, quality control and quality assurance techniques, processes and systematic actions that will be used; (c) the examinations and tests that will be carried out before, during and after manufacture, and the frequency with which they will be carried out; (d) quality records, such as inspection reports and test data, calibration data, and qualification reports on the personnel concerned; (e) the means of monitoring the achievement of the required product quality and the effective operation of the quality system. (20) (1) The approved body must assess the quality system to determine whether it satisfies the requirements referred to in paragraph 19 and, where applicable, it must presume conformity with those requirements in respect of the elements of the quality system that comply with the corresponding specifications of the relevant designated standard. (2) The audit team appointed by the approved body to carry out the audit in sub-paragraph (1) (“the audit”) must have experience in quality management systems, with at least one member of the team having experience of evaluation in the relevant product field and product technology concerned, and knowledge of the applicable requirements of these Regulations. (3) The audit must include an assessment visit to the manufacturer's premises. (4) The audit team must review the technical documentation referred to in paragraph 18(2)(e) to verify the manufacturer's ability to identify the relevant requirements of these Regulations and to carry out the necessary examinations with a view to ensuring compliance of the explosive with those requirements. (5) The decision of the approved body must be notified to the manufacturer and must contain the conclusions of the audit and a reasoned assessment of the decision. (21) (1) A manufacturer must— (a) fulfil the obligations arising out of the quality system as approved and maintain it in an adequate and efficient state; and (b) keep the approved body that has approved the quality system informed of any intended change to the quality system. (2) Where the approved body is notified by a manufacturer of any proposed change to the quality system the approved body must— (a) evaluate such proposed changes and decide whether the modified quality system will continue to satisfy the requirements referred to in paragraph 19 or whether a reassessment is necessary; and (b) notify the manufacturer of its decision and, that notification must contain the conclusions of the examination and a reasoned assessment of the decision. (22) (1) The approved body must carry out surveillance, the purpose of which is to ensure that a manufacturer fulfils the obligations arising out of the approved quality system. (2) A manufacturer must, for assessment purposes, allow the approved body access to the manufacture, inspection, testing and storage sites and must provide the approved body with all necessary information including, in particular— (a) the quality system documentation; (b) the quality records, such as inspection reports and test data, calibration data, and qualification reports on the personnel concerned. (3) The approved body must carry out periodic audits to ensure that a manufacturer maintains and applies the quality system and, following each audit, must provide the manufacturer with an audit report. (4) The approved body may pay unexpected visits to a manufacturer; during such visits the approved body may, if necessary, carry out product tests, or have them carried out, in order to verify that the quality system is functioning correctly; and following such a visit the approved body must provide the manufacturer with a visit report and, if tests have been carried out, with a test report. (23) (1) A manufacturer must affix the UK marking, and, under the responsibility of the approved body referred to in paragraph 18(1), the latter's identification number to each individual explosive that is in conformity with the type described in the Type examination certificate and which satisfies the applicable requirements of these Regulations. (2) A manufacturer must draw up a written declaration of conformity for each explosive type and keep it at the disposal of the relevant authority for 10 years beginning on the day on which the explosive has been placed on the market; the declaration of conformity must identify the explosive type for which it has been drawn up. (3) A copy of the declaration of conformity must be made available to the relevant authority upon request. (24) A manufacturer must, for a period of 10 years beginning on the day on which the explosive has been placed on the market, keep at the disposal of the relevant authority— (a) the documentation referred to in paragraph 18(2); (b) any information relating to the change referred to in paragraph 21(1)(b) and 21(2), as approved; (c) the decisions and reports of the approved body referred to in paragraphs 21, 22(3) and 22(4). (25) Each approved body must inform the Secretary of State of quality system approvals issued or withdrawn and must, periodically or upon request, make available to the Secretary of State the list of quality system approvals refused, suspended or otherwise restricted. (26) Each approved body must inform other approved bodies of quality system approvals which it has refused, suspended, withdrawn or otherwise restricted, and, upon request, of quality system approvals which it has issued. (27) A manufacturer's obligations set out in paragraphs 18(1), 18(2), 21(1)(b), 21(2), 23 and 24 may be fulfilled by the manufacturer's authorised representative (if any), on the manufacturer's behalf and under the manufacturer's responsibility, provided that they are specified in the mandate by which they were appointed under regulation 12. (28) Conformity to type based on product quality assurance (Module E) is that part of a conformity assessment procedure whereby the manufacturer fulfils the obligations laid down in paragraphs 29 and 34, and it is solely manufacturer's responsibility to ensure and declare that the explosives concerned are in conformity with the type described in the Type examination certificate and satisfy the requirements of these Regulations that apply to them. (29) A manufacturer must operate an approved quality system for final product inspection and testing of the explosives concerned as specified in paragraphs 30 and 31 and, which must be subject to surveillance as specified in paragraph 33. (30) (1) A manufacturer must lodge an application for assessment of the manufacturer's quality system with an approved body of the manufacturer's choice for the explosives concerned. (2) The application must include— (a) the name and address of the manufacturer and, if the application is lodged by the authorised representative, the name and address of the authorised representative; (b) a written declaration that the same application has not been lodged with any other approved body; (c) all relevant information for the explosive category envisaged; (d) the documentation concerning the quality system; (e) the technical documentation of the approved type and a copy of the Type examination certificate. (3) The quality system must ensure compliance of the explosives with the type described in the Type examination certificate and with the applicable requirements of these Regulations. (4) All the elements, requirements and provisions adopted by the manufacturer must be documented in a systematic and orderly manner in the form of written policies, procedures and instructions; this quality system documentation must permit a consistent interpretation of the quality programmes, plans, manuals and records and, it must, in particular, contain an adequate description of— (a) the quality objectives and the organisational structure, responsibilities and powers of the management with regard to product quality; (b) the examinations and tests that will be carried out after manufacture; (c) the quality records, such as inspection reports and test data, calibration data and qualification reports on the personnel concerned; (d) the means of monitoring the effective operation of the quality system. (31) (1) The approved body must assess the quality system to determine whether it satisfies the requirements referred to in paragraph 30(3) and (4) and, where applicable, it must presume conformity with those requirements in respect of the elements of the quality system that comply with the corresponding specifications of a relevant designated standard. (2) The audit team, appointed by the approved body to carry out the audit under sub-paragraph (1) (“the audit”) must have experience in quality management systems and have at least one member with experience of evaluation in the relevant product field and product technology concerned, and knowledge of the applicable requirements of these Regulations. (3) The audit must include an assessment visit to the manufacturer's premises. (4) The audit team must review the technical documentation referred to in paragraph 30(2)(e), in order to verify the manufacturer's ability to identify the relevant requirements of these Regulations and to carry out the necessary examinations with a view to ensuring compliance of the explosive with those requirements. (5) The decision of the approved body must be notified to the manufacturer and, the notification must contain the conclusions of the audit and the reasoned assessment for the decision. (32) (1) A manufacturer must— (a) fulfil the obligations arising out of the quality system as approved and maintain it in an adequate and efficient state; and (b) keep the approved body that has approved the quality system informed of any intended change to the quality system. (2) Where the approved body is notified by a manufacturer of any proposed change to the quality system the approved body must— (a) evaluate any proposed changes and decide whether the modified quality system will continue to satisfy the requirements referred to in paragraph 30(3) and (4) or whether a reassessment is necessary; and (b) notify the manufacturer of its decision and, that notification must contain the conclusions of the examination and the reasoned assessment for the decision. (33) (1) The approved body must carry out surveillance, the purpose of which is to ensure that a manufacturer fulfils the obligations arising out of the approved quality system. (2) A manufacturer must, for assessment purposes, allow the approved body access to the manufacture, inspection, testing and storage sites and must provide it with all necessary information, in particular— (a) the quality system documentation; (b) the quality records, such as inspection reports and test data, calibration data and qualification reports on the personnel concerned. (3) The approved body must carry out periodic audits to ensure that a manufacturer maintains and applies the quality system and, following each audit, must provide the manufacturer with an audit report. (4) The approved body may pay unexpected visits to the manufacturer; during such visits the approved body may carry out product tests, or have them carried out, in order to verify that the quality system is functioning correctly and, following such a visit, the approved body must provide the manufacturer with a visit report and, if tests have been carried out, a test report. (34) (1) A manufacturer must affix the UK marking and, under the responsibility of the approved body referred to in paragraph 30(1), the latter's identification number to each individual explosive that is in conformity with the type described in the Type examination certificate and satisfies the applicable requirements of these Regulations. (2) A manufacturer must draw up a written declaration of conformity for each explosive type and keep it at the disposal of the relevant authority for 10 years beginning on the day on which the explosive has been placed on the market. (3) A copy of the declaration of conformity must be made available to the relevant authority upon request. (35) A manufacturer must, for a period of 10 years, beginning on the day on which the explosive has been placed on the market, keep at the disposal of the relevant authority— (a) the documentation referred to in paragraph 30(1) and 30(2); (b) the information relating to the change referred to in paragraph 32, as approved; (c) the decisions and reports of the approved body referred to in paragraphs 32(2), 33(3) and 33(4). (36) (1) Each approved body must inform the Secretary of State of quality system approvals issued or withdrawn, and must, periodically or upon request, make available to the Secretary of State the list of quality system approvals refused, suspended or otherwise restricted. (2) Each approved body must inform the other approved bodies of quality system approvals which it has refused, suspended or withdrawn, and, upon request, of quality system approvals which it has issued. (37) A manufacturer's obligations set out in paragraphs 30(1), 30(2), 32(1)(b), 34 and 35 may be fulfilled by the manufacturer's authorised representative (if any), on the manufacturer's behalf and under the manufacturer's responsibility, provided that they are specified in the mandate by which they were appointed under regulation 12. (38) Conformity to type based on product verification (Module F) is the part of a conformity assessment procedure whereby a manufacturer fulfils the obligations laid down in paragraphs 39, 42(1) and 43, and it is solely the manufacturer's responsibility to ensure and declare that the explosives concerned, which have been subject to examinations and tests under paragraph 40, are in conformity with the type described in the Type examination certificate and satisfy the requirements of these Regulations that apply to them. (39) A manufacturer must take all measures necessary so that the manufacturing process and its monitoring ensure conformity of the manufactured explosives with the approved type described in the Type examination certificate and with the requirements of these Regulations that apply to them. (40) (1) An approved body chosen by the manufacturer must carry out appropriate examinations and tests in order to check the conformity of the explosives with the approved type described in the Type examination certificate and with the appropriate requirements of these Regulations. (2) The examinations and tests to check the conformity of the explosives with the appropriate requirements must be carried out, at the choice of the manufacturer, either— (a) by examination and testing of every product as specified in paragraph 41; or (b) by examination and testing of the explosives on a statistical basis as specified in paragraph 42. (41) (1) All explosives must be individually examined and appropriate tests in the relevant designated standard or equivalent tests in other relevant technical specifications must be carried out in order to verify conformity with the approved type described in the Type examination certificate and with the appropriate requirements of these Regulations; in the absence of such a designated standard, the approved body concerned must decide on the appropriate tests to be carried out. (2) The approved body must issue a certificate of conformity in respect of the examinations and tests carried out, and must affix its identification number to each approved explosive or have it affixed under its responsibility. (3) A manufacturer must keep the certificates of conformity available for inspection by the relevant authority for 10 years beginning on the day on which the explosive has been placed on the market. (42) (1) A manufacturer must take all measures necessary so that the manufacturing process and its monitoring ensure the homogeneity of each lot produced, and must present the manufacturer's explosives for verification in the form of homogeneous lots. (2) The approved body must take a random sample from each lot; all explosives in a sample must be individually examined and appropriate tests set out in the relevant designated standards, or equivalent tests set out in other relevant technical specifications, must be carried out in order to verify their conformity with the approved type described in the Type examination certificate and with the applicable requirements of these Regulations and to determine whether the lot is accepted or rejected; in the absence of such a designated standard, the approved body concerned must decide on the appropriate tests to be carried out. (3) If a lot is accepted, all explosives of the lot must be considered approved, except for those explosives from the sample that have been found not to satisfy the tests. (4) The approved body must issue a certificate of conformity in respect of the examinations and tests carried out, and must affix its identification number to each approved explosive or have it affixed under its responsibility. (5) A manufacturer must keep the certificates of conformity at the disposal of the relevant authority for 10 years beginning on the day on which the explosive has been placed on the market. (6) If a lot is rejected, the approved body, or enforcing authority, must take appropriate measures to prevent the placing on the market of that lot and, in the event of the frequent rejection of lots the approved body may suspend statistical verification and take appropriate measures. (43) (1) A manufacturer must affix the UK marking, and, under the responsibility of the approved body referred to in paragraph 40(1), the latter's identification number to each individual explosive confirming that the explosive is in conformity with the approved type described in the Type examination certificate and that it satisfies the applicable requirements of these Regulations. (2) A manufacturer must draw up a written declaration of conformity for each explosive type and keep it at the disposal of the relevant authority for 10 years beginning on the day on which the explosive has been placed on the market and, such a declaration of conformity must identify the explosive type for which it has been drawn up. (3) A copy of the declaration of conformity must be made available to the relevant authority upon request. (4) If the approved body referred to in paragraph 40(1) agrees, and under its responsibility, the manufacturer may affix the approved body's identification number to the explosives. (5) If the approved body referred to in paragraph 40(1) agrees and under its responsibility, a manufacturer may affix the approved body's identification number to the explosives during the manufacturing process. (44) A manufacturer's obligations under this Part of this Schedule may be fulfilled by the manufacturer's authorised representative (if any), on the manufacturer's behalf and under the manufacturer's responsibility, provided that they are specified in the mandate by which they were appointed under regulation 12, but an authorised representative may not fulfil the manufacturer's obligations set out in paragraphs 39 and 42(1). (45) Conformity based on unit verification (Module G) is the conformity assessment procedure whereby a manufacturer fulfils the obligations laid down in paragraphs 46, 47 and 49, and it is solely the manufacturer's responsibility to ensure and declare that the explosive concerned, which has been subject to the provisions of paragraph 48, is in conformity with the requirements of these Regulations that apply to it. (46) (1) A manufacturer must establish the technical documentation and make it available to the approved body referred to in paragraph 48; the documentation must make it possible to assess the explosive's conformity with the relevant requirements and must include an adequate analysis and assessment of any risks. (2) The technical documentation must specify the applicable requirements and cover, as far as relevant for the assessment, the design, manufacture and operation of the explosive and, wherever applicable, the technical documentation must contain at least the following elements— (a) a general description of the explosive; (b) conceptual design and manufacturing drawings and schemes of components, sub-assemblies and circuits; (c) descriptions and explanations necessary for the understanding of the drawings and schemes and the operation of the explosive; (d) a list of the designated standards applied in full or in part and, where those designated standards have not been applied, descriptions of the solutions adopted to meet the essential safety requirements of these Regulations, including a list of other relevant technical specifications applied; and in the case of partly applied designated standards, the technical documentation must specify the parts which have been applied; (e) results of design calculations made and examinations carried out; and (f) test reports. (3) A manufacturer must keep the technical documentation at the disposal of the relevant authority for 10 years beginning on the day on which the explosive has been placed on the market. (47) A manufacturer must take all measures necessary so that the manufacturing process and its monitoring ensure conformity of the manufactured explosive with the applicable requirements of these Regulations. (48) (1) An approved body chosen by the manufacturer must carry out, or have carried out, appropriate examinations and tests set out in the relevant designated standards, or equivalent tests set out in other relevant technical specifications, to check the conformity of the explosive with the applicable requirements of these Regulations; in the absence of such a designated standard, the approved body concerned must decide on the appropriate tests to be carried out. (2) The approved body must issue a certificate of conformity in respect of the examinations and tests carried out and must affix its identification number to the approved explosive, or have it affixed under its responsibility. (3) A manufacturer must keep the certificates of conformity at the disposal of the relevant authority for 10 years beginning on the day on which the explosive has been placed on the market. (49) (1) A manufacturer must affix the UK marking and, under the responsibility of the approved body referred to in paragraph 48, the latter's identification number to each explosive that satisfies the applicable requirements of these Regulations. (2) A manufacturer must draw up a written declaration of conformity and keep it at the disposal of the relevant authority for 10 years beginning on the day on which the explosive has been placed on the market and, the declaration of conformity must identify the explosive for which it has been drawn up. (3) A copy of the declaration of conformity must be made available to the relevant authority upon request. (50) A manufacturer's obligations set out in paragraphs 46(3) and 49 may be fulfilled by the manufacturer's authorised representative (if any), on the manufacturer's behalf and under the manufacturer's responsibility, provided that they are specified in the mandate by which they were appointed under regulation 12. SCHEDULE 6 Declaration of conformity (No XXXX) (1) No … (product, type, batch or serial number): (2) Name and address of the manufacturer and, where applicable, the manufacturer's authorised representative: (3) This declaration of conformity is issued under the sole responsibility of the manufacturer. (4) Object of the declaration (identification of product allowing traceability): (5) The object of the declaration described above is in conformity with the relevant statutory requirements: (6) References to the relevant designated standards used or references to the other technical specifications in relation to which conformity is declared: (7) The approved body … (name, number) performed … (description of intervention) and issued the certificate: (8) Additional information: Signed for and on behalf of: (place and date of issue): (name, function) (signature):

SCHEDULE 32 — Amendment of the Equipment and Protective Systems Intended for Use in Potentially Explosive Atmospheres Regulations (Northern Ireland) 2017

Introduction

1

The Equipment and Protective Systems Intended for Use in Potentially Explosive Atmospheres Regulations (Northern Ireland) 2017 are amended in accordance with paragraphs 2 to 41.

Amendment to regulation 2

2

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

• (2) In paragraph (1)—

• (a) in the definition of the “1994 Directive” at the end insert “ (as it has effect immediately before exit day) ”;

• (b) after the definition of the “1996 Regulations” insert—

“approved body” has the meaning given to it in regulation 42;

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

• (d) in the definition of “attestation of conformity”—

• (i) omit “EU”; and

• (ii) for “CE” substitute “ UK ”;

• (e) 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 17; 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 17 as it had effect immediately before exit day;

• (f) omit the definition of “CE Marking”;

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

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

“conformity assessment activities” means any activities connected with conformity assessment including calibration, testing, certification and inspection;

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

“conformity assessment procedure” means a procedure referred to in regulation 39 (conformity assessment procedures); “declaration of conformity” means a declaration of conformity required to be drawn up in accordance with regulation 7(1)(a) (declaration of conformity and UK marking); “designated standard” has the meaning given to it in regulation 2A;

• (j) for the definition of “equipment category” substitute—

“equipment category” means the classification of equipment, within each equipment group, specified in Schedule 1A to these Regulations;

• (k) in the definition of “equipment-group I” for “as set out in Annex I to the ATEX Directive (as amended from time to time)” substitute “ as set out in Schedule 1A to these Regulations ”;

• (l) in the definition of “equipment-group II” for “as set out in Annex I to the ATEX Direction (as amended from time to time)” substitute “ as set out in Schedule 1A to these Regulations ”;

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

• (n) omit the definition of “European Commission”;

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

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

“importer” means any person who— (a) is established in the United Kingdom; and (b) places a product from a country outside of the United Kingdom on the market;

• (q) in the definition of “make available on the market” for “EU” substitute “ United Kingdom ”;

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

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

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

• (u) in the definition of “place on the market” for “EU” substitute “ United Kingdom ”;

• (v) in the definition of “putting into service” omit “within the EU market”;

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

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

• (3) After paragraph (1) insert—

(1A) Schedule 1A reproduces the provisions of Annex I to the ATEX Directive with amendments to correct deficiencies in retained EU law. (1B) A reference to a provision of Schedule 1A is a reference to the equivalent provision of Annex I to the ATEX Directive as set out in Schedule 1A. (1C) Schedule 3A reproduces the provisions of Annexes III to IX to the ATEX Directive with amendments to correct deficiencies in retained EU law (1D) A reference to any provision of Schedule 3A is a reference to the equivalent provision of Annexes III to IX as set out in Schedule 3A.

• (4) Omit paragraph (3).

• (5) Omit paragraph (6).

Insertion of regulation 2A

3

After regulation 2 insert—

(2A) (1) Subject to paragraphs (6) and (7), in these Regulations a “designated standard” means a technical specification which is— (a) adopted by a recognised standardisation body, for repeated or continuous application, with which compliance is not compulsory; and (b) designated by the Secretary of State by publishing the reference to the standard and maintaining that publication in a manner the Secretary of State considers appropriate. (2) For the purposes of paragraph (1), a “technical specification” means a document that prescribes technical requirements to be fulfilled by a product, process, service or system and which lays down one or more of the following— (a) the characteristics required of a product, service or system, including— (i) levels of quality, performance, interoperability, environmental protection, health, safety or dimensions, and (ii) the requirements applicable to the product, service or system as regards the name under which the product is sold, terminology, symbols, testing and test methods, packaging, marking or labelling and conformity assessment procedures; and (b) production methods and processes relating to the product, where these have an effect on the characteristics of the product, service or system. (3) For the purposes of this regulation a “recognised standardisation body” means any one of the following organisations— (a) the European Committee for Standardisation (CEN); (b) the European Committee for Electrotechnical Standardisation (Cenelec); (c) the European Telecommunications Standards Institute (ETSI); (d) the British Standards Institution (BSI). (4) When considering whether the manner of publication of a reference is appropriate in accordance with paragraph (1)(b), the Secretary of State shall have regard to whether the publication will draw the standard to the attention of any person who may have an interest in the standard. (5) Before publishing the reference to a technical specification adopted by the British Standards Institution, the Secretary of State shall have regard to whether the technical specification is consistent with technical specifications adopted by the other recognised standardisation bodies. (6) The Secretary of State may remove from publication the reference to a standard which has been published in accordance with paragraph (1)(b). (7) Where the Secretary of State removes the reference to a standard from publication, that standard is no longer a designated standard. (8) The Secretary of State may by regulations amend paragraph (3) to reflect any changes in the name or structure of the recognised standardisation bodies. (9) Regulations made under paragraph (8) are to be made by statutory instrument. (10) A statutory instrument containing regulations made under paragraph (8) is subject to annulment in pursuance of a resolution in the House of Commons.

Amendment to regulation 3

4

In regulation 3(3) (scope) for paragraph (g) substitute—

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

Amendment to regulation 6

5

In regulation 6 (technical documentation and conformity assessment) for paragraph (b) substitute—

(b) draw up the technical documentation referred to— (i) for a product in respect of which the conformity assessment procedure in regulation 39(1)(a) is being carried out, in paragraph 3(c) of Part 1 of Schedule 3A to these Regulations; (ii) for a product in respect of which the conformity assessment procedure in regulation 39(1)(b) is being carried out, in paragraph 3(c) of Part 1 of Schedule 3A to these Regulations; (iii) for a product in respect of which the conformity assessment procedure in regulation 39(1)(c) is being carried out, in paragraph 2 of Part 6 of Schedule 3A to these Regulations; (iv) for a product in respect of which the conformity assessment procedure in regulation 39(1)(d) is being carried out, in paragraph 2 of Part 7 of Schedule 3A to these Regulations.

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 ”; and

• (ii) for “CE” substitute “ UK ”;

• (b) in paragraph (1)(a) omit “EU”;

• (c) in paragraph (1)(b) for “CE” substitute “ UK ” each time it occurs;

• (d) in paragraphs (2), (4) and (5) omit “EU”;

• (e) for paragraph (6) substitute—

(6) Where a product is subject to more than one enactment requiring the drawing up of a declaration of conformity, the manufacturer shall 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 of 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 13

9

In regulation 13 (information identifying manufacturer), for paragraph 3 substitute—

(3) The information specified in paragraph (1) must be in a language which can be easily understood by end users and the market surveillance authority.

Amendment to regulation 14

10

For regulation 14 (instructions and safety information) substitute—

(14) When placing a product on the market, a manufacturer must ensure that a product is accompanied by instructions and safety information in clear, legible and easily understandable English.

Amendment to regulation 15

11

In regulation 15 (duty to take action in respect of a product placed on the market which is considered not to be in conformity), in paragraph (2) omit “, and the competent national authorities of any other Member State in which the manufacturer made the product available on the market,”.

Amendment to regulation 17

12

In regulation 17 (authorised representatives)—

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

• (b) in paragraph (4)(a) omit “EU”.

Amendment to regulation 19

13

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

• (a) in paragraph (1)(c)(i) for “CE” substitute “ UK ”;

• (b) in paragraph (1)(c)(ii) omit “EU”;

• (c) in paragraph (2)(c) for “14(1) (instructions and safety information)” substitute “ 14 (provision of instructions and safety information) ”.

Amendment to regulation 21

14

Regulation 21 (information identifying importer) is amended as follows—

• (a) in paragraph (2) for “by the competent national authority in the Member State in which it is to be made available to end-users” substitute “ the enforcing authority ”;

• (b) for paragraph (3) substitute—

(3) Paragraph (1) does not apply where— (a) either— (i) it is not possible to set out the information referred to in paragraph (1) on the product, or (ii) the importer has imported the product from an EEA state or Switzerland and places it on the market within the period of 18 months beginning with exit day, and (b) before placing the product on the market, the importer sets out the information referred to in paragraph (1)— (i) on the packaging; or (ii) in a document accompanying the product.

Amendment to regulation 22

15

For regulation 22 (instructions and safety information) substitute—

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

Amendment to regulation 25

16

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

Amendment to regulation 27

17

In regulation 27 (retention of technical documentation and EU declaration of conformity) and in the heading to that regulation omit “EU”.

Amendment to regulation 29

18

In regulation 29 (requirements which must be satisfied before a distributor makes a product available on the market)—

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

• (b) in paragraph (1)(a)(ii) omit “EU”;

• (c) for paragraph (1)(a)(iv) substitute—

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

Amendment to regulation 32

19

In regulation 32 (duty to take action in respect of products made available on the market which are not in conformity), in paragraph (2) omit “, and the competent national authorities of the other Member States in which the distributor has made the product available on the market,”.

Amendment to regulation 36

20

In regulation 36 (prohibition on improper use of CE marking) in each place in which it occurs, and in the heading, for “CE” substitute “ UK ”.

Insertion of regulations 36A and 36B

21

After regulation 36 insert—