The Explosives Regulations 2014

Regulation 66

[F1 SCHEDULE 17 U.K. CONFORMITY ASSESSMENT PROCEDURES

Textual Amendments

F1 Schs. 17, 18 inserted (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. 35 (with Sch. 16 para. 29) (as amended by S.I. 2020/676, regs. 1(1), 2); 2020 c. 1, Sch. 5 para. 1(1)

PART 1 U.K. TYPE EXAMINATION (MODULE B)

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. U.K.

(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. U.K.

(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— U.K.

(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. U.K.

(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. U.K.

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— U.K.

(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. U.K.

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. U.K.

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. U.K.

(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 authorities 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 46. U.K.

PART 2 U.K. CONFORMITY TO TYPE BASED ON INTERNAL PRODUCTION CONTROL PLUS SUPERVISED PRODUCT CHECKS AT RANDOM INTERVALS (MODULE C2)

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. U.K.

Manufacturing U.K.

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.

Product checks U.K.

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.

UK marking and declaration of conformity U.K.

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 authorities 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 authorities upon request.

Authorised representative U.K.

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 46.

PART 3 U.K. CONFORMITY TO TYPE BASED ON QUALITY ASSURANCE OF THE PRODUCTION PROCESS (MODULE D)

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. U.K.

Manufacturing U.K.

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.

Quality system U.K.

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. U.K.

(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. U.K.

(2) The audit team appointed by the approved body to carry out the audit in paragraph 20(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— U.K.

(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.

Surveillance under the responsibility of the approved body U.K.

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.

UK marking and declaration of conformity U.K.

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 authorities 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 authorities 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 authorities— U.K.

(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. U.K.

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. U.K.

Authorised representative U.K.

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 46.

PART 4 U.K. CONFORMITY TO TYPE BASED ON PRODUCT QUALITY ASSURANCE (MODULE E)

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 the responsibility of the manufacturer 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. U.K.

Manufacturing U.K.

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.

Quality system U.K.

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. U.K.

(2) The audit team appointed by the approved body to carry out the audit under paragraph 31(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— U.K.

(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.

Surveillance under the responsibility of the approved body U.K.

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.

UK marking and declaration of conformity U.K.

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 authorities 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 authorities 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 authorities— U.K.

(a) the documentation referred to in paragraph 30(1) and 30(2);

(b) the information relating to the change referred to in paragraph 32(1)(b) and 32(2), 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. U.K.

(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.

Authorised representative U.K.

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 46.

PART 5 U.K. CONFORMITY TO TYPE BASED ON PRODUCT VERIFICATION (MODULE F)

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 responsibility of the manufacturer 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. U.K.

Manufacturing U.K.

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.

Verification U.K.

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.

Verification of conformity by examination and testing of every product U.K.

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 authorities for 10 years beginning on the day on which the explosive has been placed on the market.

Statistical verification of conformity U.K.

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 authorities 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.

UK marking and declaration of conformity U.K.

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 authorities 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 authorities 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.

Authorised representative U.K.

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 46, but an authorised representative may not fulfil the manufacturer's obligations set out in paragraphs 39 and 42(1).

PART 6 U.K. CONFORMITY BASED ON UNIT VERIFICATION (MODULE G)

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 responsibility of the manufacturer 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. U.K.

Technical documentation U.K.

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 authorities for 10 years beginning on the day on which the explosive has been placed on the market.

Manufacturing U.K.

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.

Verification U.K.

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 authorities for 10 years beginning on the day on which the explosive has been placed on the market.

UK marking and declaration of conformity U.K.

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 authorities 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 authorities upon request.

Authorised representative U.K.

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 46.]