The Explosives Regulations 2014

• (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

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

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—

• (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.

• (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

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 — 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.

Manufacturing

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

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

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

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

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

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 — 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.

Technical documentation

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

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

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

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

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.

SCHEDULE 18 — DECLARATION OF CONFORMITY

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:

Further use of the UK marking