Textual Amendments
F1Schs. 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)
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.
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.
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 authorities 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 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.
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.]