The Supply of Machinery (Safety) Regulations 2008

PART 3 General prohibitions and obligations

Supply of machinery: general obligations and prohibition

7.—(1) No responsible person shall place machinery on the market or put it into service unless it is safe.

(2) Before machinery is placed on the market or put into service, the responsible person must—

(a) ensure that the applicable essential health and safety requirements are satisfied in respect of it;

(b) ensure that the technical file is compiled and made available in accordance with the requirements of Annex VII (Part 7 of Schedule 2), part A;

(c) provide, in particular, the information necessary to operate it safely, such as instructions;

(d) follow, as appropriate—

(i) the conformity assessment procedure prescribed by regulation 10;

(ii) one of the conformity assessment procedures prescribed by regulation 11; or

(iii) one of the conformity assessment procedures prescribed by regulation 12;

(e) draw up the EC declaration of conformity in accordance with the requirements of Annex II (Part 2 of Schedule 2), section A, part 1, and ensure that—

(i) a copy of it accompanies the machinery; and

(ii) the original is retained in accordance with the requirements of Annex II, part 2, first paragraph; and

(f) affix the CE marking to the machinery—

(i) visibly, legibly and indelibly; and

(ii) as prescribed in Annex III (Part 3 of Schedule 2).

(3) In order to comply with the requirements of paragraphs (1) and (2), a responsible person must carry out, or procure the carrying out of, all the necessary research and tests on components, fittings or the completed machinery to determine whether, by its design and construction, it is capable of being assembled and put into service safely.

(4) For the purposes of paragraph (2)(a), machinery which is manufactured in conformity with a harmonised standard, the references to which have been published in the Official Journal of the European Union (a “published harmonised standard”) shall be presumed to comply with the essential health and safety requirements covered by that standard.

(5) Where—

(a) the conformity assessment procedure specified in regulations 11(2)(b) and 12(2)(a) has been followed; and

(b) a type-examination certificate has been issued,

in respect of machinery, the manufacturer must comply with the ongoing obligations of manufacturers prescribed in Annex IX (Part 9 of Schedule 2), point 9, in respect of that machinery.

(6) Where—

(a) the conformity assessment procedure specified in regulations 11(2)(c) and 12(2)(b) has been followed; and

(b) a quality system has been approved,

in respect of machinery, the manufacturer must comply with the ongoing obligations of manufacturers prescribed in Annex X (Part 10 of Schedule 2) in respect of that machinery.

Supply of partly completed machinery: general obligations and prohibition

8.—(1) Before partly completed machinery is placed on the market, the responsible person must ensure that—

(a) the relevant technical documentation is prepared and made available in accordance with the requirements of Annex VII (Part 7 of Schedule 2), part B;

(b) assembly instructions are prepared in accordance with Annex VI (Part 6 of Schedule 2);

(c) a declaration of incorporation has been drawn up in accordance with Annex II (Part 2 of Schedule 2), part 1, section B, and that—

(i) a copy of it accompanies the machinery; and

(ii) the original is retained in accordance with Annex II, part 2, second paragraph.

(2) The assembly instructions and the declaration of incorporation shall accompany partly completed machinery until it is incorporated into machinery.

(3) After partly completed machinery is incorporated into machinery its assembly instructions and declaration of incorporation shall form part of the technical file for that machinery.

(4) In order to comply with the requirements of paragraph (1), a responsible person must carry out, or procure the carrying out of, all the necessary research and tests on components, fittings or the partly completed machinery to determine whether, by its design and construction, it is capable of being assembled and used safely.

Putting machinery into service

9.  A person who is not a responsible person shall not put machinery into service unless it satisfies the applicable essential health and safety requirements and is safe.

Conformity assessment procedures

Machinery not referred to in Annex IV

10.  If machinery falls within a category which is not referred to in Annex IV (Part 4 of Schedule 2), the responsible person shall follow the conformity assessment procedure with internal checks on the manufacture of machinery prescribed in Annex VIII (Part 8 of Schedule 2) in respect of it.

Annex IV machinery manufactured fully in accordance with published harmonised standards and fully covered by such standards

11.—(1) This regulation applies to machinery—

(a) which falls within a category which is referred to in Annex IV (Part 4 of Schedule 2); and

(b) in respect of which both of the following conditions are satisfied—

(i) that the machinery is manufactured in accordance with published harmonised standards; and

(ii) that the published harmonised standards in accordance with which it is manufactured cover all the applicable essential health and safety requirements.

(2) Where this regulation applies, the responsible person shall follow one of the following conformity assessment procedures—

(a) the conformity assessment procedure with internal checks on the manufacture of machinery prescribed in Annex VIII (Part 8 of Schedule 2); or

(b) the EC type-examination procedure prescribed in Annex IX (Part 9 of Schedule 2) and the internal checks on the manufacture of machinery prescribed in Annex VIII, point 3; or

(c) the full quality assurance procedure prescribed in Annex X (Part 10 of Schedule 2).

Annex IV machinery not manufactured fully in accordance with published harmonised standards or not fully covered by such standards

12.—(1) This regulation applies to machinery—

(a) which falls within a category which is referred to in Annex IV (Part 4 of Schedule 2); and

(b) in respect of which any of the following conditions is satisfied—

(i) that the machinery is not manufactured in accordance with the published harmonised standards which relate to it; or

(ii) that the machinery is only partly manufactured in accordance with the published harmonised standards which relate to it; or

(iii) that the published harmonised standards in accordance with which the machinery is manufactured do not cover all the applicable essential health and safety requirements; or

(iv) that no harmonised standards exist for the machinery.

(2) Where this regulation applies, the responsible person shall follow one of the following conformity assessment procedures—

(a) the EC type-examination procedure prescribed in Annex IX (Part 9 of Schedule 2) and the internal checks on the manufacture of machinery prescribed in Annex VIII (Part 8 of Schedule 2), point 3; or

(b) the full quality assurance procedure prescribed in Annex X (Part 10 of Schedule 2).