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PART 3U.K.General prohibitions and obligations

Supply of machinery: general obligations and prohibitionE+W+S

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 F1... 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 [F2UK] marking to the machinery [F3or where paragraph (2A) applies, or on a label affixed to, or document accompanying, the machinery] —

(i)visibly, legibly and indelibly; and

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

[F4(2A) For a period of [F5seven years] beginning with IP completion day, the UK marking may be affixed to—

(a)a label affixed to the machinery; or

(b)a document accompanying the machinery.]

(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 [F6designated] standard, F7... 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.

Extent Information

E1This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only

Textual Amendments

Supply of machinery: general obligations and prohibitionN.I.

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 UK marking to the machinery—

(i)visibly, legibly and indelibly; and

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

[F19(2A) Where a UK notified body carries out the functions of notified bodies specified in Annexes IX and X the CE marking must be accompanied by the UK(NI) indication affixed in accordance with paragraph (2B).

(2B) The UK(NI) indication must be affixed—

(a)in a visible, legible and indelible form to the machinery; and

(b)before the machinery is placed on the market in Northern Ireland.

(2C) Where paragraph (2A) applies, the reference to the identification number of the notified body in Schedule 2, Part 3 Annex III, is a reference to the identification number assigned to the UK notified body by the Secretary of State pursuant to regulation 19A.]

(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.

Extent Information

E4This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

Textual Amendments

Supply of partly completed machinery: general obligations and prohibitionU.K.

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 serviceU.K.

F89.  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Textual Amendments

Conformity assessment proceduresU.K.

Machinery not referred to in Annex IVU.K.

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 [F9designated] standards and fully covered by such standardsE+W+S

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 [F10designated] standards; and

(ii)that the [F11designated] 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 [F12 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).

Extent Information

E2This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only

Textual Amendments

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

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).

Extent Information

E5This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

Annex IV machinery not manufactured fully in accordance with [F13designated] standards or not fully covered by such standardsE+W+S

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 [F14designated] standards which relate to it; or

(ii)that the machinery is only partly manufactured in accordance with the [F14designated] standards which relate to it; or

(iii)that the [F14designated] standards in accordance with which the machinery is manufactured do not cover all the applicable essential health and safety requirements; or

(iv)that no [F15designated] standards exist for the machinery.

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

(a)the [F16Type-] 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).

Extent Information

E3This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only

Textual Amendments

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

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).

Extent Information

E6This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

[F17Obligations which are met by complying with obligations in the DirectiveE+W+S

12A.—(1) In this regulation—

(a)any reference to an Article or an Annex is a reference to an Article of or an Annex to the Directive;

(b)“CE marking” means the marking referred to in Article 16(1);

(c)“harmonised standard” means a harmonised standard within the meaning of Article 2(l), the reference to which has been published in the Official Journal of the European Union.

(2) Subject to paragraphs (6) and (7), paragraph (3) applies where, before placing machinery on the market or putting machinery into service, the responsible person—

(a)ensures that the machinery satisfies the essential health and safety requirements set out in Annex I;

(b)ensures that the technical file referred to in Annex VII, part A is available to the enforcement authorities on request;

(c)provides the necessary information, referred to in Article 5(1)(c);

(d)carries out the appropriate procedures for assessing conformity in accordance with Article 12;

(e)ensures that the technical file, necessary information and records and correspondence relating to the conformity assessment procedures are prepared in or translated into English;

(f)draws up the EC declaration of conformity in accordance with Annex II, part I, Section A and ensure that it accompanies the machinery;

(h)ensures that the EC declaration of conformity is prepared in or translated into English; and

(i)affixes the CE marking in accordance with Article 16.

(3) Where this paragraph applies—

(a)the requirements of regulation 7(2)(a), (b), (c), (e)(i) and (f) are to be treated as being satisfied;

(b)regulations 7(2)(e)(ii), 15 and 21 apply subject to the modifications in paragraph (8);

(c)Part 8 of Schedule 2 does not apply.

(4) Subject to paragraphs (6) and (7) paragraph (5) applies where, before placing partly completed machinery on the market, the responsible person ensures that—

(a)the relevant technical documentation referred to in Annex VII part B is prepared in or translated into English;

(b)the assembly instructions referred to in Annex VI are prepared in or translated into English; and

(c)a declaration of incorporation referred to in Annex II part 1, Section B has been drawn up in or translated into English.

(5) Where this paragraph applies the requirements of regulation 8(1) are to be treated as being satisfied.

(6) This paragraph applies to machinery listed in Annex IV where there is no designated standard or part of a designated standard which corresponds exactly to a harmonised standard or part of a harmonised standard referred to in Article 7(2).

(7) Where paragraph (6) applies, paragraph (2)(d) is to be read as requiring the responsible person to have carried out the conformity assessment procedure in Article 12(4).

(8) The modifications referred to in paragraph (3)(b) are that—

(a)any reference to “declaration of conformity” is to be read as a reference to the EU declaration of conformity;

(b)any reference to “UK marking” is to be read as a reference to the CE marking.

Textual Amendments

[F18Further use of UK markingE+W+S

12B.—(1) In this regulation—

(a)any reference to an Article or an Annex is a reference to an Article or an Annex of the Directive;

(b)“harmonised standard” means a harmonised standard within the meaning of Article 2(l) the reference to which has been published in the Official Journal of the European Union.

(2) Subject to paragraphs (4) and (5), paragraph (3) applies where, before placing machinery on the market or putting machinery into service, the responsible person ensures that—

(a)the machinery satisfies the essential health and safety requirements set out in Annex I;

(b)the appropriate procedure for assessing conformity as set out in Article 12 is carried out;

(c)the technical file referred to in Annex VII, part A is compiled and can be made available to enforcement authorities on request;

(d)the technical file, necessary information and records and correspondence relating to the assessment of conformity are prepared in or translated into English.

(3) Where this paragraph applies—

(a)regulation 7(2)(a), (b) and (d) is to be treated as being satisfied;

(b)regulations 10 to 12 do not apply;

(c)regulations 7(2)(f)(ii), (5) and (6) and 13 and Part 2 of Schedule 2 apply subject to the modifications in paragraph (6).

(4) This paragraph applies to machinery listed in Annex IV in relation to which there is no designated standard or part of a designated standard which corresponds exactly to a harmonised standard or part of a harmonised standard referred to in Article 7(2).

(5) Where paragraph (4) applies, paragraph (2)(b) is to be read as requiring the manufacturer to carry out the procedure for assessing conformity set out in Article 12(4).

(6) The modifications referred to in paragraph (3)(c) are that—

(a)in regulation 7(2)(f)(ii) the reference to Part 3 of Schedule 2 is to be read as a reference to the first paragraph of that Part only;

(b)in regulation 7(5)—

(i)sub-paragraph (a) is to be read as referring to the procedure for assessing conformity set out in Annex IX;

(ii)the reference in sub-paragraph (b) to a “type-examination certificate” is to be read as a reference to an EC type-examination certificate issued pursuant to the procedure set out in Annex IX;

(iii)the reference to “Annex IX (Part 9 of Schedule 2), point 9” is to be read as a reference to point 9 of Annex IX;

(c)in regulation 7(6)—

(i)sub-paragraph (a) is to be read as referring to the procedure for assessing conformity set out in Annex X;

(ii) the reference to “Annex X (Part 10 of Schedule 2)” is to be read as a reference to Annex X;

(d)in section 1, Part A of Part 2 of Schedule 2—

(i)in point 4—

(aa)the reference to the “relevant provisions of these Regulations” is to be read as including the Directive;

(bb)in the second place in which it occurs, the reference to “relevant provisions” is to be read as including a reference to other provisions of European Union legislation with which the machinery complies, where applicable;

(ii)point 5 is to be read as requiring the name, address and identification of the conformity assessment body which undertook the procedure for assessing conformity set out in Annex IX and the number of the EC type-examination certificate issued pursuant to that procedure;

(iii)point 6 is to be read as requiring the name, address and identification of the conformity assessment body which undertook the procedure for assessing conformity set out in Annex X;

(iv)in point 7 the reference to “designated standards” is to be read as a reference to harmonised standards;

(v)the second paragraph of Part 3 of Schedule 2 does not apply.]

Textual Amendments

Qualifying Northern Ireland GoodsE+W+S

12C.—(1) Where paragraph (2) applies the requirements of Part 3, other than those in regulations 12A, 12B and this regulation, are treated as being satisfied.

(2) This paragraph applies where—

(a)the responsible person has complied with the requirements of Part 3, as that Part applies in Northern Ireland; and

(b)the machinery or partly completed machinery is qualifying Northern Ireland goods.

(3) In this regulation “qualifying Northern Ireland goods has the meaning given to it in regulations made under section 8C(6) of the European Union (Withdrawal) Act 2018.]

Textual Amendments