The Supply of Machinery (Safety) Regulations 2008

Designated standard

2A

• (1) Subject to paragraphs (6) and (7), in these Regulations a “designated standard” means a technical specification which is—

• (a) adopted by a recognised standardisation body or an international standardising body, for repeated or continuous application, with which compliance is not compulsory; and

• (b) designated by the Secretary of State by publishing the reference to the standard and maintaining that publication in a manner the Secretary of State considers appropriate.

• (2) For the purposes of paragraph (1), a “technical specification” means a document that prescribes technical requirements to be fulfilled by a product, process, service or system and which lays down one or more of the following—

• (a) the characteristics required of a product, including—

• (i) levels of quality, performance, interoperability, environmental protection, health, safety or dimensions; and

• (ii) the requirements applicable to the product as regards the name under which the product is sold, terminology, symbols, testing and test methods, packaging, marking or labelling and conformity assessment procedures; and

• (b) production methods and processes relating to the product, where these have an effect on the characteristics of the product.

• (3) For the purposes of this regulation a “recognised standardisation body” means any one of the following organisations—

• (a) the European Committee for Standardisation (CEN);

• (b) the European Committee for Electrotechnical Standardisation (Cenelec);

• (c) the European Telecommunications Standards Institute (ETSI);

• (d) the British Standards Institution (BSI).

• (3A) In this regulation “international standardising body” has the same meaning as it has for the purposes of the Agreement on Technical Barriers to Trade, part of Annex 1A to the agreement establishing the World Trade Organisation signed at Marrakesh on 15 April 1994 (as modified from time to time).

• (4) When considering whether the manner of publication of a reference is appropriate in accordance with paragraph (1)(b), the Secretary of State must have regard to whether the publication will draw the standard to the attention of any person who may have an interest in the standard.

• (5) Before publishing the reference to a technical specification adopted by the British Standards Institution, the Secretary of State must have regard to whether the technical specification is consistent with such technical specifications adopted by the other recognised standardisation bodies or by international standardising bodies as the Secretary of State considers to be relevant.

• (6) The Secretary of State may remove from publication the reference to a standard which has been published in accordance with paragraph (1)(b).

• (7) Where the Secretary of State removes the reference to a standard from publication, that standard is no longer a designated standard.

• (8) In this regulation, a reference to a “product” is a reference to machinery to which these Regulations apply.

• (9) The Secretary of State may by regulations amend paragraph (3) to reflect any changes in the name or structure of the recognised standardisation bodies.

• (10) Regulations made under paragraph (9) are to be made by statutory instrument.

• (11) A statutory instrument containing regulations made under paragraph (9) is subject to annulment in pursuance of a resolution of either House of Parliament.

Placing on the market and putting into service; supplies outside Great Britain and showing at trade fairs not covered

Disapplication where more specific ... safety rules apply

Obligations which are met by complying with obligations in the Directive

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.

Expiry of regulation 12A

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.

Qualifying Northern Ireland Goods

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.

UK -marked machinery to be taken to comply with Regulations

Machinery covered by more than one enactment

Protection of UK marking

Approved bodies

16A

• (1) An approved body is a person who—

• (a) on or after IP completion day has been designated to carry out conformity assessment in accordance with regulation 16B, to the extent that the designation remains in effect; or

• (b) immediately before IP completion day was a UK notified body.

• (2) Paragraph (1) is subject to regulation 17.

• (3) In this Part a “UK notified body” means a person who immediately before IP completion day was a UK notified body as defined in regulation 16(3) of these Regulations as they had effect immediately before IP completion day.

Approved body designation

16B

• (1) The Secretary of State may only designate a person to carry out conformity assessment if that person qualifies for approval.

• (2) A person qualifies for approval if the Secretary of State—

• (a) is satisfied that the person meets the criteria specified in Annex XI (Part 11 of Schedule 2) (“approved body criteria”); and

• (b) makes a designation in respect of that person (an “approved body designation”).

• (3) Where a person meets the assessment criteria laid down in a designated standard (or part of such a standard) the Secretary of State is to presume that the person meets the approved body criteria covered by that standard (or that part of that standard).

• (4) Where the Secretary of States makes an approved body designation, that designation—

• (a) must be in writing;

• (b) must specify the conformity assessment procedures that the person designated may carry out;

• (c) may relate to all the categories of machinery listed in Annex IV (Part 4 of Schedule 2) or to such of those categories as are specified in the designation;

• (d) may designate a person for a specified period; and

• (e) may be made subject to such other conditions as are specified in the designation, including conditions which are to apply upon or following termination of the designation.

• (5) In making an approved body designation the Secretary of State may have regard (in addition to the approved body criteria) to any other matter which appears to the Secretary of State to be relevant.

• (6) Where an approved body was a UK notified body immediately before IP completion, an “approved body designation” means a notified body designation within the meaning of regulation 16(2) and (4) of these Regulations, as they had effect immediately before IP completion.

Monitoring

16C

• (1) The Secretary of State must, from time to time, carry out an inspection of each approved body with a view to verifying that it—

• (a) meets the approved body criteria;

• (b) complies with any condition to which its designation is subject—

• (i) in accordance with regulation 16B(4)(e);

• (ii) in the case of an approved body which was a UK notified body immediately before IP completion, in accordance with regulation 16(8)(e) as it applied before IP completion; and

• (c) complies with these Regulations.

• (2) An approved body must comply with any request of the Secretary of State to provide information relevant to determining its compliance with the approved body criteria, these Regulations, or any condition to which its designation is subject.

Duration, variation and termination of designations

Functions of approved bodies

Fees

Register of approved bodies

19A

• (1) The Secretary of State must—

• (a) assign an approved body identification number to each approved body; and

• (b) compile and maintain a register of—

• (i) approved bodies;

• (ii) their approved body identification numbers;

• (iii) the activities for which they have been approved: and

• (iv) any restriction on those activities.

• (2) The register referred to in paragraph (1) must be made publicly available.

Non-compliance with UK marking requirements

Transitional provisions in relation to EU Exit

30

• (1) In this regulation—

• “pre-exit period” means the period beginning with 29 December 2009 and ending immediately before IP completion day;

• “product” means machinery to which these Regulations apply.

• (2) Where a product was made available on the market during the pre-exit period, despite the amendments made by Schedule 12 to the Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019, any obligation to which a person was subject under these Regulations as they had effect immediately before IP completion day, continues to have effect as it did immediately before IP completion day, in relation to that product.

• (3) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

• (4) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

• (5) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

31

• (1) In this regulation—

• (2) The information requirements do not apply to a person who—

• (a) falls within paragraph (b) of the definition of manufacturer in regulation 2(2);

• (b) has imported machinery from an EEA state and places it on the market within a period of seven years beginning with IP completion day; and

• (c) before placing the machinery on the market, sets out the information referred to in sections 1.7.3 and 4.3.1 of Schedule 2, Part 1 in a document accompanying the machinery.

The UK marking must be affixed in the immediate vicinity of the name of the responsible person, using the same technique.

Where the full quality assurance procedure prescribed in Annex X (Part 10 of this Schedule) has been applied, the UK marking must be followed by the identification number of the approved body.

Further use of UK marking