Health And Safety PART 1 Preliminary Citation, commencement and revocation 1 1 These Regulations may be cited as the Supply of Machinery (Safety) Regulations 2008 and shall come into force on 29th December 2009. 2 The Regulations listed in the first column of the table in Schedule 1 are revoked to the extent specified in the third column of that table. Interpretation 2 1 In these Regulations— a references to “ the Directive ” are references to Directive 2006/42/EC of the European Parliament and of the Council on machinery, and amending Directive 95/16/EC , as amended by Directive 2009/127/ EC of the European Parliament and of the Council amending Directive 2006/42/ EC with regard to machinery for pesticide application ...; and b Annexes I to XI to the Directive are reproduced in Schedule 2 (with minor changes reflecting the Directive's application to the EEA , and certain details of the Directive's implementation in these Regulations – in particular, the use of certain defined terms and the adoption of gender neutral drafting), so that each Annex is a separate Part of that Schedule; accordingly, where reference is made to an Annex designated by a Roman numeral, the reference is to the Part of Schedule 2 designated by the corresponding Arabic numeral and reproducing the text of the Annex to the Directive designated by that Roman numeral in the Directive. 2 In these Regulations— “ the 1974 Act ” means the Health and Safety at Work etc Act 1974 ; “ the 1978 Order ” means the Health and Safety at Work (Northern Ireland) Order 1978 ; “ the 1987 Act ” means the Consumer Protection Act 1987 ; “ the 1992 Regulations ” means the Supply of Machinery (Safety) Regulations 1992 ; “ applicable ” means, in relation to the application of essential health and safety requirements to any machine, those essential health and safety requirements which are expressed in Annex I (Part 1 of Schedule 2) as applying either to all machinery or to machinery of a category to which that machine belongs or which has a characteristic that it shares; “ approved body ” has the meaning given to it in regulation 16A; “ authorised representative ” means a person established in the United Kingdom who has received a written mandate from the manufacturer to perform, on the manufacturer's behalf, all or part of the obligations and formalities imposed on manufacturers (either as “manufacturers” or “responsible persons”) by these Regulations or otherwise in connection with the Directive; ... “ chains, ropes and webbing ” has the meaning given in regulation 4(2)(e); ... “ conformity assessment ” means the assessment, in accordance with Annex VIII, IX or X (Part 8, Part 9 or Part 10 of Schedule 2), of whether machinery, or a representative model of machinery, satisfies the applicable requirements of these Regulations, and “ conformity assessment procedure ” means the procedures specified in any of those Annexes; “ designated standard ” has the meaning given to it in regulation 2A; “ enforcement authority ” means— in Great Britain, subject to sub-paragraph (b) and (ba) — in relation to machinery and partly completed machinery for use at work, the Health and Safety Executive; and in relation to any other machinery or partly completed machinery— within each local weights and measures authority's area, that authority; or the Secretary of State; the Office of Rail and Road where, in Great Britain, the Health and Safety (Enforcing Authority for Railways and Other Guided Transport Systems) Regulations 2006 make it the enforcing authority, within the meaning of section 18(7) of the 1974 Act, in relation to machinery for use in the operation of a railway, tramway or any other system of guided transport, as defined in those Regulations; and the Office for Nuclear Regulation in relation to— machinery and partly completed machinery which is intended exclusively or primarily for use on a relevant nuclear site; or putting machinery into service on such a site. in Northern Ireland— in relation to machinery and partly completed machinery for use at work, the Health and Safety Executive for Northern Ireland; and in relation to any other machinery or partly completed machinery— within each district council's area, that council; or the Secretary of State; “essential health and safety requirements” means the requirements set out in Annex I (Part 1 of Schedule 2), being requirements relating to the design and construction of the products to which these Regulations apply to ensure a high level of protection of the health and safety of persons and, where appropriate, of domestic animals and property and, in the case of machinery referred to in section 2.4 of Annex I, of the environment; “ follow ”, in relation to a responsible person and a conformity assessment procedure, means the responsible person complying with the requirements which the conformity assessment procedure, as expressed in Annex VIII, IX or X (Part 8, Part 9 or Part 10 of Schedule 2), imposes on responsible persons; ... “ the Health and Safety Executive ” (except where express reference is made to the Health and Safety Executive for Northern Ireland) means the Health and Safety Executive established under section 10 of the 1974 Act; “ the Health and Safety Executive for Northern Ireland ” means the Health and Safety Executive for Northern Ireland established under Article 12 of the 1978 Order; “ interchangeable equipment ” has the meaning given in regulation 4(2)(b); “ lifting accessory ” has the meaning given in regulation 4(2)(d); “ machine ” means an item of machinery; “ machinery ” has the meaning given in regulation 4(3); “ manufacturer ” means, in relation to machinery or partly completed machinery— a person who designs or manufactures that machinery or partly completed machinery— with a view to its being placed on the market under that person's own name or trademark; or for that person's own use in Great Britain ; or if there is no such person, the person who places that machinery or partly completed machinery on the market or puts it into service; ... ... ... ... “ partly completed machine ” means an item of partly completed machinery; “ partly completed machinery ” has the meaning given in regulation 6; “place on the market” and related expressions have the meaning given in regulation 3; ... “put into service” and related expressions have the meaning given in regulation 3; “relevant nuclear site” means a site which is— a GB nuclear site (within the meaning given in section 68 of the Energy Act 2013); an authorised defence site (within the meaning given in regulation 2(1) of the Health and Safety (Enforcing Authority) Regulations 1998); or a new nuclear build site (within the meaning given in regulation 2A of those Regulations); “ removable mechanical transmission device ” has the meaning given in regulation 4(2)(f); “ responsible person ” means, in relation to machinery or partly completed machinery— the manufacturer of that machinery or partly completed machinery; or the manufacturer's authorised representative; “ safe ” means, in relation to machinery, that when it is properly installed and maintained, and used for the purposes for which it is intended, or under conditions which can reasonably be foreseen, it does not— endanger the health of, or result in death or injury to, any person; or where appropriate— endanger the health of, or result in death or injury to, domestic animals; or endanger property; or in the case of machinery referred to in section 2.4 of Annex I (Part 1 of Schedule 2), endanger the environment; “ safety component ” has the meaning given in regulation 4(2)(c); “ UK marking ” means the marking in the form set out in Annex 2 of Regulation (EC) No 765/2008 setting out the requirements for accreditation and market surveillance relating to the marketing of products and repealing Regulation (EEC) No 339/93 ; “ UK notified body ” has the meaning given in regulation 16(3) and (4); and “ use at work ” means, in relation to machinery or partly completed machinery, use or operation— by persons at work (whether exclusively or not); or otherwise than at work, in non-domestic premises made available to persons at a place where they may use the machinery or partly completed machinery provided for their use there, and for these purposes, “ at work ” has the same meaning as it does under or by virtue of section 52 of the 1974 Act for the purposes of Part 1 of that Act. 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 3 1 In these Regulations, subject to paragraph (2)— a references to placing machinery or partly completed machinery on the market are references to making it available in Great Britain — i for the first time; ii with a view to distribution or use, whether by the person making it available or another; and iii whether for reward or free of charge; and b references to putting any machinery or partly completed machinery into service are references to the first time that it is used for its intended purpose in Great Britain . 2 For the purposes of these Regulations, machinery or partly completed machinery shall not be regarded as being placed on the market or put into service where— a it does not have affixed to it either the UK marking, or any inscription likely to be confused with the UK marking, and— i it will not be put into service in Great Britain ; ii it is imported into Great Britain state for re-export to a country which is not Great Britain ; or iii it is imported into Great Britain other than in the course of a business by a person who intends to use it other than in the course of a business; or b it is shown at a trade fair, exhibition or other similar demonstration; provided that, where any machinery or partly completed machinery which does not comply with the requirements of these Regulations which would apply to it but for this paragraph is shown at a trade fair, exhibition or other similar demonstration, the responsible person— i displays a notice in relation to it, stating that— aa it does not comply with the requirements of these Regulations; and bb it will not be made available until it does comply with those requirements; and ii takes adequate safety measures to ensure that it does not kill or injure any person. PART 2 Application Products to which Regulations apply; definition of “machinery” 4 1 These Regulations apply— a to products in respect of which the following conditions are satisfied— i that they fall within one of the descriptions of products specified in paragraph (2); ii that they do not fall within any of the categories of products specified in Schedule 3 as being products to which these Regulations do not apply; iii that they are placed on the market or put into service on or after 29th December 2009; and iv that these Regulations are not disapplied in respect of them by regulation 5; and b to partly completed machinery, as defined in regulation 6. 2 The following descriptions of products are specified in this paragraph— a assemblies which fall within one of the following descriptions— i an assembly, fitted with or intended to be fitted with a drive system other than directly applied human or animal effort, consisting of linked parts or components, at least one of which moves, and which are joined together for a specific application; ii an assembly as referred to in sub-paragraph (i), missing only the components to connect it on site or to sources of energy and motion; iii an assembly as referred to in sub-paragraph (i) or (ii), ready to be installed and able to function as it stands only if mounted on a means of transport, or installed in a building or structure; iv assemblies of machinery as referred to in sub-paragraphs (i), (ii) and (iii) or partly completed machinery, which, in order to achieve the same end, are arranged and controlled so that they function as an integral whole; v an assembly of linked parts or components, at least one of which moves and which are joined together, intended for lifting loads and whose only power source is directly applied human effort; b devices which, after the putting into service of machinery or of a tractor, are assembled with that machinery or tractor by operators themselves in order to change its function or attribute a new function, in so far as they are not tools (“interchangeable equipment”); c components— i which serve to fulfil a safety function; ii which are independently placed on the market; iii the failure or malfunction of which endangers the safety of persons; and iv which are not necessary in order for the machinery to function, or for which other components which do not fall within sub-paragraphs (i) to (iii) may be substituted in order for the machinery to function, (“safety components”, examples of which are listed in Annex V (Part 5 of Schedule 2)); d components or equipment (including slings and their components) which— i are not attached to lifting machinery; ii allow a load to be held; iii are placed between the machinery and the load or on the load itself, or are intended to constitute an integral part of the load; and iv are independently placed on the market (“lifting accessories”); e chains, ropes and webbing designed and constructed for lifting purposes as part of lifting machinery or lifting accessories (“chains, ropes and webbing”); and f removable components for transmitting power between self-propelled machinery or a tractor and another machine by joining them at the first fixed bearing (“removable mechanical transmission devices”) (when such components are placed on the market with a guard the components and the guard together shall be regarded as one product). 3 Subject to paragraph (4), in these Regulations, the word “ machinery ” refers to products of any of the descriptions specified in paragraph (2) in respect of which the conditions specified in paragraph (1)(a)(ii), (iii) and (iv) are satisfied. 4 Where an essential health and safety requirement is expressed to apply both to “machinery” generally and to a particular description of machinery referred to in paragraph (2)(b), (c), (d), (e) or (f), the general reference to “machinery” is to be understood— a as not referring to machinery of that particular description; and b as referring only to those descriptions of machinery referred to in paragraph (2) for which the hazard corresponding to that essential health and safety requirement exists when they are used under the conditions foreseen by the responsible person or in foreseeable abnormal situations. Disapplication where more specific ... safety rules apply 5 These Regulations do not apply to a product if, or to the extent that, other enactments (as they apply in Great Britain) , which apply to it, make more specific provision than these Regulations in connection with the hazards referred to in Annex I (Part 1 of Schedule 2). Partly completed machinery 6 1 Subject to paragraph (2), provisions of these Regulations which refer to “partly completed machinery” apply to drive systems and other assemblies which— a are almost machinery; b cannot in themselves perform a specific application; and c are only intended to be incorporated into or assembled with other machinery or other partly completed machinery or equipment, thereby forming machinery. 2 Paragraph (1) does not apply to assemblies of the kind described in paragraph (1) which— a are placed on the market before 29th December 2009; or b are only intended to be incorporated into or assembled with other products to form a product which falls within any of the categories of products specified in Schedule 3 as being products to which these Regulations do not apply. 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 ... 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 or 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). 2A For a period of seven 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 designated 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 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 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 designated 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 designated standards; and ii that the designated 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 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 designated 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 designated standards which relate to it; or ii that the machinery is only partly manufactured in accordance with the designated standards which relate to it; or iii that the designated standards in accordance with which the machinery is manufactured do not cover all the applicable essential health and safety requirements; or iv that no designated standards exist for the machinery. 2 Where this regulation applies, the responsible person shall follow one of the following conformity assessment procedures— a the 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). 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. Further use of UK marking 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. PART 4 CE Marking UK Marking UK -marked machinery to be taken to comply with Regulations 13 1 Unless there is evidence to the contrary— a an enforcement authority; b the Secretary of State (where the Secretary of State is not an enforcement authority); and c any court or tribunal of competent jurisdiction which is called upon to decide a matter which involves the application of these Regulations, shall presume that machinery which bears the UK marking and is accompanied by a declaration of conformity which complies with Annex II (Part 2 of Schedule 2), part 1, section A complies with these Regulations. 1A For the purposes of paragraph (1) machinery bears the UK marking if, in accordance with regulation 7(2A), the UK marking is affixed to — a a label affixed to the machinery; or b a document accompanying the machinery. 2 The failure or refusal by a responsible person, in response to a duly reasoned request from an enforcement authority, to make the technical file or a copy of it available in accordance with Annex VII (Part 7 of Schedule 2), part A, point 2 shall be reasonable grounds for the authority— a to doubt the conformity of machinery with the essential health and safety requirements, in accordance with Annex VII, part A, point 3; or b to doubt the conformity of partly completed machinery with the essential health and safety requirements, in accordance with Annex VII, part B, last paragraph, and it may make such use of its powers under Schedule 5 as is appropriate in the light of such doubts. Machinery covered by more than one enactment 14 1 Subject to paragraph (2), where machinery falls within the scope of an enactment other than these Regulations (“ the other enactment ”), the affixing of the UK marking indicates that the relevant requirements of the other enactment are also satisfied. 2 Where— a the other enactment includes a provision allowing the responsible person to choose, during a transitional period that has not ended, the system to be applied; b the responsible person takes advantage of this option; and c the particulars of the other enactment which the responsible person has chosen to apply, ... are given in the ... declaration of conformity, the affixing of the UK marking indicates that the machinery conforms only to the provisions of the other enactment which the responsible person has chosen to apply. Protection of UK marking 15 1 No person shall affix the UK marking to machinery which does not comply with these Regulations. 2 No person shall affix to machinery any marking, sign or inscription which is likely to mislead any other person as to the meaning or form of the UK marking (or both). 3 Other markings may be affixed to machinery which bears the UK marking only if the visibility, legibility or meaning of the UK marking is not impaired as a result. PART 5 Notified bodies Approved Bodies Designation and monitoring of UK notified bodies 16 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 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 17 1 An approved body designation which does not designate a person as an approved body for a specified period shall have effect until such time as it is terminated under paragraph (4). 2 An approved body designation which designates a person as an approved body for a specified period shall expire in accordance with its terms unless the period so specified is extended or shortened under paragraph (3) before the date on which it had been due to expire. 3 The Secretary of State may vary any aspect of an approved body designation if— a the approved body so requests; or b it appears to the Secretary of State necessary or expedient to do so. 4 The Secretary of State may terminate an approved body designation— a on the expiry of 90 days' notice in writing at the request of the approved body; b if it appears to the Secretary of State that any condition of the designation is not complied with; or c if the Secretary of State considers that the approved body no longer satisfies the notified body criteria. 5 Where the Secretary of State is minded to vary an approved body designation in accordance with paragraph (3)(b), or to terminate an approved body designation under paragraph (4)(b) or (c), the Secretary of State shall— a give notice in writing to the approved body of the proposed variation or termination and the reasons for it, stating that the approved body has 21 days from the date of the notice in which to make representations to the Secretary of State in respect of the proposed variation or termination; and b consider any representations received from the approved body in accordance with the notice. 6 If an approved body designation is terminated under paragraph (4), the Secretary of State may, by notice in writing— a authorise another approved body to take over the functions of the approved body whose designation has been terminated in respect of such cases as are specified in the notice; and b give such directions as the Secretary of State considers appropriate (either to the approved body whose designation has been terminated or to another approved body) in respect of an approved body's files or any other matter which the Secretary of State considers expedient for the purposes of ensuring that another approved body carries out the functions of an approved body for the existing customers of the notified body whose designation has been terminated. 7 The activities undertaken as an approved body referred to in paragraph (6) include any activities that the body has undertaken as a UK notified body. Functions of approved bodies 18 1 Subject to the terms of their approved body designations and paragraph (2), approved bodies shall carry out the functions of approved bodies specified in Annexes IX and X (Parts 9 and 10 of Schedule 2). 2 An approved body shall not be obliged to carry out these functions where— a the documents submitted to it in relation to the carrying out of any such function (other than the instructions for the machinery) are not in English or another language acceptable to the body; b the responsible person has not submitted with its application the amount of the fee which the body requires to be submitted with the application; or c the body reasonably believes that, having regard to the number of outstanding applications made to it in relation to its appointment under these Regulations, it will be unable to carry out the required work within 3 months of receiving the application. 3 If, having issued a certificate to a responsible person under Annex IX or an approval to a manufacturer under Annex X, an approved body finds— a that the manufacturer has, after the issue of that certificate or approval, failed to satisfy applicable requirements of these Regulations in respect of the machinery to which the certificate or approval relates (whether or not such failure is continuing); or b that the certificate or approval should not have been issued, it shall proceed in accordance with paragraph (4). 4 Where paragraph (3) applies, the approved body concerned shall— a consider— i what corrective action, if any, the manufacturer should take in the light of its findings; and ii whether, and, if so, on what terms, the certificate or approval should be suspended, withdrawn, or made subject to restrictions; b send to the manufacturer a notice in writing, setting out the conclusions it has provisionally reached under paragraph (a), and the reasons for those conclusions, and invite the manufacturer to respond to them within such reasonable period of time as is specified in the notice; c make a decision on the matters specified in paragraph (a), including provision for the suspension or withdrawal of a certificate or approval, or making it subject to restrictions, if it considers the taking of any such action appropriate, having regard to— i the manufacturer's response; ii the principle of proportionality; and iii paragraph (6); and d communicate the decision, with a detailed statement of the reasons for it, to the manufacturer. 5 Where an approved body, acting under paragraph (4)— a suspends or withdraws a certificate, or makes it subject to restrictions; or b considers that action by an enforcement authority may prove necessary in connection with the machinery which is the subject of its decision, it shall communicate its decision under that paragraph to the enforcement authorities and the Secretary of State (if the Secretary of State is not an enforcement authority in relation to the machinery concerned). 6 In making a decision under paragraph (4), an approved body shall not suspend or withdraw a certificate or approval, or make it subject to restrictions, if the manufacturer has ensured compliance with the applicable requirements of these Regulations by means of appropriate corrective measures. 7 An appeal may be made in accordance with the provisions of Schedule 4— a by a manufacturer who is aggrieved by a decision which an approved body has made under paragraph (4); or b by a responsible person who is aggrieved by a decision of an approved body— i not to issue a type-examination certification pursuant to Annex IX (Part 9 of Schedule 2), point 5; or ii in relation to a quality system which is approved to a responsible person pursuant to Annex X (Part 10 of Schedule 2), point 2.3. Fees 19 1 An approved body may charge such fees in connection with, or incidental to, carrying out its functions under regulation 18 as it may determine; provided that such fees shall not exceed the sum of— a the costs incurred or to be incurred by the body in performing the relevant functions; plus b an amount on account of profit which is reasonable in the circumstances having regard to— i the character and extent of the work done or to be done by the body on behalf of the responsible person; and ii the commercial rate normally charged on account of profit for that work or similar work. 2 An approved body may require the payment of fees or a reasonable estimate of fees in advance of carrying out the work required by the responsible person. 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. PART 6 Enforcement General duties and powers of enforcement authorities 20 Schedule 5, which makes provision about the general duties and powers of enforcement authorities, shall have effect. Non-compliance with UK marking requirements 21 1 For the purposes of this regulation, a product is deficient as regards UK marking— a if it is not subject to these Regulations , but the UK marking is affixed to it (or, where regulation 7(2A) applies, to a label affixed to it or a document accompanying it) pursuant to these Regulations ; or b if it is machinery and— i the UK marking is not affixed to it (or, where regulation 7(2A) applies, to a label affixed to it or a document accompanying it) ; ii it is not accompanied by a copy of the ... declaration of conformity; or iii the UK marking is affixed to it (or, where regulation 7(2A) applies, to a label affixed to it or a document accompanying it) but it does not conform to the relevant provisions of these Regulations; or iv a marking other than the UK marking, which is prohibited by regulation 15(2) or (3), is affixed to it (or, where regulation 7(2A) applies, to a label affixed to it or a document accompanying it) . 2 Where an enforcement authority has reasonable grounds for suspecting that a product is deficient as regards UK marking, but does not have reasonable grounds for suspecting that it is not safe, the enforcement authority may take action under the following provisions as they are applied by Schedule 5 — a in the case of the Health and Safety Executive , the Office for Nuclear Regulation or the Office of Rail and Road , section 20 of the 1974 Act; b in the case of the Health and Safety Executive for Northern Ireland, Article 22 of the 1978 Order; and c in the case of any other enforcement authority, section 29 of the 1987 Act, but no other action may be taken pursuant to Schedule 5 and no proceedings may be brought pursuant to regulation 22 in respect of that product until the enforcement authority has served on the responsible person a notice in writing in accordance with paragraph (3) and the responsible person has failed to comply with its requirements. 3 Where an enforcement authority has reasonable grounds for considering that a product is deficient as regards UK marking, it may serve a notice on the responsible person which— a identifies the product concerned; b states that the enforcement authority considers that it is deficient as regards UK marking and the reasons why the authority considers that this is the case; c requires the responsible person to take (or refrain from taking) specified action within a specified period to bring the deficiency to an end; and d warns the responsible person that if the deficiency continues beyond the period specified in the notice, further action may be taken under these Regulations. 4 In any proceedings under regulation 22 in respect of a person's alleged failure to comply with a notice under paragraph (3), an enforcement authority must show that the product concerned was deficient as regards UK marking at the time when the notice was served. Offences and penalties 22 1 A person who contravenes or fails to comply with— a a requirement of regulations 7, 8, ... 10, 11, 12 or 15; or b a requirement under regulation 21(3)(c) of a notice served under regulation 21(3); is guilty of an offence. 2 Subject to paragraph (3), a person guilty of an offence under paragraph (1) shall be liable— a on summary conviction, to a fine not exceeding the statutory maximum or to imprisonment for a term not exceeding three months or to both; and b on conviction on indictment, to a fine or to imprisonment for a term not exceeding two years or to both. 3 A person who is guilty of an offence as a result of having contravened or failed to comply with— a regulation 7(2)(b), (e) or (f); b regulation 8; c regulation 15; or d a requirement under regulation 21(3)(c) of a notice served under regulation 21(3); shall be liable on summary conviction to a fine not exceeding level 5 on the standard scale. Defence of due diligence 23 1 Subject to the following provisions of this regulation, in proceedings for an offence under these Regulations, a person who is shown to have taken all reasonable steps and exercised all due diligence to avoid committing the offence shall have a defence. 2 Where, in any proceedings against a person for such an offence, the defence provided by paragraph (1) involves an allegation that the commission of the offence was due to— a the act or default of another; or b reliance on information given by another, such a defence shall not, without leave of the court, be relied on unless, not later than seven clear days before the hearing of the proceedings (or, in Scotland, the trial diet), that person has served a notice in accordance with paragraph (3) on the person bringing the proceedings. 3 A notice under this regulation shall give such information identifying or assisting in the identification of the person who committed the act or default or gave the information as is in the possession of the person serving the notice at the time it is served. 4 A person shall not be entitled to rely on the defence provided by paragraph (1) by reason of that person's reliance on information supplied by another, unless it is shown that it was reasonable in all the circumstances for that person to have relied on the information, having regard in particular to— a the steps which that person took and those which might reasonably have been taken, for the purpose of verifying the information; and b whether that person had any reason to disbelieve the information. Liability of persons other than the principal offender 24 1 Where the commission by a person of an offence under these Regulations is due to anything which another person did or failed to do in the course of a business, that other person shall be guilty of the offence and may be proceeded against and punished, whether or not proceedings are taken against the first person 2 Where a body corporate commits an offence and it is proved that the offence was committed— a with the consent or connivance of an officer of the body corporate; or b as a result of the negligence of an officer of the body corporate, the officer, as well as the body corporate, shall be guilty of the offence. 3 In paragraph (2), a reference to an officer of a body corporate includes a reference to— a a director, manager, secretary or other similar officer of the body corporate; b a person purporting to act as a director, manager, secretary or other similar officer; and c if the affairs of the body corporate are managed by its members, a member. 4 In this regulation, references to a “body corporate” include references to a partnership in Scotland, and in relation to such partnership, any reference to a director, manager, secretary or other similar officer of a body corporate is a reference to a partner. PART 7 Miscellaneous Amendment of the Lifts Regulations 1997 25 The amendments to the Lifts Regulations 1997 specified in Schedule 6 shall have effect. Other amendments 26 The amendments specified in Schedule 7 shall have effect. Consequential disapplication of domestic health and safety law 27 1 Subject to paragraph (3), any requirement which— a is imposed by or under any of the enactments (relating to various aspects of the safety of machinery) specified in paragraph (2); and b but for this paragraph, would have to be satisfied by or in respect of machinery if it is to be lawfully placed on the market or put into service, is disapplied. 2 The enactments specified in this paragraph are— a . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . b section 85(1) of the Mines Act (Northern Ireland) 1969 ; c . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . d . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . e . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . f in the Docks Regulations 1988 — i regulation 13(1)(a), (b), and (c); ii the words “or assembled” in regulation 13(1)(d); and iii regulations 13(2)(b), (c) and (d); g in the Docks Regulations (Northern Ireland) 1989 — i regulation 13(1)(a), (b), and (c); ii the words “or assembled” in regulation 13(1)(d); and iii regulations 13(2)(b), (c) and (d); h . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . i . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . j . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 This regulation does not affect the application of the enactments listed in paragraph (2) to machinery after it has been placed on the market or put into service. Time-limited derogation for impact machinery 28 These Regulations shall not have effect in relation to— a portable cartridge-operated fixing machinery; or b other impact machinery, before 29 June 2011, but shall have effect in relation to such machinery from that date. Review 29 1 Before the end of each review period, the Secretary of State must— a carry out a review of these Regulations, b set out the conclusions of the review in a report, and c publish the report. 2 In carrying out the review the Secretary of State must, so far as is reasonable, have regard to how the Directive is implemented in other member States. 3 The report must in particular— a set out the objectives intended to be achieved by the regulatory system established by these Regulations, b assess the extent to which those objectives are achieved, and c assess whether those objectives remain appropriate and, if so, the extent to which they could be achieved with a system that imposes less regulation. 4 “Review period” means— a the period of five years beginning with 1st December 2009, and b subject to paragraph (5), each successive period of five years. 5 If a report under this regulation is published before the last day of the review period to which it relates, the following review period is to begin with the day on which that report is published. 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— “ information requirements ” means the requirements set out in— section 1.7.3 of Schedule 2, Part 1 that all machinery must be marked visibly, legibly and indelibly with the business name and full address of the manufacturer and where applicable the manufacturer's authorised representative; and section 4.3.1 of Schedule 2, Part 1 that each length of lifting chain, rope or webbing not forming part of an assembly must bear a mark or, where this is not possible, a plate or irremovable ring bearing the name and address of the responsible person and the identifying reference of the relevant certificate. 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. Gareth Thomas Parliamentary Under Secretary of State for Trade and Consumer Affairs, Department for Business, Enterprise and Regulatory Reform