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PART 1U.K.Preliminary

Citation, commencement and revocationU.K.

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.

InterpretationE+W+S

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 [F1, 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] [F2 (as it had effect immediately before IP completion day)]; 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 M1, 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 M2;

“the 1978 Order” means the Health and Safety at Work (Northern Ireland) Order 1978 M3;

“the 1987 Act” means the Consumer Protection Act 1987 M4;

“the 1992 Regulations” means the Supply of Machinery (Safety) Regulations 1992 M5;

“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;

[F3“approved body” has the meaning given to it in regulation 16A;]

“authorised representative” means a person established in [F4the 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;

F5...

“chains, ropes and webbing” has the meaning given in regulation 4(2)(e);

F6...

“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;

[F7“designated standard” has the meaning given to it in regulation 2A;]

“enforcement authority” means—

(a)

in Great Britain, subject to sub-paragraph (b) [F8and (ba)]—

(i)

in relation to machinery and partly completed machinery for use at work, the Health and Safety Executive; and

(ii)

in relation to any other machinery or partly completed machinery—

(aa)

within each local weights and measures authority's area, that authority; or

(bb)

the Secretary of State;

(b)

[F9the Office of Rail and Road] where, in Great Britain, the Health and Safety (Enforcing Authority for Railways and Other Guided Transport Systems) Regulations 2006 M6 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

(ba)

[F10the Office for Nuclear Regulation in relation to—

(i)

machinery and partly completed machinery which is intended exclusively or primarily for use on a relevant nuclear site; or

(ii)

putting machinery into service on such a site.]

(c)

in Northern Ireland—

(i)

in relation to machinery and partly completed machinery for use at work, the Health and Safety Executive for Northern Ireland; and

(ii)

in relation to any other machinery or partly completed machinery—

(aa)

within each district council's area, that council; or

(bb)

the Secretary of State;

[F11“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;

F12...

“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)

a person who designs or manufactures that machinery or partly completed machinery—

(i)

with a view to its being placed on the market under that person's own name or trademark; or

(ii)

for that person's own use in [F13Great Britain]; or

(b)

if there is no such person, the person who places that machinery or partly completed machinery on the market or puts it into service;

F14...

F15...

F16...

F17...

“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;

F18...

“put into service” and related expressions have the meaning given in regulation 3;

[F19“relevant nuclear site” means a site which is—

(a)

a GB nuclear site (within the meaning given in section 68 of the Energy Act 2013);

(b)

an authorised defence site (within the meaning given in regulation 2(1) of the Health and Safety (Enforcing Authority) Regulations 1998); or

(c)

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—

(a)

the manufacturer of that machinery or partly completed machinery; or

(b)

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—

(a)

endanger the health of, or result in death or injury to, any person; or

(b)

where appropriate—

(i)

endanger the health of, or result in death or injury to, domestic animals; or

(ii)

endanger property; [F20or

(c)

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);

[F21“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—

(a)

by persons at work (whether exclusively or not); or

(b)

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.

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

F4Words in reg. 2(2) substituted (E.W.S.) (31.12.2020) by The Product Safety and Metrology etc. (Amendment etc.) (UK(NI) Indication) (EU Exit) Regulations (2020 S.I. 2020/1460), reg. 1(2), Sch. 5 para. 1(2)

Marginal Citations

M1By virtue of Decision No. 6/2007 of the EEA Joint Committee: O.J. No. L 209, 9.8.2007, p.8.

M5S.I. 1992/3073, amended by S.I. 1994/2063, S.I. 2004/693 and S.I. 2005/831.

M6S.I. 2006/557, to which there are amendments not relevant to these Regulations.

InterpretationN.I.

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[F96, 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 [F97and Northern Ireland] F98, 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 F99;

“the 1978 Order” means the Health and Safety at Work (Northern Ireland) Order 1978 F100;

“the 1987 Act” means the Consumer Protection Act 1987 F101;

“the 1992 Regulations” means the Supply of Machinery (Safety) Regulations 1992 F102;

“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;

“authorised representative” means a person established in [F103a relevant] state 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;

“CE marking” means a mark consisting of the symbol “CE” set out in the form shown in Annex III (Part 3 of Schedule 2);

“chains, ropes and webbing” has the meaning given in regulation 4(2)(e);

“Commission” means Commission of the [F104European Union];

“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;

“enforcement authority” means—

(a)

in Great Britain, subject to sub-paragraph (b) [F105and (ba)]—

(i)

in relation to machinery and partly completed machinery for use at work, the Health and Safety Executive; and

(ii)

in relation to any other machinery or partly completed machinery—

(aa)

within each local weights and measures authority's area, that authority; or

(bb)

the Secretary of State;

(b)

[F106the Office of Rail and Road] where, in Great Britain, the Health and Safety (Enforcing Authority for Railways and Other Guided Transport Systems) Regulations 2006 F107 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

(ba)

[F108the Office for Nuclear Regulation in relation to—

(i)

machinery and partly completed machinery which is intended exclusively or primarily for use on a relevant nuclear site; or

(ii)

putting machinery into service on such a site.]

(c)

in Northern Ireland—

(i)

in relation to machinery and partly completed machinery for use at work, the Health and Safety Executive for Northern Ireland; and

(ii)

in relation to any other machinery or partly completed machinery—

(aa)

within each district council's area, that council; or

(bb)

the Secretary of State;

[F109“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;

“harmonised standard” means a non-binding technical specification adopted by the European Committee for Standardisation (CEN), the European Committee for Electrotechnical Standardisation (CENELEC) or the European Telecommunications Standards Institute (ETSI), on the basis of a remit issued by the Commission in accordance with the procedures laid down in Directive 98/34/EC of the European Parliament and of the Council of 22 June 1998 laying down a procedure for the provision of information in the field of technical standards and regulations and of rules on Information Society services F110;

“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)

a person who designs or manufactures that machinery or partly completed machinery—

(i)

with a view to its being placed on the market under that person's own name or trademark; or

(ii)

for that person's own use in [F111a relevant] state; or

(b)

if there is no such person, the person who places that machinery or partly completed machinery on the market or puts it into service;

[F112“NI Protocol obligation” means any obligation created or arising by or under the Protocol on Ireland/ Northern Ireland in the EU withdrawal agreement, whether or not an obligation to which section 7A(2) of the European Union (Withdrawal) Act 2018 applies;]

“notified body” means—

(a)

a UK notified body;

(b)

a person designated as a notified body for the purposes of the Directive by another [F113relevant] state and notified by that state to the Commission and the other [F113relevant] states under Article 14(1) of the Directive; or

(c)

a person recognised for the purpose of carrying out the functions of a notified body under the Directive under or by virtue of—

(i)

a mutual recognition agreement relating to the Directive; or

(ii)

a similar agreement (including a Protocol to a Europe Agreement, or another Agreement, on Conformity Assessment and Acceptance of Industrial Products),

which has been concluded between the [F104European Union and a state other than [F114a relevant] state;

“notified body criteria” has the meaning given in regulation 16(6);

“notified body designation” has the meaning given in regulations 16(2) and (4);

“official Community language” means an official language of an EEA state;

“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;

“published harmonised standard” has the meaning given in regulation 7(4);

“put into service” and related expressions have the meaning given in regulation 3;

[F115“relevant market” means—

(a)

the market of Northern Ireland; and

(b)

the markets of the EEA states;]

[F116“relevant nuclear site” means a site which is—

(a)

a GB nuclear site (within the meaning given in section 68 of the Energy Act 2013);

(b)

an authorised defence site (within the meaning given in regulation 2(1) of the Health and Safety (Enforcing Authority) Regulations 1998); or

(c)

a new nuclear build site (within the meaning given in regulation 2A of those Regulations);]

[F117“relevant state” means—

(a)

Northern Ireland; or

(b)

any EEA state;]

“removable mechanical transmission device” has the meaning given in regulation 4(2)(f);

“responsible person” means, in relation to machinery or partly completed machinery—

(a)

the manufacturer of that machinery or partly completed machinery; or

(b)

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—

(a)

endanger the health of, or result in death or injury to, any person; or

(b)

where appropriate—

(i)

endanger the health of, or result in death or injury to, domestic animals; or

(ii)

endanger property; [F118or

(c)

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);

[F119“UK(NI) indication” means the marking in the form set out in Schedule 1 to the Product Safety and Metrology etc. (Amendment etc.) (UK(NI) Indication) (EU Exit) Regulations 2020;]

“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—

(a)

by persons at work (whether exclusively or not); or

(b)

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.]

Extent Information

E17This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

Textual Amendments

F98By virtue of Decision No. 6/2007 of the EEA Joint Committee: O.J. No. L 209, 9.8.2007, p.8.

F107S.I. 2006/557, to which there are amendments not relevant to these Regulations.

F110O.J. No. L 204, 21.7.1998, p.37, as amended by Directives 98/48/EC (O.J. No. L 217, 5.8.1998, p.18) and 2006/96/EC (O.J. No. L 363, 20.12.2006, p.81).

[F22Designated standardU.K.

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 [F23or 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).

[F24(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 [F25such] technical specifications adopted by the other recognised standardisation bodies [F26or 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.]

Textual Amendments

Placing on the market and putting into service; supplies outside [F27Great Britain] and showing at trade fairs not coveredE+W+S

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 [F28Great 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 [F28Great 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 [F29UK] marking, or any inscription likely to be confused with the [F29UK] marking, and—

(i)it will not be put into service in [F28Great Britain];

(ii)it is imported into [F28Great Britain] state for re-export to a country which is not [F28Great Britain]; or

(iii)it is imported into [F28Great 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.

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

Placing on the market and putting into service; supplies outside the [F120relevant market] and showing at trade fairs not coveredN.I.

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 [F121a relevant] state—

(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 [F121a relevant] state.

(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 CE marking, or any inscription likely to be confused with the CE marking, and—

(i)it will not be put into service in [F122a relevant] state;

[F123(ii)is imported into the relevant market for re-export to a market outside of the relevant market;]

(iii)it is imported into [F124a relevant] state 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.

Extent Information

E18This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

Textual Amendments

PART 2U.K.Application

Products to which Regulations apply; definition of “machinery”U.K.

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 F30... safety rules applyE+W+S

5.  These Regulations do not apply to a product if, or to the extent that, [F31other enactments (as they apply in Great Britain)], which apply to it, make more specific provision than [F32these Regulations] in connection with the hazards referred to in Annex I (Part 1 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

[F125Disapplication where more specific safety obligations applyN.I.

5.—(1) These Regulations do not apply to a product if, or to the extent that, paragraph (2) applies.

(2) This paragraph applies where any NI Protocol obligation, other than any obligation in relation to the Directive, applies to the product and makes more specific provision than the Directive in connection with the hazards referred to in Annex I (Part 1 of Schedule 2).]

Extent Information

E19This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

Textual Amendments

Partly completed machineryU.K.

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 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 F33... 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 [F34UK] marking to the machinery [F35or 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).

[F36(2A) For a period of [F37seven 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 [F38designated] standard, F39... 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 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).

[F126(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

E20This 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.

F409.  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

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 [F41designated] 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 [F42designated] standards; and

(ii)that the [F43designated] 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 [F44 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 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

E21This 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 [F45designated] 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 [F46designated] standards which relate to it; or

(ii)that the machinery is only partly manufactured in accordance with the [F46designated] standards which relate to it; or

(iii)that the [F46designated] standards in accordance with which the machinery is manufactured do not cover all the applicable essential health and safety requirements; or

(iv)that no [F47designated] standards exist for the machinery.

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

(a)the [F48Type-] 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 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

E22This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

[F49Obligations 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

Expiry of regulation 12AE+W+S

12B.—(1) Subject to paragraph (2), regulation 12A ceases to have effect at the end of the period of [F50four years] beginning with IP completion day.

(2) Notwithstanding the expiry of regulation 12A—

(a)any machinery or partly completed machinery which was placed on the market or put into service pursuant to regulation 12A may continue to be made available on the market on or after the expiry of regulation 12A;

(b)any obligation to which a person was subject under regulation 12A(2) in respect of machinery or partly completed machinery placed on the market or put into service pursuant to regulation 12A continues to have effect after the expiry of regulation 12A, in respect of that machinery or partly completed machinery.

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

PART 4U.K.[F51CE Marking] [F51UK Marking]

Textual Amendments

[F52UK] -marked machinery to be taken to comply with RegulationsE+W+S

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 [F53UK] marking and is accompanied by [F54a] declaration of conformity which complies with Annex II (Part 2 of Schedule 2), part 1, section A complies with these Regulations.

[F55(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.

Extent Information

E7This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only

Textual Amendments

CE -marked machinery to be taken to comply with RegulationsN.I.

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 CE marking and is accompanied by an EC declaration of conformity which complies with Annex II (Part 2 of Schedule 2), part 1, section A complies with these Regulations.

[F127(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.

Extent Information

E23This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

Textual Amendments

Machinery covered by more than one [F56enactment] E+W+S

14.—(1) Subject to paragraph (2), where machinery falls within the scope of [F57an [F58enactment]] other than [F59these Regulations] (“ [F60the other enactment]”), the affixing of the [F61UK] marking indicates that the relevant requirements of [F60the other enactment] are also satisfied.

(2) Where—

(a)the other [F62enactment] 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 [F62enactment] which the responsible person has chosen to apply, F63... are given in the F64... declaration of conformity,

the affixing of the [F65UK] marking indicates that the machinery conforms only to the provisions of the other [F62enactment] which the responsible person has chosen to apply.

Extent Information

E8This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only

Textual Amendments

Machinery covered by more than one DirectiveN.I.

14.—(1) Subject to paragraph (2), where machinery falls within the scope of [F128an [F129NI Protocol obligation]] other than the Directive (“the [F130other NI Protocol obligation]”), the affixing of the CE marking indicates that the relevant requirements of the [F130other NI Protocol obligation] are also satisfied.

(2) Where—

(a)the [F130other NI Protocol obligation] 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 [F130other NI Protocol obligation] which the responsible person has chosen to apply, as published in the Official Journal of the European Union, are given in the EC declaration of conformity,

the affixing of the CE marking indicates that the machinery conforms only to the provisions of the [F130other NI Protocol obligation] which the responsible person has chosen to apply.

Extent Information

E24This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

Textual Amendments

Protection of [F66UK] markingE+W+S

15.—(1) No person shall affix the [F67UK] 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 [F67UK] marking (or both).

(3) Other markings may be affixed to machinery which bears the [F67UK] marking only if the visibility, legibility or meaning of the [F67UK] marking is not impaired as a result.

Extent Information

E9This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only

Textual Amendments

Protection of CE markingN.I.

15.—(1) No person shall affix the CE 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 CE marking (or both).

(3) Other markings may be affixed to machinery which bears the CE marking only if the visibility, legibility or meaning of the CE marking is not impaired as a result.

Extent Information

E25This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

PART 5E+W+S[F68Notified bodies] [F68Approved Bodies]

Textual Amendments

Designation and monitoring of UK notified bodiesE+W+S

F6916.  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Extent Information

E10This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only

Textual Amendments

Designation and monitoring of UK notified bodiesN.I.

16.—(1) The Secretary of State may designate a person to carry out conformity assessment.

(2) Except as provided in paragraph (4), any such designation (a “notified body designation”) shall be made in accordance with paragraphs (5) to (9) of this regulation.

(3) A person in respect of whom—

(a)a notified body designation has been made under this regulation; and

(b)whose designation has been notified by the Secretary of State to the Commission and the other [F131relevant] states under Article 14(1) of the Directive,

is a “UK notified body” to the extent that that designation remains in effect.

(4) If a person holds an appointment as a United Kingdom approved body under the 1992 Regulations which has been notified to the Commission and the other [F131relevant] states under Article 9(1) of Directive 98/37/EC and has not been terminated—

(a)the appointment—

(i)is a “notified body designation” for the purposes of these Regulations; and

(ii)shall be varied in accordance with regulation 17 to the extent that it is necessary or expedient to vary it to take account of the repeal of Directive 98/37/EC and the revocation of the 1992 Regulations and their replacement by the Directive and these Regulations; and

(b)that person is a “UK notified body” to the extent that the appointment remains in effect.

(5) Except where paragraph (4) applies, any person wishing to be a UK notified body must apply to the Secretary of State for designation under this regulation.

(6) A notified body designation shall not be made unless the Secretary of State is satisfied that the person in respect of whom it is to be made meets the criteria specified in Annex XI (Part 11 of Schedule 2) (the “notified body criteria”).

(7) A person who meets the assessment criteria laid down in a published harmonised standard shall be presumed to meet that part of the notified body criteria which corresponds to the criteria in that standard.

(8) A notified body designation—

(a)shall be in writing;

(b)shall 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.

(9) In making a notified body designation the Secretary of State may have regard (in addition to the notified body criteria) to any other matter which appears to the Secretary of State to be relevant.

F132(10) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(11) The Secretary of State shall, from time to time, carry out an inspection of each UK notified body with a view to verifying that it—

(a)meets the notified body criteria;

(b)complies with any condition to which its designation is subject; and

(c)complies with these Regulations.

(12) A UK notified body shall comply with any request of the Secretary of State to provide information relevant to determining its compliance with the notified body criteria, these Regulations, or any condition to which its designation is subject.

Extent Information

E26This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

Textual Amendments

[F70Approved bodiesE+W+S

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.

Textual Amendments

Approved body designationE+W+S

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.

Textual Amendments

MonitoringE+W+S

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.]

Textual Amendments

Duration, variation and termination of designationsE+W+S

17.—(1) [F71An approved] body designation which does not designate a person as [F72an approved] body for a specified period shall have effect until such time as it is terminated under paragraph (4).

(2) [F71An approved] body designation which designates a person as [F72an 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 [F71an approved] body designation if—

(a)[F73the 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 [F71an approved] body designation—

(a)on the expiry of 90 days' notice in writing at the request of [F73the 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 [F73the approved] body no longer satisfies the notified body criteria.

(5) Where the Secretary of State is minded to vary [F71an approved] body designation in accordance with paragraph (3)(b), or to terminate [F71an approved] body designation under paragraph (4)(b) or (c), the Secretary of State shall—

(a)give notice in writing to [F73the approved] body of the proposed variation or termination and the reasons for it, stating that [F73the 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 [F73the approved] body in accordance with the notice.

(6) If [F71an approved] body designation is terminated under paragraph (4), the Secretary of State may, by notice in writing—

(a)authorise [F74another approved] body to take over the functions of [F73the 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 [F73the approved] body whose designation has been terminated or to [F74another approved] body) in respect of [F72an approved] body's files or any other matter which the Secretary of State considers expedient for the purposes of ensuring that [F75another approved] body carries out the functions of [F71an approved] body for the existing customers of the notified body whose designation has been terminated.

[F76(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.]

Extent Information

E11This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only

Textual Amendments

Duration, variation and termination of designationsN.I.

17.—(1)  A notified body designation which does not designate a person as a UK notified body for a specified period shall have effect until such time as it is terminated under paragraph (4).

(2) A notified body designation which designates a person as a UK notified 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 a notified body designation if—

(a)the UK notified 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 a notified body designation—

(a)on the expiry of 90 days' notice in writing at the request of the UK notified 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 UK notified body no longer satisfies the notified body criteria.

(5) Where the Secretary of State is minded to vary a notified body designation in accordance with paragraph (3)(b), or to terminate a notified body designation under paragraph (4)(b) or (c), the Secretary of State shall—

(a)give notice in writing to the UK notified body of the proposed variation or termination and the reasons for it, stating that the UK notified 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 UK notified body in accordance with the notice.

(6) If a notified body designation is terminated under paragraph (4), the Secretary of State may, by notice in writing—

(a)authorise another UK notified body to take over the functions of the UK notified 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 UK notified body whose designation has been terminated or to another UK notified body) in respect of a UK notified body's files or any other matter which the Secretary of State considers expedient for the purposes of ensuring that another notified body carries out the functions of a notified body for the existing customers of the notified body whose designation has been terminated.

Extent Information

E27This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

Functions of [F77approved] bodiesE+W+S

18.—(1) Subject to the terms of their [F78approved] body designations and paragraph (2), [F77approved] bodies shall carry out the functions of [F78approved] bodies specified in Annexes IX and X (Parts 9 and 10 of Schedule 2).

(2) [F79An 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, [F79an 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, [F80the 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 [F79an 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), [F79an 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 [F79an approved] body has made under paragraph (4); or

(b)by a responsible person who is aggrieved by a decision of [F79an 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 [F78approved] to a responsible person pursuant to Annex X (Part 10 of Schedule 2), point 2.3.

Extent Information

E12This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only

Textual Amendments

Functions of UK notified bodiesN.I.

18.—(1) Subject to the terms of their notified body designations and paragraph (2), UK notified bodies shall carry out the functions of notified bodies specified in Annexes IX and X (Parts 9 and 10 of Schedule 2).

(2) A UK notified 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, a UK notified 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 UK notified 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 a UK notified 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), a UK notified 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 a UK notified body has made under paragraph (4); or

(b)by a responsible person who is aggrieved by a decision of a UK notified 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 notified to a responsible person pursuant to Annex X (Part 10 of Schedule 2), point 2.3.

Extent Information

E28This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

FeesE+W+S

19.—(1) [F81An 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) [F81An 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.

Extent Information

E13This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only

Textual Amendments

FeesN.I.

19.—(1) A UK notified 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) A UK notified 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.

Extent Information

E29This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

[F82Register of approved bodiesE+W+S

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.]

Extent Information

E14This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only

Textual Amendments

[F133Register of UK notified bodiesN.I.

19A.—(1) The Secretary of State must ensure that—

(a)each UK notified body is assigned an identification number; and

(b)there is a register of—

(i)UK notified bodies;

(ii)their notified body identification number;

(iii)the activities for which they have been notified;

(iv)any restrictions on those activities.

(2) The Secretary of State must ensure that the register referred to in paragraph (1) is maintained and made publicly available.

(3) The Secretary of State may authorise the United Kingdom Accreditation Service to compile and maintain the register in accordance with paragraph (1)(b).]

Extent Information

E30This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

Textual Amendments

PART 6U.K.Enforcement

General duties and powers of enforcement authoritiesU.K.

20.  Schedule 5, which makes provision about the general duties and powers of enforcement authorities, shall have effect.

Non-compliance with [F83UK] marking requirementsE+W+S

21.—(1) For the purposes of this regulation, a product is deficient as regards [F83UK] marking—

(a)if it is not subject to [F84these Regulations], but the [F83UK] marking is affixed to it [F85(or, where regulation 7(2A) applies, to a label affixed to it or a document accompanying it)] pursuant to [F84these Regulations]; or

(b)if it is machinery and—

(i)the [F83UK] marking is not affixed to it [F85(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 F86... declaration of conformity; or

(iii)the [F83UK] marking is affixed to it [F85(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 [F83UK] marking, which is prohibited by regulation 15(2) or (3), is affixed to it [F85(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 [F83UK] 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[F87, the Office for Nuclear Regulation] or [F88the 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 [F83UK] 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 [F83UK] 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 [F83UK] marking at the time when the notice was served.

Extent Information

E15This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only

Textual Amendments

Non-compliance with CE marking requirementsN.I.

21.—(1) For the purposes of this regulation, a product is deficient as regards CE marking—

(a)if it is not subject to the Directive, but the CE marking is affixed to it pursuant to the Directive; or

(b)if it is machinery and—

(i)the CE marking is not affixed to it;

(ii)it is not accompanied by a copy of the EC declaration of conformity; or

(iii)the CE marking is affixed to it but it does not conform to the relevant provisions of these Regulations; F134...

[F135(iiia)the UK(NI) indication does not accompany the CE marking in contravention of regulation 7(2A); or

(iiib)the UK(NI) indication is affixed other than in accordance with regulation 7(2B); or]

(iv)a marking other than the CE marking [F136or the UK(NI) indication], which is prohibited by regulation 15(2) or (3), is affixed to it.

(2) Where an enforcement authority has reasonable grounds for suspecting that a product is deficient as regards CE 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 [F137, the Office for Nuclear Regulation] or [F138the 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 CE 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 CE 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 CE marking at the time when the notice was served.

Extent Information

E31This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

Textual Amendments

Offences and penaltiesE+W+S

22.—(1) A person who contravenes or fails to comply with—

(a)a requirement of regulations 7, 8, F89... 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.

Textual Amendments

F89Word in reg. 22(1)(a) omitted (15.12.2011) by virtue of The Supply of Machinery (Safety) (Amendment) Regulations 2011 (S.I. 2011/2157), regs. 1, 6

Offences and penaltiesN.I.

22.—(1) A person who contravenes or fails to comply with—

(a)a requirement of regulations 7, 8, F139... 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) [F140, (f), (2A) or (2B)];

(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.

Extent Information

E32This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

Textual Amendments

F139Word in reg. 22(1)(a) omitted (15.12.2011) by virtue of The Supply of Machinery (Safety) (Amendment) Regulations 2011 (S.I. 2011/2157), regs. 1, 6

Defence of due diligenceU.K.

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 offenderU.K.

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 7U.K.Miscellaneous

Amendment of the Lifts Regulations 1997U.K.

25.  The amendments to the Lifts Regulations 1997 M7 specified in Schedule 6 shall have effect.

Marginal Citations

Other amendmentsU.K.

26.  The amendments specified in Schedule 7 shall have effect.

Consequential disapplication of domestic health and safety lawU.K.

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—

F90(a). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(b)section 85(1) of the Mines Act (Northern Ireland) 1969 M8;

F90(c). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

F90(d). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

F90(e). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(f)in the Docks Regulations 1988 M9—

(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 M10—

(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);

F90(h). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

F91(i). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

F90(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.

Textual Amendments

F90Reg. 27(2)(a)(c)(d)(e)(h)(j) revoked (6.4.2015) by The Mines Regulations 2014 (S.I. 2014/3248), reg. 1(2), Sch. 4 Pt. 2 (with reg. 1(3))

Marginal Citations

Time-limited derogation for impact machineryU.K.

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.

[F92ReviewE+W+S

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.]

Extent Information

E16This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only

Textual Amendments

[F141ReviewN.I.

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 [F142relevant] 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.]

Extent Information

E33This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

Textual Amendments

[F93Transitional provisions in relation to EU ExitU.K.

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) Where during the pre-exit period—

(a)a product has not been placed on the market; and

(b)a manufacturer has taken any action to comply with regulations 10 to 12 as they had effect immediately before IP completion day in relation to that product

that action has effect as if it had been done under regulations 10 to 12 as they have effect on and after IP completion day.

[F94(4) Subject to paragraph (5), where before 11pm on 31st December 2024—

(a)the product has not been placed on the market or put into service; and

(b)a responsible person has taken any action under the conformity assessment procedure that applies to that product in accordance with Article 12 of the Directive

that action has effect as if it had been done under the applicable conformity assessment procedure referred to in regulation 10, 11 or 12.

(5) Paragraph (4) does not apply—

(a)after the expiry of the validity of any certificate issued pursuant to the applicable conformity assessment procedure; and

(b)in any event, after 31st December 2027.]

Textual Amendments

31.—(1) In this regulation—U.K.

“information requirements” means the requirements set out in—

(a)

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

(b)

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 [F95seven 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.]

Textual Amendments

Gareth Thomas

Parliamentary Under Secretary of State for Trade and Consumer Affairs,

Department for Business, Enterprise and Regulatory Reform

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