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The Supply of Machinery (Safety) Regulations 2008

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Statutory Instruments

2008 No. 1597

Health And Safety

The Supply of Machinery (Safety) Regulations 2008

Made

19th June 2008

Laid before Parliament

23rd June 2008

Coming into force

29th December 2009

The Secretary of State is a Minister designated(1) for the purposes of section 2(2) of the European Communities Act 1972(2) in relation to machinery, including component parts of machines, components or equipment to be attached to or used with machines, and sub-assemblies to be incorporated into or assembled with machines, and in relation to measures relating to lifts and the safety components for use in lifts.

The Secretary of State, in exercise of the powers conferred by section 2(2) of that Act, makes the following Regulations.

PART 1Preliminary

Citation, commencement and revocation

1.—(1) These Regulations may be cited as the Supply of Machinery (Safety) Regulations 2008 and shall come into force on 29th December 2009.

(2) The Regulations listed in the first column of the table in Schedule 1 are revoked to the extent specified in the third column of that table.

Interpretation

2.—(1) In these Regulations—

(a)references to “the Directive” are references to Directive 2006/42/EC of the European Parliament and of the Council on machinery, and amending Directive 95/16/EC(3); 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(4), 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(5);

“the 1978 Order” means the Health and Safety at Work (Northern Ireland) Order 1978(6);

“the 1987 Act” means the Consumer Protection Act 1987(7);

“the 1992 Regulations” means the Supply of Machinery (Safety) Regulations 1992(8);

“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 an EEA 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 European Communities;

“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)—

(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)

the Office of Rail Regulation where, in Great Britain, the Health and Safety (Enforcing Authority for Railways and Other Guided Transport Systems) Regulations 2006(9) 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

(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;

“essential health and safety requirements” means the requirements set out in Annex I (Part 1 of Schedule 2), sections 1 to 6, read in the light of the General Principles set out at the start of that Annex;

“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(10);

“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 an EEA 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;

“notified body” means—

(a)

a UK notified body;

(b)

a person designated as a notified body for the purposes of the Directive by another EEA state and notified by that state to the Commission and the other EEA 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 European Community and a state other than an EEA 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;

“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;

“safety component” has the meaning given in regulation 4(2)(c);

“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.

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

3.—(1) In these Regulations, subject to paragraph (2)—

(a)references to placing machinery or partly completed machinery on the market are references to making it available in an EEA 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 an EEA 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 an EEA state;

(ii)it is imported into an EEA state for re-export to a country which is not an EEA state; or

(iii)it is imported into an EEA 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.

PART 2Application

Products to which Regulations apply; definition of “machinery”

4.—(1) These Regulations apply—

(a)to products in respect of which the following conditions are satisfied—

(i)that they fall within one of the descriptions of products specified in paragraph (2);

(ii)that they do not fall within any of the categories of products specified in Schedule 3 as being products to which these Regulations do not apply;

(iii)that they are placed on the market or put into service on or after 29th December 2009; and

(iv)that these Regulations are not disapplied in respect of them by regulation 5; and

(b)to partly completed machinery, as defined in regulation 6.

(2) The following descriptions of products are specified in this paragraph—

(a)assemblies which fall within one of the following descriptions—

(i)an assembly, fitted with or intended to be fitted with a drive system other than directly applied human or animal effort, consisting of linked parts or components, at least one of which moves, and which are joined together for a specific application;

(ii)an assembly as referred to in sub-paragraph (i), missing only the components to connect it on site or to sources of energy and motion;

(iii)an assembly as referred to in sub-paragraph (i) or (ii), ready to be installed and able to function as it stands only if mounted on a means of transport, or installed in a building or structure;

(iv)assemblies of machinery as referred to in sub-paragraphs (i), (ii) and (iii) or partly completed machinery, which, in order to achieve the same end, are arranged and controlled so that they function as an integral whole;

(v)an assembly of linked parts or components, at least one of which moves and which are joined together, intended for lifting loads and whose only power source is directly applied human effort;

(b)devices which, after the putting into service of machinery or of a tractor, are assembled with that machinery or tractor by operators themselves in order to change its function or attribute a new function, in so far as they are not tools (“interchangeable equipment”);

(c)components—

(i)which serve to fulfil a safety function;

(ii)which are independently placed on the market;

(iii)the failure or malfunction of which endangers the safety of persons; and

(iv)which are not necessary in order for the machinery to function, or for which other components which do not fall within sub-paragraphs (i) to (iii) may be substituted in order for the machinery to function,

(“safety components”, examples of which are listed in Annex V (Part 5 of Schedule 2));

(d)components or equipment (including slings and their components) which—

(i)are not attached to lifting machinery;

(ii)allow a load to be held;

(iii)are placed between the machinery and the load or on the load itself, or are intended to constitute an integral part of the load; and

(iv)are independently placed on the market

(“lifting accessories”);

(e)chains, ropes and webbing designed and constructed for lifting purposes as part of lifting machinery or lifting accessories (“chains, ropes and webbing”); and

(f)removable components for transmitting power between self-propelled machinery or a tractor and another machine by joining them at the first fixed bearing (“removable mechanical transmission devices”) (when such components are placed on the market with a guard the components and the guard together shall be regarded as one product).

(3) Subject to paragraph (4), in these Regulations, the word “machinery” refers to products of any of the descriptions specified in paragraph (2) in respect of which the conditions specified in paragraph (1)(a)(ii), (iii) and (iv) are satisfied.

(4) Where an essential health and safety requirement is expressed to apply both to “machinery” generally and to a particular description of machinery referred to in paragraph (2)(b), (c), (d), (e) or (f), the general reference to “machinery” is to be understood—

(a)as not referring to machinery of that particular description; and

(b)as referring only to those descriptions of machinery referred to in paragraph (2) for which the hazard corresponding to that essential health and safety requirement exists when they are used under the conditions foreseen by the responsible person or in foreseeable abnormal situations.

Disapplication where more specific Community safety rules apply

5.  These Regulations do not apply to a product if, or to the extent that, Community directives other than the Directive, which apply to it, make more specific provision than the Directive in connection with the hazards referred to in Annex I (Part 1 of Schedule 2).

Partly completed machinery

6.—(1) Subject to paragraph (2), provisions of these Regulations which refer to “partly completed machinery” apply to drive systems and other assemblies which—

(a)are almost machinery;

(b)cannot in themselves perform a specific application; and

(c)are only intended to be incorporated into or assembled with other machinery or other partly completed machinery or equipment, thereby forming machinery.

(2) Paragraph (1) does not apply to assemblies of the kind described in paragraph (1) which—

(a)are placed on the market before 29th December 2009; or

(b)are only intended to be incorporated into or assembled with other products to form a product which falls within any of the categories of products specified in Schedule 3 as being products to which these Regulations do not apply.

PART 3General prohibitions and obligations

Supply of machinery: general obligations and prohibition

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

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

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

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

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

(d)follow, as appropriate—

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

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

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

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

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

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

(f)affix the CE marking to the machinery—

(i)visibly, legibly and indelibly; and

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

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

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

(5) Where—

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

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

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

(6) Where—

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

(b)a quality system has been approved,

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

Supply of partly completed machinery: general obligations and prohibition

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

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

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

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

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

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

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

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

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

Putting machinery into service

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

Conformity assessment procedures

Machinery not referred to in Annex IV

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

PART 4CE Marking

CE-marked machinery to be taken to comply with Regulations

13.—(1) Unless there is evidence to the contrary—

(a)an enforcement authority;

(b)the Secretary of State (where the Secretary of State is not an enforcement authority); and

(c)any court or tribunal of competent jurisdiction which is called upon to decide a matter which involves the application of these Regulations,

shall presume that machinery which bears the 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.

(2) The failure or refusal by a responsible person, in response to a duly reasoned request from an enforcement authority, to make the technical file or a copy of it available in accordance with Annex VII (Part 7 of Schedule 2), part A, point 2 shall be reasonable grounds for the authority—

(a)to doubt the conformity of machinery with the essential health and safety requirements, in accordance with Annex VII, part A, point 3; or

(b)to doubt the conformity of partly completed machinery with the essential health and safety requirements, in accordance with Annex VII, part B, last paragraph,

and it may make such use of its powers under Schedule 5 as is appropriate in the light of such doubts.

Machinery covered by more than one Directive

14.—(1) Subject to paragraph (2), where machinery falls within the scope of a Community directive other than the Directive (“the other Directive”), the affixing of the CE marking indicates that the relevant requirements of the other Directive are also satisfied.

(2) Where—

(a)the other Directive 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 Directive 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 other Directive which the responsible person has chosen to apply.

Protection of CE marking

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.

PART 5Notified bodies

Designation and monitoring of UK notified bodies

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 EEA 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 EEA 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.

(10) The Secretary of State shall, from time to time, publish a list of UK notified bodies, identifying, in the case of each UK notified body, the description of machinery for which that notified body is designated.

(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.

Duration, variation and termination of designations

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.

Functions of UK notified bodies

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.

Fees

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.

PART 6Enforcement

General duties and powers of enforcement authorities

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

Non-compliance with CE marking requirements

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; or

(iv)a marking other than the CE marking, 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 or the Office of Rail Regulation, 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.

Offences and penalties

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

(a)a requirement of regulations 7, 8, 9, 10, 11, 12 or 15; or

(b)a requirement under regulation 21(3)(c) of a notice served under regulation 21(3);

is guilty of an offence.

(2) Subject to paragraph (3), a person guilty of an offence under paragraph (1) shall be liable—

(a)on summary conviction, to a fine not exceeding the statutory maximum or to imprisonment for a term not exceeding three months or to both; and

(b)on conviction on indictment, to a fine or to imprisonment for a term not exceeding two years or to both.

(3) A person who is guilty of an offence as a result of having contravened or failed to comply with—

(a)regulation 7(2)(b), (e) or (f);

(b)regulation 8;

(c)regulation 15; or

(d)a requirement under regulation 21(3)(c) of a notice served under regulation 21(3);

shall be liable on summary conviction to a fine not exceeding level 5 on the standard scale.

Defence of due diligence

23.—(1) Subject to the following provisions of this regulation, in proceedings for an offence under these Regulations, a person who is shown to have taken all reasonable steps and exercised all due diligence to avoid committing the offence shall have a defence.

(2) Where, in any proceedings against a person for such an offence, the defence provided by paragraph (1) involves an allegation that the commission of the offence was due to—

(a)the act or default of another; or

(b)reliance on information given by another,

such a defence shall not, without leave of the court, be relied on unless, not later than seven clear days before the hearing of the proceedings (or, in Scotland, the trial diet), that person has served a notice in accordance with paragraph (3) on the person bringing the proceedings.

(3) A notice under this regulation shall give such information identifying or assisting in the identification of the person who committed the act or default or gave the information as is in the possession of the person serving the notice at the time it is served.

(4) A person shall not be entitled to rely on the defence provided by paragraph (1) by reason of that person’s reliance on information supplied by another, unless it is shown that it was reasonable in all the circumstances for that person to have relied on the information, having regard in particular to—

(a)the steps which that person took and those which might reasonably have been taken, for the purpose of verifying the information; and

(b)whether that person had any reason to disbelieve the information.

Liability of persons other than the principal offender

24.—(1) Where the commission by a person of an offence under these Regulations is due to anything which another person did or failed to do in the course of a business, that other person shall be guilty of the offence and may be proceeded against and punished, whether or not proceedings are taken against the first person

(2) Where a body corporate commits an offence and it is proved that the offence was committed—

(a)with the consent or connivance of an officer of the body corporate; or

(b)as a result of the negligence of an officer of the body corporate,

the officer, as well as the body corporate, shall be guilty of the offence.

(3) In paragraph (2), a reference to an officer of a body corporate includes a reference to—

(a)a director, manager, secretary or other similar officer of the body corporate;

(b)a person purporting to act as a director, manager, secretary or other similar officer; and

(c)if the affairs of the body corporate are managed by its members, a member.

(4) In this regulation, references to a “body corporate” include references to a partnership in Scotland, and in relation to such partnership, any reference to a director, manager, secretary or other similar officer of a body corporate is a reference to a partner.

PART 7Miscellaneous

Amendment of the Lifts Regulations 1997

25.  The amendments to the Lifts Regulations 1997(11) specified in Schedule 6 shall have effect.

Other amendments

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

Consequential disapplication of domestic health and safety law

27.—(1) Subject to paragraph (3), any requirement which—

(a)is imposed by or under any of the enactments (relating to various aspects of the safety of machinery) specified in paragraph (2); and

(b)but for this paragraph, would have to be satisfied by or in respect of machinery if it is to be lawfully placed on the market or put into service,

is disapplied.

(2) The enactments specified in this paragraph are—

(a)section 83 of the Mines and Quarries Act 1954(12);

(b)section 85(1) of the Mines Act (Northern Ireland) 1969(13);

(c)regulation 3(3) of the Coal and Other Mines (Locomotives) Regulations 1956(14);

(d)regulation 52 of the Miscellaneous Mines (General) Regulations 1956(15);

(e)regulation 11 of the Coal Mines (Firedamp Drainage) Regulations 1960(16);

(f)in the Docks Regulations 1988(17)—

(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(18)—

(i)regulation 13(1)(a), (b), and (c);

(ii)the words “or assembled” in regulation 13(1)(d); and

(iii)regulations 13(2)(b), (c) and (d);

(h)regulation 26 of the Electricity at Work Regulations 1989(19);

(i)regulation 26 of the Electricity at Work Regulations (Northern Ireland) 1991(20); and

(j)regulations 4 to 8 of the Boulby Mine (Storage and Battery Locomotives) Special Regulations 1972(21).

(3) This regulation does not affect the application of the enactments listed in paragraph (2) to machinery after it has been placed on the market or put into service.

Time-limited derogation for impact machinery

28.  These Regulations shall not have effect in relation to—

(a)portable cartridge-operated fixing machinery; or

(b)other impact machinery,

before 29 June 2011, but shall have effect in relation to such machinery from that date.

Gareth Thomas

Parliamentary Under Secretary of State for Trade and Consumer Affairs,

Department for Business, Enterprise and Regulatory Reform

19th June 2008

Regulation 1(2)

SCHEDULE 1REGULATIONS REVOKED

RegulationsReferenceExtent of revocation
The All-Terrain Motor Vehicles (Safety) Regulations 1989S.I. 1989/2288Regulations 4, 5 and 6
The Supply of Machinery (Safety) Regulations 1992S.I. 1992/3073The whole Regulations
The Supply of Machinery (Safety) (Amendment) Regulations 1994S.I. 1994/2063The whole Regulations
The Supply of Machinery (Safety) (Amendment) Regulations 2005S.I. 2005/831The whole Regulations

Regulation 2(1)(b)

SCHEDULE 2ANNEXES TO THE DIRECTIVE

Regulation 2(2)

PART 1Annex I: Essential health and safety requirements relating to the design and construction of machinery

GENERAL PRINCIPLES

1.
  • The responsible person must ensure that a risk assessment is carried out in order to determine the health and safety requirements which apply to the machinery. The machinery must then be designed and constructed taking into account the results of the risk assessment.

  • By the iterative process of risk assessment and risk reduction referred to above, the responsible person shall:

    • determine the limits of the machinery, which include the intended use and any reasonably foreseeable misuse thereof,

    • identify the hazards that can be generated by the machinery and the associated hazardous situations,

    • estimate the risks, taking into account the severity of the possible injury or damage to health and the probability of its occurrence,

    • evaluate the risks, with a view to determining whether risk reduction is required, in accordance with the objective of the Directive,

    • eliminate the hazards or reduce the risks associated with these hazards by application of protective measures, in the order of priority established in section 1.1.2(b) of this Annex.

2.The obligations laid down by the essential health and safety requirements only apply when the corresponding hazard exists for the machinery in question when it is used under the conditions foreseen by the responsible person or in foreseeable abnormal situations. In any event, the principles of safety integration referred to in section 1.1.2 of this Annex and the obligations concerning marking of machinery and instructions referred to in sections 1.7.3 and 1.7.4 of this Annex apply.
3.The essential health and safety requirements laid down in this Annex are mandatory. However, taking into account the state of the art, it may not be possible to meet the objectives set by them. In that event, the machinery must, as far as possible, be designed and constructed with the purpose of approaching these objectives.
4.This Annex is organised in several sections. The first section has a general scope and is applicable to all kinds of machinery. The other sections refer to certain kinds of more specific hazards. Nevertheless, it is essential to examine the whole of this Annex in order to be sure of meeting all the applicable essential requirements. When machinery is being designed, the requirements of the general section and the requirements of one or more of the other sections shall be taken into account, depending on the results of the risk assessment carried out in accordance with point 1 of these General Principles.
1.ESSENTIAL HEALTH AND SAFETY REQUIREMENTS
1.1.GENERAL REMARKS
1.1.1.

Definitions

For the purpose of this Annex:

(a)

“hazard” means a potential source of injury or damage to health;

(b)

“danger zone” means any zone within and/or around machinery in which persons are subject to a risk to their health or safety;

(c)

“exposed person” means any person wholly or partially in a danger zone;

(d)

“operator” means the person or persons installing, operating, adjusting, maintaining, cleaning, repairing or moving machinery;

(e)

“risk” means a combination of the probability and the degree of an injury or damage to health that can arise in a hazardous situation;

(f)

“guard” means a part of the machinery used specifically to provide protection by means of a physical barrier;

(g)

“protective device” means a device (other than a guard) which reduces the risk, either alone or in conjunction with a guard;

(h)

“intended use” means the use of machinery in accordance with the information provided in the instructions for use;

(i)

“reasonably foreseeable misuse” means the use of machinery in a way not intended in the instructions for use, but which may result from readily predictable human behaviour.

1.1.2.

Principles of safety integration

(a)

Machinery must be designed and constructed so that it is fitted for its function, and can be operated, adjusted and maintained without putting persons at risk when these operations are carried out under the conditions foreseen but also taking into account any reasonably foreseeable misuse thereof.

The aim of measures taken must be to eliminate any risk throughout the foreseeable lifetime of the machinery including the phases of transport, assembly, dismantling, disabling and scrapping.

(b)

In selecting the most appropriate methods, the responsible person must apply the following principles, in the order given:

  • eliminate or reduce risks as far as possible (inherently safe machinery design and construction),

  • take the necessary protective measures in relation to risks that cannot be eliminated,

  • inform users of the residual risks due to any shortcomings of the protective measures adopted, indicate whether any particular training is required and specify any need to provide personal protective equipment.

(c)

When designing and constructing machinery and when drafting the instructions, the responsible person must envisage not only the intended use of the machinery but also any reasonably foreseeable misuse thereof.

The machinery must be designed and constructed in such a way as to prevent abnormal use if such use would engender a risk. Where appropriate, the instructions must draw the user’s attention to ways – which experience has shown might occur – in which the machinery should not be used.

(d)

Machinery must be designed and constructed to take account of the constraints to which the operator is subject as a result of the necessary or foreseeable use of personal protective equipment.

(e)

Machinery must be supplied with all the special equipment and accessories essential to enable it to be adjusted, maintained and used safely.

1.1.3.

Materials and products

The materials used to construct machinery or products used or created during its use must not endanger persons’ safety or health. In particular, where fluids are used, machinery must be designed and constructed to prevent risks due to filling, use, recovery or draining.

1.1.4.

Lighting

Machinery must be supplied with integral lighting suitable for the operations concerned where the absence thereof is likely to cause a risk despite ambient lighting of normal intensity.

Machinery must be designed and constructed so that there is no area of shadow likely to cause nuisance, that there is no irritating dazzle and that there are no dangerous stroboscopic effects on moving parts due to the lighting.

Internal parts requiring frequent inspection and adjustment, and maintenance areas, must be provided with appropriate lighting.

1.1.5.

Design of machinery to facilitate its handling

Machinery, or each component part thereof, must:

  • be capable of being handled and transported safely,

  • be packaged or designed so that it can be stored safely and without damage.

During the transportation of the machinery and/or its component parts, there must be no possibility of sudden movements or of hazards due to instability as long as the machinery and/or its component parts are handled in accordance with the instructions.

Where the weight, size or shape of machinery or its various component parts prevents them from being moved by hand, the machinery or each component part must:

  • either be fitted with attachments for lifting gear, or

  • be designed so that it can be fitted with such attachments, or

  • be shaped in such a way that standard lifting gear can easily be attached.

Where machinery or one of its component parts is to be moved by hand, it must:

  • either be easily moveable, or

  • be equipped for picking up and moving safely.

Special arrangements must be made for the handling of tools and/or machinery parts which, even if lightweight, could be hazardous.

1.1.6.

Ergonomics

Under the intended conditions of use, the discomfort, fatigue and physical and psychological stress faced by the operator must be reduced to the minimum possible, taking into account ergonomic principles such as:

  • allowing for the variability of the operator’s physical dimensions, strength and stamina,

  • providing enough space for movements of the parts of the operator’s body,

  • avoiding a machine-determined work rate,

  • avoiding monitoring that requires lengthy concentration,

  • adapting the man/machinery interface to the foreseeable characteristics of the operators.

1.1.7.

Operating positions

The operating position must be designed and constructed in such a way as to avoid any risk due to exhaust gases and/or lack of oxygen.

If the machinery is intended to be used in a hazardous environment presenting risks to the health and safety of the operator or if the machinery itself gives rise to a hazardous environment, adequate means must be provided to ensure that the operator has good working conditions and is protected against any foreseeable hazards.

Where appropriate, the operating position must be fitted with an adequate cabin designed, constructed and/or equipped to fulfil the above requirements. The exit must allow rapid evacuation. Moreover, when applicable, an emergency exit must be provided in a direction which is different from the usual exit.

1.1.8.

Seating

Where appropriate and where the working conditions so permit, work stations constituting an integral part of the machinery must be designed for the installation of seats.

If the operator is intended to sit during operation and the operating position is an integral part of the machinery, the seat must be provided with the machinery.

The operator’s seat must enable the operator to maintain a stable position. Furthermore, the seat and its distance from the control devices must be capable of being adapted to the operator.

If the machinery is subject to vibrations, the seat must be designed and constructed in such a way as to reduce the vibrations transmitted to the operator to the lowest level that is reasonably possible. The seat mountings must withstand all stresses to which they can be subjected. Where there is no floor beneath the feet of the operator, footrests covered with a slip-resistant material must be provided.

1.2.CONTROL SYSTEMS
1.2.1.

Safety and reliability of control systems

Control systems must be designed and constructed in such a way as to prevent hazardous situations from arising. Above all, they must be designed and constructed in such a way that:

  • they can withstand the intended operating stresses and external influences,

  • a fault in the hardware or the software of the control system does not lead to hazardous situations,

  • errors in the control system logic do not lead to hazardous situations,

  • reasonably foreseeable human error during operation does not lead to hazardous situations.

Particular attention must be given to the following points:

  • the machinery must not start unexpectedly,

  • the parameters of the machinery must not change in an uncontrolled way, where such change may lead to hazardous situations,

  • the machinery must not be prevented from stopping if the stop command has already been given,

  • no moving part of the machinery or piece held by the machinery must fall or be ejected,

  • automatic or manual stopping of the moving parts, whatever they may be, must be unimpeded,

  • the protective devices must remain fully effective or give a stop command,

  • the safety-related parts of the control system must apply in a coherent way to the whole of an assembly of machinery and/or partly completed machinery.

For cable-less control, an automatic stop must be activated when correct control signals are not received, including loss of communication.

1.2.2.

Control devices

Control devices must be:

  • clearly visible and identifiable, using pictograms where appropriate,

  • positioned in such a way as to be safely operated without hesitation or loss of time and without ambiguity,

  • designed in such a way that the movement of the control device is consistent with its effect,

  • located outside the danger zones, except where necessary for certain control devices such as an emergency stop or a teach pendant,

  • positioned in such a way that their operation cannot cause additional risk,

  • designed or protected in such a way that the desired effect, where a hazard is involved, can only be achieved by a deliberate action,

  • made in such a way as to withstand foreseeable forces; particular attention must be paid to emergency stop devices liable to be subjected to considerable forces.

Where a control device is designed and constructed to perform several different actions, namely where there is no one-to-one correspondence, the action to be performed must be clearly displayed and subject to confirmation, where necessary.

Control devices must be so arranged that their layout, travel and resistance to operation are compatible with the action to be performed, taking account of ergonomic principles.

Machinery must be fitted with indicators as required for safe operation. The operator must be able to read them from the control position.

From each control position, the operator must be able to ensure that no-one is in the danger zones, or the control system must be designed and constructed in such a way that starting is prevented while someone is in the danger zone.

If neither of these possibilities is applicable, before the machinery starts, an acoustic and/or visual warning signal must be given. The exposed persons must have time to leave the danger zone or prevent the machinery starting up.

If necessary, means must be provided to ensure that the machinery can be controlled only from control positions located in one or more predetermined zones or locations.

Where there is more than one control position, the control system must be designed in such a way that the use of one of them precludes the use of the others, except for stop controls and emergency stops.

When machinery has two or more operating positions, each position must be provided with all the required control devices without the operators hindering or putting each other into a hazardous situation.

1.2.3.

Starting

It must be possible to start machinery only by voluntary actuation of a control device provided for the purpose.

The same requirement applies:

  • when restarting the machinery after a stoppage, whatever the cause,

  • when effecting a significant change in the operating conditions.

However, the restarting of the machinery or a change in operating conditions may be effected by voluntary actuation of a device other than the control device provided for the purpose, on condition that this does not lead to a hazardous situation.

For machinery functioning in automatic mode, the starting of the machinery, restarting after a stoppage, or a change in operating conditions may be possible without intervention, provided this does not lead to a hazardous situation.

Where machinery has several starting control devices and the operators can therefore put each other in danger, additional devices must be fitted to rule out such risks. If safety requires that starting and/or stopping must be performed in a specific sequence, there must be devices which ensure that these operations are performed in the correct order.

1.2.4.Stopping
1.2.4.1.

Normal stop

Machinery must be fitted with a control device whereby the machinery can be brought safely to a complete stop.

Each workstation must be fitted with a control device to stop some or all of the functions of the machinery, depending on the existing hazards, so that the machinery is rendered safe.

The machinery’s stop control must have priority over the start controls.

Once the machinery or its hazardous functions have stopped, the energy supply to the actuators concerned must be cut off.

1.2.4.2.

Operational stop

Where, for operational reasons, a stop control that does not cut off the energy supply to the actuators is required, the stop condition must be monitored and maintained.

1.2.4.3.

Emergency stop

Machinery must be fitted with one or more emergency stop devices to enable actual or impending danger to be averted.

The following exceptions apply:

  • machinery in which an emergency stop device would not lessen the risk, either because it would not reduce the stopping time or because it would not enable the special measures required to deal with the risk to be taken,

  • portable hand-held and/or hand-guided machinery.

The device must:

  • have clearly identifiable, clearly visible and quickly accessible control devices,

  • stop the hazardous process as quickly as possible, without creating additional risks,

  • where necessary, trigger or permit the triggering of certain safeguard movements.

Once active operation of the emergency stop device has ceased following a stop command, that command must be sustained by engagement of the emergency stop device until that engagement is specifically overridden; it must not be possible to engage the device without triggering a stop command; it must be possible to disengage the device only by an appropriate operation, and disengaging the device must not restart the machinery but only permit restarting.

The emergency stop function must be available and operational at all times, regardless of the operating mode.

Emergency stop devices must be a back-up to other safeguarding measures and not a substitute for them.

1.2.4.4.

Assembly of machinery

In the case of machinery or parts of machinery designed to work together, the machinery must be designed and constructed in such a way that the stop controls, including the emergency stop devices, can stop not only the machinery itself but also all related equipment, if its continued operation may be dangerous.

1.2.5.

Selection of control or operating modes

The control or operating mode selected must override all other control or operating modes, with the exception of the emergency stop.

If machinery has been designed and constructed to allow its use in several control or operating modes requiring different protective measures and/or work procedures, it must be fitted with a mode selector which can be locked in each position. Each position of the selector must be clearly identifiable and must correspond to a single operating or control mode.

The selector may be replaced by another selection method which restricts the use of certain functions of the machinery to certain categories of operator.

If, for certain operations, the machinery must be able to operate with a guard displaced or removed and/or a protective device disabled, the control or operating mode selector must simultaneously:

  • disable all other control or operating modes,

  • permit operation of hazardous functions only by control devices requiring sustained action,

  • permit the operation of hazardous functions only in reduced risk conditions while preventing hazards from linked sequences,

  • prevent any operation of hazardous functions by voluntary or involuntary action on the machine’s sensors.

If these four conditions cannot be fulfilled simultaneously, the control or operating mode selector must activate other protective measures designed and constructed to ensure a safe intervention zone.

In addition, the operator must be able to control operation of the parts which are being worked on from the adjustment point.

1.2.6.

Failure of the power supply

The interruption, the re-establishment after an interruption or the fluctuation in whatever manner of the power supply to the machinery must not lead to dangerous situations.

Particular attention must be given to the following points:

  • the machinery must not start unexpectedly,

  • the parameters of the machinery must not change in an uncontrolled way when such change can lead to hazardous situations,

  • the machinery must not be prevented from stopping if the command has already been given,

  • no moving part of the machinery or piece held by the machinery must fall or be ejected,

  • automatic or manual stopping of the moving parts, whatever they may be, must be unimpeded,

  • the protective devices must remain fully effective or give a stop command.

1.3.PROTECTION AGAINST MECHANICAL HAZARDS
1.3.1.

Risk of loss of stability

Machinery and its components and fittings must be stable enough to avoid overturning, falling or uncontrolled movements during transportation, assembly, dismantling and any other action involving the machinery.

If the shape of the machinery itself or its intended installation does not offer sufficient stability, appropriate means of anchorage must be incorporated and indicated in the instructions.

1.3.2.

Risk of break-up during operation

The various parts of machinery and their linkages must be able to withstand the stresses to which they are subject when used.

The durability of the materials used must be adequate for the nature of the working environment foreseen by the responsible person, in particular as regards the phenomena of fatigue, ageing, corrosion and abrasion.

The instructions must indicate the type and frequency of inspections and maintenance required for safety reasons. They must, where appropriate, indicate the parts subject to wear and the criteria for replacement.

Where a risk of rupture or disintegration remains despite the measures taken, the parts concerned must be mounted, positioned and/or guarded in such a way that any fragments will be contained, preventing hazardous situations.

Both rigid and flexible pipes carrying fluids, particularly those under high pressure, must be able to withstand the foreseen internal and external stresses and must be firmly attached and/or protected to ensure that no risk is posed by a rupture.

Where the material to be processed is fed to the tool automatically, the following conditions must be fulfilled to avoid risks to persons:

  • when the workpiece comes into contact with the tool, the latter must have attained its normal working condition,

  • when the tool starts and/or stops (intentionally or accidentally), the feed movement and the tool movement must be coordinated.

1.3.3.

Risks due to falling or ejected objects

Precautions must be taken to prevent risks from falling or ejected objects.

1.3.4.

Risks due to surfaces, edges or angles

Insofar as their purpose allows, accessible parts of the machinery must have no sharp edges, no sharp angles and no rough surfaces likely to cause injury.

1.3.5.

Risks related to combined machinery

Where the machinery is intended to carry out several different operations with manual removal of the piece between each operation (combined machinery), it must be designed and constructed in such a way as to enable each element to be used separately without the other elements constituting a risk for exposed persons.

For this purpose, it must be possible to start and stop separately any elements that are not protected.

1.3.6.

Risks related to variations in operating conditions

Where the machinery performs operations under different conditions of use, it must be designed and constructed in such a way that selection and adjustment of these conditions can be carried out safely and reliably.

1.3.7.

Risks related to moving parts

The moving parts of machinery must be designed and constructed in such a way as to prevent risks of contact which could lead to accidents or must, where risks persist, be fitted with guards or protective devices.

All necessary steps must be taken to prevent accidental blockage of moving parts involved in the work. In cases where, despite the precautions taken, a blockage is likely to occur, the necessary specific protective devices and tools must, when appropriate, be provided to enable the equipment to be safely unblocked.

The instructions and, where possible, a sign on the machinery shall identify these specific protective devices and how they are to be used.

1.3.8.

Choice of protection against risks arising from moving parts

Guards or protective devices designed to protect against risks arising from moving parts must be selected on the basis of the type of risk. The following guidelines must be used to help to make the choice.

1.3.8.1.

Moving transmission parts

Guards designed to protect persons against the hazards generated by moving transmission parts must be:

  • either fixed guards as referred to in section 1.4.2.1 of this Annex, or

  • interlocking movable guards as referred to in section 1.4.2.2 of this Annex.

Interlocking movable guards should be used where frequent access is envisaged.

1.3.8.2.

Moving parts involved in the process

Guards or protective devices designed to protect persons against the hazards generated by moving parts involved in the process must be:

  • either fixed guards as referred to in section 1.4.2.1 of this Annex, or

  • interlocking movable guards as referred to in section 1.4.2.2 of this Annex, or

  • protective devices as referred to in section 1.4.3 of this Annex, or

  • a combination of the above.

However, when certain moving parts directly involved in the process cannot be made completely inaccessible during operation owing to operations requiring operator intervention, such parts must be fitted with:

  • fixed guards or interlocking movable guards preventing access to those sections of the parts that are not used in the work, and

  • adjustable guards as referred to in section 1.4.2.3 of this Annex restricting access to those sections of the moving parts where access is necessary.

1.3.9.

Risks of uncontrolled movements

When a part of the machinery has been stopped, any drift away from the stopping position, for whatever reason other than action on the control devices, must be prevented or must be such that it does not present a hazard.

1.4.REQUIRED CHARACTERISTICS OF GUARDS AND PROTECTIVE DEVICES
1.4.1.

General requirements

Guards and protective devices must:

  • be of robust construction,

  • be securely held in place,

  • not give rise to any additional hazard,

  • not be easy to by-pass or render non-operational,

  • be located at an adequate distance from the danger zone,

  • cause minimum obstruction to the view of the production process, and

  • enable essential work to be carried out on the installation and/or replacement of tools and for maintenance purposes by restricting access exclusively to the area where the work has to be done, if possible without the guard having to be removed or the protective device having to be disabled.

In addition, guards must, where possible, protect against the ejection or falling of materials or objects and against emissions generated by the machinery.

1.4.2.Special requirements for guards
1.4.2.1.

Fixed guards

Fixed guards must be fixed by systems that can be opened or removed only with tools.

Their fixing systems must remain attached to the guards or to the machinery when the guards are removed.

Where possible, guards must be incapable of remaining in place without their fixings.

1.4.2.2.

Interlocking movable guards

Interlocking movable guards must:

  • as far as possible remain attached to the machinery when open,

  • be designed and constructed in such a way that they can be adjusted only by means of an intentional action.

Interlocking movable guards must be associated with an interlocking device that:

  • prevents the start of hazardous machinery functions until they are closed, and

  • gives a stop command whenever they are no longer closed.

Where it is possible for an operator to reach the danger zone before the risk due to the hazardous machinery functions has ceased, movable guards must be associated with a guard locking device in addition to an interlocking device that:

  • prevents the start of hazardous machinery functions until the guard is closed and locked, and

  • keeps the guard closed and locked until the risk of injury from the hazardous machinery functions has ceased.

Interlocking movable guards must be designed in such a way that the absence or failure of one of their components prevents starting or stops the hazardous machinery functions.

1.4.2.3.

Adjustable guards restricting access

Adjustable guards restricting access to those areas of the moving parts strictly necessary for the work must be:

  • adjustable manually or automatically, depending on the type of work involved, and

  • readily adjustable without the use of tools.

1.4.3.

Special requirements for protective devices

Protective devices must be designed and incorporated into the control system in such a way that:

  • moving parts cannot start up while they are within the operator’s reach,

  • persons cannot reach moving parts while the parts are moving, and

  • the absence or failure of one of their components prevents starting or stops the moving parts.

Protective devices must be adjustable only by means of an intentional action.

1.5.RISKS DUE TO OTHER HAZARDS
1.5.1.

Electricity supply

Where machinery has an electricity supply, it must be designed, constructed and equipped in such a way that all hazards of an electrical nature are or can be prevented.

The safety objectives set out in Directive 2006/95/EC(22) shall apply to machinery. However, the obligations concerning conformity assessment and the placing on the market and/or putting into service of machinery with regard to electrical hazards are governed solely by the Directive.

1.5.2.

Static electricity

Machinery must be designed and constructed to prevent or limit the build-up of potentially dangerous electrostatic charges and/or be fitted with a discharging system.

1.5.3.

Energy supply other than electricity

Where machinery is powered by sources of energy other than electricity, it must be so designed, constructed and equipped as to avoid all potential risks associated with such sources of energy.

1.5.4.

Errors of fitting

Errors likely to be made when fitting or refitting certain parts which could be a source of risk must be made impossible by the design and construction of such parts or, failing this, by information given on the parts themselves and/or their housings. The same information must be given on moving parts and/or their housings where the direction of movement needs to be known in order to avoid a risk.

Where necessary, the instructions must give further information on these risks.

Where a faulty connection can be the source of risk, incorrect connections must be made impossible by design or, failing this, by information given on the elements to be connected and, where appropriate, on the means of connection.

1.5.5.

Extreme temperatures

Steps must be taken to eliminate any risk of injury arising from contact with or proximity to machinery parts or materials at high or very low temperatures.

The necessary steps must also be taken to avoid or protect against the risk of hot or very cold material being ejected.

1.5.6.

Fire

Machinery must be designed and constructed in such a way as to avoid any risk of fire or overheating posed by the machinery itself or by gases, liquids, dust, vapours or other substances produced or used by the machinery.

1.5.7.

Explosion

Machinery must be designed and constructed in such a way as to avoid any risk of explosion posed by the machinery itself or by gases, liquids, dust, vapours or other substances produced or used by the machinery.

Machinery must comply, as far as the risk of explosion due to its use in a potentially explosive atmosphere is concerned, with the provisions of the specific Community directives.

1.5.8.

Noise

Machinery must be designed and constructed in such a way that risks resulting from the emission of airborne noise are reduced to the lowest level, taking account of technical progress and the availability of means of reducing noise, in particular at source.

The level of noise emission may be assessed with reference to comparative emission data for similar machinery.

1.5.9.

Vibrations

Machinery must be designed and constructed in such a way that risks resulting from vibrations produced by the machinery are reduced to the lowest level, taking account of technical progress and the availability of means of reducing vibration, in particular at source.

The level of vibration emission may be assessed with reference to comparative emission data for similar machinery.

1.5.10.

Radiation

Undesirable radiation emissions from the machinery must be eliminated or be reduced to levels that do not have adverse effects on persons.

Any functional ionising radiation emissions must be limited to the lowest level which is sufficient for the proper functioning of the machinery during setting, operation and cleaning. Where a risk exists, the necessary protective measures must be taken.

Any functional non-ionising radiation emissions during setting, operation and cleaning must be limited to levels that do not have adverse effects on persons.

1.5.11.

External radiation

Machinery must be designed and constructed in such a way that external radiation does not interfere with its operation.

1.5.12.

Laser radiation

Where laser equipment is used, the following should be taken into account:

  • laser equipment on machinery must be designed and constructed in such a way as to prevent any accidental radiation,

  • laser equipment on machinery must be protected in such a way that effective radiation, radiation produced by reflection or diffusion and secondary radiation do not damage health,

  • optical equipment for the observation or adjustment of laser equipment on machinery must be such that no health risk is created by laser radiation.

1.5.13.

Emissions of hazardous materials and substances

Machinery must be designed and constructed in such a way that risks of inhalation, ingestion, contact with the skin, eyes and mucous membranes and penetration through the skin of hazardous materials and substances which it produces can be avoided.

Where a hazard cannot be eliminated, the machinery must be so equipped that hazardous materials and substances can be contained, evacuated, precipitated by water spraying, filtered or treated by another equally effective method.

Where the process is not totally enclosed during normal operation of the machinery, the devices for containment and/or evacuation must be situated in such a way as to have the maximum effect.

1.5.14.

Risk of being trapped in a machine

Machinery must be designed, constructed or fitted with a means of preventing a person from being enclosed within it or, if that is impossible, with a means of summoning help.

1.5.15.

Risk of slipping, tripping or falling

Parts of the machinery where persons are liable to move about or stand must be designed and constructed in such a way as to prevent persons slipping, tripping or falling on or off these parts.

Where appropriate, these parts must be fitted with handholds that are fixed relative to the users and that enable them to maintain their stability.

1.5.16.

Lightning

Machinery in need of protection against the effects of lightning while being used must be fitted with a system for conducting the resultant electrical charge to earth.

1.6.MAINTENANCE
1.6.1.

Machinery maintenance

Adjustment and maintenance points must be located outside danger zones. It must be possible to carry out adjustment, maintenance, repair, cleaning and servicing operations while machinery is at a standstill.

If one or more of the above conditions cannot be satisfied for technical reasons, measures must be taken to ensure that these operations can be carried out safely (see section 1.2.5 of this Annex).

In the case of automated machinery and, where necessary, other machinery, a connecting device for mounting diagnostic fault-finding equipment must be provided.

Automated machinery components which have to be changed frequently must be capable of being removed and replaced easily and safely. Access to the components must enable these tasks to be carried out with the necessary technical means in accordance with a specified operating method.

1.6.2.

Access to operating positions and servicing points

Machinery must be designed and constructed in such a way as to allow access in safety to all areas where intervention is necessary during operation, adjustment and maintenance of the machinery.

1.6.3.

Isolation of energy sources

Machinery must be fitted with means to isolate it from all energy sources. Such isolators must be clearly identified. They must be capable of being locked if reconnection could endanger persons. Isolators must also be capable of being locked where it is not possible, from any of the points to which the operator has access, to check that the energy is still cut off.

In the case of machinery capable of being plugged into an electricity supply, removal of the plug is sufficient, provided that the operator can check from any of the points to which the operator has access that the plug remains removed.

After the energy is cut off, it must be possible to dissipate normally any energy remaining or stored in the circuits of the machinery without risk to persons.

As an exception to the requirement laid down in the previous paragraphs, certain circuits may remain connected to their energy sources in order, for example, to hold parts, to protect information, to light interiors, etc. In this case, special steps must be taken to ensure operator safety.

1.6.4.

Operator intervention

Machinery must be so designed, constructed and equipped that the need for operator intervention is limited. If operator intervention cannot be avoided, it must be possible to carry it out easily and safely.

1.6.5.

Cleaning of internal parts

The machinery must be designed and constructed in such a way that it is possible to clean internal parts which have contained dangerous substances or preparations without entering them; any necessary unblocking must also be possible from the outside. If it is impossible to avoid entering the machinery, it must be designed and constructed in such a way as to allow cleaning to take place safely.

1.7.INFORMATION
1.7.1.

Information and warnings on the machinery

Information and warnings on the machinery should preferably be provided in the form of readily understandable symbols or pictograms. Any written or verbal information and warnings must be expressed in an official Community language or languages, which may be determined in accordance with the Treaty or the EEA Agreement by the EEA state in which the machinery is placed on the market and/or put into service and may be accompanied, on request, by versions in any other official Community language or languages understood by the operators.

1.7.1.1.

Information and information devices

The information needed to control machinery must be provided in a form that is unambiguous and easily understood. It must not be excessive to the extent of overloading the operator.

Visual display units or any other interactive means of communication between the operator and the machine must be easily understood and easy to use.

1.7.1.2.

Warning devices

Where the health and safety of persons may be endangered by a fault in the operation of unsupervised machinery, the machinery must be equipped in such a way as to give an appropriate acoustic or light signal as a warning.

Where machinery is equipped with warning devices these must be unambiguous and easily perceived. The operator must have facilities to check the operation of such warning devices at all times.

The requirements of the specific Community directives concerning colours and safety signals must be complied with.

1.7.2.

Warning of residual risks

Where risks remain despite the inherent safe design measures, safeguarding and complementary protective measures adopted, the necessary warnings, including warning devices, must be provided.

1.7.3.

Marking of machinery

All machinery must be marked visibly, legibly and indelibly with the following minimum particulars:

  • the business name and full address of the manufacturer and, where applicable, the manufacturer’s authorised representative,

  • designation of the machinery,

  • the CE Marking (see Annex III (Part 3 of this Schedule)),

  • designation of series or type,

  • serial number, if any,

  • the year of construction, that is the year in which the manufacturing process is completed.

It is prohibited to pre-date or post-date the machinery when affixing the CE marking.

Furthermore, machinery designed and constructed for use in a potentially explosive atmosphere must be marked accordingly.

Machinery must also bear full information relevant to its type and essential for safe use. Such information is subject to the requirements set out in section 1.7.1 of this Annex.

Where a machine part must be handled during use with lifting equipment, its mass must be indicated legibly, indelibly and unambiguously.

1.7.4.

Instructions

All machinery must be accompanied by instructions in the official Community language or languages of the EEA state in which it is placed on the market and/or put into service.

The instructions accompanying the machinery must be either “Original instructions” or a “Translation of the original instructions”, in which case the translation must be accompanied by the original instructions.

By way of exception, the maintenance instructions intended for use by specialised personnel mandated by the responsible person may be supplied in only one official Community language which the specialised personnel understand.

The instructions must be drafted in accordance with the principles set out below.

1.7.4.1.

General principles for the drafting of instructions

(a)

The instructions must be drafted in one or more official Community languages. The words “Original instructions” must appear on the language version(s) verified by the responsible person.

(b)

Where no “Original instructions” exist in the official language(s) of the country where the machinery is to be used, a translation into that/those language(s) must be provided by the responsible person or by the person bringing the machinery into the language area in question. The translations must bear the words “Translation of the original instructions”.

(c)

The contents of the instructions must cover not only the intended use of the machinery but also take into account any reasonably foreseeable misuse thereof.

(d)

In the case of machinery intended for use by non-professional operators, the wording and layout of the instructions for use must take into account the level of general education and acumen that can reasonably be expected from such operators.

1.7.4.2.

Contents of the instructions

Each instruction manual must contain, where applicable, at least the following information:

(a)

the business name and full address of the manufacturer and of the manufacturer’s authorised representative;

(b)

the designation of the machinery as marked on the machinery itself, except for the serial number (see section 1.7.3 of this Annex);

(c)

the EC declaration of conformity, or a document setting out the contents of the EC declaration of conformity, showing the particulars of the machinery, not necessarily including the serial number and the signature;

(d)

a general description of the machinery;

(e)

the drawings, diagrams, descriptions and explanations necessary for the use, maintenance and repair of the machinery and for checking its correct functioning;

(f)

a description of the workstation(s) likely to be occupied by operators;

(g)

a description of the intended use of the machinery;

(h)

warnings concerning ways in which the machinery must not be used that experience has shown might occur;

(i)

assembly, installation and connection instructions, including drawings, diagrams and the means of attachment and the designation of the chassis or installation on which the machinery is to be mounted;

(j)

instructions relating to installation and assembly for reducing noise or vibration;

(k)

instructions for the putting into service and use of the machinery and, if necessary, instructions for the training of operators;

(l)

information about the residual risks that remain despite the inherent safe design measures, safeguarding and complementary protective measures adopted;

(m)

instructions on the protective measures to be taken by the user, including, where appropriate, the personal protective equipment to be provided;

(n)

the essential characteristics of tools which may be fitted to the machinery;

(o)

the conditions in which the machinery meets the requirement of stability during use, transportation, assembly, dismantling when out of service, testing or foreseeable breakdowns;

(p)

instructions with a view to ensuring that transport, handling and storage operations can be made safely, giving the mass of the machinery and of its various parts where these are regularly to be transported separately;

(q)

the operating method to be followed in the event of accident or breakdown; if a blockage is likely to occur, the operating method to be followed so as to enable the equipment to be safely unblocked;

(r)

the description of the adjustment and maintenance operations that should be carried out by the user and the preventive maintenance measures that should be observed;

(s)

instructions designed to enable adjustment and maintenance to be carried out safely, including the protective measures that should be taken during these operations;

(t)

the specifications of the spare parts to be used, when these affect the health and safety of operators;

(u)

the following information on airborne noise emissions:

  • the A-weighted emission sound pressure level at workstations, where this exceeds 70 dB(A); where this level does not exceed 70 dB(A), this fact must be indicated,

  • the peak C-weighted instantaneous sound pressure value at workstations, where this exceeds 63 Pa (130 dB in relation to 20 μPa),

  • the A-weighted sound power level emitted by the machinery, where the A-weighted emission sound pressure level at workstations exceeds 80 dB(A).

These values must be either those actually measured for the machinery in question or those established on the basis of measurements taken for technically comparable machinery which is representative of the machinery to be produced.

In the case of very large machinery, instead of the A-weighted sound power level, the A-weighted emission sound pressure levels at specified positions around the machinery may be indicated.

Where the harmonised standards are not applied, sound levels must be measured using the most appropriate method for the machinery. Whenever sound emission values are indicated the uncertainties surrounding these values must be specified. The operating conditions of the machinery during measurement and the measuring methods used must be described.

Where the workstation(s) are undefined or cannot be defined, A-weighted sound pressure levels must be measured at a distance of 1 metre from the surface of the machinery and at a height of 1.6 metres from the floor or access platform. The position and value of the maximum sound pressure must be indicated.

Where specific Community directives lay down other requirements for the measurement of sound pressure levels or sound power levels, the provisions of those Community directives must be applied and the corresponding provisions of this section shall not apply;

(v)

where machinery is likely to emit non-ionising radiation which may cause harm to persons, in particular persons with active or non-active implantable medical devices, information concerning the radiation emitted for the operator and exposed persons.

1.7.4.3.

Sales literature

Sales literature describing the machinery must not contradict the instructions as regards health and safety aspects. Sales literature describing the performance characteristics of machinery must contain the same information on emissions as is contained in the instructions.

2.

SUPPLEMENTARY ESSENTIAL HEALTH AND SAFETY REQUIREMENTS FOR CERTAIN CATEGORIES OF MACHINERY

Foodstuffs machinery, machinery for cosmetics or pharmaceutical products, hand-held and/or hand-guided machinery, portable fixing and other impact machinery, machinery for working wood and material with similar physical characteristics must meet all the essential health and safety requirements described in this section (see point 4 of the General Principles at the start of this Annex).

2.1.FOODSTUFFS MACHINERY AND MACHINERY FOR COSMETICS OR PHARMACEUTICAL PRODUCTS
2.1.1.

General

Machinery intended for use with foodstuffs or with cosmetics or pharmaceutical products must be designed and constructed in such a way as to avoid any risk of infection, sickness or contagion.

The following requirements must be observed:

(a)

materials in contact with, or intended to come into contact with, foodstuffs or cosmetics or pharmaceutical products must satisfy the conditions set down in the relevant Directives. The machinery must be designed and constructed in such a way that these materials can be cleaned before each use. Where this is not possible disposable parts must be used;

(b)

all surfaces in contact with foodstuffs or cosmetics or pharmaceutical products, other than surfaces of disposable parts, must:

  • be smooth and have neither ridges nor crevices which could harbour organic materials. The same applies to their joinings,

  • be designed and constructed in such a way as to reduce the projections, edges and recesses of assemblies to a minimum,

  • be easily cleaned and disinfected, where necessary after removing easily dismantled parts; the inside surfaces must have curves with a radius sufficient to allow thorough cleaning;

(c)

it must be possible for liquids, gases and aerosols deriving from foodstuffs, cosmetics or pharmaceutical products as well as from cleaning, disinfecting and rinsing fluids to be completely discharged from the machinery (if possible, in a “cleaning” position);

(d)

machinery must be designed and constructed in such a way as to prevent any substances or living creatures, in particular insects, from entering, or any organic matter from accumulating in, areas that cannot be cleaned;

(e)

machinery must be designed and constructed in such a way that no ancillary substances hazardous to health, including the lubricants used, can come into contact with foodstuffs, cosmetics or pharmaceutical products. Where necessary, machinery must be designed and constructed in such a way that continuing compliance with this requirement can be checked.

2.1.2.

Instructions

The instructions for foodstuffs machinery and machinery for use with cosmetics or pharmaceutical products must indicate recommended products and methods for cleaning, disinfecting and rinsing, not only for easily accessible areas but also for areas to which access is impossible or inadvisable.

2.2.PORTABLE HAND-HELD AND/OR HAND-GUIDED MACHINERY
2.2.1.

General

Portable hand-held and/or hand-guided machinery must:

  • depending on the type of machinery, have a supporting surface of sufficient size and have a sufficient number of handles and supports of an appropriate size, arranged in such a way as to ensure the stability of the machinery under the intended operating conditions,

  • except where technically impossible, or where there is an independent control device, in the case of handles which cannot be released in complete safety, be fitted with manual start and stop control devices arranged in such a way that the operator can operate them without releasing the handles,

  • present no risks of accidental starting and/or continued operation after the operator has released the handles. Equivalent steps must be taken if this requirement is not technically feasible,

  • permit, where necessary, visual observation of the danger zone and of the action of the tool with the material being processed.

The handles of portable machinery must be designed and constructed in such a way as to make starting and stopping straightforward.

2.2.1.1.

Instructions

The instructions must give the following information concerning vibrations transmitted by portable hand-held and hand-guided machinery:

  • the vibration total value to which the hand-arm system is subjected, if it exceeds 2.5 m/s2. Where this value does not exceed 2.5 m/s2, this must be mentioned,

  • the uncertainty of measurement.

These values must be either those actually measured for the machinery in question or those established on the basis of measurements taken for technically comparable machinery which is representative of the machinery to be produced.

If harmonised standards are not applied, the vibration data must be measured using the most appropriate measurement code for the machinery.

The operating conditions during measurement and the methods used for measurement, or the reference of the harmonised standard applied, must be specified.

2.2.2.Portable fixing and other impact machinery
2.2.2.1.

General

Portable fixing and other impact machinery must be designed and constructed in such a way that:

  • energy is transmitted to the impacted element by the intermediary component that does not leave the device,

  • an enabling device prevents impact unless the machinery is positioned correctly with adequate pressure on the base material,

  • involuntary triggering is prevented; where necessary, an appropriate sequence of actions on the enabling device and the control device must be required to trigger an impact,

  • accidental triggering is prevented during handling or in case of shock,

  • loading and unloading operations can be carried out easily and safely.

Where necessary, it must be possible to fit the device with splinter guard(s) and the appropriate guard(s) must be provided by the manufacturer of the machinery.

2.2.2.2.

Instructions

The instructions must give the necessary information regarding:

  • the accessories and interchangeable equipment that can be used with the machinery,

  • the suitable fixing or other impacted elements to be used with the machinery,

  • where appropriate, the suitable cartridges to be used.

2.3.

MACHINERY FOR WORKING WOOD AND MATERIAL WITH SIMILAR PHYSICAL CHARACTERISTICS

Machinery for working wood and materials with similar physical characteristics must comply with the following requirements:

(a)

the machinery must be designed, constructed or equipped in such a way that the piece being machined can be placed and guided in safety; where the piece is hand-held on a work-bench, the latter must be sufficiently stable during the work and must not impede the movement of the piece;

(b)

where the machinery is likely to be used in conditions involving the risk of ejection of workpieces or parts of them, it must be designed, constructed, or equipped in such a way as to prevent such ejection, or, if this is not possible, so that the ejection does not engender risks for the operator and/or exposed persons;

(c)

the machinery must be equipped with an automatic brake that stops the tool in a sufficiently short time if there is a risk of contact with the tool whilst it runs down;

(d)

where the tool is incorporated into a non-fully automated machine, the latter must be designed and constructed in such a way as to eliminate or reduce the risk of accidental injury.

3.

SUPPLEMENTARY ESSENTIAL HEALTH AND SAFETY REQUIREMENTS TO OFFSET HAZARDS DUE TO THE MOBILITY OF MACHINERY

Machinery presenting hazards due to its mobility must meet all the essential health and safety requirements described in this section (see point 4 of the General Principles at the start of this Annex).

3.1.GENERAL
3.1.1.

Definitions

(a)

“Machinery presenting hazards due to its mobility” means:

  • machinery the operation of which requires either mobility while working, or continuous or semi-continuous movement between a succession of fixed working locations, or

  • machinery which is operated without being moved, but which may be equipped in such a way as to enable it to be moved more easily from one place to another.

(b)

“Driver” means an operator responsible for the movement of a machine. The driver may be transported by the machinery or may be on foot, accompanying the machinery, or may guide the machinery by remote control.

3.2.WORK POSITIONS
3.2.1.

Driving position

Visibility from the driving position must be such that drivers can, in complete safety for themselves and the exposed persons, operate the machinery and its tools in their foreseeable conditions of use. Where necessary, appropriate devices must be provided to remedy hazards due to inadequate direct vision.

Machinery on which the driver is transported must be designed and constructed in such a way that, from the driving positions, there is no risk to the driver from inadvertent contact with the wheels and tracks.

The driving position of ride-on drivers must be designed and constructed in such a way that a driver’s cab may be fitted, provided this does not increase the risk and there is room for it. The cab must incorporate a place for the instructions needed for the driver.

3.2.2.

Seating

Where there is a risk that operators or other persons transported by the machinery may be crushed between parts of the machinery and the ground should the machinery roll or tip over, in particular for machinery equipped with a protective structure referred to in section 3.4.3 or 3.4.4 of this Annex, their seats must be designed or equipped with a restraint system so as to keep the persons in their seats, without restricting movements necessary for operations or movements relative to the structure caused by the suspension of the seats. Such restraint systems should not be fitted if they increase the risk.

3.2.3.

Positions for other persons

If the conditions of use provide that persons other than the driver may occasionally or regularly be transported by the machinery or work on it, appropriate positions must be provided which enable them to be transported or to work on it without risk.

The second and third paragraphs of section 3.2.1 of this Annex also apply to the places provided for persons other than the driver.

3.3.

CONTROL SYSTEMS

If necessary, steps must be taken to prevent unauthorised use of controls.

In the case of remote controls, each control unit must clearly identify the machinery to be controlled from that unit.

The remote control system must be designed and constructed in such a way as to affect only:

  • the machinery in question,

  • the functions in question.

Remote controlled machinery must be designed and constructed in such a way that it will respond only to signals from the intended control units.

3.3.1.

Control devices

The driver must be able to actuate all control devices required to operate the machinery from the driving position, except for functions which can be safely actuated only by using control devices located elsewhere. These functions include, in particular, those for which operators other than the driver are responsible or for which the driver has to leave the driving position in order to control them safely.

Where there are pedals, they must be so designed, constructed and fitted as to allow safe operation by the driver with the minimum risk of incorrect operation. They must have a slip—resistant surface and be easy to clean.

Where their operation can lead to hazards, notably dangerous movements, the control devices, except for those with preset positions, must return to the neutral position as soon as they are released by the operator.

In the case of wheeled machinery, the steering system must be designed and constructed in such a way as to reduce the force of sudden movements of the steering wheel or the steering lever caused by shocks to the guide wheels.

Any control that locks the differential must be so designed and arranged that it allows the differential to be unlocked when the machinery is moving.

The sixth paragraph of section 1.2.2 of this Annex, concerning acoustic and/or visual warning signals, applies only in the case of reversing.

3.3.2.

Starting/moving

All travel movements of self-propelled machinery with a ride-on driver must be possible only if the driver is at the controls.

Where, for operating purposes, machinery is fitted with devices which exceed its normal clearance zone (e.g. stabilisers, jib, etc.), the driver must be provided with the means of checking easily, before moving the machinery, that such devices are in a particular position which allows safe movement.

This also applies to all other parts which, to allow safe movement, have to be in particular positions, locked if necessary.

Where it does not give rise to other risks, movement of the machinery must depend on safe positioning of the aforementioned parts.

It must not be possible for unintentional movement of the machinery to occur while the engine is being started.

3.3.3.

Travelling function

Without prejudice to road traffic regulations, self-propelled machinery and its trailers must meet the requirements for slowing down, stopping, braking and immobilisation so as to ensure safety under all the operating, load, speed, ground and gradient conditions allowed for.

The driver must be able to slow down and stop self-propelled machinery by means of a main device. Where safety so requires, in the event of a failure of the main device, or in the absence of the energy supply needed to actuate the main device, an emergency device with a fully independent and easily accessible control device must be provided for slowing down and stopping.

Where safety so requires, a parking device must be provided to render stationary machinery immobile. This device may be combined with one of the devices referred to in the second paragraph, provided that it is purely mechanical.

Remote-controlled machinery must be equipped with devices for stopping operation automatically and immediately and for preventing potentially dangerous operation in the following situations:

  • if the driver loses control,

  • if it receives a stop signal,

  • if a fault is detected in a safety-related part of the system,

  • if no validation signal is detected within a specified time.

Section 1.2.4 of this Annex does not apply to the travelling function.

3.3.4.

Movement of pedestrian-controlled machinery

Movement of pedestrian-controlled self-propelled machinery must be possible only through sustained action on the relevant control device by the driver. In particular, it must not be possible for movement to occur while the engine is being started.

The control systems for pedestrian-controlled machinery must be designed in such a way as to minimise the risks arising from inadvertent movement of the machine towards the driver, in particular:

  • crushing,

  • injury from rotating tools.

The speed of travel of the machinery must be compatible with the pace of a driver on foot.

In the case of machinery on which a rotary tool may be fitted, it must not be possible to actuate the tool when the reverse control is engaged, except where the movement of the machinery results from movement of the tool. In the latter case, the reversing speed must be such that it does not endanger the driver.

3.3.5.

Control circuit failure

A failure in the power supply to the power-assisted steering, where fitted, must not prevent machinery from being steered during the time required to stop it.

3.4.PROTECTION AGAINST MECHANICAL HAZARDS
3.4.1.

Uncontrolled movements

Machinery must be designed, constructed and where appropriate placed on its mobile support in such a way as to ensure that, when moved, uncontrolled oscillations of its centre of gravity do not affect its stability or exert excessive strain on its structure.

3.4.2.

Moving transmission parts

By way of exception to section 1.3.8.1 of this Annex, in the case of engines, moveable guards preventing access to the moving parts in the engine compartment need not have interlocking devices if they have to be opened either by the use of a tool or key or by a control located in the driving position, providing the latter is in a fully enclosed cab with a lock to prevent unauthorised access.

3.4.3.

Roll-over and tip-over

Where, in the case of self-propelled machinery with a ride-on driver, operator(s) or other person(s), there is a risk of rolling or tipping over, the machinery must be fitted with an appropriate protective structure, unless this increases the risk.

This structure must be such that in the event of rolling or tipping over it affords the ride-on person(s) an adequate deflection-limiting volume.

In order to verify that the structure complies with the requirement laid down in the second paragraph, the responsible person must, for each type of structure concerned, perform appropriate tests or have such tests performed.

3.4.4.

Falling objects

Where, in the case of self-propelled machinery with a ride-on driver, operator(s) or other person(s), there is a risk due to falling objects or material, the machinery must be designed and constructed in such a way as to take account of this risk and fitted, if its size allows, with an appropriate protective structure.

This structure must be such that, in the event of falling objects or material, it guarantees the ride-on person(s) an adequate deflection-limiting volume.

In order to verify that the structure complies with the requirement laid down in the second paragraph, the responsible person must, for each type of structure concerned, perform appropriate tests or have such tests performed.

3.4.5.

Means of access

Handholds and steps must be designed, constructed and arranged in such a way that the operators use them instinctively and do not use the control devices to assist access.

3.4.6.

Towing devices

All machinery used to tow or to be towed must be fitted with towing or coupling devices designed, constructed and arranged in such a way as to ensure easy and secure connection and disconnection and to prevent accidental disconnection during use.

Insofar as the tow bar load so requires, such machinery must be equipped with a support with a bearing surface suited to the load and the ground.

3.4.7.

Transmission of power between self-propelled machinery (or tractor) and recipient machinery

Removable mechanical transmission devices linking self-propelled machinery (or a tractor) to the first fixed bearing of recipient machinery must be designed and constructed in such a way that any part that moves during operation is protected over its whole length.

On the side of the self-propelled machinery (or tractor), the power take-off to which the removable mechanical transmission device is attached must be protected either by a guard fixed and linked to the self-propelled machinery (or tractor) or by any other device offering equivalent protection.

It must be possible to open this guard for access to the removable transmission device. Once it is in place, there must be enough room to prevent the drive shaft damaging the guard when the machinery (or the tractor) is moving.

On the recipient machinery side, the input shaft must be enclosed in a protective casing fixed to the machinery.

Torque limiters or freewheels may be fitted to universal joint transmissions only on the side adjoining the driven machinery. The removable mechanical transmission device must be marked accordingly.

All recipient machinery, the operation of which requires a removable mechanical transmission device to connect it to self-propelled machinery (or a tractor), must have a system for attaching the removable mechanical transmission device so that, when the machinery is uncoupled, the removable mechanical transmission device and its guard are not damaged by contact with the ground or part of the machinery.

The outside parts of the guard must be so designed, constructed and arranged that they cannot turn with the removable mechanical transmission device. The guard must cover the transmission to the ends of the inner jaws in the case of simple universal joints and at least to the centre of the outer joint or joints in the case of wide-angle universal joints.

If means of access to working positions are provided near to the removable mechanical transmission device, they must be designed and constructed in such a way that the shaft guards cannot be used as steps, unless designed and constructed for that purpose.

3.5.PROTECTION AGAINST OTHER HAZARDS
3.5.1.

Batteries

The battery housing must be designed and constructed in such a way as to prevent the electrolyte being ejected on to the operator in the event of rollover or tipover and to avoid the accumulation of vapours in places occupied by operators.

Machinery must be designed and constructed in such a way that the battery can be disconnected with the aid of an easily accessible device provided for that purpose.

3.5.2.

Fire

Depending on the hazards anticipated by the manufacturer, machinery must, where its size permits:

  • either allow easily accessible fire extinguishers to be fitted, or

  • be provided with built-in extinguisher systems.

3.5.3.

Emissions of hazardous substances

The second and third paragraphs of section 1.5.13 of this Annex do not apply where the main function of the machinery is the spraying of products. However, the operator must be protected against the risk of exposure to such hazardous emissions.

3.6.INFORMATION AND INDICATIONS
3.6.1.

Signs, signals and warnings

All machinery must have signs and/or instruction plates concerning use, adjustment and maintenance, wherever necessary, so as to ensure the health and safety of persons. They must be chosen, designed and constructed in such a way as to be clearly visible and indelible.

Without prejudice to the provisions of road traffic regulations, machinery with a ride-on driver must have the following equipment:

  • an acoustic warning device to alert persons,

  • a system of light signals relevant to the intended conditions of use; the latter requirement does not apply to machinery intended solely for underground working and having no electrical power,

  • where necessary, there must be an appropriate connection between a trailer and the machinery for the operation of signals.

Remote-controlled machinery which, under normal conditions of use, exposes persons to the risk of impact or crushing must be fitted with appropriate means to signal its movements or with means to protect persons against such risks. The same applies to machinery which involves, when in use, the constant repetition of a forward and backward movement on a single axis where the area to the rear of the machine is not directly visible to the driver.

Machinery must be constructed in such a way that the warning and signalling devices cannot be disabled unintentionally. Where it is essential for safety, such devices must be provided with the means to check that they are in good working order and their failure must be made apparent to the operator.

Where the movement of machinery or its tools is particularly hazardous, signs on the machinery must be provided to warn against approaching the machinery while it is working; the signs must be legible at a sufficient distance to ensure the safety of persons who have to be in the vicinity.

3.6.2.

Marking

The following must be shown legibly and indelibly on all machinery:

  • nominal power expressed in kilowatts (kW),

  • mass of the most usual configuration, in kilograms (kg);

and, where appropriate:

  • maximum drawbar pull provided for at the coupling hook, in Newtons (N),

  • maximum vertical load provided for on the coupling hook, in Newtons (N).

3.6.3.Instructions
3.6.3.1.

Vibrations

The instructions must give the following information concerning vibrations transmitted by the machinery to the hand-arm system or to the whole body:

  • the vibration total value to which the hand-arm system is subjected, if it exceeds 2.5 m/s2. Where this value does not exceed 2.5 m/s2, this must be mentioned,

  • the highest root mean square value of weighted acceleration to which the whole body is subjected, if it exceeds 0.5 m/s2. Where this value does not exceed 0.5 m/s2, this must be mentioned,

  • the uncertainty of measurement.

These values must be either those actually measured for the machinery in question or those established on the basis of measurements taken for technically comparable machinery which is representative of the machinery to be produced.

Where harmonised standards are not applied, the vibration must be measured using the most appropriate measurement code for the machinery concerned.

The operating conditions during measurement and the measurement codes used must be described.

3.6.3.2.

Multiple uses

The instructions for machinery allowing several uses depending on the equipment used and the instructions for the interchangeable equipment must contain the information necessary for safe assembly and use of the basic machinery and the interchangeable equipment that can be fitted.

4.

SUPPLEMENTARY ESSENTIAL HEALTH AND SAFETY REQUIREMENTS TO OFFSET HAZARDS DUE TO LIFTING OPERATIONS

Machinery presenting hazards due to lifting operations must meet all the relevant essential health and safety requirements described in this section (see point 4 of the General Principles at the start of this Annex).

4.1.GENERAL
4.1.1.

Definitions

(a)

“Lifting operation” means a movement of unit loads consisting of goods and/or persons necessitating, at a given moment, a change of level.

(b)

“Guided load” means a load where the total movement is made along rigid or flexible guides whose position is determined by fixed points.

(c)

“Working coefficient” means the arithmetic ratio between the load guaranteed by the responsible person up to which a component is able to hold it and the maximum working load marked on the component.

(d)

“Test coefficient” means the arithmetic ratio between the load used to carry out the static or dynamic tests on lifting machinery or a lifting accessory and the maximum working load marked on the lifting machinery or lifting accessory.

(e)

“Static test” means the test during which lifting machinery or a lifting accessory is first inspected and subjected to a force corresponding to the maximum working load multiplied by the appropriate static test coefficient and then re-inspected once the said load has been released to ensure that no damage has occurred.

(f)

“Dynamic test” means the test during which lifting machinery is operated in all its possible configurations at the maximum working load multiplied by the appropriate dynamic test coefficient with account being taken of the dynamic behaviour of the lifting machinery in order to check that it functions properly.

(g)

“Carrier” means a part of the machinery on or in which persons and/or goods are supported in order to be lifted.

4.1.2.Protection against mechanical hazards
4.1.2.1.

Risks due to lack of stability

Machinery must be designed and constructed in such a way that the stability required by section 1.3.1 of this Annex is maintained both in service and out of service, including all stages of transportation, assembly and dismantling, during foreseeable component failures and also during the tests carried out in accordance with the instruction handbook. To that end, the responsible person must use the appropriate verification methods.

4.1.2.2.

Machinery running on guide rails and rail tracks

Machinery must be provided with devices which act on the guide rails or tracks to prevent derailment.

If, despite such devices, there remains a risk of derailment or of failure of a rail or of a running component, devices must be provided which prevent the equipment, component or load from falling or the machinery from overturning.

4.1.2.3.

Mechanical strength

Machinery, lifting accessories and their components must be capable of withstanding the stresses to which they are subjected, both in and, where applicable, out of use, under the installation and operating conditions provided for and in all relevant configurations, with due regard, where appropriate, to the effects of atmospheric factors and forces exerted by persons. This requirement must also be satisfied during transport, assembly and dismantling.

Machinery and lifting accessories must be designed and constructed in such a way as to prevent failure from fatigue and wear, taking due account of their intended use.

The materials used must be chosen on the basis of the intended working environments, with particular regard to corrosion, abrasion, impacts, extreme temperatures, fatigue, brittleness and ageing.

Machinery and lifting accessories must be designed and constructed in such a way as to withstand the overload in the static tests without permanent deformation or patent defect. Strength calculations must take account of the value of the static test coefficient chosen to guarantee an adequate level of safety. That coefficient has, as a general rule, the following values:

(a)

manually-operated machinery and lifting accessories: 1.5;

(b)

other machinery: 1.25.

Machinery must be designed and constructed in such a way as to undergo, without failure, the dynamic tests carried out using the maximum working load multiplied by the dynamic test coefficient. This dynamic test coefficient is chosen so as to guarantee an adequate level of safety: the coefficient is, as a general rule, equal to 1.1. As a general rule, the tests will be performed at the nominal speeds provided for. Should the control circuit of the machinery allow for a number of simultaneous movements, the tests must be carried out under the least favourable conditions, as a general rule by combining the movements concerned.

4.1.2.4.

Pulleys, drums, wheels, ropes and chains

Pulleys, drums and wheels must have a diameter commensurate with the size of the ropes or chains with which they can be fitted.

Drums and wheels must be designed, constructed and installed in such a way that the ropes or chains with which they are equipped can be wound without coming off.

Ropes used directly for lifting or supporting the load must not include any splicing other than at their ends. Splicings are, however, tolerated in installations which are intended by design to be modified regularly according to needs of use.

Complete ropes and their endings must have a working coefficient chosen in such a way as to guarantee an adequate level of safety. As a general rule, this coefficient is equal to 5.

Lifting chains must have a working coefficient chosen in such a way as to guarantee an adequate level of safety. As a general rule, this coefficient is equal to 4.

In order to verify that an adequate working coefficient has been attained, the responsible person must, for each type of chain and rope used directly for lifting the load and for the rope ends, perform the appropriate tests or have such tests performed.

4.1.2.5.

Lifting accessories and their components

Lifting accessories and their components must be sized with due regard to fatigue and ageing processes for a number of operating cycles consistent with their expected life-span as specified in the operating conditions for a given application.

Moreover:

(a)

the working coefficient of wire-rope/rope-end combinations must be chosen in such a way as to guarantee an adequate level of safety; this coefficient is, as a general rule, equal to 5. Ropes must not comprise any splices or loops other than at their ends;

(b)

where chains with welded links are used, they must be of the short-link type. The working coefficient of chains must be chosen in such a way as to guarantee an adequate level of safety; this coefficient is, as a general rule, equal to 4;

(c)

the working coefficient for textile ropes or slings is dependent on the material, method of manufacture, dimensions and use. This coefficient must be chosen in such a way as to guarantee an adequate level of safety; it is, as a general rule, equal to 7, provided the materials used are shown to be of very good quality and the method of manufacture is appropriate to the intended use. Should this not be the case, the coefficient is, as a general rule, set at a higher level in order to secure an equivalent level of safety. Textile ropes and slings must not include any knots, connections or splicing other than at the ends of the sling, except in the case of an endless sling;

(d)

all metallic components making up, or used with, a sling must have a working coefficient chosen in such a way as to guarantee an adequate level of safety; this coefficient is, as a general rule, equal to 4;

(e)

the maximum working load of a multilegged sling is determined on the basis of the working coefficient of the weakest leg, the number of legs and a reduction factor which depends on the slinging configuration;

(f)

in order to verify that an adequate working coefficient has been attained, the responsible person must, for each type of component referred to in (a), (b), (c) and (d), perform the appropriate tests or have such tests performed.

4.1.2.6.

Control of movements

Devices for controlling movements must act in such a way that the machinery on which they are installed is kept safe.

(a)

Machinery must be designed and constructed or fitted with devices in such a way that the amplitude of movement of its components is kept within the specified limits. The operation of such devices must, where appropriate, be preceded by a warning.

(b)

Where several fixed or rail-mounted machines can be manoeuvred simultaneously in the same place, with risks of collision, such machinery must be designed and constructed in such a way as to make it possible to fit systems enabling these risks to be avoided.

(c)

Machinery must be designed and constructed in such a way that the loads cannot creep dangerously or fall freely and unexpectedly, even in the event of partial or total failure of the power supply or when the operator stops operating the machine.

(d)

It must not be possible, under normal operating conditions, to lower the load solely by friction brake, except in the case of machinery whose function requires it to operate in that way.

(e)

Holding devices must be designed and constructed in such a way that inadvertent dropping of the loads is avoided.

4.1.2.7.

Movements of loads during handling

The operating position of machinery must be located in such a way as to ensure the widest possible view of trajectories of the moving parts, in order to avoid possible collisions with persons, equipment or other machinery which might be manoeuvring at the same time and liable to constitute a hazard.

Machinery with guided loads must be designed and constructed in such a way as to prevent persons from being injured by movement of the load, the carrier or the counterweights, if any.

4.1.2.8.Machinery serving fixed landings
4.1.2.8.1.

Movements of the carrier

The movement of the carrier of machinery serving fixed landings must be rigidly guided to and at the landings. Scissor systems are also regarded as rigid guidance.

4.1.2.8.2.

Access to the carrier

Where persons have access to the carrier, the machinery must be designed and constructed in such a way as to ensure that the carrier remains stationary during access, in particular while it is being loaded or unloaded.

The machinery must be designed and constructed in such a way as to ensure that the difference in level between the carrier and the landing being served does not create a risk of tripping.

4.1.2.8.3.

Risks due to contact with the moving carrier

Where necessary in order to fulfil the requirement expressed in the second paragraph of section 4.1.2.7 of this Annex, the travel zone must be rendered inaccessible during normal operation.

When, during inspection or maintenance, there is a risk that persons situated under or above the carrier may be crushed between the carrier and any fixed parts, sufficient free space must be provided either by means of physical refuges or by means of mechanical devices blocking the movement of the carrier.

4.1.2.8.4.

Risk due to the load falling off the carrier

Where there is a risk due to the load falling off the carrier, the machinery must be designed and constructed in such a way as to prevent this risk.

4.1.2.8.5.

Landings

Risks due to contact of persons at landings with the moving carrier or other moving parts must be prevented.

Where there is a risk due to persons falling into the travel zone when the carrier is not present at the landings, guards must be fitted in order to prevent this risk. Such guards must not open in the direction of the travel zone. They must be fitted with an interlocking device controlled by the position of the carrier that prevents:

  • hazardous movements of the carrier until the guards are closed and locked,

  • hazardous opening of a guard until the carrier has stopped at the corresponding landing.

4.1.3.

Fitness for purpose

When lifting machinery or lifting accessories are placed on the market or are first put into service, the responsible person must ensure, by taking appropriate measures or having them taken, that the machinery or the lifting accessories which are ready for use – whether manually or power-operated – can fulfil their specified functions safely.

The static and dynamic tests referred to in section 4.1.2.3 of this Annex must be performed on all lifting machinery ready to be put into service.

Where the machinery cannot be assembled in the responsible person’s premises, the appropriate measures must be taken at the place of use. Otherwise, the measures may be taken either in the manufacturer’s premises or at the place of use.

4.2.REQUIREMENTS FOR MACHINERY WHOSE POWER SOURCE IS OTHER THAN MANUAL EFFORT
4.2.1.

Control of movements

Hold-to-run control devices must be used to control the movements of the machinery or its equipment. However, for partial or complete movements in which there is no risk of the load or the machinery colliding, the said devices may be replaced by control devices authorising automatic stops at pre-selected positions without the operator holding a hold-to-run control device.

4.2.2.

Loading control

Machinery with a maximum working load of not less than 1000 kilograms or an overturning moment of not less than 40000 Nm must be fitted with devices to warn the driver and prevent dangerous movements in the event:

  • of overloading, either as a result of the maximum working load or the maximum working moment due to the load being exceeded, or

  • of the overturning moment being exceeded.

4.2.3.

Installations guided by ropes

Rope carriers, tractors or tractor carriers must be held by counterweights or by a device allowing permanent control of the tension.

4.3.INFORMATION AND MARKINGS
4.3.1.

Chains, ropes and webbing

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.

The certificate mentioned above must show at least the following information:

(a)

the name and address of the manufacturer and, if appropriate, the manufacturer’s authorised representative;

(b)

a description of the chain or rope which includes:

  • its nominal size,

  • its construction,

  • the material from which it is made, and

  • any special metallurgical treatment applied to the material;

(c)

the test method used;

(d)

the maximum load to which the chain or rope should be subjected in service. A range of values may be given on the basis of the intended applications.

4.3.2.

Lifting accessories

Lifting accessories must show the following particulars:

  • identification of the material where this information is needed for safe use,

  • the maximum working load.

In the case of lifting accessories on which marking is physically impossible, the particulars referred to in the first paragraph must be displayed on a plate or other equivalent means and securely affixed to the accessory.

The particulars must be legible and located in a place where they are not liable to disappear as a result of wear or jeopardise the strength of the accessory.

4.3.3.

Lifting machinery

The maximum working load must be prominently marked on the machinery. This marking must be legible, indelible and in an un-coded form.

Where the maximum working load depends on the configuration of the machinery, each operating position must be provided with a load plate indicating, preferably in diagrammatic form or by means of tables, the working load permitted for each configuration.

Machinery intended for lifting goods only, equipped with a carrier which allows access to persons, must bear a clear and indelible warning prohibiting the lifting of persons. This warning must be visible at each place where access is possible.

4.4.INSTRUCTIONS
4.4.1.

Lifting accessories

Each lifting accessory or each commercially indivisible batch of lifting accessories must be accompanied by instructions setting out at least the following particulars:

(a)

the intended use;

(b)

the limits of use (particularly for lifting accessories such as magnetic or vacuum pads which do not fully comply with section 4.1.2.6(e) of this Annex);

(c)

instructions for assembly, use and maintenance;

(d)

the static test coefficient used.

4.4.2.

Lifting machinery

Lifting machinery must be accompanied by instructions containing information on:

(a)

the technical characteristics of the machinery, and in particular:

  • the maximum working load and, where appropriate, a copy of the load plate or load table described in the second paragraph of section 4.3.3 of this Annex,

  • the reactions at the supports or anchors and, where appropriate, characteristics of the tracks,

  • where appropriate, the definition and the means of installation of the ballast;

(b)

the contents of the logbook, if the latter is not supplied with the machinery;

(c)

advice for use, particularly to offset the lack of direct vision of the load by the operator;

(d)

where appropriate, a test report detailing the static and dynamic tests carried out by or for the responsible person;

(e)

for machinery which is not assembled on the premises of the manufacturer in the form in which it is to be used, the necessary instructions for performing the measures referred to in section 4.1.3 of this Annex before it is first put into service.

5.

SUPPLEMENTARY ESSENTIAL HEALTH AND SAFETY REQUIREMENTS FOR MACHINERY INTENDED FOR UNDERGROUND WORK

Machinery intended for underground work must meet all the essential health and safety requirements described in this section (see point 4 of the General Principles at the start of this Annex).

5.1.

RISKS DUE TO LACK OF STABILITY

Powered roof supports must be designed and constructed in such a way as to maintain a given direction when moving and not slip before and while they come under load and after the load has been removed. They must be equipped with anchorages for the top plates of the individual hydraulic props.

5.2.

MOVEMENT

Powered roof supports must allow for unhindered movement of persons.

5.3.

CONTROL DEVICES

The accelerator and brake controls for movement of machinery running on rails must be hand-operated. However, enabling devices may be foot-operated.

The control devices of powered roof supports must be designed and positioned in such a way that, during displacement operations, operators are sheltered by a support in place. The control devices must be protected against any accidental release.

5.4.

STOPPING

Self-propelled machinery running on rails for use in underground work must be equipped with an enabling device acting on the circuit controlling the movement of the machinery such that movement is stopped if the driver is no longer in control of the movement.

5.5.

FIRE

The second indent of section 3.5.2 of this Annex is mandatory in respect of machinery which comprises highly flammable parts.

The braking system of machinery intended for use in underground workings must be designed and constructed in such a way that it does not produce sparks or cause fires.

Machinery with internal combustion engines for use in underground workings must be fitted only with engines using fuel with a low vaporising pressure and which exclude any spark of electrical origin.

5.6.

EXHAUST EMISSIONS

Exhaust emissions from internal combustion engines must not be discharged upwards.

6.

SUPPLEMENTARY ESSENTIAL HEALTH AND SAFETY REQUIREMENTS FOR MACHINERY PRESENTING PARTICULAR HAZARDS DUE TO THE LIFTING OF PERSONS

Machinery presenting hazards due to the lifting of persons must meet all the relevant essential health and safety requirements described in this section (see point 4 of the General Principles at the start of this Annex).

6.1.GENERAL
6.1.1.

Mechanical strength

The carrier, including any trapdoors, must be designed and constructed in such a way as to offer the space and strength corresponding to the maximum number of persons permitted on the carrier and the maximum working load.

The working coefficients for components set out in sections 4.1.2.4 and 4.1.2.5 of this Annex are inadequate for machinery intended for the lifting of persons and must, as a general rule, be doubled. Machinery intended for lifting persons or persons and goods must be fitted with a suspension or supporting system for the carrier designed and constructed in such a way as to ensure an adequate overall level of safety and to prevent the risk of the carrier falling.

If ropes or chains are used to suspend the carrier, as a general rule, at least two independent ropes or chains are required, each with its own anchorage.

6.1.2.

Loading control for machinery moved by power other than human strength

The requirements of section 4.2.2 of this Annex apply regardless of the maximum working load and overturning moment, unless the manufacturer can demonstrate that there is no risk of overloading or overturning.

6.2.

CONTROL DEVICES

Where safety requirements do not impose other solutions, the carrier must, as a general rule, be designed and constructed in such a way that persons in the carrier have means of controlling upward and downward movements and, if appropriate, other movements of the carrier.

In operation, those control devices must override any other devices controlling the same movement with the exception of emergency stop devices.

The control devices for these movements must be of the hold-to-run type except where the carrier itself is completely enclosed.

6.3.RISKS TO PERSONS IN OR ON THE CARRIER
6.3.1.

Risks due to movements of the carrier

Machinery for lifting persons must be designed, constructed or equipped in such a way that the acceleration or deceleration of the carrier does not engender risks for persons.

6.3.2.

Risk of persons falling from the carrier

The carrier must not tilt to an extent which creates a risk of the occupants falling, including when the machinery and carrier are moving.

Where the carrier is designed as a work station, provision must be made to ensure stability and to prevent hazardous movements.

If the measures referred to in section 1.5.15 of this Annex are not adequate, carriers must be fitted with a sufficient number of suitable anchorage points for the number of persons permitted on the carrier. The anchorage points must be strong enough for the use of personal protective equipment against falls from a height.

Any trapdoor in floors or ceilings or side doors must be designed and constructed in such a way as to prevent inadvertent opening and must open in a direction that obviates any risk of falling, should they open unexpectedly.

6.3.3.

Risk due to objects falling on the carrier

Where there is a risk of objects falling on the carrier and endangering persons, the carrier must be equipped with a protective roof.

6.4.MACHINERY SERVING FIXED LANDINGS
6.4.1.

Risks to persons in or on the carrier

The carrier must be designed and constructed in such a way as to prevent risks due to contact between persons and/or objects in or on the carrier with any fixed or moving elements. Where necessary in order to fulfil this requirement, the carrier itself must be completely enclosed with doors fitted with an interlocking device that prevents hazardous movements of the carrier unless the doors are closed. The doors must remain closed if the carrier stops between landings where there is a risk of falling from the carrier.

The machinery must be designed, constructed and, where necessary, equipped with devices in such a way as to prevent uncontrolled upward or downward movement of the carrier. These devices must be able to stop the carrier at its maximum working load and at the foreseeable maximum speed.

The stopping action must not cause deceleration harmful to the occupants, whatever the load conditions.

6.4.2.

Controls at landings

Controls, other than those for emergency use, at landings must not initiate movements of the carrier when:

  • the control devices in the carrier are being operated,

  • the carrier is not at a landing.

6.4.3.

Access to the carrier

The guards at the landings and on the carrier must be designed and constructed in such a way as to ensure safe transfer to and from the carrier, taking into consideration the foreseeable range of goods and persons to be lifted.

6.5.

MARKINGS

The carrier must bear the information necessary to ensure safety including:

  • the number of persons permitted on the carrier,

  • the maximum working load.

Regulations 7(2)(e) and 8(1)(c)

PART 2Annex II: Declarations

1.CONTENT
A.

EC DECLARATION OF CONFORMITY OF THE MACHINERY

This declaration and translations thereof must be drawn up under the same conditions as the instructions (see Annex I (Part 1 of this Schedule), section 1.7.4.1(a) and (b)), and must be typewritten or else handwritten in capital letters.

This declaration relates exclusively to the machinery in the state in which it was placed on the market, and excludes components which are added and/or operations carried out subsequently by the final user.

The EC declaration of conformity must contain the following particulars:

1.

business name and full address of the manufacturer and, where appropriate, the manufacturer’s authorised representative;

2.

name and address of the person authorised to compile the technical file, who must be established in an EEA state;

3.

description and identification of the machinery, including generic denomination, function, model, type, serial number and commercial name;

4.

a sentence expressly declaring that the machinery fulfils all the relevant provisions of the Directive and where appropriate, a similar sentence declaring the conformity with other Directives and/or relevant provisions with which the machinery complies. These references must be those of the texts published in the Official Journal of the European Union;

5.

where appropriate, the name, address and identification number of the notified body which carried out the EC type-examination referred to in Annex IX (Part 9 of this Schedule) and the number of the EC type-examination certificate;

6.

where appropriate, the name, address and identification number of the notified body which approved the full quality assurance system referred to in Annex X (Part 10 of this Schedule);

7.

where appropriate, a reference to the published harmonised standards used;

8.

where appropriate, the reference to other technical standards and specifications used;

9.

the place and date of the declaration;

10.

the identity and signature of the person empowered to draw up the declaration on behalf of the responsible person.

B.

DECLARATION OF INCORPORATION OF PARTLY COMPLETED MACHINERY

This declaration and translations thereof must be drawn up under the same conditions as the instructions (see Annex I (Part 1 of this Schedule), section 1.7.4.1(a) and (b)), and must be typewritten or else handwritten in capital letters.

The declaration of incorporation must contain the following particulars:

1.

business name and full address of the manufacturer of the partly completed machinery and, where appropriate, the manufacturer’s authorised representative;

2.

name and address of the person authorised to compile the relevant technical documentation, who must be established in an EEA state;

3.

description and identification of the partly completed machinery including generic denomination, function, model, type, serial number and commercial name;

4.

a sentence declaring which essential health and safety requirements are applied and fulfilled and that the relevant technical documentation is compiled in accordance with Annex VII (Part 7 of this Schedule), part B, and, where appropriate, a sentence declaring the conformity of the partly completed machinery with other relevant Directives. These references must be those of the texts published in the Official Journal of the European Union;

5.

an undertaking to transmit, in response to a reasoned request by the national authorities, relevant information on the partly completed machinery. This shall include the method of transmission and shall be without prejudice to the intellectual property rights of the manufacturer of the partly completed machinery;

6.

a statement that the partly completed machinery must not be put into service until the final machinery into which it is to be incorporated has been declared in conformity with the provisions of the Directive, where appropriate;

7.

the place and date of the declaration;

8.

the identity and signature of the person empowered to draw up the declaration on behalf of the responsible person.

2.

CUSTODY

The manufacturer of machinery or the manufacturer’s authorised representative shall keep the original EC declaration of conformity for a period of at least 10 years from the last date of manufacture of the machinery.

The manufacturer of partly completed machinery or the manufacturer’s authorised representative shall keep the original declaration of incorporation for a period of at least 10 years from the last date of manufacture of the partly completed machinery.

Regulation 7(2)(f)(ii)

PART 3Annex III: CE marking

The CE conformity marking shall consist of the initials “CE” taking the following form:

If the CE marking is reduced or enlarged the proportions shown in the above drawing must be respected.

The various components of the CE marking must have substantially the same vertical dimension, which may not be less than 5 mm. The minimum dimension may be waived for small-scale machinery.

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

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

Regulations 11 and 12

PART 4Annex IV: Categories of machinery to which one of the procedures referred to in regulation 11 or 12 must be applied

1.Circular saws (single- or multi-blade) for working with wood and material with similar physical characteristics or for working with meat and material with similar physical characteristics, of the following types:
1.1.sawing machinery with fixed blade(s) during cutting, having a fixed bed or support with manual feed of the workpiece or with a demountable power feed;
1.2.sawing machinery with fixed blade(s) during cutting, having a manually operated reciprocating saw-bench or carriage;
1.3.sawing machinery with fixed blade(s) during cutting, having a built-in mechanical feed device for the workpieces, with manual loading and/or unloading;
1.4.sawing machinery with movable blade(s) during cutting, having mechanical movement of the blade, with manual loading and/or unloading.
2.Hand-fed surface planing machinery for woodworking.
3.Thicknessers for one-side dressing having a built-in mechanical feed device, with manual loading and/or unloading for woodworking.
4.Band-saws with manual loading and/or unloading for working with wood and material with similar physical characteristics or for working with meat and material with similar physical characteristics, of the following types:
4.1.sawing machinery with fixed blade(s) during cutting, having a fixed or reciprocating-movement bed or support for the workpiece;
4.2.sawing machinery with blade(s) assembled on a carriage with reciprocating motion.
5.Combined machinery of the types referred to in points 1 to 4 and point 7 of this Annex, for working with wood and material with similar physical characteristics.
6.Hand-fed tenoning machinery with several tool holders for woodworking.
7.Hand-fed vertical spindle moulding machinery for working with wood and material with similar physical characteristics.
8.Portable chainsaws for woodworking.
9.Presses, including press-brakes, for the cold working of metals, with manual loading and/or unloading, whose movable working parts may have a travel exceeding 6 mm and a speed exceeding 30 mm/s.
10.Injection or compression plastics-moulding machinery with manual loading or unloading.
11.Injection or compression rubber-moulding machinery with manual loading or unloading.
12.Machinery for underground working of the following types:
12.1.locomotives and brake-vans;
12.2.hydraulic-powered roof supports.
13.Manually loaded trucks for the collection of household refuse incorporating a compression mechanism.
14.Removable mechanical transmission devices including their guards.
15.Guards for removable mechanical transmission devices.
16.Vehicle servicing lifts.
17.Devices for the lifting of persons or of persons and goods involving a hazard of falling from a vertical height of more than three metres.
18.Portable cartridge-operated fixing and other impact machinery.
19.Protective devices designed to detect the presence of persons.
20.Power-operated interlocking movable guards designed to be used as safeguards in machinery referred to in points 9, 10 and 11 of this Annex.
21.Logic units to ensure safety functions.
22.Roll-over protective structures (ROPS).
23.Falling-object protective structures (FOPS).

Regulation 4(2)(c)

PART 5Annex V: Indicative list of safety components

1.Guards for removable mechanical transmission devices.
2.Protective devices designed to detect the presence of persons.
3.Power-operated interlocking movable guards designed to be used as safeguards in machinery referred to in Annex IV (Part 4 of this Schedule), points 9, 10 and 11.
4.Logic units to ensure safety functions.
5.Valves with additional means for failure detection intended for the control of dangerous movements on machinery.
6.Extraction systems for machinery emissions.
7.Guards and protective devices designed to protect persons against moving parts involved in the process on the machinery.
8.Monitoring devices for loading and movement control in lifting machinery.
9.Restraint systems to keep persons on their seats.
10.Emergency stop devices.
11.Discharging systems to prevent the build-up of potentially dangerous electrostatic charges.
12.Energy limiters and relief devices referred to in Annex I (Part 1 of this Schedule), sections 1.5.7, 3.4.7 and 4.1.2.6.
13.Systems and devices to reduce the emission of noise and vibrations.
14.Roll-over protective structures (ROPS).
15.Falling-object protective structures (FOPS).
16.Two-hand control devices.
17.

Components for machinery designed for lifting and/or lowering persons between different landings and included in the following list:

(a)

devices for locking landing doors;

(b)

devices to prevent the load-carrying unit from falling or unchecked upwards movement;

(c)

overspeed limitation devices;

(d)

energy-accumulating shock absorbers,

  • non-linear, or

  • with damping of the return movement;

(e)

energy-dissipating shock absorbers;

(f)

safety devices fitted to jacks of hydraulic power circuits where these are used as devices to prevent falls;

(g)

electric safety devices in the form of safety switches containing electronic components.

Regulation 8(1)(b)

PART 6Annex VI: Assembly instructions for partly completed machinery

The assembly instructions for partly completed machinery must contain a description of the conditions which must be met with a view to correct incorporation in the final machinery, so as not to compromise safety and health.

The assembly instructions must be written in an official Community language acceptable to the manufacturer of the machinery in which the partly completed machinery will be assembled, or to the manufacturer’s authorised representative.

Regulations 7(2)(b) and 8(1)(a)

PART 7Annex VII: Technical files

A.

Technical file for machinery

This part describes the procedure for compiling a technical file. The technical file must demonstrate that the machinery complies with the provisions of the Directive. It must cover the design, manufacture and operation of the machinery to the extent necessary for this assessment. The technical file must be compiled in one or more official Community languages, except for the instructions for the machinery, for which the special provisions of Annex I (Part 1 of this Schedule), section 1.7.4.1 apply.

1.

The technical file shall comprise the following:

(a)

a construction file including:

  • a general description of the machinery,

  • the overall drawing of the machinery and drawings of the control circuits, as well as the pertinent descriptions and explanations necessary for understanding the operation of the machinery,

  • full detailed drawings, accompanied by any calculation notes, test results, certificates, etc., required to check the conformity of the machinery with the essential health and safety requirements,

  • the documentation on risk assessment demonstrating the procedure followed, including:

    (i)

    a list of the essential health and safety requirements which apply to the machinery,

    (ii)

    the description of the protective measures implemented to eliminate identified hazards or to reduce risks and, when appropriate, the indication of the residual risks associated with the machinery,

  • the standards and other technical specifications used, indicating the essential health and safety requirements covered by these standards,

  • any technical report giving the results of the tests carried out either by the manufacturer or by a body chosen by the responsible person,

  • a copy of the instructions for the machinery,

  • where appropriate, the declaration of incorporation for included partly completed machinery and the relevant assembly instructions for such machinery,

  • where appropriate, copies of the EC declaration of conformity of machinery or other products incorporated into the machinery,

  • a copy of the EC declaration of conformity;

(b)

for series manufacture, the internal measures that will be implemented to ensure that the machinery remains in conformity with the provisions of the Directive.

The manufacturer must carry out necessary research and tests on components, fittings or the completed machinery to determine whether by its design or construction it is capable of being assembled and put into service safely. The relevant reports and results shall be included in the technical file.

2.

The technical file referred to in point 1 of this Annex must be made available to the enforcement authorities and the competent authorities of any other EEA state for at least 10 years following the date of manufacture of the machinery or, in the case of series manufacture, of the last unit produced.

The technical file does not have to be located in the territory of an EEA state, nor does it have to be permanently available in material form. However, it must be capable of being assembled and made available within a period of time commensurate with its complexity by the person designated in the EC declaration of conformity.

The technical file does not have to include detailed plans or any other specific information as regards the sub-assemblies used for the manufacture of the machinery unless a knowledge of them is essential for verification of conformity with the essential health and safety requirements.

3.

Failure to present the technical file in response to a duly reasoned request by the competent national authorities may constitute sufficient grounds for doubting the conformity of the machinery in question with the essential health and safety requirements.

B.

Relevant technical documentation for partly completed machinery

This part describes the procedure for compiling relevant technical documentation. The documentation must show which provisions of the Directive are applied and fulfilled. It must cover the design, manufacture and operation of the partly completed machinery to the extent necessary for the assessment of conformity with the essential health and safety requirements applied. The documentation must be compiled in one or more official Community languages.

Relevant technical documentation shall comprise the following:

(a)

a construction file including:

  • the overall drawing of the partly completed machinery and drawings of the control circuits,

  • full detailed drawings, accompanied by any calculation notes, test results, certificates, etc., required to check the conformity of the partly completed machinery with the applied essential health and safety requirements,

  • the risk assessment documentation showing the procedure followed, including:

    (i)

    a list of the essential health and safety requirements applied and fulfilled,

    (ii)

    the description of the protective measures implemented to eliminate identified hazards or to reduce risks and, where appropriate, the indication of the residual risks,

    (iii)

    the standards and other technical specifications used, indicating the essential health and safety requirements covered by these standards,

    (iv)

    any technical report giving the results of the tests carried out either by the manufacturer or by a body chosen by the responsible person,

    (v)

    a copy of the assembly instructions for the partly completed machinery;

(b)

for series manufacture, the internal measures that will be implemented to ensure that the partly completed machinery remains in conformity with the essential health and safety requirements applied.

The manufacturer must carry out necessary research and tests on components, fittings or the partly completed machinery to determine whether by its design or construction it is capable of being assembled and used safely. The relevant reports and results shall be included in the technical file.

The relevant technical documentation must be available for at least 10 years following the date of manufacture of the partly completed machinery or, in the case of series manufacture, of the last unit produced, and on request presented to an enforcement authority or a competent authority of any other EEA state. It does not have to be located in the territory of an EEA state, nor does it have to be permanently available in material form. It must be capable of being assembled and presented to the relevant authority by the person designated in the declaration for incorporation.

Failure to present the relevant technical documentation in response to a duly reasoned request by an enforcement authority or a competent authority of any other EEA state may constitute sufficient grounds for doubting the conformity of the partly completed machinery with the essential health and safety requirements applied and attested.

Regulations 10, 11(2), 12(2)(a)

PART 8Annex VIII: Assessment of conformity with internal checks on the manufacture of machinery

1.This Annex describes the procedure by which the responsible person, who carries out the obligations laid down in points 2 and 3 of this Annex, ensures and declares that the machinery concerned satisfies the relevant provisions of the Directive.
2.For each representative type of the series in question, the responsible person shall draw up the technical file referred to in Annex VII (Part 7 of this Schedule), part A.
3.The manufacturer must take all measures necessary in order that the manufacturing process ensures compliance of the manufactured machinery with the technical file referred to in Annex VII, part A, and with the provisions of the Directive.

Regulations 11(2)(b), 12(2)(a), 18(1)

PART 9Annex IX: EC type-examination

EC type-examination is the procedure whereby a notified body ascertains and certifies that a representative model of machinery referred to in Annex IV (Part 4 of this Schedule) (hereafter named the type) satisfies the provisions of the Directive.

1.The responsible person must, for each type, draw up the technical file referred to in Annex VII (Part 7 of this Schedule), part A.
2.

For each type, the application for an EC type-examination shall be submitted by the responsible person to a notified body chosen by the responsible person.

The application shall include:

  • the name and address of the manufacturer and, where appropriate, the manufacturer’s authorised representative,

  • a written declaration that the application has not been submitted to another notified body,

  • the technical file.

Moreover, the applicant shall place at the disposal of the notified body a sample of the type. The notified body may ask for further samples if the test programme so requires.

3.The notified body shall:
3.1.examine the technical file, check that the type was manufactured in accordance with it and establish which elements have been designed in accordance with the relevant provisions of published harmonised standards, and those elements whose design is not based on the relevant provisions of those standards;
3.2.carry out or have carried out appropriate inspections, measurements and tests to ascertain whether the solutions adopted satisfy the essential health and safety requirements, where published harmonised standards were not applied;
3.3.where published harmonised standards were used, carry out or have carried out appropriate inspections, measurements and tests to verify that those standards were actually applied;
3.4.agree with the applicant as to the place where the check that the type was manufactured in accordance with the examined technical file and the necessary inspections, measurements and tests will be carried out.
4.

If the type satisfies the provisions of the Directive, the notified body shall issue the applicant with an EC type-examination certificate. The certificate shall include the name and address of the manufacturer and the manufacturer’s authorised representative, the data necessary for identifying the approved type, the conclusions of the examination and the conditions to which its issue may be subject.

The manufacturer and the notified body shall retain a copy of this certificate, the technical file and all relevant documents for a period of 15 years from the date of issue of the certificate.

5.If the type does not satisfy the provisions of the Directive, the notified body shall refuse to issue the applicant with an EC type-examination certificate, giving detailed reasons for its refusal. It shall inform the applicant, the other notified bodies and the Member State which notified it. An appeal procedure must be available.
6.The applicant shall inform the notified body which retains the technical file relating to the EC type-examination certificate of all modifications to the approved type. The notified body shall examine these modifications and shall then either confirm the validity of the existing EC type-examination certificate or issue a new one if the modifications are liable to compromise conformity with the essential health and safety requirements or the intended working conditions of the type.
7.The Commission, the Member States and the other notified bodies may, on request, obtain a copy of the EC type-examination certificates. On reasoned request, the Commission and the Member States may obtain a copy of the technical file and the results of the examinations carried out by the notified body.
8.Files and correspondence referring to the EC type-examination procedures shall be written in the official language(s) of the EEA state where the notified body is established or in any other official Community language acceptable to the notified body.
9.Validity of the EC type-examination certificate
9.1.The notified body has the ongoing responsibility of ensuring that the EC type-examination certificate remains valid. It shall inform the manufacturer of any major changes which would have an implication on the validity of the certificate. The notified body shall withdraw certificates which are no longer valid.
9.2.The manufacturer of the machinery concerned has the ongoing responsibility of ensuring that the said machinery meets the corresponding state of the art.
9.3.

The manufacturer shall request from the notified body the review of the validity of the EC type-examination certificate every five years.

If the notified body finds that the certificate remains valid, taking into account the state of the art, it shall renew the certificate for a further five years.

The manufacturer and the notified body shall retain a copy of this certificate, of the technical file and of all the relevant documents for a period of 15 years from the date of issue of the certificate.

9.4.In the event that the validity of the EC-type examination certificate is not renewed, the manufacturer shall cease the placing on the market of the machinery concerned.

Regulations 11(2)(c), 12(2)(b), 18(1)

PART 10Annex X: Full quality assurance

This Annex describes the conformity assessment of machinery referred to in Annex IV (Part 4 of this Schedule), manufactured using a full quality assurance system, and the procedure whereby a notified body assesses and approves the quality system and monitors its application.

1.The manufacturer must operate an approved quality system for design, manufacture, final inspection and testing, as specified in point 2 of this Annex, and shall be subject to the surveillance referred to in point 3 of this Annex.
2.Quality system
2.1.

An application for assessment of a quality system shall be lodged by the responsible person with a notified body chosen by the responsible person.

The application shall contain:

  • the name and address of the manufacturer and, where appropriate, the manufacturer’s authorised representative,

  • the places of design, manufacture, inspection, testing and storage of the machinery,

  • the technical file described in Annex VII (Part 7 of this Schedule), part A, for one model of each category of machinery referred to in Annex IV (Part 4 of this Schedule) which the manufacturer intends to manufacture,

  • the documentation on the quality system,

  • a written declaration that the application has not been submitted to another notified body.

2.2.

The quality system must ensure conformity of the machinery with the provisions of the Directive. All the elements, requirements and provisions adopted by the manufacturer must be documented in a systematic and orderly manner, in the form of measures, procedures and written instructions. The documentation on the quality system must permit a uniform interpretation of the procedural and quality measures, such as quality programmes, plans, manuals and records.

It must contain, in particular, an adequate description of:

  • the quality objectives, the organisational structure, and the responsibilities and powers of the management with regard to the design and quality of the machinery,

  • the technical design specifications, including standards that will be applied and, where published harmonised standards are not applied in full, the means that will be used to ensure that the essential health and safety requirements are fulfilled,

  • the design inspection and design verification techniques, processes and systematic actions that will be used when designing machinery covered by the Directive,

  • the corresponding manufacturing, quality control and quality assurance techniques, processes and systematic actions that will be used,

  • the inspections and tests that will be carried out before, during and after manufacture, and the frequency with which they will be carried out,

  • the quality records, such as inspection reports and test data, calibration data, and reports on the qualifications of the personnel concerned,

  • the means of monitoring the achievement of the required design and quality of the machinery, as well as the effective operation of the quality system.

2.3.

The notified body shall assess the quality system to determine whether it satisfies the requirements of point 2.2 of this Annex.

The elements of the quality system which conform to the relevant harmonised standard shall be presumed to conform to the corresponding requirements referred to in point 2.2.

The team of auditors must have at least one member who is experienced in the assessment of the technology of the machinery. The assessment procedure shall include an inspection to be carried out at the manufacturer’s premises. During the assessment, the team of auditors shall carry out a review of the technical files referred to in the third indent of the second paragraph of point 2.1 of this Annex, to ensure their compliance with the applicable health and safety requirements.

The responsible person shall be notified of the decision. The notification shall contain the conclusions of the examination and the reasoned assessment decision. An appeal procedure must be available.

2.4.

The manufacturer shall undertake to fulfil the obligations arising from the quality system as approved and to ensure that it remains appropriate and effective.

The responsible person shall inform the notified body which approved the quality system of any planned change to it.

The notified body shall evaluate the proposed changes and decide whether the modified quality assurance system will continue to satisfy the requirements referred to in point 2.2, or whether a re-assessment is necessary.

It shall notify the manufacturer of its decision. The notification shall contain the conclusions of the examination and the reasoned assessment decision.

3.Surveillance under the responsibility of the notified body
3.1.The purpose of surveillance is to make sure that the manufacturer duly fulfils the obligations arising out of the approved quality system.
3.2.

The manufacturer shall, for inspection purposes, allow the notified body access to the places of design, manufacture, inspection, testing and storage, and shall provide it with all necessary information, such as:

  • the documentation concerning the quality system,

  • the quality records provided for in that part of the quality system concerned with design, such as the results of analyses, calculations, tests, etc.,

  • the quality records provided for in that part of the quality system concerned with manufacture, such as inspection reports and test data, calibration data, reports on the qualifications of the personnel concerned, etc.

3.3.The notified body shall conduct periodic audits to make sure that the manufacturer is maintaining and applying the quality system; it shall provide the manufacturer with an audit report. The frequency of the periodic audits shall be such that a full reassessment is carried out every three years.
3.4.

Moreover, the notified body may pay the manufacturer unannounced visits. The need for these additional visits and their frequency will be determined on the basis of a visit monitoring system managed by the notified body. In particular, the following factors will be taken into account in the visits monitoring system:

  • the results of previous surveillance visits,

  • the need to monitor remedial measures,

  • where appropriate, special conditions attaching to approval of the system,

  • significant modifications in the organisation of the manufacturing process, measures or techniques.

On the occasion of such visits, the notified body may, if necessary, carry out tests or have them carried out in order to check the proper functioning of the quality system. It shall provide the manufacturer with a visit report and, if a test was carried out, with a test report.

4.

The responsible person shall keep available for the national authorities, for a period of ten years from the last date of manufacture:

  • the documentation referred to in point 2.1 of this Annex,

  • the decisions and reports of the notified body referred to in the third and fourth subparagraphs of point 2.4 of this Annex, and in points 3.3 and 3.4 of this Annex.

Regulation 16(6)

PART 11Annex XI: Minimum criteria to be taken into account by Member States for the notification of bodies

1.The body, its director and the staff responsible for carrying out the verification tests shall not be the designer, manufacturer, supplier or installer of machines which they inspect, nor the authorised representative of any of these parties. They shall not become involved, either directly or as authorised representatives, in the design, construction, marketing or maintenance of the machines. This does not preclude the possibility of exchanges of technical information between the manufacturer and the body.
2.The body and its staff shall carry out the verification tests with the highest degree of professional integrity and technical competence and shall be free from all pressures and inducements, particularly financial, which might influence their judgement or the results of the inspection, especially from persons or groups of persons with an interest in the result of verifications.
3.For each category of machinery for which it is notified, the body must possess personnel with technical knowledge and sufficient and appropriate experience to perform a conformity assessment. It must have the means necessary to complete the technical and administrative tasks connected with implementation of the checks in an appropriate manner; it must also have access to the equipment necessary for the exceptional checks.
4.

The staff responsible for inspection shall have:

  • sound technical and vocational training,

  • satisfactory knowledge of the requirements of the tests they carry out and adequate experience of such tests,

  • the ability to draw up the certificates, records and reports required to authenticate the performance of the tests.

5.The impartiality of inspection staff shall be guaranteed. Their remuneration shall not depend on the number of tests carried out or on the results of such tests.
6.The body shall satisfy the Secretary of State that it has adequate civil liability insurance.
7.The staff of the body shall be bound to observe professional secrecy with regard to all information obtained in carrying out its tasks (except vis-à-vis the Secretary of State) under these Regulations.
8.Notified bodies shall participate in coordination activities. They shall also take part directly or be represented in European standardisation, or ensure that they know the situation in respect of relevant standards.

Regulations 4(1)(a)(ii) and 6(2)(b)

SCHEDULE 3PRODUCTS TO WHICH THE REGULATIONS DO NOT APPLY

1.  These Regulations do not apply to—

(a)safety components which are—

(i)intended to be used as spare parts to replace identical components; and

(ii)supplied by the manufacturer of the original machinery;

(b)equipment specifically for use in fairgrounds and/or amusement parks;

(c)machinery specially designed or put into service for nuclear purposes which, in the event of failure, may result in an emission of radioactivity;

(d)weapons, including firearms;

(e)subject to paragraph 2, the following means of transport—

(i)agricultural and forestry tractors, in respect of the risks covered by Directive 2003/37/EC(23);

(ii)motor vehicles and trailers as defined in Article 3(11) and (12) of Directive 2007/46/EC of the European Parliament and the Council of 5 September 2007 establishing a framework for the approval of motor vehicles and their trailers, and of systems, components and separate technical units intended for such vehicles(24);

(iii)vehicles covered by Directive 2002/24/EC of the European Parliament and of the Council of 18 March 2002 relating to the type-approval of two or three-wheel motor vehicles(25);

(iv)motor vehicles exclusively intended for competition; and

(v)means of transport by air, on water and on rail networks,

(f)seagoing vessels, mobile offshore units and machinery installed on board such vessels or units;

(g)machinery specially designed and constructed for military or police purposes;

(h)machinery specially designed and constructed for research purposes for temporary use in laboratories;

(i)mine winding gear;

(j)machinery intended to move performers during artistic performances;

(k)electrical and electronic products falling within the following areas, insofar as they are covered by Council Directive 2006/95/EC of 12 December 2006(26) on the harmonisation of the laws of Member States relating to electrical equipment designed for use within certain voltage limits—

(i)household appliances intended for domestic use,

(ii)audio and video equipment,

(iii)information technology equipment,

(iv)ordinary office machinery,

(v)low-voltage switchgear and control gear,

(vi)electric motors; and

(l)the following types of high-voltage electrical equipment—

(i)switch gear and control gear, and

(ii)transformers.

2.  The following products are subject to these Regulations—

(a)machinery mounted on vehicles of the kinds specified in paragraph 1(e)(i) to (iii);

(b)products which—

(i)but for regulations 4(1)(a)(iii) and 6(2)(b) and paragraph 1(e)(ii), would be machinery or partly completed machinery;

(ii)fall within one of the categories specified in Article 2(3)(a) to (c) or 2(4)(b) of Directive 2007/46/EC; and

(iii)are not excluded from these Regulations by paragraph 1(g)); and

(c)machinery mounted on the means of transport specified in paragraph 1(e)(v).

Regulation 18(7)

SCHEDULE 4APPEALS AGAINST NOTIFIED BODY DECISIONS

1.  Where a manufacturer or authorised representative (“the appellant”) is aggrieved by one of the kinds of decision of a UK notified body specified in regulation 18(7) (“the decision”), the grounds on which such an appeal may be made are that, in reaching the decision, the UK notified body (“the respondent”) made a material error of law or fact.

2.  Any appeal made under paragraph 1 (“an appeal”) shall be—

(a)made to the Secretary of State; and

(b)heard by a person appointed by the Secretary of State, on such terms as the Secretary of State sees fit, to hear one or more appeals (an “Appeal Officer”).

In this Schedule, “the Appeal Officer” means the person who hears a particular appeal.

3.  No person shall be appointed as an Appeal Officer unless the Secretary of State considers that that person has sufficient knowledge and experience, or sufficiently ready access to independent sources of technical or legal expertise, to be able to reach independent, impartial and properly informed decisions on the appeals which that person is appointed to hear.

4.  An appeal must be made by giving a notice of appeal in writing to the Secretary of State so as to be received by the Secretary of State within one month of the date upon which the decision was notified to the appellant.

5.  On receiving the notice of appeal, the Secretary of State must—

(a)send a copy of the notice, endorsed with the date of receipt, to the respondent;

(b)send an acknowledgement of its receipt to the appellant;

(c)forward the notice of appeal, endorsed with the date of receipt, to the Appeal Officer; and

(d)notify the appellant and the respondent of the arrangements for communicating with the Appeal Officer.

6.  The notice of appeal must—

(a)state the name and address of the appellant and an address for service;

(b)concisely state the grounds for the appeal and the arguments supporting each ground;

(c)contain a schedule listing any documents annexed to it;

(d)be accompanied by a copy of the decision and, as far as practicable, every other document on which the appellant relies;

(e)be signed and dated by the appellant, or on the appellant’s behalf by the appellant’s duly authorised officer or legal representative.

7.  The respondent may make a written response to the notice of appeal. Any such written response must be sent to the Appeal Officer so as to be received by the Appeal Officer within one month of the date on which the Secretary of State received the notice of appeal or such further time as the Appeal Officer may allow.

8.  The Appeal Officer must send a copy of the written response to the appellant.

9.  The Appeal Officer may—

(a)give the appellant and the respondent the opportunity to make further written or oral representations; and

(b)specify the time and manner in which such further representations are to be made.

10.  The Appeal Officer may—

(a)make enquiries of any person;

(b)receive representations from any person;

(c)hold any meeting or hearing; and

(d)subject to this Schedule, follow such practice and procedure,

as the Appeal Officer thinks fit, having regard to the just, expeditious and economical conduct of the appeal.

11.  The Appeal Officer may specify the time and place at which any meeting or hearing is to be held.

12.  In determining an appeal, the Appeal Officer must—

(a)dismiss the appeal;

(b)allow the appeal; or

(c)remit the decision to the respondent.

13.  Where a decision is remitted the respondent must reconsider it in accordance with any rulings of law and findings of fact made by the Appeal Officer.

14.  The Appeal Officer may dismiss an appeal at any stage if satisfied that—

(a)the notice of appeal discloses no valid ground of appeal;

(b)the notice of appeal fails to comply with the requirements of paragraph 6; or

(c)the appellant is not entitled to bring the appeal.

15.  If satisfied that the appeal was not brought within the time limit imposed by paragraph 4, the Appeal Officer must dismiss an appeal, unless satisfied that the circumstances are exceptional.

16.  The Appeal Officer may dismiss an appeal at any stage at the request of the appellant.

17.  The Appeal Officer must give the appellant and the respondent reasons for any decision to—

(a)dismiss an appeal;

(b)allow an appeal; or

(c)remit a decision to the respondent.

Regulation 20

SCHEDULE 5ENFORCEMENT

General duties of enforcement authorities

1.  Except as specified in paragraph 3, it shall be the duty of the Health and Safety Executive to make adequate arrangements for the enforcement of these Regulations in Great Britain in relation to machinery and partly completed machinery for use at work.

2.  Except as specified in paragraph 3, it shall be the duty of every local weights and measures authority in Great Britain to enforce these Regulations within its area in relation to machinery or partly completed machinery which is not for use at work.

3.  It shall be the duty of the Office of Rail Regulation to make adequate arrangements for the enforcement of these Regulations in Great Britain where the Health and Safety (Enforcing Authority for Railways and Other Guided Transport Systems) Regulations 2006 make it the enforcing authority, within the meaning of section 18(7) of the 1974 Act, in relation to machinery or partly completed machinery for use in the operation of a railway, tramway or any other system of guided transport, as defined in those Regulations.

4.  It shall be the duty of the Health and Safety Executive for Northern Ireland to make adequate arrangements for the enforcement of these Regulations in Northern Ireland in relation to machinery and partly completed machinery for use at work.

5.  It shall be the duty of every district council in Northern Ireland to enforce these Regulations within its area in relation to machinery or partly completed machinery which is not for use at work.

6.  The Secretary of State may enforce these Regulations in relation to machinery or partly completed machinery which is not for use at work in cases where the Office of Rail Regulation is not the enforcement authority.

Powers of the Health and Safety Executive and the Office of Rail Regulation as enforcement authorities

7.  In relation to the enforcement of these Regulations by the Health and Safety Executive or the Office of Rail Regulation—

(a)sections 19 to 28(27), 33 to 35(28), 38, 39, 41 and 42 of the 1974 Act shall apply as provided in paragraph 8; and

(b)sections 36(1) and (2) and 37 of the 1974 Act shall apply in relation to offences under section 33 as applied in relation to these Regulations and modified by paragraph 8.

8.  For the purposes of the enforcement of these Regulations by the Health and Safety Executive or the Office of Rail Regulation, and in respect of any related proceedings for contravention of these Regulations, the provisions specified in paragraph 7 shall apply as if—

(a)references to relevant statutory provisions were references to those provisions as modified by this paragraph and to these Regulations;

(b)references to articles, substances, articles and substances, or plant, were references to machinery or partly completed machinery, or a machine or partly completed machine, as the context may require;

(c)references to an “enforcing authority” were references to the Health and Safety Executive or the Office of Rail Regulation, as appropriate;

(d)references to the field of responsibility of an enforcing authority, however expressed, were omitted;

(e)in section 20, subsection (3) were omitted;

(f)section 22, as well as permitting an inspector to serve a prohibition notice in the circumstances specified in section 22(2), permitted an inspector to serve a prohibition notice in any case where—

(i)a responsible person has failed to comply with the requirements of these Regulations in relation to CE marking; and

(ii)the responsible person—

(aa)has been served with a notice under regulation 21(3), or an improvement notice under section 21, in respect of that failure; and

(bb)has continued to fail to comply with those requirements after the period for remedying the contravention specified in the improvement notice;

(g)in section 23, subsections (3), (4) and (6) were omitted;

(h)in section 33—

(i)in subsection (1) the whole of paragraphs (a) to (d) were omitted;

(ii)subsection (1A) were omitted;

(iii)in subsection (2), the reference to paragraph (d) of subsection (1) were omitted;

(iv)subsection (2A) were omitted;

(v)for subsection (3) there were substituted the following—

(3) A person guilty of an offence under any paragraph of subsection (1) not mentioned in subsection (2), or of an offence under subsection (1)(e) not falling within subsection (2), shall be liable—

(a)on summary conviction, to a fine not exceeding level 5 on the standard scale; or

(b)on conviction on indictment—

(i)in the case of an offence under subsection (1)(g) or of an offence under subsection (1)(j), to imprisonment for a term not exceeding two years, or a fine, or both; or

(ii)in all other cases, to a fine.; and

(vi)subsection (4) were omitted;

(i)in section 34—

(i)paragraphs (a) and (b) of subsection (1) were omitted; and

(ii)in subsection (3) for “six months” there were substituted “twelve months”; and

(j)in section 42, subsections (4) and (5) were omitted.

Powers of the Health and Safety Executive for Northern Ireland as an enforcement authority

9.  In relation to the enforcement of these Regulations by the Health and Safety Executive for Northern Ireland—

(a)Articles 21 to 33(29), 35, 36, 38 and 39 of the 1978 Order shall apply as provided in paragraph 10; and

(b)Articles 34(1) and (2) and 34A(30) of the 1978 Order shall apply in relation to offences under Article 31 as applied in relation to these Regulations and modified by paragraph 10.

10.  For the purposes of the enforcement of these Regulations by the Health and Safety Executive for Northern Ireland, and in respect of any related proceedings for contravention of these Regulations, the provisions specified in paragraph 9 shall apply as if—

(a)references to relevant statutory provisions were references to those provisions as modified by this paragraph and to these Regulations;

(b)references to articles, substances, articles and substances, or plant, were references to machinery or partly completed machinery, or a machine or partly completed machine, as the context may require;

(c)references to an “enforcing authority” or to its field of responsibility (however expressed) or to “the Department concerned” were to the Health and Safety Executive for Northern Ireland;

(d)in Article 22, paragraph (3) were omitted;

(e)Article 24, as well as permitting an inspector to serve a prohibition notice in the circumstances specified in Article 24(2), permitted an inspector to serve a prohibition notice in any case where—

(i)a responsible person has failed to comply with the requirements of these Regulations in relation to CE marking; and

(ii)the responsible person—

(aa)has been served with a notice under regulation 21(3), or an improvement notice under Article 23, in respect of that failure; and

(bb)has continued to fail to comply with those requirements after the period for remedying the contravention specified in the improvement notice;

(f)in Article 25, paragraphs (3), (4) and (5) were omitted;

(g)in Article 31—

(i)in paragraph (1), the whole of sub-paragraphs (a) to (d) were omitted;

(ii)paragraph (1A) were omitted;

(iii)in paragraph (2), the reference to sub-paragraph (d) of paragraph (1) were omitted;

(iv)paragraph (2A) were omitted;

(v)for paragraph (4) there were substituted the following—

(4) A person guilty of an offence under any sub-paragraph of paragraph (1) not mentioned in paragraph (2) or of an offence under paragraph (1)(e) not falling within paragraph (2) shall be liable—

(a)on summary conviction, to a fine not exceeding £2000; or

(b)on conviction on indictment—

(i)in the case of an offence under paragraph (1)(g) or of an offence under paragraph (1)(j), to imprisonment for a term not exceeding two years, or a fine, or both; or

(ii)in all other cases, to a fine.; and

(vi)paragraph (5) were omitted;

(h)in Article 32—

(i)sub-paragraphs (a) and (b) were omitted from paragraph (1); and

(ii)in paragraph (3), for “six months” there were substituted “twelve months”; and

(i)in Article 39, paragraphs (4) and (5) were omitted.

Powers of other enforcement authorities

11.  In relation to the enforcement of these Regulations by local weights and measures authorities, Northern Ireland district councils or the Secretary of State—

(a)sections 14, 15, 28 to 35, 37(31), 44 and 47(32) of the 1987 Act shall apply as provided in paragraph 12;

(b)sections 39(33) and 40 shall apply in relation to offences under section 32 as applied in relation to these Regulations and modified by paragraph 12.

12.  For the purposes of the enforcement of these Regulations by local weights and measures authorities, Northern Ireland district councils or the Secretary of State, and in respect of any related proceedings for contravention of these Regulations, the provisions specified in paragraph 11 shall apply as if—

(a)references to safety provisions were references to these Regulations;

(b)references to goods were references to machinery or partly completed machinery, or a machine or partly completed machine, as the context may require;

(c)references to an “enforcement authority” were to the local weights and measures authority or Northern Ireland district council concerned, or to the Secretary of State, as appropriate;

(d)in section 14, in subsection (6), for “six months” there were substituted “three months”;

(e)in sections 28, 29, 30, 33, 34 and 35, the words “or of any provision made by or under Part III of this Act”, or “or any provision made by or under Part III of this Act”, on each occasion that they occur, were omitted;

(f)in section 28, subsections (3), (4) and (5) were omitted;

(g)in section 29, subsection (4) were omitted; and

(h)in section 30, subsections (7) and (8) were omitted.

13.  In relation to proceedings for an offence in relation to machinery or partly completed machinery which is not for use at work—

(a)in Great Britain, section 34 of the 1974 Act shall apply as if—

(i)paragraphs (a) and (b) of subsection (1) were omitted;

(ii)references to an “enforcing authority” were references to local weights and measures authorities and the Secretary of State, and “responsible enforcing authority” were construed accordingly;

(iii)references to “relevant statutory provisions” were references to these Regulations; and

(iv)in subsection (3), for “six months” there were substituted “twelve months”; and

(b)in Northern Ireland, Article 32 of the 1978 Order shall apply as if—

(i)sub-paragraphs (a) and (b) of paragraph (1) were omitted;

(ii)references to an “enforcing authority” were references to Northern Ireland district councils, and “responsible enforcing authority” were construed accordingly;

(iii)references to “relevant statutory provisions” were references to these Regulations; and

(iv)in paragraph (3), for “six months” there were substituted “twelve months”.

Forfeiture: England and Wales and Northern Ireland

14.—(1) An enforcement authority in England and Wales or Northern Ireland may apply under this paragraph for an order for the forfeiture of any machinery or partly completed machinery on the grounds that there has been a contravention of regulation 7 or 8 in relation to it.

(2) An application under this paragraph may be made to a magistrates’ court—

(a)where proceedings have been brought in that court in respect of an offence in relation to some or all of the machinery or partly completed machinery under regulation 22;

(b)where an application with respect to some or all of the machinery or partly completed machinery has been made to that court under section 15 or 33 of the 1987 Act as applied for the purposes of the enforcement of these Regulations by paragraph 11; and

(c)by way of complaint, where no application for the forfeiture of the machinery or partly completed machinery has been made under sub-paragraph (a) or (b).

(3) On an application under this paragraph the court shall make an order for the forfeiture of the machinery or partly completed machinery only if satisfied that there has been a contravention of regulation 7 or 8 in relation to it.

(4) A court may infer for the purposes of this paragraph that there has been a contravention of regulation 7 or 8 in relation to any machinery or partly completed machinery if satisfied that either of those regulations has been contravened in relation to a machine or partly completed machine which is representative of that machinery or partly completed machinery (whether by reason of its being of the same design or part of the same consignment or batch or otherwise).

(5) Any person aggrieved by an order made under this paragraph by a magistrates’ court, or by a decision of such court not to make such an order, may appeal against that order or decision—

(a)in England and Wales, to the Crown Court;

(b)in Northern Ireland, to the county court,

and an order so made may contain such provision as appears to the court to be appropriate for delaying the coming into force of an order pending the making and determination of any appeal (including any application under section 111 of the Magistrates’ Courts Act 1980, or Article 146 of the Magistrates’ Courts (Northern Ireland) Order 1981 (statement of case)).

(6) Subject to sub-paragraph (7), where any machinery or partly completed machinery is forfeited under this paragraph it shall be destroyed in accordance with such directions as the court may give.

(7) On making an order under this paragraph a magistrates’ court may, if it considers it appropriate to do so, direct that the machinery or partly completed machinery to which the order relates shall (instead of being destroyed) be released, to such person as the court may specify, on condition that that person—

(a)does not supply the machinery or partly completed machinery to any person otherwise than—

(i)to a person who carries on a business of buying machinery or partly completed machinery of the same description as that machinery or partly completed machinery and repairing or reconditioning it; or

(ii)as scrap (that is to say, for the value of materials included in the machinery or partly completed machinery rather than for the value of the machinery or partly completed machinery itself); and

(b)complies with any order to pay costs or expenses (including any order under section 35 of the 1987 Act as applied for the purposes of the enforcement of these Regulations by paragraph 11) which has been made against that person in the proceedings for the order for forfeiture.

Forfeiture: Scotland

15.—(1) In Scotland a sheriff may make an order for forfeiture of any machinery or partly completed machinery in relation to which there has been a contravention of any provision of regulation 7 or 8—

(a)on an application by the procurator-fiscal made in the manner specified in section 134 of the Criminal Procedure (Scotland) Act 1995 (“the 1995 Act”); or

(b)where a person is convicted of any offence in respect of any such contravention, in addition to any other penalty which the sheriff may impose.

(2) The procurator-fiscal making an application under sub-paragraph (1)(a) shall serve on any person appearing to the procurator-fiscal to be the owner of, or otherwise to have an interest in, machinery or partly completed machinery to which the application relates a copy of the application, together with a notice giving that person the opportunity to appear at the hearing of the application to show cause why the machinery or partly completed machinery should not be forfeited.

(3) Service under sub-paragraph (2) shall be carried out, and such service may be proved, in the manner specified for citation of an accused in summary proceedings under the 1995 Act.

(4) Any person upon whom a notice is served under sub-paragraph (2) and any other person claiming to be the owner of, or otherwise to have an interest in, the machinery or partly completed machinery to which an application under this paragraph relates shall be entitled to appear at the hearing of the application to show cause why the machinery or partly completed machinery should not be forfeited.

(5) The sheriff shall not make an order following an application under sub-paragraph (1)(a)—

(a)if any person on whom notice is served under sub-paragraph (2) does not appear, unless service of the notice on that person is proved; or

(b)if no notice under sub-paragraph (2) has been served, unless the court is satisfied that in the circumstances it was reasonable not to serve notice on any person.

(6) The sheriff shall make an order under this paragraph only if satisfied that there has been a contravention in relation to the machinery or partly completed machinery of regulation 7 or 8.

(7) The sheriff may infer for the purposes of this paragraph that there has been a contravention of regulation 7 or 8 in relation to any machinery or partly completed machinery if satisfied that either of those regulations has been contravened in relation to a machine or partly completed machine which is representative of that machinery or partly completed machinery (whether by reason of being of the same design or part of the same consignment or batch or otherwise).

(8) Where an order for the forfeiture of any machinery or partly completed machinery is made following an application by the procurator-fiscal under sub-paragraph (1)(a), any person who appeared, or was entitled to appear, to show cause why it should not be forfeited may, within twenty-one days of the making of the order, appeal to the High Court by Bill of Suspension on the ground of an alleged miscarriage of justice; and section 182(5)(a) to (e) of the 1995 Act shall apply to an appeal under this sub-paragraph as it applies to a stated case under Part 10 of that Act.

(9) An order following an application under sub-paragraph (1)(a) shall not take effect—

(a)until the end of the period of twenty-one days beginning with the day after the day on which the order is made; or

(b)if an appeal is made under sub-paragraph (8) within that period, until the appeal is determined or abandoned.

(10) An order under sub-paragraph (1)(b) shall not take effect—

(a)until the end of the period within which an appeal against the order could be brought under the 1995 Act; or

(b)if an appeal is made within that period, until the appeal is determined or abandoned.

(11) Subject to sub-paragraph (12), machinery or partly completed machinery forfeited under this paragraph shall be destroyed in accordance with such directions as the sheriff may give.

(12) The sheriff may direct the machinery or partly completed machinery to be released to such person as the sheriff may specify, on condition that that person does not supply it to any person otherwise than—

(a)to a person who carries on a business of buying machinery or partly completed machinery of the same description as that machinery or partly completed machinery and repairing or reconditioning it; or

(b)as scrap (that is to say, for the value of materials included in the machinery or partly completed machinery rather than for the value of the machinery or partly completed machinery itself).

Duty of enforcement authority to inform Secretary of State of action taken

16.  Any enforcement authority (other than the Secretary of State) which takes action (whether under these Regulations or otherwise) to prohibit or restrict the placing on the market or putting into service of any machinery or partly completed machinery which bears the CE marking must immediately inform the Secretary of State of the action taken, and the reasons for it, with a view to that information being passed by the Secretary of State to the Commission.

Savings

17.—(1) Nothing in these Regulations prevents an enforcement authority from taking any action (whether by way of investigation, prosecution or otherwise) which it is permitted to take in relation to machinery or partly completed machinery under or by virtue of the 1974 Act, the 1978 Order or the 1987 Act.

(2) To the extent that an enforcement authority takes action in relation to machinery or partly completed machinery under or by virtue of the 1974 Act, the 1978 Order or the 1987 Act, and not under these Regulations, any modification made to those Acts by these Regulations shall be disregarded.

18.  Nothing in these Regulations shall authorise an enforcement authority to bring proceedings in Scotland for an offence.

Regulation 25

SCHEDULE 6AMENDMENTS TO THE LIFTS REGULATIONS 1997

1.  In this Schedule, any reference to a regulation or Schedule is a reference to the relevant regulation of or Schedule to the Lifts Regulations 1997.

2.  For regulation 2(1)(b) there shall be substituted the following—

(b)except for the reference to the European Communities in the definition of “the Commission” and in relation to the Official Journal, a reference to the Community includes a reference to the European Economic Area, and a reference to a member State includes a reference to an EEA state which is not a member State; and.

3.  In regulation 2(1)(c)(ii), for “Directive 98/37/EC” there shall be substituted “Directive 2006/42/EC”.

4.  Before the definition of “CE marking” in regulation 2(2), there shall be inserted—

“carrier” means a part of a lift by which persons or goods are transported in order to be lifted or lowered;.

5.  The following shall be substituted for the definition of “lift” in regulation 2(2)—

“lift” means a lifting appliance—

(a)

serving specific levels,

(b)

having a carrier moving along guides which are rigid and inclined at an angle of more than 15 degrees to the horizontal, and

(c)

intended for the transport of—

(i)

persons,

(ii)

persons and goods, or

(iii)

goods alone, if the carrier is—

(aa)

accessible, that is to say a person may enter it without difficulty, and

(bb)

fitted with controls situated inside the carrier or within reach of a person inside the carrier,

but lifting appliances moving along a fixed course even where they do not move along guides which are rigid shall be considered as lifts falling within the scope of these Regulations...

6.  In Schedule 1—

(a)for each of the references to “Directive 98/37/EC” in the heading and text of section 1.1, and in the text of section 5, of Annex I to the Lifts Directive (Directive 95/16/EC), there shall be substituted a reference to “Directive 2006/42/EC”, and the references to other directives in the heading to section 1.1 of that Annex shall be deleted; and

(b)for section 1.2, the following shall be substituted—

The carrier of each lift must be a car. This car must be designed and constructed to offer the space and strength corresponding to the maximum number of persons and the rated load of the lift set by the installer.

Where the lift is intended for the transport of persons, and where its dimensions permit, the car must be designed and constructed in such a way that its structural features do not obstruct or impede access and use by disabled persons and so as to allow any appropriate adjustments intended to facilitate its use by them..

7.  For the lifts specified in Schedule 14 (Excluded lifts) there shall be substituted the following—

1.  Lifting appliances whose speed is not greater than 0.15m/s.

2.  Construction site hoists.

3.  Cableways, including funicular railways.

4.  Lifts specially designed and constructed for military or police purposes.

5.  Lifting appliances from which work can be carried out.

6.  Mine winding gear.

7.  Lifting appliances intended for lifting performers during artistic performances.

8.  Lifting appliances fitted in means of transport.

9.  Lifting appliances connected to machinery and intended exclusively for access to workstations including maintenance and inspection points on the machinery.

10.  Rack and pinion trains.

11.  Escalators and mechanical walkways..

Regulation 26

SCHEDULE 7OTHER AMENDMENTS

The Provision and Use of Work Equipment Regulations 1998

1.  In Schedule 1 to the Provision and Use of Work Equipment Regulations 1998(34)—

(a)the entry relating to the 1992 Regulations shall be deleted; and

(b)a new entry shall be inserted at the end, as follows—

(i)in the first column: “The Supply of Machinery (Safety) Regulations 2008”; and

(ii)in the second column, the S.I. number of these Regulations.

The Lifting Operations and Lifting Equipment Regulations 1998

2.  In regulation 2(1) of the Lifting Operations and Lifting Equipment Regulations 1998(35)—

(a)the definition of “the 1992 Regulations” shall be deleted; and

(b)in sub-paragraph (a) of the definition of “EC declaration of conformity”, for “regulation 22 of the 1992 Regulations”, there shall be substituted “section A of part 1 of Part 2 of Schedule 2 to the Supply of Machinery (Safety) Regulations 2008”.

The Pressure Equipment Regulations 1999

3.  In the Pressure Equipment Regulations 1999(36)—

(a)for regulation 2(1)(b) there shall be substituted the following—

(b)except for the reference to the European Communities in the definition of “the Commission” and in relation to the Official Journal, a reference to the Community includes a reference to the European Economic Area, and a reference to a member State includes a reference to an EEA state which is not a member State; and;

(b)for regulation 2(4) there shall be substituted—

(4) For the purposes of these Regulations, an item of pressure equipment or an assembly which is made available for the first time in the Community, whether for reward or free of charge, shall not be regarded as having been placed on the market if, prior to its being made so available, it has been used otherwise than in the course of business at all times since its manufacture or import.; and

(c)for the first indent in paragraph 6 of Schedule 1, there shall be substituted—

  • Directive 2006/42/EC of the European Parliament and of the Council of 17 May 2006 on machinery, and amending Directive 95/16/EC;.

The Noise Emission in the Environment by Equipment for use Outdoors Regulations 2001

4.—(1) For regulation 2(1)(b) of the Noise Emission in the Environment by Equipment for use Outdoors Regulations 2001(37) (“the 2001 Regulations”), there shall be substituted—

(b)except for the reference to the European Communities in the definition of “the Commission” and in relation to the Official Journal, a reference to the Community includes a reference to the European Economic Area, and a reference to a member State includes a reference to an EEA state which is not a member State; and.

(2) For the definition of “equipment for use outdoors”, in regulation 2(2) of the 2001 Regulations there shall be substituted the following—

“equipment for use outdoors” means all the kinds of machinery referred to in Article 2(a), (b) and (c) of Directive 2006/42/EC of the European Parliament and of the Council of 17 May 2006 on machinery, and amending Directive 95/16/EC, that is to say—

(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”); and

(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,

to the extent that they are either self-propelled or can be moved and which, irrespective of the driving element(s), are intended to be used, according to their type, in the open air and which contribute to environmental noise exposure, including non-powered equipment for industrial or environmental applications which is intended, according to its type, to be used outdoors and which contributes to environmental noise exposure;..

(3) In regulation 3(2) of the 2001 Regulations, for “paragraphs 1.5.8 and 1.7.4(f) of Schedule 3 to the Supply of Machinery (Safety) Regulations 1992” there shall be substituted “sections 1.5.8 and 1.7.4(u) of Part 1 of Schedule 2 to the Supply of Machinery (Safety) Regulations 2008”.

The Enterprise Act 2002 (Part 9 Restrictions on Disclosure of Information) (Specification) Order 2004

5.  In Schedule 1 to the Enterprise Act 2002 (Part 9 Restrictions on Disclosure of Information) (Specification) Order 2004(38) a new entry shall be inserted at the end, as follows—

  • The Supply of Machinery (Safety) Regulations 2008..

The Merchant Shipping and Fishing Vessels (Provision and Use of Work Equipment) Regulations 2006

6.  In Schedule 1 to the Merchant Shipping and Fishing Vessels (Provision and Use of Work Equipment) Regulations 2006(39)—

(a)the entry relating to the 1992 Regulations shall be deleted; and

(b)a new entry shall be inserted at the end, as follows—

(i)in the left-hand column: “The Supply of Machinery (Safety) Regulations 2008”; and

(ii)in the right-hand column, the S.I. number of these Regulations.

The Legislative and Regulatory Reform (Regulatory Functions) Order 2007

7.  In Part 3 of the Schedule to the Legislative and Regulatory Reform (Regulatory Functions) Order 2007(40), in the reference to the 1992 Regulations under the heading “Public health and safety”, “2008” shall be substituted for “1992” and the associated footnote.

EXPLANATORY NOTE

(This note is not part of the Regulations)

These Regulations implement Directive 2006/42/EC of the European Parliament and of the Council (O.J. No. L 157, 9.6.2006, p.24) on machinery, and amending Directive 95/16/EC (“the Machinery Directive”). The Machinery Directive revokes and replaces Directive 98/37/EC of the European Parliament and of the Council on the approximation of the laws of the Member States relating to machinery (O.J. No. L 207, 23.7.98, p.1) with effect from 29 December 2009. Directive 98/37/EC was implemented in the United Kingdom by the Supply of Machinery (Safety) Regulations 1992 (S.I. 1992/3063), as amended, which these Regulations revoke with effect from the same date.

The Machinery Directive is a “New Approach” directive. New Approach directives aim to remove technical barriers to trade in particular products by harmonising national health and safety provisions applicable to such products when they are first placed on the market or put into service in the EEA. Products which comply with their requirements are “CE” marked and can be placed on the market and put into service throughout the EEA.

The scope of the Regulations is set out in Part 1 (which also deals with other preliminary matters, such as commencement) and Part 2. In particular, regulations 4(2) and 6 set out the types of product which constitute “machinery” and “partly completed machinery” and are subject to the Regulations.

Part 3 sets out the key obligations on those who place machinery or partly completed machinery on the market or put it into service (referred to in the Directive as “manufacturers or their authorised representatives” and in the Regulations as “responsible persons”). These obligations include ensuring the safety of products (by reference to the essential health and safety requirements set out in Part 1 of Schedule 2); following a “conformity assessment procedure” (regulations 10 to 12); and documenting their compliance with the requirements of the Directive in various ways (notably by drawing up an “EC declaration of conformity” and affixing the CE marking to the product).

Part 4 makes further provision about CE marking. Part 5 is concerned with the activities of “notified bodies”, whose function is to assess the conformity of products with the Regulations. Part 6 makes provision about enforcement.

One of the functions of the Machinery Directive is to redefine the boundary between the regulation of machinery in general and the regulation of passenger lifts under the “Lifts Directive” (Directive 95/16/EC, O.J. No. L 213, 7.9.1995, p.1). Regulation 25 makes the changes to the United Kingdom regulations implementing the Lifts Directive (the Lifts Regulations 1997 (S.I. 1997/831)) which the Machinery Directive requires. The remaining provisions of Part 7 make consequential changes to or avoid overlaps with other pieces of legislation, as well as rectifying some technical drafting defects in regulations implementing other New Approach Directives.

An Impact Assessment (IA) in respect of these Regulations is available and a copy can be obtained from the Department for Business, Enterprise and Regulatory Reform. As these Regulations transpose the Machinery Directive, a transposition note (TN) setting out how the Government will transpose the Directive into UK law has been prepared. Copies of the IA and TN are available from the Business Group, Department for Business, Enterprise and Regulatory Reform, 1 Victoria Street, London SW1H 0ET. Copies of these documents have been placed in the libraries of both Houses of Parliament.

(1)

S.I. 2007/1679 (machinery etc) and S.I. 1996/1912 (lifts etc).

(3)

O.J. No. L 157, 9.6.2006, p.24, with corrigendum at O.J. No. L 76, 16.3.2007, p.35.

(4)

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

(9)

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

(10)

O.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).

(12)

1954 c.70.

(13)

1969 c.6.

(22)

O.J. No. L 374, 27.12.2006, p.10.

(23)

O.J. No. L 171, 9.7.2003, p.1.

(24)

O.J. No. L 263, 9.10.2007, p.1.

(25)

O.J. No. L 49, 22.2.2003, p.23.

(26)

O.J. No. L 374, 27.12.2006, p.10.

(27)

Sections 18, 27, 28 and 34(1) were amended by S.I. 2008/960. Section 20(7) was amended by the Civil Partnership Act 2004 (c.33), section 261(1) and Schedule 27, paragraph 49. Sections 22 and 28(1)(a) were amended, and sections 25A and 27A were inserted, by section 36 of, and Schedule 3 to, the 1987 Act. Section 23(4) was amended by the Fire and Rescue Services Act 2004 (c.21), Schedule 1, paragraph 44 and by S.I. 2005/1541, S.I. 2006/475, and (in relation to Scotland) S.S.I. 2005/383. Section 24 was amended by section 1(2)(a) of the Employment Rights (Dispute Resolution) Act 1998 (c.8). Section 27 was amended by the Employment Act 1989 (c.38), Schedule 6, paragraph 10 and Schedule 7, Part I. Section 27A was amended by the Commissioners for Revenue and Customs Act 2005 (c.11), Schedule 4, paragraph 18. Section 28(1)(a) was amended by section 105(2) of the Railways and Transport Safety Act 2003 (c.20). Subsections (3), (4) and (5) of section 28 were amended by the Environment Act 1995 (c.25), Schedule 22, paragraph 30(6); subsection (3)(c) was also amended by the Water Act 1989 (c.15), Schedule 25, paragraph 46, and (in relation to Scotland) by the Local Government etc. (Scotland) Act 1994 (c.39), Schedule 13, paragraph 93 and S.I. 2004/1822. Section 28(3)(f) was inserted by S.I. 2004/3363. Section 28(5) was amended by the Water Act 1989, Schedule 25, paragraph 46, S.I. 2004/1822 and S.I. 2004/3363. Section 28(6) was amended by the Local Government Act 1985 (c.51), Schedule 14, paragraph 52, by the Education Reform Act 1988 (c.40), Schedule 13, Part I, by the Greater London Authority Act 1999 (c.29), Schedule 29, Part I, paragraph 23, and by the Local Government and Public Involvement in Health Act 2007 (c.28), Schedule 13, Part 2, paragraph 32. Section 28(9) was inserted by the Employment Protection Act 1975 (c.71), Schedule 15, paragraph 9. Section 28(9A) was inserted by S.I. 2004/3363. Section 28(10) was inserted by the Norfolk and Suffolk Broads Act 1988 (c.4), Schedule 6, paragraph 13, and substituted by the Environment Act 1995, Schedule 10, paragraph 12. Section 33(2) was amended by section 31 of, and Schedule 6 to, the Criminal Law Act 1977 (c.45) and sections 37 and 46 of the Criminal Justice Act 1982 (c.48).

(28)

Section 33 was amended by the Employment Protection Act 1975, Schedule 15, paragraph 11 and Schedule 18, by section 32(2) of the Magistrates’ Courts Act 1980 (c.43), by the Forgery and Counterfeiting Act 1981 (c.45), Schedule, Part I, by section 36 of, and Schedule 3 to, the 1987 Act, and by section 4 of the Offshore Safety Act 1992 (c.15). In section 34, subsection (5) was amended by section 461(1) of, and Schedule 9, paragraph 51 to, the Criminal Procedure (Scotland) Act 1975 (c.21); and subsection (6) was inserted, in relation to Scotland, by the Gas Act 1986 (c.44), Schedule 7, paragraph 18.

(29)

All these provisions were modified by S.R. (NI) 2000/87, S.R. (NI) 2000/120 and section 1 of the Railway Safety Act (Northern Ireland) 2002 (c.8 (N.I.)). Article 22(7) was amended by the Civil Partnerships Act 2004 (c.33). Article 26(4) was repealed by Article 35 of, and Schedule 4 to, the Industrial Training (Northern Ireland) Order 1984 (S.I. 1984/1159 (N.I. 9)). Articles 27A and 29A were inserted, and Articles 30(1)(a) and 31(1)(h) amended, by Article 28 of, and Schedule 2 to, the Consumer Protection (Northern Ireland) Order 1987 (S.I. 1987/2049 (N.I. 20)). Article 29(1) was amended, and Article 31(3) was repealed, by the Health and Safety at Work (Amendment) (Northern Ireland) Order 1998 (S.I. 1998/2795 (N.I. 18)), Schedule 1, paragraphs 14 and 15 respectively. Articles 29(2) to (4) were repealed, and Article 31(1)(j) was amended, by Article 10(1)(c) of the Statistics of Trade and Employment (Northern Ireland) Order 1988 (S.I. 1988/595 (N.I. 3)). Article 29A was amended by the Commissioners for Revenue and Customs Act 2005 (c.11), Schedule 4, paragraph 19. Article 31(1)(m) was amended by Article 13(3) of, and Schedule 5 to, the Criminal Justice (Northern Ireland) Order 1986 (S.I. 1986/1883 (N.I. 15)). Article 31(5)(d) and (6) was repealed by Article 6(6) of the Offshore, and Pipelines, Safety (Northern Ireland) Order 1992 (S.I. 1992/1728 (N.I. 17)). Article 31(7) was repealed by Part III of the Schedule to the Forgery and Counterfeiting Act 1981 (c.45). There are other amendments to these provisions which are not relevant to these Regulations.

(30)

Article 34A was inserted by the Health and Safety at Work (Amendment) (Northern Ireland) Order 1998 (S.I. 1998/2795 (N.I. 18)), Schedule 1, paragraph 16.

(31)

Section 37 was amended by the Commissioners for Revenue and Customs Act 2005 (c.11), Schedule 4, paragraph 36.

(32)

Section 47(2) was amended by the Civil Partnerships Act 2004 (c.33), Schedule 27, paragraph 126.

(33)

Section 39(5) was amended by S.I. 2005/1803.

(34)

S.I. 1998/2306, amended by S.I. 2005/831; there are other amending instruments but none is relevant.

(35)

S.I. 1998/2307, amended by S.I. 2005/831; there are other amending instruments but none is relevant.

(36)

S.I. 1999/2001, to which there are amendments not relevant to these Regulations.

(37)

S.I. 2001/1701, amended by S.I. 2001/3958; there are other amending instruments but none is relevant.

(38)

S.I. 2004/693, to which there are amendments not relevant to these Regulations.

(40)

S.I. 2007/3544, to which there are amendments not relevant to these Regulations.

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