11.10.2005 EN Official Journal of the European Union C 251E/1

I

(Information)

COUNCIL

COMMON POSITION (EC) No 29/2005

adopted by the Council on 18 July 2005

with a view to the adoption of Directive 2005/.../EC of the European Parliament and of the

Council of ... on machinery, and amending Directive 95/16/EC

(2005/C 251 E/01)

(Text with EEA relevance)

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EURO- of the Community economy. The social cost of the large

PEAN UNION, number of accidents caused directly by the use of

machinery can be reduced by inherently safe design and

Having regard to the Treaty establishing the European Com- construction of machinery and by proper installation

munity, and in particular Article 95 thereof, and maintenance.

Having regard to the proposal from the Commission (1),

(3) Member States are responsible for ensuring the health

Having regard to the Opinion of the European Economic and and safety on their territory of persons, in particular of

Social Committee (2), workers and consumers and, where appropriate, of

domestic animals and goods, notably in relation to the

risks arising out of the use of machinery.

Acting in accordance with the procedure laid down in Article

251 of the Treaty (3),

Whereas: (4) In order to ensure legal certainty for users, the scope of

this Directive and the concepts relating to its application

should be defined as precisely as possible.

(1) Directive 98/37/EC of the European Parliament and of

the Council of 22 June 1998 on the approximation of

the laws of the Member States relating to machinery (4)

codified Council Directive 89/392/EEC of 14 June 1989 (5) The Member States' mandatory provisions governing

on the approximation of the laws of the Member States construction site hoists intended for lifting persons or

relating to machinery (5). Now that new substantial persons and goods, which are often supplemented by de

amendments are being made to Directive 98/37/EC, it is facto compulsory technical specifications and/or by

desirable, in order to clarify matters, that the Directive in voluntary standards, do not necessarily lead to different

question should be recast. levels of health and safety but, because of their dispari-

ties, do nevertheless constitute barriers to trade within

(2) The machinery sector is an important part of the engi- the Community. Moreover, the national systems for the

neering industry and is one of the industrial mainstays conformity assessment and certification of these

machines diverge considerably. It is therefore desirable

not to exclude from the scope of this Directive construc-

(1) OJ C 154 E, 29.5.2001, p. 164.

(2) OJ C 311, 7.11.2001, p. 1. tion site hoists intended for lifting persons or persons

(3) Opinion of the European Parliament of 4 July 2002 (OJ C 271 E, and goods.

12.11.2003, p. 491), Council Common Position of 18 July 2005

and Position of the European Parliament of ... (not yet published in

the Official Journal).

(4) OJ L 207, 23.7.1998, p. 1. Directive as amended by Directive (6) It is appropriate to exclude from the scope of this Direc-

98/79/EC (OJ L 331, 7.12.1998, p. 1).

(5) OJ L 183, 29.6.1989, p. 9. Directive as last amended by Directive tive weapons, including firearms that are subject to

93/68/EEC (OJ L 220, 30.8.1993, p. 1). Council Directive 91/477/EEC of 18 June 1991 on

C 251E/2 EN Official Journal of the European Union 11.10.2005

control of the acquisition and possession of weapons (1); assisted by a committee, in the light of consultations

the exclusion of firearms should not apply to portable with the Member States and other interested parties.

cartridge-operated fixing and other impact machinery Since such measures are not directly applicable to

designed for industrial or technical purposes only. It is economic operators, Member States should take all

necessary to provide for transitional arrangements necessary measures for their implementation.

enabling Member States to authorise the placing on the

market and putting into service of such machinery

manufactured in accordance with national provisions in

force upon adoption of this Directive, including those (12) The essential health and safety requirements should be

implementing the Convention of 1 July 1969 on the satisfied in order to ensure that machinery is safe; these

Reciprocal Recognition of Proofmarks on Small Arms. requirements should be applied with discernment to take

Such transitional arrangements will also enable the Euro- account of the state of the art at the time of construction

pean standardisation organisations to draft standards and of technical and economic requirements.

ensuring the safety level based on the state of the art.

(13) Where the machinery may be used by a consumer, that

(7) This Directive does not apply to the lifting of persons by is to say, a non-professional operator, the manufacturer

means of machines not designed for the lifting of should take account of this in the design and construc-

persons. However, this does not affect the right of tion. The same applies where a machine is normally

Member States to take national measures, in accordance used to provide a service to a consumer.

with the Treaty, with respect to such machines, with a

view to implementing Council Directive 89/655/EEC of

30 November 1989 concerning the minimum safety and

health requirements for the use of work equipment by (14) Although the requirements of this Directive do not

workers at work (second individual Directive within the apply to partly completed machinery in their entirety, it

meaning of Article 16(1) of Directive 89/391/EEC) (2). is nevertheless important that the free movement of

such machinery be guaranteed by means of a specific

procedure.

(8) Market surveillance is an essential instrument inasmuch

as it ensures the proper and uniform application of

Directives. It is therefore appropriate to put in place the (15) For trade fairs, exhibitions, etc., it should be possible to

legal framework within which market surveillance can exhibit machinery which does not satisfy the require-

proceed harmoniously. ments of this Directive. However, interested parties

should be properly informed that the machinery does

not conform and cannot be purchased in that condition.

(9) In the context of market surveillance, a clear distinction

should be established between the disputing of a harmo-

nised standard conferring a presumption of conformity

on machinery and the safeguard clause relating to (16) This Directive defines only the essential health and safety

machinery. requirements of general application, supplemented by a

number of more specific requirements for certain cate-

gories of machinery. In order to help manufacturers to

prove conformity to these essential requirements, and to

(10) The putting into service of machinery within the allow inspection of conformity to the essential require-

meaning of this Directive can relate only to the use of ments, it is desirable to have standards that are harmo-

the machinery itself for its intended purpose or for a nised at Community level for the prevention of risks

purpose which can reasonably be foreseen. This does arising out of the design and construction of machinery.

not preclude the laying down of conditions of use These standards are drawn up by private-law bodies and

external to the machinery, provided that it is not thereby should retain their non-binding status.

modified in a way not specified in this Directive.

(11) It is also necessary to provide for an adequate (17) In view of the nature of the risks involved in the use of

mechanism allowing for the adoption of specific machinery covered by this Directive, procedures for

measures at Community level requiring Member States assessing conformity to the essential health and safety

to prohibit or restrict the placing on the market of requirements should be established. These procedures

certain types of machinery presenting the same risks to should be devised in the light of the extent of the danger

the health and safety of persons either due to shortcom- inherent in such machinery. Consequently, each category

ings in the relevant harmonised standard(s) or by virtue of machinery should have its appropriate procedure in

of their technical characteristics, or to make such conformity with Council Decision 93/465/EEC of 22

machinery subject to special conditions. In order to July 1993 concerning the modules for the various

ensure the appropriate assessment of the need for such phases of the conformity assessment procedures and the

measures, they should be taken by the Commission, rules for the affixing and use of the CE conformity

marking, which are intended to be used in the technical

harmonisation directives (3), taking account of the nature

(1) OJ L 256, 13.9.1991, p. 51. of the verification required for such machinery.

(2) OJ L 393, 30.12.1989, p. 13. Directive as last amended by Directive

2001/45/EC of the European Parliament and of the Council (OJ

L 195, 19.7.2001, p. 46). (3) OJ L 220, 30.8.1993, p. 23.

11.10.2005 EN Official Journal of the European Union C 251E/3

(18) Manufacturers should retain full responsibility for certi- (26) Since the objective of this Directive, namely, to lay

fying the conformity of their machinery to the provi- down the essential health and safety requirements in

sions of this Directive. Nevertheless, for certain types of relation to design and manufacture in order to improve

machinery having a higher risk factor, a stricter certifica- the safety of machinery placed on the market, cannot be

tion procedure is desirable. sufficiently achieved by the Member States and can be

better achieved at Community level, the Community

may adopt measures, in accordance with the principle of

(19) The CE marking should be fully recognised as being the subsidiarity as set out in Article 5 of the Treaty. In

only marking which guarantees that machinery accordance with the principle of proportionality, as set

conforms to the requirements of this Directive. All other out in that Article, this Directive does not go beyond

markings which are liable to mislead third parties as to what is necessary in order to achieve that objective.

the meaning and/or the form of the CE marking should

be prohibited.

(27) The Council, in accordance with paragraph 34 of the

Interinstitutional agreement on better law-making (2),

(20) In order to ensure the same quality for the CE marking should encourage Member States to draw up, for them-

and the manufacturer's mark, it is important that they be selves and in the interests of the Community, their own

affixed according to the same techniques. In order to tables which will, as far as possible, illustrate the correla-

avoid confusion between any CE markings which might tion between this Directive and the transposition

appear on certain components and the CE marking measures and to make them public.

corresponding to the machinery, it is important that the

latter marking be affixed alongside the name of the

person who has taken responsibility for it, namely the (28) The measures necessary for the implementation of this

manufacturer or his authorised representative. Directive should be adopted in accordance with Council

Decision 1999/468/EC of 28 June 1999 laying down

the procedures for the exercise of implementing powers

(21) The manufacturer or his authorised representative conferred on the Commission (3),

should also ensure that a risk assessment is carried out

for the machinery which he wishes to place on the

market. For this purpose, he should determine which are

the essential health and safety requirements applicable to

his machinery and in respect of which he must take

measures. HAVE ADOPTED THIS DIRECTIVE:

(22) It is essential that, before drawing up the EC declaration

of conformity, the manufacturer or his authorised repre- Article 1

sentative established in the Community should prepare a

technical construction file. However, it is not essential

that all documentation should be permanently available Scope

in material form, but it must be possible to make it

available on request. It need not include detailed plans of 1. This Directive applies to the following products:

subassemblies used for the manufacture of machinery,

unless knowledge of such plans is essential in order to

ascertain conformity with the essential health and safety (a) machinery;

requirements. (b) interchangeable equipment;

(23) The addressees of any decision taken under this Directive (c) safety components;

should be informed of the reasons for such a decision

and of the legal remedies open to them. (d) lifting accessories;

(e) chains, ropes and webbing;

(24) Member States should provide for penalties applicable to

infringements of the provisions of this Directive. Those (f) removable mechanical transmission devices;

penalties should be effective, proportionate and dissua-

sive. (g) partly completed machinery.

(25) The application of this Directive to a number of 2. The following are excluded from the scope of this Direc-

machines intended for lifting persons requires a better tive:

delimitation of the products covered by this Directive

with respect to those covered by Directive 95/16/EC of (a) safety components intended to be used as spare parts to

the European Parliament and of the Council of 29 June replace identical components and supplied by the manufac-

1995 on the approximation of the laws of the Member turer of the original machinery;

States relating to lifts (1). A redefinition of the scope of

the latter Directive is thus deemed necessary. Directive (b) specific equipment for use in fairgrounds and/or amuse-

95/16/EC should therefore be amended accordingly. ment parks;

(1) OJ L 213, 7.9.1995, p. 1. Directive as amended by Regulation (EC) (2) OJ C 321, 31.12.2003, p. 1.

No 1882/2003 (OJ L 284, 31.10.2003, p. 1). (3) OJ L 184, 17.7.1999, p. 23.

C 251E/4 EN Official Journal of the European Union 11.10.2005

(c) machinery specially designed or put into service for nuclear harmonisation of the laws of Member States relating to

purposes which, in the event of failure, may result in an electrical equipment designed for use within certain voltage

emission of radioactivity; limits (4):

- household appliances intended for domestic use,

(d) weapons, including firearms;

- audio and video equipment,

(e) the following means of transport: - information technology equipment,

- agricultural and forestry tractors for the risks covered - ordinary office machinery,

by Directive 2003/37/EC of the European Parliament

and of the Council of 26 May 2003 on type-approval - circuit-breakers and switches;

of agricultural and forestry tractors, their trailers and (l) the following types of high-voltage electrical equipment:

interchangeable towed machinery, together with their

systems, components and separate technical units and - switch gear and control gear,

repealing Directive 74/150/EEC (1), with the exclusion

of machinery mounted on these vehicles, - transformers.

- motor vehicles and their trailers covered by Council Article 2

Directive 70/156/EEC of 6 February 1970 on the

approximation of the laws of the Member States

relating to the type-approval of motor vehicles and Definitions

their trailers (2), with the exclusion of machinery

mounted on these vehicles, For the purposes of this Directive, `machinery' designates the

products listed in Article 1(1)(a) to (f).

- vehicles covered by Directive 2002/24/EC of the Euro-

pean Parliament and of the Council of 18 March 2002 The following definitions shall apply:

relating to the type-approval of two or three-wheel (a) `machinery' means:

motor vehicles and repealing Council Directive

92/61/EEC (3), with the exclusion of machinery (i) an assembly, fitted with or intended to be fitted with a

mounted on these vehicles, drive system other than directly applied human or

animal effort, consisting of linked parts or compo-

- motor vehicles exclusively intended for competition, nents, at least one of which moves, and which are

and joined together for a specific application;

(ii) an assembly referred to in (i), missing only the compo-

- means of transport by air, on water and on rail nents to connect it on site or to sources of energy and

networks with the exclusion of machinery mounted on motion;

these means of transport; (iii) an assembly referred to in (i) or (ii), ready to be

installed and able to function as it stands only if

(f) seagoing vessels and mobile offshore units and machinery mounted on a means of transport, or installed in a

installed on board such vessels and/or units; building or a structure;

(g) machinery specially designed and constructed for military (iv) assemblies of machinery referred to in (i), (ii) or (iii) or

or police purposes; partly completed machinery referred to in (g) which, in

order to achieve the same end, are arranged and

controlled so that they function as an integral whole;

(h) machinery specially designed and constructed for research

purposes for temporary use in laboratories; (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

(i) mine winding gear; is directly applied human effort;

(j) machinery intended to move performers during artistic (b) 'interchangeable equipment' means a device which, after

performances; the putting into service of machinery or of a tractor, is

assembled with that machinery or tractor by the operator

himself in order to change its function or attribute a new

(k) electrical and electronic products falling within the function, in so far as this equipment is not a tool;

following areas, insofar as they are covered by Council

Directive 73/23/EEC of 19 February 1973 on the (c) `safety component' means a component:

- which serves to fulfil a safety function, and

(1) OJ L 171, 9.7.2003, p. 1. Directive as last amended by Commission

Directive 2005/13/EC (OJ L 55, 1.3.2005, p. 35). - which is independently placed on the market, and

(2) OJ L 42, 23.2.1970, p. 1. Directive as last amended by Commission

Directive 2005/49/EC (OJ L 194, 26.7.2005, p. 12).

(3) OJ L 124, 9.5.2002, p. 1. Directive as last amended by Commission (4) OJ L 77, 26.3.1973, p. 29. Directive as amended by Directive

Directive 2005/30/EC (OJ L 106, 27.4.2005, p. 17). 93/68/EEC.

11.10.2005 EN Official Journal of the European Union C 251E/5

- the failure and/or malfunction of which endangers the European Committee for Standardization (CEN), the Euro-

safety of persons, and pean Committee for Electrotechnical Standardization

(Cenelec) or the European Telecommunications Standards

- which is not necessary in order for the machinery to Institute (ETSI), on the basis of a remit issued by the

function, or for which normal components may be Commission in accordance with the procedures laid down

substituted in order for the machinery to function. in Directive 98/34/EC of the European Parliament and of

the Council of 22 June 1998 laying down a procedure for

An indicative list of safety components is set out in Annex the provision of information in the field of technical stan-

V, which may be updated in accordance with Article dards and regulations and of rules on Information Society

8(1)(a); services (1).

(d) `lifting accessory' means a component or equipment not

attached to the lifting machinery, allowing the load to be Article 3

held, which is placed between the machinery and the load

or on the load itself, or which is intended to constitute an Specific Directives

integral part of the load and which is independently placed

on the market; slings and their components are also Where, for machinery, the hazards referred to in Annex I are

regarded as lifting accessories; wholly or partly covered more specifically by other Community

Directives, this Directive shall not apply, or shall cease to

(e) `chains, ropes and webbing' means chains, ropes and apply, to that machinery in respect of such hazards from the

webbing designed and constructed for lifting purposes as date of implementation of those other Directives.

part of lifting machinery or lifting accessories;

(f) `removable mechanical transmission device' means a remo- Article 4

vable component for transmitting power between self-

propelled machinery or a tractor and another machine by Market surveillance

joining them at the first fixed bearing. When it is placed on

the market with the guard it shall be regarded as one 1. Member States shall take all appropriate measures to

product; ensure that machinery may be placed on the market and/or put

into service only if it satisfies the relevant provisions of this

(g) `partly completed machinery' means an assembly which is Directive and does not endanger the health and safety of

almost machinery but which cannot in itself perform a persons and, where appropriate, domestic animals or property,

specific application. A drive system is partly completed when properly installed and maintained and used for its

machinery. Partly completed machinery is only intended to intended purpose or under conditions which can reasonably be

be incorporated into or assembled with other machinery or foreseen.

other partly completed machinery or equipment, thereby

forming machinery to which this Directive applies; 2. Member States shall take all appropriate measures to

ensure that partly completed machinery can be placed on the

(h) `placing on the market' means making available for the first market only if it satisfies the relevant provisions of this Direc-

time in the Community machinery or partly completed tive.

machinery with a view to distribution or use, whether for

reward or free of charge; 3. Member States shall institute or appoint the competent

authorities to monitor the conformity of machinery and partly

(i) `manufacturer' means any natural or legal person who completed machinery with the provisions set out in paragraphs

designs and/or manufactures machinery or partly 1 and 2.

completed machinery covered by this Directive and is

responsible for the conformity of the machinery or the 4. Member States shall define the tasks, organisation and

partly completed machinery with this Directive with a view powers of the competent authorities referred to in paragraph 3

to its being placed on the market, under his own name or and shall notify the Commission and other Member States

trademark or for his own use. In the absence of a manufac- thereof and also of any subsequent amendment.

turer as defined above, any natural or legal person who

places on the market or puts into service machinery or

partly completed machinery covered by this Directive shall Article 5

be considered a manufacturer; Placing on the market and putting into service

(j) `authorised representative' means any natural or legal

person established in the Community who has received a 1. Before placing machinery on the market and/or putting it

written mandate from the manufacturer to perform on his into service, the manufacturer or his authorised representative

behalf all or part of the obligations and formalities shall:

connected with this Directive; (a) ensure that it satisfies the relevant essential health and

safety requirements set out in Annex I;

(k) `putting into service' means the first use, for its intended

purpose, in the Community, of machinery covered by this (b) ensure that the technical file referred to in Section A of

Directive; Annex VII is available;

(l) `harmonised standard' means a non-binding technical speci- (1) OJ L 204, 21.7.1998, p. 37. Directive as last amended by the 2003

fication adopted by a standardisation body, namely the Act of Accession.

C 251E/6 EN Official Journal of the European Union 11.10.2005

(c) provide, in particular, the necessary information, such as Article 7

instructions;

(d) carry out the appropriate conformity assessment proce- Presumption of conformity and harmonised standards

dures in accordance with Article 12;

1. Member States shall regard machinery bearing the CE

(e) draw up the EC declaration of conformity in accordance marking and accompanied by the EC declaration of conformity,

with Section A in Part 1 of Annex II and ensure that it the content of which is set out in Annex II, Part 1, Section A,

accompanies the machinery; as complying with the provisions of this Directive.

(f) affix the CE marking in accordance with Article 16. 2. Machinery manufactured in conformity with a harmo-

2. Before placing partly completed machinery on the nised standard, the references to which have been published in

market, the manufacturer or his authorised representative shall the Official Journal of the European Union, shall be presumed to

ensure that the procedure referred to in Article 13 has been comply with the essential health and safety requirements

completed. covered by such a harmonised standard.

3. For the purposes of the procedures referred to in Article 3. The Commission shall publish in the Official Journal of the

12, the manufacturer or his authorised representative shall European Union the references of the harmonised standards.

have, or shall have access to, the necessary means of ensuring

that the machinery satisfies the essential health and safety 4. Member States shall take the appropriate measures to

requirements set out in Annex I. enable the social partners to have an influence at national level

on the process of preparing and monitoring the harmonised

4. Where machinery is also the subject of other Community standards.

Directives relating to other aspects and providing for the

affixing of the CE marking, the marking shall indicate that the

machinery also conforms to the provisions of those other

Directives. Article 8

However, where one or more of those Directives allow the Specific measures

manufacturer or his authorised representative to choose, during

a transitional period, the system to be applied, the CE marking

shall indicate conformity only to the provisions of those Direc- 1. The Commission, acting in accordance with the proce-

tives applied by the manufacturer or his authorised representa- dure referred to in Article 22(3), may take any appropriate

tive. Particulars of the Directives applied, as published in the measure to implement the provisions relating to the following

Official Journal of the European Union, shall be given on the EC points:

declaration of conformity. (a) updating of the indicative list of safety components in

Annex V referred to in point (c) in Article 2;

Article 6 (b) restriction of the placing on the market of machinery

referred to in Article 9.

Freedom of movement 2. The Commission, acting in accordance with the proce-

dure referred to in Article 22(2), may take any appropriate

1. Member States shall not prohibit, restrict or impede the measure connected with the implementation and practical

placing on the market and/or putting into service in their terri- application of this Directive, including measures necessary to

tory of machinery which complies with this Directive. ensure cooperation of Member States with each other and with

the Commission, as provided for in Article 19(1).

2. Member States shall not prohibit, restrict or impede the

placing on the market of partly completed machinery where

the manufacturer or his authorised representative makes a Article 9

declaration of incorporation, referred to in Annex II, Part 1,

Section B, stating that it is to be incorporated into machinery

or assembled with other partly completed machinery to form Specific measures to deal with potentially hazardous

machinery. machinery

3. At trade fairs, exhibitions, demonstrations, etc., Member 1. When, in accordance with the procedure referred to in

States shall not prevent the showing of machinery or partly Article 10, the Commission considers that a harmonised stand-

completed machinery which does not conform to this Direc- ard does not entirely satisfy the essential health and safety

tive, provided that a visible sign clearly indicates that it does requirements which it covers and which are set out in Annex I,

not conform and that it will not be made available until it has the Commission may, in accordance with paragraph 3, take

been brought into conformity. Furthermore, during demonstra- measures requiring Member States to prohibit or restrict the

tions of such non-conforming machinery or partly completed placing on the market of machinery with technical characteris-

machinery, adequate safety measures shall be taken to ensure tics presenting risks due to the shortcomings in the standard or

the protection of persons. to make such machinery subject to special conditions.

11.10.2005 EN Official Journal of the European Union C 251E/7

When, in accordance with the procedure referred to in Article (b) incorrect application of the harmonised standards referred

11, the Commission considers that a measure taken by a to in Article 7(2);

Member State is justified, the Commission may, in accordance

with paragraph 3, take measures requiring Member States to (c) shortcomings in the harmonised standards themselves

prohibit or restrict the placing on the market of machinery referred to in Article 7(2).

presenting the same risk by virtue of its technical characteristics

or to make such machinery subject to special conditions. 3. The Commission shall enter into consultation with the

parties concerned without delay.

2. Any Member State may request the Commission to

examine the need for the adoption of the measures referred to The Commission shall consider, after this consultation, whether

in paragraph 1. or not the measures taken by the Member State are justified,

and it shall communicate its decision to the Member State

3. In the cases referred to in paragraph 1, the Commission which took the initiative, the other Member States, and the

shall consult the Member States and other interested parties manufacturer or his authorised representative.

indicating the measures it intends to take, in order to ensure, at

Community level, a high level of protection of the health and

safety of persons. 4. Where the measures referred to in paragraph 1 are based

on a shortcoming in the harmonised standards and if the

Member State which instigated the measures maintains its posi-

Taking due account of the results of this consultation, it shall tion, the Commission or the Member State shall initiate the

adopt the necessary measures in accordance with the procedure procedure referred to in Article 10.

referred to in Article 22(3).

5. Where machinery does not conform and bears the CE

marking, the competent Member State shall take appropriate

Article 10 action against whomsoever has affixed the marking and shall

so inform the Commission. The Commission shall inform the

other Member States.

Procedure for disputing a harmonised standard

6. The Commission shall ensure that Member States are kept

Where a Member State or the Commission considers that a informed of the progress and outcome of the procedure.

harmonised standard does not entirely satisfy the essential

health and safety requirements which it covers and which are

set out in Annex I, the Commission or the Member State shall

bring the matter before the committee set up by Directive

98/34/EC, setting out the reasons therefor. The committee shall Article 12

deliver an opinion without delay. In the light of the commit-

tee's opinion, the Commission shall decide to publish, not to Procedures for assessing the conformity of machinery

publish, to publish with restriction, to maintain, to maintain

with restriction or to withdraw the references to the harmo-

nised standard concerned in the Official Journal of the European 1. The manufacturer or his authorised representative shall,

Union. in order to certify the conformity of machinery with the provi-

sions of this Directive, apply one of the procedures for assess-

ment of conformity described in paragraphs 2, 3 and 4.

Article 11 2. Where the machinery is not referred to in Annex IV, the

manufacturer or his authorised representative shall apply the

Safeguard clause procedure for assessment of conformity with internal checks

on the manufacture of machinery, provided for in Annex VIII.

1. Where a Member State ascertains that machinery covered

by this Directive, bearing the CE marking, accompanied by the 3. Where the machinery is referred to in Annex IV and

EC declaration of conformity and used in accordance with its manufactured in accordance with the harmonised standards

intended purpose or under conditions which can reasonably be referred to in Article 7(2), and provided that those standards

foreseen, is liable to compromise the health and safety of cover all of the relevant essential health and safety require-

persons and, where appropriate, domestic animals or property, ments, the manufacturer or his authorised representative shall

it shall take all appropriate measures to withdraw such apply one of the following procedures:

machinery from the market, to prohibit the placing on the

market and/or putting into service of such machinery or to (a) the procedure for assessment of conformity with internal

restrict free movement thereof. checks on the manufacture of machinery, provided for in

Annex VIII;

2. The Member State shall immediately inform the Commis-

sion and the other Member States of any such measure, indi- (b) the EC type-examination procedure provided for in Annex

cating the reasons for its decision and, in particular, whether IX, plus the internal checks on the manufacture of

the non-conformity is due to: machinery provided for in Annex VIII, point 3;

(a) failure to satisfy the essential requirements referred to in (c) the full quality assurance procedure provided for in Annex

Article 5(1)(a); X.

C 251E/8 EN Official Journal of the European Union 11.10.2005

4. Where the machinery is referred to in Annex IV and has and their identification numbers and the tasks for which they

not been manufactured in accordance with the harmonised have been notified. The Commission shall ensure that this list

standards referred to in Article 7(2), or only partly in accord- is kept up to date.

ance with such standards, or if the harmonised standards do

not cover all the relevant essential health and safety require-

ments or if no harmonised standards exist for the machinery in 5. Bodies meeting the assessment criteria laid down in the

question, the manufacturer or his authorised representative relevant harmonised standards, the references of which shall be

shall apply one of the following procedures: published in the Official Journal of the European Union, shall be

presumed to fulfil the relevant criteria.

(a) the EC type-examination procedure provided for in Annex

IX, plus the internal checks on the manufacture of 6. If a notified body finds that relevant requirements of this

machinery provided for in Annex VIII, point 3; Directive have not been met or are no longer met by the manu-

facturer or that an EC type-examination certificate or the

(b) the full quality assurance procedure provided for in Annex approval of a quality assurance system should not have been

X. issued, it shall, taking account of the principle of proportion-

ality, suspend or withdraw the certificate or the approval issued

or place restrictions on it, giving detailed reasons, unless

Article 13 compliance with such requirements is ensured by the imple-

mentation of appropriate corrective measures by the manufac-

Procedure for partly completed machinery turer. In the event of suspension or withdrawal of the certificate

or the approval or of any restriction placed on it, or in cases

1. The manufacturer of partly completed machinery or his where intervention by the competent authority may prove

authorised representative shall, before placing it on the market, necessary, the notified body shall inform the competent

ensure that: authority pursuant to Article 4. The Member State shall inform

the other Member States and the Commission without delay.

(a) the relevant technical documentation described in Annex An appeal procedure shall be available.

VII, Part B is prepared;

7. The Commission shall provide for the organisation of an

(b) assembly instructions described in Annex VI are prepared; exchange of experience between the authorities responsible for

appointment, notification and monitoring of notified bodies in

(c) a declaration of incorporation described in Annex II, Part 1, the Member States, and the notified bodies, in order to coordi-

Section B has been drawn up. nate the uniform application of this Directive.

2. The assembly instructions and the declaration of incor-

poration shall accompany the partly completed machinery until 8. A Member State which has notified a body shall immedi-

it is incorporated into the final machinery and shall then form ately withdraw its notification if it finds:

part of the technical file for that machinery.

(a) that the body no longer meets the criteria set out in Annex

XI; or

Article 14 (b) that the body seriously fails to fulfil its responsibilities.

Notified bodies The Member State shall immediately inform the Commission

and the other Member States accordingly.

1. Member States shall notify the Commission and the other

Member States of the bodies which they have appointed to

carry out the assessment of conformity for placing on the

market referred to in Article 12(3) and (4), together with the Article 15

specific conformity assessment procedures and categories of

machinery for which these bodies have been appointed and the Installation and use of machinery

identification numbers assigned to them beforehand by the

Commission. Member States shall notify the Commission and

other Member States of any subsequent amendment. This Directive shall not affect Member States' entitlement to lay

down, in due observance of Community law, such require-

2. The Member States shall ensure that the notified bodies ments as they may deem necessary to ensure that persons, and

are monitored regularly to check that they comply at all times in particular workers, are protected when using machinery,

with the criteria set out in Annex XI. The notified body shall provided that this does not mean that such machinery is modi-

provide all relevant information on request, including fied in a way not specified in this Directive.

budgetary documents, to enable the Member States to ensure

that the requirements of Annex XI are met.

Article 16

3. Member States shall apply the criteria set out in Annex XI

in assessing the bodies to be notified and the bodies already

notified. CE marking

4. The Commission shall publish in the Official Journal of the 1. The CE conformity marking shall consist of the initials

European Union, for information, a list of the notified bodies 'CE' as shown in Annex III.

11.10.2005 EN Official Journal of the European Union C 251E/9

2. The CE marking shall be affixed to the machinery visibly, cooperate with each other and with the Commission and

legibly and indelibly in accordance with Annex III. transmit to each other the information necessary to enable this

Directive to be applied uniformly.

3. The affixing on machinery of markings, signs and inscrip-

tions which are likely to mislead third parties as to the 2. The Commission shall provide for the organisation of an

meaning and/or form of the CE marking shall be prohibited. exchange of experience between the competent authorities

Any other marking may be affixed to the machinery provided responsible for market surveillance in order to coordinate the

that the visibility, legibility and meaning of the CE marking is uniform application of this Directive.

not thereby impaired.

Article 20

Article 17 Legal remedies

Non-conformity of marking Any measure taken pursuant to this Directive which restricts

1. Member States shall consider the following marking not the placing on the market and/or putting into service of any

to conform: machinery covered by this Directive shall state the exact

grounds on which it is based. Such a measure shall be notified

(a) the affixing of the CE marking pursuant to this Directive as soon as possible to the party concerned, who shall at the

on products not covered by this Directive; same time be informed of the legal remedies available to him

under the laws in force in the Member State concerned and of

(b) the absence of the CE marking and/or the absence of the the time limits to which such remedies are subject.

EC declaration of conformity for machinery;

(c) the affixing on machinery of a marking, other than the CE

marking, which is prohibited under Article 16(3). Article 21

2. Where a Member State ascertains that marking does not Dissemination of information

conform to the relevant provisions of this Directive, the manu-

facturer or his authorised representative shall be obliged to The Commission shall take the necessary measures for appro-

make the product conform and to put an end to the infringe- priate information concerning the implementation of this

ment under conditions fixed by that Member State. Directive to be made available.

3. Where non-conformity persists, the Member State shall

take all appropriate measures to restrict or prohibit the placing Article 22

on the market of the product in question or to ensure that it is

withdrawn from the market in accordance with the procedure Committee

laid down in Article 11. 1. The Commission shall be assisted by a committee, herein-

after referred to as the `Machinery Committee'.

Article 18 2. Where reference is made to this paragraph, Articles 3 and

7 of Decision 1999/468/EC shall apply, having regard to the

Confidentiality provisions of Article 8 thereof.

1. Without prejudice to existing national provisions and 3. Where reference is made to this paragraph, Articles 5 and

practices in the area of confidentiality, Member States shall 7 of Decision 1999/468/EC shall apply, having regard to the

ensure that all parties concerned by the application of this provisions of Article 8 thereof.

Directive are required to treat as confidential information

obtained in the execution of their tasks which is covered by The period laid down in Article 5(6) of Decision 1999/468/EC

professional secrecy, unless the divulging of such information shall be three months.

is necessary in order to protect the health and safety of

persons. 4. The Machinery Committee shall adopt its rules of proce-

dure.

2. The provisions of paragraph 1 shall not affect the obliga-

tions of the Member States and the notified bodies with regard

to mutual exchange of information and the issuing of warn- Article 23

ings.

Penalties

3. Any decisions taken by the Member States and by the

Commission in accordance with Articles 9 and 11 shall be Member States shall lay down the rules on penalties applicable

published. to infringements of the national provisions adopted pursuant

to this Directive and shall take all measures necessary to ensure

that they are implemented. The penalties provided for must be

Article 19 effective, proportionate and dissuasive. Member States shall

notify those provisions to the Commission by ... (*) and shall

Cooperation between Member States notify it without delay of any subsequent amendment affecting

them.

1. Member States shall take the appropriate measures to

ensure that the competent authorities referred to in Article 4(3) (*) 24 months after the date of entry into force of this Directive.

C 251E/10 EN Official Journal of the European Union 11.10.2005

Article 24 - rack and pinion trains,

- escalators and mechanical walkways.';

Amendment of Directive 95/16/EC 2. in Annex I, point 1.2 shall be replaced by the following:

Directive 95/16/EC is hereby amended as follows:

`1.2. Carrier

1. in Article 1, paragraphs 2 and 3 shall be replaced by the

following: The carrier of each lift must be a car. This car must be

designed and constructed to offer the space and

`2. For the purposes of this Directive, "lift" shall mean a strength corresponding to the maximum number of

lifting appliance serving specific levels, having a carrier persons and the rated load of the lift set by the

moving along guides which are rigid and inclined at an installer.

angle of more than 15 degrees to the horizontal, intended

for the transport of: Where the lift is intended for the transport of persons,

and where its dimensions permit, the car must be

- persons, designed and constructed in such a way that its struc-

tural features do not obstruct or impede access and

use by disabled persons and so as to allow any appro-

- persons and goods, priate adjustments intended to facilitate its use by

them.'.

- goods alone if the carrier is accessible, that is to say, a

person may enter it without difficulty, and fitted with

controls situated inside the carrier or within reach of a

person inside the carrier. Article 25

Lifting appliances moving along a fixed course even where Repeal

they do not move along guides which are rigid shall be

considered as lifts falling within the scope of this Directive. Directive 98/37/EC is hereby repealed.

A "carrier" means a part of the lift by which persons and/or References made to the repealed Directive shall be construed as

goods are supported in order to be lifted or lowered. being made to this Directive and should be read in accordance

with the correlation table in Annex XII.

3. This Directive shall not apply to:

Article 26

- lifting appliances whose speed is not greater than

0,15 m/s, Implementation

- construction site hoists, 1. Member States shall bring into force the laws, regulations

and administrative provisions necessary to comply with this

- cableways, including funicular railways, Directive by ... (*). They shall forthwith inform the Commis-

sion thereof.

- lifts specially designed and constructed for military or

police purposes, They shall apply those provisions with effect from ... (**).

- lifting appliances from which work can be carried out, When Member States adopt those measures, they shall contain

a reference to this Directive or be accompanied by such a refer-

- mine winding gear, ence on the occasion of their official publication. The methods

of making such reference shall be laid down by Member States.

- lifting appliances intended for lifting performers during

artistic performances, 2. Member States shall communicate to the Commission the

text of the provisions of national law which they adopt in the

- lifting appliances fitted in means of transport, field covered by this Directive, together with a table showing

how the provisions of this Directive correspond to the national

provisions adopted.

- lifting appliances connected to machinery and intended

exclusively for access to workstations including mainte- (*) 24 months after the date of entry into force of this Directive.

nance and inspection points on the machinery, (**) 42 months after the date of entry into force of this Directive.

11.10.2005 EN Official Journal of the European Union C 251E/11

Article 27 Article 29

Derogation Addressees

Until ... (*) Member States may allow the placing on the

market and the putting into service of portable cartridge-oper- This Directive is addressed to the Member States.

ated fixing and other impact machinery which are in confor-

mity with the national provisions in force upon adoption of

this Directive.

Article 28 Done at Brussels,

Entry into force For the European Parliament For the Council

This Directive shall enter into force on the 20th day following

that of its publication in the Official Journal of the European The President The President

Union. ... ...

(*) Five years after the date of entry into force of this Directive.

C 251E/12 EN Official Journal of the European Union 11.10.2005

ANNEX I

ESSENTIAL HEALTH AND SAFETY REQUIREMENTS RELATING TO THE DESIGN AND CONSTRUCTION

OF MACHINERY

GENERAL PRINCIPLES

1. The manufacturer of machinery or his authorised representative 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 manufacturer or his

authorised representative 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 this 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).

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 manufac-

turer or his authorised representative or in foreseeable abnormal situations. In any event, the principles of

safety integration referred to in Section 1.1.2 and the obligations concerning marking of machinery and

instructions referred to in Sections 1.7.3 and 1.7.4 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 objec-

tives.

4. This Annex is organised in several parts. The first one has a general scope and is applicable to all kinds of

machinery. The other parts 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 relevant essential requirements. When

machinery is being designed, the requirements of the general part and the requirements of one or more of the

other parts shall be taken into account, depending on the results of the risk assessment carried out in accord-

ance 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 a person is subject to a risk to

his 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 conjunc-

tion with a guard;

11.10.2005 EN Official Journal of the European Union C 251E/13

(h) `intended use' means the use of machinery in accordance with the information provided in the instruc-

tions 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 manufacturer or his authorised representative 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, indi-

cate 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 manufacturer or his

authorised representative must envisage not only the intended use of the machinery but also any reason-

ably 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.

C 251E/14 EN Official Journal of the European Union 11.10.2005

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 light-

weight, 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 him 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,

11.10.2005 EN Official Journal of the European Union C 251E/15

- 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 ambi-

guity,

- 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 confir-

mation, 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 posi-

tions 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.

C 251E/16 EN Official Journal of the European Union 11.10.2005

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 hazar-

dous 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.

11.10.2005 EN Official Journal of the European Union C 251E/17

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 over-

ridden; 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 excep-

tion 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 acti-

vate 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 he is working 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.

C 251E/18 EN Official Journal of the European Union 11.10.2005

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 uncon-

trolled movements during transportation, assembly, dismantling, scrapping 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 manufacturer or his authorised representative, 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 hazar-

dous 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 move-

ment 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

In so far 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 reli-

ably.

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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, or

- interlocking movable guards as referred to in Section 1.4.2.2.

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, or

- interlocking movable guards as referred to in Section 1.4.2.2, or

- protective devices as referred to in Section 1.4.3, 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 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,

C 251E/20 EN Official Journal of the European Union 11.10.2005

- 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 mainte-

nance 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 inter-

locking 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.

11.10.2005 EN Official Journal of the European Union C 251E/21

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 73/23/EEC 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 present Directive.

1.5.2. Static electricity

Machinery must be designed and constructed to prevent or limit the build-up of potentially dangerous electro-

static charges and/or be fitted with a discharging system.

1.5.3. Energy supply other than electricity

Where machinery is powered by source 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.

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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 acci-

dental 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 contain-

ment 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 user and that

enable them to maintain their stability.

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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).

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 iden-

tified. They must be capable of being locked if reconnection could endanger persons. Isolators must also be

capable of being locked where an operator is unable, from any of the points to which he 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 he 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 inter-

iors, 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.

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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 understand-

able symbols or pictograms. Any written or verbal information and warnings must be expressed in the official

Community language(s) which may be determined in accordance with the Treaty by the Member 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(s) 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, his authorised representa-

tive,

- designation of the machinery,

- the CE Marking (see Annex III),

- designation of series or type,

- serial number, if any,

- the year of construction, i.e. 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 requirement in Section 1.7.1.

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(s) of the Member

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.

11.10.2005 EN Official Journal of the European Union C 251E/25

By way of exception, the maintenance instructions intended for use by specialised personnel mandated by the

manufacturer or his authorised representative may be supplied in only one 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 manufacturer or his authorised repre-

sentative;

(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 manufacturer or his authorised

representative or by the person introducing the machinery into the language area in question. The transla-

tions 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 his authorised representative;

(b) the designation of the machinery as marked on the machinery itself, except for the serial number (see

Section 1.7.3);

(c) the EC declaration of conformity, or a document setting out the contents of the EC declaration of confor-

mity, 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 attach-

ment 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;

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(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 µ a),

- 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 emis-

sion 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 appro-

priate 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 measure-

ment 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 pres-

sure levels or sound power levels, those 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 infor-

mation 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

chapter (see General principles, Item 4).

11.10.2005 EN Official Journal of the European Union C 251E/27

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 pharmaceu-

tical 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 assem-

blies 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 crea-

tures, 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.

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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.

11.10.2005 EN Official Journal of the European Union C 251E/29

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 chapter (see General principles, Item 4).

3.1. General

3.1.1. Definitions

(a) `Machinery presenting hazards due to its mobility':

- machinery the operation of which requires either mobility while working, or continuous or semi-

continuous movement between a succession of fixed working locations;

- 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': 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 the driver can, in complete safety for himself 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. 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, 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 trans-

ported 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. 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.

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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, 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 require-

ments 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.

11.10.2005 EN Official Journal of the European Union C 251E/31

Remote-controlled machinery must be equipped with devices for stopping operation automatically and imme-

diately 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 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 derogation from Section 1.3.8.1, 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

manufacturer or his authorised representative must, for each type of structure concerned, perform appropriate

tests or have such tests performed.

C 251E/32 EN Official Journal of the European Union 11.10.2005

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

manufacturer or his authorised representative 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.

In so far 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 mechan-

ical 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 mechan-

ical 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.

11.10.2005 EN Official Journal of the European Union C 251E/33

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 roll-over or tip-over 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 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 hazar-

dous 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, wher-

ever 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 suffi-

cient 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 kilogrammes (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).

C 251E/34 EN Official Journal of the European Union 11.10.2005

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 chapter (see General principles, Item 4).

4.1. General

4.1.1. Definitions

(a) `Lifting operation': a movement of unit loads consisting of goods and/or persons necessitating, at a given

moment, a change of level;

(b) `Guided load': load where the total movement is made along rigid or flexible guides whose position is

determined by fixed points;

(c) `Working coefficient': the arithmetic ratio between the load guaranteed by the manufacturer or his

authorised representative up to which a component is able to hold it and the maximum working load

marked on the component;

(d) `Test coefficient': 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': 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': 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': a part of the machinery on or in which persons and/or goods are supported in order to be lifted.

11.10.2005 EN Official Journal of the European Union C 251E/35

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 in Section 1.3.1 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 manufacturer or his authorised representative must use the appropriate verifica-

tion 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 atmo-

spheric 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 over-

load 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 coeffi-

cient 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.

C 251E/36 EN Official Journal of the European Union 11.10.2005

In order to verify that an adequate working coefficient has been attained, the manufacturer or his authorised

representative 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 guar-

antee 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 coeffi-

cient 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 configura-

tion;

(f) in order to verify that an adequate working coefficient has been attained, the manufacturer or his

authorised representative 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.

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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 land-

ings. 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, 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 land-

ings, 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 manu-

facturer or his authorised representative 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 must be performed on all lifting machinery ready

to be put into service.

Where the machinery cannot be assembled in the manufacturer's premises or in the premises of his

authorised representative, 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.

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4.2.2. Loading control

Machinery with a maximum working load of not less than 1 000 kilograms or an overturning moment of not

less than 40 000 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 manufacturer or his

authorised representative 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, his 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.

11.10.2005 EN Official Journal of the European Union C 251E/39

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));

(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;

- 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 manufac-

turer or his authorised representative;

(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 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 chapter (see General principles, Item 4).

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.

C 251E/40 EN Official Journal of the European Union 11.10.2005

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 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 chapter (see General principles, Item 4).

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 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 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 move-

ments 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.

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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 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.

C 251E/42 EN Official Journal of the European Union 11.10.2005

ANNEX 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, 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, his authorised representative;

2. name and address of the person authorised to compile the technical file, who must be established in the

Community;

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 this Directive and

where appropriate, a similar sentence declaring the conformity with other Community Directives and/or rele-

vant 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 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;

7. where appropriate, a reference to the harmonised standards used, as referred to in Article 7(2);

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 manufacturer

or his authorised representative.

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 1, 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,

his authorised representative;

2. name and address of the person authorised to compile the relevant technical documentation, who must be

established in the Community;

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 requirements of this Directive are applied and fulfilled and that the rele-

vant technical documentation is compiled in accordance with Part B of Annex VII, and, where appropriate, a

sentence declaring the conformity of the partly completed machinery with other relevant Community Direc-

tives. 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 preju-

dice to the intellectual property rights of the manufacturer of the partly completed machinery;

11.10.2005 EN Official Journal of the European Union C 251E/43

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 this 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 manufacturer

or his authorised representative.

2. CUSTODY

The manufacturer of machinery or his 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 his 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.

C 251E/44 EN Official Journal of the European Union 11.10.2005

ANNEX 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 manufacturer or his authorised representa-

tive, using the same technique.

Where the full quality assurance procedure referred to in Article 12(3)(c) and 12(4)(b) has been applied, the CE marking

must be followed by the identification number of the notified body.

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ANNEX IV

CATEGORIES OF MACHINERY TO WHICH ONE OF THE PROCEDURES REFERRED TO IN ARTICLE 12(3)

AND (4) 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 work-

piece 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 char-

acteristics 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 in point 7 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 charac-

teristics.

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.

21. Logic units to ensure safety functions.

22. Roll-over protective structures (ROPS).

23. Falling-object protective structures (FOPS).

C 251E/46 EN Official Journal of the European Union 11.10.2005

ANNEX V

INDICATIVE LIST OF THE SAFETY COMPONENTS REFERRED TO IN ARTICLE 2(c)

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 Items 9,

10 and 11 of Annex IV;

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 Sections 1.5.7, 3.4.7 and 4.1.2.6 of Annex I;

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.

ANNEX 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 his authorised representative.

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ANNEX VII

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 requirements 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,

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 descrip-

tions 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:

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

- 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 require-

ments 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 manufacturer or his authorised representative;

- a copy of the instructions for the machinery;

- where appropriate, the declaration of incorporation for included partly completed machinery and the rele-

vant assembly instructions for such machinery;

- where appropriate, copies of the EC declaration of conformity of machinery or other products incorpo-

rated 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 this 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 must be made available to the competent authorities of the Member

States for at least 10 years following the date of manufacture of the machinery or, in the case of series manufac-

ture, of the last unit produced.

The technical file does not have to be located in the territory of the Community, nor does it have to be perma-

nently 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 subas-

semblies 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 requirements of this 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.

C 251E/48 EN Official Journal of the European Union 11.10.2005

It 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:

- a list of the essential health and safety requirements applied and fulfilled;

- the description of the protective measures implemented to eliminate identified hazards or to reduce risks

and, where appropriate, the indication of the residual risks;

- 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 manufacturer or his authorised representative;

- 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 the competent authorities of the Member States. It does not have to be located in the territory of the

Community, 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 the competent

national authorities may constitute sufficient grounds for doubting the conformity of the partly completed machinery

with the essential health and safety requirements applied and attested.

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ANNEX VIII

ASSESSMENT OF CONFORMITY WITH INTERNAL CHECKS ON THE MANUFACTURE OF MACHINERY

1. This Annex describes the procedure by which the manufacturer or his authorised representative, who carries out the

obligations laid down in points 2 and 3, ensures and declares that the machinery concerned satisfies the relevant

requirements of this Directive.

2. For each representative type of the series in question, the manufacturer or his authorised representative shall draw up

the technical file referred to in Annex VII, 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 requirements of

this Directive.

C 251E/50 EN Official Journal of the European Union 11.10.2005

ANNEX 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 (hereafter named the type) satisfies the provisions of this Directive.

1. The manufacturer or his authorised representative must, for each type, draw up the technical file referred to in

Annex VII, Part A.

2. For each type, the application for an EC type-examination shall be submitted by the manufacturer or his authorised

representative to a notified body of his choice.

The application shall include:

- the name and address of the manufacturer and, where appropriate, his 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 the standards referred to in Article 7(2),

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 of this Directive, where the standards referred to in

Article 7(2) were not applied;

3.3. where harmonised standards referred to in Article 7(2) were used, carry out or have carried out appropriate inspec-

tions, 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 this 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 his 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 this 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 modifica-

tions 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 Com-

munity language(s) of the Member State where the notified body is established or in any other official Community

language acceptable to the notified body.

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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 certi-

ficate. 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 certifi-

cate 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 rele-

vant 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.

C 251E/52 EN Official Journal of the European Union 11.10.2005

ANNEX X

FULL QUALITY ASSURANCE

This Annex describes the conformity assessment of machinery referred to in Annex IV, 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, and shall be subject to the surveillance referred to in point 3.

2. Quality system

2.1. The manufacturer or his authorised representative shall lodge an application for assessment of his quality system to

a notified body of his choice.

The application shall contain:

- the name and address of the manufacturer and, where appropriate, his authorised representative;

- the places of design, manufacture, inspection, testing and storage of the machinery;

- the technical file described in Annex VII, Part A, for one model of each category of machinery referred to in

Annex IV which he 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 this 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 the standards referred to

in Article 7(2) are not applied in full, the means that will be used to ensure that the essential health and safety

requirements of this Directive are fulfilled;

- the design inspection and design verification techniques, processes and systematic actions that will be used

when designing machinery covered by this 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.

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.

The manufacturer or his authorised representative 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 manufacturer or his authorised representative shall inform the notified body which approved the quality

system of any planned change to it.

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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, manufac-

ture, 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 inspec-

tion 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 par-

ticular, 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 manufacturer or his authorised representative shall keep available for the national authorities, for a period of

10 years from the last date of manufacture:

- the documentation referred to in point 2.1;

- the decisions and reports of the notified body referred to in point 2.4, third and fourth subparagraphs, and in

points 3.3 and 3.4.

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ANNEX 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, manu-

facturer, 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 informa-

tion 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 tech-

nical 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 take out liability insurance unless its liability is assumed by the State in accordance with national law,

or the Member State itself is directly responsible for the tests.

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 competent administrative authorities of the State in which its activities are

carried out) under this Directive or any provision of national law giving effect to it.

8. Notified bodies shall participate in coordination activities. They shall also take part directly or be represented in Euro-

pean standardisation, or ensure that they know the situation in respect of relevant standards.

9. Member States may take all necessary measures they regard as necessary in order to ensure that, in the event of cessa-

tion of the activities of a notified body, the files of its customers are sent to another body or are made available to

the Member State which has notified it.

11.10.2005 EN Official Journal of the European Union C 251E/55

ANNEX XII

CORRELATION TABLE (1)

Directive 98/37/EC This Directive

Article 1(1) Article 1(1)

Article 1(2)(a) Article 2(a) and (b)

Article 1(2)(b) Article 2(c)

Article 1(3) Article 1(2)

Article 1(4) Article 3

Article 1(5) -

Article 2(1) Article 4(1)

Article 2(2) Article 15

Article 2(3) Article 6(3)

Article 3 Article 5(1)(a)

Article 4(1) Article 6(1)

Article 4(2), first subparagraph Article 6(2)