CE Marking (CE Mark) for Machinery: Directive 98/37/EC of the European Parliament and of the Council of 22 June 1998 & Annex I, II, ... IX

Brief Introduction of
Directive 98/37/EC
Machinery
& Annex I, II, ... IX

Official Journal L 207 , 23/07/1998 p. 0001 - 0046

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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

The Machinery Directive came into force on January 1, 1993 and has become mandatory since January 1, 1995. This means that from that date, no machine can be placed on the EU single market or installed if it does not bear the CE Marking.

Chapter I :
SCOPE, PLACING ON THE MARKET AND FREEDOM OF MOVEMENT

Article 1

1. This Directive applies to machinery and lays down the essential health and safety requirements therefor, as defined in Annex I.
It shall also apply to safety components placed on the market separately.

2. For the purposes of this Directive:

(a) machinery means:
- an assembly of linked parts or components, at least one of which moves, with the appropriate actuators, control and power circuits, etc., joined together for a specific application, in particular for the processing, treatment, moving or packaging of a material,
- an assembly of machines which, in order to achieve the same end, are arranged and controlled so that they function as an integral whole,
- interchangeable equipment modifying the function of a machine, which is placed on the market for the purpose of being assembled with a machine or a series of different machines or with a tractor by the operator himself in so far as this equipment is not a spare part or a tool;
(b) safety components means a component, provided that it is not interchangeable equipment, which the manufacturer or his authorised representative established in the Community places on the market to fulfil a safety function when in use and the failure or malfunctioning of which endangers the safety or health of exposed persons.

3. The following are excluded from the scope of this Directive:

- machinery whose only power source is directly applied manual effort, unless it is a machine used for lifting or lowering loads,
- machinery for medical use used in direct contact with patients,
- special equipment for use in fairgrounds and/or amusement parks,
- steam boilers, tanks and pressure vessels,
- machinery specially designed or put into service for nuclear purposes which, in the event of failure, may result in an emission of radioactivity,
- radioactive sources forming part of a machine,
- firearms,
- storage tanks and pipelines for petrol, diesel fuel, inflammable liquids and dangerous substances,
- means of transport, i.e. vehicles and their trailers intended solely for transporting passengers by air or on road, rail or water networks, as well as means of transport in so far as such means are designed for transporting goods by air, on public road or rail networks or on water. Vehicles used in the mineral extraction industry shall not be excluded,
- seagoing vessels and mobile offshore units together with equipment on board such vessels or units,
- cableways, including funicular railways, for the public or private transportation of persons,
- agricultural and forestry tractors, as defined in Article 1(1) of Directive 74/150/EEC (7),
- machines specially designed and constructed for military or police purposes,
- lifts which permanently serve specific levels of buildings and constructions, having a car moving between guides which are rigid and inclined at an angle of more than 15 degrees to the horizontal and designed for the transport of:
(i) persons;
(ii) persons and goods;
(iii) goods alone if the car is accessible, that is to say, a person may enter it without difficulty, and fitted with controls situated inside the car or within reach of a person inside,
- means of transport of persons using rack and pinion rail mounted vehicles,
- mine winding gear,
- theatre elevators,
- construction site hoists intended for lifting persons or persons and goods.

4. Where, for machinery or safety components, the risks referred to in this Directive are wholly or partly covered by specific Community Directives, this Directive shall not apply, or shall cease to apply, in the case of such machinery or safety components and of such risks on the implementation of these specific Directives.

5. Where, for machinery, the risks are mainly of electrical origin, such machinery shall be covered exclusively by Directive 73/23/EEC (8).

Article 2

1. Member States shall take all appropriate measures to ensure that machinery or safety components covered by this Directive may be placed on the market and put into service only if they do not endanger the health or safety of persons and, where appropriate, domestic animals or property, when properly installed and maintained and used for their intended purpose.

2. This Directive shall not affect Member States' entitlement to lay down, in due observance of the Treaty, such requirements as they may deem necessary to ensure that persons and in particular workers are protected when using the machinery or safety components in question, provided that this does not mean that the machinery or safety components are modified in a way not specified in the Directive.

3. At trade fairs, exhibitions, demonstrations, etc., Member States shall not prevent the showing of machinery or safety components which do not conform to the provisions of this Directive, provided that a visible sign clearly indicates that such machinery or safety components do not conform and that they are not for sale until they have been brought into conformity by the manufacturer or his authorised representative established in the Community. During demonstrations, adequate safety measures shall be taken to ensure the protection of persons.

Article 3

Machinery and safety components covered by this Directive shall satisfy the essential health and safety requirements set out in Annex I.

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Article 4

1. Member States shall not prohibit, restrict or impede the placing on the market and putting into service in their territory of machinery and safety components which comply with this Directive.

2. Member States shall not prohibit, restrict or impede the placing on the market of machinery where the manufacturer or his authorised representative established in the Community declares in accordance with point B of Annex II that it is intended to be incorporated into machinery or assembled with other machinery to constitute machinery covered by this Directive, except where it can function independently.
'Interchangeable equipment`, as referred to in the third indent of Article 1(2)(a), must in all cases bear the CE marking and be accompanied by the EC declaration of conformity referred to in Annex II, point A.

3. Member States may not prohibit, restrict or impede the placing on the market of safety components as defined in Article 1(2) where they are accompanied by an EC declaration of conformity by the manufacturer or his authorised representative established in the Community as referred to in Annex II, point C.

Article 5

1. Member States shall regard the following as conforming to all the provisions of this Directive, including the procedures for checking the conformity provided for in Chapter II:
- machinery bearing the CE marking and accompanied by the EC declaration of conformity referred to in Annex II, point A,
- safety components accompanied by the EC declaration of conformity referred to in Annex II, point C.
In the absence of harmonised standards, Member States shall take any steps they deem necessary to bring to the attention of the parties concerned the existing national technical standards and specifications which are regarded as important or relevant to the proper implementation of the essential safety and health requirements in Annex I.

2. Where a national standard transposing a harmonised standard, the reference for which has been published in the Official Journal of the European Communities, covers one or more of the essential safety requirements, machinery or safety components constructed in accordance with this standard shall be presumed to comply with the relevant essential requirements.
Member States shall publish the references of national standards transposing harmonised standards.

3. Member States shall ensure that appropriate measures are taken to enable the social partners to have an influence at national level on the process of preparing and monitoring the harmonised standards.

Article 6

1. Where a Member State or the Commission considers that the harmonised standards referred to in Article 5(2) do not entirely satisfy the essential requirements referred to in Article 3, the Commission or the Member State concerned shall bring the matter before the committee set up under Directive 83/189/EEC, giving the reasons therefor. The committee shall deliver an opinion without delay.
Upon receipt of the committee's opinion, the Commission shall inform the Member States whether or not it is necessary to withdraw those standards from the published information referred to in Article 5(2).

2. A standing committee shall be set up, consisting of representatives appointed by the Member States and chaired by a representative of the Commission.
The standing committee shall draw up its own rules of procedure.
Any matter relating to the implementation and practical application of this Directive may be brought before the standing committee, in accordance with the following procedure:
The representative of the Commission shall submit to the committee a draft of the measures to be taken. The committee shall deliver its opinion on the draft, within a time limit which the chairman may lay down according to the urgency of the matter, if necessary by taking a vote.
The opinion shall be recorded in the minutes; in addition, each Member State shall have the right to ask to have its position recorded in the minutes.
The Commission shall take the utmost account of the opinion delivered by the committee. It shall inform the committee of the manner in which its opinion has been taken into account.

Article 7

1. Where a Member State ascertains that:
- machinery bearing the CE marking, or
- safety components accompanied by the EC declaration of conformity,
used in accordance with their intended purpose are liable to endanger the safety of persons, and, where appropriate, domestic animals or property, it shall take all appropriate measures to withdraw such machinery or safety components from the market, to prohibit the placing on the market, putting into service or use thereof, or to restrict free movement thereof.
Member States shall immediately inform the Commission of any such measure, indicating the reason for its decision and, in particular, whether non-conformity is due to:
(a) failure to satisfy the essential requirements referred to in Article 3;
(b) incorrect application of the standards referred to in Article 5(2);
(c) shortcomings in the standards themselves referred to in Article 5(2).

2. The Commission shall enter into consultation with the parties concerned without delay. Where the Commission considers, after this consultation, that the measure is justified, it shall immediately so inform the Member State which took the initiative and the other Member States. Where the Commission considers, after this consultation, that the action is unjustified, it shall immediately so inform the Member State which took the initiative and the manufacturer or his authorised representative established within the Community. Where the decision referred to in paragraph 1 is based on a shortcoming in the standards, and where the Member State at the origin of the decision maintains its position, the Commission shall immediately inform the committee in order to initiate the procedures referred to in Article 6(1).

3. Where:
- machinery which does not comply bears the CE marking,
- a safety component which does not comply is accompanied by an EC declaration of conformity,
the competent Member State shall take appropriate action against whom so ever has affixed the marking or drawn up the declaration and shall so inform the Commission and other Member States.

4. The Commission shall ensure that Member States are kept informed of the progress and outcome of this procedure.

CHAPTER II: CONFORMITY ASSESSMENT PROCEDURES

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CHAPTER III: CE MARKING

CHAPTER IV: FINAL PROVISIONS

Article 15
This Directive shall enter into force on the 20th day following that of its publication in the Official Journal of the European Communities.

ANNEX I
ESSENTIAL HEALTH AND SAFETY REQUIREMENTS RELATING TO THE DESIGN AND CONSTRUCTION OF MACHINERY AND SAFETY COMPONENTS

1. ESSENTIAL HEALTH AND SAFETY REQUIREMENTS

1.1. General remarks
1.1.1. Definitions
1.1.1.1. danger zone
1.1.1.2. exposed person
1.1.1.3. operator
1.1.2. Principles of safety integration
1.1.3. Materials and products
1.1.4. Lighting
1.1.5. Design of machinery to facilitate its handling

1.2. Controls
1.2.1. Safety and reliability of control systems
1.2.2. Control devices
1.2.3. Starting
1.2.4. Stopping device
1.2.5. Mode selection
1.2.6. Failure of the power supply
1.2.7. Failure of the control circuit
1.2.8. Software

1.3. Protection against mechanical hazards
1.3.1. Stability
1.3.2. Risk of break-up during operation
1.3.3. Risks due to falling or ejected objects
1.3.4. Risks due to surfaces, edges or angles
1.3.5. Risks related to combined machinery
1.3.6. Risks relating to variations in the rotational speed of tools
1.3.7. Prevention of risks related to moving parts
1.3.8. Choice of protection against risks related to moving parts

1.4. Required characteristics of guards and protection devices
1.4.1. General requirements
1.4.2. Special requirements for guards
1.4.3. Special requirements for protection devices

1.5. Protection against other hazards
1.5.1. Electricity supply
1.5.2. Static electricity
1.5.3. Energy supply other than electricity
1.5.4. Errors of fitting
1.5.5. Extreme temperatures
1.5.6. Fire
1.5.7. Explosion
1.5.8. Noise
1.5.9. Vibration
1.5.10. Radiation
1.5.11. External radiation
1.5.12. Laser equipment
1.5.13. Emissions of dust, gases, etc.
1.5.14. Risk of being trapped in a machine
1.5.15. Risk of slipping, tripping or falling

1.6. Maintenance
1.6.1. Machinery maintenance
1.6.2. Access to operating position and servicing points
1.6.3. Isolation of energy sources
1.6.4. Operator intervention
1.6.5. Cleaning of internal parts

1.7. Indicators
1.7.0. Information devices
1.7.1. Warning devices
1.7.2. Warning of residual risks
1.7.3. Marking
1.7.4. Instructions

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2. ESSENTIAL HEALTH AND SAFETY REQUIREMENTS FOR CERTAIN CATEGORIES OF MACHINERY

2.1. Agri-foodstuffs machinery
2.2. Portable hand-held and/or hand-guided machinery

3. ESSENTIAL HEALTH AND SAFETY REQUIREMENTS TO OFFSET THE PARTICULAR HAZARDS DUE TO THE MOBILITY OF MACHINERY

3.1. General
3.1.1. Definition
3.1.2. Lighting
3.1.3. Design of machinery to facilitate its handling

3.2. Work stations
3.2.1. Driving position
3.2.2. Seating
3.2.3. Other places

3.3. Controls
3.3.1. Control devices
3.3.2. Starting/moving
3.3.3. Travelling function
3.3.4. Movement of pedestrian-controlled machinery
3.3.5. Control circuit failure

3.4. Protection against mechanical hazards
3.4.1. Uncontrolled movements
3.4.2. Risk of break-up during operation
3.4.3. Rollover
3.4.4. Falling objects
3.4.5. Means of access
3.4.6. Towing devices
3.4.7. Transmission of power between self-propelled machinery (or tractor) and recipient machinery
3.4.8. Moving transmission parts

3.5. Protection against other hazards
3.5.1. Batteries
3.5.2. Fire
3.5.3. Emissions of dust, gases, etc.

3.6. Indications
3.6.1. Signs and warning
3.6.2. Marking
3.6.3. Instruction handbook

4. ESSENTIAL HEALTH AND SAFETY REQUIREMENTS TO OFFSET THE PARTICULAR HAZARDS DUE TO A LIFTING OPERATION

4.1. General remarks
4.1.1. Definitions
4.1.2. Protection against mechanical hazards
4.1.2.1. Risks due to lack of stability
4.1.2.2. Guide rails and rail tracks
4.1.2.3. Mechanical strength
4.1.2.4. Pulleys, drums, chains or ropes
4.1.2.5. Separate lifting accessories
4.1.2.6. Control of movements
4.1.2.7. Handling of loads
4.1.2.8. Lightning

4.2. Special requirements for machinery whose power source is other than manual effort
4.2.1. Controls
4.2.1.1. Driving position
4.2.1.2. Seating
4.2.1.3. Control devices
4.2.1.4. Loading control
4.2.2. Installation guided by cables
4.2.3. Risks to exposed persons. Means of access to driving position and intervention points
4.2.4. Fitness for purpose

4.3. Marking
4.3.1. Chains and ropes
4.3.2. Lifting accessories
4.3.3. Machinery

4.4. Instruction handbook
4.4.1. Lifting accessories
4.4.2. Machinery

5. ESSENTIAL HEALTH AND SAFETY REQUIREMENTS FOR MACHINERY INTENDED FOR UNDERGROUND WORK

5.1. Risks due to lack of stability
5.2. Movement
5.3. Lighting
5.4. Control devices
5.5. Stopping
5.6. Fire
5.7. Emissions of dust, gases, etc.

6. ESSENTIAL HEALTH AND SAFETY REQUIREMENTS TO OFFSET THE PARTICULAR HAZARDS DUE TO THE LIFTING OR MOVING OF PERSONS

6.1. General
6.1.1. Definition
6.1.2. Mechanical strength
6.1.3. Loading control for types of device moved by power other than human strength

6.2. Controls
6.3. Risks of persons falling from the carrier
6.4. Risks of the carrier falling or overturning
6.5. Markings

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ANNEX II

A. Contents of the EC declaration of conformity for machinery (1)
B. Contents of the declaration by the manufacturer or his authorised representatives established in the Community (Article 4(2))
C. Contents of the EC declaration of conformity for safety components placed on the market separately (4)

ANNEX III
CE CONFORMITY MARKING

ANNEX IV
TYPES OF MACHINERY AND SAFETY COMPONENTS FOR WHICH THE PROCEDURE REFERRED TO IN ARTICLE 8(2)(b) AND (c) MUST BE APPLIED

A. Machinery

1. Circular saws (single or multi-blade) for working with wood and analogous materials or for working with meat and analogous materials.
1.1. Sawing machines with fixed tool during operation, having a fixed bed with manual feed of the workpiece or with a demountable power feed.
1.2. Sawing machines with fixed tool during operation, having a manually operated reciprocating saw-bench or carriage.
1.3. Sawing machines with fixed tool during operation, having a built-in mechanical feed device for the work-pieces, with manual loading and/or unloading.
1.4. Sawing machines with movable tool during operation, with a mechanical feed device and manual loading and/or unloading.
2. Hand-fed surface planing machines for woodworking.
3. Thicknessers for one-side dressing with manual loading and/or unloading for woodworking.
4. Band-saws with a fixed or mobile bed and band-saws with a mobile carriage, with manual loading and/or unloading, for working with wood and analogous materials or for working with meat and analogous materials.
5. Combined machines of the types referred to in 1 to 4 and 7 for working with wood and analogous materials.
6. Hand-fed tenoning machines with several tool holders for woodworking.
7. Hand-fed vertical spindle moulding machines for working with wood and analogous materials.
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 machines with manual loading or unloading.
11. Injection or compression rubber-moulding machines with manual loading or unloading.
12. Machinery for underground working of the following types:
- machinery on rails: locomotives and brake-vans,
- hydraulic-powered roof supports,
- internal combustion engines to be fitted to machinery for underground working.
13. Manually-loaded trucks for the collection of household refuse incorporating a compression mechanism.
14. Guards and detachable transmission shafts with universal joints as described in section 3.4.7.
15. Vehicles servicing lifts.
16. Devices for the lifting of persons involving a risk of falling from a vertical height of more than three metres.
17. Machines for the manufacture of pyrotechnics.

B. Safety components

1. Electro-sensitive devices designed specifically to detect persons in order to ensure their safety (non-material barriers, sensor mats, electromagnetic detectors, etc.).
2. Logic units which ensure the safety functions of bimanual controls.
3. Automatic movable screens to protect the presses referred to in 9, 10 and 11.
4. Roll-over protection structures (ROPS).
5. Falling-object protective structures (FOPS).

ANNEX V
EC DECLARATION OF CONFORMITY

ANNEX VI
EC TYPE-EXAMINATION

ANNEX VII
MINIMUM CRITERIA TO BE TAKEN INTO ACCOUNT BY MEMBER STATES FOR THE NOTIFICATION OF BODIES

ANNEX VIII

ANNEX IX

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