S.I. No. 407/2008 - European Communities (Machinery) Regulations 2008

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

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

3.6.2. Marking

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

— nominal power expressed in kilowatts (kW),

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

and, where appropriate:

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

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

3.6.3. Instructions

3.6.3.1. Vibrations

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

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

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

— the uncertainty of measurement.

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

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

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

3.6.3.2. Multiple uses

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

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

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

4.1. GENERAL

4.1.1. Definitions

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

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

• (c) “Working coefficient” means the arithmetic ratio between the load guaranteed by the 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” means the arithmetic ratio between the load used to carry out the static or dynamic tests on lifting machinery or a lifting accessory and the maximum working load marked on the lifting machinery or lifting accessory.

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

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

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

4.1.2. Protection against mechanical hazards

4.1.2.1. Risks due to lack of stability

Machinery must be designed and constructed in such a way that the stability required by section 1.3.1 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 verification methods.

4.1.2.2. Machinery running on guide rails and rail tracks

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

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

4.1.2.3. Mechanical strength

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

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

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

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

• (a) manually-operated machinery and lifting accessories: 1.5;

• (b) other machinery: 1.25.

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

4.1.2.4. Pulleys, drums, wheels, ropes and chains

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

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

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

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

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

In order to verify that an adequate working coefficient has been attained, the 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 guarantee an adequate level of safety; this coefficient is, as a general rule, equal to 5. Ropes must not comprise any splices or loops other than at their ends;

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

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

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

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

• (f) in order to verify that an adequate working coefficient has been attained, the 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.

4.1.2.8. Machinery serving fixed landings

4.1.2.8.1. Movements of the carrier

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

4.1.2.8.2. Access to the carrier

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

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

4.1.2.8.3. Risks due to contact with the moving carrier

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

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

4.1.2.8.4. Risk due to the load falling off the carrier

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

4.1.2.8.5. Landings

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

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

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

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

4.1.3. Fitness for purpose

When lifting machinery or lifting accessories are placed on the market or are first put into service, the manufacturer 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.

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.

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 manufacturer 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, point 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.

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, point 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 movements and, if appropriate, other movements of the carrier.

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

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

6.3. RISKS TO PERSONS IN OR ON THE CARRIER

6.3.1. Risks due to movements of the carrier

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

6.3.2. Risk of persons falling from the carrier

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

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

If the measures referred to in section 1.5.15 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.

Regulation 3(1)

SCHEDULE 2 Annex II to Directive 2006/42/EC

Declarations (EC Declaration of conformity of machinery and Declaration of incorporation of partly completed machinery).

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:

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:

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.

Regulation 3(1)

SCHEDULE 3 Annex III to Directive 2006/42/EC

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 representative, 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.

Regulation 9(a)

SCHEDULE 4 Annex IV to Directive 2006/42/EC

Categories of machinery to which one of the procedures referred to in Article 12(3) and (4) must be applied.

1.1. sawing machinery with fixed blade(s) during cutting, having a fixed bed or support with manual feed of the workpiece or with a demountable power feed;

1.2. sawing machinery with fixed blade(s) during cutting, having a manually operated reciprocating saw-bench or carriage;

1.3 sawing machinery with fixed blade(s) during cutting, having a built-in mechanical feed device for the workpieces, with manual loading and/or unloading;

1.4. sawing machinery with movable blade(s) during cutting, having mechanical movement of the blade, with manual loading and/or unloading.

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.

12.1. locomotives and brake-vans;

12.2. hydraulic-powered roof supports.

Regulation 3(1)

SCHEDULE 5 Annex V to Directive 2006/42/EC

Indicative list of the safety components referred to in Article 2(c).

• (a) devices for locking landing doors;

• (b) devices to prevent the load-carrying unit from falling or unchecked upwards movement;

• (c) overspeed limitation devices;

• (d) energy-accumulating shock absorbers,

— non-linear, or

— with damping of the return movement;

• (e) energy-dissipating shock absorbers;

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

• (g) electric safety devices in the form of safety switches containing electronic components.

Regulation 10(b)

SCHEDULE 6 Annex VI to Directive 2006/42/EC

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.

Regulation 3(1)

SCHEDULE 7 Annex VII to Directive 2006/42/EC

Part A, Technical file for machinery

and

Part B, Relevant technical documentation for partly completed machinery.

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 this 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.

• (a) a construction file including:

— a general description of the machinery,

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

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

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

• (i) a list of the essential health and safety requirements which apply to the machinery,

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

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

— any technical report giving the results of the tests carried out either by the manufacturer or by a body chosen by the 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 relevant assembly instructions for such machinery,

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

— a copy of the EC declaration of conformity;

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

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

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

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.

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:

• (i) a list of the essential health and safety requirements applied and fulfilled,

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

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

• (iv) any technical report giving the results of the tests carried out either by the manufacturer or by a body chosen by the manufacturer or his authorised representative,

• (v) a copy of the assembly instructions for the partly completed machinery;

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

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

The relevant technical documentation must be available for at least 10 years following the date of manufacture of the partly completed machinery or, in the case of series manufacture, of the last unit produced, and on request presented to 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.

Regulation 9(a)

SCHEDULE 8 Annex VIII to Directive 2006/42/EC

Assessment of conformity with internal checks on the manufacture of machinery.

Regulation 3(1)

SCHEDULE 9 Annex IX to Directive 2006/42/EC

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.

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.

3.1. 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 inspections, measurements and tests to verify that those standards were actually applied;

3.4. agree with the applicant as to the place where the check that the type was manufactured in accordance with the examined technical file and the necessary inspections, measurements and tests will be carried out.

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.

9.1. The notified body has the ongoing responsibility of ensuring that the EC type-examination certificate remains valid. It shall inform the manufacturer of any major changes which would have an implication on the validity of the certificate. The notified body shall withdraw certificates which are no longer valid.

9.2. The manufacturer of the machinery concerned has the ongoing responsibility of ensuring that the said machinery meets the corresponding state of the art.

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

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

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

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

Regulation 3(1)

SCHEDULE 10 Annex X to Directive 2006/42/EC

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.

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. During the assessment, the team of auditors shall carry out a review of the technical files referred to in point 2.1, second paragraph, third indent to ensure their compliance with the relevant health and safety requirements.

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.

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.

3.1. The purpose of surveillance is to make sure that the manufacturer duly fulfils the obligations arising out of the approved quality system.

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

— the documentation concerning the quality system,

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

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

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

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

— the results of previous surveillance visits,

— the need to monitor remedial measures,

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

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

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

— 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.

Regulation 14(3)(c)

SCHEDULE 11 Annex XI to Directive 2006/42/EC

Minimum criteria to be taken into account by Member States for the notification of bodies.

— 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.

Regulation 3(3)

SCHEDULE 12 Article 1(2) of Directive 2006/42/EC

Equipment excluded from the application of these Regulations:

• (a) safety components intended to be used as spare parts to replace identical components and supplied by the manufacturer of the original machinery;

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

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

• (d) weapons, including firearms;

• (e) the following means of transport:

— agricultural and forestry tractors for the risks covered by Directive 2003/37/EC, with the exclusion of machinery mounted on these vehicles,

— motor vehicles and their trailers covered by Council 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 their trailers (OJ L42, 23.2.1970, p. 1.) as last amended by Commission Directive 2006/28/EC (OJ L 65, 7.3.2006, p. 27), with the exclusion of machinery mounted on these vehicles,

— vehicles covered by Directive 2002/24/EC of the European Parliament and of the Council of 18 March 2002 relating to the type-approval of two or three-wheel motor vehicles (OJ L 124, 9.5.2002, p. 1.) as last amended by Commission Directive 2005/30/EC (OJ L 106, 27.4.2005, p. 17), with the exclusion of machinery mounted on these vehicles,

— motor vehicles exclusively intended for competition, and

— means of transport by air, on water and on rail networks with the exclusion of machinery mounted on these means of transport;

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

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

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

• (i) mine winding gear;

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

• (k) electrical and electronic products falling within the following areas, insofar as they are covered by Council Directive 73/23/EEC of 19 February 1973 on the harmonisation of the laws of Member States relating to electrical equipment designed for use within certain voltage limits (OJ L 77, 26.3.1973, p. 29.) as amended by Directive 93/68/EEC (OJ L 220, 30.8.1993, p. 1):

— household appliances intended for domestic use,

— audio and video equipment,

— information technology equipment,

— ordinary office machinery,

— low-voltage switchgear and control gear,

— electric motors;

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

— switch gear and control gear,

— transformers.

GIVEN under my Official Seal,

17 October 2008

MARY COUGHLAN

Minister for Enterprise, Trade and Employment.

EXPLANATORY NOTE

(This note is not part of the Instrument and does not purport to be a legal interpretation.)

These Regulations come into effect on 29 December 2009 and implement Directive 2006/42/EC of the European Parliament and of the Council of 17 May 2006 on machinery and amending Directive 95/16/EC of 29 June 1995. In the case of portable cartridge operated fixing and other impact machinery that are in conformity with existing provisions in force at 17 May 2006 the Regulations come into effect on 29 June 2011. Article 24 of this Directive is implemented separately through the European Communities (Lifts) (Amendment) Regulations 2008.

These Regulations provide for the continued harmonisation of the essential health and safety requirements on machinery across the European Union while also promoting the free movement of machinery within the single market.

These Regulations are applicable to additional products such as construction-site hoists, cartridge-operated fixing and other impact machinery. The Regulations also clarify the boundary between the Machinery Directive and the Low Voltage and Lifts Directives.Various machinery excluded from the scope of the Directive are listed in Annex 1(2) to the Directive as set out in Schedule 12 to the Regulations.

These Regulations set down requirements for placing machinery on the market, conformity assessment and CE marking. The Regulations make provisions regarding the organisation of, and access to, technical documentation and also set down a requirement to ensure risk assessment is carried out for machinery. The Regulations also make provision for the appointment and monitoring of Notified Bodies and for the appointment and functions of Competent Authorities responsible for enforcing the Regulations and carrying out market surveillance.

Footnotes