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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 manufacturer 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 objectives.

4. This Annex is organised in several parts. The first one is of general scope and 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 accordance with point 1 of these General Principles. Essential health and safety requirements for the protection of the environment are applicable only to the machinery referred to in section 2.4.

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 conjunction with a guard;

(h) ‘intended use’ means the use of machinery in accordance with the information provided in the instructions for use;

(i) ‘reasonably foreseeable misuse’ means the use of machinery in a way not intended in the instructions for use, but which may result from readily predictable human behaviour.

1.1.2. Principles of safety integration

(a) Machinery must be designed and constructed so that it is fitted for its function, and can be operated, adjusted and maintained without putting persons at risk when these operations are carried out under the conditions foreseen but also taking into account any reasonably foreseeable misuse thereof. The aim of measures taken must be to eliminate any risk throughout the foreseeable lifetime of the machinery including the phases of transport, assembly, dismantling, disabling and scrapping.

(b) In selecting the most appropriate methods, the 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, indicate whether any particular training is required and specify any need to provide personal protective equipment.

(c) When designing and constructing machinery and when drafting the instructions, the manufacturer or his authorised representative must envisage not only the intended use of the machinery but also any reasonably foreseeable misuse thereof. The machinery must be designed and constructed in such a way as to prevent abnormal use if such use would engender a risk. Where appropriate, the instructions must draw the user's attention to ways — which experience has shown might occur — in which the machinery should not be used.

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

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

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

1.1.4. Lighting

Machinery must be supplied with integral lighting suitable for the operations concerned where the absence thereof is likely to cause a risk despite ambient lighting of normal intensity. Machinery must be designed and constructed so that there is no area of shadow likely to cause nuisance, that there is no irritating dazzle and that there are no dangerous stroboscopic effects on moving parts due to the lighting. Internal parts requiring frequent inspection and adjustment, and maintenance areas must be provided with appropriate lighting.

1.1.5. Design of machinery to facilitate its handling Machinery, or each component part thereof, must:

— be capable of being handled and transported safely,

— be packaged or designed so that it can be stored safely and without damage. During the transportation of the machinery and/or its component parts, there must be no possibility of sudden movements or of hazards due to instability as long as the machinery and/or its component parts are handled in accordance with the instructions. Where the weight, size or shape of machinery or its various component parts prevents them from being moved by hand, the machinery or each component part must:

— either be fitted with attachments for lifting gear, or — be designed so that it can be fitted with such attachments, or — be shaped in such a way that standard lifting gear can easily be attached. Where machinery or one of its component parts is to be moved by hand, it must:

— either be easily moveable, or — be equipped for picking up and moving safely. Special arrangements must be made for the handling of tools and/or machinery parts which, even if lightweight, could be hazardous.

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

— allowing for the variability of the operator's physical dimensions, strength and stamina,

— providing enough space for movements of the parts of the operator's body,

— avoiding a machine-determined work rate,

— avoiding monitoring that requires lengthy concentration,

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

1.1.7. Operating positions

The operating position must be designed and constructed in such a way as to avoid any risk due to exhaust gases and/or lack of oxygen. If the machinery is intended to be used in a hazardous environment presenting risks to the health and safety of the operator or if the machinery itself gives rise to a hazardous environment, adequate means must be provided to ensure that the operator has good working conditions and is protected against any foreseeable hazards. Where appropriate, the operating position must be fitted with an adequate cabin designed, constructed and/or equipped to fulfil the above requirements. The exit must allow rapid evacuation. Moreover, when applicable, an emergency exit must be provided in a direction which is different from the usual exit.

1.1.8. Seating Where appropriate and where the working conditions so permit, work stations constituting an integral part of the machinery must be designed for the installation of seats. If the operator is intended to sit during operation and the operating position is an integral part of the machinery, the seat must be provided with the machinery.

The operator's seat must enable 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,

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

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