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ESSENTIAL HEALTH AND SAFETY REQUIREMENTS RELATING TO THE DESIGN AND CONSTRUCTION OF MACHINERY OR RELATED PRODUCTS PART A Definitions For the purposes of this Annex, the following definitions apply:

(a) ‘hazard’ means a potential source of injury or damage to health;

(b) ‘danger zone’ means any zone within and/or around machinery or a related product in which a person is subject to a risk to his or her 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 or a related product;

(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 machinery or a related product 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 or a related product in accordance with the information provided in the instructions for use;

1. The manufacturer of machinery or a related product shall ensure that a risk assessment is carried out in order to determine the essential health and safety requirements which apply to the machinery or related product. The machinery or related product shall then be designed and constructed to eliminate hazards or, if that is not possible, to minimise all relevant risks, taking into account the results of the risk assessment. By the iterative process of risk assessment and risk reduction referred to in the first subparagraph, the manufacturer shall:

(a) determine the limits of the machinery or related product, which include the intended use and any reasonably foreseeable misuse thereof;

(b) identify the hazards that may be generated by the machinery or related product and the associated hazardous situations;

(c) estimate the risks, taking into account the severity of the possible injury or damage to health and the probability of its occurrence;

(d) evaluate the risks, with a view to determining whether risk reduction is required, in accordance with the objective of this Regulation;

(e) 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). The risk assessment and risk reduction shall include hazards that might arise during the lifecycle of the machinery or related product that are foreseeable at the time of placing the machinery or related product on the market as an intended evolution of its fully or partially self-evolving behaviour or logic as a result of the machinery or related product designed to operate with varying levels of autonomy. The risk assessment and risk reduction shall include risks resulting from interactions between machinery in order to achieve the same end that are arranged and controlled so that they function as an integral whole, thus forming machinery as defined in Article 3, point 1, point (d).

2. The obligations laid down by the essential health and safety requirements only apply when the corresponding hazard exists for the machinery or related product in question when it is used under the conditions foreseen by the manufacturer or in foreseeable abnormal situations. However, the principles of safety integration established in section 1.1.2 and the obligations concerning marking of machinery or related products referred to in section 1.7.3, and instructions for use referred to in section 1.7.4 apply in all cases.

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 or related product shall, as far as possible, be designed and constructed with the purpose of approaching those objectives.

4. This Annex is organised into six chapters. The first chapter is of general scope and applicable to all machinery or related products. The other chapters refer to certain sorts 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 health and safety requirements. When machinery or a related product is being designed, the requirements of the first chapter and the requirements of one or more of the other chapters 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 or related products referred to in section 2.4.

5. These general principles shall apply to the risk assessment carried out by the manufacturer of partly completed machinery.

1. ESSENTIAL HEALTH AND SAFETY REQUIREMENTS 1.1. General remarks 1.1.1. Applicability The obligations laid down by the essential health and safety requirements are applicable to partly completed machinery insofar as those requirements are relevant.

The relevant requirements in relation to partly completed machinery do not cover the requirements that can only be fulfilled at the time of the incorporation of the partly completed machinery. However, the principles of safety integration established in section 1.1.2 are applicable in all cases.

1.1.2. Principles of safety integration (a) Machinery or related products shall be designed and constructed so that they are fit for their 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 protective measures shall be to eliminate any risk throughout the foreseeable lifetime of the machinery or related product including the phases of transport, assembly, dismantling, disabling and scrapping.

(b) In selecting the most appropriate methods, the manufacturer shall apply the following principles, in the order given:

(i) eliminate hazards or, if that is not possible, minimise risks (inherently safe machinery or related product design and construction);

(ii) take the necessary protective measures in relation to risks that cannot be eliminated;

(iii) 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 or a related product and when drafting the instructions for use, the manufacturer shall envisage not only the intended use of the machinery or related product but also any reasonably foreseeable misuse thereof. The machinery or related product shall be designed and constructed in such a way as to prevent abnormal use if such use would engender a risk. Where appropriate, the instructions for use shall draw the user’s attention to ways – which experience has shown might occur – in which the machinery or related product should not be used.

Machinery or related products shall 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 or related products shall 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 shall be provided with appropriate lighting.

1.1.5. Design of machinery or a related product to facilitate its handling Machinery or a related product or each component part thereof, shall:

(a) be capable of being handled and transported safely;

(b) be packaged or designed so that it can be stored safely and without damage. During the transportation of the machinery or related product or its component parts, there shall be no possibility of sudden movements or of hazards due to instability as long as the machinery or related product or its component parts are handled in accordance with the instructions.

The operating position shall be designed and constructed in such a way as to avoid any risk due to exhaust gases or lack of oxygen. If the machinery or related product is intended to be used in a hazardous environment presenting risks to the health and safety of the operator or if the machinery or related product itself gives rise to a hazardous environment, adequate means shall be provided to ensure that the operator has good working conditions and is protected against any foreseeable hazards. Where appropriate, the operating position shall be fitted with an adequate cabin designed, constructed or equipped to fulfil the above requirements. The exit shall allow rapid evacuation. Moreover, when applicable, an emergency exit shall 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 or related product shall 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 or related product, the seat shall be provided with the machinery or related product. The operator’s seat shall enable him or her to maintain a stable position. Furthermore, the seat and its distance from the control devices shall be capable of being adapted to the operator. If the machinery or related product is subject to vibrations, the seat shall 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 shall 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 shall be provided.

1.1.9. Protection against corruption The machinery or related product shall be designed and constructed so that the connection to it of another device, via any feature of the connected device itself or via any remote device that communicates with the machinery or related product does not lead to a hazardous situation.