Annex III B.1 · Risk assessment and risk reduction

What it requires

Annex III B.1 of Regulation (EU) 2023/1230 requires: the manufacturer must carry out an iterative risk assessment (limits, hazards, estimation, evaluation, reduction) covering the hazards foreseeable throughout the lifecycle, including those arising from self-evolving behaviour or logic. It has changed compared with Directive 2006/42/EC and applies to machinery placed on the market from 20 January 2027.

What changes compared with Directive 2006/42/EC

Adds hazards arising from self-evolving behaviour or logic and from varying levels of autonomy.

What the instruction manual must reflect

Intended use and reasonably foreseeable misuse, limits of the machinery, residual risks identified in the assessment. (The full assessment belongs in the technical documentation, not in the manual.)

Official text

PART B General principles 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.

Source: Regulation (EU) 2023/1230, OJ L 165, 29.6.2023, Annex III, Part B, point 1. The sections ‘What it requires’ and ‘What the instruction manual must reflect’ are our own summary and do not replace the official text.