Machinery safety requirements

KEY POINTS

Scope

This regulation covers machinery and the following related products:

• interchangeable equipment,
• safety components,
• lifting accessories,
• chains, ropes and webbing,
• removable mechanical transmission devices.

The above are hereinafter referred to as machinery or related products.

It also applies to partly completed machinery.

The regulation does not apply to various areas, including means of transport by air, on water and on rail networks, except for machinery mounted on those means of transport.

Obligations of economic operators

The regulation contains lists of obligations of manufacturers, importers and distributors.

Health and safety essential requirements and presumption of conformity

• When placing machinery or related products covered by the regulation on the market or putting them into service, manufacturers must ensure that they have been designed and constructed in accordance with the essential health and safety requirements set out in Annex III to the regulation.
• When placing partly completed machinery covered by the regulation on the market, manufacturers must ensure that it has been designed and constructed in accordance with the relevant essential health and safety requirements set out in Annex III to the regulation.
• Voluntary harmonised standards (cited in the Official Journal of the European Union) or common specifications (published in the Official Journal) provide, if applied, presumption of conformity to the corresponding essential requirements.
• Common specifications may be established by the European Commission, via implementing acts, where certain conditions have been fulfilled.

Conformity assessment procedures

• The regulation allows the internal production control procedure (self-assessment) to be applied in order to demonstrate conformity with the applicable essential requirements for most products (with the exception of those listed in Part A of Annex I).
• More specifically, for products listed in Annex I, a conformity-assessment² procedure involving a notified body must be followed; however, for products listed in Part B of that annex, the internal production control procedure (self-assessment) may be followed when the products are designed and constructed in accordance with the relevant harmonised standards (cited in the Official Journal) or the relevant common specifications (published in the Official Journal), if they are specific to that category of product and cover all relevant essential requirements.
• The Commission can modify the list of categories in Annex I by adopting delegated acts, after assessing relevant data and information.

CE marking, EU declaration of conformity, safety information and instructions: machinery or related products

• Where the compliance of machinery or related products covered by the regulation with the applicable requirements has been demonstrated, manufacturers must then draw up an EU declaration of conformity³ and affix the CE marking (under Decision No 768/2008/EC).
• The EU declaration of conformity and instructions for use (which also include the safety information) will have to be provided with all machinery or related products. The EU declaration of conformity and instructions for use (which also include the safety information) may be provided in digital format. If they are provided in digital format, the manufacturer must fulfil specific obligations. For machinery or related products for non-professional use, the safety information that is essential for putting it into service and for using it in a safe way must, however, be provided in paper format. Customers will still be able to ask to be provided with the instructions for use in paper format free of charge.

EU declaration of incorporation and assembly instructions: partly completed machinery

• Where the compliance of partly completed machinery covered by the regulation with the relevant essential requirements has been demonstrated, manufacturers must draw up the EU declaration of incorporation.
• The EU declaration of incorporation and the assembly instructions, which may be provided in digital format, have to be provided with every type of partly completed machinery covered by the regulation. If they are provided in digital format, the manufacturer must fulfil specific obligations. The person who incorporates the partly completed machinery will still be able to ask to be provided with the assembly instructions in paper format free of charge.

Internal market emergency mode

Amending Regulation (EU) 2024/2748 seeks to avoid disruptions to the internal market in the event of an emergency (such as a pandemic or natural disaster) by ensuring that, once an internal market emergency mode, as set out in Regulation (EU) 2024/2747 (the Internal Market Emergency and Resilience Act), has been activated by means of an implementing act adopted by the Council of the European Union, designated crisis-relevant goods and services⁴ can be placed on the market as rapidly as possible.

Amending Regulation (EU) 2024/2748 adds a chapter to Regulation (EU) 2023/1230 detailing how these emergency procedures would apply. The new chapter:

• requires conformity-assessment bodies to prioritise applications for conformity of crisis-relevant products over those for products that are not;
• allows EU Member States, on an exceptional basis and where there is a duly justified request, to temporarily authorise the placing on the market of machinery, related products and partly completed machinery without carrying out the normal conformity-assessment procedures, where the involvement of a notified body is mandatory and can ensure that all essential requirements are met;
• permits Member States’ competent authorities to presume that machinery, related products and partly completed machinery manufactured in accordance with EU standards, relevant applicable national standards or relevant applicable international standards developed by an accredited international standardisation body, identified by the European Commission as suitable to reach conformity and ensuring an equivalent level of protection to that offered by the harmonised standards, comply with the relevant applicable essential requirements;
• gives the Commission the possibility to adopt, by means of implementing acts, common specifications on which the manufacturers can rely in order to benefit from a presumption of conformity with the applicable essential requirements (implementing acts laying down such common specifications remain applicable for the duration of the internal market emergency mode).