The EU's Regulation on Machinery Products (Regulation (EU) 2023/1230) was recently published in the Official Journal of the European Union.
It has been clear for some time now that the EU's product safety regime is outdated and there are lots of changes to the legal landscape ahead to account for the emergence of new digital technologies. The new rules for machinery products will complement the other changes being made, especially because they encompass technologies such as robots and artificial intelligence, which currently do not fall within the scope of existing legislation.
The Machinery Regulation (which will apply, in full, from 14 January 2027) will repeal the Machinery Directive 2006/42/EC, which was one of the main pieces of legislation governing the harmonisation of essential health and safety requirements for machinery at EU level. The Regulation will promote the free movement of machinery and it aims to ensure a high level of protection for both workers and citizens.
Directive to Regulation
First, the fact that the new rules will take the form of a Regulation instead of a Directive is fundamental because this means the rules will be directly applicable in Member States without the need for implementation. As such, the new rules will have the same effect in all EU countries, so there will be less national variation and thus greater certainty for companies which handle "machinery".
The definition of "machinery"
The Regulation applies to machinery and "related products" (set out in Article 2(1)), which includes eg, "safety components". It also applies to partly completed machinery. The definition of a safety component includes both a physical and digital component, including software, which was not included in the previous definition and thus provides welcome clarity that new digital technologies are in scope.
The definition of "machinery" is wide in scope and includes "an assembly, fitted with or intended to be fitted with a drive system other than directly applied human or animal effort, consisting of linked parts or components, at least one of which moved, and which are joined together for a specification application" (Article 3(1)(a)). However, the new definition also refers to "an assembly … missing only the uploading of software intended for the specific application foreseen by the manufacturer" (Article 3(1)(f)).
Other key changes
Some of the other key changes to be implemented are as follows:
- A person carrying out a substantial modification of machinery or a related product is subject to the obligations of a manufacturer, eg, conducting a new conformity assessment.
- The name and address of machinery importers will have to be labelled.
- Third-party conformity assessments will be mandatory for six categories of "high risk" machinery listed in Annex I, including software related products.
- Instructions for use and safety information will have to be provided with every product, but it can be in a digital format provided it can be given as a printed version (free of charge) at the customer's request. If the manufacturer opts for digital instructions, there must be information on the machinery as to how to access the instructions and they must be in a printable format eg, a PDF document. However, in case the machinery or related product are intended for or foreseeably used by non-professional users, certain safety information has to be provided in paper format.
- Manufacturers must comply with specific safety requirements for machinery that use artificial intelligence.
- Manufacturers must take appropriate measures to ensure the security of their machinery against potential cyber threats and protection against interference. This includes the implementation of security measures to prevent accidental or intentional corruption, manipulation, or theft of data.
- Manufacturers will have specific after-market obligations, including notifying the competent national authorities and withdrawing or recalling the machinery if necessary.
The UK
Although the Regulation will not automatically be implemented in the UK because of Brexit, the measures will still apply to UK producers placing machinery products on the market in the EU.
Similar proposals may also be carried into English law in the future, so producers of applicable products should follow developments in this area closely.
If you need further information, please contact a member of our international product liability and product safety team.
