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New Machinery Regulation 2023/1230

12 July 2023
The EU has been regulating at an electric pace recently. In addition to the vast array of new laws in production, and the recent General Product Safety Regulation, on 29 June 2023 the EU recast the old Machinery Directive 2006/42/EC and replaced it with a new regulation, Regulation (EU) 2023/1230 (the 'Machinery Regulation')..

What's new?

While it is easy to think that machinery is just limited to systems found in factories or heavy industry, the reality is that the definition and scope of the definition is broad and impacts amongst other things anything within the following definition: '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 moves, and which are joined together for a specific application'.

As is usual in product law, there is a hierarchy of duties depending on the role played by the actor in the supply chain: 

  • Manufacturer obligations: ensure machinery is designed and constructed safely, draw up technical documentation, carry out relevant conformity assessment (dependant on machinery type), draw up EU declaration of conformity, affix CE marking, and documentary and information requirements – such as manufacturer details being on the product and accompanying instructions.
  • Importer obligations: only place compliant machinery on the market, ensure conformity assessment procedures have been carried out, and the machinery has the required technical documentation, CE marking, and instructions along with importer details. 
  • Distributor obligations: Act with due care in relation to the Machinery Regulation requirements, and specifically verify certain requirements are complete e.g. CE marking.

The obligations differ for partly completely machinery. Notable is that the Machinery Regulation explicitly states that "instructions may be provided in a digital format" if they meet requirements, (Article 10(7), the Machinery Regulation).

Directive to Regulation

The most significant change is that the new law is a regulation. That means that unlike the previous directive, the new Machinery Regulation will be directly applicable in all EU Member States meaning there is no scope for differing implementation, (Article 54, the Machinery Regulation).

The Machinery Regulation's preamble notes that the "experience with the application of Directive 2006/42/EC has shown inadequacies and inconsistencies in the product coverage and conformity assessment procedures", (Preamble (3), the Machinery Regulation). Our experience is that it was relatively consistently implemented, though as is the case with all EU laws the interpretation of the same obligations can differ.

Key changes: scope adjusted to reflect role played by software

The EU recognises that there has been a "growing use of digital means, and software plays a more and more important role in machinery design", (Preamble (19), the Machinery Regulation).

The Machinery Regulation consequently has an adapted definition of machinery (New rules to ensure the safety of machinery and robots (europa.eu)) and safety component to address this:

  • The machinery definition includes machinery "missing only the uploading of the software intended for the specific application foreseen by the manufacturer", (Article 3(1) (f), the Machinery Regulation). Software was not mentioned in the machinery definition under the Machinery Directive.
  • The definition of 'safety component' covers both physical and digital components including software, (Article 3(3), the Machinery Regulation). The definition of safety component under the Machinery Directive did not make any reference to either physical or digital, so this provides clarity that digital safety components are in scope.

Key change: conformity assessment specific requirements

The Machinery Regulation also includes a requirement for six machinery/related product categories to undergo specific conformity assessments, (Annex I, Article 6(1), and Article 25(2) and (3), the Machinery Regulation). The purpose of this update is partly to ensure that 'newer' categories of machinery (those with self-evolving behaviour, those capable of machine learning) are more trusted by consumers due to their needing to go through specific conformity assessment procedures. This is particularly where their role is ensuring safety functions.

Key change: EU expects penalties for non-compliance

While the EU does not get involved in setting penalties as this is a Member State competence, this Regulation continues the trend of the EU being more directive and mandating that Member States shall lay down the rules on penalties and shall take all measures necessary to ensure that they are implemented. The penalties provided for shall be 'effective, proportionate and dissuasive and may include criminal penalties for serious infringements'.

Staggered implementation between now and 2027 

While the Machinery Regulation does not apply in full until 14 January 2027, as is often the case several other obligations arise before then which means that it is necessary to keep this under review.  

In particular, on 13 July 2023: Article 6(7) and Articles 48 and 52 apply, these allow for additional machinery/related products to be added to Annex I (the categories requiring specific conformity assessment procedures) where they present a serious inherent potential risk and fulfil other conditions. Then on 14 July 2024 the EU is able to adopt delegated acts to amend Annex I.

Inbetween, on 14 October 2023 Article 50(1) applies which requires Member States to put in place rules setting out penalties. Member States then have a rather generous amount of time to tell the EU about them as that is not due until nearly three years later on 14 October 2026.

On 14 January 2024 Articles 26 to 42 apply which require Member States to notify the Commission of which bodies are authorised to carry out third party conformity assessments, and designate notifying authorities. 

We would like to acknowledge the contribution of Kirsty PootsLauren Crockett to this article.

Please contact Dominic Watkins if you have any queries regarding the above.

Further Reading