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The Council and the European Parliament reached a provisional agreement on 15 December on the Machinery regulation to replace the 2006 directive.
Transforming the directive into a regulation will provide a legal framework that is directly applicable in all Member States and clear for all economic operators. Indeed, a directive requires transposition into national law, which can lead to delays and differences in interpretation between Member States, and thus to legal uncertainty. And thus legal uncertainty.
The regulation covers machinery, consumer products and industrial machinery, or heavy construction machinery, complete industrial production lines, highly digitalised products such as robots or the manufacture of 3D printers. In order to ensure legal certainty, the co-legislators decided to clarify the scope and definitions proposed by the European Commission.
The Council and the European Parliament agreed to split the list of “high risk” machines subject to mandatory third party conformity assessment, as proposed by the Commission in Annex 1, into two parts. According to the agreement, only six categories of machinery will be subject to this third party assessment. This leaves the possibility of self-assessment by manufacturers open for most product categories, with the involvement of conformity assessment bodies being a choice that manufacturers make according to the procedure they choose to apply.
After careful evaluation and consultation with relevant stakeholders, the European Commission will be able to update the list of products that need to be assessed by a conformity assessment body because of their complexity and the potential risks they may pose. This will ensure a balance between the need to ensure the highest level of safety and the need to avoid placing a disproportionate burden on EU industry.
The Regulation strikes the right balance between digital and paper documentation. This means that the co-legislators have agreed in principle that :
- digital instructions will be the default option
paper instructions will remain an option at the time of purchase for customers who do not have access to the digital copy; - basic safety information should be provided with each product.
The draft agreement is now subject to approval by the Council and the European Parliament. Once the formal adoption steps are completed, Member States will have 42 months to implement the regulation.
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