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Proposal for a new European regulation on machinery products

Proposal for a new European regulation on machinery products
On 26 April 2021, the Council of the EU launched discussion of the proposal for a new European regulation on machinery products (Machinery Products Regulation).  Under the leadership of the Portuguese Presidency, the meetings will continue at fortnightly intervals, with a total of five online meetings scheduled until the end of June 2021. It is provisionally expected that the draft deliberations may take between one and two years.

Like major changes the proposal contains? These are mainly the following amendments and additions.

Form of legislation
The proposal takes the form of a European regulation. The choice of a Regulation will allow for a faster and more coherent application of the proposed legislation and will create a clear regulatory environment for economic operators.

Scope and definitions
The scope of the Regulation in terms of the scope of machinery remains the same, but the subject matter in Article 1 is added by adding a new bullet point to the definition of machinery, the definition of safety component is extended to include software and a definition of substantial modification is added.

The exclusion has been extended to all means of transport moving on roads. As regards the exclusion from the list of electrical and electronic products under the Low Voltage Devices Directive (LVD), it has been extended to LVD products with Wi-Fi.

High-risk machines
The proposal lays down rules for the classification of high-risk machinery currently listed in Annex IV of Directive 2006/42/EC.

Obligations of economic operators
The proposal brings the obligations of manufacturers, authorised representatives, importers and distributors into line with Decision NLF 768/2008/EC.

Presumption of conformity of machinery
The presumption of conformity for the use of harmonised standards or parts thereof published in the Official Journal of the EU remains.

Conformity assessment
The proposal retains internal production control for machinery not classified as high risk. For high-risk machinery, it accepts only conformity assessment with the involvement of an independent third party.

Notified entities
In line with Decision NLF 768/2008/EC, the proposal sets out the requirements for conformity assessment bodies as well as for the national authorities responsible for these bodies.

Proposal a new European regulation on machinery products has been published together with a proposal for a regulation on artificial intelligence (Artificial Intelligence Regulation) as part of a package of AI initiatives. The two proposals are interlinked.

The text of both proposals, including the impact assessment, can be found at: