EU: The planned EU Machinery Regulation is coming

Surprisingly, on June 24, 2022, the Council of the European Union, still under the French Presidency, cleared the way for the new Machinery Regulation. Member states agreed on a mandate for negotiations with the European Parliament on the proposal for a Machinery Products Regulation.

The proposal aims to transform the 2006 Machinery Directive into a regulation and thus acquires direct legal effect without national transposition. The 2006 Directive is one of the most important pieces of legislation harmonizing the essential health and safety requirements for machinery at EU level. It promotes the free movement of machinery within the internal market and ensures a high level of protection for workers and citizens in the EU.

Converting the directive into a regulation consolidates the legal framework and strengthens the harmonization of standards in the internal market. The text has the necessary flexibility to accommodate emerging technologies, including the future use of artificial intelligence in the machinery sector.
 

Scope

To ensure legal certainty, the proposal clarifies the scope of the directive. In particular, the text proposed by the Council aims not to exclude small personal transport vehicles and light electric vehicles such as electric scooters and electric bicycles, as they are widely used and could be potentially dangerous for their users.
 

List of products

The Council mandate has changed the structure of the list of machines or products found in Annex I of the Commission's proposal. This change leaves the option of self-assessment of conformity open for most products, while the involvement of conformity assessment bodies is mandatory only for some products. The European Commission will be able to adopt delegated acts to update this list of products that need to be assessed by a conformity assessment body due to the greater risk they may pose. In this way, a balance is struck between the need to ensure the highest level of safety and the need to avoid a disproportionate burden on industry.
 

Other changes to the text

The Council text proposes that the Commission may develop technical specifications where standards are not available or are unsatisfactory. However, this option remains a last resort and is only available to the Commission in certain circumstances.

The Council's mandate strikes a balance between digital and paper documents. This means that manufacturers must provide paper instructions to customers who request them within six months of purchasing the product.
 

The other changes to the commission's proposal are:

  • clarified terms such as "machine," "associated products," "products subject to this regulation," and "substantial modification"
  • the requirement for third party conformity assessment for certain categories of products has been clarified
  • the text has been decoupled from the future regulation on artificial intelligence
  • the provisions have been consistently aligned with the new regulatory framework (NLF).


Next steps

The mandate issued on June 24, 2022, has been approved by the Council's Permanent Representatives Committee (Coreper), allowing the Presidency to start negotiations with the European Parliament shortly.


If you have any questions regarding the new Machinery Regulation or the Machinery Directive, please feel free to contact our team of experts. 

Published on 11.07.2022
Category: Fokus Industry, Compliance

Compliance News

The latest developments in all areas of market authorization and product compliance.

Comprehensive expertise in Standards Management
More News
USA: TSCA - new requirements for PFAS in the USA

EPA establishes Significant New Use Rule (SNUR)

Read more

EU: Battery Regulation 2023/1542 - implementation of important producer obligations as early as August 18, 2024

Conformity assessment, harmonized standards and CE marking

Read more

EU: Current REACH monitoring projects - findings and consequences

Imported products, chemicals and consumer products

Read more

Login
x

In accordance with the EU ePrivacy (Cookie) Directive (2009/136/EG), we would like to inform you that our website uses cookies. By using our website, you accept and agree to our Privacy policy. Please view our Privacy policy to find out what cookies we use and how to disable them.

OK