Statement of CEN/CENELEC on the Machinery Regulation

In a recent technical article we presented selected contents from the European Commission’s draft for a new Machinery Regulation. Until August 2021, users and interested parties were given the opportunity to comment that draft and propose ideas for an improvement of the final version of the regulation. In the next steps, the draft will again be revised, afterwards submitted to the European Parliament for voting.

An interesting topic within this context is the position paper from the European Standardization Organizations (ESOs) CEN and CENELEC.

In the scope of standardisation mandates, the ESOs create harmonized standards. The latter are meant to cover the essential health and safety requirements of selected EU-directives and regulations.

Standards that are listed within the Official Journal of the EU in accordance to the Machinery Directive 2006/42/EC are not automatically published in the upcoming OJEU for the new Machinery Regulation. Before, CEN and CENELEC will need to verify, which of the existing Machinery standards already fulfil the requirements of the future Machinery Regulation.

In their position paper the ESOs have repeatedly criticised the draft for a Machinery Regulation. In summary they claim that barely any of their proposals found its way into the draft. In the following, you can find some of the content-related criticism summed up:

• In order to adapt the about 780 harmonized standards of the current Machinery Directive to the revised essential health and safety requirements of the new regulation, CEN and CENELEC want the implementation period of the standardisation mandate to be extended from 30 to 36 months (3 years).
• Article 17.3 shall be deleted: this article authorizes the European Commission to introduce so-called “Implementing Acts”, which are supposed to establish technical specifications instead of harmonized standards for the fulfilment of the Machinery Regulation’s requirements. Reasons for CEN and CENELEC’s request are the following: 
  • The European standardization is based upon consensus between national (e.g. DIN, Austrian Standards) and international standardization organizations (ISO, IEC). Hence a parallel process to develop such specifications would impede the collaboration of all experts and create substantial efforts.
  • The application of such technical specifications might no longer be voluntary but mandatory. Yet, this is contrary to the current voluntary use of standards, a basic principle of the New Legislative Framework.
• The conformity assessment for high-risk machinery in article 5.1 and 21.2 of the Machinery Regulation draft replaces the current approach in Annex IV and article 12 of the valid Machinery Directive. CEN and CENELEC argue that the evaluation of such high-risk machinery is reliable and a deletion would solely result in confusion, therefore the new clauses should be deleted from the draft.
• Due to the linkage with the new Artificial Intelligence (AI) Regulation there is a necessity to include specialists into the standards work. Therefore, the ESOs once more call for additional time to implement the regulation.
• CEN and CENELEC also scrutinized the elaboration of the existing essential health and safety requirements:
  • Especially for technical committees, who are responsible for the development of harmonized standards, some of the requirements listed in the draft are too descriptive. This would impede their elaboration of technologically neutral standards based upon those requirements.
  • Some of the suggested essential health and safety requirements are already covered by existing requirements. CEN and CENELEC mention that the latter are repeated in Annex III of the new Regulation’s draft. This would then complicate an elaboration of Annexes ZA/ZZ, that contain a listing of the correspondence. Hence the ESOs want the Commission not to display the requirements in a repeating manner.

Conclusion

• Different interest groups – like CEN and CENELEC – criticize the draft for a new Machinery Regulation
• Especially article 17 paragraph 3 of the new Machinery Regulation, the suggested competence for the Commission to develop technical specifications instead of harmonized standards, is likely to be fiercely discussed in the future.