CE Europäische Union
  • 13 - Umwelt, Gesundheitsschutz, Sicherheit

Safety of machinery (ICS 13.110)

Proposal for a Regulation of the European Parliament and of the Council on machinery products (COM(2021) 202 final) (55 page(s), in English; 67 page(s), in English)

This proposal for a Regulation takes into account the result of the evaluation of the machinery Directive 2006/42/EC.

Following the recommendations highlighted during the evaluation the proposal covers:

·         Clarity on the scope, exclusions and some definitions, including a new definition on "substantial modification" when the machine suffers a substantial modification, without the manufacturers agreement once is placed on the market.  

·         New risks originating from digitalised machinery. In particular those originated from a direct human-robot collaboration, connected machinery, software updates that affects the behaviour of the machinery after its placing on the market, as well as the ability of manufacturers to conduct a full risk assessment on machine learning applications before the product is placed on the market. As far as the autonomous machines, the Regulation explicitly considers the possibility of no driver, and sets up requirements. 

·         Clarifications on a number of requirements on "traditional machinery" related to installation of lifting appliances, slow speed lifts, seating, protection against hazardous substances, overhead power lines and vibration from portable handheld and hand guided machinery  

·         Criteria to define high risk machinery and the possibility to adapt the current list of high-risk machinery to the state of the art as well as a mandatory third-party conformity assessment for this type of machinery.

·         Digitalisation of the machinery instructions and the manufacturers declaration of conformity with the possibility to request paper instructions at the time of buying the machinery product.

·        Alignment to Decision 768/2008/EC to bring together all the elements required for a comprehensive regulatory framework to operate effectively for the safety and compliance of machinery products.