New Machinery Regulations: amendments of March 2022

On March 31, 2022, the compromise text of the French Presidency of the proposal for the new Machinery Regulation was published.

The new Machinery Regulations will replace the Machinery Directive as we have described in the dedicated blog article where you can also download the text of the proposal of April 21, 2021.

Main news of the text of the Machinery Regulations

The new text of March 31, 2022 (further modification of the texts published on January 17 and 28, 2022 and February 9 and 25, 2022) has made numerous NEWS and CHANGES to the original proposal of April 21, 2021, among which the main ones are:

  • distinction between machines, related products (interchangeable equipment, safety components, chains, ropes and belts, removable mechanical transmission devices) and partly completed machinery which are all products subject to the regulation;
  • modification of the definition of "security component", which can be physical, digital or mixed in nature;
  • introduction of the definition of "safety function": function which serves to implement a protective measure, to eliminate or, if not possible, to reduce risks and whose absence may lead to an increase in risks;
  • modified the definition of "substantial modification", i.e. a modification of machinery or a related product by physical or digital means after it has been placed on the market or put into service, which is not envisaged by the manufacturer and changes its original specific application and purpose and which affects its safety by creating a new risk or increasing an existing one and requires additional guards or protective devices, the control of which alters the existing safety-related control system, or requires additional protective measures to ensure the stability or mechanical strength of the machinery;
  • specified that if the substantial modification has an impact on the safety of a part of an assembly, the person making the modification is considered to be the manufacturer only for the affected part of that assembly;
  • clarified the obligations concerning instructions when provided in digital format:
    • indicate on the machine and in an accompanying document how to access the digital instructions;
    • clearly describe which version of the instructions corresponds to the machine model;
    • present the instructions in a format that allows the end user to download them and save them on an electronic device so that it can access it at any time, in particular during a machine breakdown; this requirement also applies to machinery where the instruction manual is incorporated in the software of the machine itself;
    • make them available online during the expected life cycle of the machine or related product and for no less than 10 years after the product is placed on the market;
    • provide them free of charge in paper format at the request of the buyer;
  • modification of the procedure for assessing the conformity of partly completed machinery:
    • partly completed machinery must be designed and built in compliance with the relevant essential health and safety requirements;
    • procedures must be implemented to ensure the conformity of partly completed machines produced in series; manufacturers must take into account changes in the production process, in the characteristics of the partly completed machinery and changes in harmonized standards or common specifications;
    • the partly completed machinery must bear the indication of information that allows its univocal identification and the name and address of the manufacturer;
    • the assembly instructions and the EU declaration of incorporation can be provided in digital format; however, at the request of the purchaser, the assembly instructions must be provided free of charge in paper format;
    • the assembly instructions and the EU declaration of incorporation must be in a language easily understood by the person incorporating the partly completed machinery, as determined by the Member State concerned;
  • clarification of the obligations for importers and distributors of machines or related products ;
  • insertion of obligations for importers and distributors of partly completed machinery ;
  • clarifications on "Common (technical) specifications" that can be adopted by the commission in the absence of harmonised standards and on the role of interested parties in the process of drafting these specifications; if a harmonised standard covering the same aspects as a common specification is published, the harmonised standard replaces the common specification;
  • indication of the purpose and content of the EU declaration of incorporation for partly completed machinery:
    • certify that compliance with the applicable essential health and safety requirements has been demonstrated;
    • it must be translated into the language or languages required by the Member State in which the partly completed machinery is placed on the market;
    • if a partly completed machinery is subject to several Union acts requiring an EU declaration of conformity, the EU declaration of incorporation includes a declaration of conformity with these Union acts;
  • divided the list of products in Annex I (former Annex IV of Directive 2006/42 / EC) into part A and part B, with two different conformity assessment procedures described in article 21;
  • partially modified some essential health and safety requirements of Annex III;
  • addition letter C to Annex IV concerning the relevant technical documentation for substantially modified machines;
  • addition letter C to Annex V concerning the EU declaration of conformity for substantially modified machines;
  • addition letter B to Annex VI concerning internal production control for partly completed machinery;
  • added Annex IXa concerning the conformity assessment procedure based on unit verification;
  • the contents of the assembly instructions for partly completed machinery are indicated in Annex X.
Regolamento Macchine - Testo di compromesso della presidenza - 31.03.2022
Regolamento Macchine - Testo di compromesso della presidenza - 25.02.2022
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