Drives & Controls April 2024

32 n MACHINE BUILDING April 2024 What does the EU Machinery Regulation mean for you? The European Union (EU) recently introduced the Machinery Regulation 2023/1230, which came into e ect on June 29, 2023. This regulation replaces the previous Machinery Directive 2006/42/EC and signiƒcantly a ects manufacturers, importers and distributors The main changes in Chapter 1, which have practical implications compared to the old Machinery Directive, are outlined below. The regulation provides clarity on deƒnitions, which have been expanded. It now includes any assembly with a drive system (other than direct human or animal e ort) designed for a speciƒc application. This broader scope encompasses various products, including those with embedded software. The new Annex 1 has been segregated into parts A and B. A good way to think of this is that while machine groups in Annex 1.B are classed as “high risk” machinery, those in Annex 1.A are classed as “very high risk”. All machinery listed in Annex 1.A must receive a conformity assessment from a Notiƒed Body. The practical implication of this is that manufacturers will need to consider applying for, and carrying out, conformity assessments before the transition date to ensure continued market access. You therefore need to consider the availability of Notiƒed Bodies to perform these assessments, and not to wait too long. High-risk machinery groups in Annex 1.B can continue to be self-certiƒed by the manufacturer. Wider obligations Chapter Two of the regulation provides clarity on the legal obligations of operators. Some of the main aspects are listed below. Manufacturers Technical documentation and a Declaration of Conformity (DofC) must be stored for a minimum of 10 years after the last machine type is placed on the market. The marking on the machine must now contain a digital contact detail, such as Web site or email, and remain valid for 10 years from the last machine type being placed on the market. “Professional use” machinery instructions must be made available digitally and marked directly on the machine to allow digital access, such as via QR code. The same applies to the DofC. Where it is foreseeable that users will be non-professionals, then hard-copy instructions and DofC must also be provided. For partly-completed machinery, the same requirements remain, but access to the Declaration of Incorporation (DofI) is provided digitally instead of the DofC. Authorised representatives (ARs) The minimum tasks of the AR are to keep the technical documentation and the DofC/DofI for a minimum of 10 years after placing the machinery on the market. Importers Importers must only place compliant machinery on the market. It’s important to note that a machine end-user could also be the importer of the machine. For example, if an employer in Ireland orders a machine directly from China to be installed on their shop ›oor, they now assume the role of importer. While storing or transporting machinery, importers must ensure that they do not jeopardise any essential health and safety requirements (EHSRs). They must also verify that conformity assessments have been carried out, and ensure that the machinery has the required technical documentation, CE marking, and instructions. Importers must not place products on the market that they believe are not in conformance with the Regulation, and they must inform the manufacturer and market surveillance authorities regarding any cases of risk to health and safety. As well as ensuring that technical documentation is available, importers must also store copies of DofCs for 10 years, and machinery must be marked with their details. Where deemed appropriate, they are required to perform sample testing of products. Where necessary, they must also maintain a register of complaints and keep distributors informed. They may also be required to take corrective actions to recall non-conforming products from the market and to inform local authorities and the manufacturer. They will also be responsible for cooperating with authorities in the case of any requests. Distributors Distributors need to act with due care in relation to Regulation requirements, and verify that certain requirements, DofC, instructions for safe use, and safety information are available digitally or, where required, also supplied as hard copies with the machinery. When storing or transporting the machinery, distributors must also ensure they do not jeopardise any EHSRs. Where required, they must take corrective actions to recall non-conforming products and inform local authorities and the manufacturer. In conclusion, the enactment of the Machinery Regulation 2023/1230 heralds signiƒcant changes and obligations for operators in the EU machinery industry. Compliance with these regulations is crucial, not only for ensuring the safety and quality of machinery and related products, but also for fostering trust and adherence across the market. n The EU’s new Machinery Regulation replaces the earlier Machinery Directive. Darren Hugheston-Roberts, head of machinery safety at TÜV SÜD, looks at the implications for machinery suppliers and users.