The new Machinery Regulation (EU) 2023/1230 has significant ergonomics and human factors implications. The regulation lays down health and safety requirements for the design and construction of machinery, aiming to ensure high protection for persons, particularly consumers and professional users.
The regulation considers digital technologies like AI, IoT, and robotics and their safety/liability challenges. These technologies directly impact ergonomics and human factors as they change how humans interact with machinery. For instance, AI can lead to more intuitive user interfaces, while IoT can provide real-time feedback to operators, enhancing safety and efficiency.
Furthermore, the regulation mandates that machinery or related products may only be made available on the market or put into service if they meet the essential health and safety requirements in Annex III. These requirements likely include ergonomic considerations, such as the design of controls and displays, the provision of adjustable workstations, and the minimization of physical strain and fatigue.
While the specific requirements are mainly provided through European harmonized standards elaborated by European standards organizations, they generally cover aspects such as:
- The design and construction of machinery to ensure safety.
- The proper installation and maintenance of machinery.
- The intended use or any reasonably foreseeable misuse of machinery.
It’s important to note that these requirements are directly applicable in Member States as, unlike those of a Directive, there is no need to be transposed into national legislation. This ensures uniform application for all operators across the Union and does not give room for divergent implementation by Member states.
The new regulation also aims to better cover new technologies such as autonomous mobile machinery (robots), the Internet of Things with connected equipment, or artificial intelligence (AI), where specific modules of AI using learning techniques ensure safety functions1. This highlights the evolving nature of these requirements in response to technological advancements.
The regulation also addresses the issue of ‘incomplete machinery’ and ‘substantial modifications’, providing clearer rules for manufacturers and other economic operators. This clarity can help ensure that modifications to machinery do not negatively impact ergonomics or compromise user safety.
Pascal Etienne represented FEES at the November 2023 Machinery Expert Group meeting. From an Ergonomics and Human Factors perspective, several advances in this field are expected in the next few months.
The New Machinery Regulation (EU) 2023/1230
The new Machinery Regulation (EU) 2023/1230 is set to come into effect on January 20, 2027. However, it’s important to note that some articles will apply before this date due to Article 54 of the regulation. This includes aspects related to notified bodies, penalties, the Committee, delegated acts, and the categories of machines mentioned in Annex I.
Template for Collection of Machinery-Related Accident Data
The Commission has proposed a template for collecting machinery-related accident data by Member States. This template includes accidents causing harm and also damage to health caused by machines or related products.
Guide to Application of the New Machinery Regulation
The European Commission (EC) has announced that work on the Guide to applying the new Machinery Regulation will start in 2024. Stakeholders are asked to express their interest in this matter. The issue at hand is to identify what needs to be changed or not. As of now, no specific date or document is available.
Digital Format of Instructions for Use and Declaration of Conformity
The EC has presented a proposal concerning § 255 and 261 of the Guide. According to the Commission, this is not an anticipation of the regulation but an appropriate updating of the directive. An updated document will be discussed during the next Machinery Expert Group on 12th April.
Standardization
The draft standardization request in support of the new Machinery Regulation will be published later. About 700 EN standards (hENs) under the machinery directive will be revised, with 40% under the ISO CEN agreement. Modifications in some essential health and safety requirements (EHSR) will impact about 60% of the EN standards.
For CEN, the task is to transfer the EN standards under the Machinery Directive to the new Machines Regulation. The work program results will be communicated to the Commission, and the work must be carried out by the end of 2024 using a tool to be developed. The first batches of revised standards will be presented in April/May 2026.
The Judgment of the Court in Case C-588/21 by the European Court of Justice, declaring that European harmonized technical standards on toy safety must be accessible to EU citizens, has significant implications for machinery safety.
Firstly, the ruling emphasizes the importance of transparency and accessibility of safety standards. This is particularly relevant for machinery manufacturers and other economic operators, who must ensure their products meet these standards to be placed on the European market. By making these standards accessible, manufacturers can better understand and comply with safety requirements, leading to safer machinery and reduced risk of accidents.
Secondly, the ruling could potentially lead to greater involvement of stakeholders in developing and revising safety standards. This could result in more comprehensive, up-to-date standards that reflect real-world conditions and challenges.
Finally, the ruling underscores the role of harmonized standards as part of EU law. This means these standards are not just guidelines but have legal implications. Manufacturers who fail to comply with these standards could face legal consequences.
Stay tuned for more updates on these important matters.
Project supported by the European Union
