UNDERSTANDING NEW EU MACHINERY REGULATION
June 13, 2024 | Blog Post, Venus Automation
OVERVIEW
The machinery industry in the EU is undergoing a significant transformation with the introduction of the new EU Machinery Regulation (EU) No. 2023/1230. This regulation, which replaces the previous EC Machinery Directive 2006/42/EC, represents a pivotal shift aimed at harmonizing safety and performance standards across the EU. As businesses prepare to comply by the January 20, 2027 deadline, understanding the key changes and implications is crucial for manufacturers, importers, distributors, and other stakeholders in the machinery supply chain.
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From Directive to Regulation: Why The change?
The shift from a directive to a regulation is a fundamental change in how machinery safety is governed in the EU. Unlike a directive, which requires transposition into national laws, a regulation is directly applicable across all member states. This change eliminates variations in national legislations, ensuring a more uniform application of safety and performance standards. The new regulation came into force on July 19, 2023, providing a clear, consistent framework for all EU countries.
Key changes and new definitions:
The new regulation introduces several key changes and updates to the definitions and scope of machinery covered. Here’s a dynamic breakdown:
BROADER DEFINITION OF MACHINERY:
The regulation now includes newer technologies and machinery types, ensuring comprehensive coverage. This includes software performing safety functions and components with self-developing behaviour, reflecting the rise of AI and Machine Learning in industrial applications.
High-risk machinery categories:
Certain types of machinery are now classified as high-risk (Annex IV Machines). These machines will undergo more stringent conformity assessments. They are divided into Type A and Type B.
Type A: Require mandatory type examination by a notified body regardless of compliance with standards.
Type B: Follow harmonized standards but may still need notified bod testing.
Digital instructions and documentation:
Recognizing the digital age, the regulation allows for digital instructions for use. Users can request paper copies if needed. This change modernizes documentation practices and reduces environmental impact.
CYBERSECURITY AND SELF-EVOLVING MACHINERY:
The regulation emphasizes cybersecurity aspects, ensuring that machinery integrated with digital technologies is secure against cyber threats. machinery that evolves through machine learning and AI must meet specific safety standards to address the unique risks posed by these technologies. Additionally, clear guidelines are provided on the safety integration of software used in machinery to ensure it does not introduce new risks.
hamronized standards and modifications
The transition to new harmonized standards aims to ensure consistent safety and performance levels across all machinery. The regulation also defines what constitutes a substantial modification to machinery, which would necessitate a new conformity assessment, ensuring any significant changes maintain compliance with safety standards.
Responsibilities of economic operators
Essential Health and safety requirements (gsa)
The regulation delineates the responsibilities for manufacturers, importers, and distributors more clearly than ever before:
Manufacturers: Must ensure their machinery meets the updated safety requirements and maintain proper documentation. They are responsible for conducting risk assessments and ensuring compliance with the new regulation.
Importers: Must verify that manufacturers outside the EU comply with the new regulation. They need to ensure proper storage, transportation, and that machinery is accompanied by the necessary documentation.
Distributors: Like importers, distributors must ensure that machinery complies with the regulation. If they place products on the market under their own name, they assume the manufacturer’s responsibilities.
The regulation includes updated General Safety and Health Requirements (GSA) found in Annex III. These requirements address:
- Ergonomics: Machines must be designed to minimize user fatigue and injury.
- Communication Failures: Machinery should not create dangerous situations if communication fails.
- Maintenance and Emergency Rescue: Requirements include safe access for maintenance and procedures for emergency rescues.
recommendations for compliance
To ensure a smooth transition and compliance by January 2027, stakeholders should take several steps. Manufacturers should review and update their current CE marking processes and risk assessment templates, incorporating considerations for cybersecurity and AI. Businesses should develop digital documentation strategies in line with the allowance for digital operating instructions, while still maintaining the ability to provide paper copies upon request. Investing in comprehensive training programs is crucial to ensure all staff understand the new regulatory environment and their specific obligations. Maintaining meticulous documentation and record-keeping is essential to demonstrate compliance during audits and inspections. Additionally, seeking external assistance can be beneficial to navigate the complexities of the new regulation and ensure full compliance.
conclusion
The new EU Machinery Regulation 2023/1230 represents a significant advancement in the regulation of machinery safety and performance in the EU. By understanding and adapting to these changes, manufacturers, importers, and distributors can ensure they meet the updated requirements, leveraging the regulation’s provisions to enhance safety, performance, and technological integration in their machinery. As the deadline approaches, proactive steps in compliance strategy, training, and documentation will be key to a successful transition.