ECHA Report Details SDS Compliance Gaps
Written By: Atanu Das on Monday, March 17, 2025
The REF-11 project, conducted by the European Chemicals Agency (ECHA), aimed to assess compliance with new requirements for Safety Data Sheets (SDS) across the EU/EEA. The project inspected over 2,500 SDS documents, highlighting both improvements in compliance and areas for further enhancement. This post delves into the key findings, challenges, and recommendations from the project, focusing on improving SDS quality and compliance.
Introduction to the REF-11 Project
The REF-11 project was launched following the introduction of Regulation (EU) 2020/878, which updated Annex II of the REACH Regulation. This regulation introduced new requirements for SDS, including information on nanoforms, endocrine disrupting properties, specific concentration limits (SCL), acute toxicity estimates (ATE), and multiplication factors (M-factors). The project's primary objective was to evaluate how well dutyholders had adapted to these changes.
Key Findings
• Compliance Rate: 87% of inspected SDS complied with the new format required by Regulation (EU) 2020/878. However, 13% did not meet this requirement.
• Provision of SDS: 95% of suppliers provided SDS to recipients, but there were issues with updating procedures.
• Nanoforms and Endocrine Disruptors: Information on nanoforms was missing in 67% of relevant SDS, and endocrine disrupting properties were not fully documented in 48% of applicable cases.
• SCL, ATE, M-factors: While compliance rates were generally high, with 82% for SCL and 79% for M-factors, ATE was only included in 65% of relevant SDS.
Challenges in Compliance
1. Nanoforms: The project highlighted significant challenges in providing information on nanoforms. Inspectors found that in 67% of relevant SDS, this information was not provided. This lack of compliance poses risks, as nanoforms can have unique safety implications.
2. Endocrine Disrupting Properties: Only 52% of SDS for substances with endocrine disrupting properties included the necessary information. This is concerning, as accurate information is crucial for managing risks associated with these substances.
3. Authorisations: While 84% of SDS provided information on authorisation conditions, only 32% included the required authorisation numbers. This discrepancy suggests a need for clearer guidance on how to present this information consistently across different sections of the SDS.
4. Physical-Chemical Properties: Many SDS lacked necessary data or provided inconsistent information in section 9.1 and 9.2, which are critical for safe handling.
Recommendations for Improvement
• Dutyholders: Ensure all required information is accurately included in SDS and maintain procedures for updating SDS when new information becomes available.
• ECHA: Provide more guidance, particularly on new requirements like nanoforms and endocrine disruptors, and support awareness-raising efforts among stakeholders.
• National Enforcement Authorities (NEAs): Continue to conduct regular inspections focusing on both completeness and quality of SDS information. Utilize tools like the EUON list of substances in nanoform to facilitate inspections.
Enforcement Measures
The project identified over 900 non-compliant SDS, leading to various enforcement actions. The most common measure was issuing written advice, reflecting a preference for guiding dutyholders towards compliance rather than imposing severe penalties. This approach emphasizes education and guidance in improving SDS quality.
Conclusion
The REF-11 project demonstrates the importance of ongoing efforts to enhance SDS compliance and quality. By addressing the identified challenges and implementing the recommended improvements, dutyholders, ECHA, and NEAs can work together to ensure that SDS provide accurate and comprehensive safety information, ultimately protecting workers and the environment across the EU/EEA. Future projects should continue to monitor progress and adapt to evolving regulatory requirements.