December 2024
Summary of the REF-11 Project Report on Safety Data Sheets (SDS)
Executive Summary: The REF-11 project, conducted in 2023, aimed to assess compliance with the new requirements introduced by Regulation (EU) 2020/878 for Safety Data Sheets (SDS). The project involved inspections across 28 EU/EEA countries, covering 2528 SDS. The primary focus was on the completeness and quality of the information provided in the SDS, including new requirements for nanoforms, endocrine-disrupting properties, and specific concentration limits (SCL), acute toxicity estimates (ATE), and M-factors.
Key Findings:
- Compliance: 87% of the SDS reviewed complied with the new format required by Regulation (EU) 2020/878. However, a non-compliance rate of 35% was reported, indicating room for improvement.
- Nanoforms: 67% of the SDS requiring information on nanoforms did not provide it.
- Endocrine Disruptors: 52% of the SDS for substances with endocrine-disrupting properties contained the required information.
- SCL, ATE, M-factors: Compliance rates were 82% for SCL, 65% for ATE, and 79% for M-factors.
- Specific concentration limits (SCL), multiplication factors for acute and chronic aquatic hazards (M-factors) and acute toxicity estimates (ATE) according to Regulation (EC) 1272/2008 (CLP Regulation)
- Quality Issues: Common issues included incorrect or implausible information in sections 1, 2, 3, 8, and 9 of the SDS.
Enforcement Actions:
- Measures: Enforcement measures included written advice (69%), administrative orders (11%), fines (11%), and criminal complaints (6%).
- Follow-up: 59% of follow-up activities were completed during the operational phase.
Recommendations:
- Dutyholders: Ensure SDS compliance with the latest requirements and improve understanding of SDS obligations.
- ECHA/COM: Develop further Q&A and raise awareness among stakeholders, especially SMEs.
- NEAs: Continue quality controls on SDS and organize awareness-raising measures.
- Forum: Consider a follow-up project to monitor SDS quality improvements.
Graphs:
- Compliance Rate for SDS Format:
- Non-compliant SDS Identified Through Different Enforcement Projects:
The report highlights the need for ongoing efforts to improve the quality and compliance of SDS to ensure safe handling of hazardous substances and mixtures.
REF-11 project report on: Safety Data Sheets (SDS); December 2024: https://echa.europa.eu/documents/10162/2304648/wg_ref11_project_report_en.pdf/c9c78941-48bf-c6eb-38ca-11e55e18f889?t=1733136406554
Ekotox Centers SDS webpages: https://ekotox.eu/safety-data-sheet-sds/
Ekotox Centers Chemicals Management webpages: https://ekotox.eu/chemicals-management/