by Alexis Sumner
Since mid-2015, European Union (EU) Safety Data Sheets (SDSs) have been required to be written in compliance with Annex II of the REACH regulation, Reg. (EC) No 1907/2006, as amended. On 18-19 June 2019, the Forum for Exchange of Information on Enforcement met in Helsinki. Many non-compliance issues were discussed, dealing specifically with SDSs that were found during inspections. Forty-five hundred (4500) were evaluated during this process which concluded that about 50% of the reviewed SDSs had defects. Deficiencies were noted in multiple sections, including use information in Section 1, classification in Section 2, and component ranges in Section 3. It was also noted that Section 8 in many cases lacked Member State occupational exposure limits.
Noted in the Forum report from 16 May 2019 was the concern over ranges listed in Section 3.2 of the SDS and incorrect classifications, based on the ranges listed. The report specifically calls out that: Basing the classification on the highest percentage, the classification in section 2 was incorrect. However, in reality the classification was based on real concentration(s) which highlights the issue about incorrect use of concentration ranges. Additionally, data in Sections 8–12, should support the classification listed in Section 2. One of the main issues noted related to the lack of information on the physical/chemical, toxicological and eco-toxicological properties in Sections 9, 11 and 12, with no explanation as to the reason for the absence of the information as required to be stated.
Starting in November 2019, a pilot project will be instituted addressing the classification of mixtures and enforcement by inspectors in their Member State. More information will be released by the end of 2019 after a stakeholder meeting that will occur on 4 July 2019. The goal of this program is to improve the quality of the SDSs in the EU market.
Recommended Action Items:
Review ECHA guidance
Checklist – https://echa.europa.eu/regulations/reach/safety-data-sheets/checklist
Compilation – https://echa.europa.eu/-/guidance-on-the-compilation-of-safety-data-sheets
Review EU SDSs for compliance, especially classification.
Enforcement Forum announcement: https://echa.europa.eu/-/enforcement-forum-inspectors-to-look-into-classification-of-mixtures
Upcoming: EU SDS & Labeling Training Course July 23 – July 25, 2019 – This interactive 3 day course provides a broad overview of European Chemicals Legislation, Classification, Labeling and SDS requirements, and the fundamentals of the REACH regulation, as well as country-specific legislation which may affect you and your company. Visit the course information page to learn more and register today.
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