by Charlotte Blackburn, PhD
In December 2020, the updated ECHA Guidance on the compilation of safety data sheets (Version 4.0) was published. The updated guidance takes into account the revised REACH Annex II, Regulation (EU) 2020/878, which applied from 1st January 2021.
The guidance provides advice on the various new requirements, including but not limited to:
- Nanoforms
- Endocrine disrupting properties
- Changes to Section 3 of the SDS (additional information and disclosure requirements)
- Expansion of Section 9 of the SDS (Physical and chemical properties)
Of particular note is the clarification on the application of the transition period for Regulation (EU) 2020/878. The guidance has confirmed the following:
“…Until 31 December 2022, all safety data sheets provided after 1st January 2021, including new and updated safety data sheets, can be provided in the current format according to Regulation (EU) 2015/830 or in the new format according to Regulation (EU) 2020/878, including the following scenarios:
- No change to safety data sheet
- Small change to safety data sheets not within scope of Article 31(9)
- Update to safety data sheets within the scope of Article 31(9) or introducing the UFI
- New safety data sheets authored for the first time after 1st January 2021
All safety data sheets provided after 31 December 2022 have to be in the format according to Regulation (EU) 2020/878.”
Recommended Action Items
Review the revised text of this Guidance document and update SDSs accordingly prior to the end of the transition period.
Resources
ECHA Guidance: https://echa.europa.eu/documents/10162/23036412/sds_en.pdf/01c29e23-2cbe-49c0-aca7-72f22e101e20
Regulation (EU) 2020/878: https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32020R0878&rid=1
Related articles
https://msc.ul.com/en/resources/article/amendment-to-reach-annex-ii-published/
Never Miss an Update:
UL’s global Regulatory Assurance Team contains more than 50 regulatory analysts worldwide, serving customers in six continents, with multi-lingual support in more than 30 languages. Our team can help you navigate the complex, ever changing regulatory landscape to understand and execute your compliance obligations.
For all of the latest regulatory news and the most important industry updates, sign up for our monthly Regulatory Round-Up Newsletter.