by Charlotte Blackburn, Ph.D.
The latest amendment to REACH Annex II, which sets out the requirements for the compilation of safety data sheets (SDS), was published in the Official Journal on 26th June 2020 (Regulation (EU) 2020/278).
The regulation aligns Annex II with the 6th and 7th revisions of GHS, and brings in a number of modifications to the SDS and the information required to be provided within the document.
The main sections of the SDS which have undergone revision are 1, 2, 3, 9, 11 and 12, with sections 3 and 9 seeing the biggest changes:
- Additional information required for substances disclosed in Section 3 (e.g. specific concentration limits, M-factors and ATE values)
- Changes to Section 3 disclosure requirements for both hazardous and non-hazardous mixtures
- Changes to Section 9 requirements, with additional information on physical hazards addressed within subsection 9.2
The updated Annex II also incorporates the possibility to include the Unique Formula Identifier (UFI), when it is required to be indicated in the SDS; additionally, it introduces the requirement for provision of information on nanoforms and endocrine disruptors in relevant sections of the SDS, which are both topics that have featured heavily in ECHA’s chemical management plan.
When does the new regulation apply from?
The regulation applies from 1st January 2021. Due to the large burden that updating all current SDS would place on suppliers, by derogation existing SDS that are in accordance with the current requirements [as per Regulation (EU) 2015/830] can continue to be provided until 31st December 2022.
How we can help?
Our regulatory experts can provide global SDS authoring, SDS consulting and SDS training services for your entire product inventory and/or intermediates. We have professional knowledge and skill in the Globally Harmonized System (GHS), ISO and ANSI formats. With our sophisticated software, SDSs are prepared in HTML and/or PDF formats and can be translated into multiple languages.
Your UL SDS author can also perform ongoing review and updates of your existing SDSs or those we have created for your company. Read more about Hazard Communication Advisory Services.
Regulation (EU) 2020/878: https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32020R0878&from=EN
Regulation (EU) 2015/830: https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32015R0830&from=EN
Regulation (EC) No 1907/2006 (latest consolidated version): https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:02006R1907-20200428&rid=1
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