REGULATION AND LEGISLATION
Changes to REACH Safety Data Sheets
Interview with Dr. Ralf Michael, head of chemicals legislation and occupational safety at UNITI, first published in the December 2020 issue of the UNITI Magazine, Mineralölrundschau
A new Safety Data Sheet (SDS) format applies as of 2021 in the European Union. What changes need to be made and what do companies in the sector have to take into consideration?
We have heard that there is a new format for the Safety Data Sheet (SDS) according to the European Union (EU) chemicals regulation REACH? Dr. Ralf Michael: Yes, that’s right. The current format for the compilation of the Safety Data Sheet (SDS) in accordance with Annex II of the Registration, Evaluation and Authorisation of Chemicals (REACH) regulation has been in force since June 2015. Five years later, the EU Commission has published an update of Annex II of REACH with the Regulation (EU) 2020/878 of 18 June 2020.
Why is the SDS format being updated? There are several reasons for this. On the one hand, the amendments include the 6th and 7th revisions of the United Nations’ (UN) Globally Harmonised System (GHS) (1) and also they take account of requirements from the new Annex VIII of the Classification of Labelling and Packaging (CLP) regulation (2).
On the other hand, new knowledge on data requirements and substance properties are included in the SDS, for example substances with nanoforms, and substances with endocrine disrupting properties.
What are the specific changes in the SDS? I cannot go into all detailed changes here, but I would like to point out the following important additions and amendments with reference to the relevant SDS section and/or subsection:
In section 1, in subsection 1.1. “Product identifier” the UFI (Unique Formula Identifier) according to Annex
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VIII of CLP for hazardous mixtures with physical or health hazards has to be indicated. This is mandatory for unpackaged mixtures and optional for mixtures for industrial use instead of the indication on the label or packaging.
In section 2, subsection 2.3. “Other hazards” require that information on endocrine disrupting properties for substances or for substances present in a mixture in a concentration of 0.1 percent or more shall be provided.
In Section 3, subsection 3.2. “Mixtures” also contain a number of additions and amendments:
Substances with endocrine disrupting properties are now to be specified as components if the concentration is 0.1 percent or more.
For mixtures classified as hazardous according to CLP the concentration limits for substances has changed for some hazard classes and categories:
For substances classified as skin sensitisers, category 1A or respiratory sensitisers, category 1A the concentration limit has been lowered to ≥ 0.01 percent.
The concentration limit for aspiration toxicity has been reduced from ≥ 10 percent to ≥ 1 percent.
Substances with the classification of specific target organ toxicity, single exposure, category 3 need to be specified in a concentration ≥ 1 percent.
There are also various additions for mixtures not classified as hazardous under CLP with regard to the indication of substances with certain health hazards.
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