As part of the amendments made to Annex II of REACH (Registration, Evaluation, Authorisation and Restriction of Chemicals), Safety Data Sheets – also called Material Safety Data Sheets – must now comply with a new set of requirements by January 2021. This rare but important update will align REACH Safety Data Sheets with the 6th and 7th revised editions of the Globally Harmonized System of Classification and Labelling of Chemicals (GHS). Continue reading for important information about what the new requirements are, who they apply to, and how you can begin the process of updating SDSs.
In this post:
New SDS Requirements
The recent amendments to REACH Annex II were published in the Official Journal of the European Union on 26th June 2020. While SDS sections 1, 2, 3, 9, 11, and 12 have all had big changes made to them, the most important parts of the Annex II revisions are:
The alignment of Safety Data Sheets with UN GHS Revisions 6 & 7
Changes to Section 9 of REACH Annex II mean that SDSs and GHSs will now require the same information about the physical properties of a product. Section 9 has also been revised so that the wording of SDS and GHS regulations is more cohesive. To see a detailed outline of what these changes entail, you can refer to the revised requirements for SDS Section 9 and all its subsections, as well as for Sections 14 and 14.7.
The alignment with requirements for nanomaterials
Regulations for SDS Section 1.1 regarding Product Identifiers have been revised so that SDSs pertaining to any substance that includes nanomaterials have to now state these in Section 1, using the term ‘nanoforms.’ Additionally, any nanoform characteristics of a substance must be indicated in Sections 3.1 and 9. Similarly, if substances in mixtures exist in different nanoforms, their particle characteristics will need to be specified in Section 3.2 of the SDS.
To clarify requirements related to Poison Centres (Unique Formula Identifiers)
Revisions to Section 1.1 require that hazardous mixtures that aren’t packaged be provided with a Unique Formula Identifier (UFI) and included in SDS Section 1.1. This requirement is part of the process for poison centre notifications, and pertains to Annex VIII of the Classification, Labelling and Packaging of substances and mixtures (CLP) Regulation (EC) No 1272/2008.
Additional information for substances and mixtures with endocrine-disrupting properties
According to Regulation (EU) 2017/2100, if a substance has an endocrine-disrupting property, it is now mandatory to state this in Section 2.3 of the SDS. Additionally, information must be provided for:
- Every constituent in a chemical mixture if they have properties that are disruptive to the endocrine system
- Substances in mixtures that are present at a w/v% concentration equal to or above 0.1% and have been identified as having endocrine-disrupting properties
As well as all this, if a substance contains endocrine-disrupting properties, information pertaining to adverse health effects or environmental impacts must be stated in Sections 11.2 and 12.6 of the SDS. Endocrine-disrupting properties are assessed by this list, which was created inline with REACH Article 59(1), EU Regulation 2017/2100(3) and EU Regulation 2018/605.
The addition of Specific Concentration Limits, M-factors & Acute Toxicity Estimates
Information about a pure chemical substance’s Specific Concentration Limit (SCL), Multiplying-Factor and Acute Toxicity Estimates must now be provided in Section 3.1 of the respective SDS. This is also where, if necessary, any particle characteristics specifying nanoforms should be stated.
Who Does It Apply To?
The changes to SDS requirements have come in towards the end of a Brexit transition. This means that the UK is unlikely to adopt the REACH Annex II update. However, the new requirements will apply to every chemical manufacturer or importer of chemical substances in the EU. For UK chemical suppliers, this means that if their SDSs fail to comply with the Annex II updates, they will be unable to trade their products in the EU.
Since SDS requirements for UK REACH won’t be compliant with the EU REACH updates, UK manufacturers must ensure that their SDSs satisfy both sets of regulations if they want to carry on trading in the EU after 1st January 2021.
When Is The Deadline?
All new SDSs authored after the 1st January 2021 must be updated to meet these new requirements. Organisations should start updating their SDSs as soon as possible in order to avoid non-compliance penalty fines.
That said, there is a grace period that allows SDSs authored before January 2021 to be valid until 31st December 2022. This will give organisations the time they need to update all their existing SDSs.
How To Get Started
There are a few things you can do to make sure you’re ready for the official SDS update in January. You can start by gathering all the information you need to update your Safety Data Sheets. Below are a few useful links to resources you can use:
- Annex II REACH, Regulation (EU) 2020/878
- New nanoform requirements, Regulation (EU) 2018/1881
- CLP Annex VIII requirements on poison
It’s important to ensure that all SDSs authored after 1st January 2021 comply with the REACH (EU) Annex II update. You should then also put all the necessary plans in place to ensure that all existing SDSs are updated before 1st January 2022.
