REACH Annex II updates came into force in January 2021What businesses must do to remain compliant
Annex II of the Registration, Evaluation and Authorisation of Chemicals (REACH) Regulation (EC) No 1907/2006 was amended in July 2020. The amendment, known as Commission Regulation (EU) 2020/878, came into force on 1 January 2021. All EU safety data sheets (SDS) authored from this date will have to comply with the amendment.
What happens to SDSs authored before January 2021?
Any SDS compiled according to the old Annex II requirements will have to be rewritten to comply with the updated requirements. A grace period to update such SDSs has now passed. Organisations should start the process of updating their SDSs urgently if not already done so.
What has changed?
Inclusion of Unique Formula Identifier (UFI) in section 1.1 of the SDS
The requirement to assign a UFI to a product comes from Annex VIII of the Classification, Labelling and Packaging of substances and mixtures (CLP) Regulation (EC) No 1272/2008 and is part of the process for poison centre notifications. As per Annex VIII, UFIs assigned to hazardous mixtures for industrial use and to unpackaged mixtures have to be included in their respective SDSs. Annex II now specifies that these UFIs have to be included in section 1.1 of the SDS. This requirement is mandatory and not subject to the same implementation timeline as the rest of the new Regulation.
Nanoform specifications must be stated
If a substance exists in different nanoforms, this should be stated in section 1 of the substance’s SDS. In addition, the relevant nanoform/particle characteristics must be specified in sections 3.1 and 9. Certain substances have to be disclosed when they are in mixtures (based on their concentration and hazards) in section 3.2. If these substances can exist in different nanoforms, then the relevant nanoform/particle characteristics should also be specified.
Information on endocrine disruptors is now mandatory
It will become mandatory to state in section 2.3 of the SDS if a substance has an endocrine disrupting property. This property will be assessed based on a list established in accordance with REACH Article 59(1), EU Regulation 2017/2100(3) and EU Regulation 2018/605. This will also be applicable to substances in mixtures that are present at or above 0.1% and have been identified as having endocrine disrupting properties according to the list above.
If available, information on adverse health/environmental effects caused by the endocrine disrupting properties of such substances should also be provided in section 11.2 and 12.6 of the SDS.
Inclusion of properties from Annex VI of the CLP
For pure substances and substances that must be disclosed in a mixture, the specific concentration limit, the Multiplying Factor (M-factor) and the acute toxicity estimate for substances included in Part 3 of Annex VI to Regulation (EC) No 1272/2008, or as determined in accordance with Annex I to that Regulation, shall be indicated, if available, in section 3 of the SDS.
Disclosure limits change for category 1A sensitisers
For mixtures classified as health or environmental hazards, the section 3 disclosure limits have changed. Ingredients that trigger the supplementary hazard statement EUH208, because of a sensitiser 1A classification (present in the mixture at 1/10th of the general or specific concentration limit) now need to be disclosed. Substances that are classified for aspiration hazard now need to be disclosed if present at concentration of equal or greater than 1%.
Updates to the ingredients that must be disclosed
For non-hazardous and classified mixtures, the requirement to disclose ingredients has been updated to include:
- Sensitisers, carcinogens (category 2) and reproductive toxins at lower concentrations.
- Substances, present at concentrations equal or greater than 0.1% that are identified as having endocrine disrupting properties in accordance with to EU Regulation 2017/2100(3) or EU Regulation 2018/605.
This requirement applies if these ingredients do not have to be disclosed because of any other hazard endpoint.
Alignment with GHS
Section 9 of REACH Annex II has been updated to align it with the Globally Harmonised System of Classification and Labelling of Chemicals (GHS). The information on physical properties that is required for SDS is now the same as that for GHS. The wording of the two regulations is now more closely aligned.
Section 9.2 contains information about properties that should be provided for the safe use of the substance or mixture (if the property is relevant to the chemical). It is divided into two sections:
- 9.2.1 – Information regarding physical hazard classes.
- 9.2.2 – Other safety characteristics.
Section 14 has also been revised so that it is more closely aligned with GHS. In particular, the name and text of section 14.7 has been changed to very similar to that in GHS.
Who does the REACH Annex II amendment apply to?
Relevant UK authorities have indicated that the UK will not be adopting this update to Annex II after the UK leaves the EU (31 December 2020). This means that one SDS will not be compliant for UK REACH and EU REACH. If you are a manufacturer or importer of chemical substances in the UK, it is critical that you put a plan in place to ensure that your SDSs are compliant according to the regulations in both places and that you can continue trading your products in the UK and EU from 1 January 2021.
We strongly recommend that chemical suppliers begin the process of updating their SDSs as soon as possible so that they can remain compliant with UK REACH and EU REACH, thus avoiding any disruption to operations in the future.
How can NCEC help?
NCEC’s expert SDS authoring team, equipped with years of regulatory experience and close links with regulatory bodies such as the European Chemicals Agency (ECHA), the Health & Safety Executive (HSE) and Member State competent authorities can assist with all your SDS requirements – from compliance reviews and product classification to regional regulatory template set-up and translation services (in over 40 languages). We provide ongoing regulatory tracking, notifications and updates – helping mitigate risks in an ever-changing regulatory arena.
If you have any questions or concerns regarding these forthcoming changes, or want to understand what this could mean for your business, please feel free to contact us through the form on the right hand side or email us at [email protected]. You can find out more about our SDS services here.