New changes to Safety Data Sheets under REACH: What you need to know
By Bill Atkinson, Chief Scientific Adviser
Don’t get caught out by changes to Safety Data Sheets coming into force in 2021…
Since 2007, EU REACH regulations (Annex II) have required suppliers of chemical substances to supply a Safety Data Sheet (SDS) detailing information on hazards, handling, storage and emergency measures of a substance. On 25 June 2020, the European Commission published an amendment to Annex II, to come into force on 1 January 2021. Bill Atkinson, Chief Scientific Adviser, explains why it is vital chemical substances suppliers are aware of these changes, and are ready to implement them on any new SDS completed from 1 January 2021.
What does this amendment require?
The amendment requires (i) the alignment of safety data sheets with UN GHS Revisions 6 & 7; (ii) the inclusion of Unique Formula Identifiers; (iii) additional information on nanomaterials; (iv) additional information for substances and mixtures with endocrine-disrupting properties; and (v) the addition of Specific Concentration Limits (SCLs), M-factors and Acute Toxicity Estimates.
What about existing Safety Data Sheets?
Don’t panic: existing SDS’s are valid for a further 2 years, until 31 December 2022. But new ones, created 1 January 2021 onwards, that need to adhere to the new rules.
But if this is an EU Regulation, why do these changes still apply to UK suppliers?
It’s a good point. The UK has now left the EU, and is currently in a transition period until 31 December 2020, during which time EU legislation does still apply to us. But by the time these updates to Annex II come into force on 1 January 2021, our transition period will have ended and EU law no longer applies.
However, it is anticipated that transition period, the UK will continue to align with the Globally Harmonised System of Classification and Labelling of Chemicals (GHS) with which REACH regulation also align. So, whilst everything about UK REACH is still up for discussion, it’s fairly safe to assume that these latest amendments to Annex II will be reflected in UK law – whether immediately or subsequently.
So it would certainly be sensible to prepare for that until informed otherwise – a case of better safe than sorry.
So, what are the main changes to the rules?
Taking Annex II section by section, in brief this is what’s changing:
If your SDS pertains to one or more nanomaterials (or materials including them) you must now state this using the term ‘nanoform’.
You must now provide the substance’s Unique Formula Identifier (the 16-character UFI code given when products are labelled) for mixtures that are not packaged or supplied for use at industrial sites.
With increasing focus on health and the environment, when detailing your product’s potential hazards, you must now include information on properties which might pose a risk to the human endocrine system.
If your chemical is a mixture, information must be provided for each constituent endocrine-disrupting substance at a concentration equal to or greater than 0.1% by weight.
For pure chemical substances, you must now provide product information on specific concentration limits, M-factors, and acute toxicity estimates. If your substance covers a nanomaterial, the particle characteristics that specify the nanoform must be indicated.
For hazardous mixtures, there are changes to the list of hazard classes, hazard categories and concentration limits for which a substance must be listed if it’s part of a mixture intended for the consumer.
Look into the details of these changes to ensure you continue to fulfil all requirements.
The list of properties you must detail about your chemical substance in Section 9 has been updated: make sure you’re using the up-to-date version on any new SDS.
There are 17 ‘hazard’ properties that are particularly important to detail, as well as other various safety characteristics. Check the regulations for the full list and make sure you’re covered.
Sections 11 and 12 aim to improve health and the environment: Section 11 requires you list hazards relating to acute toxicity, skin corrosion, eye damage, respiratory or skin sensitisation, germ cell mutagenicity, carcinogenicity, reproductive toxicity, STOT-single or repeated exposure, or aspiration hazard.
Section 11.2 has been added, requiring that you specify information on any adverse health effects relating to the endocrine system from your chemical substance(s).Section 12
A new section, 12.6, has been added requiring you to give product information on adverse effects on the environment caused by endocrine-disrupting properties.
Make sure you’re ready for the implementation date next January, and start to prepare for the changes now:
- Gather the relevant information so that you can update your Safety Data Sheets.
- Update any Safety Data Sheet templates to the new requirements - if you’re using software make your software supplier is aware of the requirements.
- Ensure that you update existing safety data sheets in good time for the 31 December 2022 deadline.
Make a vital New Year’s Resolution at the beginning of 2021, to ensure that any new Safety Data Sheets written from the January 1 meet the new requirements.
Need any advice? We have specialist teams of qualified chemists and regulatory affairs specialists who can advise in detail on the changes to Safety Data Sheets and make sure you’re compliant.