Last reviewed 11 November 2021
Great Britain’s transition period with the European Union ended on 31 December 2020. Nearly a year on, Caroline Raine looks at some of the divergence from the EU with regards to chemicals regulations and discusses potential future divergence.
The chemicals legislation was lifted and shifted at the end of the transition period and so most of the rules that applied in the EU on 31 December 2020 applied in the UK/GB on 1 January 2021. Since then, we have started to see some divergence. In this article we will look at the impact on the chemicals industry, focusing on the classification, labelling and packaging (CLP) and REACH regulations looking at harmonised classifications, poison centres, substances of concern in products (SCIP), REACH and safety data sheets.
Classification, Labelling and Packaging Regulations (CLP)
At the point of exit, the HSE created the GB mandatory classification and labelling list (GB CLP). This sets out the classification and hazard labelling of substances and is legally binding in Great Britain. The HSE will keep this list updated annually through scientific and technical developments. In the EU CLP is updated through adaptations to technical progress (ATPs).
The 14th and 15th ATPs come into force on 9 October 2021 and 1 March 2022 respectively, but as both were published prior to the date of 31 December 2020 they have been adopted into GB CLP. Recent ATPs 16 and 17 have not yet been adopted into the GB CLP; here we have divergence.
Since the EU implementation from date of 1 January 2021 was after the end of the transition period on 31 December 2020, Great Britain (GB) has not adopted the requirement to make Annex VIII harmonised poison centre notifications. England, Scotland and Wales have not adopted Annex VIII of CLP but Northern Ireland has.
For GB, poison centre notifications will remain voluntary and if you wish to make a voluntary notification you only need to send a copy of your safety data sheets to the National Poison Information Service (NPIS). There is no obligation to generate or submit a unique formula identifier (UFI) code in GB but the NPIS will register your product with its associated UFI if one has already been generated.
Northern Ireland will follow the Annex VIII requirements, but not through the ECHA portal. Instead, once the Annex VIII dossier has been created, because NPIS does not have access to the European Chemicals Agency (ECHA) poison centre notification (PCN), submissions for NI must be provided in the form of a PCN and sent directly to NPIS Birmingham as the appointed body.
Substances of concern in products (SCIP)
Since the EU implementation from date of 5 January 2021 was after the end of the transition period on 31 December 2020, Great Britain (GB) has not adopted the requirement to notify to the SCIP database.
This means that companies in GB who produce, assemble, import or distribute articles in GB that contain above 0.1% weight by weight of a substance of very high concern (SVHC) Candidate List Substance will not need to make a notification to the SCIP database.
GB companies who produce, assemble, import or distribute articles that contain above 0.1% weight by weight of a substance of very high concern (SVHC) Candidate List Substance in the EU must make a notification to the SCIP database. The obligation to make this notification will lie with the EU importer, but GB companies may choose to make a voluntary notification. This will require an EU legal entity.
EU companies who produce, assemble, import or distribute articles that contain above 0.1% weight by weight of a substance of very high concern (SVHC) Candidate List Substance will need to make notifications in the EU, but not in GB.
The candidate list is a list of substances of very high concern (SVHC) for Authorisation. It is updated by ECHA twice a year, in January and July. It currently lists 219 substances. Since 31 December 2020 it has been updated twice, adding 10 substances.
The HSE adopted the candidate list as it was on 31 December 2020 and so we have not yet added those 10 substances to our version.
Since 1 January 2021, the UK has had its own UK REACH regulations — The REACH, etc (Amendment, etc) (EU Exit) Regulations 2020. UK downstream users (those who do not hold an EU REACH registration) currently importing chemicals from an EU/EEA country need to ensure the substances they purchase are covered by a valid UK REACH registration. UK downstream users were required to notify the Health and Safety Executive (HSE) using a Downstream User Import Notification (DUIN) of their intention to continue importing substances from the EU/EEA by 27 October 2021.
A new registration must then be submitted to the HSE within 2, 4 or 6 years of 28 October 2021. Alternatively, UK downstream users can encourage their EU/EEA supplier to appoint a UK-based Only Representative (OR) or change their source to a UK registered supplier.
Deadline (last date for dossier submission)
27 October 2023
1000 tonnes or more per year
Candidate list substances (as at 31 December 2020)
27 October 2025
100 tonnes or more per year
Candidate list substances (as at 27 October 2023)
27 October 2027
1 tonne or more per year
UK REACH follows EU REACH very closely and so at the moment there is very little divergence.
For now, all but one of the annexes and amendments in EU REACH have been adopted in the UK. The only exception to this is the recent Annex II amendment; since this has an implementation date after the end of the transition period (31 December 2020) it has not been carried into UK law.
The EU is looking very closely at registrations of polymers of concern. At the moment only monomers must be registered under EU and UK REACH, but the introduction of a new requirement in the EU to register polymers of concern would perhaps be significant divergence from the EU if the UK chooses not to introduce it. Of course, the HSE has a newly-formed team for UK REACH and has not indicated either way if the UK would or would not adopt the registration of polymers of concern.
Safety data sheet formats
REACH Annex II was recently updated through an amendment. REACH Annex II regulation (2020/878) was published in July and will require all safety data sheets (SDSs) to be updated by the end of December 2022. It applies from 1 January 2021, requiring all SDSs to be written in this new format. This date is after the transition period ends, so for that reason it will not be adopted into law in Scotland, England or Wales. SDSs in GB will need to comply with the “old” REACH Annex II requirements.
The EU will of course adopt it in full and so any EU safety data sheets must comply with it. This means that GB and the EU and NI will have different formats that need to be followed. It is likely that the HSE will take a pragmatic approach and accept SDSs in GB that follow either format.
The chemical strategy for sustainability intends to ensure that CLP is the central piece of legislation for hazard classification, and to do that new hazard classes will be required for environmental toxicity, persistence, mobility and bioaccumulation. Environmental classification will be moved from REACH into CLP and we will see new classifications for endocrine disruptors, persistent, mobile and toxic, and very persistent, very mobile substances, immunotoxicity and neurotoxicity. There are also discussions ongoing about the new concept of the mixture assessment factor. Will the HSE implement all of these? Or will we see further divergence?
Questions still remain about the degree to which HSE will continue to diverge from ECHA. You will need to allow extra time and budget to be able to keep up with and comply with two different regimes so it’s important to keep monitoring both the HSE changes to regulations and what comes from ECHA.
Finally, don’t forget: you can always keep up to date with the changes by following the news updates in your Croner-i Inform product.