Possible reform of UK chemicals regulations
05 Sep 2024
The Retained EU Law (Revocation and Reform) Act 2023 gave UK ministers and devolved authorities powers to revoke, replace and reformat assimilated EU law until 23 June 2026. In view of this, the HSE are undertaking a review of the assimilated chemicals regulations for which they have responsibility, including CLP, Biocides and PIC, to ascertain if changes to these regulations would make them work better in a UK-only context.
This includes not only looking at these regulations from the industry perspective, but also from the regulators point of view. Since leaving the EU, the HSE must now undertake many tasks that were previously carried out by ECHA or shared amongst the various EU Member State Competent Authorities. They are therefore looking simplify and streamline tasks where possible.
For example, they have previously suggested that the processes for approving active biocidal substances and authorising biocidal products could be more efficient as these activities are being carried out within the same agency – meaning the current delays in the EU processes that ensue from waiting for each party to complete their tasks before moving on to the next task and party could be reduced or eliminated.
GB CLP Survey
As part of this review HSE have been engaging informally with stakeholders over the summer to seek their input. They have launched a survey to gather feedback from active participants in the GB CLP supply chain on how the current system is working and what impact any changes may have on their businesses and sectors.
They have stated that they are particularly interested in feedback on:
- notification (by manufacturers and importers)
- re-labelling
- label formatting
- chemicals under pressure
- explosives not in transport configuration
- 'Keep out of reach of children’ pictogram
- precautionary statements
The survey is expected to take no longer than 15 minutes to complete and closes on Wednesday 18 September. Time is therefore of the essence if you wish to participate!
Interested parties can also send their feedback on these, or any aspects of the regulations, directly to the HSE at Chemicals.Reform@hse.gov.uk.
Depending on the feedback, HSE’s findings and subsequent Ministerial approval, the next steps in the process would be a formal public consultation, potentially during Winter 2024, with the deadline for enacting new or amended regulation being June 2026 (as stated above).
UK REACH Fees
The UK Department for Environment, Food and Rural Affairs (Defra) is planning changes to the UK REACH fee structure.
The proposed changes would implement a flat fee for Registration for all tonnage bands – a major divergence from the REACH model implemented by the EU with higher tonnage registrations being charged up to ten times more than the lowest tonnage band. Defra aims to implement the new model in April 2025 when large companies will have to pay £2,142 for registration at any tonnage band and SME companies will have reduced flat fees of £57 for Micro enterprises, £399 for Small enterprises and £740 for Medium enterprises for registration. These changes will apply to both substances and intermediates. Fees to update a registration will also be reduced, however fees for confidentiality claims and changes to access granted will remain unchanged.
The flat fee model was developed to reflect the work which needs to be done by the HSE and Defra and in accordance with the UK Managing Public Money (MPM) guidance on cost recovery. Fees to Authorisations will be rising moderately in-line with UK MPM guidance on cost recovery, while retaining the current cost determination structure.
Reducing the cost of higher tier registration fees will make the prospect of UK REACH registration less objectionable to higher tier registrants that were unable to Grandfather their registrations, and therefore unable to claim a free registration number under UK REACH. Uptake of UK REACH Lead Registrant roles has been slow for substances which are not part of established consortiums as individual companies are faced with the prospect of duplicating the cost-sharing work already done for EU REACH, and updating technical dossiers and Chemical Safety Reports (CSR) which may not have been updated since the initial registration at the 2010 or 2013 EU REACH deadlines. This may require a large amount of work to bring them inline with current requirements of UK REACH. By reducing the registration fee Defra will reduce the initial investment by Lead Registrants to secure their UK supply chains and increase the percentage of the overall registration cost that can be recouped through the established REACH cost sharing mechanisms.
GB Article 95 list
The HSE have also announced plans to update the GB Article 95 list under the GB BPR (Great Britain Biocidal Products Regulation). The GB Article 95 list of biocidal active substance suppliers was established when the UK left the EU. As a temporary measure, all suppliers on the EU list were automatically added to the GB list, however, to remain on the list suppliers must submit information to the HSE including confirmation that they are established in the UK (GB & NI), and resubmission of their data dossier or Letter of Access to a relevant data dossier.
The HSE has extended the deadline for GB Article 95 listed suppliers to submit this – which is now 1 November 2024 – with GB Article 95 listed suppliers that do not provide their information by this date removed from the list on 3 March 2025, meaning they will no longer be able to supply biocidal active substances to the GB market.
If you are concerned that you or your supplier could be removed from the list you can check the list on the HSE website, or speak to our team of regulatory experts for tailored guidance.