Overview
The HSE has issued a public consultation on broad legislative reform proposals to three core pieces of "assimilated" chemicals legislation (EU derived law, incorporated in Great Britain):
- GB BPR (Regulation (EU) No 528/2012 on biocidal products);
- GB CLP (Regulation (EC) No 1272/2008 on the classification, labelling and packaging of substances and mixtures); and
- GB PIC (Regulation (EU) No 649/2012 on prior informed consent).
The consultation is further evidence that the UK government is in ‘listening mode’, with significant changes to chemicals legislation anticipated in Great Britain (England, Scotland and Wales – excluding Northern Ireland).
Comments can be submitted until 18 August 2025.
Policy context and powers
The Retained EU Law Act 2023 provides powers for assimilated law to be amended, subject to certain conditions. Importantly, those powers expire in less than a year, on 23 June 2026, and cannot be used to increase the overall regulatory burden for duty holders. Therefore, the HSE has a narrow window within which to bring forward its proposed reforms. The proposals seek to help the HSE remain efficient and effective in its regulation of chemicals, and to provide cost savings for industry. This reflects wider UK governmental policy to overhaul the regulatory landscape to support economic growth.
Key proposed changes
GB BPR
1. Recognition of active substances approvals and biocidal products authorisations in foreign jurisdictions – the HSE is proposing to allow recognition of active substances approvals granted outside of Great Britain (GB). This could be extended to biocidal products authorisations as well. Recognition would be made subject to the condition that the foreign jurisdiction has similar (or better) evaluation standards for biocides than those in Great Britain.
Ancillary aspects which are being considered as part of this measure include:
- the precise mechanics of the recognition principle, such as:
- whether recognition occurs on an active or passive basis (i.e., whether the Secretary of State (SoS) actively approves active substances when they are approved abroad versus an automatic recognition of active substances approved abroad, with residual powers to refuse on specified grounds);
- whether to include a list of ‘trusted jurisdictions’ in a Schedule to an Act or in a Statutory Instrument.
- how subsequent decisions in the foreign jurisdiction (e.g., renewals, restrictions and non-approvals) should be handled. The consultation proposes three different approaches and asks stakeholders to rank these in order of preference:
- subsequent decisions are recognized in GB, in a similar way to the initial approvals;
- renewals are recognized in GB, but restrictions or bans are subject to a separate GB review.
- subsequent decisions are normally recognized, but where an applicant disagrees with a restriction or a ban, the applicant can submit a data package and pay for re-evaluation in GB, and an independent GB decision is taken.
- whether, and how, to acknowledge and protect the data submitted in support of foreign active substance approval, when such approval is recognised in GB. This implies that an applicant may be required to submit the underlying data package to HSE.
(i) Revamp of the renewal system for active substances and biocidal products – the HSE is considering removing the expiry dates attached to active substances approvals and potentially to biocidal products authorisations as well. Instead, a ‘call-in’ system operating on a ‘risk-based’ approach would be used to trigger reviews of active substances approvals and biocidal products authorisations (either a full re-evaluation or a targeted review). Details of how the call-in system would work, including the risk-based approach, are still being developed.
(ii) Expansion of essential use provisions – the SoS would be granted the power to issue an essential use derogation to any active substance that is considered essential to society at any time. Specific safeguards (e.g., public consultation on any proposed derogation, risk mitigation measures to minimise exposure and a requirement to seek alternatives) would be put in place to avoid potential abuse.
(iii) Powers to amend GB BPR through secondary legislation – amending powers would focus on specific areas including international recognitions, BPR procedures & timeframes, enforcement, identification of new risks, etc.
CLP
1. Improvement of the GB mandatory classification and labelling (MCL) process – The following changes are being proposed:
- remove the legal obligation under Article 37 of GB CLP, for the HSE, to automatically consider all RAC opinions on EU harmonized classifications and labelling proposals and prepare a technical report. Note: the HSE would still retain the ability to consider RAC opinions, even those relating to the new EU hazard classes, on a case-by-case basis;
- merge Articles 37 and 37A of GB CLP into one procedure;
- introduce a fast-track evaluation pathway for classification proposals originating from countries that adopt the UN GHS and have a transparent classification process; and
- complement the procedure with a GB MCL workplan, which would set out the classification proposals intended to be considered in the future.
2. Revocation of the notification requirement under Article 40 of GB CLP – this obligation, which is aimed at providing oversight of chemicals placed on the GB market, is viewed as 'disproportionately burdensome' by the HSE. It is also looking to remove Article 42, which requires it to establish and maintain a database for Article 40 notifications. Such a database was never put in place following the UK’s exit from the EU and would, in the HSE's view, represent a significant financial expense.
3. Relocate the explanatory notes associated with MCLs from Annex VI to GB CLP to the HSE’s website – the notes assigned to GB MCL entries would be moved to the HSE's website (either on the same spreadsheet as the GB MCL list or in an accompanying document). This change will allow the HSE to make revisions without adopting a Statutory Instrument. It also raises questions of legal certainty.
4. Power to make general updates to GB CLP beyond the implementation of scientific and technical developments arising from UN GHS.
5. Consistency with Northern Ireland – notably, this part of the consultation potentially opens the door towards a greater alignment between GB CLP and EU CLP (in contrast to those other measures in the consultation that seek to 'decouple' the parallel systems). The HSE is seeking stakeholders' views on the merits of applying some of the recent changes made to EU CLP to avoid adverse impacts on trade between GB (where EU law no longer applies) and Northern Ireland (where EU law continues to apply, dynamically). EU CLP changes which are being considered include the six new hazard classes, the More than One Constituent Substance (MOCS) classification rules and revised labelling requirements.
PIC
1. Removal of the Special Reference Identification Numbers (SRIN) procedure for small quantities (≤ 10kg per year) of chemicals being exported for R&D purposes. The SRIN requirement was introduced under the EU PIC but is not a requirement under the Rotterdam Convention.
2. Removal of the hazard classification criteria which apply to consideration by the Designated National Authority (DNA) for a waiver from explicit consent to import. The proposal is that a one-year waiver may be granted for Rotterdam Convention-listed chemicals if (i) no response is received from the importing country, (ii) the intended use is outside Part 3 of the GB PIC list, and (iii) official evidence shows the chemical was used or imported there in the last five years. This aims to remove some barriers to exports from the GB market and provide greater regulatory clarity.
3. Powers to amend PIC beyond the existing power to make technical changes to PIC Annexes. It is proposed to grant the HSE powers to amend UK legislation to reflect future Rotterdam Convention changes and implement scientific and technical aspects of other international agreements.
Strategies for an effective submission
This consultation represents an important opportunity for companies to share how they would like to see chemicals legislation refined for a post-Brexit Great Britain. Stakeholders are strongly encouraged to respond and provide their views on the HSE’s proposals – using the "free text" boxes and not just the multiple-choice Q&A options.
It is important that both trade associations – in the UK and outside – express their views. Individual company submission also have an important role to play - bringing to light specific issues raised by the proposal which may not be apparent to policy makers.
Our European chemicals team (in London and Brussels) has extensive experience in assisting companies prepare submissions to public consultations. If you would like to discuss how we can support you, do not hesitate to reach out.
For more information, please contact Darren, Tom, Zanda, and/or Elodie.
Our recent webinar on this topic is also available on demand here: Effective Advocacy on Proposed Reform to CLP, Biocides and PIC in the UK
