Regulatory developments in EU and UK expected in 2022-23
As European and UK businesses emerge from the pandemic, new developments are anticipated in respect of compliance expectations. A range of new technical challenges are expected to be brought in as part of regulatory compliance for industrial chemicals within the European Union, while deadlines, scope and procedure for the new UK system are under review.
In the EU: REACH and CLP
The European Commission is considering a range of new developments affecting technical aspects of REACH and CLP compliance in Europe. As part of the Chemicals Strategy for Sustainability, changes being considered include:
Introduction of additional information on use and exposure.
Introduction of mixture assessment factors in REACH into chemical risk assessment.
Developing criteria for chemicals that are safe and sustainable by design.
Introduction of revising and developing new classifications covering:
Endocrine disruption;
Immunotoxicology and developmental neurotoxicity.
Persistent, bioaccumulative and toxic (PBT) and very persistent, very bioaccumulative (vPvB) substances;
Persistent, mobile and toxic (PMT) and very persistent and very mobile (vPvM) substances;
Terrestrial effects.
Changes to the restriction and authorisation process.
Introduction of the concept of “essential use”.
Extension of REACH to cover polymers. This may include
Introduction of criteria for identifying polymers of low concern (PLC) and polymers requiring registration (PRR).
Notification of polymers indicating whether or not they meet the PLC or PRR criteria.
Registration of polymers meeting the PRR criteria.
Commission proposals are likely to start appearing towards the end of 2022.
In the UK: REACH
UK REACH covers companies manufacturing or importing chemicals into England, Scotland and Wales (Northern Ireland is still covered by EU REACH).
Decisions made in EU REACH are no longer automatically applied in the UK and differences between UK REACH and EU REACH are likely to arise over the coming months and years. This may include differences in registration requirements.
A consultation is currently being carried out on the information that will be required for full registration of substances under UK REACH following transitional registration. The consultation is exploring if there are opportunities to reduce the need for registrants to replicate existing EU REACH data by placing a greater emphasis on understanding how chemicals are used in GB. As a result, the deadlines for registration have been extended. Additionally:
Interim principles have been published on how substances of very high concern (SVHC) will be on the candidate list in UK REACH (Approach to including substances of very high concern on the UK REACH candidate list – GOV.UK (www.gov.uk)). A Regulatory Management Options Analysis (RMOA), informed by calls for evidence, will be used to determine if inclusion on the candidate list is the correct route. As a result, the UK REACH candidate list may start to diverge from the EU REACH candidate list. An initial assessment of the substances added to the EU REACH candidate list has recently been published (Initial assessments of substances added to the EU Candidate List in 2021 (hse.gov.uk)).
The UK REACH Rolling Action Plan (RAP) is expected to be published soon and will give details of the substances that will undergo substance evaluation under UK REACH.
The UK’s approach to the topics and challenges being considered under the EU Chemicals Strategy for Sustainability are not yet known.
As regulators on both sides of the English Channel assess their respective priorities, planning for a future of compliance with similar but potentially divergent systems will present a new challenge for companies supplying into both markets.
