UK REACH came into force on 1st January 2021 after the UK withdrew from the European Union. Under the terms of the Northern Ireland Protocol, UK REACH only applies in Great Britain (GB) as EU REACH continues to apply in Northern Ireland. Then, under the terms of the Withdrawal Bill, EU law was retained as UK/GB law. The only changes that were made were to remove/fix parts that were inoperable in a GB-only context. For example, replacing references to the Commission and EU bodies. As a result, most of the EU REACH law exists under UK REACH, but in a GB-only context. The only exception to this is the addition of transitional provisions, which were added to ease the change for GB-businesses.
Due to UK REACH being a replica of EU REACH, the registration process is the same and companies should negotiate access to a data package required for registration. However, for some businesses this would mean negotiating access to the data in both the UK and EU, which could be extremely costly. As such, the UK chemical industry raised concerns with Defra, the policy lead for UK REACH, and in response they are exploring an an Alternative Transitional Registration model (ATRm). The ATRm applies to substances that were registered under EU REACH before the 1 January 2021 by any legal entity as these substances were registered under EU REACH at the time the UK left the European Union. These are otherwise known as transitional substance and/or transitional registrations.
A public consultation was released on the ATRm on Tuesday 16th May and companies had until Thursday 25th July to comment (please see previous article here: https://www.h2compliance.com/2024/05/20/regulatory-update-defra-release-public-consultation-on-uk-reach-atrm/).
However, since then there has been a change in government in the UK. The ATRm public consultation was proposed by the old Conservative government and so the ATRm may not be implemented by the new Labour government.
Consequently, here we expand on the 4 key areas covered by the public consultation and discuss the future of UK REACH.
The 4 key areas in the ATRm public consultation are:
-
Registration related requirements: hazard requirements, use and exposure information, and Chemical Safety Reports (CSRs).
In a standard REACH registration, a registrant must negotiate access to physicochemical, toxicological and ecotoxicological data of a substance to understand the intrinsic properties of the substance and ensure it can be used safely. However, in the case of transitional registrations, this would mean registrants would need to access data that is already readily available under EU REACH, which would be extremely costly to the registrant. As a result, Defra have assessed whether this data needs to be replicated under UK REACH and determined that the same hazard conclusions would be made under EU and UK REACH. Therefore, the data does not need to be replicated and the hazard information requirements in UK REACH transitional registrations can be reduced without undermining the “no data, no market” principle of REACH.
As such, the ATRm proposes that for 1-10 tonne registrations, registrants only need to provide the hazard classification and associated labelling of the substance rather than the full hazard data previously required. For registrations above 10 tonnes, further information on PBT/vPvB assessments, PNECs and DNELS will be required as well as some physicochemical properties. Consequently, the reduction in hazard requirements in transitional registration dossiers should significantly reduce costs for UK REACH registrants.
Instead of the costly hazard requirements, the ATRm proposes that UK REACH registrants provide additional use and exposure information compared to a standard registration. This additional requirement will also apply to new registrations of novel substances for consistency. The aim is that Defra will receive enhanced information on the use of chemicals in GB to inform regulatory activities under UK REACH. In addition, it is hoped that the increased requirements will address shortcomings in current EU REACH registrations where the use and exposure information is often incomplete in registration dossiers.
The new use and exposure information proposed in the ATRm public consultation follows a tiered approach, whereby the level of information required depends on the hazard and tonnage of the substance. In each category, there are then different levels of information required for the human health and environment.
Level 1 represents the current use and exposure requirements for a 1-10 tonne registration under EU REACH. This will only be required for some human health information and Level 2 will be the new baseline for the environmental information, where the registrant will be required to provide new information such as the number of sites and exposure reduction methods.
Each level builds on the lower level, so Level 2 includes everything required for Level 1 and, Level 3 includes everything required for both Level 1 and Level 2. Level 3 is only applicable for substances where the tonnage is below 10 tonnes because above this the duty to complete a Chemical Safety Report (CSR) takes effect and the information in Level 3 is already covered. Please see Annex B (link: Annex B Use and Exposure Information Requirements Triggers table.pdf (defra.gov.uk)) of the consultation for the full details.
Following on from the changes above, the public consultation also proposes changes to the information requirements in CSRs. If a hazard endpoint is no longer required in the registration dossier under the ATRm, then it will also not be required in the CSR. Furthermore, if DNEL and PNEC values are the same as under EU REACH, it is not necessary to explain how these are derived. The reduction in this information is not thought to negatively impact the CSR or the ability to generate exposure scenarios and communicate risks and control methods.
-
ATRm regulatory powers and duties: transitional evaluations, compliance checks and publication of data.
To aid the function of the new registration requirements in transitional registrations, Defra have proposed new regulatory powers. The most notable of these is the introduction of a third type of evaluation under UK REACH called transitional evaluations. A transitional evaluation would allow the regulator to request any hazard information that would normally be required under a REACH registration but is no longer required under the ATRm proposal. Depending on the information request in the transitional evaluation, registrants would have between 3 and 12 months to respond.
It is proposed that compliance checks will stay the same under the ATRm and the Agency will check a minimum of 20 % of registrations. However, they may wish to focus on ensuring the new use and exposure information is fulfilled.
Another change suggested is an amendment in the publication of data under Article 119 of REACH. Article 119 lists the information that should be made publicly available about REACH registrations. However, if the hazard and use requirements are amended, some of the information in Article 119 will no longer make sense. As such, the public consultation proposes an amendment of Article 119 in line with the changes to the hazard and use information requirements.
-
Substance groups: data sharing and joint data.
Defra also propose the addition of Substance Groups under UK REACH, which would operate in a similar manner to Substance Information Exchange Fora (SIEFs) under EU REACH. They would apply to all UK REACH registrants, regardless of whether the substance is a transitional substance or novel, and they would enable the joint submission of data by UK REACH registrants of the same substance.
Within the public consultation, Defra also seek views on whether operation of SIEFs could be improved, so there could be some minor amendments to Substance Groups compared to SIEFs.
-
UK REACH improvement policy: the restriction process, reporting processes, and protections against animal testing.
Finally, the ATRm public consultation suggests improvements to UK REACH. While these do not strictly fall under the ATRm, Defra is using powers from the Environmental Act 2021 to make other changes to UK REACH while the legislation is being amended. The first one is a change in the restriction process. Defra plan to change the restriction process so it is reflective of the GB Committee structure, rather than the EU one where the process was adopted from. As such, there are proposed changes to the statutory consultation requirements. Rather than having two consultations running for 8 months in total, Defra propose having just one running for 3 months. This would accelerate the process, remove unnecessary crunch points, and bring the process in line with the UK Governments requirements for consultations. In this proposal, the final RA and SEA opinions would also be formulated at the same time.
That said, the Agency could hold shorter, informal consultations after draft opinions are formed if more than one consultation is deemed necessary, and Defra are seeking views on this in the public consultation.
Another planned change is amendments to the UK REACH reporting process with the aim of reducing administrative burden on the Agency and increasing their capacity as the regulator. Defra propose that the Work Program for the coming year and the Multi-Annual Work Program are consolidated into 1 report as there is repetition between the two reports currently. Then, the Annual Accounts and Forecast Budget reports will be removed because this information is already known to Defra through business-planning discussions.
Defra also want to increase protections against unnecessary animal testing and seek opinions on the most efficient method of doing this, either through non-legislative means or legislative means. Currently, under REACH, a testing proposal is required in registrations of 100 tonnes or more where the registrant is intending to generate new information to meet the information requirements. The testing proposal is examined by the Agency to ensure the registrant adequately meets the information needs and avoids unnecessary testing on vertebrate animals. If legislative means were taken to reduce animal testing further, testing proposals could be introduced for the lower tonnage band registrations with the hope of incentivising the development of non-animal testing methods. Note, the new proposals would only be required for studies involving vertebrate animals, rather than all new information requirements, which is the case for registrations above 100 tonnes.
Alternatively, a non-legislation approach could be taken where further guidance is published on alternative testing methods. The aim of this approach would be to educate registrants and support them in meeting the information requirements in new ways.
The Future of the ATRm Public Consultation
The four key areas discussed in the public consultation could see many changes to UK REACH. However, there could be further changes yet. As detailed above, there has been a change in government in the UK from Conservative to Labour. The ATRm was proposed by the Conservative government, and so under a new Labour government this could be dismissed. Labour has close alignment with the NGO’s, and it is rumoured that the UK chemical regulations could either see realignment with EU REACH, or a Swiss-like model might be introduced.
Prior to the UK general election, in an interview with the Financial Times, the now Chancellor Rachel Reeves said Labour would ditch the previous Conservative government’s fixation on regulatory divergence and seek a “bespoke” arrangement for the chemical industry. This means there could be further changes to UK REACH.
Nevertheless, it is still important to understand the ATRm public consultation as nothing is certain yet, and the new Labour government will have received a comprehensive view from the UK chemical industry in the comments to the public consultation, which could impact their policy going forward.
The full ATRm public consultation can be found here: https://consult.defra.gov.uk/reach-policy/atrm-consultation/
For further updates and developments in relation to the ATRm and UK REACH make sure you follow H2 Compliance on LinkedIn.
For any queries relating to UK REACH please contact H2 Compliance at info@h2compliance.com
Published August 16, 2024
Image generated with the assistance of Artificial Intelligence.