Overview
Environment analysis: The Department for Environment, Food and Rural Affairs (Defra) released its analysis on the UK registration, evaluation, authorization and restriction of chemicals (UK REACH) in June 2023. We consider the reviews and reports published by Defra and overall conclusions from the reports.
Designed to ensure a high level of protection of human health and the environment, while allowing the free circulation of substances on the EU market, Regulation (EC) 1907/2006 of the European Parliament and of the Council concerning the registration, evaluation, authorization and restriction of chemicals (REACH) entered into force on 1 June 2007. Given the innovative and ambitious nature of the regime, it was recognized, even before its enactment, that REACH would pose unique challenges. As a result, the EU legislature hard-wired monitoring and reporting milestones into REACH to allow for adjustment and improvement over time.
When UK REACH was created, by lifting and shifting the EU legal text onto the UK statute book after Brexit, many of those reporting obligations were retained in some form. The Defra published the first tranche of that analysis on 29 June 2023.
Scope of the reviews and reports published
Article 117(4) of UK REACH places a duty on the UK government to publish a high-level report every five years on the operation of UK REACH, including in relation to funding and value for money. Article 138 of UK REACH places a duty on the UK government to carry out three reviews of specific aspects of UK REACH, looking at:
- whether to extend the requirement for Chemical Safety Assessments (CSAs) and Chemical Safety Reports (CSRs) to those registrants who produce substances in the smallest tonnage band
- the scope of Article 33 of UK REACH, under which suppliers must provide, and consumers may demand, information about substances of very high concern (SVHCs) in articles
- the standard testing requirements for reproductive toxicity at lower tonnages
What are the key findings of the 'Evaluation of the Early Transition from EU REACH to UK REACH' report?
The Article 117 report, undertaken by third party consultants, is the first stage of a larger evaluation framework set out in a UK REACH Monitoring and Evaluation (M&E) strategy designed for Defra in 2021, and is designed to allow government and other stakeholders to receive timely feedback on how well the transition to UK REACH is working from a process, impact and value for money perspective.
The report identified 'no significant or widespread process problems,' and concluded that the various transitional measures established under UK REACH to prevent immediate market disruption met their objectives—ie significant adverse effects to the market have been avoided to date. It is also noted that feedback was broadly positive for the new 'Comply with UK REACH' digital service, a central component of the transition and new regulatory framework.
There is, however, clear acknowledgement of uncertainty as to the future direction of UK REACH, and in particular uncertainty created by the ongoing work on an Alternative Transitional Registration model. The recent amendment to UK REACH to extend data submission deadlines by three years (to 27 October 2026, 27 October 2028 and 27 October 2030 depending on tonnage and toxicity) has provided some comfort to industry since the publication of the report, but uncertainty remains since the new model is likely to make changes to the nature of the substance data that will ultimately need to be submitted to the HSE.
The report also confirms that since many companies are yet to make decisions on how many and which substances they will fully register for the Great Britain market, it is simply too early to identify impacts of UK REACH on human health and the environment, or indeed the ultimate cost to business. Perhaps the most eye-catching aspect of the report is the financial cost of UK REACH to Defra, the Environment Agency and the Health and Safety Executive (HSE) from 2018 to 2022: just over £72m. This includes the costs for the Comply with UK REACH digital service, the UK Chemicals Helpline and the HSE Helpdesk, but little in the way of substantive regulatory work, such as dossier and substance evaluation.
What were the outcomes of the three specific reviews required under Article 138?
The review on whether to extend duties in relation to CSAs and CSRs comprised a cost-benefit analysis, focused only on carcinogenic, mutagenic or reproductive toxic (CMR) substances. Potential benefits (such as improved risk management, human health protection, business benefits, regulatory management, and innovation) were identified at an estimated overall cost of £3.7m for all 262 CMR substances registered or notified under UK REACH. However, in light of the work currently underway by Defra to explore an Alternative Transitional Registration model, it was concluded that it would not be appropriate to draw conclusions on CSAs and CSRs independently of that wider development work and, therefore, no amendments to the current requirements were proposed at this time.
In the (Great Britain-focused) review of Article 33, which places a duty on suppliers to pass information on SVHCs down the supply chain information, it was found that the level of consumer awareness of rights under Article 33 in the UK was low and the extent to which these rights were exercised was even lower. However, of the small number of suppliers surveyed (129 people), it was reported that a considerable level of understanding of, and compliance with, their obligations under Article 33 was found. Overall it was concluded that there is not sufficient evidence to consider an extension of Article 33 duties, for example to cover other hazardous chemicals, at present.
The review of the standard testing methodologies specified for assessing the reproductive toxicity of substances registered at 10 to 100 tons a year was similarly inconclusive. UK REACH (Section 8.7 of Annex VIII) provides that two screening tests using rats, validated by the Organization for Economic Co-operation and Development and known as OECD 421 and 422, should be used in this assessment. Annex VIII also provides for circumstances where these tests need not be followed.
The scope of the review was to determine if there is an alternative for reproductive toxicity testing that can be mandated as the standard test method. It was reported that most of the evidence signals that it is not currently possible to make amendments to the standard information requirements. It is also indicated that it is unlikely that validated new approach methodologies (NAMs), ie methodologies that do not involve tests on live animals, suitable for this purpose will be available in the immediate future. It is anticipated that the forthcoming Chemicals Strategy (promised before the end of 2023) will seek to support ongoing work across government to facilitate the further regulatory acceptance of NAMs.
What can be concluded from the reports when considered together?
The reports have provided an opportunity for civil servants and decision-makers to take a step back to consider progress with the implementation of UK REACH, and reflect on whether now is a good time to make substantive changes to regulatory processes. While most will agree that the launch phase of UK REACH has been relatively smooth, many of the trickier decisions (including registration) have been deferred. Until the HSE has access to that (all-important) registration data, the extent to which it can start to take regulatory positions on specific chemistries will be significantly curtailed. The current uncertainty, and perhaps a wider recognition of the challenges posed by proactive divergence from the EU, also appears to have left policy-makers reluctant to increase regulatory burden on business, as would be the case if it chose to extend Article 33 duties or impose additional safety assessment requirements on low-tonnage manufacturers/importers.
The key milestones to watch for later this year will be the publication of the UK Chemical Strategy, and any developments in relation to the Alternative Transitional Registration model. We anticipate that these milestones will be fundamental to the future direction and success of UK REACH, setting the stage for the next phase.
This article was first published by Lexis+ on 18 July 2023.
