1. Overview

It is anticipated that 2024 will be the biggest year ever for democracy. Over four billion people – more than half of the world's population across more than 40 countries – will go to the polls. National elections are expected in major global economies, including the United States, India, Indonesia, Pakistan, Bangladesh, Taiwan, Mexico, South Africa, and Russia. In each of those jurisdictions, the choices and decisions of the electorate will inevitably have a profound impact on the environment, for good or ill.

In Europe, the UK and the European Union will (likely) both hold their own 2024 parliamentary elections. We have already seen the significant impacts of those forthcoming votes, with key policies and legislative action both accelerated and deferred to adjust to the realities of legislative timeframes and political narratives. While the alignment of the UK and EU elections is entirely coincidental, the timing of the elections (and the associated electioneering) may well serve to highlight differences in the direction of travel on environmental issues on either side of the channel. Within each jurisdiction there will be profound disagreements on the appropriate measures to address climate change, curb pollution and protect the natural environment.

EU citizens will elect a new European Parliament in June 2024 – 705 lawmakers that, alongside member countries' representatives, will pass new EU policies and laws. The European Council on Foreign Relations think-tank published a report in January 2024 that predicts "a major shift to the right in many [EU] countries, with populist radical right parties gaining votes and seats across the EU, and centre-left and green parties losing votes and seats". It concludes that this "'sharp right turn' is likely to have significant consequences for European-level policies, which will affect the foreign policy choices that the EU can make, particularly on environmental issues, where the new majority is likely to oppose ambitious EU action to tackle climate change".

Meanwhile, in the UK, after a number of years of uncharacteristic political instability following Brexit, few are yet prepared to predict the outcome of the General Election, but it is possible to say with some certainty that environmental issues and relations with the EU will remain key concerns for a significant numbers of voters. Indeed, in September 2023, the incumbent Conservative government was already rowing back on some of its net zero climate policies, and particularly those that impose costs on consumers directly, as they began preparations for the election. If the UK electorate opts for a left-leaning government for the first time since 2010, there will be many expecting to see firmer and deeper commitments to environmental protections.

In-land water quality, clean air, "forever chemicals", climate change and resource management: issues concerned with chemicals regulation will all play a significant role in the forthcoming manifestos and political debate. With elections come uncertainty, but it is possible to predict with some confidence that the regulatory divergence in Europe in the field of chemicals law and regulation will continue, irrespective of the make-up of the new parliaments. The trajectory of that course was set by the terms of the UK's withdrawal from the EU and the decisions taken by the elected representatives on both sides of the channel at that time. In this chapter we explore the factors that will continue to determine the speed and extent of that divergence.

2. Chemical Regulation Must be "Good Regulation"

Chemistry has a critical role to play in better environmental outcomes: it represents the building blocks of the natural environment and all life therein. Chemicals regulation is therefore an essential tool in meeting global environmental ambitions (such as UN sustainable development goals and those under the UN Framework Convention on Climate Change), as well as commitments at national level. Chemistry is also fundamental to a move to a circular economy, in which monitoring of chemicals in recyclate and reused materials is paramount.

From an environmental lawyers' perspective, chemicals regulation can no longer be treated as a topic limited to emissions from industrial sites, or workforce exposure, and has increasingly become central to a wide variety of historically siloed work areas: product standards; product liability; trade; energy and transport; and waste. Similarly, the regulators themselves have been grappling with how best to structure and organise the legislative frameworks to manage such complex and intersected issues. All agree that "good regulation" is required, but what does that mean? Protection of the environment and human health? Providing space for growth and innovation? Delivering appropriate systems of accountability? Ensuring measures are fair? All of the above?

The EU's Green Deal shaped the work of the last European Parliament, promoting a zero-pollution ambition for a toxic-free environment. The Chemical Strategy for Sustainability (CSS) provides the policy detail. Since its publication, the CSS has proved an important springboard for EU action and the promised evolution of EU chemicals policy and regulation. In 2022, there were a number of key developments under the CSS, including: a public consultation on a substantive revision of the REACH Regulation (the cornerstone of EU chemicals legislation); the publication of a proposed "safe and sustainable by design" framework to encourage innovation to replace hazardous substances in products and processes; and measures to revise the EU Regulation on classification, labelling and packaging of chemicals (CLP) and introduce new hazard classes for substances that are endocrine disrupting (ED), persistent, bioaccumulative and toxic (PBT), very persistent and very bioaccumulative (vPvB), persistent, mobile and toxic (PMT), or very persistent and very mobile (vPvM).

In 2023 there was a notable change of pace that did not match the flurry of new proposals in 2022. With the notable exception of the PFAS restriction proposal (on which there is more below), the number of new proposals for chemicals regulation was significantly reduced. Perhaps most importantly, the revision of the REACH Regulation was postponed until 2025, likely in recognition of the challenges of passing such a significant and complex piece of legislation prior to the European parliamentary elections. There will likely be no significant new legislative proposals in 2024 while the new parliament beds in.

This does not mean that the relevant EU authorities were idle in 2023. Many of the ambitious plans already put in place continued their trajectory and are now close to adoption in this legislative cycle. The Commission and the European Chemicals Agency (ECHA) used their powers under the existing legislation to pursue new measures for specific chemicals or groups of chemicals. It is anticipated that the following initiatives will create impactful new obligations in 2024 and beyond:

  • Eco-design: Product parameters, with reverberations throughout the supply chain: The Eco-Design Sustainable Products Regulation (ESPR) is expected to be adopted and enter into force in 2024. The Commission has started reviewing product groups that will be subject to eco-design parameters, and we understand these include textiles, aluminium, cement, and potentially chemicals and cosmetics.
  • Green claims: The Commission published its proposal for a Directive to regulate green claims, and while the obligations will not become binding until implementation in Member States legislation, we expect consumer organisations to use the definitions and parameters in the proposal to keep companies and organisations responsible.
  • Hazard-based measures: PFAS is the most prominent proposal for restrictions based on the substances' persistent properties. The PFAS proposal will continue to be discussed by the ECHA committees, with the process expected to continue beyond 2024. In addition, national authorities and ECHA are initiating proposals based on the new hazard properties in the CLP Regulation.
  • Measures addressing groups of chemicals: ECHA has embarked on a programme that looks at assessing the regulatory needs for groups of chemicals, and will propose measures accordingly.

In England, the Government's 25-Year Environment Plan of January 2018, and its recent update as the Environmental Improvement Plan 2023, echoed the CSS goals of "managing exposure to chemicals", and promised further detail to be set out in a UK Chemicals Strategy that would address similar issues to those raised in the CSS, such as combination (or "cocktail") effects, the concept of essential use, and tackling chemicals in the waste stream.

Looking back at 2023 in the UK, it might be characterised as a year of high-profile missed deadlines and policy U-turns. In January 2023, the UK Government committed in its statutory Environmental Improvement Plan to publish a Chemicals Strategy in 2023 to set out strategic priorities for addressing risks from chemicals and to encourage a more sustainable use of chemicals. While stakeholder groups continued to work hard behind the scenes to support this important initiative, the strategy (which was first promised back in 2018) has yet to materialise. More popular within the chemical industry and business at large, was the UK government climbdown on its proposed revocation of all retained EU law (including most environmental and chemicals legislation). Instead, the scope of the revocation was replaced with a targeted list in May 2023 (which came into force at year end). The much-heralded display of "Brexit freedoms" was scaled back to, in effect, a legislative "spring clean". This was largely viewed as a welcome pivot since it avoided unnecessarily increasing the regulatory divergence between the UK and EU.

3. It's the Economy, Stupid

Slowing economies often curb environmental ambition, but the importance of the chemical industry to the European balance sheet ensures that chemical businesses remain valued stakeholders in the debate on the future direction of chemicals regulation.

The UK exports £340 billion of goods and services to the EU per year, 42% of total UK exports. The UK imports £432 billion from the EU, 48% of total UK imports (see 2022 "Statistics on UK-EU trade", Research Briefing, House of Commons Library). As a result, the UK runs a significant trade deficit (£92 billion) with the EU and a small trade surplus (£5 billion) with non-EU countries. This demonstrates two important things. First, while EU trade is not the "only game in town" for the UK, it certainly remains the biggest. Second, the flow of products (and services) into the UK from the EU is significantly bigger than the flow out – so any additional costs caused by non-tariff barriers to trading with the EU will likely hit the pockets of UK consumers the hardest.

Since the end of 2020, UK trade with the EU has been governed by the Trade and Co-operation Agreement (TCA). The TCA contains broad, high-level commitments, such as "the need for an ambitious, wide-ranging and balanced economic partnership to be underpinned by a level playing field for open and fair competition and sustainable development" and "a commitment to uphold (...) respective high levels of protection in the areas of (...) environment" and "climate change". There is also a specific commitment that:

"'where there are reasonable grounds for concern that there are potential threats of serious or irreversible damage to the environment or human health, the lack of full scientific certainty shall not be used as a reason for preventing a Party from adopting appropriate measures to prevent such damage', in accordance with the precautionary principle."

Save for demonstrating a baseline level of goodwill, it is difficult to see the practical application of such commitments, or indeed under what circumstances they might be enforced. Having spent decades operating under a vast array of common (EU-wide) environmental law, such loose alignment is a significant departure. Nevertheless, Annex 13 on chemicals, specifically, acknowledges that "the commitments made under this Annex do not prevent either Party from setting its own priorities on chemicals regulation, including establishing its own levels of protection in respect of the environment, and human and animal health".

Three years on from the end of the Brexit transitional period (the point at which the common regulatory rulebooks were formally decoupled, as of 1 January 2021) the differences in priorities have become more pronounced: divergence on chemicals regulation between the UK (or more precisely Great Britain); and the EU is no longer a theoretical concept.

In fact, divergence between the EU and Great Britain has occurred both at a "macro level" and "by decision" (i.e. at a granular, substance level). Macro level divergence is evidenced by, for example, new or amended legislation, or indeed new interpretations of existing legislation or case law. Divergence by decision is perhaps less obvious to the casual observer, but with equally significant impacts on businesses and the environment. Examples of divergence by decision are noted in the different treatment of specific substances due to different scientific assessments by regulators using (potentially) different datasets or with different priorities or objectives.

This trend for divergence looks set to continue.

4. UK REACH: Measuring Success to Date

Providing, as it does, the principal framework for European chemicals regulation, Regulation (EC) 1907/2006 of the European Parliament and of the Council concerning the registration, evaluation, authorisation, and restriction of chemicals (REACH) is a key yardstick for monitoring divergence: no discussion on chemicals regulation can be complete without a review of the interaction between the parallel EU and UK REACH regimes.

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, REACH entered into force in the EU on 1 June 2007. Given the innovative and ambitious nature of the regime, it was recognised, 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 UK Government published the first tranche of that analysis on 29 June 2023.

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. 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 the Department of Environment, Food and Rural Affairs (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 – i.e. 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.

The report accepts 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 £72 million. 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 (registration) dossier and substance evaluation.

The Office for Environmental Protection, the independent public body tasked with holding the (UK) Government to account for its own environmental commitments, published its own assessment in January 2024. Its findings are even less positive than those of DEFRA:

  • "The lack of a UK Chemicals Strategy has been, and continues to be, a major gap that is hindering progress."
  • "The development of UK REACH has been too slow."
  • "If the UK government is to achieve its stated intention of remaining a global scientific leader on chemicals management, it needs to be proactive in identifying and responding to emerging issues, while also delivering the registration phase of UK REACH. There is an urgent need to develop the evidence base on the environmental impacts of chemicals within the UK, to ensure that strategic responses are targeted and proportionate to deliver the best outcomes for people and the environment. It is essential that any divergence from EU REACH is due to robust, evidence-based decision making and applicability to the UK environment, not merely to a lack of resources and capability."

5. UK REACH: Alternative Transitional Registration Model

The purpose of REACH was (and remains) to improve the protection of both human health and the environment through the identification of the intrinsic properties, as well as use and exposure, of chemical substances, coupled with facilitating the free circulation of substances while enhancing competitiveness and innovation. The industry carries the burden (and, importantly, the costs) of generating those data. Those data, contained in more than 100,000 individual substance registrations held by the European Chemicals Agency (ECHA) in Helsinki, give rise to a range of further regulatory measures implemented by the EU institutions.

Following the United Kingdom's departure from the EU, UK REACH retains both the fundamental approach and key principles of the EU REACH, while allowing UK regulators to implement UK-specific risk management measures. EU REACH continues to apply in Northern Ireland under the Windsor Framework.

The challenge with this "copy and paste" approach to post-Brexit UK chemicals legislative drafting has always been that it could leave the industry with rather a large bill (and no immediate or obvious future benefit). The UK did not reach an agreement with the EU for the retention of access to the existing database, so it must create its own parallel dataset. The industry has estimated that the replication of the full EU REACH registration model will come at an industry cost of around £2 billion. As a result, it has been robustly challenging and testing the model and asking the Government to consider an alternative approach.

In December 2021 DEFRA published an open letter to the Chemical Industry Association confirming that it recognised "industry concerns around accessing data packages to support UK REACH transition", and the associated cost to businesses. As a result, DEFRA, along with the HSE and Environment Agency, has been tasked with exploring "a new model for transitional registrations".

The first substantive announcement about what that model may look like was published in November 2023. Initial indications are that, should the new model be adopted, there will be significant additional divergence from the EU REACH model.

DEFRA confirmed that UK regulators "do not need to hold a complete replica of all the registration data on all chemical substances held under EU REACH in order for UK REACH to undertake its regulatory work" and that the UK "can adopt a more targeted approach by using information already available and building on work done in the EU and globally to identify areas of emerging risk and shape our regulatory priorities". It confirms that in order to achieve this "light-touch" approach, it will be necessary to refine "what information on 'use and exposure' (...) registrants will need to provide". It remains to be seen what the additional burden of generating such information for the GB market (only) will be, and indeed whether there are really any substantive differences in "use and exposure" of specific chemistries between (neighbouring) markets.

Even more striking, the proposal seeks to reduce "to the essential minimum the 'hazard' information required for transitional registrations and intermediates". Early indications suggest that this could involve a major re-write to UK REACH, such that "'UK REACH registrants will not generally need to access and pay for data packages held by EU industry consortia".

While efforts to support a reduction in unnecessary duplication will be widely welcomed, there are those who will also (quite rightly) ask the question about whether denying UK regulators access to the full data sets for all chemicals on the market may ultimately result in a lowering of environmental protections, and indeed undermine legal commitments to a "level playing field" under the EU-UK TCA.

A consultation on the new model is promised in 2024, which will hopefully provide answers to important industry questions raised by the latest public announcements.

6. >Divergence by Substance

Divergence under REACH is of course not limited to the framework itself – divergence in terms of the management of specific chemistries is also evident. One (high-profile) example is the EU's proposed universal ban on all PFAS (thought to cover more than 10,000 individual chemistries), which continues to capture headlines. At the end of the EU's consultation on 25 September 2023, ECHA had received more than 5,600 comments from more than 4,400 organisations, companies, and individuals.

While the UK is also considering a restriction under UK REACH, it is anticipated that it will adopt a narrower definition of PFAS (by removing the criterion that a single isolated methylene group (–CF2–) is sufficient for classification as a PFAS), targeting only the most persistent chemistries. As such, this will be a fascinating case study on regulatory approach and results, given that the regulators in both markets have an identical regulatory "toolbox". The UK has been keen to present this approach as more pragmatic and industry-friendly, but whether there is any real competitive advantage in having two separate standards remains to be seen.

The Classification, Labelling and Packaging (CLP) Regulation ((EC) No 1272/2008), which works alongside REACH in both the EU and UK, also serves as an important basis for control of substances and regulatory actions.

In addition to the new hazard classes set out in Commission Delegated Regulation (EU) 2023/707 (covering endocrine disruption and persistence in the Environment), a separate political agreement was reached by the European Parliament and Council at the end of 2023 to revise the EU CLP more widely. This agreement would empower the European Commission, under the new Article 37(7) of the EU CLP, to carry over conclusions related to the new hazard classes from the REACH Substance of Very High Concern (SVHC) listing, as well as from regulatory frameworks for biocidal and plant protection products, introducing those conclusions as harmonised classifications.

Once formally adopted, the revised EU CLP will introduce additional requirements, including the obligation for websites to display the hazardous properties of their products. Moreover, companies will be required to provide clearer labelling for hazardous chemicals, extending to online sales, with the revision introducing advertising requirements and stipulating a minimum font size. Businesses will also have the option to utilise fold-out labels and digital labelling, while ensuring that essential safety information and hazard pictograms remain on the packaging. The update also brings forth new regulations for refillable products, promoting the safe sale of household chemicals in bulk.

The above changes do not apply in GB and currently there is no proposal to introduce similar changes by the UK government. In fact, the UK is currently focusing CLP efforts on the introduction of harmonised classification for 90 substances from the EU Adaptation to Technical Progress (ATPs) 14 and 15, first adopted in the EU in 2017 and 2018, respectively.

In a somewhat extraordinary admission, and illustrating the challenges facing industry seeking to maintain compliance in both markets, the Health and Safety Executive (HSE), as regulator for GB CLP, confessed publicly that it had assumed harmonised classifications were retained EU law in the UK – this was not the case. It is now taking action to normalise this situation. For the vast majority of classifications, this will mean simply adopting the EU classifications, however, the HSE has also announced that it will carry out further assessment (under the Article 37A procedure of GB CLP) in respect of the classification of titanium dioxide in powder form and granulated copper. In the case of titanium dioxide, this is likely due to the fact that, in the EU, the decision to classify certain powder forms of titanium dioxide as a suspected carcinogen category 2 by inhalation has been the subject of litigation before the EU Courts. In Joined Cases T-279/20, T-288/20 and T-283/20, the General Court found that the European Commission had wrongly classified titanium dioxide, a decision that has now been appealed by the European Commission and France. While the UK is no longer bound to follow the decisions of the European Courts, the outcomes of such cases are followed closely and will no doubt have some bearing on future UK decision making.

7. UK HSE's Work Programme and Resourcing

As required under the UK REACH legislation, the HSE published its first "Work Programme" (2021/2022) in June 2021. The publication of the programme highlighted the challenges faced by the HSE to implement, manage and regulate the new regulatory regime – with UK bodies required to fulfil the full range of roles, tasks and responsibilities currently shared between ECHA, the European Commission and 27 EU Member States. By way of an example of the scale of the task, the HSE predicted that 26% of its overall capacity for 2021/2022 would be required simply for training and "understanding the legislation and associated guidance; learning processes and procedures; developing knowledge of regulatory science, especially in the area of toxicology".

With limited resources, it is no surprise that the HSE is taking a risk-based prioritisation approach to its Work Programme. In 2021/2022, key delivery objectives included work on restriction dossiers for tattoo inks and lead ammunition. Going forward, it has been confirmed that the HSE will assess all EU REACH restriction proposals, but will not be bound to follow the EU, and it will also identify priorities from other sources.

The five priorities identified for the 2022/2023 UK REACH Work Programme were: PFAS; intentionally added microplastics; formaldehyde and formaldehyde releasers in articles; bisphenols in thermal paper; and hazardous flame retardants. These priorities were developed following a series of focus groups. Around 40 stakeholder organisations, such as NGOs and industry representatives, participated. The focus groups sought input on priorities as a whole and on individual proposals – including proposals suggested by stakeholders.

At the time of writing (February 2024), the 2023–2024 working programme for UK REACH, which should outline priorities for the coming year, has still not been published. In the context of the delays to a wider UK chemical strategy, it is more difficult to predict forthcoming regulatory actions on the UK side. One clue, however, is the Rolling Action Plan (RAP) for UK REACH 2023–2025, which identifies specific substances for evaluation (mirroring the structure of the EU's Community rolling action plan or CoRAP). On the RAP, against 2024, the only "substance" listed is PFAS, with a note confirming "we will focus on poly- and perfluoroalkyl substances (PFAS) and consider recommendations from broader scoping activities, regulatory management options analyses (RMOAs) and the Environment Agency's updated report on flame retardants when published". By way of comparison, the EU equivalent CoRAP for 2023–2025 listed 24 substances that were suspected of posing a risk to human health or the environment (for evaluation by 12 Member State Competent Authorities), nine of which are scheduled for evaluation in 2024.

8. Concluding Thoughts

Chemicals was highlighted as one of the legal regimes that would be most impacted by the UK's exit from the EU, and indeed many of those predictions of challenges and difficulties have come true. Perhaps the determinative and highly emotive political slogan that ensured the UK's exit from the EU was "take back control", and a key aspect of that tenet was for the UK electorate to "take back control" of its laws and regulations. The inevitable divergence that this slogan implies has already been significant, but in truth is as much the product of economic circumstances, capacity, and the unintended consequences of Brexit than the result of purposeful and strategic policy delivered in an efficient manner – at least to date.

In 2024, we hope to see the UK's vision for the chemicals sector when the chemicals strategy is published. For businesses operating in both UK and EU markets, a comprehensive strategy is required to stay on top of developments and influence the future regulatory directions that will be taken. For European environmental lawyers, chemicals regulation will continue to be an important, interesting, and growing area of practice for a long time to come – irrespective of who prevails at the ballot box.

Originally published by International Comparative Legal Guide.

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.