As explained in Part 1, PFAS, a family of approximately 10,000 chemicals, are notoriously difficult to break down, hence the colloquial term, “forever chemicals”. They are used in non-stick cookware and stain-resistant surfaces; dental floss; menstrual products; food packaging; takeaway containers; plastic lunch boxes; waterproof and synthetic clothing; cosmetics and firefighting foam.
PFAS attach to the proteins in our blood and accumulate within us as we age. An ever-growing body of peer-reviewed scientific research demonstrates the significant risk to public health posed by these chemicals, linking PFAS to multiple cancers, ulcerative colitis, immunotoxicity, endocrine disorders, pregnancy-induced hypertension, decreased fertility and infertility, high cholesterol and thyroid disease.
The UN Stockholm Convention on Persistent Organic Pollutants 2004
Almost 20 years ago, the UN Stockholm Convention on Persistent Organic Pollutants 2004 identified Persistent Organic Pollutants (“POPs”) as organic chemical substances that, once released into the environment, remain intact for exceptionally long periods of time and become widely distributed throughout the environment. As of 13 November 2023, there are 186 parties to the Convention, including the United Kingdom.
This global treaty to protect human health and the environment from the risks posed by POPs requires its parties to prohibit and/or eliminate the production, use, import and export of POPs listed at Annex A to the Convention. However, Annex A does allow exemptions for the production or use of listed POPs and the import and export of certain POPs in restrictive conditions.
POPs listed at Annex B are not earmarked for prohibition and/or elimination but are subject to restricted use, production, import and export.
As scientific studies continue to advance the state of knowledge on the environmental and public health risks associated with PFAS, new POPs are added to the annexes of the Convention following a detailed examination of the POP proposed for listing by an expert committee specialised in chemical assessment and management.
EU Regulatory Regime
At EU-level, the prohibition, elimination or restriction of PFAS is done through EU REACH, a regulatory regime that, similar to the procedures under the Stockholm Convention, provides for the collection and assessment of information on the properties and hazards of substances.
Under EU REACH, companies are obliged to identify and manage the risks linked to the substances they manufacture and market in the EU. They must demonstrate to the European Chemicals Agency (“ECHA”) how the substance can be safely used and communicate risk management measures to the users. If the risks associated with certain chemicals cannot be managed, authorities can ban or restrict their use.
The constantly evolving nature of EU REACH as risks associated with existing or new forms of PFAS come to light is evidenced by the fact that as recently as February 2023, ECHA published a proposal to restrict approximately 10,000 substances.
The proposal has been met with fierce opposition from chemicals and pharmaceutical lobbies during the six-month consultation period. Concerns raised include the impact of restrictions and bans of certain PFAS on medicine production and the production of batteries, semi-conductors, electric vehicles and renewable energy sources.
Pressure from the European chemicals industry has also created uncertainty and scepticism about the implementation of the European Commission’s 2020 Chemicals Strategy. The Strategy, which was presented as a flagship component of the European Green Deal, pledged to reform EU REACH, ban the most harmful chemicals in consumer products and phase out PFAS unless their use is essential.
Concerns that these ambitions have now been abandoned are grounded in the absence of key legislative proposals to reform EU REACH in the 2024 work programme published by the European Commission on 17 October 2023 following calls from industry leaders and French President, Emmanuel Macron, to implement a “European regulatory pause” to facilitate industry competitiveness. Indeed, the Commission’s commitment in its 2024 work programme to putting “a strong focus on simplifying rules for citizens and businesses across the European Union” is indicative of a deregulatory approach.
However, the apparent political success of the European chemicals industry to slow or even backtrack on regulatory reform has not been matched in the court room. On 9 November 2023, the Court of Justice of the European Union dismissed Chemours Netherlands’ (a spin-off of Teflon producer DuPont discussed in Part 1) appeal against the 2022 ruling of the EU General Court not to overturn ECHA’s identification of “GenX” chemicals as a “substance of very high concern”. GenX chemicals, which are commonly used in the manufacture of non-stick products, are linked to tumours in rats and toxicity in the kidneys, liver, blood and immune system.
The Court of Justice’s ruling against Chemour’s final appeal keeps GenX chemicals on the list of substances allegedly meeting the criteria of “substances – such as those having endocrine disrupting properties or those having persistent, bioaccumulative and toxic properties or very persistent and very bioaccumulative properties, which do not fulfil the criteria of points (d) or (e) – for which there is scientific evidence of probable serious effects to human health or the environment which give rise to an equivalent level of concern to those of other substances listed in points (a) to (e) and which are identified on a case-by-case basis …”
Under the European Union (Withdrawal) Act 2018, EU REACH Regulation was retained and transposed into UK law on 1 January 2021. It is known as UK REACH, regulates chemicals placed on the market in Great Britain and operates independently of the EU system.
The REACH (Amendment) Regulations 2023 came into force on 19 July 2023. They extend the deadlines for businesses to submit technical data on the hazards and risks of the chemicals they produce.
The first deadline for full registration data to be submitted to UK REACH for substances on the EU REACH candidate list before UK REACH entered into force is now set at 27 October 2026. This deadline also applies for the submission of portfolios on carcinogenic, mutagenic or reprotoxic substances. The deadline for full registration of substances added to the UK REACH candidate list between 1 January 2024 and 27 October 2026 has been moved to 27 October 2028. Finally, for data on all substances manufactured or imported in quantities of one tonne or more per year, this has now been pushed back to 27 October 2030.
This extension has received mixed views. Supporters cite the need to help UK companies cope with the transition from previously buying from EU suppliers and their new obligations under UK REACH. On the other hand, critics of the extension lament the fact that it essentially means that the government will not have adequate data on the risks associated with chemicals on the UK market until 2030.
Although it is still relatively early days for the UK REACH regime, the UK’s failure to keep pace with the registration of EU REACH-listed chemicals raises concerns that the UK will diverge from EU PFAS regulation. The effect of this regulatory divergence would be to prolong the UK population’s exposure to chemicals revealed as posing serious health risks from the scrutiny they received before EU listing. Concerns as to UK regulatory divergence on chemicals are perhaps best illustrated by the fact that the latest additions to the UK REACH list were made in June 2020. Since then, ECHA has added 26 substances to the EU REACH list.
Furthermore, the much-awaited UK Chemicals Strategy that will define the UK’s approach to regulating emerging chemicals of concern after Brexit has faced a series of delays. It was first promised in 2018 but is now expected in 2024.
Claire Nevin is a barrister at FTB specialising in planning and environmental law. She has a particular interest in the law of chemical regulation.
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