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PFAS forever?

Long lasting chemicals – restrictions, chances and challenges

For some, they are “ forever chemicals” that should never be released into the environment; for others, they are necessary substances for the production of everyday consumer products or medical devices, for instance contact lenses. We are talking about per- and polyfluoroalkyl substances – in short PFAS. At first glance, two interests seem incompatible: on the one hand to save the environment and human health and on the other hand to satisfy consumer desires and to not restricting an entire industry. But one authority has now created facts.

By Hanna Diewald

In early February 2023, the European Chemicals Agency ECHA published a ban proposal on all PFAS. It is a message with huge implications.

A choice for the environment and human health but at the same time, the industry faces huge challenges and stakeholders are lobbying for exemptions – at least for longer transition periods. But why is the topic so hotly debated?

Broadest restriction in history

According to the latest estimates, this group of substances comprises more than 10,000 different substances. It is the broadest restriction proposal in history and many different industries are affected. Among those industries that work with PFAS on a daily basis is also the ophthalmic industry. This is because PFAS are used in spectacle lens coatings as well as in contact lenses.

The European Chemicals Agency (ECHA) describes PFAS as follows: “PFAS have a wide range of different physical and chemical properties. They can be gases, liquids, or solid high-molecular weight polymers. Some PFAS are described as long-chain or short-chain, but this does not cover all of the different kinds of structures that are present in the PFAS class, which is very diverse. PFAS can be sorted in many ways based on their structure”.

Individual PFAS had already been banned, but ECHA reports that global manufacturers have started to replace certain PFAS with other PFAS or with fluorine-free substances over the past decades: “This trend has been driven by the fact that scientists and governments around the world first recognised the harmful effects of some PFAS (particularly long-chain PFAS) on human health and the environment. As the focus shifted to other PFAS, these have also been found to have properties of concern” says the agency. This is why such a comprehensive restriction is being discussed.

“Forever chemicals”

Together with 15 European partner media reporters, the so called Forever Pollution Project located more than 17,000 sites across Europe with relevant PFAS pollution, including just over 2,000 hotspots with significant human health risks.

Some PFAS are very effective at resisting heat, stains, grease and water and they are used in high tonnages in a variety of applications. The majority of PFAS are persistent in the environment.

According to ECHA, “Some PFAS are known to persist in the environment longer than any other synthetic substance. As a consequence of this persistence, as long as PFAS continue to be released to the environment, humans and other species will be exposed to ever greater concentrations. Even if all releases of PFAS would cease tomorrow, they would continue to be present in the environment, and humans, for generations to come”.

PFAS tend to pollute groundwater and drinking water. Certain PFAS are known to accumulate in people, animals and plants and cause toxic effects. Certain PFAS are toxic for reproduction and can harm the development of foetuses. Several PFAS may cause cancer in humans. Some PFAS are also suspected of interfering with the human endocrine (hormonal) system.

According to ECHA the expected mean PFAS tonnage in the European Economic Area (EEA) is 49 million tonnes, leading to emissions of about 4.5 million tonnes during the manufacture and use phase when no action is taken. The overall annual health costs following from exposure to PFAS in Europe has been estimated in a Nordic Council report from 2019 to be between €52 and €84 billion.

Argumentation

The proposal states that: “Different regulatory risk management options have been considered, e.g. CLH and authorisation, but these options follow a substance by substance approach. In contrast, a restriction offers the possibility to define a broad chemical scope, thereby avoiding regrettable substitution of one PFAS by another PFAS (which may not even be engineered yet). […] A restriction can cover a wide range of uses and can address the risks arising from the manufacture and use of the substances as such as well as in other substances, in mixtures and in articles, including imported articles from outside the EU. Hence, a restriction is the most appropriate and effective option to adequately control such a large and complex group of substances which are used in numerous applications.

The chemical scope of the restriction proposal is defined as: any substance that contains at least one fully fluorinated methyl (CF3-) or methylene (-CF2-) carbon atom (without any H/Cl/Br/I attached to it). There are however a few exceptions.”

Current situation

In January 2023, Denmark, Germany, the Netherlands, Norway and Sweden submitted to ECHA a proposal for restriction on the manufacture, placing on the market and use of around 10.000 PFAS.

Two restriction options (ROs) have been assessed. A full ban with no derogations and a transition period of 18 months (RO1), and a full ban with use-specific time-limited derogations (18 month transition period plus either a five or 12 year derogation period).

As specific information on costs of a ban of PFAS for the different actors associated with the addressed uses was scarce and mainly qualitative, the derogations and their duration were mainly based on the availability and applicability of alternatives to PFAS.

RO2 also includes a few time-unlimited, more general derogations, e.g. for PFAS used as active substances in Plant Protection Products (PPP),

Biocidal Products (BP) and human and veterinary Medicinal Products (MP) but there is no general derogation for medical devices. Besides the proposed derogations, the dossier submitters also identified uses for which a derogation could be warranted, but for which the evidence base is weak. These uses are between brackets, which indicates that additional information is needed and should be provided during the third party consultation of the restriction proposal to substantiate a derogation.

Only if substantial evidence is provided, the dossier submitters can assess this and consider whether a derogation is warranted. For the time being, uses between brackets should be read as ‘no derogation’.

Impact on the ophthalmic industry

The potential derogation covers fluoropolymer coatings on ophthalmic lenses and fluorinated monomers used in the polymer matrix of rigid gas permeable contact lenses.

According to Euromcontact: “An internal survey ran by Euromcontact showed that 3 PFAS are used to manufacture RGP contact lenses (HFPM, TFEM, BHI), for which there is currently no alternative. The dossier submitters identified uses for which a derogation could be warranted, but for which the evidence base is still weak. Among them: fluoropolymers and perfluoropolyethers for the use in rigid gas permeable contact lenses. Additional information is needed and should be provided during the consultation of the restriction proposal (March - September 2023) to substantiate a derogation. Only if substantial evidence is provided, the dossier submitters can reconsider whether a derogation is warranted or not.”

Next steps

▶ January 2023: Restriction proposal submitted to ECHA

▶ 22. March 2023: Start of a six month open consultation. The European Chemicals Agency invites interested parties to send in scientific and technical information on the manufacture, placing on the market and use of per- and polyfluoroalkyl substances (PFAS)

▶ 25. September 2023: Open consultation closes.

ECHA’s scientific committees for Risk Assessment (RAC) and for Socio-Economic Analysis (SEAC) will use the consultation input to evaluate the proposed restriction and to form an opinion on it.

▶ Opinions of ECHAs committees sent to the European Commission

Some questions remain unanswered

So there is still a long way to go before all questions can be answered. For example:

▶ Which products will finally end up with exemptions?

▶ Is it legitimate to ban all PFAS without a proper demonstration that each and all of them present an unacceptable risk?

▶ How to ensure that production and associated environmental problems do not simply shift to other countries?

▶ What about the competitive disadvantage for the European industry compared to other continents? ◆