The EU’s proposed universal PFAS ban ignores the available science

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BrusselsReport.eu
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By Dr. Lucas Bergkamp (LL.M.) is a medical doctor and lawyer, based in Brussels, who specializes in chemical regulation. He is currently working on a paper on the proposed PFAS ban. 

In February, the European Chemicals Agency (ECHA) published a proposed ban of per- and polyfluoroalkyl substances (PFAS). PFAS are diverse classes of thousands of synthetic chemicals (some of which also occur naturally) that includes gases, liquids, and solid high-molecular weight polymers.

They are used in many applications and products, varying from automotive and aviation to food contact materials, textiles, construction and household products, electronics, firefighting foams, and medical articles. PFAS have unique desirable properties, such as excellent stability under intense heat and water and grease repellents. Concerns have emerged, however, that some PFAS substances may be linked to negative effects on the environment and human health.

Universal lack of data

The proposed ‘universal’ ban defines PFAS very broadly to cover over 10,000 substances, including ‘theoretical’ PFAS substances that do not yet exist, which would mean that the EU would foreclose an entire area of chemistry going forward. Only for some PFAS, adverse effects have been demonstrated; there is no relevant data for the vast majority of PFAS.

It is merely assumed, but not proven, that all PFAS are persistent in the environment. Persistence implies that a substance is not biodegradable. This has become an issue for EU regulators, as biodegradability is the key property of future chemistry envisioned by the Commission in its ‘safe and sustainable by design’ initiative.

Unacceptable risk

The proponents of the proposed ban reason that since some PFAS, such as PFOS and PFOA, pose ‘unacceptable risk’ (which is the key condition for substance bans under the EU ‘REACH’ Regulation for chemicals) and all PFAS are persistent, precaution requires that all PFAS be deemed to pose unacceptable risk and therefore must be phased out. However, persistence, without more, is not a hazard under the REACH Regulation. So, given that risk is hazard and exposure, how can all PFAS pose risk?  Moreover, the presumption of persistence is demonstrably wrong for some PFAS, but the proponents are silent on this issue.

Persistence and durability

Persistence is deemed to be problematic in all cases, irrespective of whether a substance is bioaccumulative or toxic. Persistence, however, is the flipside of the coin called ‘durability’, or should we say ‘sustainability’? Many naturally occurring substances, such as silica and iron, are persistent too.

The persistence of PFAS makes products such as pipes and drains last long and prevents leakage from seals used in installations, which reduces cost, prevents accidents, and, thus, increases safety and environmental protection.

Unjustifiable read-across

To support a broad ban, the proponents argue that all PFAS share a common structural element and therefore all PFAS should be regarded as toxic. Their logic is flawed. Indeed, under certain conditions, a property of one substance may be imputed to one or more other substances. This is called ‘read-across’ and the REACH Regulation specifies the conditions under which read-across is permitted and valid.

These conditions are not met in relation to PFAS, however, and PFAS cannot be regarded as a group for this purpose, neither based on the science nor under the applicable law. The reference to the OECD’s definition in the proposal is hypocritical since this definition is explicitly not intended for regulatory purposes.

Regrettable substitution

A key objective of the universal ban is to prevent “regrettable substitution.” However, the proposal fails to establish why substitution of all PFAS would be desirable. Although the proposal runs many pages, nowhere is there an adequate analysis of alternatives and the ban’s costs and benefits to be found.

Thus, the proposal not only ignores the best available science and the applicable law but would also result in poor policy and set a bad precedent.

Derogations

To remedy the overly broad scope, the proposal includes a derogations regime and invites industry to apply for temporary use-specific exemptions. Whether it is lawful to use the restriction regime to this end, is questionable — the ”derogation-carrot” serves to reverse the burden of proof that the law places on the authorities. The information that will be extracted from industry may well be used to justify further regulation.

Most importantly, derogations subject entire product lines to the uncertain fiat of regulatory authorities, which undermines property rights and discourages investment.

The false promise of a toxic-free society

In short, persistence is not a ground for banning chemicals. Rather than preventing ‘regrettable substitution,’ the universal PFAS ban would result in regrettable stigmatization and may well increase risks of regrettable substitution.

If this is what a ‘toxic-free society’ has in store, both European industry and the citizenry are in for a tough ride.

Science-based chemical risk governance

The EU should go back to the drawing board. The PFAS proposal which is currently going through public consultation misses the mark on all fronts: science, law, and policy. A regulatory proposal which is aimed narrowly at reducing the known unacceptable risks of specific PFAS substances to acceptable levels is what science-based chemical risk governance and the REACH Regulation require, for PFAS and all other chemicals.

 

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