The proposed Annex XV Restriction Report, drafted and filed by the Netherlands, Germany, Denmark, Norway and Sweden last month and published by ECHA today, would constitute one of the largest bans on chemical substances ever in Europe if passed.
PFAs - A Definition
Perfluoroalkyl and Polyfluoroalkyl Substances (PFAs) are a large class of thousands of synthetic chemicals used throughout society, all of which contain carbon-fluorine bonds, one of the strongest chemical bonds in organic chemistry, thus resisting degradation when used or entering the environment.
Today, an estimated 10,000 PFAs were used in applications across a range of sectors, industries, and consumer goods, from mobile phones to wind turbines, medical devices to raincoats, and cleaning products to cosmetics, renowned for their non-stick, water-resistant and stain-resistant properties.
Two strategies for PFAs ban proposed
Under the current proposal to ban PFAs, the dossier outlined two restriction options: a full ban with no derogations and standard ECHA transition period of 18 months (R01) versus a full ban with use-specific, time-limited derogations offering a transition period of between five to 12 years (RO2). Under both scenarios, however, companies would be forced to find alternatives to PFAs produced, used and placed on the EU market – including those imported into region.
“If the European Commission adopts the proposal, companies will be forced to find alternatives for approximately 10,000 PFAs in applications in which these substances are used. In many cases, no such alternatives currently exist, and in some they possible never will,” ECHA said.
The dossier highlighted 14 sectors where the largest amount of PFAs were used and emitted: textile, upholstery, leather, apparel and carpets; food contact materials and packaging; metal plating and manufacture of metal products; consumer mixtures; cosmetics*; ski wax; applications of fluorinated glasses; medical devices; transport; electronics and semiconductors; energy sector; construction products; lubricants; and petroleum and mining.
For the EU, these sectors introduced an estimated 140,000-310,000 tonnes of PFAs into the market in 2020 – a figure set to rise alongside expected economic growth of some of these industries, according to the proposal.
*For cosmetics, the five national authorities said PFAs could be found in skin care, toiletries, hair care, perfumes and fragrances and decorative cosmetics and suggested an RO1 ban (18-month transition period) for this category, given alternatives were already available on the market.
The European Commission was slated to present the proposal to Member States formally in 2025, following a consultation process kickstarted by ECHA on March 22, 2023. A final ban – if approved – could potentially enter into force in 2026 or 2027.
‘Very high persistence’ concerns
“The restriction proposal comes after the five authorities found risks in the manufacture, placement on the market and use of PFAs that are not adequately controlled and need to be addressed throughout the EU and the European Economic Area,” ECHA said.
The five national authorities spent three years investigating different PFAs and in the proposal outlined that the “main concern” for all of these substances was their “very high persistence” – far exceeding criterion for ‘very persistent’ under today’s EU REACH Regulation.
“PFAs and their degradation products may persist in the environment longer than any other man-made chemical. Further supporting concerns are their bioaccumulation, mobility, long range transport potential, accumulation in plants, global warming potential and (eco)toxicological effects,” the proposal detailed.
Critically, PFAs entered the environment during various lifecycle phases – the manufacture, use and waste stages. And research had found that not only were PFAs contaminating surface water, groundwater, soil, sediment and biota; they had also been found in food crops and humans in highly exposed areas.
“The irreversibility of the process of a growing environmental stock of PFAs, with associated exposure of humans and the environment, make it necessary to reduce emissions of PFAs to a minimum,” the proposal said.
The five national authorities defended the move towards a blanket restriction, stating this was the only means to avoid “regrettable substitution of one PFAs by another PFAs”, in some cases with new PFAs that had not yet been engineered. This strategy also tackled the problem of “uncontrollable emissions at the source”.
“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, included 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 proposal said.
Taking action against ‘forever chemicals’
Addressing attendees at a dedicated press conference earlier today, Dr Frauke Averbeck, assistant chief of section at Germany’s Federal Institute for Occupational Safety and Health [Bundesanstalt für Arbeitsschutz und Arbeitsmedizin], said the publication of the Annex VX Restriction Report was a “huge step” for the five national authorities behind it.
“This is the broadest restriction proposal that has ever been prepared and submitted,” Averbeck said.
However, she said it was absolutely necessary for environmental and human health moving forward because every year an estimated 75,000 tonnes of PFAs entered the environment just from the production- and use-phase of the chemicals alone. “If we don’t act now, over the next 30 years, this would go up to four million PFAs in the environment,” she said.
Critically, these PFAs were found all over the world “layered in the environment” – in surface and ground water, animals, plants, and humans. “PFAs are highly persistent, they are forever chemicals. If we don’t take action now, there will be adverse effects,” Averbeck said.
Once released into the environment, she said PFAs were “very difficult to remove” and efforts costly, but it also remained technically impossible for many variants.
“There is an uncontrolled risk of PFAs, in our opinion, that needs to be addressed in a regulatory measure; this is the restriction we are putting forward.”
Speaking at the end of the press conference, Mercedes Marquez-Camacho, head of the risk management implementation unit at ECHA, said that because of the “broadness” of this proposal – covering such a large range of chemicals and including several derogations – typical consultation and analysis timelines would likely take longer than normal.
“The message from ECHA is, this is a very broad proposal and the Committees will need time to make sure that they assess the proposal properly,” Marquez Camacho said.
