In an updated proposal to restrict environmentally polluting PFAS (per- and polyfluoroalkyl substances), five European countries raised whether “additional, complimentary, risk management” beyond the EU’s F-gas Regulation and the MAC (Mobile Air-Conditioning) Directive is justified to regulate f-gases that form the very persistent degradation product trifluoracetic acid (TFA).
The updated proposal was announced on August 20 by the European Chemicals Agency (ECHA). It continued the same restrictions on most PFAS refrigerants, though some applications were given a longer exemption.
“The F-gas Regulation and the MAC Directive primarily target the GWP of f-gases, while the risks that have been identified in this restriction proposal, i.e., those associated with the formation of very persistent degradation products (e.g. TFA) in the environment, are not addressed,” the proposal said. “Therefore, it is appropriate to explore whether existing legislation for f-gases,” it added, “remains appropriate to control these other identified risks.”
PFAS refrigerants include both HFCs and HFOs, such as HFC-125, HFC-134a, HFC-143a, HFO-1234yf, HFO-1234ze(E), HFO–1336mzz(Z) and HFO-1336mzz(E). The proposal would apply to TFA, an atmospheric degradation product of, notably, HFO-1234yf (100% conversion) and HFC-134a (up to 20% conversion). TFA is absorbed in rainfall, spreads throughout the environment and has raised concerns about its potential impact on human health.
“It is appropriate to explore whether existing legislation for f-gases remains appropriate to control these other identified risks.”
ECHA’s updated PFAS restriction proposal
The updated proposal was prepared by the authorities from Denmark, Germany, the Netherlands, Norway and Sweden, who submitted their initial proposal in January 2023 for what is known as the Universal PFAS Restriction. ECHA regulates chemicals under the EU’s REACH (Registration, Evaluation, Authorisation and Restriction of Chemicals) regulation.
The five state authorities, acting as the Dossier Submitter, updated their initial restriction proposal following an evaluation of more than 5,600 scientific and technical comments received from third parties during the 2023 consultation. This updated report, called the Background Document, forms the basis for the opinions of ECHA’s risk assessment committee (RAC) and socio-economic analysis committee (SEAC). This document may still be updated further, based on the evaluation of the committees.
The RAC and SEAC committees continue to evaluate the proposed restriction. ECHA said it aims to provide the European Commission with a “transparent, independent and high-quality RAC and SEAC opinion as soon as possible.” The European Commission will ultimately decide on the restriction in consultation with the EU member states. The Universal PFAS Restriction is expected to take effect in 2028.
“This is still a work in progress,” said Marc Chasserot, CEO of ATMOsphere (publisher of NaturalRefrigerants.com) and Lead Campaigner for the Coalition for PFAS Free Cooling & Heating. “There are still many steps until the law takes effect in 2028. We, on behalf of natural refrigerant alternatives to PFAS refrigerants, will ensure that authorities have the latest information showing the viability and commercial availability of these alternatives so that the final PFAS regulation is as ambitious as possible.”
CO2 equivalents may be misleading
The proposal pointed out that the F-gas Regulation measures use emission volumes in CO2-equivalents based on an individual gases’ GWP value rather than calculating volumes in metric tons. However, when considering the degradation of f-gases in the atmosphere into TFA, “the relevant measure” is metric tons, while CO2-equivalents “may be misleading.”
Moreover, the proposal added, while the F-gas Regulation typically allows refrigerants with a GWP under 150, those refrigerants have the highest potential to form TFA in the atmosphere; for example, HFO-1234yf (GWP less than one), which is widely used in MAC, converts 100% into TFA in about two weeks. The EU estimates that through 2050 business-as-usual emissions of HFO-1234yf “will increase sharply until they level out, or increase further, albeit at a lower rate,” the proposal said. “No reduction of emissions is envisaged.”
Bur if emissions of TFA precursors like HFO-1234yf to the environment continue, TFA’s concentration in the environment will increase given its high persistence, high mobility, and the difficulty of removing it from water. The proposal noted that increasing concentrations of substances like TFA are already being detected in freshwater and the terrestrial environment.
Under the EU’s CLP (classification, labelling and packaging) Regulation, TFA is classified as Aquatic Chronic 3, H412 (harmful to aquatic life with long-lasting effects) and Skin Corrosion 1A, H314 (causes severe skin burns and eye damage). In May, three German government agencies announced that their assessment of TFA and its trifluoroacetate salts as reproductively toxic, very persistent and very mobile was officially submitted to the ECHA for consideration under the EU’s CLP Regulation.
Concerns about TFA-related harm to human health are limited to “effects at high doses in experimental animals: liver effects (increased liver weight, hepatocellular hypertrophy, increased ALT), increased kidney weight, decreased white blood cells, reduced weight of reproductive organs, litter loss, reduced body weight of offspring, and malformations,” the proposal said.
The original 2023 proposal noted that many different PFAS co-occur in the environment, drinking water, food and in human blood. Thus there is combined exposure to multiple PFAS, many exhibiting similar effects on the liver, kidney, thyroid, serum lipids and immune system. “Accordingly, an assessment of hazards and risks taking into account such combined exposure would reflect more realistic exposure conditions than single compound assessments,” the proposal said.
Following a request from the European Commission, the European Food Safety Authority (EFSA) is reviewing the health-based reference values for TFA; a conclusion is expected next year.
Notably, despite the concerns expressed about TFA, the updated restriction proposal extended the timeline for exemptions given to TFA-generating refrigerants in mobile air-conditioning.
The fluorochemical Industry points to the UN Environment Programme (UNEP) and its 2022 Environmental Effects Assessment Panel (EEAP) report. The report says that TFA is not bioaccumulative, is “not expected to pose significant risk to humans or the environment at the present time” and “is unlikely to cause adverse effects out to 2100.” The report does not comment on the contribution of pesticides and other precursors to TFA since they don’t fall under the purview of the Montreal Protocol.
The UNEP report noted that deposition of TFA from HFOs and HCFOs will result in greater concentrations near the locations of release. “This is unlikely to present a risk to humans or the environment in these locations but changes in concentration in surface water (or soil) would respond rapidly to releases,” it said, adding, “Monitoring of the environment for residues of TFA would provide an early warning if trends in concentration indicate rapid increases.”
