EFCTC prepares comprehensive response to PFAS restriction proposal

The wide scope of PFAS properties, their applications and use patterns inevitably resulted in the PFAS restriction proposal missing important technical information. EFCTC has prepared a comprehensive data package for F-gases in-scope and out-of- scope of the restriction proposal, that analyses the proposal itself, provides new data and explains potential unintended consequences for the use of F-gases. This key information is summarised below.

The effect of the F-gas Regulation and related measures: The regular review and current revision of the F-gas Regulation enables the performance of industry to reduce emissions and improve recovery and reuse to be assessed and, if necessary, further measures to be adopted. While the F-gas Regulation does not specifically address TFA and its emissions, measures to reduce HFC/HFO/HCFO emissions have a direct effect on reducing TFA emissions. In the opinion of EFCTC, the ability of the F-gas Regulation to take emissions trends into account, which directly affect TFA emissions, enables the F-gas Regulation to  have a similar effect as the other time-unlimited, more general derogations, e.g. for PFASs used as active substances in Plant Protection Products (PPP), Biocidal Products (BP) and human and veterinary Medicinal Products (MP), as these are addressed under their respective regulations. Moreover, F-gases are already subject to extensive reporting requirements not significantly different than the ones suggested by the Dossier Submitters for the PPP, BP and MP substances.

PFAS impurity concentration limits: As part of its submission package, EFCTC has prepared a paper  explaining how impurities are detected for F-gases and giving an overview of the challenges that could occur from the low concentration limits proposed by the dossier submitters. The PFAS impurity limits indicated within the restriction proposal do not consider the procedures and processes for the manufacturing, supply chain, recovery, recycling and reclamation of HFCs, HFOs and HCFOs, and the analytical methods included are not relevant to the practical analysis of these F-gases and their impurity levels.

F-gases, end-of-life and the circular economy: The HFC/HFO/HCFO supply chain has the technical requirements in place to deliver, accept recovered refrigerant, reclaim to a high standard and, if necessary, send recovered refrigerants for destruction. Service technicians have  recovery cylinders available for use with their recovery and recycle equipment from systems during maintenance or at end-of-life. This refrigerant can then be recovered and returned to the supplier. Further efforts are required to improve the performance of refrigerant emission reduction, but the required building blocks are known or already in place.  EFCTC has prepared an analysis of the different key aspects when it comes to the end-of-life of F-gases, including  HFCs, HFOs and HCFOs, as well as the recovery, recycling and reclamation for re-use and destruction.  F-gases in the  heating, ventilation, air conditioning and refrigeration (HVAC-R) sector have been recovered for many years and this has grown rapidly recently,  driven by a mix of policy ambition, particularly by the  second F-gas Regulation (Reg. (EU) N°517/2014) and its introduction of a phase-down for HFCs. The ongoing revision of the F-gas Regulation is expected to extend containment and end-of-life measures to unsaturated F-gases listed in Annex II Section 1 of the F-gas Regulation, in particular HFOs and HCFOs. This fundamental change will ensure that all these fluorinated refrigerants are well contained and can be recovered at their end of life. Procedures for transport, destruction, and handling of waste are ensured through the Waste Shipment Regulation and Industrial Emissions Directive and provide traceability and best availability techniques (BAT) for the destruction and handling of waste. Case studies on the HVAC-R sector in three EU Member States (France, Germany and Italy) were also analysed to better understand the best practices in the EU. The paper describes the main actors and their role in the circular economy for F-gases, the relevant legislations and the business case that has emerged in the last decade.  If F-gases cannot be re-used, which is economically and environmentally preferable, then destruction technologies for HFCs as refrigerants and in foams are well established and approved under the Montreal Protocol following independent evaluation of performance criteria. The Montreal Protocol’s destruction technology approval process establishes a benchmark for technologies to achieve a destruction and removal efficiency (DRE) of 99.99% minimum for concentrated sources (such as refrigerants), and a number of destruction technologies are capable of providing a minimum 99.99% (DRE) for HFC refrigerants recovered from equipment (see the 2022 MCTOC Assessment Report, Table 8.2 page 209, available at MCTOC-Assessment-Report-2022.pdf (unep.org)). The HFOs and HCFOs with double bonds have reduced stability compared to HFCs and technologies approved for HFC destruction are expected to achieve the same efficiency of destruction, if operated under conditions that destroy HFCs. There are 17 facilities registered in 2021 for the destruction of F-gas Annex I & II substances in the EU (HFCs, HCFCs, HFOs, and HCFOs), as required by the F-gas Regulation.

Forecast emissions of HFCs, HFOs and HCFOs: An analysis of the F-gas emissions forecast used in the restriction proposal dossier (Annex E) explains why the emissions forecast for the EU is considered to overstate the most likely future emissions for HFCs, HFOs and HCFOs.  Importantly, atmospheric monitoring evidence indicates that HFC-134a emissions have been overstated in recent years for the European region, which influences the input data for the restriction proposal forecast, particularly for mobile air-conditioning.

Generation of TFA from HFCs, HFOs and HCFOs:  The most recent independent publication for the yields of TFA from HFCs, HFOs and HCFOs is discussed (see EEAP 2022: TFA yields from HFCs and HFOs - Fluorocarbons), with in-scope substances producing TFA in molar yields that vary from as low as 1% and up to 100%. An analysis using these TFA yields estimates TFA generation from these substances for the EU. This results in a minimal increase (significantly less than 0.5 ng/L) in average oceanic concentration of TFA, following subsequent transfer to the oceans. This can be compared to oceanic TFA concentrations, measured around 2000, of 10 ng/L to 160 ng/L, or from a different set of measurements, a constant concentration of 200 ng/L. Europe does not have any major endorheic basins (drainage basins that normally retain water and allow no outflow to other external bodies of water, such as rivers or oceans), which means that almost all TFA deposited over land in Europe will be transported to the oceans. A new toxicity test for an aquatic organism, the most sensitive alga (Raphidocelis subcapitata), resulted in a no observed effect concentration (NOEC) of 2,500,000 ng/L TFA acid equivalent, based on inhibition of growth (see EEAP 2022: Human and environmental risks associated with TFA in the environment - Fluorocarbons). Current and projected (to 2100) concentrations of TFA in the oceans provide a very large margin of exposure (thousand-fold) when compared to thresholds of toxicity and risks to the environment and human health are de minimis (see EEAP 2022: TFA emissions until 2100 from HFCs and HFOs - Fluorocarbons). It has also been independently concluded that TFA is of low toxicity in mammals, including humans.

Margin of exposure (MOE) is the ratio of no-observed-adverse-effect level (NOAEL) obtained from animal toxicology studies to the predicted or estimated human exposure level or dose. It is commonly used in human health risk assessment.

Naturally occurring TFA: The restriction proposal dossier reviewed the evidence for the natural occurrence of TFA, however the section summary only highlighted a paper that questioned the evidence for TFA occurring naturally. The EFCTC paper discusses the conclusions of this paper and explains the evidence that a large quantity of TFA does occur naturally in the oceans, including reference to two recently published sources not available to the dossier submitters (see An Inventory of Fluorspar Production, Industrial Use, and Emissions of Trifluoroacetic Acid (TFA) in the Period 1930 to 1999 - Fluorocarbons and Montreal Protocol on Substances that Deplete the Ozone Layer UNEP 2022 Assessment Report of the Environmental Effects Assessment Panel Chapter 6, available at  http://ozone.unep.org/science/eeap).

Regulatory Management Options Analysis on 8 selected F-gases: EFCTC commissioned an independent consultant, Ricardo Energy & Environment, to conduct a Regulatory Management Options Analysis on eight F-gases. The report includes information based on the literature research and outcome of a survey for F-gas producers, importers and downstream users performed by the Ricardo team.