PFAS
Universal PFAS Restriction Process
The REACH Regulation Annex XV restriction proposal scoping more than 10,000 PFASs was prepared by the competent authorities from five countries (Denmark, Germany, the Netherlands, Norway and Sweden) and submitted to ECHA on 13 January 2023. Objective of this proposal is to reduce PFAS emissions to the environment, by proposing different restriction options and suggesting time-limited (5 or 12 years) and time-unlimited derogations for selected PFAS uses and applications.
PFAS restriction proposal scope
Per- and polyfluoroalkyl substances (PFASs) are 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).
A substance that only contains the following structural elements is excluded from the scope of the proposed restriction:
CF3-X or X-CF2-X’,
where X = -OR or -NRR’ and X’ = methyl (-CH3), methylene (-CH2-), an aromatic group, a carbonyl group (-C(O)-), -OR’’, -SR’’ or –NR’’R’’’,
and where R/R’/R’’/R’’’ is a hydrogen (-H), methyl (-CH3), methylene (-CH2-), an aromatic group or a carbonyl group (-C(O)-).
In summary, PFAS are defined as fluorinated substances that contain at least one fully fluorinated methyl or methylene carbon atom (without any H/Cl/Br/I atom attached to it), i.e. with a few noted exceptions, any chemical with at least a perfluorinated methyl group (–CF3) or a perfluorinated methylene group (–CF2–) is a PFAS.” See the OECD 2021 PFAS definition for more information.
PFAS restriction proposal scope and the F-gases: HFCs, HFOs and HCFOs
Most widely used HFCs, HFOs and HCFOs are within the scope of the restriction proposal, as they contain a CF3-C group. Excluded substances, such as HFC-32, HFC-152a, HFC-23, HFO-1132a, HFO-1132(E) do not have a CF3-C group.
Although the in-scope HFCs, HFOs and HCFOs degrade in the atmosphere, they do not break down completely. They generate trifluoroacetic acid (CF3COOH, TFA) in varying amounts, ranging from 1% to 100%, depending on the substance. See “Major HFC, HFO and HCFOs: Atmospheric degradation in the troposphere – intermediates and final products”
The PFAS restriction scope includes TFA, as it fulfils the structural definition used in the REACH restriction proposal. Sources of TFA include some HCFCs, HFCs, HFOs, HCFOs, F-gas anaesthetics, pesticides, pharmaceuticals, and longer chain PFAS when they degrade under certain conditions.
See TFA webpage for more information about its properties and eco(toxicological) properties.
PFAS restriction process
The restriction proposal and submissions to the 2023 consultation are considered by two ECHA committees that provide an opinion on the proposed restriction. Both committees allow stakeholders to join the meetings and the discussion, subject to adherence to a code of conduct. Interested EU-level associations can apply to become stakeholders and join meetings specifically on PFAS. Independent experts are nominated by an EEA country but contribute based on their personal expertise. The two committees are:
RISK ASSESSMENT COMMITTEE (RAC)
Evaluates whether the proposed restriction is appropriate in reducing the risk to human health and the environment.
SOCIO-ECONOMIC ANALYSIS COMMITTEE (SEAC)
Evaluates the socio-economic impact of the proposed restriction with particular attention to proportionality and cost/benefit.
RESTRICTION OPTION 1
- Full ban with no derogations and 18-month transition time
RESTRICTION OPTION 2
- Full ban with use-specific time-limited derogations (18-month transition period plus either a 5- or 12-year derogation period), or time-unlimited derogations
The dossier submitters proposed RO2 as the most balanced option, which sets out derogations for the time limited use of in-scope F-gases in certain applications, including some refrigeration and air-conditioning applications. There is an 18-month transition period after EiF (Entry into Force) where there is a ban and no derogation. The proposed derogations are in the Annex XV Report available on the ECHA website.
However, these restriction options will be considered by the ECHA committees who may form a final opinion that is different to the proposal.
The proposed derogations relevant to HFCs, HFOs and HCFOs are
- refrigerants in low temperature refrigeration below -50°C until 6.5 years after EiF;
- refrigerants in laboratory test and measurement equipment until 13.5 years after EiF;
- refrigerants in refrigerated centrifuges until 13.5 years after EiF;
- maintenance and refilling of existing HVACR equipment put on the market before [18 months after EiF] and for which no drop-in alternative exist until 13.5 years after EiF;
- refrigerants in HVACR-equipment in buildings where national safety standards and building codes prohibit the use of alternatives – time unlimited;
- industrial precision cleaning fluids until 13.5 years after EiF;
- cleaning fluids for use in oxygen-enriched environments until 13.5 years after EiF;
- clean fire suppressing agents where current alternatives damage the assets to be protected or pose a risk to human health until 13.5 years after EiF;
- diagnostic laboratory testing until 13.5 years after EiF;
- refrigerants in mobile air conditioning-systems in combustion engine vehicles with mechanical compressors until 6.5 years after EiF;
- refrigerants in transport refrigeration other than in marine applications until 6.5 years after EiF
The following potential derogation are marked for reconsideration after the Annex XV report consultation (relevant to HFCs and HFOs):
- [foam blowing agents in expanded foam sprayed on site for building insulation until 6.5 years after EiF];
- [propellants for technical aerosols for applications where non-flammability and high technical performance of spray quality are required until 13.5 years after EiF];
- [preservation of cultural paper-based materials until 13.5 years after EiF]; [cleaning and heat transfer: engineered fluids for medical devices until 13.5 years after EiF];
- [use as refrigerants and for mobile air conditioning in vehicles in military applications until 13.5 years after EiF];
- [the semiconductor manufacturing process until 13.5 year after EiF].
The previously mentioned time periods for the proposed derogations represent the total time period, including the duration of transition period as well as the derogation period.
Additional Restriction Option being considered
According to a November 2024 Progress update on the per- and polyfluoroalkyl substances (PFAS) restriction process, an additional restriction option is being considered by the ECHA committees. For some specific sectors, Restriction Option (RO) 3 is a ban with time limited derogations and/or additional risk management measures/regulatory tools to minimize emissions. This ensures the continued availability of critical uses, such as those where it can be demonstrated that socio-economic impacts of a ban would be disproportionate. The additional information brought forward in the 2023 consultation, also prompted the question whether restriction options other than a ban may achieve the regulatory aim of significantly reducing the PFAS emissions throughout their life cycle, in addition to the need for appropriate derogations. This assessment is particularly relevant for those uses and sectors for which information was provided that demonstrates the socioeconomic impacts of a ban are likely to be disproportionate (for example because technical substitution is currently not foreseeable). It also helps to improve the practicality of the restriction proposal for specific applications.
Overview: the PFAS restriction Process
