PFAS Restriction Proposal
PFAS are a group of several thousand different highly fluorinated synthetic (man-made) substances, both polymeric and non-polymeric. They 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.
Given the enormous public interest in PFAS as a class, and the potential for significant supply chain impacts, the dossier is certain to create a debate in the coming months. A six-month Public Consultation did start on 22 March. The proposal is covering all uses of more than 10,000 PFAS and could eliminate some key applications that are critical to society, and for which no alternatives have been identified.
The starting point is the OECD definition of per- or polyfluoroalkyl substance (PFAS), which includes fluoropolymers, such as polytetrafluoroethylene (PTFE) and others. In general, regulators act on the assumption that polymers are safe because of their high molecular weights and stability and have a distinctly different environmental and toxicological profile. Substances with high molecular weights comprise large molecules that are unlikely to pass through biological barriers and reach toxicologically sensitive cells, tissues and organs. Therefore, fluoropolymers are considered polymers of Low Concern (PLC). Consequently, fluoropolymer manufacturers and their downstream users are of the opinion, that the restriction should explicitly exclude this substance group. This is because of the recent efforts to remove non-polymer PFASs from the production processes and given that fluoropolymers are not posing any hazard and are not degrading to short chain PFAS. In conclusion, they are safe, critical to the functioning of modern society and are key to innovation.
According to the Dossier Submitters, the main problem associated with PFASs is their extremely high persistency, but it is quite controversial whether persistence per se should be sufficient for such a far-reaching restriction, since it is not considered a hazardous property in itself. The REACH legal text allows for restrictions if there is “an unacceptable risk to human health or the environment”. For a risk of any kind, there must be both a hazard and exposure. However, the
Dossier Submitters argue, that a conventional quantitative risk assessment is not sufficiently reliable or practicable for PFAS.
The EU restriction proposal aims for a full ban of fluoropolymers in several applications, while granting 5- or 12-year derogations for specific uses. The restriction proposal includes 26 derogations in total, including for textiles applications such as PPE, as well as for food contact materials (FCMs) and medical devices. Derogations are based on use, not structure or toxicology. The proposal will have an impact on many downstream products, and it will lead to disruptions of certain value chains and eventually eliminate some key applications. Moreover, it could double-regulate already highly regulated areas like fluorinated gases (F-gases), used as refrigerants in heating, ventilation and air conditioning (HVAC) systems.
The derogations are mostly time-limited. Time-unlimited derogations apply for biocides, pesticides and active substances in human and veterinary medicines, for example. Primarily for legal certainty where the restriction overlaps with other legislation. A five-year derogation applies when there is sufficiently strong evidence that:
- technically and economically feasible alternatives are not yet available (at the entry into force date) but potential alternatives to PFAS use are in development; or
- known alternatives are not available in sufficient quantities on the market at the entry into force date or known alternatives cannot be implemented before the transition period ends.
A 12-year derogation applies when there is sufficiently strong evidence that:
- technically and economically feasible alternatives are not yet available (at the entry into force date) and potential alternatives to PFAS use are unlikely to become available in the near future; or
- certification or regulatory approval of PFAS-free alternatives cannot be achieved within a five-year derogation period.
No derogations are supported where the evidence is inconclusive. In the case of weak evidence, the proposal supports potential derogations, marked for reconsideration following the public consulta¬tion. Manufacturers and importers making use of the derogation for biocides, pesticides and active substances in human and veterinary medicines have to submit information every two years to ECHA on the identity and quantity of the substance placed on the market. For all other derogations, the same reporting obligation applies but the reporting period is one year. Additionally, importers and downstream users of fluoropolymers and perfluoropolyethers making use of any of the Paragraph 5 or 6 derogations must establish a site-specific management plan, which shall include information on the identity of the substances and the products in which they are used, a justification for the use and details on the conditions of use and safe disposal. The management plan should be reviewed annually and kept available for inspection by enforcement authorities upon request.
Several concentration thresholds have been introduced, which apply simultaneously:
- 25 ppb for any PFAS as measured with targeted PFAS analysis (polymeric PFASs excluded from quantification)
- 250 ppb for the sum of PFASs measured as sum of targeted PFAS analysis, optionally with prior degradation of precursors (polymeric PFASs excluded from quantification)
- 50 ppm for PFASs (polymeric PFASs included). If total fluorine exceeds 50 mg F/kg the manufacturer, importer or downstream user shall provide to the enforcement authorities a proof for the fluorine measured as content of either PFASs or non-PFASs.