ECHA’s Enforcement Forum Releases Advice on Enforceability of PFAS Restriction Proposal

Recently, the Forum for Exchange of Information on Enforcement (hereinafter referred as the Forum) published the Advice on enforceability of the Annex XV restriction proposal regarding Per-and polyfluoroalkyl substances (PFAS) on European Chemicals Agency (ECHA)’s website.

To improve transparency of the legislative process, the Forum examines the restriction proposals with the view to advising on enforceability from the following aspect.

Restriction scope

The wide range of substances, mixtures, and articles containing PFAS presents a significant challenge as the proposed restriction measures do not encompass all types. This omission introduces considerable uncertainty in implementing the restrictions. 

• Substance identification. There are currently more than 10,000 PFAS substances, but the substance identification method detailed in the proposal is based on structural criteria only. There is no reference to a list of substance or CAS numbers. Therefore, additional support by professionals are needed to determine whether a substance belongs to PFAS, which can be challenging for enforcement authorities.

• Applicability of the restriction to articles. The Forum believes that the description in the proposal is too broad and does not clarify the specific items or components of the restriction. Take the coating of a frying pan as an example, with the current wording for an article that is coated with PTFE, the concentration of PFAS will be calculated on the whole article and not only on the concentration in the coating. From an enforcement perspective it would be easier to assess the compliance in the coating, providing the desired function to the article, rather than the whole article.

• The use of mixtures and articles are not covered in the proposal, which will affect the judgement of enforcement agencies.

Limit values

The Forum finds out that the proposal did not specify limit values applied for polymeric PFAS and prior degradation of precursors. To further complicate enforcement, the Forum points out that while degradation is a fully applicable concept in restrictions like PFCAs (REACH) or PFOA (POP) due to the concept of “related substances”, this concept seems intentionally not applied in the PFAS restriction proposal.

Derogations

The proposal involves a lot of derogation clauses. The Forum believes that the derogated uses and derogation period stated in the text is not clear enough, which will undoubtedly increase the difficulty of enforcement. 

For greater clarity, a grouping of the different derogations proposed by the length of transitional period in 3 groups (time-unlimited and time-limited with 6.5 or 13.5 years after EIF) could be considered.

Sampling and analysis

The broad PFAS restriction proposal covers a large range of articles and many chemical products, whether it is from the perspective of specific sampling, preparation, or analysis and detection of PFAS, this will be a huge, time-consuming and labor-intensive project.

• Lack of suitable sampling methods. In the current restriction proposal, the sample preparation step is not clearly defined. The extraction of organic PFAS and inorganic PFAS, and the sampling of fluorine-containing gases, and part of an article can present immense challenges, which will hamper the subsequential analysis part.

• Lack of standardized analytical methods. Most of the analytical methods available in the dossier are not standardized. There is a strong need to develop standardized methods and define which method is acceptable for which type of sample.

• The analytical conditions are stringent. Some specific analytical methods (headspace gas chromatography–mass spectrometry, extremely high temperature to fully combust, extraction of organic/inorganic fluorine substances) may be beyond the capabilities of conventional laboratories.

• Limited range. For the targeted analyses only approximately 100 PFAS can be determined, ca 1% of the estimated 10 000 PFAS covered by the proposed restriction, which obviously cannot meet the analytical needs.

Enforcement costs

The Forum expects that the overall costs of enforcement will be significantly higher than for usual restrictions with a more targeted scope, because of the very large number of substances, mixtures and articles, their widespread use, the difficult sampling, the expensive analyses and the required manpower and expertise.

• It will require a significant amount of manpower, highly equipped laboratories and potential new and substantial guidelines from official agencies to ensure the harmonised enforcement of the proposed restriction;

• The number of analytical equipment (such as GC-MS, LC-MS, GC-MS/MS, LC-MS/MS, HRMS, LC-HRMS, SFC-MS/MS, PIGE, XPS, CIC, FTIR) necessary for analysis can be a bottleneck for enforcement.

Next, ECHA's Committees for Risk Assessment (RAC) and for Socio-Economic Analysis (SEAC) will use the Forum's views in their opinion making. The advice will be shared, together with the Committees' final opinion, with the European Commission to support their decision making.