Since 2009, perfluorooctane sulfonic acid and its derivatives (PFOS) have been included in the international Stockholm Convention to eliminate their use. PFOS has then been restricted under Annex 1 of the EU’s Persistent Organic Pollutants (POPs) Regulation. Annex I entry for PFOS was amended in 2020 to remove exemptions no longer needed in the EU.
In addition, the Stockholm Convention regulates the global elimination of perfluorooctanoic acid (PFOA), its salts and PFOA-related compounds. PFOA has been banned under the POPs Regulation since 4 July 2020.
Perfluorohexane sulfonic acid (PFHxS), its salts and PFHxS-related compounds are being considered for inclusion in the Stockholm Convention and consequent global elimination.
The manufacture and use of some PFAS is being restricted under REACH.
There is an ongoing restriction proposal by Germany and Sweden for the following perfluorinated carboxylic acids (C9-14 PFCAs) including their salts and precursors:
- perfluorononan-1-oic acid (PFNA);
- nonadecafluorodecanoic acid (PFDA);
- henicosafluoroundecanoic acid (PFUnDA);
- tricosafluorododecanoic acid (PFDoDA);
- pentacosafluorotridecanoic acid (PFTrDA); and
- heptacosafluorotetradecanoic acid (PFTDA).
ECHA’s scientific committees have provided their opinion on the proposal and support the restriction. The European Commission is currently working on an amendment of Annex XVII to REACH to restrict this group of substances.
Norway has proposed a restriction on perfluorohexane-1-sulphonic acid (PFHxS), its salts and related substances. ECHA's committees support the restriction to prevent these substances being used as a regrettable substitute for PFOA. ECHAs opinion supports the restriction here.
The Netherlands and Germany, with support from Norway, Denmark and Sweden, have shown interest in preparing a restriction proposal to cover a wide range of PFAS uses – in support of the statements made in the Environment Council in December 2019. They organised a call for evidence to get more information for such a proposal from 11 May until 31 July 2020 and a webinar in October 2020.
On 1 October 2020, ECHA announced its intention to prepare a restriction dossier for PFAS in firefighting foams - on request of the European Commission. ECHA's restriction proposal is expected by 1 October 2021:
The request is based on the outcome of a study by the European Commission and ECHA.
Furthermore, ECHA and the European Commission carried out a study on PFAS in textiles. This will provide essential information that will be relevant for ongoing or future restriction work.
Substances of very high concern under REACH
A number of other PFAS are on the REACH Candidate List of substances of very high concern (SVHC).
In June 2019 and January 2020, two PFAS groups were identified as SVHCs. The SVHC identification was based on their persistence, mobility and toxicity, which were considered to pose a threat to human health and wildlife when exposed through the environment (including through drinking water). This SVHC identification identified these PFAS as of equivalent concern to carcinogens, mutagens and reprotoxicants (CMRs) and persistent, bioaccumulative and toxic/very persistent and very bioaccumulative (PBTs/vPvBs) chemicals.
These groups are:
- 2,3,3,3-tetrafluoro-2-(heptafluoropropoxy)propionic acid, its salts and its acyl halides (HFPO-DA), a short-chain PFAS substitute for PFOA in fluoropolymer production, was the first substance added to the Candidate List. Its ammonium salt is commonly known as GenX.
- perfluorobutane sulfonic acid (PFBS) and its salts, a replacement of PFOS
Evaluation of substances under REACH
Several additional PFAS are on the list for evaluation (Community rolling action plan) over the coming years or have already been evaluated. The evaluation aims to clarify initial concerns on the potential risk to human health or the environment that manufacturing or using these substances could pose.
Classification, Labelling and Packaging (CLP) Regulation
A few PFAS already have a harmonised classification and labelling under the CLP Regulation. These include:
- perfluorooctanoic acid (PFOA);
- ammonium pentadecafluorooctanoate (APFO);
- perfluorononan-1-oic acid (PFNA) and its sodium and ammonium salts;
- nonadecafluorodecanoic acid (PFDA) and its sodium and ammonium salts.
Perfluoroheptanoic acid has been proposed for harmonised classification and labelling and is in opinion development at the moment.
An informal coordination group of several EU Member States, ECHA and the European Commission has, since 2014, screened data on PFAS contained in ECHA’s registration database and coordinated group-based regulatory work.
Despite an efficient approach compared to regulating substance by substance, work has only been able to cover the PFAS groups of highest urgency due to the very large number of PFAS.
ECHA’s database contains information of over 2 000 individual PFAS on the EU market. These belong to a variety of subgroups and it seems, based on the experience that it would take too long to assess and, where relevant, manage risks subgroup by subgroup. Therefore, ECHA acknowledges that a holistic group approach to the regulatory assessment and risk management needs to be explored, as requested in the proposal for an EU strategy for PFAS, submitted to five Commissioners from several Member States in December 2019.
European Commission policy initiatives on PFAS
In October 2020, the European Commission published the Chemicals Strategy for Sustainability.
Among its many actions, it includes phasing out the use of PFAS in the EU, unless their use is essential and initiatives to reduce their emissions using all available legislative and non-legislative tools. The details of the future European actions on PFAS are presented in a specific document that accompanies the Chemicals Strategy.
The agreement by the European Parliament and the Council in December 2019 on the recast of the Drinking Water Directive includes a limit of 0.5 µg/l for all PFAS. This is in line with a grouping approach for all PFAS.
In December 2020, the European Parliament formally adopted the revised Drinking Water Directive. The Directive entered into force on 12 January 2021, and Member States will have two years to transpose it into national legislation.
PFAS and food
PFAS are released into the environment through industrial manufacturing not directly linked to food production and through the use and disposal of PFAS-containing products. However, as often with persistent pollutants, they end up in the food chain. The main contributors to human dietary exposure are certain vegetables but drinking water is also an important source. Some PFAS also accumulate to human bodies through fish and seafood, meat and meat products, eggs, milk and dairy products.
In September 2020, the European Food Safety Authority (EFSA) set a new safety threshold for the main perfluoroalkyl substances that accumulate in the body: perfluorooctanoic acid (PFOA), perfluorooctane sulfonate (PFOS), perfluorononanoic acid (PFNA), perfluorohexane sulfonic acid (PFHxS). The threshold – a group tolerable weekly intake (TWI) of 4.4 nanograms per kilogram of body weight per week – is part of a scientific opinion on the risks to people’s health from the presence of these substances in food. EFSA’s scientific advice will support risk managers in their decisions on how best to protect consumers from exposure to PFAS through food.
Valentina Bertato of the DG Environment, European Commission presented the European Union's actions to regulate PFASs. It covered recent actions for restricting PFASs compounds and a strategy moving forward.