November 11, 2024
By Roberta Canciello, senior technical specialist, Retail Consumer Products team, UL Solutions
Several regulatory actions are being taken to regulate per- and polyfluoroalkyl substances (PFAS) in consumer products in the EU. These toxic substances are also known as “forever chemicals” due to their high persistence. Without the ability to degrade, their concentration in the environment will continue to increase. Exposure to these substances can have negative effects on both humans and the environment.
PFASs are a group of about 10,000 mainly man-made substances used in numerous applications in the EU. These applications include textiles, food packaging, lubricants, refrigerants, electronics, construction and many more.
In the EU, some PFAS are already regulated under REACH and POP legislation (see Table 1) and the SVHC list, others have been recently added to list of restricted substances under REACH (Regulation (EC) No 1907/2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals) under entry 79 of Annex XVII (see Table 2), while other groups are being proposed for restrictions (see Table 3).
Table 1
PFAS currently restricted in the EU
Substance group | Limits in articles | Applicable from |
---|---|---|
PFOA and PFOA related substances (various cas numbers) | 25 ppb as total content and 1000 ppb for PFOA-related substances | July 4, 2020 |
PFOS (various CAS numbers) | 1 microg/m2 for treated articles and 0.1% by weight as total content | Aug. 25, 2010 |
PFCA and PFCA related substances (various CAS numbers) | 25 ppb for the sum of C9-C14 PFCAs and their salts or 260 ppb for the sum of C9-C14 PFCA-related substances | Feb. 25, 2023 |
PFHxS | 25 ppb for the sum of PFHxS and their salts or 1,000 ppb for the sum of PFHxS -related substances | Aug. 28, 2023 |
Table 2
PFAS groups under proposal for restrictions in the EU
Substance group | Limits in articles | Applicable from |
---|---|---|
Undecafluorohexanoic acid (PFHxA), its salts and related substances |
|
|
The current larger proposals for restriction (see Table 3) will cover a greater number of substances with specific exemptions and different dates of entry into force for specific uses.
PFAS 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)-).
Table 3
Larger proposals for PFAS restriction
Restriction proposals | Limits in articles | Applicable from |
---|---|---|
Option 1 | Full ban | Still under proposal and there will be a transition period of 18 months without derogations. |
Option 2 |
|
Still under proposal and there will be a transition period of 18 months with derogation for some uses. |
In the spring 2024 there have been some EU Initiatives at State level (Denmark and France) to introduce a legislation to limit PFAS that could enter into force in 2026, before the actual proposal under REACH for PFAS.
The Danish government proposes to introduce a national ban on PFAS in clothing, shoes and waterproofing agents. PFAS in professional clothing and safety clothing will not be part of the ban.
The executive order on the ban is expected to be ready on July 1, 2025. The government proposes to give business a transition period of one year, so that the ban applies from July 1, 2026. The ban will be implemented in practice by setting limit values that ensure that PFAS cannot be deliberately used in clothing, shoes and impregnation.
Elsewhere in the EU, France's National Assembly recently approved the first reading of a bill that would restrict the manufacture and sale of non-essential products containing PFAS, a first step in the legislative process.
This draft law is aimed at protecting the population from the risks linked to perfluoroalkyl and polyfluoroalkyl substances. It proposes, starting January 1, 2026, the prohibition of the manufacture, importation, exportation, and placing on the market of various products like cosmetic, wax and textile clothing products. It also proposes to completely prohibit the use of PFAS in any textile product by January 1, 2030.
To ensure compliance with regulatory requirements, relevant enterprises should familiarize themselves with these requirements as early as possible and adapt their protocols and manuals to investigate the presence of PFAS in their products.
UL Solutions can assist customers in finding the best strategies for complying with PFAS regulations in terms of both testing and communication along the supply chain. Additionally, we can provide support and training to help customers prepare for regulatory changes and upcoming restrictions on PFAS.
References
- Regulation (EU) 2019/1021 of the European Parliament and of the Council of 20 June 2019 on persistent organic pollutants (recast) (Text with EEA relevance)Text with EEA relevance
- COMMISSION REGULATION (EU) 2021/1297 of 4 August 2021 amending Annex XVII to Regulation (EC) No 1907/2006 of the European Parliament and of the Council as regards perfluorocarboxylic acids containing 9 to 14 carbon atoms in the chain (C9-C14 PFCAs), their salts and C9-C14 PFCA-related substances
- Commission Delegated Regulation (EU) 2023/1608 of 30 May 2023 amending Annex I to Regulation (EU) 2019/1021 of the European Parliament and of the Council as regards the listing of perfluorohexane sulfonic acid (PFHxS), its salts and PFHxS-related compounds
- DELEGATED REGULATION (EU) 2023/1608 of 30 May 2023 amending Annex I to Regulation (EU) 2019/1021 of the European Parliament and of the Council as regards the listing of perfluorohexane sulfonic acid (PFHxS), its salts and PFHxS-related compounds
- Persistent organic pollutants – perfluorohexane sulfonic acid (PFHxS)
- Registry of restriction intentions until outcome
- Submitted restrictions under consideration
- PFAS-handlingsplan: Regeringen vil indføre dansk forbud mod PFAS i tøj og sko
- Protéger la population des risques liés aux substances per- et polyfluoroalkylées (PFAS)
- Commission Regulation (EU) 2024/2462 of 19 September 2024 amending Annex XVII to Regulation (EC) No 1907/2006 of the European Parliament and of the Council as regards undecafluorohexanoic acid (PFHxA), its salts and PFHxA-related substances
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