Chemical Compliance
Intelligence & Solutions
Chemical
ChemLinkedMarketChemicalFoodCosmeticPharmaceuticalJapanAgrochemicalSustainability

EU PFAS Management

Luna Luo Last updated on: Oct 12, 2024

1 Overview

Per- and polyfluoroalkyl substances (PFAS) are a group of thousands of man-made substances that are used in numerous applications due to their water-, grease- and dirt-repellent properties in the European Union (EU). Recognition of the large number of cases of PFAS pollution has made the EU adopt increasing regulatory measures to address the use and contamination with PFAS in the past 20 years.

The EU's key regulatory actions against PFAS are rooted in the REACH and Persistent Organic Pollutants (POPs) Regulation. Compared to these regulatory approaches, the EU-wide proposed restriction of around 10,000 PFASs, publised in 2023, has a significant impact on far more use categories. In addition to the EU-level regulations, some EU member states, such as France and Denmark, have went a step further in restricting PFAS. In summary, the regulation of PFAS in the EU is a rapidly evolving field, and it is crucial for companies to stay informed about these ongoing developments.

2 PFAS Regulation at EU-wide Level

Currently several groups of PFAS chemicals are regulated under the REACH and POPs Regulation. With the publication of the PFAS restriction proposal on Feb 7, 2023, EU is likely to phase out all PFAS, allowing their use only where they are proven to be irreplaceable and essential to society.

2.1 POPs Regulation Bans

The EU’s commitments to the Stockholm Conventionon are implemented through the POPs Regulation, aiming to restrict or eliminate the production, use, import, and export of POPs. Specific subgroups of PFAS, including PFOS, PFOA, and PFHxS are currently listed in Annex I to POPs Regulation as industrial POPs. Besides, long-chain perfluorinated carboxylic acids (C9-21 PFCAs) are being considered for inclusion in the Stockholm Convention and consequent EU wide ban.

As per the POPs Regulation, the manufacturing, placing on the market and use of substances (on their own, in mixtures or articles) listed in Annex I shall be prohibited. The restricted conditions for listed PFAS are as follows:

SubstanceCAS NoEC NoSpecific exemption on intermediate use or other specificationLatest Update
Perfluorooctane sulfonic acid  and its derivatives (PFOS)  C8F17SO2X  (X = OH, Metal salt (O-M+),  halide, amide, and other derivatives including polymers)1763-23-1 and others217-179-8 and others

  • ≤10 mg/kg (0.001 % by weight) of PFOS as UTC in substances or mixtures.

  • <0.1% by weight (calculated with reference to the mass of structurally or micro-structurally distinct parts that contain PFOS) of PFOS as UTC in semi-finished products or articles, or parts thereof, or 1 μg/m2 for the amount of PFOS as UTC in the coated material.

Draft amendment to revise PFOS exemptions (Dec 4, 2023)
Perfluorooctanoic acid (PFOA), its salts and PFOA-related compounds335-67-1 and others206-397-9 and others

 

  • ≦ 0.025 mg/kg (0.0000025 % by weight) for PFOA or any of its salts.

  • ≦ 1mg/kg (0.0001 % by weight) for the sum of concentrations of all PFOA-related compounds.

  • ≦ 20 mg/kg (0.002 % by weight) for PFOA-related compounds present in a substance to be used as a transported isolated intermediate.

  • ≦ 2 mg/kg (0.0002 % by weight) for PFOA and its salts and/or PFOA-related compounds present in medical devices other than invasive devices and implantable devices.


/
Perfluorohexane sulfonic acid (PFHxS), its salts and PFHxS-related compounds355-46-4 and others206-587-1 and others

  • ≦ 0.025 mg/kg (0.0000025 % by weight) for PFHxS or any of its salts.

  • ≦ 1mg/kg (0.0001 % by weight) for the sum of concentrations of all PFHxS-related compounds.

  • ≦ 0.1 mg/kg (0.00001 % by weight) for PFHxS, its salts and PFHxS-related compounds present in concentrated firefighting foam mixtures that are to be used or are used in the production of other firefighting foam mixtures. (This exemption shall be reviewed and assessed by the Commission no later than 28 August 2026).

/

2.2 REACH Restrictions

Under REACH, certain groups of PFAS are restricted or prohibited through inclusions in the the Candidate List of Substances of Very High Concern (SVHC) and the Restriction List.

2.2.1 SVHC Listing

SVHC placement is based on the classification as carcinogenic, mutagenic or toxic for reproduction (CMR) category 1A or 1B, persistent, bioaccumulative and toxic (PBT) or very persistent and very bioaccumulative (vPvB), or equivalent with the level of concern as CMR or PBT/vPvB substances.

Eight groups of PFAS have been added to the SVHC List, including:

  1. 2,3,3,3 tetrafluoro-2-(heptafluoropropoxy)propionic acid, its salts, and its acyl halides (HFPO-DA, also known as GenX chemicals)

  2. Perfluorobutane sulfonic acid (PFBS) and its salts

  3. Perfluoroheptanoic acid (PFHpA) and its salts

  4. Perfluorocarboxylic acids (C9-14 PFCAs), their salts and related substances

  5. Perfluorohexane sulfonic acid (PFHxS) and its salts

  6. Ammonium pentadecafluorooctanoate (APFO)

  7. Perfluorooctanoic acid (PFOA)

  8. Reaction mass of 2,2,3,3,5,5,6,6-octafluoro-4-(1,1,1,2,3,3,3- heptafluoropropan-2-yl)morpholine and 2,2,3,3,5,5,6,6-octafluoro-4- (heptafluoropropyl)morpholine

For these groups of PFAS, the SVHC listing mandates the following legal obligations if the substance either on its own, in mixtures or in articles is above a concentration of 0.1 % (weight by weight).

RolesObligations
EU and EEA producers/importers of articlesTo supply appropriate instructions to the recipient of the article in order to exclude exposure of humans and the environment during the use and disposal of the article.
EU or EEA suppliers of substances or mixturesTo provide their customers with a safety data sheet (SDS).
EU or EEA suppliers of articles

  • To provide sufficient information to allow safe use of the article to their customers and consumers (within 45 days of the receipt of the request by a consumer);

  • To submit SCIP Notifications on these articles to ECHA.

2.2.2 Restricted Substances Listing

Certain PFAS are also listed in the Restriction List (Annex XVII to EU REACH). C9-14 PFCAs, their salts and related substances have been restricted in the EU/EEA since February 2023. In addition, Undecafluorohexanoic acid (PFHxA), its salts and related substances was added to the Restriction List on September 20, 2024.

C9-14 PFCAs, their salts and related substances

The EU-wide restriction of certain perfluorocarboxylic acids (C9-C14 PFCAs) started applying from February 25, 2023 onwards. PFCAs cannot be placed on the market or used in most applications after that date, except if the concentration in the substance, the mixture, or the article is:

  • ≦ 25 ppb for the sum of C9-C14 PFCAs and their salts;

  • ≦ 260 ppb for the sum of C9-C14 PFCA-related substances; or

  • ≦ 10 ppm for the sum of C9-C14 PFCAs, their salts and C9-C14 PFCA related substances (present in a substance to be used as a transported isolated intermediate).

Some uses have been granted longer transition periods as shown in the picture below.

PFHxA, its salts and related substances

These PFAS will be prohibited from being placed on the market, or used in the following concentration measured in homogeneous materials in the EU/EEA from April 2026.   

  • ≧ 25 ppb for the sum of PFHxA and its salts; or

  • ≧ 1,000 ppb for the sumb of PFHxA-related substances.

The key restrictions are summarized as follows (click here to know more details).

Regulated scopeEffective date

  • Firefighting foams and firefighting foam concentrates for training and for testing;

  • Firefighting foams and firefighting foam concentrates for public fire services.

April 10, 2026

  • Textiles, leather, furs and hides in clothing and related accessories;

  • Footwear for the general public;

  • Paper and cardboard used as food contact materials within the scope of Regulation (EC) No 1935/2004;

  • Mixtures for the general public;

  • Cosmetic products as defined in Regulation (EC) No 1223/2009.

October 10, 2026

  • Textiles, leather, furs and hides other than in clothing and related accessories, for general public.

October 10, 2027

  • Firefighting foams and firefighting foam concentrates for civil aviation (including in civilian airports).

October 10, 2029

2.3 Universal PFAS Restriction Proposal

On February 7, 2023, the European Chemicals Agency (ECHA) unveiled the details of the proposed restriction of around 10,000 PFAS, which underwent a six-month consultation ended on September 25, 2023. Following the issue of Advice on enforceability of the restriction proposal, ECHA clarified the next steps for the proposal to restrict PFAS. 

The Committees for Risk Assessment (RAC) and for Socio-Economic Analysis (SEAC) has convened in June and September of 2024 to address the PFAS ban on a sector-to-sector basis. Up until Septeber 26, 2024, RAC and SEAC Committees have reached provisional conclusions on the PFAS ban as relating to the following sectors:

  • Consumer mixtures, cosmetics, and ski wax 

  • Metal plating and the manufacture of metal products

  • Petroleum and mining sectors

Discussions will continue for more sectors to be addressed in the next meetings, including textiles, upholstery, leather, apparel and carpets, and food contact material and packaging. 

The November meeting will focus on construction products for the first time. And in 2025, the sectors for discussion are application of fluorinated gases, transport and energy. 

The universal PFAS ban is expected to be come into force in its final form in 2026/2027

2.3.1 Proposed Restriction

For the purpose of this restriction proposal PFASs are defined as substances that contain at least one fully fluorinated methyl (CF3-) or methylene (-CF2-) carbon atom, without any H/Cl/Br/I attached to it.

The PFAS proposal carries two options that can be summarized as below:

Condition of restrictionRestricted option (RO)Transitional period before RO takes effectDuration of deragation

  1. PFASs shall not be manufactured, used or placed on the market as substances on their own;

  2. PFASs shall not be placed on the market in another substance, as a constituent, a mixture, or an article;

  3. Derogation scope:

  • Active substances in biocidal, plant protection, human and veterinary medicinal products

  • Textiles used in personal protective equipment

  • Food contact materials

  • Implantable medical devices

...

RO1: Full ban18 monthsNot applicable
RO2: Ban with use-specific derogations5 or 12 years after transition period ends (unlimited time for exceptional cases)

2.3.2 Issues for Enforceability

To improve transparency of the legislative process, the Forum for Exchange of Information on Enforcement examines the proposal with the view to advise on the following issues for enforceability (click here to know more details).

3 PFAS Regulation at Member States level

In addition to the EU’s PFAS regulatory approaches, certain member states are planning to take or have taken legislative actions to restrict PFAS in certain products. The table below shows the major details.

Member StateRegulationSummary
NorwayEnvironmental Agency of Norway Regulation FOR-2013-05-27-550

PFOA and its salts and esters cannot be used in textiles and other consumer products, except if the concentration is:

  • ≦ 10 ppm in the substance and the mixture;

  • ≦ 1 mg/m2 in the individual components of textiles, carpets, and other coated consumer products;

  • ≦ 1,000 ppm in the individual components of other consumer products.

DenmarkOrder on food contact materials and on penalties for infringements of related EU legal acts, BEK no. 681 of 25/05/2020

  • Prohibition: Food contact materials made of paper and board in which PFAS have been used may not be placed on the market;

  • Exemption: PFAS use is exempted in FCMs if a functional barrier exists in the products to effectively prevent migration to food.

Proposed national ban on PFAS in clothing, shoes and waterproofing agents

  • Prohibition: to ban the sale and import of clothes, shoes and waterproofing agents for consumers by setting limit values;

  • Exemption: PFAS in professional clothing and safety clothing will not be part of the ban;

  • Expected release date: July 1, 2025;

  • Expected implementation date: July 1, 2026.

FranceProposed PFAS Law

  • Prohibition:

  1. From January 1, 2026: To ban on the the manufacture, import, export and placing on the market of any cosmetic product, wax product (for skis) or clothing textile product containing PFAS, with the exception of protective clothing for safety and civil security professionals;

  2. From January 1, 2030: To ban on the manufacture, import, export and placing on the market of all textile products containing PFAS.

  • “Polluter pays” principle: Polluters must bear an additional environmental tax of 1000 euros per kilogram to the releases of PFAS into the natural environment directly or through a collection network.

4 News

Tags:   EUChemical managementPOPsEU REACHPFAS