PFAS Regulations in the European Union: An Essential Guide

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Perfluoroalkyl and Polyfluoroalkyl Substances (PFAS) are a group of chemicals that have been used in certain consumer products for their ability to resist water and stains.

Such products include cookware, clothing, furniture, and building materials. In recent years, PFAS has been restricted by various regulations in the European Union because of their toxicity to humans and the environment.

In this article, we list examples of products that might contain PFAS, as well as regulations that restrict them, including REACH, the POPs Regulation, and the Cosmetic Products Regulation.


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What are PFAS, PFOA and PFOS?

Perfluoroalkyl and Polyfluoroalkyl Substances (PFAS) are a broad group of chemicals that contain carbon-fluorine bonds, which are extremely strong and prevent PFAS from breaking down. PFAS have beneficial properties, such as being oil and water-resistant, leading to their uses in consumer products such as textiles, apparel, and electronics.

At the same time, PFAS may be hazardous to human health and the environment, especially due to strong bonds that resist degradation. As such, more and more PFAS are becoming subject to restrictions.

Perfluorooctanoic Acid (PFOA)

Perfluorooctanoic Acid (PFOA), as well as its salts and PFOA-related compounds, is a type of PFAS that is predominantly used in the manufacturing of coatings and products that resist heat, oil, and water.

They are restricted by REACH, the POPs Regulation, and other regulations.

Perfluorooctane Sulfonate (PFOS)

Perfluorooctane Sulfonate (PFOS) and its derivatives are another type of PFAS used to make products more resistant to stains, grease, and water. They have been used in products such as rugs, upholstered furniture, and cookware.

PFOS are also restricted by regulations such as the POPs Regulation and the Cosmetic Products Regulation.

PFAS Regulations European Union

Which products and materials may contain PFAS?

In this section, we list examples of products and materials that may contain PFAS.

Food packaging

PFAS started to be applied to food packaging around 60 years ago. Food packages containing PFAS are excellent at keeping oil and moisture oozing from foods such as French fries, sandwiches, or other cooked food.

Grease-resistant food packaging that might contain PFAS includes products such as:

  • Fast food containers
  • Wrappers
  • Microwave popcorn bags
  • Pizza boxes

Non-stick cookware

PTFE (Polytetrafluoroethylene) is a type of PFAS which might be used in non-stick cookware such as:

  • Frying pans
  • Spatulas
  • Cooking pots

The use of PTFE on cookware products might result in negative health effects, as when PTFE-coated non-stick cookware is overheated (usually over 250°C), it could release toxic fumes into the air and can cause flu-like symptoms.

Furniture and carpets

PFOS is often used to provide surface protection, such as water repellence, for upholstered furniture and carpets. We list here a few examples of furniture and carpets that might contain PFOS:

Water-resistant clothing

PFOS and PFOA can be used as treatment products to protect the surface of clothing or textiles from oil and water. Here are a few examples of clothing that might be water-resistant as they may contain PFAS:

  • Raincoats
  • Yoga pants
  • Oil-repellent clothing for workers handling dangerous liquids

PTFE, another type of water-repellent PFAS, might be present in clothing such as:

  • Medical gowns
  • Wearable PPE
  • Performance uniforms

Cosmetics

PFAS are added to certain personal care products and cosmetics to increase their applicability and water resistance. Cosmetic products containing PFAS may also make skin appear more shimmery and smooth. Here are a few examples of personal care products and cosmetics that might contain PFAS:

  • Dental floss
  • Shampoo
  • Nail polish
  • Eyeshadows
  • Lipsticks

Building Materials

PFAS are widely used in building materials. For example, PFAS may be added to paints to improve glossiness and decrease bubbling and peeling. PFAS also makes the paint stain and water-resistant.

Here are some examples of building materials that might include PFAS:

  • Metal roofing
  • Asphalt roofing
  • Waterproofing membranes
  • Tensile roofing
  • Wood lacquers
  • Resilient and hard flooring
  • Windows

REACH

The REACH Regulation restricts hazardous substances such as PFAS and PFAS-related substances and their salts, including products that might contain those substances.

Product Scope

REACH regulates the usage of substances in products and materials, including products that might contain perfluorocarboxylic acids and their salts such as:

  • Oil- and water-repellent textiles for protecting workers
  • Photographic coatings for films
  • Implantable medical devices

Restricted Substances

REACH’s SVHC Candidate List contains restricted substances that might adversely affect human health and the environment. On the other hand, Annex XVII contains substances that are more hazardous and thus heavily restricted or banned.

SVHC Candidate List

The ECHA administers REACH and can propose to have SVHCs added to the Candidate List if they:

  • Are carcinogenic, mutagenic, or reprotoxic (CMR)
  • Are persistent, bioaccumulative, and toxic (PBT)
  • May negatively affect the human endocrine system

Importers and manufacturers must use the SCIP database to notify ECHA if their products contain SVHCs exceeding 0.1% by weight.

Here we list some examples of PFAS currently listed in the Candidate List:

  • Henicosafluoroundecanoic acid (PFUnA)
  • Nonadecafluorodecanoic acid (PFDA) and its sodium and ammonium salts
  • Perfluorononan-1-oic-acid (PFNA) and its sodium and ammonium salts
  • Perfluoroheptanoic acid (PFHpA) and its salts
  • Perfluorobutane sulfonic acid (PFBS) and its salts
  • Perfluorohexane-1-sulphonic acid (PFHxS) and its salts
  • Pentadecafluorooctanoic acid (PFOA)

Annex XVII

We could only find C9-C14 perfluorocarboxylic acids (PFCA) and their salts listed in Annex XVII, where examples of their concentration limitations include:

  • Below 25 part per billion (ppb) – the sum of C9-C14 PFCAs and their salts
  • 260 ppb – the sum of C9-C14 PFCA-related substances
  • 10 ppb – the sum of C9-C14 PFCAs, related substances, and salts
  • 1,000 ppb – the sum of C9-C14 PFCAs in PTFE micro powders

On January 2023, a proposal was published aiming at restricting around 10,000 PFAS under REACH. You can find more details on this page.

Persistent Organic Pollutants (POPs) Regulation

The Persistent Organic Pollutants (POPs) Regulation aims to prohibit, phase out, or restrict the manufacture, sale, and use of POPs. This includes some types of PFAS.

Product Scope

The regulation covers products that contain persistent organic pollutants (e.g., PFOS). We list a few such products below:

  • Firefighting foam
  • Textiles
  • Implantable medical devices

Restricted Substances

The POPs regulation has different restrictions for the following PFAS-related substances in Annexes I and IV:

Annex I Annex IV
PFOA a. 0.0000025% by weight

b. As PFOA-related compounds, 0.0001% by weight

a. 0.0001% by weight

b. As the sum of PFOA-related compounds, 0.004% by weight

PFOS a. 0.001% by weight a. 0.005% by weight
PFHxS / a. 0.0001% by weight

b. As the sum of PFHxS-related compounds, 0.004% by weight

The regulation prohibits the manufacture, sale, and use of substances listed in Annex I, whether these substances are made by themselves, sold in mixtures, or used in products.

Covered substances in Annex I, such as PFOA and PFOS, are exempt from the above prohibition if they:

  • Are used for research in a laboratory
  • Are used as a reference standard
  • Exist as an unintentional trace contaminant in substances, mixtures, or products

Annex IV, on the other hand, lists substances subject to waste management provisions.

Plastic Food Contact Materials Regulation

Plastic Food Contact Materials Regulation contains requirements regarding plastic food contact material (FCM) products, including substance restrictions and documentation requirements (ie. Declaration of Compliance).

Product Scope

The regulation plastic FCM products that fall under the categories specified in Article 2(1), such as:

  • Exclusively plastic products
  • Multi-layer plastic products held together by adhesives
  • Plastic products that are printed or covered with a coating

This includes products such as non-stick cookware, which might contain PFAS.

Restricted Substances

The regulation requires that only substances in the Union list of authorised substances in Annex I can be used to manufacture plastic FCM. This includes the following PFAS:

a. Perfluorooctanoic acid – for use in repeated use articles when sintered at high temperatures.

b. Perfluoromethyl perfluorovinyl ether – migration limit: 0.05 mg/kg.

c. (Perfluorobutyl)ethylene – For use as a co-monomer restricted to 0.1% weight by weight (w/w) in the polymerisation of fluoropolymers.

Cosmetic Products Regulation

The Cosmetic Products Regulation establishes requirements for cosmetic products. It forbids the use of certain chemicals in covered products, including PFOS, PFOA, and PFNA. It also sets documentation and labelling requirements.

Product Scope

PFAS might be added to cosmetic products to increase the wearability and water resistance of the products. Here are some examples of cosmetics that might contain PFAS:

  • Foundations
  • Liquid lipsticks
  • Mascaras
  • Nail polish

Restricted Substances

The Cosmetics Regulation prohibits the use of PFAS such as the following:

  • Perfluorooctanoic acid (PFOA)
  • Perfluorooctane sulfonate (PFOS)
  • Perfluorononan-1-oic acid (PFNA)

Classification, Labelling and Packaging (CLP) Regulation

The CLP Regulation sets classification, labelling, documentation and packaging requirements for substances and mixtures.

Note that the CLP Regulation also covers substances that might be sold directly to consumers (e.g. finger paints), and some of these substances might contain PFAS.

Substance examples

Here we list some examples of PFAS that are listed in the C&L inventory and, as such, are regulated by the CLP Regulation.

Perfluorooctanoic acid

This substance may be dangerous for an unborn child, and it is harmful when swallowed or inhaled. It is also suspected to cause cancer.

3,5,7,8-Tetrachloroperfluorooctanoic acid

This substance is classified under the inventory as it might cause skin burns and eye damage.

8H-Perfluorooctanoic acid

This substance might cause eye irritation, skin and respiratory irritation.

Denmark Order No. 681

The Danish Ministry of Environment and Food banned PFAS chemicals in food contact paper, cardboard materials, and articles. According to our research, Denmark was the first country in the EU to ban PFAS in food contact materials.

Product Scope

Denmark’s prohibition on PFAS applies to paper and cardboard materials that might be used in products such as:

  • Wrapping paper
  • Cardboard food plates
  • Paper cups

Requirements

According to Chapter 3(8) of the Order, PFAS-containing paper and cardboard FCMs are prohibited from use and placement in the market unless the product contains a functional barrier that prevents the migration of PFAS substances to the food.

Lab testing

You often need to have your products or substances tested against relevant regulations to prove compliance with chemical and substance requirements. For example, you should have your products tested against the requirements in the POPs Regulation to ensure that their PFOS concentrations do not exceed 0.001% by weight.

When your product passes testing, you receive a test report proving your product’s compliance with relevant requirements.

Test methods

We list below a few methods for testing products for PFAS or PFAS-related substances:

a. EN 17681-1 – Textiles and textile products – Organic fluorine – Part 1: Determination of non-volatile compounds by extraction method using liquid chromatography

b. EN 17681-2 – Textiles and textile products – Organic fluorine – Part 2: Determination of volatile compounds by extraction method using gas chromatography

c. EN ISO 23702-1 – Leather – Per- and polyfluoroalkyl substances – Part 1: Determination of non-volatile compounds by extraction method using liquid chromatography

d. CEN/TS 15968 – Determination of extractable perfluorooctanesulphonate (PFOS) in coated and impregnated solid articles, liquids and fire-fighting foams – Method for sampling, extraction and analysis by LC-qMS or LC-tandem/MS

Test labs

Here are a few companies that offer PFAS testing against EU regulations:

  • Eurofins
  • Intertek
  • UL Solutions
  • TÜV Rheinland
  • (USA & EU)

    FREE CONSULTATION CALL (US, EU & UK)

    • Request a free 30-minute call with Ivan Malloci to learn how we can help you with:
    • Find product requirements
    • Certification and labeling
    • Lab testing

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    Sources: Our articles are written in part based on publicly available information, and our own practical experience relating to product compliance. These are some of the primary sources we use:

    • ec.europa.eu
    • echa.europa.eu
    • ecfr.gov
    • cpsc.gov
    • ftc.gov
    • fcc.gov
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