PFAS Regulations in the European Union: An Overview

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PFAS Regulations European Union

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 for their toxicity to humans and the environment. In this article, we cover PFAS regulations in the EU – including covered products, testing requirements, and more.

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What are PFAS, PFOA and PFOS?

Perfluoroalkyl and Polyfluoroalkyl Substances (PFAS) are a group of man-made chemicals that are defined as containing at least one fully fluorinated methyl or methylene carbon atom. There are thousands of different PFAS and some are widely used in consumer products since the 1940s for their properties of being oil and water-resistant, flame resistant, high chemical, physical, and temperature resistance.

PFASs are called “the forever chemicals” because the carbon-fluorine bond is extremely strong and stable, which makes PFASs hard to break down.

Perfluorooctanoic Acid (PFOA) and Perfluorooctane Sulfonate (PFOS) are two of the most widely used and studied chemicals in the PFAS group. PFOA and PFOS have been prohibited and replaced with other less toxic substances in recent years in the European Union. Other common PFAS are PFCA, PFHxS, PFBS, PTFE, and PFNA – some of which are restricted in the EU.

Which products and materials may contain PFAS?

In this section, we introduce some products and materials that may contain PFAS.

Food Packaging

PFAS started to be applied to food packaging in the 1960s in the United States. Food packages containing PFAS are excellent at keeping oil and moisture oozing from food such as french fries, sandwiches, or other cooked food.

Examples of grease-resistant food packaging that might contain PFAS include:

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

Non-stick Cookware

PTFE (Polytetrafluoroethylene), which is one of the 4,700 types of PFAS, is typically used in non-stick cookware such as:

  • Frying pans
  • Spatulas
  • Spoons
  • Egg beaters

The toxicity of PTFE on cookware is controversial, but some studies have shown that when being overheated (usually over 250°C), PTFE-coated non-stick cookware could release toxic fumes into the air and can cause flu-like symptoms known as polymer fume fever such as chills, fever, headache and body aches.

Furniture and Carpets

PFAS are also used in the coatings of furniture and carpets to increase the stain and water resistance ability of these products. Examples of furniture and carpets that might contain PFAS include:

Water-Resistant Clothing

PFAS can be used as the coating to increase the stain and water resistance performance of the clothing or the textile. Examples of clothing that may contain PFAS include:

  • Gore-Tex outdoor clothing
  • Raincoat
  • Period underwear
  • Hiking boots
  • Tents

Cosmetics

PFAS are added to certain personal care and cosmetics to increase their long-term wearability, water, and sweat resistance. Cosmetics products containing PFAS may also make skin appear more shimmery and smooth. Examples of personal care products and cosmetics that might contain PFAS include:

  • Dental floss
  • Shampoo
  • Nail polish
  • Eye makeup
  • Sunscreen

Building Materials

PFAS are widely used in building materials. For example, PFAS may be added to paints to improve glossiness and to 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
  • Paints
  • Metal coatings
  • Wood lacquers
  • Plastic coatings
  • Resilient and hard flooring
  • Windows
  • Artificial turf

REACH

REACH regulates several PFAS, which might be listed in either the Substances of Very High Concern List (SVHC) Candidate List or Annex XVII. Therefore the concentration level of some PFAS is limited in some consumer products. Notification requirements might also apply.

Product Scope

PFAS were widely used in certain consumer products for their water and stain resistance ability. Examples of products that might contain PFAS include:

  • Performance fabrics
  • Furniture
  • Carpets and rugs
  • Outdoor wear
  • Outdoor gear
  • Fire-extinguishing foam

Restricted Substances

Some chemical groups that belong to the family of PFAS are either prohibited or restricted by REACH under the Annex XVII or SVHC framework. Below is restriction information about these substances.

Annex XVII

REACH regulates Perfluorocarboxylic acids (PFCAs) containing 9 to 14 carbon atoms in the chain (C9-C14 PFCAs), their salts, and C9-C14 PFCA-related substances.

REACH Annex XVII restricts the use of C9-C14 PFCAs, including their salts and any combinations in the market starting from February 25, 2023. The limit value is:

  • C9-C14 PFCAs and their salts < 0.0000025%
  • C9-C14 PFCA-related substances < 0.000026%

SVHC Candidate List

There are several substances of the PFAS family that are in the SVHC Candidate List. This means that suppliers selling products that contain more than 0.1% weight by weight of these substances must notify their customers of the presence of the substances if required. Suppliers must also provide instructions on the safe use of the products, and register the products in the SCIP database, in accordance with the Waste Framework Directive.

Perfluorohexane sulfonate (PFHxS) is a group of PFAS chemicals in the SVHC Candidate List because of their association with causing human diseases such as elevated cholesterol, disturbance with liver function, thyroid hormone levels, and reduced immune response.

PFHxS has been used in a wide range of industrial processes and is found in many consumer products, such as:

  • Stain-resistant fabrics
  • Fire-fighting foams
  • Food packaging
  • Surfactant

Perfluorobutane sulfonic acid (PFBS) and its salts are also in the SVHC Candidate List. PFBS has been widely used in consumer products such as fabrics, carpets, and paper to increase the water and stain-resistant performance of these products.

PFBS could have serious effects on human health and the environment, causing disturbances in human hormones and reproductive systems. PFBS might also have harmful effects on the human liver and kidneys.

Lab Testing

Importers and manufacturers of outdoor wear, water-resistant fabric, food packaging, or other products that might contain restricted PFAS must make sure that their products comply with the requirements of REACH.

Laboratories that provide PFAS-related testing services, such as accurate and precise measurement of the potential for contamination include SGS, Intertek, and TÜV SÜD.

Persistent Organic Pollutant (POP) Regulation

The EU Persistent Organic Pollutants (POPs) Regulation aims to reduce the impact of POPs on humans and the environment by setting the limit of POPs used in consumer and industrial products.

Currently, PFOS and PFOA are two groups of chemicals that are listed in Annex I of POPs Regulation, which means that they are prohibited.

Product Scope

The use of PFOS and PFOA in consumer products has been fading out in Europe since 2002. However, some manufacturers, especially ones from regions where these substances are loosely-regulated could still use PFOS or PFOA in their products. Here are some examples of products that might include these substances:

  • Textiles (on protective coating)
  • Leather (on protective coating)
  • Furniture (on protective coating)
  • Paper goods
  • Industrial cleaning products

Restricted Substances

Currently, there are two groups of PFAS regulated by the EU Persistent Organic Pollutants (POPs) Regulation, which are:

  • PFOS
  • PFOA

PFOS and PFOA are both listed in Annex I of the regulation. This means the use of these substances is prohibited in the EU market. The prohibition is also extended to articles that contain the substances.

The two following exceptions apply:

a. The substance is used for laboratory-scale research or as a reference standard

b. The substance is found as an unintentional contaminant, in which case it is allowed in small quantities (0.001% by weight for PFOS and 0.0000025% by weight for PFOA).

Lab Testing

Importers of water and stain-resistant fabric, garments, furniture, or other products that might contain banned substances must make sure that their products comply with the POPs Regulation.

Laboratories that provide PFOS or PFOA-related testing services include SGS, Intertek, and TÜV SÜD.

Regulation (EC) 1223/2009 on Cosmetic Products

Regulation (EC) No. 1223/2009 establishes requirements for cosmetics products that are placed within the European Union market. The regulation forbids the use of certain chemicals in covered products, including PFOS and PFOA.

Product Scope

PFAS are often added to cosmetic products to increase the wearability and water-resistance ability of the products. The following cosmetics are often found to contain PFAS:

  • Foundations
  • Liquid lipsticks
  • Mascaras
  • Sunscreen
  • Nail polish
  • Dental floss

Restricted Substances

Two types of PFAS chemicals are prohibited to be used in cosmetic products by the Cosmetics Regulation:

  • Perfluorooctane sulfonic acid (PFOA)
  • Perfluorooctane sulfonate (PFOS)

Documentation

The Cosmetics Regulation requires importers and manufacturers to prepare a Cosmetic Product Safety Report that contains information about the cosmetic products before placing their products in the EU market.

The report should include:

Part A: Cosmetic Product Safety Information

Part B: Cosmetic Product Safety Assessment

You can read our article about the Cosmetics Regulation to learn more about the requirements and standards for selling cosmetics in the EU.

Labeling

The regulation also provides labeling requirements. The label should include information such as:

  • Name and address of the responsible person
  • List of ingredients
  • Expiration date
  • User instructions
  • Batch ID

Lab Testing

To make sure the cosmetic products do not contain PFOA and PFOS, importers and manufacturers should test their products before selling them in the EU market. Laboratories that provide PFOS or PFOA-related testing services for cosmetic products include SGS, Intertek, and TÜV SÜD.

Denmark Order No. 681

The Danish Ministry of Environment and Food banned PFAS chemicals in food contact paper, cardboard materials, and articles starting from May 2020. Denmark was the first country in the EU to ban PFAS in food contact materials.

Product Scope

Denmark’s prohibition on PFAS apply to the following food contact materials:

  • Wrapping paper
  • Cardboard food plates
  • Paper cups

Lab Testing

Importers of paper food packaging should test their products before placing them in Denmark to ensure that they are PFAS free. Testing companies that provide such services include SGS, Intertek, and TÜV SÜD.

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    Disclaimer: The content on this website is provided for general information only. The content includes summaries written by our team members based on publicly available information about product safety standards, labeling, documentation, testing, processes, and other product compliance related topics. However, we don’t guarantee that we cover every single relevant regulation/standard/requirement, or that the information is free from errors, or covering every single scenario and exemption. We do make mistakes from time to time. We never provide legal advice of any sort.

    Changes/Updates: Product standards and substance restrictions are subject to frequent updates and changes. In addition, new regulations, standards, and/or requirements may also become effective at any time. We don’t update our articles whenever new standards/regulations/rules are added or changed. We recommend that you consult a lab testing company or other professional to get the latest information about mandatory standards/regulations in your market, country, or state. Lab testing companies generally stay up to date on new and updated standards and regulations.

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