Per and polyfluoroalkyl substances (PFAS), also known as “forever chemicals,” have been a significant topic in the world of product compliance for the last several years. These substances are known to accumulate in the environment and in living beings, leading to toxic effects. Recently, the European Union (EU) proposed an extensive change to the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) Annex XVII, which could lead to a ban of over 10,000 PFAS.
These restrictions will be wide-reaching and have the potential to fundamentally change the materials used in thousands of products.
If you produce materials or products in the EU or import into the EU, you will need to be ready for these changes by extensively examining your products and supply chain and finding alternative substances to replace PFAS.
What Are PFAS?
PFAS are a group of mostly man-made substances that are used in numerous applications. They can be found in everything from textiles to food packaging to electronics.
Because of their particularly strong chemical bond, they are difficult to break down, which is why they have been used in many products as protective coatings. However, this strong bond also means they accumulate in the environment without degradation. This can be harmful to human health and the environment.
PFAS persist in the environment longer than any other man-made chemical, and they can enter the environment through all stages of a product’s lifecycle, from the manufacturing stage to the waste stage.
Proposed REACH Annex XVII Update
Denmark, Germany, the Netherlands, Norway, and Sweden came together to form the proposal for PFAS restrictions.
Once the ban is in place, which could take place in 2026 or 2027, it will give companies between 18 months and 13.5 years to find alternative substances for their products. The timeline will depend on the availability of alternatives.
What is the Scope of the Proposed Update?
The chemical scope of the proposed restriction is 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). This definition is aligned with the Organization for Economic Co-operation and Development (OECD) definition of PFASs that was published in 2021, which has been analyzed by the international scientific community and is widely accepted.
This will include more than 10,000 PFAS, including a few fully degradable PFAS subgroups. The restriction addresses the manufacture, placing on the market, and the use of PFAS as constituents in other substances, in mixtures, and in articles above a certain concentration.
All uses of PFAS are covered by the proposed restriction, regardless of whether or not they have been specifically assessed by the comment submitters or are mentioned specifically in the proposal. There are very few exceptions.
Next Steps for the EU
The European Chemicals Agency (ECHA) has two committees for Risk Assessment and Socio-Economic Analysis that will review whether the proposal conforms to REACH. They will also perform a scientific evaluation and consult with industry.
Normally, these committees take 12 months for their evaluation. However, ECHA has already said it will likely need longer for evaluating this proposal.
After this evaluation, the European Commission and the EU member states will decide on the final version.
PFAS in Your Supply Chain
Identifying PFAS in your products and supply chain is the first crucial step to preparing for these changes. PFAS are so wide-ranging in their application that you may not be aware of PFAS in your products or in your supply chain. In the coming months and years, companies will need to do a deep dive into their supply chain to determine the presence of PFAS.
Any PFAS will then need to be replaced with alternative substances. This may require you to redesign your products and recertify them in the EU, which can be a lengthy process. Begin now by identifying PFAS and alternatives to maintain market access in the EU without interruption once the new restrictions go into effect.
Get Support from Tetra Tech
The presence of PFAS in products is so wide-ranging, you may not even be aware of them in your products and supply chain. With over 10,000 PFAS possibly being banned with the new EU proposal, the impact on manufacturers across the EU and the world will be enormous.
If you need help developing a plan to maintain EU market access in the face of these changes, contact Tetra Tech’s compliance experts at [email protected]. We can help you survey your products and supply chain, identify risks, and create a road map for a sustainable future.