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EU: EUROPEAN UNION launched public consultation on PFAS under REACH Annex XVII

MARCH 2023 - ELECTRICAL AND ELECTRONICS, HARDLINES, SOFTLINES, TOYS AND CHILDREN'S PRODUCTS

On 22 March 2023, the European Chemicals Agency (ECHA) launched the 1st public consultation1 of the proposal2 to restrict per- and polyfluoroalkyl substances (PFASs) under REACH Annex XVII. 

The proposed restriction aims to address the risks to human health and the environment posed by the uses of PFASs, which target more than 10000 substances which meet the definition of PFAS under the Organization for Economic Cooperation and Development (OECD). All PFASs within the proposal scope have very high persistence and can remain in the environment for decades to centuries. In addition, many PFASs have varying toxicological effects. They are bioaccumulative, mobile and can even reach remote and pristine areas of the world. As is known, PFASs are present in a wide range of products intended for industrial, professional and consumer uses and are continuously released into the environment. Taking these risks posed by the uses of PFASs into account, five European authorities (Denmark, Germany, the Netherlands, Norway and Sweden) prepared a dossier to propose the restriction on PFAS under REACH Annex XVII.

This proposal does not cover the uses of PFAS in firefighting foams, because the use of PFAS in firefighting foams has been addressed in another restriction proposal3.

The public consultation will end on 25 September 2023, and ECHA will work on its final opinion based on the comments collected. After that, ECHA will send the final opinion to the European Commission (EC), which will make the decision on whether to include the proposed restriction in REACH Annex XVII.

Moreover, an online information session4 will be held on 5 April 2023. During the session, experts from ECHA and the five national authorities will explain the restriction process, the content of the proposal and how to participate in the consultation. They will also respond to questions from the participants.

Table A shows the details of the proposed restriction.

Table A. 

Restricted substance
 Per- and polyfluoroalkyl substances (PFAS)
Proposed scope of restriction
 Substances, mixtures and articles
Proposed limit
  • < 25 ppb for any PFAS (polymeric PFASs excluded);
  • < 250 ppb for the sum of PFASs (polymeric PFASs excluded);
  • < 50 ppm for PFASs (polymeric PFASs included). If total fluorine content exceeds 50 mg/kg, the manufacturer, importer or downstream user shall upon request provide to the enforcement authorities proof for the fluorine measured as the content of either PFASs or non-PFASs.
Proposed exemption
  • Active substances in biocidal products, plant protection products, human and veterinary medicinal products;
  • Polymerisation aids in the production of polymeric PFASs (the production of polytetrafluoroethylene (PTFE), polyvinylidene fluoride (PVDF) and Family of Fluorocarbon-based Fluoroelastomer Materials (FKM) excluded) until 6.5 years after entry into force;
  • Textiles used in personal protective equipment (PPE) intended to protect users against certain risks as specified in Regulation (EU) 2016/425 until 13.5 years after entry into force;
  • Fluoropolymers and perfluoropolyethers for use in certain sectors with different transitional periods, e.g. food contact materials for the purpose of industrial and professional food and feed production until 6.5 years after entry into force, implantable medical devices until 13.5 years after entry into force;
  • The application of any restrictions on PFAS set out in this Annex or other applicable European Union (EU) legislation;
  • Etc.
Proposed date of application
 18 months after the date of entry into force

HOW DOES THIS IMPACT YOU AND YOUR BUSINESS?
CONTACT US TO DISCUSS.

TÜV SÜD has dedicated experts to assist you in the development of consumer products and meeting applicable regulations. Through a global network of laboratories, TÜV SÜD offers a wide range of services that includes chemical tests, physical or mechanical tests as well inspections to ensure the compliance of your products in target markets. 

For enquiries, please contact us at [email protected]

[1] Public consultation summary

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