ECHA Announces Revised Draft PFAS Restrictions under REACH

SafeGuardSAutomotive, Cosmetics & Personal Care, Electrical & Electronics, Hardgoods, Personal and Protective Equipment, Softlines, Toys and Juvenile ProductsSep 04, 2025

SG 128/25

The European Chemicals Agency (ECHA) has revised its proposal to restrict per- and polyfluoroalkyl substances (PFAS) under Annex XVII of REACH.

On August 20, 2025, the ECHA announced its updated proposal to restrict PFAS under Annex XVII of Regulation (EC) No 1907/2006, ‘Restriction, Evaluation, Authorization and Restriction of Chemicals (Annex XVII of REACH, consolidated version to June 2025). This revision was prepared by Denmark, Germany, the Netherlands, Norway and Sweden based on their assessment of over 5,600 scientific and technical comments received during the 2023 consultation.

These five authorities (dossier submitters) have, inter alia, identified and evaluated eight sectors that were not included in the initial January 2023 proposal (SafeGuardS 20/23):

Broader industrial uses, such as solvents and catalysts
Explosives
Machinery applications
Military applications
Other medical applications, such as immediate packaging and excipients for pharmaceuticals
Printing applications
Sealing applications
Technical textiles

Additionally, they have examined alternative restriction options beyond a blanket ban or a ban with time-limited derogations for certain applications. These alternatives allow the continued manufacture, placing on the market or use of PFAS where the risks can be controlled, including:

Electronics and semi-conductors
Energy
Machinery applications
PFAS manufacturing
Sealing applications
Technical textiles
Transport

It is important to note that the dossier submitters assessed the appropriateness of various restriction options (ROs):

RO1 – a blanket ban for PFASs with a transition period of 18 months and no derogations
RO2 – a PFAS ban with use-specific, mainly time-limited derogations in addition to a transition period of 18 months
RO3 – allowing continued use under strict conditions that minimize emissions over the full life cycle

The restriction options RO1, RO2 and RO3 are considered sufficiently enforceable. RO1 is unlikely to be workable or manageable, whereas RO2 and RO3 are concluded to be feasible and practical in relation to implementation, enforcement and management.

According to RO2, ‘PFASs’ means substances that contain at least one fully fluorinated methyl (CF3-) or methylene (-CF2-) carbon atom, without any H/Cl/Br/I attached to it. Substances containing only the following structural elements are excluded from the scope of the restriction:

CF₃-X, or X-CF₂-X’, where X = -OR or -NRR’ and X’ = methyl (-CH3), methylene (-CH2-), an aromatic group, a carbonyl group (-C(O)-), -OR’’, -SR’’ or –NR’’R’’’; and where R/R’/R’’/R’’’ is a hydrogen (-H), methyl (-CH3), methylene (-CH2-), an aromatic group or a carbonyl group (-C(O)-)

Highlights of the updated PFAS restriction proposal under Annex XVII of REACH in RO2 are summarized in Table 1.

Scope of PFAS	Requirement	Conditions of restriction
Substances on their own	Prohibited	Applies 18 months from date of entry into force (EIF) Derogations apply 6.5², 13.5³ or 23.5⁴ years after date of EIF Time-unlimited derogations for specific uses⁵
Constituents of another substance In mixtures In articles	≤ 25 ppb for any targeted PFASs (polymeric PFASs are exempt) ≤ 250 ppb for sum of targeted PFASs, where applicable with prior degradation of precursors ≤ 50 ppm for PFASs, including polymeric PFASs¹
¹If total fluorine exceeds 50 mg/kg, proof for the fluorine measured as content of either PFASs or non-PFASs is required if requested by enforcement authorities Derogations include but are not limited to: ²Fluoropolymers and perfluoropolyethers for a) polymer processing aids used in flexible plastic film extrusion (for food and non-food applications), b) non-stick coatings in industrial bakeware and c) industrial use of fluoropolymers in filtration and separation media for water treatment and purification ³a) Textile articles containing recovered material, except toys, b) personal protective equipment (PPE), c) binders and electrolytes in batteries, d) polymer additives used for fire safety purposes in construction products, e) lubricants and their additives for industrial and professional applications, f) latex printing inks, g) technical textiles in engine bays of transport vehicles for noise, vibration and harshness (NVH) insulation and ignition protection, and h) fluoropolymers and perfluoropolyethers in implantable and invasive medical devices ⁴Plastic articles containing recovered material, except food contact materials (FCMs) and food contact packaging, and toys ⁵Paper and board articles containing recovered material, except FCMs and packaging

Table 1. Revised proposed restriction – Annex XVII entry PFASs (RO2)

It is interesting to note that plastic articles or complex objects falling under the scope of Directive 2012/19/EU (Waste electrical and electronic equipment, WEEE, consolidated version to April 2024) or Directive 2000/53/EC (End-of life vehicles, ELV, consolidated version to March 2023), as well as PVC articles listed in points 18(a) to 18(f) of Regulation (EU) 2023/923 on lead and its compounds in polymers or copolymers of vinyl chloride (PVC) containing intentionally added PFAS in concentrations of or more than the limits defined in column 2 of Table 1, must carry the statement: ‘Contains intentionally added PFASs.’

The proposal is currently being evaluated by the ECHA scientific committees.

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