On September 1st 2025, the European Chemicals Agency (ECHA) announced a proposal to add three substances to the Candidate List of Substances of Very High Concern (SVHCs). A public consultation on the proposal is now open and will run until October 16, 2025.
Table of Contents
Substances Under Review
The substances under review are:
- 4,4′-[2,2,2-trifluoro-1-(trifluoromethyl)ethylidene]diphenol and its salts (commonly referred to as Bisphenol AF, CAS 1478-61-1)
- 4,4′-methylenediphenol (CAS 620-92-8)
- n-hexane (CAS 110-54-3)
Hazardous Properties and Industry Impact
4,4′-[2,2,2-trifluoro-1-(trifluoromethyl)ethylidene]diphenol (Bisphenol AF) and its salts
Proposed by Sweden, Bisphenol AF and its salts are widely used in the production of polymers, rubber, and fluoroelastomers. The substance is classified as toxic for reproduction (Category 1B). According to ECHA, salts of Bisphenol AF rapidly degrade into Bisphenol AF itself, carrying the same risks.
The proposal identifies Bisphenol AF as a per- and polyfluoroalkyl substance (PFAS), a group often referred to as “forever chemicals” because of their persistence in the environment. The EU is advancing a broad PFAS restriction that could eventually capture Bisphenol AF, signaling an elevated regulatory risk for companies relying on this substance.
4,4′-methylenediphenol (Bisphenol F)
Also proposed by Sweden, Bisphenol F shares structural similarities with Bisphenol A, a well-known restricted chemical. Its applications include adhesives, coatings, varnishes, pipes, and dental sealants, and it is also used in thermal paper at concentrations up to 2 %.
Like Bisphenol A, Bisphenol F is classified as toxic for reproduction (Category 1B). By proposing its inclusion, regulators are aiming to prevent “regrettable substitution,” where restricted chemicals are replaced with equally hazardous alternatives.
n-hexane
Proposed by Slovenia, n-hexane is a high-volume chemical used in vegetable oil extraction, rubber manufacturing, adhesives, and coatings. The substance is classified as toxic to specific target organs after repeated exposure (STOT RE 1). Prolonged or repeated exposure can cause nerve damage, including numbness and muscle weakness, which may persist even after exposure stops.
ECHA considers n-hexane to present risks equivalent to carcinogenic, mutagenic, and reprotoxic substances (CMRs), making its proposal as an SVHC a significant step toward closing regulatory gaps in worker and consumer protection.
Compliance Obligations
Once added to the SVHC list, companies handling these substances must comply with obligations under the EU REACH Regulation:
- Supply Chain Communication: If SVHC levels exceed 0.1 % in a substance, mixture, or article, suppliers must provide a Safety Data Sheet (SDS) or safe-use information to downstream users. Consumers can also request this information free of charge within 45 days.
- SVHC Notification: Producers, importers, or sole representatives must notify ECHA if articles contain SVHCs above 0.1 % and exceed 1 ton per year. Notifications must be submitted within six months of a substance’s inclusion.
- SCIP Notification: Under the Waste Framework Directive, a SCIP notification is required before articles containing SVHCs above 0.1 % can be placed on the EU market.
Conclusion
ECHA’s proposal to add these three substances to the SVHC Candidate List shows the EU’s commitment in tightening chemical safety and preventing harmful substitutions. Companies are urged to review their supply chains, assess compliance risks, and provide input during the public consultation before October 16, 2025.
