The European Chemicals Agency (ECHA) has updated its Candidate List under the EU REACH Regulation by including two substances: n-hexane and bisphenol AF (BPAF). Cosmetic manufacturers using these compounds are now subject to strict new requirements. If any product contains more than 0.1% of either ingredient, brands must provide full disclosure to both authorities and the public, and those items can no longer display the EU Ecolabel. This shift may lead many companies to rethink their processing of botanical extracts and packaging materials.
Brands now face fresh limits on sourcing and formulation choices, especially those aiming for environmental certifications or conscious consumers.
Reasons for the ECHA Update
ECHA classified n-hexane as a Substance of Very High Concern (SVHC) because repeated exposure can damage certain organs. This solvent is widely used in extracting plant-based ingredients for personal care products. BPAF, on the other hand, is linked to reproductive harm and is commonly present in specific plastics and dye formulations. The SVHC category also covers BPAF’s various salts, so the restriction applies broadly within cosmetics packaging and colorants.
Immediate Actions for Cosmetic Companies
Whenever n-hexane or BPAF exceeds the 0.1% content threshold in a product, companies must inform consumers of its presence and submit information to the relevant regulatory agencies.Exceeding this limit also means the product cannot use the EU Ecolabel, which remains a key marker for environmentally responsible and safe consumer products. Losing the Ecolabel could hurt trust and sales in a market that values green claims.
Future Regulatory Changes
Since BPAF is now recognized for its risk to fertility,the likelihood of a full ban in the EU has increased. Companies wishing to continue working with BPAF may require special permissions in future. ECHA has also signaled that both n-hexane and BPAF could be included on the Authorization List, which would demand advance approval for continued use and involve close evaluation by the European Commission.
Wider Regulatory Developments in Chemical Safety
These chemical restrictions support ECHA’s broader campaign to reduce hazardous exposures in European supply chains. Earlier this year, ECHA added five further substances to the SVHC list, such as octamethyltrisiloxane, for properties like high bioaccumulation and persistence. In February, the EU’s list of carcinogenic, mutagenic, and reproductive toxins expanded by 15 more substances. Some industry representatives in the cosmetics sector warn that expanding regulatory controls might complicate supply chains and affect manufacturing investments within Europe.
Certified Cosmetics guides brands through the process of achieving compliance with EU cosmetic safety regulations.
