The ECHA RAC has officially adopted an opinion to IL1235 20-04-2026 Tonalide – ECHA RAC Opinion as Repr 1B adopted. This is a significant escalation from its previous classification. Under the EU and UK Cosmetic Regulations (Article 15), substances classified as CMR 1B (Carcinogenic, Mutagenic, or Reprotoxic) are generally prohibited for use in cosmetic products.
For the ingredient to remain on the market, the industry must now apply for an exception. This requires:
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- Demonstrating that there are no suitable alternative substances.
- The application being limited to specific uses with defined exposure levels.
- A positive safety evaluation from the SCCS (Scientific Committee on Consumer Safety).
The formal entry into the ATP (Adaptation to Technical Progress) is expected in 2025, with the legal ban likely taking effect in late 2026 or early 2027. The International Fragrance Association (IFRA) is currently coordinating a defense of the ingredient, but manufacturers are advised to begin identifying products containing Tonalide and exploring potential reformulations to mitigate future compliance risks.
