Subject: Upcoming Ban of Lilial (Butylphenyl Methylpropional)
Lilial, also called Butylphenyl Methylpropional (CAS 80-54-6) is an important fragrance ingredient commonly found in cosmetic products. This is also an ingredient well-known from cosmetic brands since it is one of the 26 official fragrance allergens that have to be reported in cosmetics’ lists of ingredients.
End of 2017, a classification proposal was submitted to ECHA via a regular CLH dossier and the proposal was Repr.2 (Reproductive Toxicity class 2). By default, CMR substances cannot be used in cosmetic products and IFRA (the International Fragrance Association) submitted a safety dossier to the SCCS in view to get an exemption. The Scientific Opinion released by the SCCS was negative and IFRA resubmitted a new dossier with lower use concentrations. Again, the second Scientific Opinion was negative despite the conclusions let understand that safe levels could be derived for Lilial.
Unfortunately, the ECHA Risk Assessment Committee (RAC) evaluated the classification proposal in parallel and concluded that Lilial should rather get classified Repr. 1B, which is a much more severe and conservative decision. The classification has been legally adopted on June 16th, 2019 and should lead to an amendment of the CLP Regulation once the European Commission has approved it. Such an approval by the European Commission is expected to take place.
Actions need to be taken since this classification will automatically lead to a ban of Lilial in all cosmetic products. Indeed, the SCCS will not validate an exemption now that the ingredient is classified Repr. 1B. BIORIUS estimates that the ban will be adopted during the first semester of 2021. It will take the form of an Omnibus Regulation, which will immediately start to apply once published (as it happened for Omnibus Regulation 2018 and will happen soon for Omnibus Regulation 2019). By this time, all products should be reformulated to remove Lilial and product labels should be corrected if Lilial appears on the lists of ingredients.
We hope that this letter will be of help and stay at your disposal for any questions related to this topic.
Dr. Fred Lebreux