On 27 June 2024, the European Chemicals Agency (ECHA) announced Spain’s intention of an harmonised classification and labelling (CLH) for several dimethylaminobenzoate derivatives, including the UV filter Padimate O, as Reprotoxic category 1B.
This intention of classification concerns four substances, two of which are ingredients authorised for use in cosmetics:
• Ethyl 4-dimethylaminobenzoate (CAS No.-; EC No.-; INCI: Ethyl Dimethylaminobenzoate; CosIng function: Film forming) ;
• 2-ethylhexyl 4-(dimethylamino)benzoate (CAS No.21245-02-3; EC No.244-289-3; INN: Padimate O; INCI: Ethylhexyl Dimethyl PABA; CosIng functions: Light stabilizer, UV absorver, UV filter).
Ethyl dimethylaminobenzoate is not currently regulated by European Cosmetics Regulation 1223/2009.
Ethylhexyl Dimethyl PABA, on the other hand, is listed in Annex VI/21 (Authorised UV filters), which limits its maximum concentration in finished products to 8%.
Neither is currently listed in Annex VI of the European CLP Regulation 1272/2008.
Spain intends to propose the following classification:
• Repr. 1B, H360F - May damage fertility
If the process is completed and this classification becomes effective, this substance could be listed as a CMR and its use could be banned in cosmetic products in Europe, unless the ban is waived following an opinion from the SCCS.
Sources
• ECHA Weekly - New intention and proposals to harmonise classification and labelling, ECHA, 27 June 2024
• Registry of CLH intentions until outcome - ethyl 4-dimethylaminobenzoate; 2-ethylhexyl 4-(dimethylamino)benzoate; 3-methylbutyl 4-(dimethylamino)benzoate; padimate A, ECHA, 25 June 2024
