On 24 July 2023, the European Chemicals Agency (ECHA) launched a consultation on Sweden’s proposal for harmonised classification and labelling of four fragrance ingredients as “Toxic for reproduction” category 1 B. The consultation is open until 22 September 2023.
This consultation includes a total of six substances, but two are already banned for use in cosmetics. These are:
• 2-(4-tert-butylbenzyl) propionaldehyde (CAS: 80-54-6, EC: 201-289-8, INCI: Butylphenyl Methylpropional)
• 4-tert-butylbenzoic acid (CAS: 98-73-7, EC: 202-696-3, INCI: 4-t-Butylbenzoic acid)
Of the other four, one is listed in Annex III/155 (restricted substances) to Cosmetics Regulation 1223/2009:
• 3-(4-tert-butylphenyl)propionaldehyde (CAS: 18127-01-0; EC: 203-161-7; INCI: 4-tert-Butyldihydrocinnamaldehyde) has a maximum concentration limit of 0.6% in ready-to-use preparations (finished cosmetic products).
The remaining three are not currently subject to restrictions under Cosmetics Regulation 1223/2009. These are :
• 4-tert-butyltoluene (CAS: 98-51-1; EC: 202-675-9; INCI: 4-tert-Butyltoluene)
• 4-tert-butylbenzaldehyde (CAS: 939-97-9; EC: 247-768-5; INCI: 4-t-Butylbenzaldehyde)
• methyl 4-tert-butylbenzoate (CAS: 26537-19-9; EC: 247-768-5 INCI: Methyl 4-t-Butylbenzoate)
The proposal by Sweden
Sweden proposes to classify these four substances as follows.
Hazard class and Category codes, Hazard statement codes
• Repr. 1B, H360Fd - May damage fertility. Suspected of damaging the unborn child.
Pictogram, Signal word code
• GHS08
• Dgr (Danger)
Note
The classification of mixtures as reproductive toxicant is necessary if the sum of the concentrations of individual substances, forming the same metabolite, in a mixture as placed on the market is equal …
