The “Whereas” of Regulation 2022/135

(1) The substance Methyl-N-methylanthranilate (M-N-MA) (CAS No.85-91-6) is a fragrance ingredient used in various cosmetics, including fine fragrances, shampoos, soaps and other toiletries. M-N-MA is currently not subject to any prohibition or restriction pursuant to Regulation (EC) No.1223/2009.

(2) The Scientific Committee on Consumer Safety (SCCS) concluded in an opinion adopted at its plenary meeting of 13-14 December 2011 that there were no safety concerns for use of M-N-MA in a concentration of up to 0.2% in rinse-off products. It further noted that M-N-MA is phototoxic, which was the toxicological endpoint of concern in that opinion. Whilst up to 0.1% M-N-MA may be safe for use in many leave-on cosmetic products, the SCCS found that a risk cannot be excluded for the use of that substance in sunscreen or sun care products or products (including fragrances) intended for use on areas exposed to light. Moreover, the SCCS concluded that since M-N-MA is prone to nitrosation, it should not be used in combination with nitrosating agents and the nitrosamine content should be below 50 μg/kg.

(3) At the plenary meeting of 27 March 2012, the SCCS adopted an opinion on nitrosamines and secondary amines. In that …