(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 (2) 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 (3). In that opinion, the SCCS concluded that the purity specification of 50 μg nitrosamine/ kg should apply to raw materials and to all nitrosamines potentially formed, and not to finished products. It further concluded that the secondary amines should not be in contact with adventitious nitrosating agents such as nitrite treated raw material containers. That opinion applies also to M-N-MA, which is a secondary amine.

(4)

Subsequently, SCCS has concluded, in a scientific advice of 16 October 2020 on the SCCS opinion on M-N-MA (4), that M-N-MA should not be used in sunscreen products and products marketed for exposure to natural or artificial UV light. For other cosmetic products, SCCS considered the use of M-N-MA safe in a concentration of up to 0,1 % for leave-on products and 0,2 % for rinse-off products.

(5)

In light of the SCCS opinions and scientific advice, there is a potential risk to human health arising from the use of M-N-MA in sunscreen products and products marketed for exposure to natural or artificial UV light and in other cosmetic products where the concentration of the substance is more than 0,1 % for leave-on products and 0,2 % for rinse-off products. Therefore, such use of M-N-MA should be prohibited.

(6)

In light of the SCCS opinions and scientific advice, there is also a potential risk to human health arising from the use of M-N-MA with nitrosating agents. Therefore, such use of M-N-MA should be prohibited, a maximum nitrosamine content of 50 μg/kg should be set and a requirement to keep cosmetic products containing M-N-MA in nitrite-free containers should be introduced.

(7)

Regulation (EC) No 1223/2009 should therefore be amended accordingly.

(8)

The industry should be allowed a reasonable period of time to adapt to the new requirements by making the adjustments to product formulations and containers that are necessary to ensure that only cosmetic products complying with the new requirements are placed on the market. The industry should also be allowed a reasonable period of time to withdraw cosmetic products which do not comply with the new requirements from the market.

(9)

The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Cosmetic Products,