The Commission Regulation (EU) 2022/135 of 31 January 2022 was published in the Official Journal of the European Union, changing the conditions of use of Methyl-N-methylanthranilate in cosmetic products. What is this substance and what are the new regulations? I invite you to read the new post 🙂
Methyl-N-methylanthranilate (M-N-MA) is a methyl ester resulting from the condensation of the carboxy group of N-methylanthranilic acid with methanol. In cosmetics, it acts as a fragrance. It is used in fine fragrances, shampoos, soaps and many other types of cosmetics. Until now, M-N-MA has not been subject to any restrictions of use under the Regulation (EC) No 1223/2009.
The Scientific Committee on Consumer Safety (SCCS) concluded in its opinion no. SCCS/1455/11 that there are no safety concerns for the use of M-N-MA up to 0.2% in rinse-off products. However, it was noted that M-N-MA is phototoxic. Therefore, the SCCS Committee concluded that the risks associated with the use of this substance in sunscreen products or cosmetics (including fragrances) applied to body surfaces exposed to light cannot be excluded. Since M-N-MA is a secondary amine, it is susceptible to nitrosation. Hence, the SCCS emphasized that Methyl-N-methylanthranilate should not be used in combination with nitrosating agents and that the nitrosamine content should be less than 50 μg/kg.
In another scientific opinion no. SCCS/1616/20 of 16 October 2020, the SCCS Committee concluded that M-N-MA should not be used in sunscreen products and cosmetics exposed to natural or artificial UV radiation. However, with regard to other cosmetics, the use of M-N-MA was found to be safe at a concentration of up to 0.1% for rinse-off products and up to 0.2% for leave-on products.
In the light of the above opinions of the SCCS, the Regulation 1223/2009 was amended. The substance Methyl-N-methylanthranilate was included in Annex III (the list of substances with restrictions of use). From now, M-N-MA takes the position 323 in the mentioned appendix. This component can only be used in:
- Leave-on products – at a maximum concentration of 0.1%,
- Rinse-off products – at a maximum concentration of 0.2%.
Other conditions of use M-N-MA in the above products are:
- Do not use with nitrosating agents,
- Maximum nitrosamine content: 50 μg/kg,
- Keep in nitrite-free containers.
In addition, when used in leave-on cosmetics, M-N-MA should not be used in sunscreen productsa and products marketed for exposure to natural or artificial UV light.
The transitional periods provided in the regulation are as follows: August 21, 2022 – for placing cosmetics on the market, and November 21, 2022 – for making them available on the market.
You can find the new regulation at: https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32022R0135&from=EN
The opinions of the SCCS can be found at the following links: https://ec.europa.eu/health/scientific_committees/consumer_safety/docs/sccs_o_075.pdf