What is this substance and what are the new conditions?
Regulation (EU) 2022/135, of 31st January 2022, was published in the Official Journal of the European Union on 1st February 2022 and amends Annex III (restricted substances) of the Cosmetics Regulation (EC) No. 1223/2009. This amendment introduces concentration limits and new conditions of use for Methyl-N-Methylanthranilate (fragrance ingredient), effective as of August 2022.
From 21st August 2022, personal care products containing the substance and not complying with the new restrictions shall no longer be placed on the EU market (i.e. new products). From 21 November 2022, the products shall not be made available (i.e. existing products) on the Union market.
The substance Methyl-N-methylanthranilate (M-N-MA), CAS No. 85-91-6, is a methyl ester resulting from the methylation of methyl anthranilate. It is a fragrance ingredient used for its floral and fruity notes in products such as shampoos, soaps, and fine fragrances, amongst many other personal care applications.
As well as being a synthesized aroma chemical, it occurs naturally in certain oils/extracts such as citrus fruits including Mandarin and Petitgrain.
Until now, M-N-MA has not been subject to any restrictions in use under the EU Cosmetic Regulation (EC) No. 1223/2009. However, the International Fragrance Association (IFRA) already has a standard on this substance due to its phototoxic effects, with a maximum concentration of 0.1% in leave-on products. See the current IFRA standard on M-N-MA by following this link: Methyl-N-methylanthranilate (ifrafragrance.org)
WHAT ARE THE NEW CONDITIONS OF USE FOR M-N-MA ACCORDING TO THE REGULATION 2022/135?
The Scientific Committee on Consumer Safety (SCCS) concluded in its opinion SCCS/1455/11 that there are no safety concerns for the use of M-N-MA up to 0.2% in rinse-off products, although it was noted that M-N-MA is phototoxic. As a result, the SCCS Committee concluded that the risks associated with the use of this substance in sunscreen products or personal care products (including fragrances) applied to body surfaces exposed to UV light cannot be excluded. Since M-N-MA is a secondary amine, it is susceptible to nitrosation, hence the SCCS emphasized that M-N-MA should not be used in combination with nitrosating agents, and that the nitrosamine content should be less than 50 μg/kg. See the opinion following this link: 1455/11 – SCCS Opinion on methyl-N-methylanthranilate.
In another scientific opinion, SCCS/1616/20 of 16th October 2020, the SCCS Committee concluded that M-N-MA should not be used in sunscreen products and personal care products exposed to natural or artificial UV radiation. However, with regard to other personal care products, the use of M-N-MA was found to be safe at a concentration of up to 0.2% for rinse-off products and up to 0.1% for leave-on products. See the opinion following this link: 1616/20 – SCCS Opinion on methyl-N-methylanthranilate. In light of the above SCCS opinions, Regulation No. 1223/2009 was amended, and M-N-MA was included in Annex III (the list of substances with restrictions of use). M-N-MA now takes position 323 in the mentioned appendix as below:
This substance can only be present in:
- Leave-on products – at a maximum concentration of 0.1%
- Rinse-off products – at a maximum concentration of 0.2%
Other conditions for the use and presence of M-N-MA in the above personal care products categories 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 personal care products, M-N-MA should not be used in sunscreen products and products marketed for exposure to natural or artificial UV light.
TRANSITIONAL PERIODS TO COMPLY WITH THIS NEW REGULATION, (EU) 2022/135
The following enforcement dates apply:
From 21st August 2022, personal care products containing this substance and not complying with the restrictions shall not be placed on the Union market.
From 21st November 2022, personal care products containing this substance and not complying with the restrictions shall not be made available on the Union market.
If you need to find out the percentage of M-N-MA in Sozio fragrances you are purchasing, or need any further information about this new regulation, please reach out to us via email: firstname.lastname@example.org or through your designated Sales Representative.