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European Commission Restricts the Use of Methyl-N-methylanthranilate (M-N-MA) in Cosmetics

February 15 2022

With the latest update to Commission Regulation (EU) 2022/135 on January 31, 2022, the use of methyl-N-methylanthranilate will be restricted in cosmetic products under Annex III of (EC) 1223/2009. On January 31, 2022, the European...

With the latest update to Commission Regulation (EU) 2022/135 on January 31, 2022, the use of methyl-N-methylanthranilate will be restricted in cosmetic products under Annex III of (EC) 1223/2009.

On January 31, 2022, the European Commission released Regulation (EU) 2022/135, restricting the use of methyl-N-methylanthranilate (M-N-MA) in cosmetic products under Annex III of (EC) 1223/2009.

The Regulation will be effective from February 21, 2022.

The following enforcement dates apply:

  • From August 21, 2022: cosmetic products containing this substance and not complying with the restrictions shall not be placed on the Union market
  • From November 21, 2022: cosmetic products containing this substance and not complying with the restrictions shall not be made available on the Union market

    Annex III


Reference

number

Substance identification

Restrictions

Chemical

name/INN

Name of Common Ingredients Glossary CAS number EC number Product type, body parts Maximum concentration in ready for use preparation Other

323


 

 

Methyl-N-methylanthranilate


 

 

 

 

85-91-6


 

201-642-6


 

(a)Leave-on products

(a) 0.1 %

For (a): not to be used in sunscreen products and products marketed for exposure to natural or artificial UV light

(b)Rinse-off

products

(b) 0.2 %

For (a) and (b):

- Do not use with nitrosating agents

- Maximum nitrosamine content: 50 μg/kg

- Keep in nitrite-free containers

Scientific Committee on Consumer Safety (SCCS) opinions SCCS/1455/11, SCCS/1458/11, and SCCS/1616/20 state 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. This also applies to other cosmetic products where the concentration of the substance is:

  • Leave-on products: more than 0.1 %
  • Rinse-off products: more than 0.2 %

Therefore, use of M-N-MA in these products should be prohibited.

A potential risk to human health has also been identified in the use of M-N-MA with nitrosating agents. Therefore, such use of M-N-MA should be prohibited and a maximum nitrosamine content of 50 μg/kg should be set. A requirement to keep cosmetic products containing M-N-MA in nitrite-free containers should also be introduced.

Footer :

  1. Regulation (EU) 2022/135S
  2. SCCS Opinion (SCCS/1455/11)
  3. SCCS Opinion (SCCS /1458/11)
  4. SCCS opinion (SCCS/1616/20)

Next step:

Cosmetic industry shall pay attention to the new limit of M-N-MA and its uses in cosmetic products. Reducing the usage level of M-N-MA may be necessary.

Hubert Brundu
C&H Global Technical Manager 

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