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
|
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 :
- Regulation (EU) 2022/135S
- SCCS Opinion (SCCS/1455/11)
- SCCS Opinion (SCCS /1458/11)
- 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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