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Europe Union Notifies WHO of Pending Annex Changes

July 20, 2021 by Ithos Global Regulatory Team

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Last Updated on July 20, 2021 by Ithos Global Regulatory Team

The EU commission has issued the following new ingredient notification:

  • Methyl-N-methylanthranilate (M-N-MA), generally used as a fragrance component, was notified March 15, 2021 to the WHO with the following proposed changes to Annex III of 1229/2009:
  • M-N-MA content should be limited to maximum 0.1% for leave-on and 0.2% for rinse-off cosmetic products;
  • M-N-MA with nitrosating agents should be banned;
  • The maximum nitrosamine content should be restricted to 50 µg/kg both for leave-on and rinse-off products;
  • M-N-MA should not be used in leave-on sunscreen products and products marketed for exposure to natural/artificial UV light;
  • Products containing M-N-MA should be kept in nitrite-free containers

The International Fragrance Association (IFRA) does have a standard in most categories of 0.1% already, with a few categories having no restrictions. Most leave-on products will meet the new EU standard if one follows recent IFRA standards. There may be some fragrance oil adjustments required for certain rinse- off products such as shampoos, conditioners, and cleansers. Check with your fragrance suppliers to see if your products may be affected.

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  • European Union
  • Fragrance
  • IFRA

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