Our team would like to remind you about the most significant changes that have taken place in the cosmetic industry in the last few months.
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Methyl-N-methylanthranilate (M-N-MA), a hidden fragrance ingredient, is now regulated.
Methyl-N-methylanthranilate (CAS No 85-91-6) is a fragrance ingredient, usually not declared at ingredient lists. Until 2022, the use of M-N-MA wasn’t regulated, however, the IFRA 49th Amendment limited its use at 0.1% in several product categories due to its phototoxic effects.
The Commission Regulation (EU) 2022/135 includes in the EU Cosmetics Regulation the conclusions of the SCCS Scientific Advice 1616/20 and the SCCS Opinion 1455/11. According to the new entry in Annex III to the EU Cosmetics Regulation, M-N-MA can be used:
- In leave-on products up to 0.1%;
- In rinse-off products up to 0.2%.
Moreover, M-N-MA cannot be used with nitrosating agents, allowing a maximum of nitrosamine content of 50 μg/kg, and products containing M-N-MA must be stored in nitrite-free containers.
Lastly, Methyl-N-methylanthranilate cannot be used in leave-on “sunscreen products and products marketed for exposure to natural or artificial UV light”
Products that do not meet the requirements must be off shelves, as the end date was last 21st November 2022.
Regulation (EC) 1223/2009 new updated version, October 2022, consolidated text.
The new version of the cosmetic regulation was published on the 6th of October 2022. This new version includes the amendments made since the last time updated, 31st July 2022.
At the consolidated text the amendment including the last Omnibus can be found, along with the latest changes about Methyl Salicylate.
The Commission Regulation (EU) 2022/1531 was published in September. The so-called Omnibus V Regulation will enter into force on 17th December 2022, prohibiting different substances for their use in cosmetics and limiting the use of Methyl Salicylate.
Since Methyl Salicylate is a fragrance ingredient and it is not disclosed by fragrance suppliers, we recommend you to ask your fragrance supplier about Methyl Salicylate to ensure compliance of your cosmetic products.
FRANCE –Labelling Requirements for Leave-on Products Containing Phenoxyethanol
In 2019, the French Authorities published a legal requirement related to Phenoxyethanol containing leave-on products, also known as the “ANSM Decision March 13th, 2019”. Product labels of all leave-on cosmetic products intended for the French market were requested to bear the warning “Not to be used on the nappy-skin area of children under 3 years of age”.
This administrative decision led to a dispute between the Federation of Beauty Companies (FEBEA) and the National Agency for the Safety of Medicinal Products and Health Products (ANSM). It escalated finally up to the EU Court of Justice, to clarify the interpretation of Article 27 of Regulation 1223/2009.
The requirement for the labeling of the precautionary measurement “Not to be used on the nappy-skin area of children under 3 years of age” on leave-on cosmetic products containing Phenoxyethanol has been repealed. Therefore, the labeling restriction related to Phenoxyethanol is officially not mandatory for products imported into France.
The General Court annuls the Commission Delegated Regulation of 2019 about the harmonised classification and labeling of titanium dioxide as a carcinogenic substance.
Titanium dioxide is an inorganic chemical substance used for its colorant and covering properties in various products. In 2016, a proposal to classify titanium dioxide as a carcinogenic substance was submitted to the European Chemicals Agency (ECHA).
The following year, ECHA’s Committee for Risk Assessment (‘the RAC’) adopted an opinion classifying titanium dioxide as a category 2 carcinogen, and the European Commission adopted Regulation 2020/217, recognizing that that substance was suspected of being carcinogenic to humans by inhalation.
The General Court concludes now, by upholding the conclusion contained in the RAC Opinion that the mode of action of carcinogenicity on which that committee relied could not be regarded as intrinsic toxicity in the classical sense, but which had to be taken into consideration in the context of harmonised classification and labeling under Regulation No 1272/2008, the Commission committed a manifest error of assessment.
Commission Regulation (EU) 2022/2195 of 10 November 2022 as regards the use of Butylated Hydroxytoluene, Acid Yellow 3, Homosalate, HAA299, and Resorcinol in cosmetic products.
The amendment includes specific limits of use to Butylated Hydroxytoluene (BHT) and Acid Yellow, and limits the use of Homosalate. Also includes a new UV filter at Annex VI.
BHT is permitted in mouthwash products, up to 0.001%; in toothpaste, up to 0.1%; and in other leave-on and rinse-off products, up to 0.8%.
Moreover, the draft Regulation limits the use of Acid Yellow to non-oxidative hair dye products at a maximum concentration of 0.5%. Any other use not explicitly regulated will not be allowed.
After the publication of the amendment, the use of Homosalate is restricted to face products with the exception of propellent spray products, and forbidden at the rest.
The use of the substance Bis-(Diethylaminohydroxybenzoyl Benzoyl) Piperazine in regular and nano form is allowed as a UV filter up to 10%.
Finally, the entrance at annex III for Resorcinol has been modified, changing its use. Since now the substance is allowed at professional level in products intended for coloring eyelashes.
If you have any questions, please do not hesitate to contact us and our team will be happy to help you.