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METHYL-N-METHYLANTHRANILATE NEW CONDITIONS OF USE


What is this substance and what are the new conditions?

 

BACKGROUND…

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.

 

METHYL-N-METHYLANTHRANILATE (M-N-MA)

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.

 

FOLLOW UP

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: regulatory@jesozio.com or through your designated Sales Representative.

 


COMMITTED BEAUTY, THE NEW SUSTAINABLE AND RESPONSIBLE APPROACH TO BEAUTY


After the launch of its CLEAN FRAGRANCE label, Sozio goes further with its COMMITTED BEAUTY initiative, leveraging its expertise and commitment to accompany consumers and brands towards sustainable and responsible beauty.

Our COMMITTED BEAUTY concept is a personalized approach which adapts to the needs of consumers and brands in accompanying them on their journey to the new essential criteria of tomorrow’s beauty.

 

Committed beauty

 

With COMMITTED BEAUTY, Sozio commits to responsible beauty by providing fragrances that combine the maximum number of commitments:

  • NATURAL: With almost twenty years of expertise in natural fragrances, Sozio’s perfumers are recognized for their artistic sensitivity and technical knowledge in the formulation of 100% natural, COSMOS approved fragrances.
  • BIODEGRADABLE: Sozio is committed to providing fragrances that contain 100% biodegradable ingredients in which the biodegradability is being studied in 3 environments: soil, sediments and water.
  • ORGANIC: Sozio provides 100% COSMOS organic approved fragrances, composed of ingredients produced according to the rules of organic farming.
  • ENVIRONMENTALLY FRIENDLY: Aware that the environment is a resource that must be preserved, Sozio has developed demanding environmental standard.
  • HEALTH FRIENDLY: Sozio is committed to creating formulas without CMR substances and allergens in respect to skin sensitivity and human health.
  • ANIMAL FRIENDLY: Sozio does not conduct any testing on animals and does not formulate with animal raw materials.
  • SUSTAINABLE: Sozio is committed to formulating fragrances with Botanicals raw materials that are high quality natural ingredients, sustainably and ethically sourced by a direct to producer approach.

Through a customized diagnostic, Sozio will define and understand brand goals and consumer needs to offer the most relevant fragrances that are committed to sustainable and responsible beauty.

 


THE WASHINGTON STATE TOXIC-FREE COSMETICS ACT (SB5703)


BACKGROUND…

In 2019, the State of Washington introduced a new law known as the Pollution Prevention for Healthy People and Puget Sound Act, and the program that implements this law is entitled Safer Products for Washington. The law established an administrative process to be followed by the Department of Ecology (Ecology) and the Department of Health regarding priority toxic chemicals in priority consumer products, and authorizes Ecology to regulate classes of chemicals in consumer products. Under this process, certain chemicals were defined as priority chemicals, including Perfluoroalkyl and Polyfluoroalkyl (PFAS) chemicals, Polychlorinated biphenyls, Phthalates, organ halogen flame retardants and other flame retardants identified under the Children’s Safe Products Act, and Phenolic compounds. Ecology is also authorized to designate additional chemicals as priority chemicals every five years where they meet the qualifying criteria consistent with the schedule established in the 2019 law.

Under the schedule for Ecology’s regulatory activities to implement Safer Products for Washington, Ecology must:

  • Designate priority chemicals
  • Identify priority consumer products that include priority chemicals, taking into consideration specified criteria
  • Determine regulatory actions for the priority chemicals in priority consumer products. These regulatory actions may include a determination that no action is needed, may require manufacturers to provide notice of the use of a chemical, or may restrict or prohibit the manufacture, distribution, sale, or use of a priority chemical in a consumer product
  • Adopt rules to implement regulatory determinations

In this context, the Washington State Department of Ecology issue the Senate Bill 5703 relating to the use of toxic chemicals in cosmetic products.

 

SUMMARY OF THE BILL:

From the 1st January 2025, the manufacture, distribution, and sale of cosmetic products containing any of nine identified types of chemicals or chemical classes would be prohibited. Cosmetic products are defined in the same manner as cosmetics regulated by Interstate Commerce under the Drugs and Cosmetics code. Exceptions exist for prescription drugs approved by the FDA, and hydrofluoroolefins used as aerosol propellants, where both are excluded from regulated cosmetic product consideration in this context.

Cosmetic products may not contain the following eight categories of chemicals or chemical classes when intentionally added to the product:

  • Ortho-phthalates
  • Perfluoroalkyl and Polyfluoroalkyl (PFAS) substances
  • Formaldehyde and chemicals determined by Ecology to release Formaldehyde
  • Methylene glycol
  • Mercury and Mercury compounds
  • Triclosan
  • m-Phenylenediamine and its salts
  • o-Phenylenediamine and its salts

Lead or lead compounds are also similarly restricted in cosmetic products at a level of 10 parts per million (0.001%), unless Ecology determines otherwise through rulemaking.

In-State retailers may exhaust their existing stock of restricted products through sales to the public until 1st January 2026.

Ecology may adopt rules to implement, administer, or enforce restrictions on chemicals in cosmetic products, and manufacturers found to be violating a requirement, rule, or order, are subject to civil penalties of up to $5,000 per violation for a first offense, and $10,000 per violation for each repeat offense. Penalties and orders issued by Ecology can be appealed to the State Pollution Control Hearings Board (PCHB). Penalties are deposited in the Model Toxics Control Operating Account.

The prohibiting of PFAS and other harmful chemicals is an important step towards safer cosmetics, and many of these chemicals are already banned in cosmetics in other States. The departments of Ecology and Health would be required to test products for toxic content, carry out community outreach, and, if appropriate, consider additional regulations under the Safer Products for Washington program.

 

WHAT ABOUT THE FRAGRANCE COMPOUND?

By prohibiting the sale of products containing ‘undisclosed synthetic fragrance’, the original version of the bill would force companies to disclose their trade secrets, resulting in decreased competitiveness, the risk of counterfeits, and little in terms of increased safety for consumers.

Historically, fragrance formulations have been afforded trade secret protection at Federal and State level. The ability to preserve confidential business information (CBI) is essential to the fragrance industry, protecting the intellectual property of the fragrance creators/manufacturers, and allowing for competition in the marketplace. Creating a fragrance that meets olfactive requirements, is technically sound, and safe for its intended use, is a highly trained skill that is applied through substantial knowledge/experience. Without CBI protection, businesses and consumers face threat of inappropriate counterfeit fragrances, and a result, potentially dangerous products flooding the market.

Additionally, when assessing the safety of fragrance ingredients, the fragrance industry does not distinguish between natural and synthetic, and thoroughly assesses both types with the same sense of care and attention. Scientists can create ‘nature identical’ ingredients that mimic the scent of their natural counterparts, as well as that of their chemical structure. In terms of toxicity, we must refer to the structure of a molecule and its concentration, not its origin. Please refer to our Newsletter N°11 entitled « NATURAL VS SYNTHETIC INGREDIENTS : An approach that is too binary? ».

The Fragrance Creators Association (FCA) submitted a letter of opposition to the original version of this bill due to its essential ban of undisclosed fragrance ingredients, and its lack of alignment with the requirements of other States. The FCA worked with their allied trades as they negotiated with the sponsor of the bill to achieve these changes. 

Through the amended bill in early February 2022, which has been referred to as the Ways and Means Committee, in an effort to address business concerns, ‘undisclosed synthetic fragrances’ have been successfully removed from the prohibited list, and the disclosure requirements have also been withdrawn.

 

WHAT ARE THE NEXT STEPS?

The FCA will continue to monitor this bill as it moves through the legislative process to ensure that it retains these amendments. 

It is very important that every State encourages the legislature to consider the results of collaborative efforts in the same way that California did so in 2020, when it passed AB 2762 to ban certain cosmetic ingredients. This bill was the result of months of in-depth, multi-stakeholder discussions between California lawmakers, NGO representatives, trade associations, and personal care product manufacturers.  This process also took into account existing international regulations.

It is relevant to note that a patchwork of state laws and deviation from international regulations creates confusion not only among industry, but also among consumers.

In order to anticipate any new restriction and regulation on toxic substances, Sozio has created its Clean Fragrance initiative with fragrances that have been formulated without any substance of concern for human health. Sozio has also committed to do better for the environment by developing fragrances made with 100% biodegradable ingredients.

 

FOLLOW UP

If you are interested by our Clean initiative, fragrances made with 100% of biodegradable ingredients, or need any further information about this bill, please reach out to us via email: regulatory@jesozio.com or through your designated Sales Representative.