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CONSULTATION ON THE 51ST AMENDMENT TO THE IFRA STANDARDS


IFRA announced the launch of the Consultation on the IFRA Standards that will be part of the 51st Amendment.

The Consultation on all elements of the 51st Amendment was launched on June 30th 2022, and will last for five months closing on November 30th 2022.

SCOPE OF THE CONSULTATION…

The consultation includes the following documents:

  • The Excel overview of IFRA Standards in scope of the 51st Amendment (Att. 05).
  • The Guidance for the use of IFRA Standards (Att. 01):

Some additional product types have been added to the overview of categories. For example, beard and moustache care products have been added to Category 5B, whereas bath bombs have been included in Category 9, and pillow spray in Category 11B.
The Guidance document now incorporates further important information concerning the application of the Standards, and has been shared through IFRA Information Letters since the last version of the Guidance was issued with the 49th Amendment. IFRA recalls for example, that where products applied to pets (animal sprays or shampoos) are identified in the IFRA Standards Categories, the categorization of such products only relates to the human exposure during their use and does not consider the exposure to the pet itself.

  • Where applicable, the Annex on contributions from other sources to the IFRA Standards combine information from natural contributions (former Annex I) as well as Schiff bases (former Annex II) (Att. 03):

Regarding natural contributions, the Annex to the IFRA Standards provides a non-exhaustive indicative list of the typical natural presence of fragrance ingredients restricted by IFRA Standards. This list is prepared with significant input from the IFRA Natural Complex Substances Task Force (NCS TF).

  • The new and revised IFRA Standards:
  • 34 new IFRA Restriction Standards to control potential dermal sensitization effects for which the systemic toxicity endpoints have also been evaluated (like Isobutyl cinnamate, cis-3-Nonenyl acetate and Ethyl and methyl furaneol).
  • 11 new IFRA Restriction Standards to control potential dermal sensitization effects based solely on QRA2 (including carvyl acetate, methyl lavender ketone and 3-Octen-2-one).
  • 2 new IFRA Restriction Standards, for which Risk Management is based on, Threshold of Toxicological Concern (TTC) for Methoxycyclododecane and 7-Methoxy-3,7-dimethyloct-1-ene.
  • 1 new IFRA Restriction Standard due to potential of depigmentation for Cresols.
  • 1 new IFRA Prohibition Standard due to potential genotoxicity effects for 3-Acetyl-2,5-dimethylfuran.
  • 8 Revised IFRA Restriction Standards to control potential dermal sensitization effects for which the systemic toxicity endpoints have been evaluated (including carvone, eugenol, and hydroxycitronellal).
  • 1 Revised Restriction Standard based on new dermal sensitization data for 3-Propylidenephthalide.
  • 1 Revised Restriction Standard based on phototoxicity and systemic toxicity for Methyl-N-methylanthranilate.
  • 1 Revised Restriction Standard for Farnesol. Additional CAS numbers have been added to the Standard for clarification.

All documents that are part of the consultation are publicly available via the link below: https://effaiofiifra.sharepoint.com/:f:/s/IFRA51stAmendment/EiYIJApuIBBEk8jh528jgJoBfnEGLP3tkpSXPfuoldsckw?e=glHDaW

 

COMPLIANCE TIMELINES

The formal letter of notification for all the Standards covered by this consultation will be issued approximately 3 to 4 months after the end of the consultation period (around November 30th 2022) and published on the IFRA website. Therefore, we expect the notification of the 51st Amendment by the first quarter of 2023.

Given the high number of new Standards in scope of the 51st Amendment, the management of the off-cycle 50th Amendment and for reasons of consistency, predictability, and impact on members and customers, the same implementation timelines as the 49th Amendment has been agreed for the 51st Amendment. This timeline applies to all Standards, except the one that prohibits the continued use of one fragrance ingredient. For this prohibition Standard, shorter timelines apply and are in line with those used for the 50th Amendment. These timelines are detailed in the table below.

  Date for Standards entering into force for new creations  Date for Standards entering into force for existing creations
 IFRA Standards prohibiting
the use of ingredients
 2 months after the date of the
Notification
 13 months after the date of the
Notification
IFRA Standards restricting
or setting specifications
for the use of ingredients
 13 months after the date of the
Notification
 25 months after the date of the
Notification

 

FOLLOW UP

If you need any further information about the 51st Amendment, please reach out to us via email: regulatory@jesozio.com or through your designated Sales Representative.


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.