Cosmetic Ingredient Review Panel Conducts 140th Meeting

The 140th Cosmetic Ingredient Review (CIR) Expert Panel Meeting is underway right now in Washington, DC. The agenda includes the consideration of 15 ingredient groups advancing in the review process as well as a presentation by Dr. Donald Bjerke of P&G on in vitro skin sensitization. Here’s a look at some details regarding the ingredients:
 
There are four draft reports for review.
 
Alkane Diols – This is the first time the panel is seeing this report on 10 cosmetic ingredients that are simple, small diols, many of which are used as solvents in cosmetics. These ingredients are also reported to be used as humectants and skin conditioning agents, and some are known penetration enhancers.
 
Etidronic Acid and its Simple Salts  – This is the first time that the panel is seeing this report on Etidronic Acid, a crystalline diphosphonate, and three simple salts of Etidronic Acid. These ingredients are reported to function mainly as chelating agents.
 
Humulus lupulus (Hops)-Derived Ingredients (agenda and flash drive name – Humulus lupulus (hops)) – This is the first time that the panel is seeing this report on six ingredients. These ingredients are reported to function in cosmetics as antimicrobial agents, antiperspirant agents, fragrance ingredients, hair conditioning agents and skin-conditioning agents – miscellaneous. All of these ingredients are derived from part or all of the Humulus lupulus (commonly called hops) plant, which is generally known as an ingredient in the brewing of beer.
 
Hydrofluorocarbon 152a – This is the first time that the panel is seeing a report on this ingredient, which functions as a propellant in personal care products. This gas is also commonly known as 1,1-difluoroethane.
 
There are three draft tentative reports. 
 
Acryloyldimethyltaurate Polymers – At the March meeting, the panel issued an insufficient data announcement for 21 Acryloyldimethyltaurate Polymers used in cosmetics. Data requested on molecular weight, impurities, dermal/oral toxicity, genotoxicity, and/or sensitization were received and are included in the report. Updated concentration of use data have been added. If the data are still insufficient, then a tentative report with a conclusion of insufficient data should be issued. If the data are sufficient, the Panel should issue a tentative report with an appropriate discussion and conclusion. 
 
Butyrospermum parkii (Shea)-Derived Ingredients – At the June meeting, the panel issued an insufficient data announcement for the 13 Butyrospermum parkii (shea)-derived ingredients described in this report. Some additional irritation and sensitization data were received but the data requested on the method of manufacture, composition and impurities, and irritation and sensitization for specific ingredients were not submitted. Updated frequency and concentration of use data have been added. If the data are still insufficient, then a tentative report with a conclusion of insufficient data should be issued. If the data are sufficient, the panel should issue a tentative report with an appropriate discussion and conclusion. 
 
Rosa canina-Derived Ingredients – At the March meeting, the panel issued an insufficient data announcement for the 12 Rosa canina-derived ingredients. Some additional data were received and are included in the report. Technical comments have been addressed.
 
There are eight draft final reports for consideration. After reviewing these drafts, especially the rationales provided in the Discussion sections, the panel should issue them as final reports, as appropriate.
 
Citrus Flower- and Leaf-Derived Ingredients – At the June meeting, the panel issued a tentative report with the conclusion that the available data are insufficient to determine the safety of 33 Citrus flower- and leaf-derived ingredients as used in cosmetics. Some additional data requested on the composition and impurities were received. Updated concentration of use data have been added. Technical comments have been addressed.
 
Citrus Peel-Derived Ingredients – At the June meeting, the Panel issued a tentative report with the conclusion that the 48 Citrus peel-derived ingredients included in the report are safe for use in both rinse-off and leave-on cosmetic products when formulated to be non-sensitizing and non-irritating, provided that leave-on products do not contain more than 0.0015% (15 ppm) 5-MOP. No additional data were received. Technical comments have been addressed.
 
Citrus Plant- and Seed-Derived Ingredients – At the June meeting, the panel issued a tentative report with the conclusion that the available data are insufficient to determine the safety of 32 Citrus plant- and seed-derived ingredients as used in cosmetics. Some irritation data that were received have been added to the report. Additional information on the GRAS status of Citrus Aurantium Amara (Bitter Orange) Leaf/Twig Oil and on the IFRA standards for linalool and limonene has been added. No other data were received. Technical comments have been addressed.
 
Fatty Acyl Sarcosines and Their Salts – At the March meeting, the panel issued a tentative amended report with the conclusion that the 14 ingredients in this report are safe as used in cosmetics when formulated to be non-irritating, and that these ingredients should not be used in cosmetic products in which N-nitroso compounds may be formed. Because concentration of use data are now provided and sensitization was not reported in studies conducted at the highest concentration currently reported to be used, the <5% limit previously established for use in leave-on products was removed. Technical comments have been addressed.
 
Helianthus annuus (Sunflower)-Derived Ingredients – At the March meeting, the panel issued a tentative report with the conclusion of safe as used for nine Helianthus annuus (sunflower)-derived ingredients and an insufficient data conclusion for three ingredients in this report. A cautionary statement that persons with known allergies to Sunflower seed proteins should avoid using spray and powder personal care products that contain these ingredients was also added. No additional data were received. Technical comments have been addressed. 
 
Phosphoric Acid and Its Simple Salts  – At the March meeting, the panel issued a tentative report with the conclusion that 31 ingredients are safe for use when formulated to be non-irritating. Additional information on the more common chemical names for these ingredients has been added to this report to better clarify the appropriate form of the ingredients as listed in the INCI Dictionary. Technical comments have been addressed. 
 
Polyglyceryl Fatty Acid Esters – At the March meeting, the panel issued a tentative report with the conclusion of safe as used in cosmetics when formulated to be non-irritating for the 274 ingredients in this report. Additional acute toxicity, genotoxicity, irritation, sensitization, and phototoxicity data were received and are included in this report. Updated VCRP data are also included. Technical comments have been addressed. 
 
Trimellitic Anhydride Copolymers– At the March meeting, the panel issued a tentative amended report with the conclusion that the data are insufficient to support the safety of the six Trimellitic Anhydride Copolymers in this report. The Panel stated that the lack of fundamental data that defines the chemistry of these ingredients impedes an evaluation of the safety of these copolymers as used in any type of cosmetic formulation. Limited data were received and are included in this report. Technical comments have been addressed. 
 
The panel will consider the eight reports to be issued as final safety assessments, followed by the remaining reports advancing in the process.