AHPA attends Cosmetic Ingredient Review meeting
June 15, 2023
American Herbal Products Association (AHPA) Chief Information Analyst Merle Zimmermann, Ph.D., attended the 165th Cosmetic Ingredient Review (CIR) Expert Panel Meeting for Cosmetic Ingredient Safety held in a hybrid format in Washington, D.C., June 12-13, 2023.
The purpose of Cosmetic Ingredient Review is to determine those cosmetic ingredients for which there is a reasonable certainty in the judgment of competent scientists that the ingredient is safe under its conditions of use. The meetings include renowned academicians, industry leaders, and government officials from across the U.S. who regularly gather to report on the safety of cosmetics ingredients.
AHPA staff regularly attend the meetings of the CIR Expert Panel to engage and represent our industry regarding herbal cosmetic ingredients.
The June meeting of the expert panel included discussions of CIR safety reports in development on two groups of herbal cosmetic ingredients, Olea europaea (olive) and Zanththoxylum piperitum (Japanese pepper), as well as a revised draft report on yeast derived ingredients. Previous reports on Dioscorea villosa (wild yam), Prunus amygdalus (syn. Prunus dulcis; sweet almond) were revisited by the expert panel, as well as sixteen other groups of ingredients outside the botanical sphere at the session.
The revised draft report on yeast returned this June with a revision now including 56 distinct yeast-based ingredients. The discussion noted that between the established food uses as well as raw material processing which guaranteed lysis/dissolution of the cosmetic ingredients this group of ingredients was simpler to evaluate than previous discussions about red algae derived materials, some of which included live ingredients. The expert panel noted that common food yeasts were certainly well established as safe as used in the current concentration and practice, and voted to hold finalizing the report until the upcoming December 2023 CIR meeting, with an overall report that this class of ingredients are safe as used in the current concentration and practice likely.
For the tentative safety report on Japanese pepper ingredients, the discussion noted that the ingredients were safe as used when formulated to be non-sensitizing. With this conclusion, the report will next advance to a draft final, where the panel will be able to approve it for publication as a final report following a 60-day public comment period.
Another tentative safety report on olive derived ingredients was revisited since a request for additional data issued by CIR in December 2022, and concluded that with the information received and identified food uses, the ingredients derived from the fruit and leaf of the plant was safe as used in the present practices of strength and composition. Following a discussion, the seed and husk were also included as safe as used from the evidence provided in connection with olive fruit. Remaining parts, however, were noted to have insufficient data, including bark, branch, bud, flower, sap, and wood derived ingredients, with most retaining requests from the committee for method of manufacture, 28-day dermal toxicity, and dermal irritation and sensitization data to allow safe use to be well established. Companies working with these ingredients are welcomed to share this information with the expert panel to help support their evaluation as the report is moved towards finalization.
Re-review summaries of wild yam root extract and sweet almond seed meal were also visited by the safety panel, reaffirming previous conclusions of safety. Wild yam root extract was stated safe for use for extracts meeting a similar chemical profile as described in the assessment (with an expected upper limit of 3.5% diosgenin). Sweet almond seed meal also remains safe for topical application to humans in the present practices of use and concentration. Both determinations reaffirm the 2004 and 2005 conclusions regarding these two ingredients.
For the ingredients with insufficient data, additional information is welcomed by the panel. Companies who wish to share data with the panel are asked to do so as soon as possible for it to be available for consideration prior to the upcoming September 11-12 and December 4-5, 2023 meetings, with 60 days from their posting allowed for as a minimum to be included in the discussion.
Safety information for the other ingredients under consideration is available on the CIR website.
AHPA staff will continue to be involved as herbal ingredients are evaluated by the expert panel.
"As the regulatory landscape for consumer products in the U.S. maintains a safety focus on prevention, Cosmetic Ingredient Review continues dedicating thoughtful attention to maintaining ongoing validation to help ensure products for the American consumer interested in cleansing, beautifying, promoting attractiveness, or altering the appearance remain safe for use,” said Dr. Zimmermann.
CIR was established in 1976 by the industry trade association (then the Cosmetic, Toiletry, and Fragrance Association, now the Personal Care Products Council), with the support of the U.S. Food and Drug Administration and the Consumer Federation of America. Although funded by the Personal Care Products Council, CIR and the review process are independent from the council and the cosmetics industry.