American Herbal Products Association (AHPA) Chief Information Analyst Merle Zimmermann, Ph.D. attended the 157th Cosmetic Ingredient Review (CIR) Expert Panel Meeting for Cosmetic Ingredient Safety held virtually from Washington, D.C., March 11-12, 2021. The meeting included discussions of five CIR safety reports being developed on herbal cosmetic ingredients derived from coconut, papaya, red algae, tea tree, and sage. In addition, a literature review on Rosa damascena derived ingredients was presented.
The Expert Panel split their final safety report on coconut-derived ingredients in two parts to address a variety of flower, fruit, and liquid endosperm ingredients as well as shell powder, requesting a Final Report be issued for all but the shell powder cosmetic ingredients with the conclusion that they are “safe in cosmetics in the present practices of use and concentration described in the safety assessment.” The committee observed that the Cocos nucifera shell powder derived cosmetic ingredients had “insufficient data” provided in the report and additional manufacturing and composition and impurities data, concentrations of use, and dermal irritation and sensitization data would be required to make a safety determination.
The safety panel also finalized a report for several Papaya-derived ingredients, including fruit and fruit extracts as well as leaf extracts. This final report concluded the fruit-derived ingredients are “safe in cosmetics in the present practices of use and concentration described in the safety assessment,” though additional information was needed to complete a safety assessment for the leaf extract, including genotoxicity, dermal irritation and sensitization data, and phototoxicity/photosensitization data.
Draft Tentative Reports on cosmetic ingredients derived from red algae noted 11 Chondrus crispus, Gelidiella acerosa, Hypnea musciformis, Palmaria palmata, Porphyra umbilicalis, and Rhodymenia palmate ingredients were “safe in cosmetics in the present practices of use and concentration described in the safety assessment,” while requesting further information with an Insufficient Data Announcement regarding dermal irritation and sensitization on those 13 ingredients with food uses included in the report, and requested additional data for the remaining 36 algae ingredients. For these ingredients the Panel requested food use evidence, systemic toxicity and sensitization data, or detailed composition information. Further details on these additional ingredients and data needs are available in the CIR post-meeting summary at their official website. 60 days are available (up to May 24, 2021) for any who wish to share comments, provide information, or request to make an oral presentation at the next CIR meeting in September on these red algae ingredients.
For tea tree derived ingredients, the CIR determined that information received was sufficient to support safety. A tentative report concluding the plant extracts, oil, leaf and leaf powder ingredients will be issued with the conclusion they are “safe in cosmetics in the present practices of use and concentration described in the safety assessment when formulated to be non-sensitizing.”
Insufficient Data was available for CIR to complete their review of the proposed sage derived ingredients. Data, comments, or requests for making an oral presentation at the next CIR meeting scheduled in September, 2021 are welcomed by August 12, 2021. The data requested for the sage ingredients included composition and impurities data, and dermal irritation and sensitization data at maximum concentrations of use. For leaf and root extracts, 28-day dermal toxicitiy data has been requested, as well as methods of manufacture for the root extract.
Further final report(s) could be approved and ready for publishing after the 158th Expert Panel meeting scheduled for September 13-14, 2021.
The session of the CIR meetings were reported on at AHPA’s Personal Care Products Committee meeting Friday, March 26, 2021, where members of the American Herbal Products Association engaged in the cosmetic ingredient marketplace participate together in promoting responsible commerce of botanical personal care products and essential oils.
"AHPA’s participation at the Cosmetic Ingredient Review meetings is helpful in making sure the safety of a wide variety of botanical cosmetic ingredients are recognized in peer reviewed literature;" Dr. Zimmermann noted. “It is an excellent opportunity for industry members to assist in helping the public continue to have access to a diverse marketplace supported by safety studies and reports.”
“Member engagement at the trade association level, such as in AHPA’s Personal Care Products committee, helps ensure awareness that commercial participation and data sharing are welcomed as these articles are developed.”
The Cosmetic Ingredient Review 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 Council, CIR and the review process are independent from the Council and the cosmetics industry.
The purpose of the 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 US who regularly meet to report on the safety of cosmetics ingredients.