American Herbal Products Association (AHPA) Chief Information Analyst Merle Zimmermann, Ph.D., attended the 155th Cosmetic Ingredient Review (CIR) Expert Panel Meeting for Cosmetic Ingredient Safety held virtually from Washington, D.C., September 14-15. The meeting included discussions of three CIR safety reports being developed on herbal cosmetic ingredients derived from Scutellaria species, coconut, and red algae. A report on ubiquinone (CoQ-10) and derivatives was also discussed at the meeting.
The Expert Panel split their safety report on Scutellaria in two parts to address isolate and root isolate-derived and sprout-derived ingredients, requesting a Final Report be issued for isolate and root isolate-derived 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 sprout-derived Scutellaria cosmetic ingredients had “insufficient data” provided in the report and additional manufacturing and allergy information would be required to make a safety determination.
The safety panel also reviewed the Draft Tentative Report on cosmetic ingredients derived from coconut and determined fruit and endosperm ingredients to also be “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 the flower and flower nectar extracts and the shell powder extract included in the report. For these ingredients the Panel requested additional information on composition and manufacturing method, as well as allergy information to complete their determination of safety.
There was an animated discussion on the Draft Report on Red Algae-based ingredients at the two day meeting which recognized those included for review came from multiple species and sources. The Expert Panel agreed that while the 10 cosmetic ingredients described with food use and sensitivity data in the report were “safe in cosmetics in the present practices of use and concentration described in the safety assessment,” additional information and discussion would be required for the remaining ingredients, with the Panel issuing an Insufficient Data Announcement for the Draft Report. Further information about composition and impurities and a 28 day dermal testing was requested for the panel to complete their safety determination. In discussion the Expert Panel expected a focus on the ingredients with the highest concentration of algae present would allow them to best read across as they confirmed safety for the upcoming report, with further information on the other ingredients also being useful.
Regarding the Draft Report on Ubiquinone (CoQ-10) and related cosmetic ingredients, the Expert Panel noted that though the usual dietary supplement forms (ubiquinone and disodium ubiquinone) appeared “safe in cosmetics in the present practices of use and concentration described in the safety assessment,” the draft report also included two reduction products and salts of the usual supplement ingredient and for these the committee issued an overall Insufficient Data Announcement, requesting the same manufacturing and impurity data as they had reviewed for the ubiquinone ingredient.
Another 60-day, public comment period is expected once the new draft reports are published for these ingredients. Further final report(s) could be approved and ready for publishing after the 156th Expert Panel meeting scheduled for December 7-8, 2020.
AHPA staff will continue to be involved as herbal ingredients are evaluated for safe use in the marketplace, with three of the groups on the draft 2021 priority list in this important market category, including ingredients based around Zingiber officinale (ginger) root extract, Rosa centifolia flower extract, and a fermented radish root cosmetic ingredient.
"Engaging with CIR’s Expert Panel for Cosmetic Ingredient Safety provides AHPA and our members an opportunity to share expertise on the safety of these herbal ingredients;" Dr. Zimmermann reported. “the results presented in these CIR reports reflect the availability of safety data on the particular ingredients used for cosmetics, recognizing the history of safe human use of dietary supplement ingredient formulations.”
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 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.