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Safety Assessment of Brown Algae-Derived Ingredients As Used in Cosmetics

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Safety Assessment of Brown Algae-Derived Ingredients As Used in Cosmetics Safety Assessment of Brown Algae-Derived Ingredients as Used in Cosmetics Status: Draft Final Report for Panel Review Release Date: March 15, 2019 Panel Meeting Date: April 8-9, 2019 The 2019 Cosmetic Ingredient Review Expert Panel members are: Chair, Wilma F. Bergfeld, M.D., F.A.C.P.; Donald V. Belsito, M.D.; Ronald A. Hill, Ph.D.; Curtis D. Klaassen, Ph.D.; Daniel C. Liebler, Ph.D.; James G. Marks, Jr., M.D.; Ronald C. Shank, Ph.D.; Thomas J. Slaga, Ph.D.; and Paul W. Snyder, D.V.M., Ph.D. The CIR Executive Director is Bart Heldreth, Ph.D. This report was prepared by Lillian C. Becker, former Scientific Analyst/Writer and Priya Cherian, Scientific Analyst/Writer. © Cosmetic Ingredient Review 1620 L Street, NW, Suite 1200 ♢ Washington, DC 20036-4702 ♢ ph 202.331.0651 ♢ fax 202.331.0088 [email protected] Distributed for Comment Only -- Do Not Cite or Quote Commitment & Credibility since 1976 Memorandum To: CIR Expert Panel Members and Liaisons From: Priya Cherian, Scientific Writer/Analyst Date: March 15, 2019 Subject: Draft Final Report of the Safety Assessment on Brown Algae-Derived Ingredients Enclosed is the Draft Final Report of the Safety Assessment of Brown Algae-Derived Ingredients as Used in Cosmetics. (It is identified as broalg042019rep in the pdf document). At the December 2018 meeting, the Panel concluded that 6 of the 82 brown algae-derived ingredients are safe in cosmetics in the present practices of use and concentration described in the safety assessment. These ingredients include Alaria Esculenta Extract, Laminaria Digitata Extract, Laminaria Saccharina Extract, Macrocystis Pyrifera (Kelp) Extract, Undaria Pinnatifida Extract, and Undaria Pinnatifida Cell Culture Extract. The Panel came to this conclusion by assessing the systemic toxicity potential (either in repeated dose studies or GRAS status/use in food) and sensitization data of the ingredients. The Panel concluded that the data are insufficient to determine the safety of the remaining ingredients under the intended conditions of use in cosmetic formulations. In order to analyze the safety of these remaining ingredients, the following data are needed: • Systemic toxicity data • Sensitization data Although this safety assessment includes 82 brown algae-derived ingredients, it should be noted that several of these ingredients appear to be equivalent based on the accepted scientific name, as given in the definition by the wINCI Dictionary. Accordingly, the total number of distinct cosmetic ingredients is 74. Table 1 in the report has been updated to include all 82 ingredients, along with their respective synonymous names. Since the December Panel meeting, CIR has received the following data, which have been incorporated into the report and have been designated by highlighting (broalg042019data1 through broalg042019data15). • broalg042019data 1: summary of edible seaweeds and French regulations • broalg042019data2: dermal toxicity, sensitization, solvent information, and arsenic/iodine impurities data on several brown algae-derived ingredients (summary information from UNITIS) • broalg042019data3: human sensitization data on a cream containing Cystoseira Amentacea/Caespitosa/Branchycarpa Extract and a cream containing Himanthalia Elongata Extract • broalg042019data4: specifications, method of manufacturing information, heavy metal impurities, ocular irritation data, and dermal irritation data for a mixture containing water, Himanthalia Elongata Extract, Fucus Vesiculosus Extract, and saccharomyces cerevisiae extract • broalg042019data5: specifications, method of manufacturing information, heavy metal impurities, ocular irritation data, and dermal irritation data for a mixture containing caprylic/capric triglyceride, Laminaria Ochroleuca Extract, and tocopherol • broalg042019data6: specifications, method of manufacturing information, heavy metal impurities, ocular irritation data, and dermal irritation data for a mixture containing water, Ascophyllum Nodosum Extract, and Halopteris Scoparia Extract __________________________________________________________________________________________ 1620 L St NW, Suite 1200, Washington, DC 20036 (Main) 202-331-0651 (Fax) 202-331-0088 (Email) [email protected] (Website) www.cir-safety.org Distributed for Comment Only -- Do Not Cite or Quote • broalg042019data7: specifications, method of manufacturing information, heavy metal impurities, ocular irritation data, and dermal irritation data for a mixture containing water and Fucus Serratus Extract • broalg042019data8: specifications, method of manufacturing information, heavy metal impurities, ocular irritation data, and dermal irritation data for a mixture containing water, butylene glycol, and Lessonia Nigrescens Extract • broalg042019data9: specifications, method of manufacturing information, heavy metal impurities, ocular irritation data, dermal irritation data, a bacterial reverse mutation assay, and sensitization data for a mixture containing water, Fucus Spiralis Extract, and tetraselmis chi extract • broalg042019data10: specifications, method of manufacturing information, heavy metal impurities, ocular irritation data, and dermal irritation data for a mixture containing water and Sargassum Muticum Extract • broalg042019data11: specifications, method of manufacturing information, heavy metal impurities, ocular irritation data, dermal irritation data, and sensitization data for a mixture containing water and Pelvetia Canaliculata Extract • broalg042019data12: sensitization data of a trade name mixture containing Fucus Vesiculosus Extract • broalg042019data13: composition data and sensitization data of a trade name mixture containing Sargassum Filipendula Extract • broalg042019data14: updated use information for Halidrys Siliquosa Extract • broalg042019data15: additional dose information on UNITIS HRIPTs As the inclusion of this new data may help the Panel decide on a conclusion of safety for several more of these brown-algae derived ingredients, a table has been provided presenting each ingredient, as well as a notation of the presence or absence of systemic toxicity data (repeated dose studies or use in food/as a GRAS substance) and sensitization data. This table can be found in the packet as broalg042019data16. Comments provided by the Council before and after the December meeting on the Tentative Report have been addressed (broalg042019pcpc1, broalg042019pcpc2, broalg042019pcpc3, and broalg042019pcpc4). Comments received from the CIR SSC (broalg042019pcpc2) suggest that “knowing the major constituents of an ingredient should also be a route to a safe conclusion.” Does the Panel agree with this suggestion? If this suggestion is accepted, then it is important to emphasize that the conclusion applies to the material as described in the CIR safety assessment. In addition, the flow chart (broalg042019flow), updated data profile (broalg042019prof), 2019 VCRP data (broalg042019FDA), minutes (broalg042019min), history (broalg042109hist), and search strategy (broalg042019strat), have been included in this packet. The Panel should carefully consider the Abstract, Discussion, and data presented in this report. If the Panel determines that the information that was received since the Tentative Report was issued satisfies the data needs for additional ingredients, then those ingredients should be identified, and a revised Tentative Report should be issued. If the data that were received do not change the conclusion, then a Final Report with the current split conclusion should be issued. __________________________________________________________________________________________ 1620 L St NW, Suite 1200, Washington, DC 20036 (Main) 202-331-0651 (Fax) 202-331-0088 (Email) [email protected] (Website) www.cir-safety.org Distributed for Comment Only -- Do Not Cite or Quote SAFETY ASSESSMENT FLOW CHART INGREDIENT/FAMILY _Brown Algae-derived ingredients ______________________________ MEETING ___April 2019 ___________________________________________________________ Public Comment CIR Expert Panel Report Status Priority List INGREDIENT PRIORITY LIST SLR July 26, 2018 DRAFT REPORT Sept 2018 Draft Report 60 day public comment period Table Table IDA TR IDA Notice IDA DRAFT TENTATIVE REPORT Draft TR Dec 2018 Table Table Tentative Report Issue TR Jan 9, 2019 Draft FR DRAFT FINAL REPORT Apr 2019 60 day Public comment period Table Table Different Conclusion Issue PUBLISH Final Report FR Distributed for Comment Only -- Do Not Cite or Quote History of Brown Algae August 2018: SLR announced for public comment September 2018: draft report reviewed by Panel; the Panel issued an IDA; the Panel requested the following data: • Composition and organic constituent data for each of these Brown Algae-derived cosmetic ingredients • 28-Day dermal toxicity data for those ingredients that are not GRAS • Sensitization data at relevant use concentrations for all ingredients (e.g., Macrocystis Pyrifera (Kelp) Extract at 36.4%) • Genotoxicity data for those ingredients that are not GRAS Following the September 2018 meeting, information regarding manufacturing, composition, genotoxicity, sensitization, skin irritation, and ocular irritation regarding several brown algae ingredients were received. December 2018: the Panel reviews the draft tentative report; issues a safe as used conclusion for 6 of the 82 ingredients, and insufficient conclusion for the remaining ingredients. The Panel requested systemic toxicity data and sensitization data for these remaining ingredients January/February 2019:
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