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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: August 22, 2019 Panel Meeting Date: September 16-17, 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.; 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1200 ♢ Washington, DC 20036-4702 ♢ ph 202.331.0651 ♢ fax 202.331.0088 [email protected] Distributed for Comment Only -- Do Not Cite or Quote Commitment & Credibility since 1976 Memorandum To: CIR Expert Panel Members and Liaisons From: Priya Cherian, Scientific Writer/Analyst Date: August 22, 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 broalg092019rep in the pdf document). At the April 2019 meeting, the Panel concluded that 32 of the 82 brown algae-derived ingredients are safe in cosmetics in the present practices of use and concentration described in the safety assessment. 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; both types of data were needed for a conclusion of safety to be reached. As for those ingredients that are formulated differently, but are derived from the same genus and species, and would therefore are expected to be similar in composition (ex. Laminaria Digitata Extract and Laminaria Digitata Powder), the Panel confirmed that if there are sufficient data to support the safety of one of these ingredients, all related ingredients of the same genus and species would be considered safe. The Panel concluded that the data are insufficient to determine the safety of the remaining 50 ingredients under the intended conditions of use in cosmetic formulations. As an alternative method for determining safety, the Panel suggested that representative data for each genus (rather than both genus and species), if submitted, may be used to formulate decisions regarding other ingredients of the same genus. Therefore, the Panel requested data regarding the possible constituents of concern of these brown-algae derived ingredients (e.g., specific terpenoids and flavonoids, and concentrations of such). 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 broalg092019data1. An alphabetized version of this list has also been included (broalg092019data2). Comments provided by the Council on the Draft Final Report prepared for the April meeting and on the Revised Tentative Report that was issued following the April meeting have been addressed (broalg092019pcpc1 & broalg092019pcpc2). In addition, the flow chart (broalg092019flow), data profile (broalg092019prof), 2019 VCRP data (broalg092019FDA), minutes (broalg092019min), history (broalg092109hist), and search strategy (broalg092019strat), have been included in this packet. The Panel should carefully consider the Abstract, Discussion, and Conclusion presented in this report. If these are satisfactory, the Panel should issue a Final Report. __________________________________________________________________________________________ 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 ___September 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; May 16, 2019 Draft FR DRAFT FINAL REPORT Apr 2019; Sept 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: Comments received from Council; Data received from Council regarding manufacturing, composition, genotoxicity, sensitization, skin irritation, and eye irritation of several brown algae ingredients April 2019: Panel reviews the draft Final report June 2019: Comments received from Council September 2019: Panel reviews draft Final report Distributed for Comment Only -- Do Not Cite or Quote Brown Algae Data Profile for September 2019. Writer – Priya Cherian Acute Repeated ADME toxicity dose toxicity Irritation Sensitization Use Log K Penetration Dermal Oral Dermal Inhale Oral Dermal Ocular Ocular In Vitro Dermal DermalHuman Dermal In Vitro Animal Human VitroIn Repro/Devel Genotoxicity Carcinogenicity Phototoxicity Inhale ow Animal Animal 1. Agarum Cribrosum Extract x x x 2. Alaria Esculenta Extract x x x x 3. Ascophyllum Nodosum x 4. Ascophyllum Nodosum x x x x x x x x x Extract 5. Ascophyllum Nodosum x x Powder 6. Cladosiphon Novae- Caledoniae Extract 7. Cladosiphon Okamuranus x Extract 8. Cystoseira x x x x Amentacea/Caespitosa/ Branchycarpa Extract 9. Cystoseira Baccata Extract x x 10. Cystoseira Balearica Extract 11. Cystoseira Caespitosa Extract 12. Cystoseira Compressa x x Extract 13. Cystoseira Compressa Powder 14. Cystoseira Tamariscifolia x x Extract 15. Dictyopteris Membranacea Extract (Retired) 16. Dictyopteris Polypodioides x x x Extract 17. Dictyota Coriacea Extract 18. Durvillea Antarctica Extract x 19. Ecklonia Cava Extract x x x 20. Ecklonia Cava Water x 21. Ecklonia Kurome Extract 22. Ecklonia Kurome Powder 23. Ecklonia/Laminaria Extract 24. Ecklonia Maxima Extract 25. Ecklonia Maxima Powder 26. Ecklonia Radiata Extract x 27. Eisenia Arborea Extract 28. Fucus Serratus Extract x x x 29. Fucus Spiralis Extract x x x x x 30. Fucus Vesiculosus x 31. Fucus Vesiculosus Extract x x x x x x x x x 32. Fucus Vesiculosus Powder x 33. Halidrys Siliquosa Extract x x x x x 34. Halopteris Scoparia Extract x x x 35. Himanthalia Elongata x x x Extract 36. Himanthalia Elongata x Powder 37. Hizikia Fusiforme Extract x 38. Hizikia Fusiformis Water Distributed for Comment Only -- Do Not Cite or Quote Brown Algae Data Profile for September 2019. Writer – Priya Cherian Acute Repeated ADME toxicity dose toxicity Irritation Sensitization Use Log K Penetration Dermal Oral Dermal Inhale Oral Dermal Ocular Ocular In Vitro Dermal DermalHuman Dermal In Vitro Animal Human VitroIn Repro/Devel Genotoxicity Carcinogenicity Phototoxicity Inhale ow Animal Animal 39. Hizikia Fusiformis Callus Culture Extract 40. Hydrolyzed Ecklonia Cava Extract 41. Hydrolyzed Fucus Vesiculosus Extract 42. Hydrolyzed Fucus Vesiculosus Protein 43. Kappaphycus Alvarezii Extract 44. Laminaria Angustata Extract (Retired) 45. Laminaria Cloustoni Extract x 46. Laminaria Diabolica Extract 47. Laminaria Digitata Extract x x x x x x 48. Laminaria Digitata Powder x 49. Laminaria Hyperborea x x x Extract 50. Laminaria Japonica Extract x x x x x 51. Laminaria Japonica Powder x 52. Laminaria Longissima Extract 53. Laminaria Ochotensis Extract (Retired) 54. Laminaria Ochroleuca x x x Extract 55. Laminaria Saccharina x x x Extract 56. Lessonia Nigrescens x x x Extract 57. Lessonia Nigrescens Powder 58. Macrocystis Pyrifera (Kelp) x x x x 59. Macrocystis Pyrifera (Kelp) Blade/Pneumatocyst/Stipe Juice Extract 60. Macrocystis Pyrifera (Kelp) x x x Extract 61. Macrocystis Pyrifera (Kelp) Juice 62. Macrocystis Pyrifera (Kelp) x Protein 63. Nereocystis Luetkeana x x Extract 64. Pelvetia Canaliculata x x x x Extract 65. Pelvetia Siliquosa Extract 66. Phyllacantha Fibrosa x x Extract 67. Saccharina Angustata x Extract 68. Saccharina Japonica Extract 69. Saccharina Longicruris Extract Distributed for Comment Only -- Do Not Cite or Quote Brown Algae Data Profile for September 2019. Writer
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