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Safety Assessment of Citrus Plant- and Seed-Derived Ingredients As Used in Cosmetics

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Safety Assessment of Citrus Plant- and Seed-Derived Ingredients As Used in Cosmetics Safety Assessment of Citrus Plant- and Seed-Derived Ingredients as Used in Cosmetics Status: Draft Revised Final Report for Panel Review Release Date: November 11, 2016 Panel Meeting Date: December 5-6, 2016 The 2016 Cosmetic Ingredient Review Expert Panel members are: Chairman, 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 Director is Lillian J. Gill, D.P.A. This report was prepared by Christina Burnett, Senior 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♢ Washington, DC 20036-4702 ♢ ph 202.331.0651 ♢ fax 202.331.0088 ♢ [email protected] Distributed for Comment Only -- Do Not Cite or Quote Commitment & Credibility since 1976 Memorandum To: CIR Expert Panel Members and Liaisons From: Christina L. Burnett, Senior Scientific Writer/Analyst Date: November 11, 2016 Subject: Draft Revised Final Safety Assessment on Citrus Plant- and Seed-Derived Ingredients Enclosed is the Draft Revised Final Report of the Safety Assessment of Citrus Plant- and Seed-Derived Ingredients as Used in Cosmetics. (It is identified as cplant122016rep in the pdf document). At the September meeting, the Panel issued a revised tentative report with the conclusion that the following 13 ingredients are safe as used in the present practices of use and concentration when formulated to be non-irritating and non-sensitizing. Citrus Aurantium Amara (Bitter Orange) Citrus Grandis Peel/Seed Extract Leaf/Twig Extract Citrus Grandis (Grapefruit) Seed Extract Citrus Aurantium Amara (Bitter Orange) Citrus Junos Seed Extract Leaf/Twig Oil Citrus Junos Seed Oil Citrus Aurantium Dulcis (Orange) Seed Extract Citrus Paradisi (Grapefruit) Seed Extract Citrus Australasica Seed Oil Citrus Sunki Seed Extract Citrus Depressa Seed Oil Citrus Sunki Seed Oil Citrus Glauca Seed Oil The Panel concluded that the data on the remaining 19 ingredients are insufficient to determine safety. The data needed to evaluate the safety of these 19 ingredients are: • Method of manufacturing • Chemical composition and impurities • Irritation and sensitization data • If the composition data for these Citrus plant- and seed-derived ingredients are substantially different from that of the Citrus peel-, flower-, and leaf-derived ingredients, then systemic toxicity studies such as a 28-day dermal toxicity, reproductive and developmental toxicity, and genotoxicity studies are needed, as well as UV absorption spectra Since September, CIR staff received updated concentration of use data. The updates on the concentration of use had no great impact on the Use Table (Table 7 in the report). Staff also received a letter from Dr. Lena Struwe, which describes the pericarp of a fruit according to current biology academia. While the letter clarifies what the term “pericarp” technically means in relation to Citrus, it is unclear if this is what the supplier(s) meant/means by the term when the 2 pericarp ingredients were reviewed during the INC submission for inclusion in the International Cosmetic Ingredient Dictionary and Handbook. Comments provided by Council on the previous draft final and revised tentative reports have been considered. The comments and data are included in this report package (cplant122016pcpc1 and cplant122016pcpc2 and cplant 122016data1 to cplant122016data3, respectively). The Panel should carefully review the abstract, discussion, and conclusion of this report and issue a Final Safety Assessment. Distributed for Comment Only -- Do Not Cite or Quote SAFETY ASSESSMENT FLOW CHART INGREDIENT/FAMILY ____Citrus Whole Plant & Seed-Derived Ingredients_ _______ MEETING ______Dec 2016_____________________________________________________________ Public Comment CIR Expert Panel Report Status Priority List INGREDIENT At the Mar 2014 meeting, the PRIORITY LIST Panel reviewed a report on 198 citrus-derived ingredients, and split the report into sub-groups. SLR This is the citrus whole plant and Dec 2013 seed-derived subgroup. DRAFT REPORT Draft Report Dec 2015 60 day public comment period Table Table IDA TR IDA Notice IDA Dec 18, 2015 DRAFT TENTATIVE REPORT June 2016 Draft TR Table Table Tentative Report Issue TR June 16, 2016 Oct 7, 2016 DRAFT FINAL REPORT Draft FR Sept 2016 60 day Public comment period Dec 2016 Table Table Different Conclusion PUBLISH Final Report Issue FR Distributed for Comment Only -- Do Not Cite or Quote Citrus Plant- and Seed-Derived Ingredients History December 2013 – Scientific Literature Review announced. March 2014 - The Panel tabled further discussion of 198 citrus-derived ingredients to allow CIR staff to reorganize the report and to obtain clarification from RIFM on the functions of some of the ingredients. These ingredients were presented in a single safety assessment report addressing ingredients from all of the citrus plant species currently reported to be used in cosmetics in the International Cosmetic Ingredient Dictionary and Handbook. The Panel felt revising this report into smaller subgroups would be a manageable and meaningful alternative approach to assessing the safety of these ingredients. Based on the Panel’s recommendation of grouping the ingredients by plant parts according to greatest number of uses, the first assessment reviewed by the Panel was citrus-derived peel oils, followed by citrus fruit-derived ingredients. September 2015 – The Panel reviewed the report strategy for the remaining citrus ingredients. The Panel agreed that the remaining ingredients could be divided into 3 reports: citrus flower- and leaf-derived ingredients, citrus peel-derived ingredients, and citrus plant- and seed-derived ingredients. These reports can be reviewed concurrently. December 2015 - The Panel requested additional data to support the safety of the 33 Citrus plant- and seed-derived ingredients. The additional data needed are: • Method of manufacturing • Chemical composition and impurities • Irritation and sensitization, especially human repeated insult patch tests (HRIPT) on citrus aurantium amara (bitter orange) leaf/twig oil and citrus grandis (grapefruit) seed extract at maximum use concentrations or greater • If the composition for these Citrus plant- and seed-derived ingredients are significantly different from that of the Citrus peel-, flower-, and leaf-derived ingredients, then data on systemic endpoints such as a 28-day dermal toxicity, reproductive and developmental toxicity, and genotoxicity, as well as UV absorption spectra are needed June 2016 - The Panel issued a tentative report with the conclusion that the available data are insufficient to make a determination that the 32 Citrus plant- and seed-derived ingredients included in this report are safe under the intended conditions of use in cosmetic formulations. The data requested by the Panel included: • Method of manufacturing for all these ingredients, except the seed extracts • Chemical composition and impurities for all these ingredients, except the seed oils and seed extracts • Irritation and sensitization, especially human repeated insult patch tests (HRIPT) on Citrus Aurantium Amara (Bitter Orange) Leaf/Twig Oil and Citrus Grandis (Grapefruit) Seed Extract at maximum use concentrations or greater. • If the composition for these Citrus plant- and seed-derived ingredients are significantly different from that of the Citrus peel-, flower-, and leaf-derived Distributed for Comment Only -- Do Not Cite or Quote ingredients, then data on systemic endpoints such as a 28-day dermal toxicity, reproductive and developmental toxicity, and genotoxicity, as well as UV absorption spectra are needed. The Panel removed Citrus Tangerina (Tangerine) Extract from this report because it was identical to another ingredient in the Citrus fruit-derived ingredient report, bringing the total number of ingredients in this report to 32. September 2016 - The Panel issued a revised tentative report with the conclusion that the following 13 ingredients are safe as used in the present practices of use and concentration when formulated to be non-irritating and non-sensitizing. Citrus Aurantium Amara (Bitter Orange) Citrus Glauca Seed Oil Leaf/Twig Extract Citrus Grandis Peel/Seed Extract Citrus Aurantium Amara (Bitter Orange) Citrus Grandis (Grapefruit) Seed Extract Leaf/Twig Oil Citrus Junos Seed Extract Citrus Aurantium Dulcis (Orange) Seed Citrus Junos Seed Oil Extract Citrus Paradisi (Grapefruit) Seed Extract Citrus Australasica Seed Oil Citrus Sunki Seed Extract Citrus Depressa Seed Oil Citrus Sunki Seed Oil The Panel concluded that the data on 19 ingredients listed below are insufficient to determine safety. Citrus Aurantifolia (Lime) Oil Citrus Limon (Lemon) Citrus Aurantium (Bitter Orange) Oil Flower/Leaf/Stem Extract Citrus Aurantium Dulcis (Orange) Citrus Limon (Lemon) Flower/Leaf/Stem Powder Flower/Leaf/Stem Oil Citrus Aurantium Dulcis (Orange) Oil Citrus Limon (Lemon) Leaf/Peel/Stem Citrus Aurantium Sinensis Powder Oil Citrus Grandis (Grapefruit) Citrus Nobilis (Mandarin Orange) Citrus Grandis (Grapefruit) Extract Citrus Nobilis (Mandarin Orange) Oil Citrus Iyo Oil Citrus Nobilis (Mandarin Orange) Water Citrus Jabara Pericarp Extract Citrus Reticulata (Tangerine) Extract Citrus Junos Extract Citrus Unshiu Extract Citrus Unshiu Pericarp Extract The data needed to evaluate the safety of these 19 ingredients are: • Method of manufacturing • Chemical composition and impurities
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