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Safety Assessment of Apple-Derived Ingredients As Used in Cosmetics

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Safety Assessment of Apple-Derived Ingredients As Used in Cosmetics Safety Assessment of Apple-derived Ingredients as Used in Cosmetics Status: Draft Final Report for Panel Review Release Date: November 20, 2015 Panel Date: December 14-15, 2015 The 2015 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 Director is Lillian J. Gill, D.P.A. This report was prepared by Wilbur Johnson, Jr., M.S., Senior Scientific Analyst. © Cosmetic Ingredient Review 1620 L STREET, NW, SUITE 1200 ◊ WASHINGTON, DC 20036-4702 ◊ PH 202.331.0651 ◊ FAX 202.331.0088 ◊ [email protected] Commitment & Credibility since 1976 Memorandum To: CIR Expert Panel Members and Liaisons From: Wilbur Johnson, Jr. Senior Scientific Analyst Date: November 20, 2015 Subject: Draft Final Report on Apple-derived Ingredients At the September 21-22, 2015 Expert Panel meeting, a tentative report with two conclusions was issued. The Panel concluded that 25 apple-derived ingredients are safe in the present practices of use and concentration in cosmetics as described in this safety assessment, when formulated to be non-irritating and non-sensitizing. The Panel also concluded that the available data are insufficient for evaluating the safety of pyrus malus (apple) root extract, pyrus malus (apple) stem extract, and malus domestica (apple) stem extract, and the data that are needed to evaluate the safety of these three ingredients are: (1) Method of manufacture and impurities (2) 28-day dermal toxicity study; if any adverse effects are noted, genotoxicity and reproductive and developmental toxicity data may be needed The data requested have not been received. However, both updated and new use concentration data on apple-derived ingredients were received, and have been added to the safety assessment. Included in this package for your review is the draft final safety assessment (pyrusm122015rep), the CIR report history (pyrusm122015hist), literature search strategy (pyrusm122015strat), ingredient data profile (pyrusm122015prof), minutes from the September 21-22, 2015 Panel meeting (pyrusm122015min), 2015 FDA VCRP data (pyrusm122015FDAdata), comments received from the Council (pyrusm122015pcpc1), and use concentration data received from the Council (pyrusm122015data1, pyrusm122015data 2, and pyrusm122015 data3). The summary and discussion from the safety assessment on plant-derived fatty acid oils [pyrus malus (apple) seed oil included] were added to the current report for use in the safety evaluation of malus domestica (apple) seed oil and malus domestica (apple) oil. The Panel needs to determine which information from the summary and discussion is most useful in assessing the safety of these two ingredients, and, also, agree that pyrus malus (apple) seed oil should be removed from the report conclusion because its safety in cosmetics was previously determined. The use concentration data on pyrus malus (apple) seed oil is included in the safety assessment because there are no use concentration data on malus domestica (apple) seed oil and malus domestica (apple) oil, and these data are likely very similar to the actual use concentrations of these two ingredients in cosmetics. Comments on the tentative report that were received from the Council during the 60-day comment period have been addressed. Two of the comments received relate to protein components in product formulations and the potential for cross- reactivity with plant constituents, and the skin bleaching function of apple root bark powder. The Panel will need to determine whether these comments warrant changes in the report discussion. After considering the data included in this safety assessment, the Panel will need to determine whether a final report with the conclusions stated at the beginning of this memorandum should be issued. __________________________________________________________________________________________ 1620 L Street, N.W., Suite1200, Washington, DC 20036 (Main) 202-331-0651 (Fax) 202-331-0088 (Email) [email protected] (Website) www.cir-safety.org SAFETY ASSESSMENT FLOW CHART INGREDIENT/FAMILY _____Pyrus malus (apple)-derived ingredients__________________________________ MEETING ________Dec 2015______________________________________________________________________________________ Public Comment CIR Expert Panel Report Status Priority List INGREDIENT PRIORITY LIST SLR Mar 2015 DRAFT REPORT Draft Report June 2015 60 day public comment period Table Table IDA TR IDA Notice IDA June 19, 2015 DRAFT TENTATIVE Draft TR REPORT 60 day public comment period Sept 2015 Table Table Tentative Report Issue TR Oct 4, 2015 Draft FR DRAFT FINAL REPORT Dec 2015 60 day Public comment period Table Table Different Conclusion PUBLISH Final Report Issue FR Distributed for comment only -- do not cite or quote CIR History of: Pyrus malus (apple)- and Malus domestica (apple)-derived Ingredients A scientific literature review (SLR) on the Centella Asiatica-derived ingredients was issued on March 2, 2015. Unpublished data were received during the 60-day comment period. Draft Report, Belsito and Marks Teams/Panel: June 15-16, 2015 Comments received from the Council have been addressed and the following unpublished data were added to the draft report: • Chemistry data on pyrus malus (apple) fruit extract • Chemistry data on pyrus malus (apple) root bark powder • Use concentration data • Method of manufacture of malus domestica (apple) fruit water • Chemistry data on pyrus malus (apple) fiber • Chemistry data on pyrus malus (apple) fruit extract • Method of manufacture and ocular/skin irritation data on pyrus malus (apple) fruit extract Draft Report, Belsito and Marks Teams/Panel: June 15-16, 2015 Pyrus malus and Malus domestica are two genus and species names for apple. The Panel agreed that the available data are sufficient for evaluating the safety of the following 19 apple-derived ingredients in cosmetics, the ingredient source being either the fruit or seed. pyrus malus (apple) carpel powder pyrus malus (apple) pulp extract pyrus malus (apple) fiber pyrus malus (apple) seed extract pyrus malus (apple) fruit extract pyrus malus (apple) seed oil pyrus malus (apple) fruit malus domestica (apple) fiber pyrus malus (apple) fruit water malus domestica (apple) fruit extract pyrus malus (apple) juice malus domestica (apple) fruit water pyrus malus (apple) pectin extract malus domestica (apple) fruit cell culture extract pyrus malus (apple) peel extract malus domestica (apple) juice pyrus malus (apple) peel powder malus domestica (apple) seed oil pyrus malus (apple) peel wax However, the Panel issued an insufficient data announcement on the following 9 apple-derived ingredients: pyrus malus (apple) bark extract pyrus malus (apple) stem extract pyrus malus (apple) flower extract malus domestica (apple) oil pyrus malus (apple) leaf extract malus domestica (apple) stem extract pyrus malus (apple) root bark powder malus domestica (apple) callus extract pyrus malus (apple) root extract The data that are needed to evaluate the safety of these 9 ingredients are: • Method of manufacture and impurities • 28-day dermal toxicity study; if absorbed, genotoxicity and reproductive and developmental toxicity data may be needed • Skin irritation and sensitization data A memorandum (citing references from the published literature) addressing some of the data needs was received from the Council, and will be included in the Wave 2 data submission. Distributed for comment only -- do not cite or quote Draft Tentative Report, Belsito and Marks Teams/Panel: September 21-22, 2015 Comments received from the Council have been addressed. The Panel issued a tentative report for public comment with the conclusion that the following 25 apple-derived ingredients are safe in the present practices of use and concentration in cosmetics as described in this safety assessment, when formulated to be non-irritating and non-sensitizing. Pyrus Malus (apple) bark extract* Pyrus Malus (apple) pulp extract* Pyrus Malus (apple) carpel powder* Pyrus Malus (apple) root bark powder* Pyrus Malus (apple) fiber* Pyrus Malus (apple) seed extract Pyrus Malus (apple) flower extract Pyrus Malus (apple) seed oil* Pyrus Malus (apple) fruit extract Malus Domestica (apple) callus extract Pyrus Malus (apple) fruit Malus Domestica (apple) fiber Pyrus Malus (apple) fruit water Malus Domestica (apple) fruit extract Pyrus Malus (apple) juice Malus Domestica (apple) fruit water Pyrus Malus (apple) leaf extract* Malus Domestica (apple) fruit cell culture extract Pyrus Malus (apple) pectin extract Malus Domestica (apple) juice Pyrus Malus (apple) peel extract* Malus Domestica (apple) oil Pyrus Malus (apple) peel powder Malus Domestica (apple) seed oil Pyrus Malus (apple) peel wax* *Not reported to be in current use. Were ingredients in this group not in current use to be used in the future, the expectation is that they would be used in product categories and at concentrations comparable to others in this group. The Panel concluded that the available data are insufficient for evaluating the safety of the following 3 apple-derived ingredients in cosmetic products: Pyrus Malus (apple) root extract Pyrus Malus (apple) stem extract* Malus Domestica (apple) stem extract The data that are needed to evaluate the safety of these 3 ingredients are: (1) Method of manufacture and impurities (2) 28-day dermal
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