The Expert Panel for Cosmetic Ingredient Safety (Panel) assessed the safety of 12 Salvia officinalis (Sage)-derived ingredients as used in cosmetic formulations. These ingredients are most commonly reported to function as skin conditioning agents and fragrance ingredients. Because final product formulations may contain multiple botanicals, each containing the same constituents of concern, formulators are advised to be aware of these constituents and to avoid reaching levels that may be hazardous to consumers. With Salvia officinalis (Sage)-derived ingredients, the Panel was concerned about certain terpenes as potential sensitizers. Industry should use current good manufacturing practices to minimize impurities. The Panel reviewed data relevant to the safety of these ingredients in cosmetic formulations, and concluded that 6 of the ingredients (those derived from the leaves and the oil) are safe in cosmetics in the present practices of use and concentrations described in this safety assessment when formulated to be non-sensitizing, and that the data are insufficient to make a determination of safety for the remaining 6 ingredients under the intended conditions of use in cosmetic formulations.

The Expert Panel for Cosmetic Ingredient Safety (Panel) assessed the safety of 8 fatty ethers as used in cosmetic formulations. These ingredients are reported to function in cosmetics as skin conditioning agents. The Panel reviewed the available data to determine the safety of these ingredients, and concluded that these ingredients are safe in cosmetics in the present practices of use and concentrations described in this safety assessment.

The Expert Panel for Cosmetic Ingredient Safety (Panel) assessed the safety of Diatomaceous Earth as used in cosmetic formulations. It is reported to function as an abrasive, absorbent, anticaking agent, bulking agent, and opacifying agent in cosmetic products. The Panel reviewed all relevant data, and concluded that Diatomaceous Earth is safe in cosmetics in the present practices of use and concentration described in this safety assessment.

The Expert Panel for Cosmetic Ingredient Safety (Panel) assessed the safety of 4 starch phosphates as used in cosmetic formulations. Distarch Phosphate is reported to function in cosmetics as an anticaking agent and binder. Distarch Phosphate Acetate, Hydroxypropyl Starch Phosphate, and Sodium Hydroxypropyl Starch Phosphate are all reported to function as viscosity increasing agents. The Panel considered the available data and concluded that these ingredients are safe in cosmetics in the present practices of use and concentrations described in this safety assessment.

The Expert Panel for Cosmetic Ingredient Safety (Panel) assessed the safety of 9 Zingiber officinale (ginger)-derived ingredients. The majority of these ingredients are reported to function in cosmetics as skin-conditioning agents. The Panel reviewed the available data to determine the safety of these ingredients. Because final product formulations may contain multiple botanicals, each containing similar constituents of concern, formulators are advised to be aware of these constituents and to avoid reaching levels that may be hazardous to consumers. With Zingiber officinale (ginger)-derived ingredients, the Panel was concerned about the presence of potential sensitizers (e.g., citronellol) in cosmetics. Industry should continue to use good manufacturing practices to minimize impurities that could be present in botanical ingredients. The Panel concluded that 8 Zingiber officinale (ginger)-derived ingredients are safe in cosmetics in the present practices of use and concentration described in this safety assessment when formulated to be non-sensitizing. In addition, the Panel concluded that the available data are insufficient to make a determination that Zingiber Officinale (Ginger) Leaf Cell Extract is safe under the intended conditions of use in cosmetic formulations.

The Expert Panel for Cosmetic Ingredient Safety (Panel) assessed the safety of Acetyl Glucosamine, Glucosamine, Glucosamine HCl, and Glucosamine Sulfate. Two of the ingredients, Acetyl Glucosamine and Glucosamine Sulfate, are reported to function in cosmetics as skin-conditioning agents, Glucosamine HCl is reported to function as a pH adjustor, and the function of Glucosamine in cosmetics is not reported. The Panel reviewed the available data and concluded that these glucosamine ingredients are safe in cosmetics in the present practices of use and concentration described in this safety assessment when formulated to be non-irritating.

The Expert Panel for Cosmetic Ingredient Safety (Panel) reviewed the safety of 28 soy-derived ingredients as used in cosmetic products. These ingredients are reported to primarily function as antioxidants, skin protectants, skin-conditioning agents, and hair-conditioning agents. The Panel considered the available data relating to the safety of these ingredients in cosmetic formulations, and concluded that 24 of the 28 soy-derived ingredients are safe in cosmetics in the present practices of use and concentration described in this safety assessment. The Panel also concluded that the available data are insufficient to make a determination that Glycine Max (Soybean) Callus Culture, Glycine Max (Soybean) Callus Culture Extract, Glycine Max (Soybean) Callus Extract, and Glycine Max (Soybean) Phytoplacenta Conditioned Media are safe under the intended conditions of use in cosmetic formulations.

The Expert Panel for Cosmetic Safety (Panel) assessed the safety of 8 naturally-sourced clay ingredients, of which 6 were previously reviewed, as used in cosmetic formulations. All of these ingredients are reported to function in cosmetics as absorbents and bulking agents; other cosmetic functions are also reported. The Panel reviewed all relevant data and concluded that Kaolin is safe in cosmetics in the present practices of use and concentration described in this safety assessment. The remaining 7 naturally-sourced clay ingredients are safe in cosmetics in the present practices of use and concentration, with the exception that the available data are insufficient to make a determination that these ingredients are safe in products that may be incidentally inhaled.

The Expert Panel for Cosmetic Ingredient Safety (Panel) assessed the safety of Basic Yellow 87, which is reported to function as a hair dye in cosmetic products. The Panel reviewed the available data to determine the safety of this ingredient. The Panel concluded that Basic Yellow 87 is safe for use as a hair dye ingredient in the present practices of use and concentration described in this safety assessment.

The Expert Panel for Cosmetic Ingredient Safety (Panel) assessed the safety of 7 radish root-derived ingredients, most of which are reported to function as hair and skin conditioning agents in cosmetic products. Because final product formulations may contain multiple botanicals, each containing similar constituents of concern, formulators are advised to be aware of these constituents and to avoid reaching levels that may be hazardous to consumers. With radish root-derived ingredients, the Panel was concerned about the presence of anthocyanins and isothiocyanates in cosmetics. Industry should use current good manufacturing practices to minimize impurities that could be present in botanical ingredients. The Panel reviewed the available data and concluded that these ingredients are safe in cosmetics in the present practices of use and concentration described in this safety assessment when formulated to be non-sensitizing.

The Expert Panel for Cosmetic Ingredient Safety (Panel) assessed the safety of 5 glycolactone ingredients. Glucoheptonolactone and Gluconolactone are reported to function in cosmetics as skin-conditioning agents-miscellaneous, and Gluconolactone is also reported to function as a chelating agent. No functions are reported for the other 3 ingredients. The Panel considered the available data and concluded that Gluconolactone is safe in cosmetics in the present practices of use and concentration described in this safety assessment; however, the Panel concluded the available data are insufficient to make a determination that Galactonolactone, Glucarolactone, Glucoheptonolactone, and Ribonolactone are safe under the intended conditions of use in cosmetic formulations.

The Expert Panel for Cosmetic Ingredient Safety (Panel) assessed the safety of 8 Melaleuca alternifolia (tea tree)-derived ingredients as used in cosmetic formulations; 5 of these ingredients are reported to function in cosmetics as skin-conditioning agents. Because final product formulations may contain multiple botanicals, each containing the same constituents of concern, formulators are advised to be aware of these constituents and to avoid reaching levels that may be hazardous to consumers. Industry should use good manufacturing practices to minimize impurities that could be present in botanical ingredients. The Panel noted that oxidized tea tree oil could be a sensitizer, and stated that industry should employ methods to minimize oxidation of the oil in the final cosmetic product. The Panel considered all the data and concluded that these ingredients are safe in cosmetics in the present practices of use and concentration described in this safety assessment when formulated to be non-sensitizing.

The Expert Panel for Cosmetic Ingredient Safety (Panel) assessed the safety of Polyhydroxystearic Acid, Poly(3-Hydroxyoctanoic Acid), and Polylactic Acid as used in cosmetic formulations. These ingredients are reported to function in cosmetics as a non-surfactant dispersing agent, a skin-conditioning agent, and an abrasive agent, respectively. The Panel reviewed the available data to determine the safety of these ingredients and concluded that these ingredients are safe in cosmetics in the present practices of use and concentrations described in this safety assessment.

The Expert Panel for Cosmetic Ingredient Safety (Panel) considered whether the safety of Glyceryl Isostearates and Glyceryl Stearate/Acetate as used in cosmetics should be reassessed. The Panel reviewed newly available safety data related to these ingredients. The Panel concluded, based on the available data contained in the report, that these two ingredients are safe as cosmetic ingredients in the present practices of use and concentration as described in the report.

The Expert Panel for Cosmetic Ingredient Safety (Panel) reviewed the safety of 7 saccharides/saccharide derivatives as used in cosmetic products; all of these ingredients are reported to function as skin-conditioning agents-humectant in cosmetics. The Panel reviewed data relevant to the safety of these ingredients in cosmetic formulations and concluded that Anhydrogalactose, Anhydroglucitol, Anhydroxylitol, Arabinose, Psicose, Saccharide Hydrolysate, and Saccharide Isomerate are safe in cosmetics in the present practices of use and concentration described in this safety assessment.

The Expert Panel for Cosmetic Ingredient Safety (Panel) assessed the safety of Tetrasodium Glutamate Diacetate and Beta-Alanine Diacetic Acid, which are reported to function as chelating agents in cosmetic products. The Panel reviewed the available data to determine the safety of these ingredients. The Panel concluded that Tetrasodium Glutamate Diacetate is safe in cosmetics in the practices of use and concentration described in this safety assessment, and that the available data are insufficient to make a determination that Beta-Alanine Diacetic Acid is safe under the intended conditions of use in cosmetic formulations.

The Expert Panel for Cosmetic Ingredient Safety (Panel) reviewed the safety of 9 vanilla-derived ingredients as used in cosmetics. These ingredients are reported to function mostly as skin conditioning agents in cosmetic products. Because final product formulations may contain multiple botanicals, each containing the same constituents of concern, formulators are advised to be aware of these constituents, and to avoid reaching levels that may be hazardous to consumers. Industry should continue to use good manufacturing practices to limit impurities. The Panel reviewed data relating to the safety of these ingredients and concluded that 7 ingredients are safe in cosmetics in the present practices of use and concentration when formulated to be non-sensitizing. The Panel further concluded that the available data are insufficient to make a determination of safety under the intended conditions of use in cosmetic formulations for Vanilla Planifolia Flower Extract and Vanilla Planifolia Leaf Cell Extract.

The Expert Panel for Cosmetic Ingredient Safety (Panel) assessed the safety of Caprylhydroxamic Acid as used in cosmetic formulations; this ingredient is reported to function as a chelating agent. Positive sensitization results that occurred with the use of a moisturizer containing Caprylhydroxamic Acid appeared to correlate with use on damaged skin. Therefore, the Panel cautioned against the use of Caprylhydroxamic Acid in a manner that would result in increased penetration. A quantitative risk assessment (QRA) was performed, using a weight-of-evidence no-expected-sensitization-induction-level (WoE NESIL) of 1056 μg/cm2. The Panel concluded that Caprylhydroxamic Acid is safe in cosmetics in the present practices of use and concentration described in this safety assessment.

The Expert Panel for Cosmetic Ingredient Safety (Panel) reviewed the safety of five Equisetum arvense-derived ingredients as used in cosmetic products; all of these ingredients are reported to function as skin-conditioning agents in cosmetics. Industry should use current good manufacturing practices to minimize impurities that could be present in these botanical ingredients. The Panel reviewed data relevant to the safety of these ingredients in cosmetic formulations, and concluded that the five Equisetum arvense-derived ingredients are safe in cosmetics in the present practices of use and concentration described in this safety assessment.

The Expert Panel for Cosmetic Ingredient Safety (Panel) assessed the safety of 24 silicate ingredients that are solid inorganic oxides, comprising, in part, silicon dioxide, which can be derived from naturally occurring minerals or can be produced synthetically. Reported functions in cosmetics include abrasives, absorbents, bulking agents, and deodorant agents. The Panel reviewed all relevant data and concluded that the silicate ingredients are safe in cosmetics in the present practices of use and concentration described in this safety assessment when formulated to be non-irritating, with the exception that the available data are insufficient to make a determination of safety for the use of naturally sourced (i.e., mined) silicate ingredients in products that may be incidentally inhaled.