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This is a safety assessment of 6 Eucalyptus globulus (eucalyptus)-derived ingredients as used in cosmetics. The reported functions of the Eucalyptus globulus (eucalyptus)-derived ingredients include abrasive, fragrance ingredient, and skin-conditioning agent (miscellaneous and occlusive). The Expert Panel for Cosmetic Ingredient Safety (Panel) reviewed the relevant data on these 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. Industry should use good manufacturing practices to limit impurities. The Panel concluded that Eucalyptus globulus (eucalyptus)-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.

This is a review of the scientific literature and unpublished data that are relevant for assessing the safety of 12 Helianthus annuus (sunflower)-derived ingredients as used in cosmetics. 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 levels that may be hazardous to consumers. Helianthus annuus (sunflower)-derived ingredients may contain allergens, including 2S albumins and sesquiterpene lactones. Industry should use current good manufacturing practices (cGMP) to limit impurities and constituents of concern. The Expert Panel for Cosmetic Ingredient Safety (Panel) concluded that 9 Helianthus annuus (sunflower) seed- and flower-derived ingredients are safe as used in cosmetics in the present practices of use and concentration described in this safety assessment. The data are insufficient to evaluate the safety of 3 ingredients that are derived from other plant parts.

The Expert Panel for Cosmetic Ingredient Safety (Panel) assessed the safety of 11 Cocos nucifera (coconut)-derived ingredients, most of which are reported to function as skin-conditioning agents in cosmetic products. The Panel reviewed the available data to determine the safety of these ingredients. The Panel concluded that 10 ingredients, derived from coconut flower, fruit, and liquid endosperm, are safe in cosmetics in the present practices of use and concentration described in this safety assessment, and that the available data are insufficient to make a determination of safety for Cocos Nucifera (Coconut) Shell Powder under the intended conditions of use in cosmetic formulations.

The Expert Panel for Cosmetic Ingredient Safety (Panel) assessed the safety of 9 Centella asiatica-derived ingredients, which reportedly function primarily as skin conditioning agents in cosmetic products. The Panel reviewed relevant data relating to the safety of these ingredients. The Panel concluded that Centella Asiatica Extract, Centella Asiatica Callus Culture, Centella Asiatica Flower/Leaf/Stem Extract, Centella Asiatica Leaf Cell Culture Extract, Centella Asiatica Leaf Extract, Centella Asiatica Leaf Water, Centella Asiatica Meristem Cell Culture, Centella Asiatica Meristem Cell Culture Extract, and Centella Asiatica Root Extract are safe in the present practices of use and concentration in cosmetics, as described in this safety assessment, when formulated to be non-sensitizing.

The Expert Panel for Cosmetic Ingredient Safety (Panel) reviewed the safety of 26 apple-derived ingredients, which reportedly function mostly as skin conditioning agents in cosmetic products. Because apple-derived ingredients may be obtained from different apple cultivars, the composition of ingredients derived from different cultivars should be similar to that of ingredients reviewed in this safety assessment. Additionally, industry should continue to use good manufacturing practices to limit impurities that could be present in botanical ingredients. The Panel reviewed the available data to determine the safety of these ingredients and concluded that 21 of these ingredients are safe in cosmetics in the present practices of use and concentrations described in this safety assessment. However, the Panel also determined that the available data are insufficient to determine the safety of Pyrus Malus (Apple) Root Extract, Pyrus Malus (or Malus Domestica) (Apple) Stem Extract, Malus Domestica (Apple) Callus Extract, and Malus Domestica (Apple) Oil.

The Expert Panel for Cosmetic Ingredient Safety (Panel) reassessed the safety of 3 persulfate ingredients, which function as oxidizing agents in cosmetic products. The Panel reviewed relevant data relating to the safety of these ingredients and concluded that Ammonium, Potassium, and Sodium Persulfate are safe as used as oxidizing agents in hair colorants and hair lighteners designed for brief discontinuous use followed by thorough rinsing from the hair and skin. The Panel also concluded that the available data are insufficient for determining the safety of these persulfates in leave-on products and dentifrices.

The Expert Panel for Cosmetic Ingredient Safety (Panel) re-reviewed the safety of Malic Acid and Sodium Malate in cosmetics. Malic Acid is reported to function in cosmetics as a fragrance ingredient and a pH adjuster and Sodium Malate functions as a skin-conditioning agent - humectant. The Panel reviewed the available data to determine the safety of these ingredients. The Panel concluded that Malic Acid and Sodium Malate 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) reviewed the safety of 12 Rosa canina-derived ingredients, which are reported to function as skin conditioning agents, fragrance ingredients, cosmetic astringents, anti-acne agents, abrasives, humectants, and exfoliants 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 cumulative levels that may be hazardous to consumers. The Panel reviewed relevant data relating to the safety of these ingredients and concluded that these ingredients are safe in the present practices of use and concentration described in this safety assessment when formulated to be non-irritating and non-sensitizing.

The Expert Panel for Cosmetic Ingredient Safety (Panel) reviewed the safety of 16 bovine milk proteins and protein-derived ingredients, which function mainly as skin and hair conditioning agents in personal care products. The Panel reviewed relevant data provided in this safety assessment, and concluded that these ingredients are safe in the present practices of use and concentration.

The Expert Panel for Cosmetic Ingredient Safety (Panel) reviewed the safety of Hydrofluorocarbon 152a, which functions as a propellant in personal care products. The Panel reviewed relevant data provided in this safety assessment, and concluded that Hydrofluorocarbon 152a is safe 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 1-Hydroxyethyl 4,5-Diamino Pyrazole Sulfate, which functions as an oxidative hair dye ingredient. The Panel reviewed relevant data provided in this safety assessment, and concluded that 1-Hydroxyethyl 4,5-Diamino Pyrazole Sulfate is safe in the present practices of use and concentration in oxidative hair dye formulations.

The Cosmetic Ingredient Review (CIR) Expert Panel (Panel) assessed the safety of 33 Citrus flower- and leaf-derived ingredients, which are most frequently reported to function in cosmetics as fragrances and/or 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 Citrus flower- and leaf-derived ingredients, the Panel was concerned about the presence of the hydroperoxides of limonene and linalool in cosmetics. Industry should use good manufacturing practices to limit impurities that could be present in botanical ingredients. The Panel concluded that these ingredients are safe in the present practices of use and concentration when formulated to be non-irritating and non-sensitizing.

The Expert Panel for Cosmetic Ingredient Safety (Panel) reopened the safety assessment of Acid Violet 43, a cosmetic ingredient that is an anthraquinone dye reported to function in cosmetics as a colorant. This colorant has the same chemical structure as Ext. D&C Violet No. 2, which is a certified colorant; however, Acid Violet 43 is not a certified color and it could have impurities that are not allowed in the certified color. The Panel reviewed relevant new data related to this ingredient and concluded that Acid Violet 43 is safe in the present practices of use and concentration for use in hair dye formulations. This conclusion supersedes the previous conclusion for Acid Violet 43 that included impurity specifications indicated for the certified color.

The Expert Panel for Cosmetic Ingredient Safety (Panel) reviewed the safety of 8 keratin-derived ingredients, which function mainly as skin and hair conditioning agents in personal care products. The Panel reviewed relevant data provided in this safety assessment and concluded that the 8 keratin-derived ingredients are safe in the present practices of use and concentration described in this safety assessment.

This is a safety assessment of 40 saccharide ester ingredients as used in cosmetics. The saccharide esters are reported to function in cosmetics as emollients, skin-conditioning agents, fragrance ingredients, and emulsion stabilizers. The Expert Panel for Cosmetic Ingredient Safety (Panel) reviewed the relevant data for these ingredients. The Panel concluded that the saccharide esters 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 80 Citrus fruit-derived ingredients, which are most frequently reported to function in cosmetics as fragrances and/or 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. Industry should use good manufacturing practices to limit impurities that could be present in botanical ingredients. The Panel concluded that these ingredients are safe for use in both rinse-off and leave-on cosmetic products when formulated to be non-sensitizing and non-irritating, provided that leave-on products do not contain more than 0.0015% (15 ppm) 5-methoxypsoralen (5-MOP).

The Expert Panel for Cosmetic Ingredient Safety (Panel) assessed the safety of 30 Citrus plant- and seed-derived ingredients, which are most frequently reported to function in cosmetics as fragrances and/or skin conditioning agents. 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 Citrus plant- and seed-derived ingredients, the Panel was concerned about the presence of the hydroperoxides of limonene and linalool in cosmetics. Industry should use good manufacturing practices to limit impurities. The Panel reviewed the available data presented and concluded that 18 of these ingredients are safe in the present practices of use and concentration when formulated to be non-irritating and non-sensitizing. The data for the remaining 12 ingredients are insufficient to determine safety.

The Expert Panel for Cosmetic Ingredient Safety (Panel) assessed the safety of 51 triglycerides; 25 of these ingredients were previously reviewed by the Panel, and 26 are reviewed herein for the first time. The majority of the ingredients named in this assessment have several functions, with most reported to function as skin conditioning agents (occlusive or emollient) and/or viscosity increasing agents in cosmetics; some are also reported to function as a fragrance or solvent. The Panel reviewed relevant new data, including frequency and concentration of use, and considered the data from previous reports. The Panel concluded the 51 triglycerides reviewed in this report 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 Panthenol, Pantothenic Acid, and 5 derivatives as used in cosmetics. These ingredients named in this report are reported to function in cosmetics as hair conditioning agents, and Panthenol also is reported to function as a skin-conditioning agent-humectant and a solvent. The Panel reviewed relevant data for these ingredients, and concluded that these 7 ingredients are safe in cosmetics in the present practices of use concentration described in this safety assessment.

The Expert Panel for Cosmetic Ingredient Safety (Panel) assessed the safety of 47 Citrus peel-derived ingredients, which are most frequently 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 botanical ingredients, 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. Industry should use good manufacturing practices to limit impurities that could be present in botanical ingredients. The Panel concluded that Citrus peel-derived ingredients are safe in the present practices of use and concentration in both rinse-off and leave-on cosmetic products when formulated to be non-sensitizing and non-irritating, provided that leave-on products do not contain more than 0.0015% (15 ppm) 5-methoxypsoralen (5-MOP).

The Expert Panel for Cosmetic Ingredient Safety (Panel) reassessed the safety of Methylisothiazolinone, which functions as a preservative in cosmetics. The Panel reviewed relevant animal and human data provided in this safety assessment, and data from the previously published safety assessments of Methylisothiazolinone, and concluded that Methylisothiazolinone is safe for use in rinse-off cosmetic products at concentrations up to 100 ppm (ie, 0.01%) and safe in leave-on cosmetic products when they are formulated to be nonsensitizing, which may be determined based on a quantitative risk assessment or similar methodology.

The Expert Panel for Cosmetic Ingredient Safety (Panel) assessed the safety of 5 acyl sarcosines and 9 sarcosinate salts as used in cosmetics; all of these ingredients are reported to function in cosmetics as hair conditioning agents and most also can function as surfactants—cleansing agents. The ingredients reviewed in this assessment are composed of an amide comprising a fatty acyl residue and sarcosine and are either free acids or simple salts thereof. The Panel relied on relevant new data, including concentration of use, and considered data from the previous Panel report, such as the reaction of sarcosine with oxidizing materials possibly resulting in nitrosation and the formation of N-nitrososarcosine. The Panel concluded that these ingredients are safe as used in cosmetics when formulated to be non-irritating, but these ingredients should not be used in cosmetic products in which N-nitroso compounds may be formed.

The Expert Panel for Cosmetic Ingredient Safety (Panel) reassessed the safety of 8 dialkyl dimer dilinoleates as used in cosmetics. These ingredients are diesters formed from the reaction of straight-chained or branched alkyl alcohols and dilinoleic acid; these ingredients are reported to function in cosmetics as skin-conditioning agents. The Panel reviewed data relevant to the safety of these ingredients and concluded that Diisopropyl Dimer Dilinoleate, Dicetearyl Dimer Dilinoleate, Diisostearyl Dimer Dilinoleate, Diethylhexyl Dimer Dilinoleate, Dioctyldodecyl Dimer Dilinoleate, Ditridecyl Dimer Dilinoleate, Di-C16-18 Alkyl Dimer Dilinoleate, and Di-C20-40 Alkyl Dimer Dilinoleate 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) reviewed the safety of 19 skin and connective tissue-derived proteins and peptides, which are reported to function mainly as skin and/or hair conditioning agents in cosmetics. The Panel reviewed the relevant data provided and concluded that these ingredients are safe 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 19 plant-derived proteins and peptides, which function mainly as skin and/or hair conditioning agents in personal care products. The Panel concluded that 18 plant-derived proteins and peptides are safe as used in the present practices of use and concentration as described in this safety assessment, while the data on Hydrolyzed Maple Sycamore Protein are insufficient to determine safety.

The Expert Panel for Cosmetic Ingredient Safety (Panel) reviewed the safety of Hydroxyethyl-3,4-Methylenedioxyaniline HCl, which is reported to function as a hair dye ingredient. The Panel reviewed relevant data provided in this safety assessment, and concluded that Hydroxyethyl-3,4-Methylenedioxyaniline HCl is safe for use as a hair dye ingredient in the present practices of use and concentrations described in this report. The Panel cautions that this ingredient should not be used in cosmetic products in which N-nitroso compounds can be formed.

The Expert Panel for Cosmetic Ingredient Safety (Panel) reviewed the safety of 7 ethers and esters of ascorbic acid, which collectively function as antioxidants, skin-conditioning agents, skin protectants, fragrance ingredients, and skin bleaching agents in cosmetic products. The Panel reviewed relevant data relating to the safety of these ingredients, and concluded that the ethers and esters of ascorbic acid are safe in the present practices of use and concentration, as described in this safety assessment.

The Expert Panel for Cosmetic Ingredient Safety (Panel) assessed the safety of 44 monoglyceryl monoesters that are structurally constituted as the esterification products of glycerin and carboxylic acids (the majority of which are fatty acids); 36 of these monoesters were previously reviewed by the Panel, and 8 are reviewed herein for the first time. Most of the monoglyceryl monoesters have several reported functions in cosmetics, but the most common function among the ingredients is skin conditioning agent; a few are reported to function only as surfactant–emulsifying agents. The Panel reviewed relevant new data, including frequency and concentration of use and considered the data from previous Cosmetic Ingredient Review reports. The Panel concluded that these 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) reviewed the safety of polyenes, which are reported to function in cosmetics primarily as film formers and viscosity increasing agents. The Panel reviewed relevant data related to these ingredients, not inggaps in the available safety data for some of the polyenes in this safety assessment. The data available for many of the ingredients are sufficient and can be extrapolated to support the safety of the entire group because of the similarities in the chemical structures, chemical properties, use concentrations, and reported functions across the group. The Panel concluded that polyenes were 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 46 butyl polyoxyalkylene ethers that share a common structural motif, namely a butyl chain (4 carbon alkyl chain) bound to a polyoxyalkylene (PPG, PEG, or both); 23 of these ethers were previously reviewed by the Panel, and 23 are reviewed herein for the first time. Most of the butyl polyoxyalkylene ethers have several functions in cosmetics, but the most common reported functions include hair conditioning agent and skin conditioning agent, and many reportedly function as solvents. Upon review of new data, including frequency and concentration of use, and data from previous Panel reports and on read-across analogs, the Panel concluded that these ingredients are safe in the present practices of use and concentration in cosmetics when formulated to be non-irritating.

The Expert Panel for Cosmetic Ingredient Safety (Panel) reviewed the safety of inorganic hydroxides, which function in cosmetics primarily as pH adjusters. Representatives from the cosmetic industry have indicated these ingredients are used in depilating and hair waving/straightening formulations to raise pH values. The Panel considered relevant data related to these ingredients. The Panel concluded that these inorganic hydroxides are safe in hair straighteners and depilatories under conditions of recommended use; users should minimize skin contact. These ingredients are safe for all other present practices of use and concentration described in this safety assessment when formulated to be nonirritating.

This is a safety assessment of glycerin as used in cosmetics. Glycerin functions as a denaturant, fragrance ingredient, hair conditioning agent, humectant, oral care agent, oral health-care drug, skin protectant, skin conditioning agent—humectant, and viscosity-decreasing agent. The Cosmetic Ingredient Review Expert Panel (Panel) reviewed relevant animal and human data. The Panel concluded that glycerin is safe as a cosmetic ingredient in the practices of use and concentration described in this safety assessment.

This is a safety assessment of Avena sativa (oat)–derived ingredients. The reported functions of these ingredients in cosmetics include abrasives, antioxidant, skin conditioning agents, absorbents, and bulking agents. The Panel reviewed relevant animal and human data related to these 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 lead to sensitization or other toxic effects. The Panel stated that industry should continue to use good manufacturing practices to limit impurities and concluded that all but one of the Avena sativa (oat)–derived ingredients are safe as cosmetic ingredients in the practices of use and concentration described in this safety assessment when formulated to be nonsensitizing; data are insufficient to come to a conclusion of safety for Avena Sativa (Oat) Meristem Cell Extract.

The Cosmetic Ingredient Review Expert Panel (Panel) reassessed the safety of 2-pyrrolidone-5-carboxylic acid (PCA) and sodium PCA; the Panel added 3 previously unreviewed salts (calcium, magnesium, and potassium) of PCA to this safety assessment. 2-Pyrrolidone-5-carboxylic acid and its salts are reported to function in cosmetics as skin conditioning agents—humectants. The Panel reviewed the data from the 1999 report of PCA and sodium PCA, as well as additional data included in this report, to determine the safety of these ingredients. The Panel concluded that PCA and its salts are safe in cosmetics in the present practices of use and concentration; additionally, these ingredients should not be used in cosmetic products in which N-nitroso compounds can be formed.

The Expert Panel assessed the safety of 28 alkyl phosphates and concluded that these ingredients are safe in the current practices of use and concentration when formulated to be nonirritating. The ingredients in the alkyl phosphate family share a common phosphate core structure, and vary by the identity of the alkyl chains attached therein. Most of the alkyl phosphates function as surfactants in cosmetic ingredients; however, the triesters function as plasticizers rather than surfactants. The Panel reviewed the available animal and clinical data to determine the safety of these ingredients.

The Cosmetic Ingredient Review Expert Panel (Panel) reviewed the safety of methylisothiazolinone (MI), which functions as a preservative. The Panel reviewed relevant animal and human data provided in this safety assessment and in a previously published safety assessment of MI and concluded that MI is safe for use in rinse-off cosmetic products at concentrations up to 100 ppm and safe in leave-on cosmetic products when they are formulated to be nonsensitizing, which may be determined based on a quantitative risk assessment.

The Cosmetic Ingredient Review Expert Panel (Panel) assessed the safety of 25 monosaccharides, disaccharides, and related ingredients and concluded these are safe in the present practices of use and concentration described in the safety assessment. Many of these ingredients are common dietary sugars, dietary sugar replacements, or very closely related analogs and salts; 7 of the ingredients are listed by the Food and Drug Administration as generally recognized as safe food substances. The most commonly reported cosmetic function is as a skin-conditioning agent; other commonly reported functions are use as a humectant or as a flavoring agent. The Panel reviewed the animal and clinical data included in this assessment, acknowledged that the oral safety of many of these ingredients has been well established, and found it appropriate to extrapolate the existing information to conclude on the safety of all the monosaccharides, disaccharides, and related ingredients.

The Expert Panel for Cosmetic Ingredient Safety (Panel) assessed the safety of Phosphoric Acid and its salts (31 ingredients), which are reported to function as buffering agents, corrosion inhibitors, chelating agents, and pH adjusters in cosmetic products. The Panel reviewed data relating to the safety of these ingredients and concluded that Phosphoric Acid and its salts are safe in the present practices of use and concentration in cosmetics when formulated to be nonirritating.

The Expert Panel for Cosmetic Ingredient Safety (Panel) reopened the safety assessment of Sodium Sulfate, a cosmetic ingredient that is an inorganic salt reported to function in cosmetics as a viscosity increasing agent—aqueous. The Panel reviewed the relevant new data for the ingredient, including frequency of use and concentration of use, and considered data from the previous Panel assessment. The Panel concluded that Sodium Sulfate is safe in cosmetics in the present practices of use and concentrations described in this safety assessment when formulated to be nonirritating.

The Expert Panel for Cosmetic Ingredient Safety (Panel) assessed the safety of 6 trimellitic anhydride copolymers as used in cosmetics. These ingredients are related as copolymers in that they all share trimellitic anhydride (ie, 1,2,4-benzenetricarboxylic acid anhydride) as a monomer, are reported to function as film formers in cosmetics, and are reported to be primarily used in nail products. Very limited safety data were available or submitted. The Panel concluded that Adipic Acid/Neopentyl Glycol/Trimellitic Anhydride Copolymer and Phthalic Anhydride/Trimellitic Anhydride/Glycols Copolymer are safe in nail product formulations in the present practices of use and concentration, but the data are insufficient to make a determination of safety on the use of these 2 ingredients in all other types of cosmetic formulations. The Panel also concluded that the available data are insufficient to make a determination that the remaining trimellitic anhydride copolymers are safe for use in cosmetic formulations.

The Expert Panel for Cosmetic Ingredient Safety (Panel) reviewed the safety of Polyaminopropyl Biguanide (polyhexamethylene biguanide hydrochloride), which functions as a preservative in cosmetic products. The Panel reviewed relevant data relating to the safety of this ingredient and concluded that Polyaminopropyl Biguanide is safe in cosmetics in the present practices of use and concentration described in the safety assessment, when formulated to be nonirritating and nonsensitizing, which may be based on a quantitative risk assessment or other accepted methodologies. The Panel also concluded that the data are insufficient to determine the safety of Polyaminopropyl Biguanide in products that may be incidentally inhaled.

The Expert Panel for Cosmetic Ingredient Safety (Panel) reviewed the safety of ceramides, which function in cosmetics primarily as hair-conditioning agents and skin-conditioning agents—miscellaneous. The Panel considered relevant data related to these ingredients. The Panel concluded that ceramides were 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 Hydrolyzed Silk and 9 other silk protein ingredients, which function primarily as skin and hair conditioning agents and bulking agents in cosmetic products. The Panel reviewed relevant data relating to the safety of these ingredients and concluded that 8 ingredients are safe in the present practices of use and concentration in cosmetics, as described in this safety assessment, but that the available data are insufficient for determining the safety of 2 silk protein ingredients in cosmetic products, MEA-Hydrolyzed Silk and Silkworm Cocoon Extract.

The Expert Panel for Cosmetic Ingredient Safety (Panel) assessed the safety of 60 PEGylated alkyl glycerides. PEGylated alkyl glycerides are mono-, di-, and/or triglycerides that have been modified with ethylene glycol repeat units (in the starting material form as epoxide). Most of the PEGylated alkyl glycerides are reported to function as skin-conditioning agents or surfactants. The Panel reviewed the available animal and clinical data as well as data from the 1999 report for the 5 polyethylene glycol (PEG) glyceryl cocoates and the 2012 report of PEGylated oils, to determine the safety of these ingredients. The Panel concluded these ingredients are safe in the current practices of use and concentration when formulated to be nonirritating; this conclusion supersedes the 1999 conclusion issued on 5 PEG glyceryl cocoate ingredients.

The phosphoglycerides considered in this safety assessment are reported to function primarily as skin and hair conditioning agents, emulsifying agents, and surfactants in cosmetic products and are used up to a maximum reported concentration of 50%. Although phospholipids exert physiologic effects, these are not reproduced by application of phospholipid ingredients to the skin. Given the possibility that Lecithin may be derived from animal sources, it should be noted that the Food and Drug Administration does not permit the use of ingredients made from bovine specified risk materials in cosmetic products. The Expert Panel for Cosmetic Ingredient Safety concluded that the 17 phosphoglycerides are safe in the present practices of use and concentration in cosmetics, as described in this safety assessment.

The Expert Panel for Cosmetic Ingredient Safety (Panel) reviewed the safety of 2-Amino-3-Hydroxypyridine, which is reported to function as an oxidative hair dye ingredient. The Panel reviewed relevant animal and human data provided in this safety assessment, and concluded that 2-Amino-3-Hydroxypyridine is safe in the present practices of use and concentration for use in oxidative hair dye formulations.

The Expert Panel for Cosmetic Ingredient Safety (Panel) assessed the safety of 21 parabens as preservatives in cosmetic products. All of these ingredients are reported to function in cosmetics as preservatives; however, 5 are reported to also function as fragrance ingredients. The Panel reviewed relevant data relating to the safety of these ingredients under the reported conditions of use in cosmetic formulations. The Panel concluded that 20 of the 21 parabens included in this report are safe in cosmetics in the present practices of use and concentration described in this safety assessment when the sum of the total parabens in any given formulation does not exceed 0.8%. However, the available data are insufficient to support a conclusion of safety for benzylparaben in cosmetics.

The Cosmetic Ingredient Review (CIR) Expert Panel (Panel) reviewed the safety of barium sulfate, which functions as an opacifying agent in cosmetic products and is being used at concentrations up to 0.99% and 37% in rinse-off and leave-on products, respectively. The Panel noted that the history of safe medical use of barium sulfate indicates no significant toxicity concerns relating to systemic exposure to this ingredient. Furthermore, the extensive clinical experience of the Panel, including the results of numerous patch tests, indicates that barium salts do not have the potential to induce sensitization. The Panel noted that since salts of sulfuric acid can be irritating to the skin, cosmetic products containing barium sulfate should be formulated to be nonirritating. The Panel concluded that barium sulfate is safe in cosmetics in the present practices of use and concentration described in this safety assessment when formulated to be nonirritating.

Tripeptide-1, Hexapeptide-12, their metal salts and fatty acyl derivatives, and Palmitoyl Tetrapeptide-7 function primarily as skin conditioning agents, and Palmitoyl Tripeptide-1, Palmitoyl Hexapeptide-12, Tripeptide-1, Copper Tripeptide-1, and Palmitoyl Tetrapeptide-7 are also used in cosmetic products. Typical use concentrations of these ingredients are

Pentaerythrityl tetra-di -t-butyl hydroxyhydrocinnamate functions as an antioxidant in cosmetic products and is used at concentrations up to 0.8%. Given the high molecular weight of this ingredient, skin penetration is not likely. The available toxicity data, together with the low ingredient use concentrations, suggest that systemic toxicity would not be likely if percutaneous absorption were to occur. Additionally, the negative human repeated insult patch test data at a concentration of 0.5% were deemed sufficient for evaluating the skin irritation and sensitization potential of pentaerythrityl tetra-di -t-butyl hydroxyhydrocinnamate over the range of use concentrations in cosmetic products. The Cosmetic Ingredient Review Expert Panel concluded that pentaerythrityl tetra-di -t-butyl hydroxyhydrocinnamate is safe in cosmetics in the present practices of use and concentration described in this safety assessment.