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The Expert Panel for Cosmetic Ingredient Safety (Panel) assessed the safety of three methylxanthines, Caffeine, Theobromine, and Theophylline, as used in cosmetics. All of these ingredients are reported to function as skin-conditioning agents in cosmetic products. The Panel reviewed the data relevant to the safety of these ingredients and concluded that Caffeine, Theobromine, and Theophylline are safe in cosmetics in the present practices of use and concentration described in this safety assessment., Competing Interests: Declaration of Conflicting InterestThe author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.

The Expert Panel for Cosmetic Ingredient Safety (Panel) reviewed the safety of 10 polyol phosphates. Some of the possible functions in cosmetics that are reported for this ingredient group are chelating agents, oral care agents, and skin conditioning agents. The Panel reviewed relevant data relating to the safety of these ingredients under the intended conditions of use in cosmetic formulations, and concluded that Sodium Phytate, Phytic Acid, Phytin, and Trisodium Inositol Triphosphate are safe in cosmetics in the present practices of use and concentration described in the safety assessment. The Panel also concluded that the data are insufficient to determine the safety of the following 6 ingredients as used in cosmetics: Disodium Glucose Phosphate, Manganese Fructose Diphosphate, Sodium Mannose Phosphate, Trisodium Fructose Diphosphate, Xylityl Phosphate, and Zinc Fructose Diphosphate., Competing Interests: Declaration of Conflicting InterestsThe author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.

The Expert Panel for Cosmetic Ingredient Safety (Panel) reviewed the safety of 10 alkanoyl lactyl lactate salts. These ingredients have the surfactant function in cosmetics in common. The Panel reviewed data relevant to the safety of these ingredients, and concluded that these 10 ingredients are 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 (QRA) or other accepted methodologies., Competing Interests: Declaration of Conflicting InterestThe author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.

The Expert Panel for Cosmetic Ingredient Safety (Panel) reviewed the safety of 30 vinylpyrrolidone polymers as used in cosmetic products; most of these ingredients have the reported cosmetic function of film former in common. The Panel reviewed data relevant to the safety of these ingredients, and determined that 27 vinylpyrrolidone polymers are safe in cosmetics in the present practices of use and concentration described in the safety assessment. The Panel also concluded that the available data are insufficient to make a determination that 3 vinylpyrrolidone polymers (all urethanes) are safe under the intended conditions of use in cosmetic formulations., Competing Interests: Declaration of Conflicting InterestThe author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.

The Expert Panel for Cosmetic Ingredient Safety (Panel) assessed the safety of Hydrogen Peroxide for use in cosmetics. This ingredient is reported to function in cosmetics as an antimicrobial agent, cosmetic biocide, oral health care agent, and oxidizing agent. The Panel reviewed the data relevant to the safety of this ingredient and concluded that Hydrogen Peroxide is safe in cosmetics in the present practices of use and concentration described in this safety assessment., Competing Interests: Declaration of Conflicting InterestsThe author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.

The Expert Panel for Cosmetic Ingredient Safety (Panel) assessed the safety of Basic Red 76, which is reported to function in cosmetics as a hair colorant and hair-conditioning agent. The Panel reviewed the available data to determine the safety of this ingredient. The Panel concluded that Basic Red 76 is safe for use as a hair dye ingredient in the present practices of use and concentration described in the safety assessment., Competing Interests: Declaration of Conflicting InterestsThe author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.

The Expert Panel for Cosmetic Ingredient Safety (Panel) assessed the safety of Hydroxyethyl Urea, which is reported to function as a humectant and a hair and skin conditioning agent. The Panel reviewed the available data to determine the safety of this ingredient. The Panel concluded that Hydroxyethyl Urea is safe in cosmetics in the present practices of use and concentration described in the safety assessment when formulated to be non-irritating., Competing Interests: Declaration of Conflicting InterestsThe author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.

The Expert Panel for Cosmetic Ingredient Safety (Panel) assessed the safety of 10 alkane diol ingredients as used in cosmetics. The alkane diols are structurally related to each other as small diols, and most are reported to function in cosmetics as solvents. The Panel reviewed the relevant data for these ingredients, and concluded that seven alkane diols are safe in cosmetics in the present practices of use and concentration described in this safety assessment, but that the available data are insufficient to make a determination of safety for three ingredients, namely 1,4-Butanediol, 2,3-Butanediol, and Octanediol., Competing Interests: Declaration of Conflicting InterestsThe author(s) declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: The articles in this supplement were sponsored by the Cosmetic Ingredient Review.

The Expert Panel for Cosmetic Ingredient Safety (Panel) assessed the safety of 13 alkyl sultaines, which are most frequently reported to function in cosmetics as antistatic agents, surfactants, and skin and hair conditioning agents. The Panel reviewed the available data to determine the safety of these ingredients. The Panel noted gaps in the available safety data for some of the alkyl sultaines in this safety assessment; the available data on some of the ingredients are sufficient, however, and can be read across to support the safety of other members of the group. The Panel concluded that these alkyl sultaines are safe in cosmetics in the present practices of use and concentration described in this safety assessment., Competing Interests: Declaration of Conflicting InterestsThe author(s) declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: The articles in this supplement were sponsored by the Cosmetic Ingredient Review.

The Expert Panel for Cosmetic Ingredient Safety reviewed newly available studies since their original assessment in 2002, along with updated information regarding product types and concentrations of use, and confirmed that Aluminum Starch Octenylsuccinate is safe as a cosmetic ingredient in the practices of use and concentration as described in this report., Competing Interests: Declaration of Conflicting InterestsThe author(s) declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: The articles in this supplement were sponsored by the Cosmetic Ingredient Review.

The Expert Panel for Cosmetic Ingredient Safety reviewed newly available studies since their original assessment in 2002, along with updated information regarding product types and concentrations of use, and confirmed that Acetyl Triethyl Citrate, Acetyl Tributyl Citrate, Acetyl Triethylhexyl Citrate, and Acetyl Trihexyl Citrate are safe as cosmetic ingredients in the practices of use and concentration as described in this report., Competing Interests: Declaration of Conflicting InterestThe author(s) declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: The articles in this supplement were sponsored by the Cosmetic Ingredient Review.

The Expert Panel for Cosmetic Ingredient Safety reviewed newly available studies since their original assessment in 1998, along with updated information regarding product types and concentrations of use, and confirmed that sodium α-olefin sulfonates are safe as cosmetic ingredients in the practices of use and concentration as described in this report., Competing Interests: Declaration of Conflicting InterestThe author(s) declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: The articles in this supplement were sponsored by the Cosmetic Ingredient Review.

The Expert Panel for Cosmetic Ingredient Safety reviewed newly available studies since their original assessment in year 2000, along with updated information regarding product types and concentrations of use, and confirmed that sodium Quaternium-26 is safe as a cosmetic ingredient in the practices of use and concentration as described in this report., Competing Interests: Declaration of Conflicting InterestsThe author(s) declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: The articles in this supplement were sponsored by the Cosmetic Ingredient Review.

The Expert Panel for Cosmetic Ingredient Safety reviewed information that has become available since their original assessment from 2001, along with updated information regarding product types, and frequency and concentrations of use, and reaffirmed their original conclusion that Lard, Hydrogenated Lard, Lard Glyceride, Hydrogenated Lard Glyceride, Lard Glycerides, and Hydrogenated Lard Glycerides are safe as cosmetic ingredients in the practices of use and concentration as described in this report., Competing Interests: Declaration of Conflicting InterestsThe author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.

The Expert Panel for Cosmetic Ingredient Safety reviewed newly available studies since their original assessment in 2003, along with updated information regarding product types and concentrations of use, and confirmed that Sodium Naphthalenesulfonate and Sodium Polynaphthalenesulfonate are safe as cosmetic ingredients in the practices of use and concentration as described in this report in formulations intended to be applied to the skin., Competing Interests: Declaration of Conflicting InterestsThe author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.

The Expert Panel for Cosmetic Ingredient Safety reviewed updated information that has become available since their original assessment from 1980, along with updated information regarding product types, and frequency and concentrations of use, and reaffirmed their original conclusion that Isopropyl Lanolate is safe as a cosmetic ingredient in the practices of use and concentration as described in this report., Competing Interests: Declaration of Conflicting InterestsThe author(s) declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: The articles in this supplement were sponsored by the Cosmetic Ingredient Review.

The Expert Panel for Cosmetic Ingredient Safety (Panel) assessed the safety of 274 polyglyceryl fatty acid esters. Each of the esters in this group is a polyether comprising 2 to 20 glyceryl residues, end-capped by esterification with simple carboxylic acids, such as fatty acids. Most of these ingredients are reported to function in cosmetics as skin-conditioning agents and/or surfactants. The Panel reviewed the available data and considered conclusions from their relevant previous reports, and determined 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-irritating.

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) 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) 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 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 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) assessed the safety of 6 carbonate salts which function as absorbents, bulking agents, opacifying agents, pH adjusters, buffering agents, abrasives, and oral care agents in cosmetic products. The Panel reviewed relevant data relating to the safety of these ingredients, and concluded that these carbonate salts 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 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) 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) 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 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 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.

Cosmetic ingredients derived from Camellia sinensis (tea) plant parts function as antioxidants and skin conditioning agents-humectant and miscellaneous. The Cosmetic Ingredient Review (CIR) Expert Panel (Panel) reviewed relevant animal and human data related to these ingredients. The use of the leaf ingredients in beverages results in much larger systemic exposures than those possible from cosmetic use. Accordingly, concern over the systemic toxicity potential of leaf-derived ingredients is mitigated. Because product formulations may contain multiple botanical ingredients, 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 concluded that the C sinensis leaf-derived ingredients are safe in the present practices of use and concentration described in this safety assessment when formulated to be nonsensitizing. However, the available data are insufficient to determine whether the non-leaf-derived ingredients are safe for use in cosmetics.

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 (CIR) Expert Panel (Panel) assessed the safety of 14 tocopherols and tocotrienols and concluded these ingredients are safe as used in cosmetics. The tocopherols are reported to function in cosmetics as antioxidants or skin-conditioning agents; in contrast, tocotrienols are not reported to function as an antioxidants in cosmetics but as a light stabilizer, oral care agent, or skin-conditioning agent. The Panel reviewed the new and existing animal and clinical data to determine the safety of these ingredients and found it appropriate to extrapolate the existing information to conclude on the safety of all the tocopherols and tocotrienols.

The Cosmetic Ingredient Review Expert Panel assessed the safety of 47 polyethylene glycols (PEGs) cocamine and related ingredients, which are reported to function mostly as surfactants and antistatic agents. The Panel reviewed the relevant data and developed a framework to satisfy previously identified data deficiencies for this group of materials as well as extend the scope of related materials covered by the analysis. The irritation potential of these ingredients is consistent with the surface active properties that are characteristic of surfactants. The Panel concluded that the PEGs cocamine and related ingredients were safe as ingredients in cosmetic formulations in the current practices of use and concentration when formulated to be nonirritating.

The Cosmetic Ingredient Review Expert Panel (Panel) reviewed the safety of polyethylene glycol (PEG)-150 pentaerythrityl tetrastearate, which functions as a viscosity-increasing agent-aqueous in cosmetic products and is being used at concentrations up to 5%. Given the chemical structure (large molecule), skin penetration is not likely. The available toxicity data and the low ingredient use concentrations suggest that systemic toxicity would not be likely even if percutaneous absorption were to occur. Additionally, the negative human repeated insult patch test data on the undiluted ingredient were deemed sufficient for evaluating skin irritation and sensitization potential. The Panel concluded that PEG-150 pentaerythrityl tetrastearate is safe in cosmetics in the present practices of use and concentration described in this safety assessment.

Dimethiconol and its esters and reaction products are used in cosmetics as either skin-conditioning agents or hair-conditioning agents. The Cosmetic Ingredient Review (CIR) Expert Panel reviewed relevant data and concluded that these ingredients are safe in the present practices of use and concentration described in this safety assessment. While there is an absence of data on reproductive and developmental toxicity and limited tumorigenicity and toxicokinetics data, the Panel reasoned that these ingredients would not be absorbed through the skin, obviating concern over potential reproductive and developmental toxicity or carcinogenicity.

The Cosmetic Ingredient Review Expert Panel (Panel) assessed the safety of 244 plant-derived fatty acid oils as used in cosmetics. Oils are used in a wide variety of cosmetic products for their skin conditioning, occlusive, emollient, and moisturizing properties. Since many of these oils are edible, and their systemic toxicity potential is low, the review focused on potential dermal effects. The Panel concluded that the 244 plant-derived fatty acid oils are safe as used in cosmetics.

Benzyl alcohol, benzoic acid and its salts, and benzyl benzoate function mostly as fragrance ingredients/preservatives in cosmetic products. The Cosmetic Ingredient Review Expert Panel previously established concentration limits for benzyl alcohol, benzoic acid, and sodium benzoate in cosmetics and determined that the available data were insufficient to support the safety of these ingredients during inhalation exposure. After reviewing newly available data, it was concluded that benzyl alcohol, benzoic acid and its salts, and benzyl benzoate are safe in the present practices of use and concentration described in this safety assessment.

The Cosmetic Ingredient Review (CIR) Expert Panel assessed the safety of diethanolamine and its salts as used in cosmetics. Diethanolamine functions as a pH adjuster; the 16 salts included in this rereview reportedly function as surfactants, emulsifying agents, viscosity increasing agents, hair or skin conditioning agents, foam boosters, or antistatic agents. The Panel reviewed available animal and clinical data, as well as information from previous CIR reports. Since data were not available for each individual ingredient, and since the salts dissociate freely in water, the Panel extrapolated from previous reports to support safety. The Panel concluded that diethanolamine and its salts are safe for use when formulated to be nonirritating. These ingredients should not be used in cosmetic products in which N-nitroso compounds can be formed.

The Cosmetic Ingredient Review (CIR) Expert Panel assessed the safety of cross-linked alkyl acrylates as used in cosmetics. The 23 cross-linked alkyl acrylates included in this safety assessment are reported to function as absorbents, film formers, emulsion stabilizers, viscosity increasing agents, suspending agents, binders, and/or skin-conditioning agents. The Panel reviewed available animal and clinical data, as well as information from previous CIR reports on monomer components. Because data were not available for the individual ingredients, and because residual monomer may be present, the Panel extrapolated from previous reports to support safety. The Panel concluded that cross-linked alkyl acrylates are safe in the present practices of use and concentration, provided that they are not polymerized in benzene. For those ingredients polymerized in benzene, the data available were insufficient to make a determination of safety. A risk assessment for the amount of benzene present would be needed.

Formic acid functions as a fragrance ingredient, preservative, and pH adjuster in cosmetic products, whereas sodium formate functions as a preservative. Because of its acidic properties, formic acid is a dermal and ocular irritant. However, when used as a pH adjuster in cosmetic formulations, formic acid will be neutralized to yield formate salts, for example, sodium formate, thus minimizing safety concerns. Formic acid and sodium formate have been used at concentrations up to 0.2% and 0.34%, respectively, with hair care products accounting for the highest use concentrations of both ingredients. The low use concentrations of these ingredients in leave-on products and uses in rinse-off products minimize concerns relating to skin/ocular irritation or respiratory irritation potential. The Cosmetic Ingredient Review Expert Panel concluded that formic acid and sodium formate are safe in the present practices of use and concentration in cosmetics, when formulated to be nonirritating., (© The Author(s) 2016.)

The Cosmetic Ingredient Review Expert Panel (Panel) reviewed the safety of methyl glucose polyethers and esters which function in cosmetics as skin/hair-conditioning agents, surfactants, or viscosity increasing agents. The esters included in this assessment are mono-, di-, or tricarboxyester substituted methyl glucosides, and the polyethers are mixtures of various chain lengths. The Panel reviewed available animal and clinical data, including the molecular weights, log K ow s, and other properties in making its determination of safety on these ingredients. Where there were data gaps, similarities between molecular structures, physicochemical and biological characteristics, and functions and concentrations in cosmetics allowed for extrapolation of the available toxicological data to assess the safety of the entire group. The Panel concluded that there likely would be no significant systemic exposure from cosmetic use of these ingredients, and that these ingredients are safe in cosmetic formulations in the present practices of use and concentration., (© The Author(s) 2016.)

This is a safety assessment of alumina and aluminum hydroxide as used in cosmetics. Alumina functions as an abrasive, absorbent, anticaking agent, bulking agent, and opacifying agent. Aluminum hydroxide functions as a buffering agent, corrosion inhibitor, and pH adjuster. The Food and Drug Administration (FDA) evaluated the safe use of alumina in several medical devices and aluminum hydroxide in over-the-counter drugs, which included a review of human and animal safety data. The Cosmetic Ingredient Review (CIR) Expert Panel considered the FDA evaluations as part of the basis for determining the safety of these ingredients as used in cosmetics. Alumina used in cosmetics is essentially the same as that used in medical devices. This safety assessment does not include metallic or elemental aluminum as a cosmetic ingredient. The CIR Expert Panel concluded that alumina and aluminum hydroxide are safe in the present practices of use and concentration described in this safety assessment., (© The Author(s) 2016.)

Cosmetic ingredients derived from Achillea millefolium function in cosmetics as skin-conditioning agents-miscellaneous, skin-conditioning agents-humectants, and fragrance ingredients. The Cosmetic Ingredient Review Expert Panel (Panel) reviewed relevant animal and human data to determine their safety in cosmetics and raised concerns about cosmetics containing linalool, thujone, quercetin, hydroquinone, or α-peroxyachifolid. Because final product formulations may contain multiple botanicals, each containing similar constituents of concern, formulators are advised to be aware of these components and to avoid reaching levels that may be hazardous to consumers. Additionally, industry was advised to use good manufacturing practices to limit impurities. The Panel concluded that achillea millefolium extract, achillea millefolium flower extract, and achillea millefolium flower/leaf/stem extract are safe in the present practices of use and concentration in cosmetics when formulated to be nonsensitizing., (© The Author(s) 2016.)

The Cosmetic Ingredient Review Expert Panel (CIR Panel) reviewed the safety of hydroxypropyl bis(N-Hydroxyethyl-p-Phenylenediamine) HCl, which functions as an oxidative hair dye ingredient. The Panel considered relevant animal and human data provided in this safety assessment and concluded that hydroxypropyl bis(N-hydroxyethyl-p-phenylenediamine) HCl is safe for use in oxidative hair dye formulations as described in this safety assessment., (© The Author(s) 2016.)

Polyquaternium-22 and polyquaternium-39 are polymers that function as antistatic agents, film formers, and hair fixatives in cosmetic products. These ingredients are being used at concentrations up to 2% (polyquaternium-22, in a rinse-off product) and up to 3% (polyquaternium-39, in rinse-off and leave-on products). The unreacted monomer content of these ingredients was considered low and of no toxicological concern. Limited data showed no skin irritation/sensitization. Although these ingredients were nongenotoxic in bacterial assays, mammalian genotoxicity, carcinogenicity, and reproductive and developmental toxicity data were not available. These polymers, however, are large, highly polar molecules that would likely not be absorbed, and neither local effects in the respiratory tract nor systemic toxicity are expected following product application/exposure. The Expert Panel concluded that polyquaternium-22 and polyquaternium-39 are safe in the present practices of use and concentration in cosmetic formulations., (© The Author(s) 2016.)

The Cosmetic Ingredient Review (CIR) Expert Panel (Panel) assessed the safety of 8 dialkyl sulfosuccinate salts for use in cosmetics, finding that these ingredients are safe in cosmetics in the present practices of use and concentration when formulated to be nonirritating. The dialkyl sulfosuccinate salts primarily function as surfactants in cosmetics. The Panel reviewed the new and existing available animal and clinical data in making its determination of safety. The Panel found it appropriate to extrapolate the data on diethylhexyl sodium sulfosuccinate to assess the safety of the entire group because all of the diesters are of a similar alkyl chain length, all are symmetrically substituted, and all have similar functions in cosmetic formulations., (© The Author(s) 2016.)

The Cosmetic Ingredient Review Expert Panel assessed the safety of 34 microbial polysaccharide gums for use in cosmetics, finding that these ingredients are safe in cosmetic formulations in the present practices of use and concentration. The microbial polysaccharide gums named in this report have a variety of reported functions in cosmetics, including emulsion stabilizer, film former, binder, viscosity-increasing agent, and skin-conditioning agent. The Panel reviewed available animal and clinical data in making its determination of safety., (© The Author(s) 2016.)

The Cosmetic Ingredient Review Expert Panel (the Panel) assessed the safety of nitrocellulose and collodion as used in cosmetics, concluding that these ingredients are safe in the present practices of use and concentration in cosmetic formulations. Both ingredients are used almost exclusively in nail product formulations. The maximum concentration of use of nitrocellulose in nail polish and enamels is 22%; for collodion, the maximum reported concentration of use in nail polish and enamel is 14%. The Panel reviewed available animal and clinical data in making its determination of safety., (© The Author(s) 2016.)

The Cosmetic Ingredient Review (CIR) Expert Panel assessed the safety of 131 alkyl polyethylene glycol (PEG)/polypropylene glycol ethers as used in cosmetics, concluding that these ingredients are safe in the present practices of use and concentration described in this safety assessment when formulated to be nonirritating. Most of the alkyl PEG/PPG ethers included in this review are reported to function in cosmetics as surfactants, skin-conditioning agents, and/or emulsifying agents. The alkyl PEG/PPG ethers share very similar physiochemical properties as the alkyl PEG ethers, which were reviewed previously by the CIR Expert Panel and found safe when formulated to be nonirritating. The alkyl PEG ethers differ by the inclusion of PPG repeat units, which are used to fine-tune the surfactant properties of this group. The Panel relied heavily on data on analogous ingredients, extracted from the alkyl PEG ethers and PPG reports, when making its determination of safety., (© The Author(s) 2016.)