Cosmetic Ingredient Review Expert Panel Research Articles

Are cosmetics based on alpha hydroxy acids safe to use when purchased over the internet?

Alpha hydroxy acids (AHAs) are used in dermatology for topical treatment of skin disorders. Some regulatory bodies, including Food and Drug Administration (FDA), recommended labeling cosmetic products with sunburn alerts and proposed limitations regarding concentrations of AHAs in cosmetic products. In addition, The Cosmetic Ingredient Review (CIR) Expert Panel recommended 10% of AHAs in products as the maximal safe concentration. With a rapidly increasing trend of online purchasing of cosmetic products, it is important that their labels convey the necessary warnings and that they be harmonized with regulatory bodies regarding the recommended concentrations of AHAs. The aim of this report was to investigate whether or not the sunburn alert, as well as AHA recommendations mostly used for exfoliating cosmetic products, was visible to consumers during the online purchasing. The compliance with FDA and CIR Expert Panel standards was analyzed in the first 50 cosmetic products obtained after the conducted investigation on the Amazon.com e-commerce company website using the search term "AHA anti-aging." It was found that exfoliating cosmetic products contained AHAs in a broad range of concentrations, from 2.5 up to 70%. Nineteen out of 50 products contained a concentration of AHAs greater than recommended. Twelve products did not contain any data at all regarding the concentration of AHAs. Sunburn alerts were present in 16 out of 50 analyzed product pages. In conclusion, more efforts should be made in providing users with information and the necessity of protection from potential complications after topical AHAs product treatments.

Hair Dye Ingredients and Potential Health Risks from Exposure to Hair Dyeing.

Given the worldwide popularity of hair dyeing, there is an urgent need to understand the toxicities and risks associated with exposure to chemicals found in hair dye formulations. Hair dyes are categorized as oxidative and nonoxidative in terms of their chemical composition and ingredients. For several decades, the expert panel’s Cosmetic Ingredient Review (CIR) has assessed the safety of many of the chemicals used in hair dyes; however, a comprehensive review of hair dye ingredients and the risk of exposure to hair dyeing has not been documented. Herein, we review the safety of the various chemicals in oxidative and nonoxidative hair dyes, toxicities associated with hair dyeing, and the carcinogenic risks related to hair dyeing. While many compounds are considered safe for users at the concentrations in hair dyes, there are conflicting data about a large number of hair dye formulations. The CIR expert panel has ratified a number of coloring ingredients for hair dyes and banned a series of chemicals as carcinogenic to animals and unsafe for this application. The use of these chemicals as raw materials for producing hair dyes may result in the synthesis of other contaminants with potential toxicities and increased risk of carcinogenesis. It is an open question whether personal or occupational hair dyeing increases the risk of cancer; however, in specific subpopulations, a positive association between hair dye use and cancer occurrence has been reported. To address this question, a better understanding of the chemical and mechanistic basis of the reported toxicities of hair dye mixtures and individual hair dye ingredients is needed. It is anticipated that in-depth chemical and systems toxicology studies harnessing modern and emerging techniques can shed light on this public health concern in the future.

Safety Assessment of Citrus Flower- and Leaf-Derived Ingredients as Used in Cosmetics.

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.

Safety Assessment of Glycerin as Used 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.

Safety Assessment of Camellia sinensis-Derived Ingredients As Used in Cosmetics.

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.

Safety Assessment of Sorbitan Esters as Used in Cosmetics

The Cosmetic Ingredient Review Expert Panel (Panel) assessed the safety of 20 sorbitan esters; this report included sorbitan esters that were reviewed in 1985 and 2002, as well as 3 previously unreviewed sorbitan esters (sorbitan undecylenate, sorbitan sesquicaprylate, and sorbitan palmate). Most of the sorbitan esters are reported to function in cosmetics as surfactant-emulsifying agents. The Panel reviewed the data from previous sorbitan ester reports, as well as additional data included in this report, to determine the safety of these ingredients. The Panel concluded that the sorbitan esters included in this safety assessment are safe in cosmetics in the present practices of use and concentration.

Safety Assessment of Citrus-Derived Peel Oils as Used in Cosmetics.

The Cosmetic Ingredient Review Expert Panel assessed the safety of 14 citrus-derived peel oil ingredients and concluded that these ingredients are safe for use in cosmetic products when finished products, excluding rinse-off products, do not contain more than 0.0015% (15 ppm) 5-methoxypsoralen, and when formulated to be nonsensitizing and nonirritating. The citrus-derived peel oil ingredients are most frequently reported to function in cosmetics as fragrances and/or skin conditioning agents. The Panel reviewed the available animal and clinical data to determine the safety of 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 that could be present in botanical ingredients.

Safety Assessment of PCA (2-Pyrrolidone-5-Carboxylic Acid) and Its Salts as Used in Cosmetics.

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.

Safety Assessment of Fatty Acid Amidopropyl Dimethylamines as Used in Cosmetics

The Cosmetic Ingredient Review Expert Panel (Panel) reviewed the safety of fatty acid amidopropyl dimethylamines, which function primarily as antistatic agents in cosmetic products. The relevant animal and human data reviewed for these ingredients indicate that they are potential dermal sensitizers that may be due in part by the sensitizing impurity, 3,3-dimethylaminopropylamine. The Panel concluded that fatty acid amidopropyl dimethylamines were safe as cosmetic ingredients when they are formulated to be nonsensitizing, which may be based on a quantitative risk assessment.

Safety Assessment of Monosaccharides, Disaccharides, and Related Ingredients as Used in Cosmetics.

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.

Amended Safety Assessment of Methylisothiazolinone as Used in Cosmetics.

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.

Safety Assessment of Rosmarinus officinalis (Rosemary)-Derived Ingredients as Used in Cosmetics

The Cosmetic Ingredient Review Expert Panel (Panel) assessed the safety of 10 Rosmarinus officinalis (rosemary)-derived ingredients and concluded these ingredients are safe as used in cosmetics when formulated to be nonsensitizing. The R officinalis-derived ingredients are most frequently reported to function in cosmetics as skin conditioning agents or as fragrance ingredients. The Panel reviewed the available animal and clinical data to determine the safety of 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 continue to use good manufacturing practices to limit impurities that could be present in botanical ingredients.

Amended Safety Assessment of Chamomilla recutita-Derived Ingredients as Used in Cosmetics

The Chamomilla recutita-derived ingredients in this assessment are reported to function mostly as fragrance ingredients and 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. Additionally, industry should continue to use good manufacturing practices to limit impurities that could be present in botanical ingredients. The Cosmetic Ingredient Review Expert Panel concluded that the Chamomilla recutita-derived ingredients are safe in cosmetics in the present practices of use and concentration described in the safety assessment when formulated to be nonsensitizing.

Safety Assessment of Pentaerythrityl Tetra-Di-t-Butyl Hydroxyhydrocinnamate as Used in Cosmetics

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.

Safety Assessment of Barium Sulfate as Used 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.

Safety Assessment of PEGs Cocamine and Related Ingredients as Used in Cosmetics.

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.

Safety Assessment of PEG-150 Pentaerythrityl Tetrastearate as Used in Cosmetics.

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.

Safety Assessment of Tocopherols and Tocotrienols as Used in Cosmetics.

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.

Safety Assessment of Alkyl Betaines as Used in Cosmetics.

The Cosmetic Ingredient Review Expert Panel (Panel) reviewed the safety of 11 alkyl betaines as used in cosmetics. These ingredients are reported to function as hair and skin conditioning agents, antistatic agents, surfactants-cleansing agents, and viscosity-increasing agents in cosmetic products. Although there are data gaps, the shared chemical core structure, similar functions and concentrations of use in cosmetics, and the expected similarities in physicochemical properties enabled grouping these ingredients and reading across the available toxicological data to support the safety assessment of each individual compound in the entire group. The Panel concluded alkyl betaines were safe as cosmetic ingredients in the present practices of use and concentration, when formulated to be nonirritating.

Safety Assessment of Magnesium Sulfate as Used in Cosmetics.

The Cosmetic Ingredient Review Expert Panel (Panel) reviewed the safety of magnesium sulfate, which functions as a bulking agent in cosmetic products and is reportedly used at concentrations up to 11% and 25% in leave-on and rinse-off products, respectively. The Panel noted that the history of safe medical use of magnesium sulfate provides further confidence that there are no significant toxicity concerns relating to systemic exposure to this ingredient after cosmetic product application. Furthermore, the extensive clinical experience of the Panel, including the results of numerous patch tests, indicates that magnesium salts do not have the potential to induce sensitization. The Panel also noted that results were negative for 50% magnesium sulfate in a mouse skin irritation study and in an in vitro sensitization assay. The Panel concluded that magnesium sulfate is safe in cosmetics in the present practices of use and concentration described in the safety assessment.