Safety Assessment of Trialkyl Trimellitates as Used in Cosmetics.

The Expert Panel for Cosmetic Ingredient Safety (Panel) assessed the safety of 5 trialkyl trimellitates. These ingredients, which are all structurally related as alkyl esters of trimellitic acid, are reported to function in cosmetics as skin conditioning agents; 2 of the ingredients are also reported to function in cosmetics as plasticizers. The Panel reviewed the available data to determine the safety of these ingredients, and concluded that the trialkyl trimellitates are safe in the current practices of use and concentration when formulated to be non-irritating.

Sodium Naphthalenesulfonate and Sodium Polynaphthalenesulfonate.

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.

Sodium α-Olefin Sulfonates.

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.

Lard and Lard-Derived Ingredients.

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.

Safety Assessment of Polyglyceryl Fatty Acid Esters as Used in Cosmetics.

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.

Safety Assessment of Helianthus annuus (Sunflower)-Derived Ingredients as Used in Cosmetics.

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.

Safety Assessment of Apple-Derived Ingredients as Used in Cosmetics.

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.

Safety Assessment of Centella asiatica-Derived Ingredients as Used in Cosmetics.

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.

Safety Assessment of Rosa canina-derived Ingredients as Used in Cosmetics.

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.

Safety Assessment of Carbonate Salts as Used in Cosmetics.

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.

Safety Assessment of 1-Hydroxyethyl 4,5-Diamino Pyrazole Sulfate as Used in Cosmetics.

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.

Safety Assessment of Hydrofluorocarbon 152a as Used in Cosmetics.

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.

Amended Safety Assessment of Butyl Polyoxyalkylene Ethers as Used in Cosmetics.

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.

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 Keratin and Keratin-Derived Ingredients as Used in Cosmetics.

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.

Safety Assessment of Saccharide Esters as Used in Cosmetics.

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.

Safety Assessment of Inorganic Hydroxides as Used in Cosmetics.

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.

Safety Assessment of Citrus Fruit-Derived Ingredients as Used in Cosmetics.

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).

Safety Assessment of Citrus Plant- and Seed-Derived Ingredients as Used in Cosmetics.

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.

Final Amended Safety Assessment of Sodium Sulfate as Used in Cosmetics.

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.