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

The Expert Panel for Cosmetic Ingredient Safety (Panel) reviewed the safety of 8 palm tree (Euterpe edulis (juçara) and Euterpe oleracea (açaí))-derived ingredients as used in cosmetic products; these ingredients are reported to function mostly as skin conditioning agents. The Panel reviewed relevant data relating to the safety of these ingredients in cosmetic formulations. Industry should continue to use good manufacturing practices to limit impurities. The Panel concluded that palm tree (açaí and juçara)-derived ingredients are safe in cosmetics in the present practices of use and concentration described in this safety assessment.

Safety Assessment of Capryloyl Salicylic Acid as Used in Cosmetics.

The Expert Panel for Cosmetic Ingredient Safety (Panel) reassessed the safety of Capryloyl Salicylic Acid in cosmetic products; this ingredient is reported to function as a skin conditioning agent. The Panel reviewed relevant data relating to the safety of this ingredient in cosmetic formulations, and concluded that the available data are insufficient to make a determination that Capryloyl Salicylic Acid is safe under the intended conditions of use in cosmetic formulations.

Safety Assessment of Polyfluorinated Polymers as Used in Cosmetics.

The Expert Panel for Cosmetic Ingredient Safety (Panel) reviewed the safety of 12 polyfluorinated polymers in cosmetic products; most of these ingredients have the reported function of film former in common. However, PTFE, the only ingredient that is reported as currently used in cosmetics, functions as a bulking agent and slip modifier, but not as a film former. The Panel reviewed data relevant to the safety of these ingredients under the intended conditions of use in cosmetic formulations, and concluded that PTFE and Hexafluoropropylene/Tetrafluoroethylene Copolymer are safe in cosmetics in the present practices of use and concentration described in the safety assessment; the data are insufficient to determine the safety of the 4 fluorinated-side-chain polymers and 6 fluorinated polyethers.

Methacrylate Ester Monomers.

The Expert Panel for Cosmetic Ingredient Safety reviewed newly available studies since their original assessment in 2005, along with updated information regarding product types and concentrations of use, and confirmed that these 22 methacrylate ester monomers are safe as used in nail enhancement products in the practices of use and concentration as described in this report, when skin contact is avoided.

Amended Safety Assessment of Mentha piperita (Peppermint)-Derived Ingredients as Used in Cosmetics.

The Expert Panel for Cosmetic Ingredient Safety (Panel) reviewed the safety of M piperita (peppermint)-derived ingredients. The Panel reviewed data relevant to the safety of these ingredients. Because final product formulations may contain multiple botanicals, each containing the same constituent(s) of concern, formulators are advised to be aware of these constituents and 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. The Panel concluded that M piperita (Peppermint) Oil, Extract, Leaf, and leaf-derived ingredients are safe in cosmetics in the present practices of use and concentration when formulated to be non-sensitizing, and that the available data are insufficient for determining that M piperita (Peppermint) Flower/Leaf/Stem Extract, M piperita (Peppermint) Flower/Leaf/Stem Water, and M piperita (Peppermint) Meristem Cell Culture are safe under the intended conditions of use in cosmetic formulations.

Sulfites.

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 Sulfite, Potassium Sulfite, Ammonium Sulfite, Sodium Bisulfite, Ammonium Bisulfite, Sodium Metabisulfite, and Potassium Metabisulfite are safe as cosmetic ingredients in the practices of use and concentration as described in this report.

Quaternium-26.

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.

Acetyl Trialkyl Citrates.

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.

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.

Amended Safety Assessment of Persulfates as Used in Cosmetics.

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.

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 Ethers and Esters of Ascorbic Acid as Used in Cosmetics.

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.

Safety Assessment of Phosphoric Acid and Its Salts as Used in Cosmetics.

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.

Safety Assessment of Polyaminopropyl Biguanide (Polyhexamethylene Biguanide Hydrochloride) as Used in Cosmetics.

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.

Safety Assessment of Silk Protein Ingredients as Used in Cosmetics.

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.

Safety Assessment of Lecithin and Other Phosphoglycerides as Used in Cosmetics.

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.

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 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.