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46 REGULATIONS


panel assessed the safety of 8 Hamamelis virginiana (witch hazel) derivatives and concluded that they are safe in cosmetic products in the present practices of use and concentration as described in their safety assessment when formulated to be non- irritating and non-sensitising.5


The panel’s


concern that Hamamelis virginiana derived ingredients may be irritating was based on them being astringents and being applied near to the eyes and mucous membranes. The panel expressed concern that when used with other botanical ingredients the final formulation may have the potential to be sensitising.


Zinc salts


The Cosmetic Ingredient Review expert panel assessed the safety of inorganic and organometallic zinc salts. All the zinc salts have the Zn2


+ cation. They concluded that


they are safe in cosmetic products in the present practices of use and concentrations described in their safety assessment providing they are formulated to be non- irritating.6


Of the zinc salts assessed Zinc


Stearate was reported to be used up to 32% in eye shadow and Zinc Myristate up to 20% in eye shadow and face powder. Zinc Stearate and Zinc Citrate are reported to be used up to 2% in dentrifices. Zinc Myristate is used up to 5% in lipstick formulations.


Triphenyl phosphate The Cosmetic Ingredient Review expert panel assessed the safety of Triphenyl Phosphate and concluded that it was safe in cosmetic products in the present practices of use and concentrations in leave-on nail preparations.7


The use levels they


considered were from 1% in nail lotions to 14.5% in polish strips. It is used at up to 11.9% for nail enamels.


Eucalyptus globulus derived ingredients The Cosmetic Ingredient Review expert panel has reviewed the use of 6 Eucalyptus globulus (Eucalyptus) derived ingredients.8 Ingredients include Eucalyptus Globulus Leaf, Eucalyptus Globulus Leaf Extract, Eucalyptus Globulus Leaf Oil, Eucalyptus Globulus Leaf Powder, Eucalyptus Globulus Leaf/Twig Oil and Eucalyptus Globulus Leaf Water. They are used as abrasives, fragrance ingredients, and skin conditioning agents. The Cosmetic Ingredient Review expert Panel has concluded that all six ingredients are safe in cosmetic products in the present practices of use when formulated to be non-sensitising.


Dialkyl Dimer Dilinoleates Six dialkyl dimer dilinoleates were assessed for safety by the Cosmetic Ingredient Review expert panel in 2003 and found to be safe as


PERSONAL CARE NORTH AMERICA


used in cosmetic formulations. Dialkyl dimer dilinoleates are diesters formed from the reaction of straight chained or branched alkyl alcohols with Dilinoleic Acid. After 15 years the Cosmetic Ingredient Review expert panel is required to re-evaluate the conclusions of previously issued reports. The panel decided to assess the safety of Diisopropyl Dimer Dilinoleate, Dicetearyl Dimer Dilinoleate, Distearyl Dimer Dilinoleate, Diethylhexyl Dimer Dilinoleate, Dioctyldodecyl Dimer Dilinoleate, Ditridecyl Dimer Dilinoleate, Di – C16-18 Alkyl Dimer Dilinoleate and Di –C20- 40 Alkyl Dimer Dilinoleate. The panel concluded that the 8 dialkyl dimer dilinoleates are safe in cosmetic products in the present practices of use and concentrations as described in their safety assessment.9


Ginkgo


The Cosmetic Ingredient Review expert panel has assessed the safety of 10 Ginkgo biloba derivatives and concluded that 5 Ginkgo biloba leaf derived ingredients are safe in the present practises of use and concentration when formulated to be non- sensitising.10


The 5 ingredients are Ginkgo


Biloba Leaf Extract, Ginkgo Biloba Leaf, Ginkgo Biloba Leaf Cell Extract, Ginkgo Biloba Leaf Powder and Ginkgo Biloba Leaf Water. For the other 5 ingredients there was insufficient data to determine their safety in cosmetic products. The panel was concerned that Ginkgo biloba derived ingredients may be dermal skin sensitisers as they contain ginkgolic acid. Manufacturers are advised to formulate products containing Ginkgo biloba derivatives to avoid skin sensitisation especially when using them with other botanical ingredients.


Hydrogen peroxide The Cosmetic Ingredient Review expert panel has assessed the safety of Hydrogen Peroxide and concluded that Hydrogen Peroxide is safe in cosmetic products when used in the present practices of use and


concentrations as stated in their safety assessment.11


In their safety assessment they


considered exposure from its uses at up to 4% in leave–on products; 15% for rinse - off products; 0.000002% in products for the eye area; 4.6% for products that could be incidentally ingested (oral hygiene products); 4% for sprays which can be incidentally inhaled; 0.000002% from powders that could be incidentally inhaled; 3% for products which come in contact with the skin (dermal products); 4% for non-coloring hair products; 15% for hair coloring products; 4.6% for products used on the mucous membrane and 0.0019% in baby products.


Polyfluorinated polymers The Cosmetic Ingredient Review expert panel considered the safety of 12 polyfluorinated polymers and concluded that PTFE and Hexafluoropropylene/Tetrafluoroethylene Copolymer are safe in cosmetic products in the present practices of use and concentrations described in their safety assessment.12


Data was insufficient to


determine the safety of 10 polyfluorinated polymers which are not currently used in cosmetic products. The Cosmetic Ingredient Review expert panel considered the use of PTFE at up to 13% in products intended for the eye area, 12% in dermal products, 3% in face powders and 2.4% in hair coloring products.


Polyol phosphates The Cosmetic Ingredient Review expert panel has assessed the safety of 10 polyol phosphates. The panel concluded that Sodium Phytate, Phytin, Phytic Acid and Trisodium Inositol Triphosphate are safe in cosmetic products in the present practices of use and concentrations as described in their safety assessment.13


There was insufficient


data for Disodium Glucose Phosphate, Manganese Fructose Diphosphate, Sodium Mannose Phosphate, Trisodium Fructose Diphosphate, Xylityl Phosphate and Zinc Fructose Diphosphate to determine that they are safe in cosmetic products.


Ginkgo. May 2019


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