Sorbeth-8 Beeswax

The safety of Sorbeth-6 Beeswax, Sorbeth-8 Beeswax and Sorbeth-20 Beeswax has been assessed by the Cosmetic Ingredient ReviewThe Cosmetic Ingredient Review (CIR) was established in 1976 as an independent safety review program for cosmetic ingredients. The CIR Expert Panel consists of independent experts in dermatology, toxicology, pharmacolgy and veterinary medicine. The CIR includes participation by the U.S. Food & Drug Administration and the Consumer Federation of America. (CIR) Expert Panel. The CIR Expert Panel evaluated the scientific data and concluded that Sorbeth-6 Beeswax, Sorbeth-8 Beeswax and Sorbeth-20 Beeswax were safe for use as cosmetic ingredients.

CIR Safety Review: Few data on the Sorbeth Beeswax ingredients were available. This safety assessment relied upon the available data from previous safety assessments of Beeswax, Synthetic Beeswax, Sorbitan Esters, PEGs, and PEG Sorbitan fatty acidA natural organic compound that consists of a carboxyl group (oxygen, carbon and hydrogen) attached to a chain of carbon atoms with their associated hydrogen atoms. The chain of carbon atoms may be connected with single bonds, making a ‘saturated’ fat; or it may contain some double bonds, making an ‘unsaturated’ fat. The number of carbon and hydrogen atoms in the chain is what determines the qualities of that particular fatty acid. Animal and vegetable fats are made up of various combinations of fatty acids (in sets of three) connected to a glycerol molecule, making them triglycerides. esters, also known as Polysorbates. The esterAn organic compound formed by the reaction of an acid with an alcohol. linkage of PEG Sorbitan fatty acid esters was hydrolyzed after oral administration, and the PEG Sorbitan moiety was poorly absorbed from the gastrointestinal tract. Sorbitan Stearate was hydrolyzed to stearic acid and anhydrides of sorbitol. 

PEGs were readily absorbed through burned skin and were associated with kidney effects in burn patients. PEGs were not sensitizing to normal skin. PEGs did not cause reproductive toxicity, nor were they mutagenic or carcinogenic. Sorbitol was not a reproductive or developmental toxin in multigeneration studies. Neither Beeswax nor Synthetic Beeswax produced significant acute animal toxicity, ocular irritation, skin irritation, or skin sensitization. 

Polysorbates produced no acute or long-term effects, were generally not irritating or sensitizing, and were noncarcinogenic. Sorbitan fatty acid esters were relatively nontoxic via ingestion, generally were not skin irritants or sensitizers, and were not mutagenic or carcinogenic. Sorbeth-6 Beeswax delivered via a stomach tube was nontoxic in acute studies. 

Undiluted Sorbeth-6 Beeswax was nonirritating to the eyes and was nonirritating to intact and abraded skin. Sorbeth-20 Beeswax was only minimally irritating to eyes at concentrations as high as 30%, and a formulation containing 2% Sorbeth-20 Beeswax was not a significant skin irritant. In clinical tests, Sorbeth-6 Beeswax and Sorbeth-20 Beeswax at concentrations up to 3% were only minimally irritating and were not sensitizers. Small amounts of 1,4-dioxane, a by-product of ethoxylation, may be found in the Sorbeth Beeswax ingredients. The potential presence of this material is well known and can be controlled through purification steps to remove it from the ingredients before blending into cosmetic formulations. 

Link to more information about what the Food and Drug Administration (FDA) is doing to assure that cosmetics do not contain unsafe levels of 1,4-dioxane. 

http://www.fda.gov/Cosmetics/ProductandIngredientSafety/PotentialContami…

When conforming to European Union animal by-products legislation, Sorbeth-6 Beeswax, Sorbeth-8 Beeswax and Sorbeth-20 Beeswax may be used in cosmetics and personal care products marketed in Europe according to the general provisions of the Cosmetics Regulation of the European UnionUnder the general provisions of the cosmetics regulation of the EU, ingredients appearing on the following function-specific annexes must comply with the listed restrictions and/or specifications: colorants (Annex IV), preservatives (Annex V), UV filters (Annex VI) and other ingredients with specific concentration limits and/or other restrictions (Annex III). Ingredients specifically prohibited from use in cosmetic products are listed in Annex II. Other ingredients listed in the EU cosmetic ingredient database (CosIng) may be used without restrictions..

Link to the EU Cosmetic Regulation:
http://europa.eu/legislation_summaries/consumers/product_labelling_and_p…