Bertholletia Excelsa Seed Oil

The safety of Bertholletia Excelsa Seed Oil 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 scientific data and concluded that this ingredient was safe for use in cosmetics and personal care products. Botanical and botanically derived ingredients used in the formulation of cosmetics are generally mild and safe. Prior to marketing the finished cosmetic product, the safety of each ingredient must be substantiated in accordance with 21 CFR 740.10. Safety substantiation of cosmetic ingredients may include tests for ocular and skin irritation as well as allergenicity, phototoxicity, photoallergenicity and mutagenicity, depending on the application or intended use. There is a considerable body of information about the safety of botanical ingredients and a well-established history of use. These resources are consulted to ensure the safety of these materials as they are used in cosmetics.

CIR Safety Review:

Bertholletia Excelsa Seed Oil was included in the CIR Expert Panel’s review of plant-derived fatty acids oils. Based on a history of safe use in food, the composition of the oils, and data indicating these ingredients were not dermal irritants or sensitizers, the CIR Expert Panel concluded that plant-derived 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. oils including Bertholletia Excelsa Seed Oil were safe as used in cosmetic products.

Some people are allergic to tree nuts including Brazil nuts. Therefore, the FDA Food Allergen Labeling and Consumer Protection Act requires that all food containing Brazil nuts be clearly labeled.

Information about the FDA Food Allergen Labeling and Consumer Protection Act http://www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/Guidance…

More information about botanical ingredients.

Bertholletia Excelsa Seed Oil 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_packaging/co0013_en.htm