Hydrogenated Apricot Kernel Oil

The Food and Drug Administration (FDA) has reviewed the safety of Apricot Kernel Oil and determined that it is Generally Recognized As Safe (GRAS“GRAS” is an acronym for the phrase Generally Recognized As Safe. Under sections 201(s) and 409 of the Federal Food, Drug, and Cosmetic Act (the Act), any substance that is intentionally added to food is a food additive, that is subject to premarket review and approval by FDA, unless the substance is generally recognized, among qualified experts, as having been adequately shown to be safe under the conditions of its intended use, or unless the use of the substance is otherwise excluded from the definition of a food additive.) as a natural extractive. The safety of Prunus Armeniaca (Apricot) Kernel Oil and Hydrogenated Apricot Kernel 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 these ingredients were 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:

Prunus Armeniaca (Apricot) Kernel Oil and Hydrogenated Apricot Kernel were 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 that 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 Prunus Armeniaca (Apricot) Kernel Oil and Hydrogenated Apricot Kernel were safe as used in cosmetic products.

Link to FDA Code of Federal Regulations for Apricot Kernel Oil

• http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr…
• http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr…

In selecting plant-derived ingredients for preparation of cosmetic products, formulators rely on the extensive history of their preparation and use. Such materials have been used for a long time and, based upon this experience; extensive knowledge of their safety has been gained. In the situation of newly identified botanicals in the cosmetic industry, appropriate ocular and skin safety studies are conducted prior to release into general commerce. There are many different references that describe the isolation, use and safety of botanical preparations.

More information about botanical ingredients.

Apricot Kernel 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