Pyrus Malus (Apple) Fiber

Apples, the fruit of the plant from which these ingredients are derived, are listed by the Food and Drug Administration (FDA) among the 20 most commonly consumed fruits. The FDA includes pectin, including pectin derived from apples, on its list of substances considered 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 direct food substances. 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.

Link to FDA Code of Federal Regulations for apples and apple pectin:

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

The apple-derived ingredients 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

In selecting plant-derived ingredients cosmetics and personal care 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.