The Food and Drug Administration (FDA) permits the use of achillea millefolium extract as a natural flavoring substance in beverages. The safety of the achillea millefolium extract has been assessed by the Expert Panel for Cosmetic Ingredient Safety. The Expert Panel evaluated the scientific data and concluded that the available data were insufficient to assess the safety of achillea millefolium extract as used 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.

Only limited safety data were available. Crude extracts of achillea millifolium were sensitizing. Weak mutagenicity was observed in an assay in fruit flies. Products containing 0.1-0.5% achillea millifolium extract were non-irritating and non-sensitizing in clinical studies. The limited data led the Expert Panel to conclude that the data were insufficient to support the safety of achillea millefolium extract as it is used in cosmetics and personal care products.

The types of data requested includes UV absorption data, gross pathology and histopathology in skin and other major organ systems associated with repeated dermal exposures, reproductive/developmental toxicity data, genotoxicity studies and clinical sensitization testing (repeated-insult patch test with 150 subjects) at maximum concentration of use. 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.

Achillea millefolium extract may be used in cosmetics and personal care products marketed in the European Union according to the general provisions of the Cosmetics Regulation of the European Union.