Arnica Montana
What Is It?
Arnica Montana Flower ExtractThe mixture of substances drawn out of a material by solution, heat, or another physical or chemical process. is a dark brown clear liquid made from the flowers of the plant Arnica montana. In cosmetics and personal care products, Arnica Montana and Arnica Montana Flower Extract are used in the formulation of a variety of product types, including skin care products, skin fresheners, shampoos, conditioners and hair care products
Why Is It Used?
Arnica Montana and its Flower Extract enhance the appearance of dry or damaged skin by reducing flaking and restoring suppleness.
Scientific Facts
Arnica Montana is a generic term used to describe plant material derived from the dried flowers, roots, or rhizomes of the plant, Arnica montana. Arnica Montana Flower Extract is an extract of the flowerheads of this plant. Common names for A. montana include leopard’s bane, mountain tobacco, mountain snuff, and wolf’s bane. Arnica Montana has been used in traditional and medicine for its anti-inflammatory properties.
Safety Information
The Food and Drug Administration (FDA) includes Arnica montana flowers on its list of natural flavoring substances permitted for direct addition to food. The safety of Arnica Montana and its Flower Extract 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 additional data were needed to determine whether Arnica Montana Flower Extract and Arnica Montana were either safe or unsafe for use in cosmetics and personal care products.
CIR Safety Review: Extracts of Arnica montana were tested and found not toxic in acute toxicity tests; they were not irritating, sensitizing or phototoxic to skin; and they did not produce significant ocular irritation. In a mutagenicity test in bacteria, an extract of A. montana was mutagenic, possibly related to the flavenoid content of the extract. No carcinogenicity or reproductive/developmental toxicity data were available. Clinical tests of extractions failed to elicit irritation or sensitization, yet Arnica dermatitis is reported in individuals who handle arnica flowers and may be caused by sesquiterpene lactones found in the flowers.
Ingestion of A. montana-containing products induced severe gastroenteritis, nervousness, accelerated heart rate, muscular weakness, and death. These data were not considered sufficient to assess the safety of these ingredients.
The CIR Expert Panel requested additional information about concentration of use in cosmetic products, genotoxicity, and reproductive and developmental toxicity data.
Link to FDA Code of Federal Regulations for Arnica flowers
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr…
Arnica Montana 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…
More Scientific Information
The composition of Arnica montana extracts can include fatty acids, especially palmitic, linoleic, myristic, and linolenic acids, essential oils, triterpenic alcohols, sesquiterpene lactones, sugars, phytosterols, phenol acids, tannins, choline, inulin, phulin, arnicin, flavonoids, carotenoids, and coumarins. The components present in these extracts are dependent on where the plant is grown. Techniques for preparing Arnica Montana Flower Extract include hydroalcoholic maceration and gentle disintegration in soybean oil. Propylene glycol and butylene glycol extractions were also reported.
Resources
Search the Code of Federal Regulations http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm
EU Cosmetics Inventory http://ec.europa.eu/consumers/cosmetics/cosing/