Amended Safety Assessment ofChamomilla recutita-Derived Ingredients as Used in Cosmetics

Abstract

The Chamomilla recutita-derived ingredients in this assessment are reported to function mostly as fragrance ingredients and skin conditioning agents in cosmetic products. Because final product formulations may contain multiple botanicals, each containing the same constituents of concern, formulators are advised to be aware of these constituents and to avoid reaching levels that may be hazardous to consumers. Additionally, industry should continue to use good manufacturing practices to limit impurities that could be present in botanical ingredients. The Cosmetic Ingredient Review Expert Panel concluded that the Chamomilla recutita-derived ingredients are safe in cosmetics in the present practices of use and concentration described in the safety assessment when formulated to be nonsensitizing.

Integrated Testing Strategy for the Safety of Botanical Ingredients: A Case Study with German Chamomile Constituents

“…Priority was given to nonvolatile constituents since polar extracts of German chamomile are most commonly used in cosmetics and personal care products. 1 Finally, 30 constituents of German chamomile were selected as test articles (Table 1) to cover all representative chemical classes, including coumarins, flavonoid aglycones, and glucoside derivatives, phenolic compounds, bisabolane-type sesquiterpenoids, terpenes, azulenes, as well as minor compounds with known skin sensitization effects. 42 In silico classification of selected test chemicals…”

“…Chamomile extracts are added to topical formulations as a skin conditioning agent, cosmetic biocide, fragrance, or flavoring agent. 1 German chamomile belongs to the Compositae family, along with several species with documented skin sensitization adverse effects, viz., feverfew (Tanacetum parthenium), tansy (Tanacetum vulgare), and arnica (Arnica montana). 2 Although commonly reputed to be a gentle ingredient, allergic reactions to the whole plant and products containing chamomile have been observed without information on the probable causative agents.…”

“…Water, alcohol, mineral oil, apricot (Prunus armeniaca) kernel oil, and glycols of propylene (or butylene) extracts of chamomile are frequently used as sources of cosmetic raw ingredients. 1 The extracts obtained from German chamomile are typically enriched in flavonoid glucosides (cosemetin, rutin, quercitrin), nonglycosylated flavonoids (apigenin, isorhamnetin, kaempferol, luteolin acids, quercetin), organic acids (chlorogenic and caffeic acids), and coumarins (herniarin, umbelliferone). 16 The main VOCs in German chamomile essential oils include non-oxygenated terpenes (e.g., farnesene), oxygenated sesquiterpenoids (bisabolane-type), dioxa-spiro polyacetylenes (tonghaosu and derivatives), fatty acid methyl esters, and proazulenes (matricin).…”

“…Depending on the chemotype, essential oils of chamomile can contain as high as 41.45% of a-bisabolol. 1 The characteristic blue color of some German chamomile essential oils is due to chamazulene, which is an artifact formed upon degradation of matricine during the hydrodistillation process. 17 Bisabolol oxides A and B, abisabolone oxide A, aand b-farnesene, and fatty acid methyl esters (methyl palmitate) also contribute to the chemical fingerprinting, depending on the chemotype.…”

“…20 None of these fragrance ingredients is a major constituent of German chamomile, and they typically occur in concentrations below 0.1%. 1 Nonetheless, these compounds are widespread in natural essential oils, as well as synthetic raw materials used in cosmetics. For example, (4R)-(À)-carvone is the main constituent of spearmint (Mentha spicata), 21 whereas the 4S-(+)-stereoisomer is the main constituent of caraway (Carum carvi) and dill (Anethum graveolens) seed oils.…”