Photo-toxicity concerns over the extracts and oils from Tagetes spp.
The International Fragrance Association (IFRA) recommends the use of extracts and oils of Tagetes species is limited to up to 0.01% for the following situations:
For applications on areas of skin exposed to sunshine – excluding bath preparations, soaps and other products which are washed off the skin – oils and absolutes obtained from Tagetes minuta L., syn. Tagetes glandulifera Schrank and Tagetes patula L. should not be used such that the level in the consumer product exceeds 0.01%.
Tagetes belong to the Composite family, of which several members are known to be phototoxic. Tagetes flower extracts and flower oils are mixtures of many substances. Among them alpha-terthienyl, also called terthiophene (TTP), a phototoxic compound responsible for the photo-toxicity of Tagetes extracts and oils was found from below the detection level to 2.45%. However, no information regarding alpha-terthienyl was found in perfumes and cosmetic products containing Tagetes extracts/oils.
The SCCS position
On the 21st of June 2005, at its 4th plenary meeting, the Scientific Committee on Consumer Products adopted the following opinion:
“According to the data submitted, Tagetes extracts and oils are phototoxic. As no safe limit of use in cosmetic products has been demonstrated, it is recommended that Tagetes erecta, Tagetes minuta and Tagetes patula extracts and oils should not form part of cosmetic products.”
Therefore, in order to demonstrate these cosmetics ingredient’s safety when used as a fragrance in leave-on cosmetic products with a concentration limit of 0.01%, Tagetes extracts were assessed again. The extracts and essential oils were examined for their photo-toxicity potential in in vitro systems as well as in vivo in experimental animals and human volunteers. The results were presented by IFRA to the SCCS in August 2013.
Are T.minuta and T.patula extracts and essential oils safe for use as fragrance ingredients in cosmetic leave-on products with a maximum concentration limit of 0.01%?
Tagetes species were tested for their photo-toxic potential on the three-dimensional human epidermis model (EpiDermTM) as well as on mice and guinea pigs and eventually on human volunteers. The studies showed that it is only possible to apply the results from in vitro studies to humans to a certain extent; from the human photo-toxicity studies no firm conclusion regarding a safe level of Tagetes could be drawn.
The SCCS concluded that a maximum level of 0.01% Tagetes minuta and Tagetes patula extracts and essential oils in leave-on products (except sunscreen cosmetic products) is safe, provided that the alpha terthienyl (terthiophene) content of the Tagetes extracts and oils does not exceed 0.35%. As the effect of TTP, a phototoxic chemical is unpredictable in cosmetics with sunscreen effect, Tagetes extracts and oils should not be used as components in this type of cosmetic products.
What should manufacturers do?
In order to ensure the cosmetic product formulations contain only the allowed concentrations of the ingredients contact your Responsible Person for advice.
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