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Scientific Opinion on safety evaluation of Ephedra species for use in food

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The ANS Panel provides a scientific opinion evaluating the safety in use of Ephedra herb and its preparations originating from Ephedra species when used in food, e.g. in food supplements. Ephedra species contain alkaloids of biological relevance: ephedrine, pseudoephedrine, norephedrine, norpseudoephedrine (cathine), methylephedrine and methylpseudoephedrine. They have sympathomimetic activity and some of them are also used as active ingredients in medicinal products for which adverse effects are described. The use of Ephedra herb in food supplements is prohibited in several European countries, however food supplements containing Ephedra herb, also in combination with caffeine, are offered for sale via the internet. The Panel reviewed the available scientific data on a possible association between the intake of Ephedra herb, its preparations or its alkaloids and potential harmful effects on health. There is wide variation in the concentration of the individual ephedra alkaloids in different Ephedra species and in their preparations for use in food. No adequately specified individual preparations of Ephedra herb are known for which sufficient toxicological data for hazard characterisation exist. Due to the absence of adequate data on genotoxicity, short-term, long-term and reproductive and developmental toxicity the Panel could not provide advice on a daily intake of Ephedra herb and its preparations that do not give rise to concerns about harmful effects to health. Ephedra herb and its preparations in food supplements may result in exposure to total ephedra alkaloids or ephedrine which falls within or may exceed the therapeutic dose ranges for the individual ephedra alkaloids or ephedrine, respectively, in medicinal products. Such an exposure could lead to severe adverse effects, which may be enhanced by the combination with caffeine. The Panel concluded that Ephedra herb and its preparations containing ephedra alkaloids used as food supplements were of significant safety concern at the estimated use levels.