title: Safety assessment of botanicals and botanical preparations used as ingredients in food supplements: testing an European Food Safety Authority-tiered approach.
abstract: This article describes results obtained by testing the European Food Safety Authority-tiered guidance approach for safety assessment of botanicals and botanical preparations intended for use in food supplements. Main conclusions emerging are as follows. (i) Botanical ingredients must be identified by their scientific (binomial) name, in most cases down to the subspecies level or lower. (ii) Adequate characterization and description of the botanical parts and preparation methodology used is needed. Safety of a botanical ingredient cannot be assumed only relying on the long-term safe use of other preparations of the same botanical. (iii) Because of possible adulterations, misclassifications, replacements or falsifications, and restorations, establishment of adequate quality control is necessary. (iv) The strength of the evidence underlying concerns over a botanical ingredient should be included in the safety assessment. (v) The matrix effect should be taken into account in the safety assessment on a case-by-case basis. (vi) Adequate data and methods for appropriate exposure assessment are often missing. (vii) Safety regulations concerning toxic contaminants have to be complied with. The application of the guidance approach can result in the conclusion that safety can be presumed, that the botanical ingredient is of safety concern, or that further data are needed to assess safety.
authors: General-Health Effects Toxicity and Safety Food, Winterkoning, Nieuwegein, The Netherlands.
authors: Gerrit
authors: G
authors: Speijers
authors: Bernard
authors: B
authors: Bottex
authors: Birgit
authors: B
authors: Dusemund
authors: Andrea
authors: A
authors: Lugasi
authors: Jaroslav
authors: J
authors: Tóth
authors: Judith
authors: J
authors: Amberg-Müller
authors: Corrado L
authors: CL
authors: Galli
authors: Vittorio
authors: V
authors: Silano
authors: Ivonne M C M
authors: IM
authors: Rietjens
mesh_terms: D000818:Animals; D003257:Consumer Product Safety; D019587:Dietary Supplements / Q000633:toxicity*; D004785:Environmental Pollutants / Q000032:analysis; D017408:Guidelines as Topic; D006801:Humans; D010936:Plant Extracts / Q000737:chemistry / Q000592:standards / Q000633:toxicity; D028321:Plant Preparations / Q000737:chemistry / Q000592:standards / Q000633:toxicity*; D011786:Quality Control; D013045:Species Specificity; D018675:Toxicity Tests / Q000592:standards*; D014116:Toxicology / Q000379:methods
chemical_list: D004785:Environmental Pollutants; D010936:Plant Extracts; D028321:Plant Preparations