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.

Risk assessment of plant food supplements and other herbal products containing aristolochic acids using the margin of exposure (MOE) approach

“…It is important to note that most of these traditional botanical products have never been the subject of thorough pre-marketing toxicological safety assessment as required, for example, for modern pharmaceuticals or food additives (Schilter et al 2003;Speijers et al 2010). Based on their traditional use for long periods of time, these botanical preparations are often assumed to be safe.…”

The anticancer effect of Ocimum tenuiflorum leaves

“…Besides, the Scientific Committee of the European Food Safety Authority (EFSA) stated that it is important to ensure the botanical ingredients used in food supplements are safe to consume and O. tenuiflorum that is possible to cause reproduction toxicity was evaluated. The result of the evaluation showed that there was no information regarding toxic compounds for that effect (Gerrit et al, 2010).…”

Sustainable production of protein of animal origin – the state of knowledge. Part 2. Aquirements, objectives and ways of sustainbility improvement

“…Another reason for the restricted use of phytogenic substances as methane inhibitors may be their potential transfer from feed into food of animal origin and possible residues in animal products and their effects in humans (EFSA, 2009;Speijers et al, 2010).…”