Safety Assessment of Botanicals and Botanical Preparations Used as Ingredients in Food Supplements: Testing an European Food Safety Authority-Tiered ApproachSafety Assessment of Botanicals and Botanical Preparations Used as Ingredients in Food Supplements: Testing an European Food Safety Authority-Tiered Approach

Gerrit Speijers, Bernard Bottex, Birgit Dusemund, Andrea Lugasi, Jaroslav Toth, Judith Amberg-Müller, Corrado Galli, Vittorio Silano, Ivonne M.C.M. Rietjens

Research output: Chapter in Book/Report/Conference proceedingChapter

Abstract

The present paper describes results obtained by testing the EFSA tiered guidance approach for safety assessment of botanicals and botanical preparations intended for use in food supplements. Main conclusions emerging are: (1) Botanical ingredients must be identified by their scientific (binomial) name, in most cases down to the subspecies level or lower. (2) 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. (3) Because of possible adulterations, misclassifications, replacements or falsifications and restorations, establishment of adequate quality control is necessary. (4) The strength of the evidence underlying concerns over a botanical ingredient should be included in the safety assessment. (5) The matrix effect should be taken into account in the safety assessment on a case-by-case basis. (6) Adequate data and adequate methods for appropriate exposure assessment are often missing. (7) 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.

Original languageEnglish
Title of host publicationRisk Assessment of Phytochemicals in Food
Subtitle of host publicationNovel Approaches
PublisherWiley Blackwell
Pages57-77
Number of pages21
ISBN (Print)9783527329298
DOIs
Publication statusPublished - Dec 15 2010

Keywords

  • Botanical preparations
  • Carcinogenicity testing
  • Computational toxicology models
  • Food
  • Food supplements
  • Level of safety
  • Phyotchemicals
  • Toxicity testing
  • Toxicology screening
  • in silico methods

ASJC Scopus subject areas

  • Biochemistry, Genetics and Molecular Biology(all)
  • Pharmacology, Toxicology and Pharmaceutics(all)

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