Herbal food supplements safety and future regulation challenges

Dzeparoski, Marjan (2020) Herbal food supplements safety and future regulation challenges. Macedonian Pharmaceutical Bulletin, 66 (Suppl1). pp. 189-190. ISSN 1857 - 8969

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Abstract

A general framework for safety assessment is
proposed by the EFSAs Scientific Committee, in
which botanicals or botanical preparations for which
an adequate body of knowledge exists could benefit
from a “presumption of safety” without any need for
further testing, based on long history of use without
reported adverse effects and without significant
larger exposition. Botanicals and botanical
preparations for which a presumption of safety is not
possible based on available knowledge would be
subject to a more extensive safety assessment,
requiring additional data to be provided. For these
preparations with a potential to contain toxic,
addictive, psychotropic or other substances that may
be of concern (given in the Compendium),
presumption of safety can be applied only if there is
convincing evidence that these undesirable
substances in the specific plant parts or preparations
are either absent in the source material, or
significantly reduced if not excluded, or inactivated
during processing (EFSA Journal, 2009).

Item Type: Article
Subjects: Medical and Health Sciences > Health sciences
Divisions: Faculty of Medical Science
Depositing User: Marjan Dzeparoski
Date Deposited: 12 May 2023 11:55
Last Modified: 12 May 2023 11:55
URI: https://eprints.ugd.edu.mk/id/eprint/31740

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