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Safety of a feed additive consisting of a tincture derived from the roots of Gentiana lutea L. (gentian tincture) for all animal species (FEFANA asbl).
Abstract: Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety of a tincture derived from L. (gentian tincture). It is intended to be used as a sensory additive for all animal species. The product is a water/ethanol solution, with a dry matter content of approximately 4.3% and it contains on average 0.0836% polyphenols (of which 0.0463% are flavonoids and 0.0027% xanthones) and 0.0022% gentiopicroside. The additive is intended for use in complete feed or drinking water up to a maximum level of 50 mg tincture/kg for all animal species, except horses, for which the proposed use is 200 mg/kg in complete feed. In a previous assessment, due to the genotoxic potential identified in vitro for xanthones (gentisin and isogentisin) and gentiopicroside the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) could not conclude on the safety of the additive for long-living animals and on risks of genotoxicity and carcinogenicity for dermal exposure of unprotected users. The additive did not raise safety concern for short-living animals, consumers and the environment. The applicant has provided information in the form of literature to address the previously identified genotoxic activity of xanthones and gentiopicroside and the risk for the user. Considering that the literature identified provided no new evidence, the FEEDAP Panel reiterated that it is not in a position to conclude on the safety of the additive for long-living and reproductive animals. No conclusions could be drawn on the potential of the additive to be a dermal/eye irritant or a skin sensitiser. When handling the tincture, exposure of unprotected users to xanthones (gentisin and isogentisin) and gentiopicroside cannot be excluded. Therefore, to reduce the risk, the exposure of the users should be minimised.
© 2023 European Food Safety Authority. EFSA Journal published by Wiley‐VCH GmbH on behalf of European Food Safety Authority.
Publication Date: 2023-02-24 PubMed ID: 36846385PubMed Central: PMC9950874DOI: 10.2903/j.efsa.2023.7869Google Scholar: Lookup The Equine Research Bank provides access to a large database of publicly available scientific literature. Inclusion in the Research Bank does not imply endorsement of study methods or findings by Mad Barn.
- Journal Article
Summary
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The research evaluated the safety of a feed additive – a tincture derived from the roots of Gentiana lutea L, also known as gentian tincture. The scientists were unable to conclusively establish the product’s safety for long-living and reproductive animals due to potential genotoxic effects.
What is the Research About?
- The research specifically interrogates the safety of a tincture derived from the roots of Gentiana lutea L. (gentian tincture), intended to be used as a sensory additive for all animal species. The product is a water/ethanol solution notable for its dry matter content of about 4.3%. It contains on average about 0.0836% polyphenols, which are subdivided into 0.0463% flavonoids and 0.0027% xanthones, and 0.0022% gentiopicroside.
- The EFSA received this request from the European Commission to provide a scientific opinion on the safety of this tincture. The additive’s proposed use was up to 50 mg per kg of feed for all species, except horses, where 200 mg/kg in complete feed was the proposed usage.
Previous Assessment
- In an earlier assessment, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was unable to arrive at a conclusion on the safety of the additive for longer-living animals and risks associated with genotoxicity and carcinogenicity that could affect dermal exposure in unprotected users.
- This was due to identified in vitro genotoxic potential for xanthones (gentisin and isogentisin) and gentiopicroside. The additive was not deemed a safety concern for short-living animals, consumers, and the environment in this former assessment.
Further Assessment
- To address the previous findings concerning the genotoxic effects, the applicant provided additional literature for consideration. However, this new literature did not present fresh evidence that would allow the FEEDAP Panel to conclusively determine the safety of the additive for long-living and reproductive animals.
- The FEEDAP Panel also could not finalize the safety risks associated with dermal/eye irritation or skin sensitization from the additive. Their study inferred that exposure of unprotected users to the xanthones (gentisin and isogentisin), and gentiopicroside in the tincture could not be excluded. They recommended minimization of user exposure to lower the risk.
Cite This Article
APA
Bampidis V, Azimonti G, Bastos ML, Christensen H, Durjava M, Kouba M, López-Alonso M, Puente SL, Marcon F, Mayo B, Pechová A, Petkova M, Ramos F, Sanz Y, Villa RE, Woutersen R, Brantom P, Chesson A, Westendorf J, Manini P, Pizzo F, Dusemund B.
(2023).
Safety of a feed additive consisting of a tincture derived from the roots of Gentiana lutea L. (gentian tincture) for all animal species (FEFANA asbl).
EFSA J, 21(2), e07869.
https://doi.org/10.2903/j.efsa.2023.7869 Publication
Researcher Affiliations
References
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Citations
This article has been cited 1 times.- Kui L, Wang G, Huang J, Yang X, Yu J, Li X, Peng H, Leng B, Jiao Y, Zhang Z. Therapeutic efficacy and mechanisms of gentiopicroside in various diseases. Front Pharmacol 2025;16:1634722.
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