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Safety of a feed additive consisting of a tincture derived from Verbascum thapsus L. (great mullein tincture) for use in all animal species (MANGHEBATI SAS).
Abstract: The tincture derived from L. (great mullein tincture) is intended to be used as a sensory additive in feed for all animal species. The product is a water/ethanol solution, with a dry matter content of ˜ 2.8% and contains on average 0.216% polyphenols including 0.093% flavonoids. According to a previous assessment, the additive was not characterised in full and about 82% of the dry matter fraction remained uncharacterised (representing 2.26% of the tincture). There was also uncertainty on the potential presence of iridoid glycosides in the tincture. Therefore, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) could not conclude on the safety of the additive at the proposed use levels of up to 50 g/kg complete feed for all animal species or for the consumer. The applicant has provided new data which show that the unidentified fraction consists of crude fibre, other carbohydrates, and protein. The tincture also contains aucubin (0.004%). Considering the genotoxic potential of aucubin and other related iridoids, no conclusions can be drawn for long-living animals (pets and other non-food producing animals, horses and animals for reproduction). For short-living animals (animals for fattening), the FEEDAP Panel concludes that the tincture is safe at the maximum proposed use level of 50 mg/kg complete feed and that the use in water for drinking is safe provided that the total daily intake of the additive does not exceed the daily amount that is considered safe when consumed via feed. No safety concerns would arise for the consumer from the use of the tincture up to the highest safe level in animal nutrition. In the absence of data, no conclusions can be drawn on the potential of the tincture to be a dermal/eye irritant or a skin sensitiser.
© 2021 European Food Safety Authority. EFSA Journal published by John Wiley and Sons Ltd on behalf of European Food Safety Authority.
Publication Date: 2021-07-28 PubMed ID: 34335922PubMed Central: PMC8317052DOI: 10.2903/j.efsa.2021.6711Google 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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This research examines the safety of a feed additive sourced from Verbascum thapsus L., or great mullein tincture, for use in all kinds of animal species. The study couldn’t conclusively determine the safety of this additive at the proposed levels, due to uncertainties in its constituents and the potential presence of harmful compounds like iridoid glycosides. New data provided, however, has established a clearer profile of this feed additive’s constituents.
Product Description and Previous Assessments
- The additive was made from great mullein tincture, which is a water/ethanol solution with about 2.8% dry matter.
- Despite analysis, around 82% of the dry matter fraction, or 2.26% of the additive, was unidentifiable. This lack of total characterization injected uncertainty into the product’s safety profile.
- Earlier assessment processes could not provide a definite conclusion about the safety of this additive for all animal species or the potential consumer, as there was conjecture about the possible presence of iridoid glycosides, compounds triggering safety concerns.
New Findings and Safety Concerns
- New data revealed that the previously unidentified fraction of the tincture is composed of crude fibre, other carbohydrates, and protein.
- The tincture was shown to contain a very minor amount (0.004%) of aucubin, a type of iridoid glycoside known for its genotoxic potential, which directly affects genetic material and could potentially cause mutations and cancer.
- Given the genotoxic potential of aucubin and related iridoids, no safety conclusions were drawn for long-living animals like pets and other non-food producing animals, horses, and animals for reproduction.
Safety Verdict for Short-Living Animals and Consumers
- For short-living animals like those raised for fattening, the additive was found to be safe at the maximum proposed use level of 50 mg/kg of complete feed.
- If used in drinking water, safety is ensured as long as the additive’s total daily intake doesn’t exceed the safe daily amount when consumed through feed.
- At the highest safe levels in animal nutrition, no safety concerns were found for humans consuming animals feeding off this tincture.
Remaining Safety Questions
- No data was available to conclude whether the tincture causes skin or eye irritation or could be a potential skin sensitiser. So, remaining open questions still pose concerns around safety.
Cite This Article
APA
Bampidis V, Azimonti G, Bastos ML, Christensen H, Fašmon Durjava M, Kouba M, López-Alonso M, López Puente S, 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.
(2021).
Safety of a feed additive consisting of a tincture derived from Verbascum thapsus L. (great mullein tincture) for use in all animal species (MANGHEBATI SAS).
EFSA J, 19(7), e06711.
https://doi.org/10.2903/j.efsa.2021.6711 Publication
Researcher Affiliations
References
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Citations
This article has been cited 1 times.- Mihaylova R, Elincheva V, Gevrenova R, Zheleva-Dimitrova D, Momekov G, Simeonova R. Targeting Inflammation with Natural Products: A Mechanistic Review of Iridoids from Bulgarian Medicinal Plants. Molecules 2025 Aug 22;30(17).
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