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
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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
This article includes 27 references
- Alba C, Bowers MD, Blumenthal D, Hufbauer RA. Chemical and mechanical defenses vary among maternal lines and leaf ages in Verbascum thapsus L. (Scrophulariaceae) and reduce palatability to a generalist insect.. PLoS One 2014;9(7):e104889.
- Alipieva KI, Orhan IE, Cankaya IIT, Kostadinova EP, Georgiev MI. Treasure from garden: chemical profiling, pharmacology and biotechnology of mulleins. Phytochemical Reviews 2014;13:417–444.
- Bai Y, Zhu R, Tian Y, Li R, Chen B, Zhang H, Xia B, Zhao D, Mo F, Zhang D, Gao S. Catalpol in Diabetes and its Complications: A Review of Pharmacology, Pharmacokinetics, and Safety.. Molecules 2019 Sep 11;24(18).
- Bhattamisra SK, Yap KH, Rao V, Choudhury H. Multiple Biological Effects of an Iridoid Glucoside, Catalpol and Its Underlying Molecular Mechanisms.. Biomolecules 2019 Dec 24;10(1).
- Burdock GA. Fenaroli's Handbook of Flavor Ingredients. 2009;6th Edition.
- EFSA. Scientific Opinion of the Panel on Contaminants in the Food Chain on a request from the European Commission on Saponins in Madhuca Longifolia L. as undesirable substances in animal feed. EFSA Journal 2009;7(2):979, 36 pp.
- Younes M, Aquilina G, Castle L, Engel KH, Fowler P, Frutos Fernandez MJ, Fürst P, Gürtler R, Gundert-Remy U, Husøy T, Mennes W, Oskarsson A, Shah R, Waalkens-Berendsen I, Wölfle D, Boon P, Lambré C, Tobback P, Wright M, Rincon AM, Smeraldi C, Tard A, Moldeus P. Re-evaluation of Quillaia extract (E 999) as a food additive and safety of the proposed extension of use.. EFSA J 2019 Mar;17(3):e05622.
- EFSA FEEDAP Panel. Statement on the use of feed additives authorised/applied for use in feed when supplied via water. EFSA Journal 2010;8(12):1956, 9 pp.
- EFSA FEEDAP Panel. Guidance for the preparation of dossiers for sensory additives. EFSA Journal 2012;10(1):2534, 26 pp.
- EFSA FEEDAP Panel. Guidance on studies concerning the safety of use of the additive for users/workers. EFSA Journal 2012;10(1):2539, 5 pp.
- Rychen G, Aquilina G, Azimonti G, Bampidis V, Bastos ML, Bories G, Chesson A, Cocconcelli PS, Flachowsky G, Gropp J, Kolar B, Kouba M, López-Alonso M, López Puente S, Mantovani A, Mayo B, Ramos F, Saarela M, Villa RE, Wallace RJ, Wester P, Anguita M, Galobart J, Innocenti ML. Guidance on the identity, characterisation and conditions of use of feed additives.. EFSA J 2017 Oct;15(10):e05023.
- Rychen G, Aquilina G, Azimonti G, Bampidis V, Bastos ML, Bories G, Chesson A, Cocconcelli PS, Flachowsky G, Gropp J, Kolar B, Kouba M, López-Alonso M, López Puente S, Mantovani A, Mayo B, Ramos F, Saarela M, Villa RE, Wallace RJ, Wester P, Anguita M, Galobart J, Innocenti ML, Martino L. Guidance on the assessment of the safety of feed additives for the target species.. EFSA J 2017 Oct;15(10):e05021.
- Rychen G, Aquilina G, Azimonti G, Bampidis V, Bastos ML, Bories G, Chesson A, Cocconcelli PS, Flachowsky G, Gropp J, Kolar B, Kouba M, López-Alonso M, López Puente S, Mantovani A, Mayo B, Ramos F, Saarela M, Villa RE, Wallace RJ, Wester P, Anguita M, Dujardin B, Galobart J, Innocenti ML. Guidance on the assessment of the safety of feed additives for the consumer.. EFSA J 2017 Oct;15(10):e05022.
- Bampidis V, Azimonti G, Bastos ML, Christensen H, Kouba M, Kos Durjava 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, Gregoretti L, Manini P, Dusemund B. Safety and efficacy of a tincture derived from Verbascum thapsus L. when used as a sensory additive in feed for all animal species.. EFSA J 2019 Dec;17(12):e05910.
- Hardy A, Benford D, Halldorsson T, Jeger MJ, Knutsen HK, More S, Naegeli H, Noteborn H, Ockleford C, Ricci A, Rychen G, Schlatter JR, Silano V, Solecki R, Turck D, Younes M, Bresson JL, Griffin J, Hougaard Benekou S, van Loveren H, Luttik R, Messean A, Penninks A, Ru G, Stegeman JA, van der Werf W, Westendorf J, Woutersen RA, Barizzone F, Bottex B, Lanzoni A, Georgiadis N, Alexander J. Guidance on the assessment of the biological relevance of data in scientific assessments.. EFSA J 2017 Aug;15(8):e04970.
- More SJ, Bampidis V, Benford D, Bennekou SH, Bragard C, Halldorsson TI, Hernández-Jerez AF, Koutsoumanis K, Naegeli H, Schlatter JR, Silano V, Nielsen SS, Schrenk D, Turck D, Younes M, Benfenati E, Castle L, Cedergreen N, Hardy A, Laskowski R, Leblanc JC, Kortenkamp A, Ragas A, Posthuma L, Svendsen C, Solecki R, Testai E, Dujardin B, Kass GE, Manini P, Jeddi MZ, Dorne JC, Hogstrand C. Guidance on harmonised methodologies for human health, animal health and ecological risk assessment of combined exposure to multiple chemicals.. EFSA J 2019 Mar;17(3):e05634.
- More S, Bampidis V, Benford D, Boesten J, Bragard C, Halldorsson T, Hernandez-Jerez A, Hougaard-Bennekou S, Koutsoumanis K, Naegeli H, Nielsen SS, Schrenk D, Silano V, Turck D, Younes M, Aquilina G, Crebelli R, Gürtler R, Hirsch-Ernst KI, Mosesso P, Nielsen E, Solecki R, Carfì M, Martino C, Maurici D, Parra Morte J, Schlatter J. Genotoxicity assessment of chemical mixtures.. EFSA J 2019 Jan;17(1):e05519.
- More SJ, Bampidis V, Benford D, Bragard C, Halldorsson TI, Hernández-Jerez AF, Hougaard Bennekou S, Koutsoumanis KP, Machera K, Naegeli H, Nielsen SS, Schlatter JR, Schrenk D, Silano V, Turck D, Younes M, Gundert-Remy U, Kass GEN, Kleiner J, Rossi AM, Serafimova R, Reilly L, Wallace HM. Guidance on the use of the Threshold of Toxicological Concern approach in food safety assessment.. EFSA J 2019 Jun;17(6):e05708.
- nEMAn. Assessment report on Verbascum thapsus L., V. densiflorum Bertol. (V. thapsiforme Schrad) and V. phlomoides L., flos. 2018 Mar 27.
- nEMAn. European Union herbal monograph on Verbascum thapsus L., V. densiflorum Bertol. (V. thapsiforme Schrad) and V. phlomoides L., flos. 2018 Mar 27.
- Gálvez M, Martín-Cordero C, Ayuso MJ. Iridoids as DNA topoisomerase I poisons.. J Enzyme Inhib Med Chem 2005 Aug;20(4):389-92.
- Hussain H, Aziz S, Miana GA, Ahmad V, Anwar S. Minor chemical constituents of Verbascum thapsus. Biochemical Systematics and Ecology 2009;37:124–126.
- Kahraman C, Tatli II, Orhan IE, Akdemir ZS. Cholinesterase inhibitory and antioxidant properties of Verbascum mucronatum Lam. and its secondary metabolites.. Z Naturforsch C J Biosci 2010 Nov-Dec;65(11-12):667-74.
- Kim DH, Kim BR, Kim JY, Jeong YC. Mechanism of covalent adduct formation of aucubin to proteins.. Toxicol Lett 2000 Apr 3;114(1-3):181-8.
- Lee DH, Cho IG, Park MS, Kim KN, Chang IM, Mar W. Studies on the possible mechanisms of protective activity against alpha-amanitin poisoning by aucubin.. Arch Pharm Res 2001 Feb;24(1):55-63.
- Warashina T, Miyase T, Ueno A. Iridoid glycosides from Verbascum thapsus L.. Chemical and Pharmaceutical Bulletin 1991;39:3261–3264.
- Zeng X, Guo F, Ouyang D. A review of the pharmacology and toxicology of aucubin.. Fitoterapia 2020 Jan;140:104443.
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