TY - JOUR

T1 - 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)

AU - Bampidis, Vasileios

AU - Azimonti, Giovanna

AU - Bastos, Maria de Lourdes

AU - Christensen, Henrik

AU - Fašmon Durjava, Mojca

AU - Kouba, Maryline

AU - López-Alonso, Marta

AU - López Puente, Secundino

AU - Marcon, Francesca

AU - Mayo, Baltasar

AU - Pechová, Alena

AU - Petkova, Mariana

AU - Ramos, Fernando

AU - Sanz, Yolanda

AU - Villa, Roberto Edoardo

AU - Woutersen, Ruud

AU - Brantom, Paul

AU - Chesson, Andrew

AU - Westendorf, Johannes

AU - Manini, Paola

AU - Pizzo, Fabiola

AU - Dusemund, Birgit

AU - EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP)

N1 - Publisher Copyright: © 2021 European Food Safety Authority. EFSA Journal published by John Wiley and Sons Ltd on behalf of European Food Safety Authority.

PY - 2021

Y1 - 2021

N2 - The tincture derived from Verbascum thapsus 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.

AB - The tincture derived from Verbascum thapsus 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.

KW - aucubin

KW - flavouring compounds

KW - great mullein tincture

KW - safety

KW - sensory additives

KW - Verbascum thapsus L.

U2 - 10.2903/j.efsa.2021.6711

DO - 10.2903/j.efsa.2021.6711

M3 - Journal article

C2 - 34335922

AN - SCOPUS:85111642580

VL - 19

JO - E F S A Journal

JF - E F S A Journal

SN - 1831-4732

IS - 7

M1 - e06711

ER -