Safety and efficacy of a tincture derived from Verbascum thapsus L. when used as a sensory additive in feed for all animal species

sensory additives, Verbascum thapsus L., tincture, great mullein tincture, safety
First published in the EFSA Journal
6 dicembre 2019
Adopted
12 novembre 2019
Type
Scientific Opinion

Legal notice: Relevant information or parts of this scientific output have been blackened in accordance with the European Commission decision on the confidentiality requests formulated by the applicant. The full output has been shared with the European Commission, EU Member States and the applicant.

Abstract

Following a request from the European Commission, the EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on the safety and efficacy of a tincture from Verbascum thapsus L. (great mullein tincture) when used as a sensory feed additive for all animal species. The product is a water/ethanol (■■■■■) solution, with a dry matter content of approximately 2.8%. The product contains on average 0.216% polyphenols and 0.093% flavonoids. Since 82% of the dry matter fraction of the additive remains uncharacterised, the FEEDAP Panel cannot identify a safe level for the use of the additive for all animal species. Considering the uncertainty in the composition of the additive, and in the absence of information on the toxicological properties of the tincture, the FEEDAP Panel is unable to conclude on the safety for the consumers following the use of the tincture as flavouring in animal feed. No specific data were provided by the applicant regarding the safety of the additive for users. In the absence of data, no conclusions can be drawn on the additive's potential to be a dermal/eye irritant or a skin sensitiser. V. thapsus L. is native to Europe. Consequently, the use of a tincture derived from the plant at the maximum proposed dose is not considered to be a risk for the environment. Since the major components of the additive are recognised to provide flavour in food and its function in feed would be essentially the same, no demonstration of efficacy is considered necessary.

Substances
apigenin
Cas: 520-36-5
Inchi: InChI=1S/C15H10O5/c16-9-3-1-8(2-4-9)13-7-12(19)15-11(18)5-10(17)6-14(15)20-13/h1-7,16-18H
Iupac: 5,7-dihydroxy-2-(4-hydroxyphenyl)-4H-chromen-4-one
quercetin
Cas: 117-39-5
Inchi: InChI=1S/C15H10O7/c16-7-4-10(19)12-11(5-7)22-15(14(21)13(12)20)6-1-2-8(17)9(18)3-6/h1-5,16-19,21H
Iupac: 2-(3,4-dihydroxyphenyl)-3,5,7-trihydroxy-4H-chromen-4-one
Rutin
Cas: 153-18-4
Inchi: InChI=1S/C27H30O16/c1-8-17(32)20(35)22(37)26(40-8)39-7-15-18(33)21(36)23(38)27(42-15)43-25-19(34)16-13(31)5-10(28)6-14(16)41-24(25)9-2-3-11(29)12(30)4-9/h2-6,8,15,17-18,20-23,26-33,35-38H,7H2,1H3/t8-,15+,17-,18+,20+,21-,22+,23+,26+,27-/m0/s1
Iupac: 2-(3,4-dihydroxyphenyl)-5,7-dihydroxy-3-[(2S,3R,4S,5S,6R)-3,4,5-trihydroxy-6-[[(2R,3R,4R,5R,6S)-3,4,5-trihydroxy-6-methyloxan-2-yl]oxymethyl]oxan-2-yl]oxychromen-4-one
luteolin
Cas: 491-70-3
Inchi: InChI=1S/C15H10O6/c16-8-4-11(19)15-12(20)6-13(21-14(15)5-8)7-1-2-9(17)10(18)3-7/h1-6,16-19H
Iupac: 2-(3,4-dihydroxyphenyl)-5,7-dihydroxychromen-4-one
kaempferol
Cas: 520-18-3
Inchi: InChI=1S/C15H10O6/c16-8-3-1-7(2-4-8)15-14(20)13(19)12-10(18)5-9(17)6-11(12)21-15/h1-6,16-18,20H
Iupac: 3,5,7-trihydroxy-2-(4-hydroxyphenyl)-4H-chromen-4-one

Panel members at the time of adoption

Giovanna Azimonti, Vasileios Bampidis, Maria de Lourdes Bastos, Henrik Christensen, Birgit Dusemund, Maryline Kouba, Mojca Kos Durjava, Marta López‐Alonso, Secundino López Puente, Francesca Marcon, Baltasar Mayo, Alena Pechová, Mariana Petkova, Fernando Ramos, Yolanda Sanz, Roberto Edoardo Villa and Ruud Woutersen.
Panel on Additives and Products or Substances used in Animal Feed
Contact
feedap [at] efsa.europa.eu
doi
10.2903/j.efsa.2019.5910
EFSA Journal 2019;17(12):5910
Question Number
On request from
European Commission