II
(Non-legislative acts)
REGUL ATIONS
COMMISSION IMPLEMENTING REGUL ATION (EU) 2022/702 
of 5 May 2022
concer ning the author isation of great mullein tincture as a feed additiv e for certain animal species 
(Text with EEA relevance) 
THE EUR OPEAN COMMISSION,
Havi ng regar d to the Treaty on the Functioning of the European Union,
Havi ng rega rd to Regulation (EC) No 1831/2003 of the European Parliament and of the Council of 22 Sept ember 2003 on 
additives for use in animal nutr ition (1), and in particular Article 9(2) thereof,
Whereas:
(1) Regulation (EC) No 1831/2003 provid es for the author isation of additives for use in animal nutr ition and for the 
grounds and procedures for granting such an author isation.
(2) In accordance with Article 7 of Regulation (EC) No 1831/2003 an application was submitted for the author isation 
of great mullein tincture. That application was accompanied by the particulars and documents required under 
Article 7(3) of Regulation (EC) No 1831/2003.
(3) The application concer ns the author isation of great mullein tincture as a feed additive for all animal species, to be 
classifie d in the categor y ‘sensor y additives ’ and in the functional group ‘flavouring compounds’.
(4) The applicant request ed great mullein tincture to be author ised also for use in water for drinking. Howe ver, 
Regulation (EC) No 1831/2003 does not allow the author isation of ‘flavouring compo unds ’ for use in water for 
drinking. Theref ore, the use of great mullein tincture in water for drinking should not be allowed.
(5) The European Food Safety Auth ority (‘the Author ity’) concluded in its opinions of 12 November 2019 (2)and 
24 June 2021 (3)that, under the proposed conditions of use, great mullein tincture does not have adverse effects on 
animal health, consumer health or the environment. However , no conclusions could be drawn for long-living 
animals (pets and other non-f ood producing animals, horses and animals for reproduction). The Authority also 
concluded that in the absence of data, great mullein tincture should be considered as a dermal/e ye irritant or a skin 
sensitiser . Theref ore, the Commission considers that appropr iate protect ive measures should be taken to prevent 
adverse effects on human health, in particular as regar ds the users of the additive.
(1)OJ L 268, 18.10.2003, p. 29.
(2)EFSA Jour nal 2019;17(12):5910.
(3)EFSA Jour nal 2021;19(7):6711.EN Offi cial Jour nal of the European Union 6.5.2022 L 132/1  (6) The Auth ority further concluded, that great mullein tincture is recognised to flavour food and its function in feed 
would be essentially the same as that in food, theref ore, no further demonstration of efficacy is considered 
necessar y. It also verified the repor t on the methods of analysis of the feed additive in feed submitte d by the 
Reference Laboratory set up by Regulation (EC) No 1831/2003.
(7) The assessment of great mullein tincture shows that the conditions for author isation, as provided for in Article 5 of 
Regulation (EC) No 1831/2003, are satisfied. According ly, the use of the substance should be author ised as specifi ed 
in the Annex to this Regulation.
(8) The fact that great mullein tincture is not author ised for use as a flavouring in water for drinking, does not preclude 
its use in compo und feed whic h is administ ered via water .
(9) The measures provid ed for in this Regulation are in accordance with the opinion of the Standing Committ ee on 
Plants, Animals, Food and Feed,
HAS ADOPTED THIS REGUL ATION:
Article 1
The substance specified in the Annex, belonging to the additive cate gory ‘sensor y additives’ and to the functional group 
‘flavouring compounds’, is author ised as an additive in animal nutr ition, subject to the conditions laid down in that Annex.
Article 2
This Regulation shall enter into force on the twentieth day followi ng that of its publication in the Official Journal of the 
European Union.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 5 May 2022 .
For the Commission
The President
Ursula VON DER LEYENEN Offi cial Jour nal of the European Union L 132/2 6.5.2022  ANNEX 
Identification 
number of the 
additiveName of 
the holder 
of 
author isa-
tionAdditiveComposition, chemical formula, 
descr iption, analytical method.Species or categor y of 
animalMaximum 
ageMini -
mum 
contentMaximum 
content
Other provisionsEnd of period of 
author isation mg additive/kg of 
complet e feed with a 
moisture content of 
12 %
Categor y: Sensor y additiv es
Functional group: Flavour ing compounds
2b475(m)-t - Great 
mullein 
tinctureAdditive composition
Great mullein tincture derived 
from Verbascum thapsus L.Chick ens for 
fattening- 50 1.The additive shall be incor porat ed 
into the feed in the form of a pre­
mixture.
2.In the directions for use of the ad­
ditive and premixtures, the storage 
conditions and stability to heat 
treatment shall be indicated .
3.Mixture with other botanical addi ­
tives is permitted provid ed that the 
amounts of aucubin in feed mater i­
als and compo und feed are lower 
than the one resulting from the use 
of a sing le additive at the maximum 
or recommended level for the spe­
cies or animal categor y.
4.For users of the additive and pre­
mixtures, feed business operat ors 
shall establish operational proce ­
dures and organisational measures 
to address poten tial risks by inhala ­
tion, dermal contact or eyes con­
tact. Where those risks cannot be 
eliminated or reduced to a mini ­
mum by such procedures and mea ­
sures, the additive and premixtures 
shall be used with personal prote c­
tive equipment, including skin and 
eye prote ction.26 May 2032
Liquid form Turkeys for fattening
Char acter isation of the activ e substance Pigs for fattening
Great mullein tincture derived 
from Verbascum thapsus L. as 
defined by the Council of 
Europe (1).Calves for fattening
Lambs and kids for 
fattening
Dry matt er: ≤ 3 %
Solvent (water/ ethanol):
≤ 97,5 %
Ash: ≤ 0,3 %
Aucubin: ≤ 0,006 %Salmonids, excep t for 
reproduction 
purposes
Polyphenols: ≤ 0,22 %
Total flavonoids (chlorog enic acid 
equivalents): ≤ 0,10 %Rabbits for fattening
Analytical method (2)
For the charact erisation of great 
mullein tincture:EN Offi cial Jour nal of the European Union 6.5.2022 L 132/3  — Gravimetr ic method for the 
determination of loss on dry­
ing and the ash conte nt.
— Spectrophotomet ric method 
for the deter mination of total 
polyphenols content.
— High perf ormance thin layer 
chromatograph y (HPTLC) 
method for the determination 
of tota l phenolic acids.
(1)Natural sources of flavourings – Repor t No 2 (2007).
(2)Details of the analytical methods are avail able at the follo wing address of the Reference Laboratory : https://ec.europa.eu/jrc/en/eurl/feed-additives/evaluation-repor ts.EN Offi cial Jour nal of the European Union L 132/4 6.5.2022