COMMISSION IMPLEMENTING REGUL ATION (EU) 2021/421 
of 9 March 2021 
concer ning the author isation of tincture derived from Artemisia vulg aris L. (mugw ort tincture) as a 
feed additiv e for all 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 author isation. 
(2) In accordance with Article 7 of Regulation (EC) No 1831/2003, an application was submitted for the author isation 
of a tincture derived from Artemisia vulgaris L. (mugwor t tincture) as a feed additive for all animal species. This 
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 a tincture derived from Artemisia vulgaris L. (mugwor t tincture) as a 
feed additive for all animal species. The applicant requeste d this additive to be classified in the additive catego ry 
‘sensor y additives ’. 
(4) The European Food Safet y Author ity (‘the Author ity’) concluded in its opinions of 4 October 2019 (2) and 
1 July 2020 (3) that, under the proposed conditions of use the tincture derived from Artemisia vulgaris L. (mugwor t 
tincture) does not have adverse effects on animal health, consumer health or the envi ronment. The Author ity 
indicated that no conclusions can be drawn on the additive’ s pote ntial to be a dermal/ey e irritant or a skin sensitiser . 
Theref ore, the Commission considers that appropr iate prote ctive measures should be take n to prevent adverse 
effects on human health, in particular as regards the users of the additive. 
(5) The Authority also concluded, that Artemisia vulgaris L. and its extracts are universally recognised to flavour food and 
their function in feed would be essentially the same as that in food, theref ore, no further demonstration of efficacy is 
considered necessar y. The Author ity does not consider that there is a need for specific requirements of post-market 
monitori ng. It also verified the repor t on the methods of analysis of the feed additive in feed submitted by the 
Reference Laboratory set up by Regulation (EC) No 1831/2003. 
(6) The assessment of tincture derived from Artemisia vulgaris L. (mugw ort 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 
that substance should be author ised. 
(7) Restr ictions and conditions should be provid ed for to allow better control. In particular , a recommended content 
should be indicated on the label of the feed additive. Where such content is exceeded, certain information should be 
indicated on the label of premixtures. 
(8) The fact that tincture derived from Artemisia vulgaris L. (mugwor t tincture) is not author ised for use as a flavouri ng in 
water for drinking, does not preclude its use in compo und feed which is administe red via wate r. 
(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, 
(1)OJ L 268, 18.10.2003, p. 29.
(2)EFSA Jour nal 2019;17(11):5879
(3)EFSA Jour nal 2020;18(7):6206EN Offi cial Jour nal of the European Union 10.3.2021                                                                                                                                           L 83/21   HAS ADOPTED THIS REGUL ATION: 
Article 1 
The tincture derived from Artemisia vulgaris L. (mugwor t tincture) specified in the Annex, belonging to the additive categor y 
‘sensor y additives’ and to the functional group ‘flavouring compo unds ’, is author ised as a feed 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, 9 March 2021.  
For the Commission 
The President 
Ursula VON DER LEYEN     EN Offi cial Jour nal of the European Union L 83/22                                                                                                                                           10.3.2021   ANNEX 
Identification 
number of the 
additive Name of the 
holder of 
author isation Additive Compo sition, chem ical formula, 
descr iption, analytical method Species or 
categor y of 
animal Maximum 
age Minimum 
content Maximum 
content 
Other provisions End of period 
of 
author isation mg active substance/kg of 
complet e feed with a 
moisture conten t of 12 % 
Categor y: Sensor y additiv es 
Functional group: Flavour ing compounds 
2b72-t - Mugwor t 
tincture Additive composition 
Tincture produced from the 
fragment ed aerial parts of Artemisia 
vulgaris L. 
Char acter isation of the active substance 
Tincture produced from the 
fragment ed aerial parts of Artemisia 
vulgaris L by extended extraction with 
a wate r/ethanol mixture as defined by 
the Council of Europe (1). 
The specif ications of the active 
substance are: 
Dry matt er: 1,4-1,9 % 
Ash: 0,2-0,5 % 
Org anic fraction: 1,13-1,65 %, of 
which 
— Total polyphenols:0,05-0,2 % 
— Phenolic acids 0,02-0,11 % 
— Chlorogeni c acid: 0,0028- 
0,0136 % 
— α- and β-thujone: < 0,005 % 
— 1,8-cineole:0,005 % 
— Solvent (ethanol): 98,1-98,6 % All animal 
species - -  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 
additive and premixtures, the sto­
rage conditions and stability to 
heat treatment shall be indicated. 
3. On the label of the additive and 
premixtures the followi ng shall 
be indicated: 
‘Recommended maximum con­
tent of the active substance of 
compl ete feedingstuff with a 
moisture cont ent of 12 %: 400 
mg/kg’ 
4.The functional group, the identi ­
fication number , the name and 
the added amount of the active 
substance shall be indicate d on 
the label of the premixture where 
the use level on the label of the 
premixture would result in ex­
ceeding the level refer red to in 
point 3. 30.3.2031 EN Offi cial Jour nal of the European Union 10.3.2021                                                                                                                                           L 83/23   Liquid form 
CoE No 72 
Analytical method (2) 
For the charact erisation of the feed 
additive (Mugwor t tincture): 
—gravimet ric method for the deter­
mination of loss on drying and 
the ash content 
— spectrophotometr ic method for 
the determination of total poly ­
phenols cont ent 
— high perf ormance thin layer 
chromatograph y (HPTLC) 
method for the determination 
of total phenolic acids, chloro ­
genic acid, alpha- and beta- thu­
jones and eucalyp tol 5.For users of the additive and pre­
mixtures, feed business operat ors 
shall establish operational proce ­
dures and organisational mea ­
sures to address pote ntial risks 
by inhalation, dermal contact or 
eyes contact. Where those risks 
cannot be eliminated or reduced 
to a minimum by such proce ­
dures and measures, the additive 
and premixtures shall be used 
with personal protect ive equip ­
ment, including breathing prote c­
tion, safety glasses and gloves. 
(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 tsEN Offi cial Jour nal of the European Union L 83/24                                                                                                                                           10.3.2021