COMMI SSION IMPLEMENTING REGUL ATION (EU) 2018/1559 
of 17 Oct ober 2018 
concer ning the author isation of cumin tincture (Cuminum cyminum L.) as a feed additiv e for all 
animal species 
(Text with EEA relevance) 
THE EUR OPEAN COMMISSION, 
Having regar d to the Treaty on the Functioning of the European Union, 
Having regar d to Regulation (EC) No 1831/2003 of the European Parliament and of the Council of 22 September 2003 
on additives for use in animal nutr ition (1), and in particular Article 9(2) thereof, 
Whereas: 
(1)  Regulation (EC) No 1831/2003 provi des for the author isation of additives for use in animal nutr ition. 
(2) In accordance with Article 7 of Regulation (EC) No 1831/2003, an application was submitt ed for the author is­
ation of cumin tincture (Cuminum cyminum L.) as a feed additive for all animal species. That application was 
accompan ied by the particulars and documents required under Article 7(3) of Regulation (EC) No 1831/2003. 
The applicant request ed that the additive be classifie d in the additive cate gory ‘sensor y additives ’. 
(3)  The European Food Safety Authority (‘the Authority’) concluded in its opinion of 17 Apr il 2018 (2) that, under 
the proposed conditions of use, cumin tincture (Cuminum cyminum L.) does not have adverse effects on animal 
health, human health or the envi ronment. The Auth ority has concluded that since cumin seeds are universally 
recognised to flavour food and their function in feed would be essentially the same as that in food, no further 
demonstration of efficacy is necessar y. Theref ore, that conclusion can be extrapolat ed for feed. The Author ity 
further noted that for the safety of the additive for users a pote ntial to be dermal/e ye irritant cannot be excl uded. 
In addition, the additive contains a variety of compo unds kno wn to cause allergic reactions in sensitive 
persons. Theref ore, sensitisation may occur . Consequently , appropr iate protect ive measures should be take n. 
(4)  The Auth ority does not consider that there is a need for specifi c requirements of post-market monitor ing. It also 
verified the repor t on the method of analysis of the feed additive in feed submitted by the Reference Laborat ory 
set up by Regulation (EC) No 1831/2003. 
(5)  The assessment of this additive 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 this additive should be author ised as 
specified in the Annex to this Regulation. 
(6)  The applicant proposed use levels for the substances concer ned to the Author ity. Having regard to that proposal, 
the Author ity considered that certain use levels are safe. For the purpose of official controls along the food chain, 
the recommended maximum cont ent of the active substance should be indicated on the label of the feed additive. 
(7)  The fact that the use of the substance concer ned in water for drinking is not author ised should not preclude their 
use in compo und feed, which is administered via water . 
(8)  The measures provi ded for in this Regulation are in accordance with the opinion of the Standing Committee on 
Plants, Animals, Food and Feed, 
HAS ADOPTED THIS REGUL ATION: 
Article 1 
Author isation 
The substance specif ied in the Annex, belonging to the additive catego ry ‘sensor y additives’ and to the functional group 
‘flavouri ng compo unds ’, is author ised as a feed additive in animal nutr ition subject to the conditions laid down in that 
Annex. 18.10.2018 L 261/16 Official Jour nal of the European Union EN     
(1)OJ L 268, 18.10.2003, p. 29. 
(2)EFSA Jour nal 2018;16(5):5273 Article 2 
Entr y into force 
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 State s. 
Done at Brussels, 17 October 2018. 
For the Commission 
The President 
Jean-Claude JUNCK ER  18.10.2018 L 261/17 Official Jour nal of the European Union EN     ANNEX 
Identifica ­
tion 
number of 
the additive Name of 
the holder 
of author ­
isation Additive Compo sition, chemical formula,  
descr iption, analytical method Species or 
categor y of 
animal Maximum 
age Minimum 
conten t Maximum 
content 
Other provisions End of period 
of author isation ml of active substance/kg 
of compl ete feedingstuff 
with a moisture content of 
12 % 
Categor y: Sensor y additiv es. Functional group: Flavour ing compounds 
2b161 — Cumin 
tincture Additiv e composition 
Cumin tincture of Cuminum cyminum L. 
Char acter isation of the activ e substance 
Tincture from Cuminum cyminum L. 
seeds as defined by the Council of 
Europe (1). 
—  98 % ± 0,5 % of a water /ethanol 
(3:1, v/v) mixture; 
—2 ± 0,5 % of plant derived com ­
pounds; 
—  total flavonoids ≤ 300 ppm; 
—  total polyphenols ≤ 560 ppm; 
—  total p-menth-3-en-7-al ≤ 8 ppm; 
—phytochemical marker: 4-iso-pro ­
pylbenzaldeh yde (cuminaldeh yde): 
25 ± 5 ppm. 
Liquid form 
CoE No 161 
Method of analysis (2) 
For the quantifi cation of the phyt o­
chemical mark er (4-iso-prop ylbenzal ­
dehyde) in the feed additive: gas 
chromat ography coupled with flame 
ionisation detection (GC-FID) All animal 
species —  — 1.The additive shall be incor por­
ated into the feed in the form 
of a premixture. 
2.  In the directions for use of the 
additive and premixtures, the 
storag e conditions and stability 
to heat treatment shall be indi ­
cated. 
3.  On the label of the additive the 
followi ng shall be indicated: 
‘Recommended maximum con­
tent of the active substance of 
complet e feedingstuff with 
a moisture content of 12 %: 
0,03 ml/kg feed’ 
4.  For users of the additive and 
premixtures, feed business op­
erators shall establish opera ­
tional procedures and organisa ­
tional measures to address 
potential risks by inhalation, 
dermal contact or eyes contact. 
Where those risks cannot be 
eliminated or reduced to a mini ­
mum by such procedures and 
measures, the additive and pre­
mixtures shall be used with 
personal protective equipment, 
including breathing prot ection, 
safety glasses and gloves. 7 November 
2028 
(1)  Natural sources of flavourings — Repor t No 2 (2007) 
(2)  Details of the methods of analysis are available at the following address of the Reference Laborato ry: https://ec.europa.eu/jrc/en/eurl/feed -additives/evaluation-repor ts  18.10.2018 L 261/18 Official Jour nal of the European Union EN