COMMISSION IMPLEMENTING REGUL ATION (EU) 2021/485 
of 22 March 2021 
concer ning the author isation as feed additiv es of ginger essential oil from Zingiber officinale Roscoe 
for all animal species, ginger oleoresin from Zingiber officinale Roscoe for chickens for fattening, 
laying hens, turk eys for fattening, piglets, pigs for fattening, sows, dair y cows, veal calv es (milk 
replacers), cattle for fattening, sheep, goats, horses, rabbits, fish and pets and ginger tincture from 
Zingiber officinale Roscoe for horses and dogs 
(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. Article 10(2) of that Regulation provides for the 
re-evaluation of additives author ised pursuant to Council Directive 70/524/EEC (2). 
(2) Ginger essential oil, ginger oleoresin and ginger tincture from Zingiber officinale Roscoe were author ised without a 
time limit in accordance with Directive 70/524/EEC as feed additives for all animal species. These additives were 
subsequently entered in the Register of feed additives as existing products, in accordance with Article 10(1)(b) of 
Regulation (EC) No 1831/2003. 
(3) In accordance with Article 10(2) of Regulation (EC) No 1831/2003 in conjunction with Article 7 thereof, an 
application was submitted for the re-evaluation of ginger essential oil from Zingiber officinale Roscoe for all animal 
species, ginger oleoresin from Zingiber officinale Roscoe for chick ens for fattening, laying hens, turke ys for fattening, 
piglets, pigs for fattening, sows, dair y cows, veal calves (milk replacers), cattle for fattening, sheep, goats, horses, 
rabbits, fish and pets and ginge r tincture from Zingiber officinale Roscoe for horses and dogs. 
(4) The applicant requeste d ginger essential oil, ginger oleoresin and ginger tincture from Zingiber officinale Roscoe to be 
author ised for use also 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 ginger essential oil, 
ginger oleoresin and ginger tincture from Zingiber officinale Roscoe in water for drinking should not be allowed. 
(5) The applicant requeste d the additives to be classified in the additive cate gory ‘sensor y additives ’ and in the functional 
group ‘flavouring compo unds ’. That application was accompan ied by the particulars and documents required under 
Article 7(3) of Regulation (EC) No 1831/2003. 
(6) The European Food Safety Author ity (‘the Author ity’) concluded in its opinion of 7 May 2020 (3) that, under the 
proposed conditions of use ginger essential oil, ginger oleoresin and ginge r tincture from Zingiber officinale Roscoe 
do not have adverse effects on animal health, consumer health or the environment. The Author ity also concluded 
that ginger essential oil, ginger oleoresin and ginge r tincture from Zingiber officinale Roscoe should be considered as 
irritants to skin and eyes and the respirato ry tract and as skin sensitisers. Theref ore, the Commission considers that 
appropr iate prote ctive measures should be taken to prevent adverse effects on human health, in particular as 
regards the users of the additive. 
(1)OJ L 268, 18.10.2003, p. 29.
(2)Council Directive 70/524/EEC of 23 November 1970 concer ning additives in feedingstuffs (OJ L 270, 14.12.1970, p. 1).
(3)EFSA Journal 2020;18(6):6147.EN Offi cial Jour nal of the European Union 23.3.2021                                                                                                                                           L 100/3   (7) The Author ity concluded, that ginger essential oil, ginger oleoresin and ginger tincture from Zingiber officinale 
Roscoe are 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 specifi c requirements of post-market monit oring. It also verified the repor t on the methods of analysis 
of the feed additive in feed submitted by the Reference Laborator y set up by Regulation (EC) No 1831/2003. 
(8) The assessment of ginger essential oil, ginge r oleoresin and ginger tincture from Zingiber officinale Roscoe shows that 
the conditions for author isation, as provid ed for in Article 5 of Regulation (EC) No 1831/2003, are satisfi ed. 
According ly, the use of these substances should be author ised [as specified in the Annex to this Regulation]. 
(9) 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 additives. Where such cont ent is exceed ed, certain information should 
be indicated on the label of premixtures. 
(10) The fact that ginger essential oil, ginger oleoresin and ginger tincture from Zingiber officinale Roscoe are not 
author ised for use as a flavourings in water for drinking, does not preclude their use in compo und feed whic h is 
administe red via wate r. 
(11) Since safet y reasons do not require the immediate application of the modifications to the conditions of author isation 
of the substances concer ned, it is appropr iate to allow a transitional period for interest ed parties to prepare 
themselves to meet the new requirements resulting from the author isation. 
(12) 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 
Author isation 
The substances specifi ed in the Annex, belonging to the additive cate gory ‘sensor y additives ’ and to the functional group 
‘flavouring compo unds ’, are author ised as feed additives in animal nutr ition, subject to the conditions laid down in that 
Annex. 
Article 2 
Use in water for drinking 
The author ised substances specified in the Annex shall not be used in wate r for drinking. 
Article 3 
Transitional measures 
1. The substances specifi ed in the Annex and premixtures containing these substances, which are produced and labelled 
before 12 October 2021 in accordance with the rules applicable before 12 Apr il 2021 may continue to be placed on the 
mark et and used until the existing stoc ks are exhaust ed. 
2. Com pound feed and feed mat erials containing the substances as specifi ed in the Annex which are produced and 
labelled before 12 Apr il 2022 in accordance with the rules applicable before 12 Apr il 2021 may continue to be placed on 
the mark et and used until the existing stoc ks are exhaust ed if they are intended for food-producing animals. EN Offi cial Jour nal of the European Union L 100/4                                                                                                                                           23.3.2021   3. Com pound feed and feed mat erials containing the substances as specifi ed in the Annex which are produced and 
labelled before 12 Apr il 2023 in accordance with the rules applicable before 12 Apr il 2021 may continue to be placed on 
the mark et and used until the existing stoc ks are exhaust ed if they are intended for non-f ood-producing animals. 
Article 4 
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 States. 
Done at Brussels, 22 Marc h 2021.  
For the Commission 
The President 
Ursula VON DER LEYEN     EN Offi cial Jour nal of the European Union 23.3.2021                                                                                                                                           L 100/5   ANNEX 
Identifi -
cation 
number 
of the 
additive Name of 
the 
holder 
of 
author i-
sation Additive Composition, chemical formula, descr iption, 
analytical method. Species or 
category of animal Maxi -
mum 
age Mini -
mum 
content Maxi -
mum 
content 
Other provisions End of period of 
author isation mg active  
substance/kg of 
complet e feed 
with a moisture 
content of 12 % 
Categor y: Sensor y additiv es 
Functional group: Flavour ing compounds 
2b489- 
eo - Ginger 
essential oil Additive composition 
Essential oil derived by steam distillation from 
the dried rhizomes of Zingiber officinale Roscoe. 
Char acter isation of the active substance 
Essential oil derived by steam distillation from 
the dried rhizomes of Zingiber officinale Roscoe as 
defined by the Council of Europe (1). 
— α-zingiberene: 29–40 % 
— β-sesquiphellandrene: 8–14 % 
— ar-curcumene: 5–12 % 
— α-farnesene: 4–10 % 
— camphe ne: 2–10 % 
— β-bisabolene: 2–9 % 
CAS number: 8007-08-7, 
EINECS number: 283-634-2 
FEMA number: 2522 
CoE number 489 
Liquid form 
Analytical method (2) 
For the quantifi cation of alpha-zingiberene, beta- 
sesquiphellandrene and ar-curcumene in the feed 
additive: 
—Gas chromatograph y coupled to mass spec ­
trometr y (GC-MS) (full scan mode) using 
Retenti on Time Locking (RTL) methodology 
(or standard substances of the phytochemical All animal 
species - - - 1.The additive shall be incor porat ed 
into the feed in the form of a premix ­
ture. 
2.In the directions for use of the addi ­
tive and premixtures, the storage 
conditions and stability to heat treat ­
ment shall be indicated. 
3.On the label of the additive and pre­
mixtures the followi ng shall be indi ­
cated : 
‘Recommended maximum content 
of the active substance per kg of 
compl ete feedingstuff with a 
moisture conte nt of 12 %: 
— veal calves (milk replacer): 
80 mg, 
—other species or catego ries of ani­
mals: 20 mg.’ 
4.The functional group, the identific a­
tion number , the name and the added 
amount of the active substance shall 12 Apr il 2031 EN Offi cial Jour nal of the European Union L 100/6                                                                                                                                           23.3.2021   mark ers) with (or without) gas chromat ogra ­
phy coupled to flame ionisation detection 
(GC-FID) based on the ISO 11024 standard 
method. be indicat ed on the label of the pre­
mixture where the use level on the 
label of the premixture would result 
in exceeding the level referred to in 
point 3. 
5.The mixture of ginger essential oil 
with other author ised additives ob­
tained from Zingiber officinale Roscoe 
shall be not be allowed in feeding ­
stuffs. 
6.For users of the additive and premix ­
tures, feed business operat ors shall 
establish operational procedures 
and organisational measures to ad­
dress pote ntial risks by inhalation, 
dermal contact or eyes contact. 
Where those risks cannot be elimi ­
nated or reduced to a minimum by 
such procedures and measures, the 
additive and premixtures shall be 
used with personal prot ective equip ­
ment, including breathing prot ec­
tion, safety glasses and gloves. 
2b489- 
or  Ginger 
oleoresin Additive composition 
Ginger oleoresin obtained by steam distillation 
and solvent extraction of dried rhizomes of 
Zingiber officinale Roscoe. 
Char acter isation of the active substance 
Ginger oleoresin obtained by steam distillation 
and solvent extraction of dried rhizomes of 
Zingiber officinale Roscoe as defined by the 
Council of Europe (1). — Chick ens for 
fattening 
— Laying hens 
— Turkeys for 
fattening. 
— Piglets 
—Pigs for fat­
tening 
— Sows 
— Dair y cows 
— Veal calves 
(milk repla ­
cers) 
—Cattle for fat­
tening 
— Sheep and 
goats 
— Horses 
— Rabbits 
— Fish 
— Pets - - - 1.The additive shall be incor porat ed 
into the feed in the form of a premix ­
ture. 
2.In the directions for use of the addi ­
tive and premixtures, the storage 
conditions and stability to heat treat ­
ment shall be indicated. 12 Apr il 2031 EN Offi cial Jour nal of the European Union 23.3.2021                                                                                                                                           L 100/7   Essential oil: 25-30 (w/w) 
Total ginge rols: 0,5–8 % (w/w) 
— 6-Ginge rol 
— 8-Ginge rol 
— 10-Gingero l 
Total shog aols: 3–6 % (w/w) 
— 6 Shog aol 
— 8-Shogaol 
Humidity and volatiles: 25-30 (w/w) 
CoE number: 489 
Liquid form 
Analytical method (2) 
For the quantification of the phytochemical 
mark ers: total ginger ols and total shogaols in the 
feed additive (ginger oleoresin): 
— High performa nce liquid chromat ography 
(HPL C) with spectrophotom etric (UV) detec ­
tion – ISO 13685  3.On the label of the additive and pre­
mixtures the followi ng shall be indi ­
cated : 
‘Recommended maximum conte nt of 
the active substance per kg of 
compl ete feedin gstuff with a moisture 
content of 12 % and for milk replacers 
with a moisture content of 5,5 %: 
— chick ens for fattening: 5 mg; 
— laying hens and rabbits: 7 mg; 
— turke ys for fattening: 6 mg; 
— piglets: 8mg; 
— pigs for fattening: 10 mg; 
— sows: 13 mg; 
— dair y cows: 12 mg; 
— veal calves (milk replacers): 21 
mg; 
— cattle for fattening: 19 mg; 
— sheep, goats, horses and fish: 20 
mg; 
— pets: 1 mg.’ 
4.The functional group, the identific a­
tion number , the name and the added 
amount of the active substance shall 
be indicat ed on the label of the pre­
mixture where the use level on the 
label of the premixture would result 
in exceeding the level referred to in 
point 3. 
5.The mixture of ginger oleoresin with 
other author ised additives obtained 
from Zingiber officinale Roscoe shall 
be not be allowed in feedingstuffs. EN Offi cial Jour nal of the European Union L 100/8                                                                                                                                           23.3.2021   6.For users of the additive and premix ­
tures, feed business operat ors shall 
establish operational procedures 
and organisational measures to ad­
dress pote ntial risks by inhalation, 
dermal contact or eyes contact. 
Where those risks cannot be elimi ­
nated or reduced to a minimum by 
such procedures and measures, the 
additive and premixtures shall be 
used with personal prot ective equip ­
ment, including breathing prot ec­
tion, safety glasses and gloves. 
2b489- 
t  Ginger 
tincture Additive composition 
Ginger tincture obtained by extraction of ground 
dried rhizomes of Zingiber officinale Roscoe using 
an ethanol/wate r mixture. 
Char acter isation of the active substance 
Ginger tincture is obtained by extraction of 
ground dried rhizomes of Zingiber officinale 
Roscoe using an ethanol/wate r mixture as 
defined by the Council of Europe (1) 
Solvent (ethanol/water , 90/10): 97-98 % (w/w) 
Dry matt er: 2-3 % (w/w) 
Total ginge rols: 0,14-0,11 % (w/w) 
— 6-Ginge rol 
— 8-Ginge rol 
— 10-Gingero l 
Total shog aols: 0,043-0,031 % (w/w) 
— 6 Shog aol 
— 8-Shogaol 
Analytical method (2) — Horses 
— Dogs - - - 1.The additive shall be incor porat ed 
into the feed in the form of a premix ­
ture. 
2.In the directions for use of the addi ­
tive and premixtures, the storage 
conditions and stability to heat treat ­
ment shall be indicated. 
3.On the label of the additive and pre­
mixtures the followi ng shall be indi ­
cated : 
‘Recommended maximum content 
of the active substance per kg of 
compl ete feedingstuff with a 
moisture conte nt of 12 %: 
— Horses 1,58 mL 
— Dogs 1,81 mL’ 
4.The functional group, the identif ica­
tion number , the name and the 
added amount of the active sub­
stance shall be indicated on the label 12 Apr il 2031 EN Offi cial Jour nal of the European Union 23.3.2021                                                                                                                                           L 100/9   For the quantification of the phytochemical 
mark ers: total ginger ols and total shogaols in the 
feed additive (ginger tincture): 
— High performa nce liquid chromat ography 
(HPL C) with spectrophotom etric (UV) detec ­
tion – ISO 13685 of the premixture where the use level 
on the label of the premixture would 
result in exce eding the level referred 
to in point 3. 
5.The mixture of ginger tincture with 
other author ised additives obtained 
from Zingiber officinale Roscoe shall 
be not be allowed in feedingstuffs. 
6.For users of the additive and premix ­
tures, feed business operat ors shall 
establish operational procedures 
and organisational measures to ad­
dress pote ntial risks by inhalation, 
dermal contact or eyes contact. 
Where those risks cannot be elimi ­
nated or reduced to a minimum by 
such procedures and measures, the 
additive and premixtures shall be 
used with personal prot ective equip ­
ment, including breathing prot ec­
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 100/10                                                                                                                                         23.3.2021