COMMISSION IMPLEMENTING REGUL ATION (EU) 2022/652 
of 20 Apr il 2022
concer ning the author isation of bitter orange extract 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. Article 10(2) of that Regulation provides for the 
re-evaluation of additives author ised pursuant to Council Directive 70/524/EEC (2).
(2) Bitter orang e extract was author ised without a time limit in accordance with Directive 70/524/EEC as a feed additive 
for all animal species. That additive was subsequently entered in the Register of feed additives as an existing product, 
in accordance with Article 10(1)(b) of Regulation (EC) No 1831/2003.
(3) The applicant requeste d the additive to be classifie d in the additive catego ry ‘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.
(4) 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 bitter orange extract for all animal species.
(5) The applicant request ed bitter orange extract to be author ised also for use in water for drinking. However , Regulation 
(EC) No 1831/2003 does not allow the author isation of flavouri ng compo unds for use in water for drinking. 
Theref ore, the use of bitter orange extract in wate r for drinking should not be allowed.
(6) The European Food Safet y Author ity (‘the Author ity’) concluded in its opinion of 23 June 2021 (3)that, under the 
proposed conditions of use, bitter orang e extract does not have adverse effects on animal health, consumer health 
or the environment. The Auth ority also concluded that bitter orange extract should be considered as an irritant to 
skin and eyes, and as a skin and respirato ry sensitiser . Theref ore, the Commission considers that appropr iate 
prote ctive measures should be taken to prevent adverse effects on human health, in particular as regar ds the users 
of the additive.
(7) The Author ity concluded, that bitter orange extract 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.
(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 Jour nal 2021;19(7):6709.EN Offi cial Jour nal of the European Union L 119/74 21.4.2022  (8) The assessment of bitter orange extract shows that the conditions for author isation, as provided for in Article 5 of 
Regulation (EC) No 1831/2003, are satisfi ed. According ly, the use of that substance should be author ised as 
specifi ed in the Annex to this Regulation.
(9) Certain 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 exce eded, certain information should be indicated 
on the label of premixtures.
(10) The fact that bitter orange extract is not author ised for use as a flavouring in water for drinking does not preclude its 
use in compo und feed which is administe red via water .
(11) Since safet y reasons do not require the immediate application of the modifications to the conditions of author isation 
of the substance 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 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
Transitional measures
1. The substance specified in the Annex and premixtures containing this substance, which are produced and labelled 
before 11 November 2022 in accordance with the rules applicable before 11 May 2022 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 mate rials containing the substance as specifi ed in the Annex whic h are produced and 
labelled before 11 May 2023 in accordance with the rules applicable before 11 May 2022 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.
3. Com pound feed and feed mate rials containing the substance as specifi ed in the Annex whic h are produced and 
labelled before 11 May 2024 in accordance with the rules applicable before 11 May 2022 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 3
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.EN Offi cial Jour nal of the European Union 21.4.2022 L 119/75  This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 20 Apr il 2022 .
For the Commission
The President
Ursula VON DER LEYENEN Offi cial Jour nal of the European Union L 119/76 21.4.2022  ANNEX 
Identific ation 
number of the 
additiveName of 
the holder 
of 
author isa-
tionAdditiveComposition, chemical formula, 
descr iption, analytical method.Species or categ ory 
of animalMaximum 
ageMinimum 
contentMaximum 
conten t
Other provisionsEnd of period of 
author isationmg 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
2b136-ex - Bitter orange 
extractAdditive composition:
Bitte r orang e extract from the 
fruit of Citrus x aurantium L.
Solid form
Char acter isation of the activ e 
substance:
Bitte r orang e extract from the 
fruit of Citrus x aurantium L. as 
defined by the Council of 
Europe (1).
Flavonoids: 45-55 % of whic h
— Naringin: 20-30 %
— Neohesper idin: 10-20 %
5- metho xypsoralen (also 
kno wn as bergap ten): ≤ 0,03 %
(-)-Synephr ine: ≤ 1 %
CoE number: 136Chick ens for 
fattening
Laying hens
Turkeys for 
fattening
Piglets
Pigs for fattening
Sows
Dair y cows
Calves
Cattle for 
fattening
Sheep/goats
Horses
Rabbits
Salmonids
Ornamental fish
Dogs
Cats- - 1.The additive shall be incor porate d into the 
feed in the form of a premixture.
2.In the directions for use of the additive and 
premixtures, the storage conditions and 
stability to heat treatment shall be indi ­
cated .
3.The additive shall be not used in combina ­
tion with neohesper idine dihy drochal ­
cone (2b959).
4.On the label of the additive the followi ng 
shall be indicate d:
‘Recommended maximum conte nt of the 
active substance per kg of compl ete fee­
dingstuff with a moisture cont ent of 12 %:
— Chick ens for fattening: 102 mg.
— Laying hens: 151 mg.
— Turkeys for fattening: 136 mg.
— Piglets: 182 mg.
— Pigs for fattening: 217 mg.
— Sows: 268 mg.
— Dair y cows: 259 mg.
—Calves (milk replacer), cattle for fat­
tening, sheep/goats, horses, salmo ­
nids, dogs and ornamental fish: 
400 mg.
— Cats: 80 mg.
— Rabbits: 161 mg.’.11 May 2032EN Offi cial Jour nal of the European Union 21.4.2022 L 119/77  Analytical method (2)
For the quantifi cation of 
naringin (phy tochemical 
mark er) in the feed additive:
— High performa nce liquid 
chromat ography (HPL C) 
with spectrophotometr ic 
(UV) detection5.The functional group, the identif ication 
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 exceeding the level re­
ferred to in point 4.
6.The mixture of bitter orang e extract from 
the fruit of Citrus x aurantium L with other 
author ised additives obtained from Citrus 
aurantium L. shall not be allowed in fee­
dingstuffs.
7.For users of the additive and premixtures, 
feed business operators shall establish op­
erational procedures and orga nisational 
measures to address potential risks by in­
halation, dermal contact or eyes contact. 
Where those risks cannot be eliminate d or 
reduced to a minimum by such proce ­
dures and measures, the additive and pre­
mixtures shall be used with personal pro­
tective equipment, including skin, eye and 
breathing prot ection.
(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 119/78 21.4.2022