COMMISSION IMPLEMENTING REGUL ATION (EU) 2023/54 
of 4 Januar y 2023
correcting Implementing Regulation (EU) 2022/652 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) The use of the bitter orange extract as a feed additive was author ised for certain animal species by Commission 
Implementing Regulation (EU) 2022/652 (2).
(2) Bitter orange extract is known to contain 10 to 20 % neohesper idin, as detailed in the column ‘Compos ition, 
chemical formula, descr iption, analytical method’ in the Annex to Imp lementing Regulation (EU) 2022/652.
(3) An incor rect presump tion of a relationship between neohesper idin, identif ied with CAS number 13241-33-3, and 
neohesper idin dihy droch alcone, identified with CAS number 20702-77-6, which has a similar name, but is a 
distinct substance, result ed in point 3 of the column ‘Other provisions’ in the Annex to Implementing Regulation 
(EU) 2022/652, which mistakenly provid es for the excl usion of the use of bitter orange extract in combination with 
neohesper idin dihydroc halcone.
(4) Theopinion of the European Food Safe ty Author ity of 23 June 2021 on the safety of bitter orang e extract (3)does not 
mention any risk as regards the use of bitter orange extract in combination with neohesper idin dihy drochalcone.
(5) It is theref ore necessar y to correct the Annex to Implementing Regulation (EU) 2022/652 by deleting point 3 of the 
column ‘Other provisions’ in that Annex. For the sake of clarity, it is appropr iate to replace the whole Annex to that 
Implementing Regulation.
(6) In the inter est of preventing disruptions to the placing of the feed additive in the mark et due to the error in 
Implementing Regulation (EU) 2022/652, this Regulation should enter into force as a matt er of urgency .
(7) 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)Commission Implementing Regulation (EU) 2022/652 of 20 Apr il 2022 concer ning the author isation of bitter orange extract as a feed 
additive for certain animal species (OJ L 119, 21.4.2022, p. 74).
(3)EFSA Jour nal 2021;19(7):6709.EN Offi cial Jour nal of the European Union L 3/12 5.1.2023  HAS ADOPTED THIS REGUL ATION:
Article 1
The Annex to Implementing Regulation (EU) 2022/652 is replaced by the Annex to this Regulation.
Article 2
This Regulation shall enter into force on the day following 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, 4 Januar y 2023 .
For the Commission
The President
Ursula VON DER LEYENEN Offi cial Jour nal of the European Union 5.1.2023 L 3/13  ANNEX 
‘ANNEX
Identifica -
tion 
number of 
the additiveName 
of the 
holder 
of 
author -
isationAdditiveCompo sition, chem ical formula, 
descr iption, analytical method.Species or categor y of 
animalMaxi -
mum 
ageMini -
mum 
contentMaxi -
mum 
content
Other provisionsEnd of 
period of 
author isa-
tionmg active  
substance/kg of 
complet e feed with 
a moisture conten t 
of 12 %
Categor y: Sensor y additiv es. Functional group: Flav our ing compounds
2b136-ex - Bitter 
orange 
extractAdditive composition
Bitter orange extract from the fruit of 
Citrus x aurantium L.
Solid form
Char acter isation of the active substance
Bitter orange extract from the fruit of 
Citrus x aurantium L. as defined by the 
Council of Europe (1).
Flavonoids: 45-55 % of which
— Naringin: 20-30 %
— Neohesper idin: 10-20 %
5- metho xypsoralen (also known as 
bergap ten): ≤ 0,03 %
(-)-Synephr ine: ≤ 1 %
CoE number: 136
Analytical method (2)
For the quantification of naringin 
(phyt ochemical mark er) in the feed 
additive:
—High performa nce liquid chro­
matog raphy (HPL C) with spec ­
trophot ometr ic (UV) detectionChick 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 porated 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 
indicated .
3.On the label of the additive the follo w­
ing shall be indicate d:
‘Recommended maximum content of 
the active substance per kg of compl ete 
feedingstuff 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 L 3/14 5.1.2023  4.The functional group, the identification 
number , the name and the added 
amount of the active substance shall 
be indicated on the label of the premix ­
ture where the use level on the label of 
the premixture would result in exceed ­
ing the level referred to in point 3.
5.The mixture of bitter orang e extract 
from the fruit of Citrus x aurantium L 
with other author ised additives ob­
tained from Citrus aurantium L. shall 
not be allowed in feedingstuffs.
6.For users of the additive and premix ­
tures, feed business operators shall es­
tablish operational procedures and or­
gani sational measures to address 
poten tial risks by inhalation, dermal 
contact or eyes contact. Where those 
risks cannot be eliminated or reduced 
to a minimum by such procedures and 
measures, the additive and premixtures 
shall be used with personal protective 
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 5.1.2023 L 3/15