II
(Non-legislative acts)
REGUL ATIONS
COMMISSION IMPLEMENTING REGUL ATION (EU) 2022/347 
of 1 March 2022
concer ning the author isation of petitg rain bigarade essential oil 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) Petitgrain bigarade essential oil 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 
existing product, 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 petitgrain bigarade essential oil for all animal species.
(4) The applicant requeste d petitgrain bigarade essential oil to be author ised for use also in wate r for drinking. However , 
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 petitgrain bigarade essential oil in wate r for drinking should not be allowe d.
(5) 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.
(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).EN Offi cial Jour nal of the European Union 2.3.2022 L 64/1  (6) The European Food Safety Author ity (‘the Author ity’) concluded in its opinion of 5 May 2021 (3)that, under the 
proposed conditions of use, petitgrain bigar ade essential oil does not have adverse effects on animal health, 
consumer health or the environment. The Author ity also concluded that petitgrain bigarade essential oil 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 take n to prevent adverse effects on human health, in 
particular as regar ds the users of the additive.
(7) The Author ity concluded, that petitgrain bigara de essential oil 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.
(8) The assessment of petitgrain bigarade essential oil shows that the conditions for author isation, as provi ded 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 specif ied 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 petitgrain bigara de essential oil is not author ised for use as a flavouring in water for drinking does not 
preclude its use in compo und feed which is administered 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 22 Sept ember 2022 in accordance with the rules applicable before 22 March 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 22 March 2023 in accordance with the rules applicable before 22 March 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 22 March 2024 in accordance with the rules applicable before 22 March 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.
(3)EFSA Jour nal 2021;19(6):6624.EN Offi cial Jour nal of the European Union L 64/2 2.3.2022  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.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 1 March 2022 .
For the Commission
The President
Ursula VON DER LEYENEN Offi cial Jour nal of the European Union 2.3.2022 L 64/3  ANNEX 
Identifica -
tion 
number of 
the additiveName of 
the holder 
of 
author isa-
tionAdditiveCompo sition, chem ical formula, 
descr iption, analytical method.Species or categor y 
of animalMaximum 
ageMinimum 
contentMaximum 
content
Other provisionsEnd of period of 
author isationmg active substance/kg 
of compl ete feed with a 
moisture content of 
12 %
Categor y: Sensor y additiv es
Functional group: Flavour ing compounds
2b136-eo - Petitgrain 
bigara de essential 
oilAdditive composition
Petitgrain bigarade essential oil 
obtained from the leav es of Citrus 
aurantium L.
Liquid form
Char acter isation of the activ e substance
Petitgrain bigarade essential oil 
obtained by steam distillation from 
the leaves of Citrus aurantium L. as 
defined by the Council of Europe (1).
Linalyl acetate : 40–72 %.
Linalool: 10–32 %.
α-Terpineol: 1–7 %.
d-Limonene: 1–6 %.
Geran yl acetate : 1,5–5,5 %.
Geraniol: 1–4 %.
CAS number : 8014-17-3
Einecs number: 283-881-6
FEMA number : 2855
CoE number: 136Chic kens for 
fatteni ng
Laying hens
Turke ys for 
fatteni ng
Pigs for fattening
Piglets
Lactating sows
Calves
Dair y cows
Cattle for 
fatteni ng
Sheep/Goats
Horses
Rabbits
Salmonids- - - 1.The additive shall be incor po­
rated into the feed in the form of 
a premixture.
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 the 
follo wing shall be indicated:
‘Recommended maximum 
conte nt of the active substance 
per kg of compl ete feedingstuff 
with a moisture content of 12 %:
— Chick ens for fattening: 10 
mg.
— Laying hens: 14 mg.
— Turkeys for fattening: 13 mg.
— Pigs for fattening: 20 mg.
— Piglets: 17 mg.
— Lactating sows: 25 mg.
— Calves (milk replacer): 43 mg.22 March 2032EN Offi cial Jour nal of the European Union L 64/4 2.3.2022  Analytical method (2)
For the quantifi cation of the 
phytoc hemical mark ers Linalyl 
acetate and Linalool in the feed 
additive (petigrain bigarade oil) or in 
mixture of flavouring compo unds:
— gas chromat ography coupled 
with flame ionisation detection 
(GC-FID) (based on ISO 8901)Dogs
Cats
Ornamental fish— Cattle for fattening, sheep, 
goats and horses: 38 mg.
— Dair y cows: 24 mg.
— Rabbits: 15 mg.
— Salmonids: 42 mg.
— Dogs: 44 mg.
— Cats: 8 mg.
— Ornamental fish: 125 mg’.
4.The functional group, the identi ­
fication number , the name and 
the added amount of the active 
substance shall be indicated 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.
5.For users of the additive and pre­
mixtures, feed business operat ors 
shall establish operational proce ­
dures and organisational mea ­
sures 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 proce ­
dures and measures, the additive 
and premixtures shall be used 
with personal prot ective equip ­
ment, 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 tsEN Offi cial Jour nal of the European Union 2.3.2022 L 64/5