COMMISSION IMPLEMENTING REGUL ATION (EU) 2022/537 
of 4 Apr il 2022
concer ning the author isation of a preparation of lemon extract as a feed additiv e for all 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) Lemon 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) 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 a preparation of lemon extract for all animal species.
(4) 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.
(5) The applicant requested the preparation of lemon 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 flavouring compounds for use in 
water for drinking. Theref ore, the use of the preparation of lemon extract in water for drinking should not be 
allowe d.
(6) The European Food Safety Author ity (‘the Auth ority’) concluded in its opinion of 29 September 2021 (3)that, under 
the proposed conditions of use, the preparation of lemon extract does not have adverse effects on animal health, 
consumer health or the environment. The Author ity also concluded that the preparation of lemon extract should 
be considered a skin and eye irritant, and a poten tial corrosive. 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.
(7) The Authority concluded, that the preparation of lemon 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 submitt ed 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(11):6893.EN Offi cial Jour nal of the European Union L 106/4 5.4.2022  (8) The assessment of the preparation of lemon extract shows that the conditions for author isation, as provid ed for in 
Article 5 of Regulation (EC) No 1831/2003, are satisfied. According ly, the use of that preparation 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 the preparation of lemon 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 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 preparation 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 preparation specif ied in the Annex, belonging to the additive catego ry ‘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 preparation specifi ed in the Annex and premixtures containing this preparation, which are produced and labelled 
before 25 October 2022 in accordance with the rules applicable before 25 Apr il 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 mat erials containing the preparation as specified in the Annex whic h are produced and 
labelled before 25 Apr il 2023 in accordance with the rules applicable before 25 Apr il 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 mat erials containing the preparation as specified in the Annex whic h are produced and 
labelled before 25 Apr il 2024 in accordance with the rules applicable before 25 Apr il 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 5.4.2022 L 106/5  This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 4 Apr il 2022 .
For the Commission
The President
Ursula VON DER LEYENEN Offi cial Jour nal of the European Union L 106/6 5.4.2022  ANNEX 
Identification 
number of 
the additiveAdditiveComposition, chemical formula, descr iption, 
analytical method.Species or 
categ ory of 
animalMaximum 
ageMinimum 
conten tMaximum 
conten t
Other provisi onsEnd of period of 
author isationmg active substance/kg 
of complet e feed with a 
moisture content of 
12 %
Categor y: Sensor y additiv es. Functional group: Flavour ing compounds
2b139a-ex Lemon extract Additive composition
Preparation of lemon extract derived from 
the fruit of Citrus limon (L.) Osbeck (1) with 
propionic acid ≤ 1 %.
Liquid formAll animal 
species- - 1.The additive shall be incor porat ed into 
the feed in the form of a premixture.
2.In the directions for use of the additive 
and premixtures, the stora ge condi ­
tions and stability to heat treatment 
shall be indicate d.
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 %: 1 000 mg’.
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 3.25 Apr il 2032
Char acter isation of the active substance
Aqueous extract of the mate rial remaining 
after the extraction of juice from the fruit of 
Citrus limon (L.) Osbec k as defined by the 
Council of Europe (2).
Dry matt er: 51-53 %
Total polyphenols (expressed as
pyrogallol equivalents): ≥ 1 %
Eriocitr in: ≥ 4 000 mg/kg
Hesper idin: ≥ 2 000 mg/kg
Limonin: 36-92 mg/kg
Nomilin: 14-113 mg/kg
Citric acid: 4-7 %
Osidic compo unds: ≥ 42 %EN Offi cial Jour nal of the European Union 5.4.2022 L 106/7  5.The mixture of lemon extract with 
other author ised additives obtained 
from Citrus limon (L.) Osbeck shall not 
be allowed in feedingstuffs.
6.For users of the additive and premix ­
tures, feed business operat ors 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 eliminate d or reduced 
to a minimum by such procedures and 
measures, the additive and premixtures 
shall be used with personal prot ective 
equipment, including skin and eye pro­
tectio n.CAS number: 84929-31-7
Einecs number: 284-515-8
FEMA number: 2623
CoE number: 139a
Analytical method (3)
For the quantifi cation of the phytochemical 
mark er (total polyphenols) in the feed 
additive:
—spectrophotometr y at 760 nm expres ­
sing the total polyphenols conte nt as 
pyrogallol equivalent (European Phar ­
macopoeia monograph 2.8.14)
_____________
(1)Synon ym Citrus Limon (L.) Burm. f.
(2)Natural sources of flavourings – Repor t No 2 (2007).
(3)Details of the analytical methods are available at the following address of the Reference Laborato ry: https://ec.europa.eu/jrc/en/eurl/feed -additives/evaluation-repor ts.EN Offi cial Jour nal of the European Union L 106/8 5.4.2022