COMMISSION IMPLEMENTING REGUL ATION (EU) 2022/653 
of 20 Apr il 2022
concer ning the author isation of a preparation of the leav es extract of Melissa officinalis L. 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) The leaves extract of Melissa officinalis L. 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 Registe r 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 the leav es extract of Melissa officinalis L. 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 the leav es extract of Melissa officinalis L. 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 
compo unds for use in water for drinking. Theref ore, the use of the preparation of the leaves extract of Melissa 
officinalis L. in wate r for drinking should not be allowed.
(6) The European Food Safety Author ity (‘the Author ity’) concluded in its opinions of 28 Januar y 2020 (3)and 
29 Sept ember 2021 (4)that, under the proposed conditions of use, the preparation of the leaves extract of Melissa 
officinalis L. does not have adverse effects on animal health, consumer health or the environment. The Author ity 
also concluded that the exposure of users to dusts from the additive is not of concer n. However , no data was 
provid ed on irritant proper ties for eyes or skin, thus no conclusion could be drawn on these aspects. Due to the 
nature of the additive, it may be assumed to be poten tially both a skin and respirator y sensitiser . Theref ore, the 
Commission considers that appropr iate prot ective measures should be take n to prevent adverse effects on human 
health, in particular as regards the users of the additive.
(7) The Auth ority concluded, that the preparation of the leav es extract of Melissa officinalis L. 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 
submitted 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 2020;18(2):6016.
(4)EFSA Jour nal 2021;19(10):6904.EN Offi cial Jour nal of the European Union 21.4.2022 L 119/79  (8) The assessment of the preparation of the leaves extract of Melissa officinalis L. shows that the conditions for 
author isation, as provided for in Article 5 of Regulation (EC) No 1831/2003, are satisfied. According ly, the use of 
that preparation should be author ised as specified 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 the leaves extract of Melissa officinalis L. is not author ised for use as a flavouri ng in 
water for drinking does not preclude its use in compound 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 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 mat erials containing the preparation as specified 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 mat erials containing the preparation as specified 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 L 119/80 21.4.2022  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 21.4.2022 L 119/81  ANNEX 
Identifica -
tion 
number of 
the additiveAdditiveCompo sition, chem ical formula, descr iption, 
analytical method.Species or 
categor y of 
animalMaximum 
ageMinimum 
contentMaximum 
content
Other provisionsEnd of period of 
author isation mg 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
2b280-ex Leaves extract of 
Melissa officinalis L.Additive composition
Preparation of the leav es extract of Melissa 
officinalis L. (with a minimum content of 50 %) 
with maltod extr in and silicon dioxide.
Solid form
Char acter isation of the active substance
Dried aqueous ethanol extract from Melissa 
officinalis L. leav es as defined by the Council of 
Europe (1)
Total phenolic compo unds (total 
hydroxycinnamic acid derivatives):
≥ 10 %
Flavonoids: ≤ 3 mg/kg
Rosmar inic acid: 3-6 %
Dry matt er ≥ 94 %
CAS number: 84082-61-1
Einecs number: 282-007-0
FEMA number: 2112
CoE number: 280All animal 
species- - 1.The additive shall be incor porat ed 
into the feed in the form of a pre­
mixture.
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 content 
of the active substance per kg of 
com plete feedingstuff with a moist ­
ure content of 12 %: 100 mg’.
4.The functional group, the identi ­
fication 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 ex­
ceeding the level refer red to in 
point 3.11 May 2032EN Offi cial Jour nal of the European Union L 119/82 21.4.2022  Analytical method (2)
For the quantification of rosmar inic acid 
(phyt ochemical mark er) in the feed additive 
(Melissa officinalis L. dry extract):
— reversed phase high performa nce liquid 
chromatograph y coupled to spectropho ­
tometr ic detec tion (HPLC-UV) (European 
Phar macopoeia monograph 2524)5.The mixture of leav es extract of 
Melissa officinalis L. with other 
author ised additives obtained 
from Melissa officinalis L. shall 
not be allowed in feedingstuffs.
6.For users of the additive and pre­
mixtures, feed business operat ors 
shall establish operational proce ­
dures and organisational mea ­
sures to address pote ntial 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 protect ive 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 ts.EN Offi cial Jour nal of the European Union 21.4.2022 L 119/83