COMMISSION IMPLEMENTING REGUL ATION (EU) 2022/1419 
of 22 August 2022
concer ning the author isation of buchu leaf essential oil from Agathosma betulina (P.J. Bergius) Pillans 
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) Buchu leav es 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 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 submitte d for the re-evaluation of an essential oil from the leaves of Agathosma betulina (P.J. Bergius) 
Pillans (buc hu leaf essential oil) 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 additive to be author ised also for use 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 buchu leaf essential oil from Agathosma betulina (P.J. Bergius) Pillans in water for drinking should not be 
allowe d.
(6) The European Food Safety Author ity (‘the Author ity’) concluded in its opinion of 27 Januar y 2022 (3)that, under the 
proposed conditions of use, buchu leaf essential oil from Agathosma betulina (P.J. Bergius) Pillans does not have 
adverse effects on animal health, consumer health or the environment. The Author ity also concluded that buchu 
leaf essential oil from Agathosma betulina (P.J. Bergius) Pillans should be considered as an irritant to skin and eyes, 
and as a dermal and respirato ry 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 Author ity further concluded, that buchu leaf essential oil from Agathosma betulina (P.J. Bergius) Pillans 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 2022;20(3):7160.EN Offi cial Jour nal of the European Union L 218/12 23.8.2022  (8) The assessment of buchu leaf essential oil from Agathosma betulina (P.J. Bergius) Pillans 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 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 additive. Where such content is exceed ed, certain information should be indicated on 
the label of premixtures.
(10) The fact that buchu leaf essential oil from Agathosma betulina (P.J. Bergius) Pillans is not author ised for use as a 
flavouring in wate r for drinking, does not preclude its use in compo und feed, whic h is administ ered 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 compo unds ’, is author ised as a feed 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 12 March 2023 in accordance with the rules applicable before 12 Sept ember 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 12 Sept ember 2023 in accordance with the rules applicable before 12 Sept ember 2022 may continue to be 
placed on the market 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 12 Sept ember 2024 in accordance with the rules applicable before 12 Sept ember 2022 may continue to be 
placed on the market 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 23.8.2022 L 218/13  This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 22 August 2022 .
For the Commission
The President
Ursula VON DER LEYENEN Offi cial Jour nal of the European Union L 218/14 23.8.2022  ANNEX 
Identification 
number of the 
additiveAdditiveCompo sition, chem ical formula, descr iption, 
analytical method.Species or 
category of 
animalMaximum 
ageMinimum 
contentMaximum 
content
Other provisionsEnd of period of 
author isationmg additive/kg of 
complet e feed with a 
moisture content of 
12 %
Categor y: Sensor y additiv es. Functional group: Flavour ing compounds
2b85c-eo Buchu leaf essential 
oilAdditive composition
Buchu leaf essential oil obtained from the 
leav es of Agathosma betulina (P.J. Bergius) 
Pillans
Liquid form
Methyleug enol ≤ 0,17 %
Char acter isation of the active substance
Buchu leaf essential oil produced by steam 
distillation from the leaves of Agathosma 
betulina (P.J. Bergius) Pillans as defined by the 
Council of Europe (1).
d,l-Isomenthone: 19–27 %
d-Limonene: 19–26 %
2-Hydro xypiper itone (or diosphenol): 8–17 %
p-Menthan-3-one: 5–12 %
Pulegone: 1,5–8 %
CAS number: 68650-46-4
CoE number: 85c
FEMA number: 2169All 
animal 
species 
excep t 
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 storag e conditions 
and stability to heat treatment shall be 
indicated .
3.Mixture with other additives containing 
meth yleugenol is not permitted.
4.On the label of the additive the following 
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 and other minor 
poultr y species for fattening: 0,1 mg;
—laying hens and other minor poultr y spe­
cies for laying and breeding purposes, 
turke ys for fattening and rabbits: 
0,15 mg;
— piglets of all Suidae species: 0,20 mg;
— all Suidae for fattening: 0,25 mg;
— sows and dair y ruminants: 0,30 mg;12.9.2032
Cats - - 0,2EN Offi cial Jour nal of the European Union 23.8.2022 L 218/15  Analytical method (2)
For the determination of d-limonene and d,l- 
isomenthone (phy tochemical markers) in the 
feed additive (buc hu leav e essential oil):
— gas chromat ography coupled with flame 
ionisation detection (GC-FID) (based on 
ISO 11024)— ruminants for fattening and horses: 
0,45 mg;
— calves (milk replacer), dogs, fish and 
ornamental fish: 0,5 mg;
— other species, excep t cats: 0,1 mg.’
5.The functional group, the identification 
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 exceed ing the level re­
ferred to in point 4.
6.For users of the additive and premixtures, 
feed business operat ors shall establish 
operational procedures and organisa ­
tional 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 addi ­
tive and premixtures shall be used with 
personal prot ective equipment, including 
skin, eye and breathing protect ion.
(1)Natural sources of flavourings – Repor t No 2 (2007).
(2)Details of the analytical methods are available at the following address of the Reference Laborato ry: https://joint-research-c entre.ec.europa.eu/eurl-fa-eurl-f eed-additives/eurl-fa-author isation/eurl-f a-evaluation- 
repor ts_enEN Offi cial Jour nal of the European Union L 218/16 23.8.2022