COMMISSION IMPLEMENTING REGUL ATION (EU) 2022/1383 
of 8 August 2022
concer ning the author isation of olibanum extract from Bosw ellia serrata Roxb.ex Colebr . as a feed 
additiv e for horses and dogs 
(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) Olibanum 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 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 olibanum extract from Bosw ellia serrata Roxb. ex Colebr . for 
horses and dogs.
(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 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, olibanum extract from Boswellia serrata Roxb. ex Colebr . does not have adverse effects on 
animal health, consumer health or the environment. The Author ity also concluded that olibanum extract from 
Bosw ellia serrata Roxb. ex Colebr . should be considered as a non-ir ritant to skin and eyes, but in the absence of data, 
no conclusion could be drawn on its pote ntial to be a dermal and respirator y 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.
(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 Journal 2022;20(3):7158.EN Offi cial Jour nal of the European Union 9.8.2022 L 207/19  (6) The Author ity further concluded, that olibanum extract from Boswellia serrata Roxb. ex Colebr . 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.
(7) The assessment of olibanum extract from Boswellia serrata Roxb. ex Colebr . 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.
(8) Certain conditions should be provid ed for to allow better control. In particular , a recommended content should be 
indicated on the label of the additives. Where such content is exceeded, certain information should be indicated on 
the label of premixtures.
(9) 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.
(10) 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 28 Febr uary 2023 in accordance with the rules applicable before 29 August 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 29 August 2023 in accordance with the rules applicable before 29 August 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 29 August 2024 in accordance with the rules applicable before 29 August 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 207/20 9.8.2022  This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 8 August 2022 .
For the Commission
The President
Ursula VON DER LEYENEN Offi cial Jour nal of the European Union 9.8.2022 L 207/21  ANNEX 
Identification 
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 isationmg additive/kg of 
complet e feed with a 
moisture content of 
12 %
Categor y: Sensor y additiv es. Functional group: Flavour ing compounds
2b2816-ex Olibanum extract Additive composition
Dry extract of olibanum from 
Bosw ellia serrata Roxb. ex Colebr .
Solid form
Methyleug enol ≤ 0,009 %
Estragole ≤ 0,028 %
Char acter isation of the active substance
Dry extract of olibanum produced 
by extraction from the oleoresin of 
Bosw ellia serrata Roxb. ex Colebr . as 
defined by the Council of Europe (1).
Olibanum oil:
FEMA number: 2816
Boswellic acids: ≥ 65 %
11-ke to-β-boswellic acid (KBA): 
2,53-3,86 %
CAS number: 17019-92-0
3-O-acetyl-11-k eto β-boswellic acid 
(AKBA ): 2,35–3,57 %
CAS number: 67416-61-9Horses
Dogs- - - 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 
stora ge conditions and stability 
to heat treatment shall be indi ­
cated .
3.Mixture with other additives 
containing meth yleugeno l and 
estragole is not permitted .
4.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 cont ent of 12 %:
— horses: 100 mg;
— dogs: 330 mg.’
5.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 4.29 August 2032EN Offi cial Jour nal of the European Union L 207/22 9.8.2022  Analytical method (2)
For the determination of 11-k eto-β- 
boswellic acid and 3-O-acetyl- 
11-ke to-β-boswellic acid 
(phyt ochemical mark ers) in the feed 
additive (olibanum extract):
—high performa nce liquid chro­
matog raphy (HPL C) with spec ­
trophot ometr ic (UV) detection 
– European Phar macopeia 
monograph ‘Indian Frankin ­
cense (Olibanum indicum)’6.For users of the additive and pre­
mixtures, feed business opera ­
tors shall establish operational 
procedures and organisational 
measures to address poten tial 
risks by inhalation, dermal con­
tact or eyes contact. Where those 
risks cannot be eliminated or re­
duced to a minimum by such 
procedures and measures, the 
additive and premixtures shall 
be used with personal prot ective 
equipment, including skin and 
breathing prot ection.
(1)Natural sources of flavourings – Repor t No 2 (2007).
(2)Details of the analytical methods are available at the follo wing address of the Reference Laboratory : 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 9.8.2022 L 207/23