COMMISSION IMPLEMENTING REGUL ATION (EU) 2021/658 
of 21 Apr il 2021
concer ning the author isation of essential oil from Origanum vulg are L. subsp. hirtum (Link) letsw . Var. 
Vulkan (DOS 00001) 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 author isation. Article 4(1) of that Regulation provid es for the 
author isation of additives.
(2) In accordance with Article 4(1) of Regulation (EC) No 1831/2003 in conjunction with Article 7 thereof, an 
application was submitted for the author isation of essential oil from Origanum vulgare L. subsp. hirtum (Link) letsw . 
Var. Vulkan (DOS 00001) as a feed additive for all animal species.
(3) The applicant request ed the additive to be classif ied in the additive catego ry ‘sensor y additives ’. That application was 
accompan ied by the particulars and documents required under Article 7(3) of Regulation (EC) No 1831/2003.
(4) The European Food Safet y Auth ority (‘the Author ity’) concluded in its opinions of 29 November 2017 (2)and 4 July 
2019 (3)that, under the proposed conditions of use, the essential oil from Origanum vulgare L. subsp. hirtum (Link) 
letsw . Var. Vulkan (DOS 00001) does not have an adverse effect on animal health, consumer health or the 
environment. It also concluded that the additive is considered as a potential irritant to skin and eye and a poten tial 
respirato ry and skin sensitiser in suscept ible individuals. Theref ore, the Commission considers that appropr iate 
prote ctive measures should be taken to prevent adverse effects on human health, in particular as regar ds the users 
of the additive. The Author ity does not consider that there is a need for specific requirements of post-market 
monitori ng. It also verified the repor t on the methods of analysis of the feed additives in feed submitte d by the 
Reference Laboratory set up by Regulation (EC) No 1831/2003.
(5) Article 5(2)(b) of Regulation (EC) No 1831/2003 lays down that additives may not be presented in a manner whic h 
may mislead the user . This concer ns in particular the presentation of the effects of an additive taking account of the 
catego ry and group for whic h it has been author ised. The additive concer ned contains some compo nents such as 
carvacrol and thymol for whic h zootec hnical effects have been demonstrated in certain additives already author ised. 
In order to prevent that the proposed level of use of 150 mg/kg compl ete feed is exceed ed, having an effect for whic h 
this additive is not author ised, it is necessar y to establish a maximum content as condition of use of the additive in 
feed.
(6) The assessment of that substance shows that the conditions for author isation, as provided for in Article 5 of 
Regulation (EC) No 1831/2003, are satisfi ed. According ly, the use of essential oil from Origanum vulgare L. subsp. 
hirtum (Link) letsw . Var. Vulkan (DOS 00001) should be author ised as specif ied in the Annex to this Regulation.
(7) 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,
(1)OJ L 268, 18.10.2003, p. 29.
(2)EFSA Jour nal 2017;15(12):5095.
(3)EFSA Jour nal 2019;17(7):5794.EN Offi cial Jour nal of the European Union L 137/16                                                                                                                                         22.4.2021  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
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, 21 Apr il 2021 .
For the Commission
The President
Ursula VON DER LEYENEN Offi cial Jour nal of the European Union 22.4.2021                                                                                                                                         L 137/17  ANNEX 
Identification 
number of the 
additiveName of 
the holder 
of 
author isa-
tionAdditiveCompo sition, chem ical formula, 
descr iption, analytical methodSpecies or 
category of animalMaximum 
ageMinimum 
contentMaximum 
content
Other provisionsEnd of period of 
author isationmg of active  
substance/kg of 
complet e feedingstuff 
with a moisture conten t 
of 12 %
Categor y: Sensor y additiv es
Functional group: Flavour ing compounds
2b317eo — Essential oil 
from Origanum 
vulgare L., subsp. 
hirtum, (Link) 
letsw . Var. 
Vulkan (DOS 
00001)Additive composition
Essential oil from Origanum vulgare 
L. subsp. hirtum (Link) letsw . Var. 
Vulkan (DOS 00001).
Char acter isation of the active 
substance
Essential oil as defined by the 
Council of Europe (1)
— 60-65 % carvacrol;
— 1-3 % thymol
— 4-9 % γ-terp inene
— 5-10 % p-cymene
— < 5 % linalool
— 2-5 % ß caryophy llene
— < 1,5 % α-terpinene
— < 2 % terpinen-4-ol
— 0,3-1,0 % trans sabinene 
hydrate
CoE No: 317
CAS number: 336185-21-8
FEMA: 2660
Method of analysis (2)
For the identification of the major 
constituents and for the 
quantifi cation of the 
phytochemical marker (carvacrol) 
in the feed additive:All animal 
species— — 150 1.The additive shall be incor po­
rated into feed in the form of a 
premixture.
2.In the directions for use of the 
additive and premixtures, the 
stora ge and stability conditions 
shall be indicate d.
3.The mixture of Essential oil 
from Origanum vulgare L. subsp. 
hirtum (Link) letsw . Var. Vulkan 
(DOS 00001) with other 
author ised additives obtained 
from Origanum vulgare L. shall 
not be allowe d in feedingstuffs.
4.For users of the additive and 
premixtures, feed business op­
erators shall establish opera ­
tional procedures and organi ­
sational 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 additive and 12 May 2031EN Offi cial Jour nal of the European Union L 137/18                                                                                                                                         22.4.2021  — gas chromat ography coupled 
to mass spectrometr y and 
flame ionisation detection 
(GC-MS and GC-FID)
For the determination of Oregan o 
essential oil in premixtures:
—water -steam distillation com ­
bined with gas chromat ogra ­
phy coupled to mass spectro ­
metr y and flame ionisation 
detection (GC-MS and
GC-FID)premixtures shall be used with 
personal protect ive equipment, 
including breathing protection, 
safety glasses and gloves .
(1)Natural sources of flavourings – Repor t No 2 (2007).
(2)Details of the methods of analysis are avai lable 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 22.4.2021                                                                                                                                         L 137/19