COMMI SSION IMPLEMENTING REGUL ATION (EU) 2019/111 
of 24 Januar y 2019 
concer ning the author isation of hop extract (Humulus lupulus L. flos) as a feed additiv e for weaned 
piglets, pigs for fattening and minor porcine species weaned and for fattening 
(Text with EEA relevance) 
THE EUR OPEAN COMMISSION, 
Having regar d to the Treaty on the Functioning of the European Union, 
Having regar d to Regulation (EC) No 1831/2003 of the European Parliament and of the Council of 22 September 2003 
on additives for use in animal nutr ition, and in particular Article 9(2) thereof (1), 
Whereas: 
(1)  Regulation (EC) No 1831/2003 provi des for the author isation of additives for use in animal nutr ition. 
(2) In accordance with Article 7 of Regulation (EC) No 1831/2003, an application was submitt ed for the author is­
ation of hop extract (Humulus lupulus L. flos) as a feed additive for all animal species. The application was 
accompan ied by the particulars and documents required under Article 7(3) of that Regulation. The applicant 
request ed that the additive be classified in the additive cate gory ‘sensor y additives’. 
(3)  The European Food Safety Author ity (‘the Auth ority’) concluded in its opinion of 3 Octobe r 2018 (2) that, under 
the proposed conditions of use, hop extract (Humulus lupulus L. flos) does not have adverse effects on animal 
health, human health or the environment. The Auth ority concluded that the tolerance study made with weaned 
piglets shows that the additive is safe for the proposed dose of 50 mg/kg of compl ete feed and can be 
extrapolat ed to pigs for fattening and to minor growing porcine species weaned and for fattening. It is theref ore 
appropr iate to author ise hop extract as a feed additive only for those species and catego ries. The Author ity also 
concluded that since harvested hop and its extracts are universally recognised to flavour food and their function 
in feed would be essentially the same as that in food, no further demonstration of efficacy was necessar y. 
Theref ore, that conclusion can be extrapolat ed for feed. 
(4)  The Authority further noted that the additive is a pote ntial respirato ry and skin sensitiser for users and contains 
a variety of compo unds kno wn to cause allergic reactions in sensitive persons. Consequently , appropr iate 
prot ective measures should be taken. 
(5)  The Author ity did not consider that there was a need for specifi c requirements of post-market monitoring. It also 
verified the repor t on the method of analysis of the feed additive in feed submitted by the Reference Laborat ory 
set up by Regulation (EC) No 1831/2003. 
(6)  The assessment of this additive 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 this additive should be author ised as 
specified in the Annex to this Regulation. 
(7)  Having regard to the use level proposed by the applicant, the Author ity considered that the maximum proposed 
use level is safe. For the purpose of official controls along the food chain, the recommended maximum conte nt 
of the active substance should be indicated on the label of the feed additive and the incor poration into the 
feedingstuffs should be done via premixtures. 
(8)  The fact that the use of the substances concer ned in water for drinking is not author ised should not preclude 
their use in compo und feed, whic h is administe red via water . 
(9)  The measures provi ded for in this Regulation are in accordance with the opinion of the Standing Committee on 
Plants, Animals, Food and Feed, 25.1.2019 L 23/14 Official Jour nal of the European Union EN     
(1)OJ L 268, 18.10.2003, p. 29. 
(2)EFSA Jour nal 2018;16(10):5462 HAS ADOPTED THIS REGUL ATION: 
Article 1 
Author isation 
The substance specif ied in the Annex, belonging to the additive catego ry ‘sensor y additives’ and to the functional group 
‘flavouri ng compo unds ’, is author ised as a feed 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 State s. 
Done at Brussels, 24 Januar y 2019. 
For the Commission 
The President 
Jean-Claude JUNCK ER  25.1.2019 L 23/15 Official Jour nal of the European Union EN     ANNEX 
Identi ­
fica­
tion number 
of the  
additive Name of 
the holder 
of author ­
isation Additive Composition, chemical formula,  
descr iption, analytical method. Species or categ ory 
of animal Maximum 
age Minimum 
content Maximum 
conten t 
Other provisions End of period 
of author ­
isation mg/kg of complet e feed 
with a moisture content of 
12 % 
Categor y: Sensor y additiv es. Functional group: Flavour ing compounds 
2b233 — Hop 
extract 
(strobiles) 
rich in 
beta acids Additiv e composition 
Preparation of supercr itical carbon di­
oxide extract of Humulus lupulus L. 
flos extract treated with potassium hy­
droxide to form potassium salts of the 
beta acids and dissolved in prop ylene 
glycol. 
The specifi cations of the additive are: 
—  Beta-acids: 40 ± 1,5 % 
—  Alpha acids: 0,4 ± 0,3 % 
—  Hop oils: 1,5 ± 0,3 % 
—  Prop ylene glycol: 20 ± 15 % 
—  Moisture < 8 % 
—  Ash: 10 ± 2 % 
—  Other resins: 25 ± 8 % 
—  8-Prenylnar ingenin < 500 mg/kg 
—  Xanthohumol < 500 mg/kg 
—  2-Methyl-2-but en-2-ol < 10 mg/kg  — Weaned 
piglets and 
pigs for 
fattening 
— Minor 
porcine 
species 
weaned and 
for fattening — — — 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 storage conditions and 
stability to heat treatment 
shall be indicated . 
3.  On the label of the additive 
and premixtures the follo w­
ing shall be indicated : 
‘Recommended maximum 
cont ent of the additive of 
compl ete feedingstuff with 
a moisture content of 12 %: 
50 mg/kg’  14 Febr uary 
2029 25.1.2019 L 23/16 Official Jour nal of the European Union EN     Identi ­
fica­
tion number 
of the  
additive Name of 
the holder 
of author ­
isation Additive Composition, chemical formula,  
descr iption, analytical method. Species or categ ory 
of animal Maximum 
age Minimum 
content Maximum 
conten t 
Other provisions End of period 
of author ­
isation mg/kg of complet e feed 
with a moisture content of 
12 % 
Char acter isation of the activ e substance 
Humulus lupulus L. flos flowers (stro ­
biles) pelleted and further extract ed 
with supercr itical carbon dioxide ex­
traction 
Liquid viscous form 
CAS number: 8060-28-4 
CoE No 233 
Analytical method (1) 
For the quantific ation of hops beta- 
acids in the feed additive: 
—  reversed phase high performa nce 
liquid chromat ography with UV 
detec tion (HPLC-UV) – ring-tr ial 
validate d European Brewer y Con ­
vention (EBC) method 7.7 4.  For users of the additive and 
premixtures, feed business 
operat ors shall establish 
operational procedures and 
organisational 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 
premixtures shall be used 
with personal prot ective 
equipment, including breath ­
ing protection, safety glasses 
and gloves. 
(1)  Details of the analytical methods are available at the following address of the Reference Laborato ry: https://ec.europa.eu/jrc/en/eurl/feed-addi tives/evaluation-repor ts   25.1.2019 L 23/17 Official Jour nal of the European Union EN