COMMISSION IMPLEMENTING REGUL ATION (EU) 2023/1708 
of 7 September 2023
concer ning the renewal of the author isation of urea as a feed additiv e for ruminants with a 
functional rumen and repealing Implementing Regulation (EU) No 839/2012 
(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 and renewing such author isation.
(2) Urea was author ised for a period of 10 years as a feed additive for ruminants with a functional rumen by 
Commission Implementing Regulation (EU) No 839/2012 (2).
(3) In accordance with Article 14(1) of Regulation (EC) No 1831/2003, an application was submitted for the renewal of 
the author isation of urea as a feed additive for ruminants with a functional rumen, requesting the additive to be 
classifie d in the additive catego ry ‘nutr itional additives’ and in the functional group ‘urea and its derivatives’. That 
application was accompanied by the particulars and documents required under Article 14(2) of that Regulation.
(4) The European Food Safe ty Author ity (‘the Authority’) concluded in its opinion of 11 Januar y 2023 (3)that the 
applicant provid ed evidence that the additive remains safe for the targe t species, the consumers and the 
environment under the existing conditions of author isation. In the absence of new information provid ing evidence 
for the safet y of the additive for the user , the Author ity could not conclude on the users’ safety . The Auth ority also 
indicated that the conclusion made previously on the efficacy remains valid. It did not consider that there is a need 
for specifi c requirements of post-market monitoring.
(5) The Reference Laborator y set up by Regulation (EC) No 1831/2003 considered that the conclusions and 
recommendations reach ed in the assessment carried out regarding the method of analysis of urea as a feed additive 
in the conte xt of the previous author isation are valid and applicable for the current application. In accordance with 
Article 5(4), point (c), of Commission Regulation (EC) No 378/2005 (4), an evaluation repor t of the Reference 
Laboratory is theref ore not required.
(6) In view of the above, the Commission considers that the conditions for author isation, as provided for in Article 5 of 
Regulation (EC) No 1831/2003, are satisfi ed. According ly, the author isation of that additive should be renewed. In 
addition, the Commission considers that appropr iate prot ective measures should be take n to prevent adverse effects 
on the health of the users of the additive.
(7) As a consequence of the renewal of the author isation of urea as a feed additive, Implementing Regulation (EU) 
No 839/2012 should be repealed.
(1)OJ L 268, 18.10.2003, p. 29.
(2)Commission Implementing Regulation (EU) No 839/2012 of 18 September 2012 concer ning the author isation of urea as a feed 
additive for ruminants (OJ L 252, 19.9.2012, p. 11).
(3)EFSA Journal 2023;21(2):7821.
(4)Commission Regulation (EC) No 378/2005 of 4 March 2005 on detailed rules for the implement ation of Regulation (EC) 
No 1831/2003 of the European Parliament and of the Council as regards the duties and tasks of the Community Reference 
Laborato ry concer ning applications for author isations of feed additives (OJ L 59, 5.3.2005, p. 8).EN Offi cial Jour nal of the European Union 8.9.2023 L 221/31  (8) 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
Renewal of author isation
The author isation of the substance specified in the Annex, belonging to the additive cate gory ‘nutr itional additives’ and to 
the functional group ‘urea and its derivatives ’, is renewed subject to the conditions laid down in that Annex.
Article 2
Repeal of Implementing Regulation (EU) No 839/2012
Implementing Regulation (EU) No 839/2012 is repealed.
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.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 7 Sept ember 2023 .
For the Commission
The President
Ursula VON DER LEYENEN Offi cial Jour nal of the European Union L 221/32 8.9.2023  ANNEX 
Identifica -
tion 
number of 
the additiveAdditiveComposition, chemical formula, descr iption, 
analytical methodSpecies or 
categor y of 
animalMaximum 
ageMinimum 
contentMaximum 
content
Other provisionsEnd of period of 
author isation mg of the additive/kg of 
complet e feed with a 
moisture conten t of 12 %
Categor y: nutr itional additiv es. Functional group: Urea and its derivativ es
3d1 Urea Additive composition
Urea content: minimum 97 %
Nitrogen cont ent: 46 %
Solid form
Char acter isation of the active substance
Diaminomethanone, CAS number 
57-13-6, chemical formula: (NH 2)2CO
Analytical method (1)
For the determination of the total 
nitrogen in the additive: Titrimetr y (EN 
15478)
For the determination of the biuret 
contr ibution to the total nitrogen in the 
additive: Spectrophotometr y  
(EN 15479)
For the determination of urea in 
premixtures, compo und feed and feed 
mater ials: Spectrophotometr y (Annex 
III.D to Regulation (EC) No 152/2009)Ruminants 
with a 
functional 
rumen8 800 1. In the directions for use of the additive 
and feed containing it, the following shall 
be indicated:
‘Ure a shall only be fed to animals with a 
functional rumen. Feeding urea to the 
maximum level dose should be done 
gradually . The maximum cont ent of urea 
should be fed only as part of diets rich in 
easily digestible carboh ydrates and low in 
soluble nitroge n.
A maximum 30 % of total nitroge n in the 
daily ration should come from urea-N.’
2. For users of the additive and premixtures, 
feed business operat ors shall establish 
operational procedures and organisa ­
tional measures to address poten tial risks 
resulting from their use. Where those 
risks cannot be eliminate d by such pro­
cedures and measures, the additive and 
premixtures shall be used with personal 
skin, eye and breathing prot ective equip ­
ment.28 September 
2033
(1)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_en .EN Offi cial Jour nal of the European Union 8.9.2023 L 221/33  