ELI: http://data.europa.eu/eli/reg_impl/2024/265/oj 1/4COMMISSION IMPLEMENTING REGUL ATION (EU) 2024/265 
of 17 Januar y 2024
concer ning the author isation of zinc(II)– betaine complex as a feed additiv e for all animal species 
except aquatic animals farmed in mar ine aquaculture systems 
(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.
(2) In accordance with Article 7 of Regulation (EC) No 1831/2003, an application was submitted for the author isation 
of zinc(II)– betaine compl ex. That application was accompan ied by the particulars and documents required under 
Article 7(3) of Regulation (EC) No 1831/2003.
(3) The application concer ns the author isation of zinc(II)– betaine compl ex as a feed additive for all animal species, to be 
classifie d in the additive catego ry ‘nutr itional additives ’ and in the functional group ‘compounds of trace elements’.
(4) The European Food Safety Author ity (‘the Author ity’) concluded in its opinion of 11 Januar y 2023 (2)that, under the 
proposed conditions of use, zinc(II)– betaine complex is safe for all animal species and consumers, provi ded that the 
maximum author ised levels for total zinc in feed are not exceeded. As regar ds the safety of zinc(II)– betaine compl ex 
for the environment, the available data do not allow to conclude on its safety for the mar ine sediment when that 
substance is used in sea cages. The Author ity further concluded that zinc(II)– betaine compl ex is considered a skin 
and respirato ry sensitiser , due to the presence of nick el. It is an eye irritant, but it is non-ir ritant to skin. The 
Authority concluded that the substance is efficacious as a source of zinc in covering the animals’ requirements The 
Authority did not consider that there is 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 Laboratory set up by 
Regulation (EC) No 1831/2003.
(5) In view of the abov e, the Commission considers that zinc(II)– betaine complex satisfi es the conditions provid ed for 
in Article 5 of Regulation (EC) No 1831/2003. According ly, the use of that substance should be author ised. 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.
(6) 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 Journal 2023;21(2):7819
Offi cial Jour nal  
of the European Union EN 
L series    
2024/265  18.1.2024ELI: http://data.europa.eu/eli/reg_im pl/2024/265/oj 2/4HAS ADOPTED THIS REGUL ATION:
Article 1
Author isation
The substance specifi ed in the Annex, belonging to the additive categor y ‘nutr itional additives ’ and to the functional group 
‘compounds of trace elements’, 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, 17 Januar y 2024 .
For the Commission
The President
Ursula VON DER LEYENOJ L, 18.1.2024 EN  ELI: http://data.europa.eu/eli/reg_impl/2024/265/oj 3/4ANNEX 
Identifica -
tion 
number 
of the 
additiveAdditiveComposition, chemical formula, descr iption, 
analytical methodSpecies or categor y of 
animalMaximum 
ageMinimum 
contentMaximum 
content
Other provisi onsEnd of period of 
author isationContent of the element 
(Zn) in mg/kg of 
complet e feed with a 
moisture content of 
12 %
Categor y: nutr itional additiv es. Functional group: compounds of trace elements
3b616 Zinc(II)– 
betaine 
compl exAdditive composition
Zinc betaine compl ex with a minimum of 20 % 
of zinc and a minimum of 41 % of betaine
Nick el: maximum 60 mg/kg
Solid form
Char acter isation of the active substances
Name: catena- [μ3-sulphato-
(trimethyla mmonio)acetato-zinc(II)]
Chemical formula: [Zn((CH 3)3NCH 2COO) 
(SO 4)]n
Specifi cations
— Minimum of 20 % of zinc
— Minimum 41 % betaine,
— 9 %–12 % sulphur
— Maximum 5 % moisture
Analytical methods (1)
For the quantification of total zinc in the feed 
additive:
—Inductively coupled plasma-atomic emis ­
sion spectrometr y, ICP-AES (EN 15621 or 
EN 15510) or
— Atomic absor ption spectrometr y, AAS 
(ISO 6869)
For the quantification of total zinc in 
premixtures:
—Inductively coupled plasma-atomic emis ­
sion spectrometr y, ICP-AES (EN 15621 or 
EN 15510) or— Dogs
— Cats- - 200 1. The additive shall be incor po­
rated into feed in the form of a 
premixture.
2. For users of the additive and pre­
mixtures, feed business opera ­
tors shall establish operational 
procedures and organisational 
measures to address the poten ­
tial risks resulting from their use. 
Where those risks cannot be 
eliminated by such procedures 
and measures, the additive and 
premixtures shall be used with 
personal breathing eye and skin 
prote ctive equipment.7 Febr uary 2034
— Piglets
— Sows
— Rabbits
— Fish farmed in 
land-based aqua ­
culture systems, 
other than salmo ­
nids- - 150
— Calves (milk 
replacer)
— Salmonids 
farmed in land- 
based aquacul ­
ture system s- - 180
Other species and 
catego ries excep t 
aquatic animals 
farmed in mar ine 
aquaculture systems- - 120OJ L, 18.1.2024 EN  ELI: http://data.europa.eu/eli/reg_im pl/2024/265/oj 4/4
— Atomic absor ption spectrometr y, AAS 
(ISO 6869) or
—Inductively coupled plasma-mass spectro ­
metr y, ICP-MS (EN 17053)
For the quantification of total zinc in 
compo und feed:
—Inductively coupled plasma-atomic emis ­
sion spectrometr y, ICP-AES (EN 15621 or 
EN 15510) or
— Atomic absor ption spectrometr y, AAS 
(Commission Regulation (EC) 
No 152/2009 (Annex IV-C) or ISO 6869) 
or
—Inductively coupled plasma-mass spectro ­
metr y, ICP-MS (EN 17053)
For the quantification of betaine in the feed 
additive:
— High performa nce liquid chromat ography 
with refraction index detection (HPLC-RI)
For the quantification of sulphur and sulfate in 
the feed additive:
—Inductively coupled plasma-atomic emis ­
sion spectrometr y, ICP-AES (EN 15621)
Proof of complex formation between zinc, 
betaine and sulfat e: Powder X-ra y diffraction 
(XRD) (2)
(1)Details of the analytical methods are avail able at the follo wing address of the Reference Laboratory : https://ec.europa.eu/jrc/en/eurl/feed-additives/evaluation-repor ts
(2)Stoe Stadi P diffracto meter in Guinier geometry using Cu-Κα1 radiation (Johann Gemonochromat or) and a Stoe imagepl ate detect or IP-PSD.OJ L, 18.1.2024 EN