COMMISSION IMPLEMENTING REGUL ATION (EU) 2024/1055 
of 10 Apr il 2024
concer ning the author isation of iron(II) – betaine complex 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.
(2) In accordance with Article 7 of Regulation (EC) No 1831/2003, an application was submitted for the author isation 
of iron(II) – betaine complex. That application was accompanied 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 iron(II) – betaine complex as a feed additive for all animal species, 
requesting that additive to be classified in the categor y ‘nutr itional additives’ and in the functional group 
‘compounds of trace elements’.
(4) The European Food Safety Auth ority (‘the Author ity’) concluded in its opinion of 5 September 2023 (2)that, under 
the proposed conditions of use, iron(II) – betaine compl ex is safe for, consumers and the envi ronment provided that 
the maximum author ised levels for total iron in feed are not exceed ed. The Author ity further concluded that iron(II)- 
betaine complex is safe for chick ens for fattening . This conclusion can be extrapolated to all animal species and 
catego ries provid ed that the maximum author ised levels in the EU for total iron in feed are not exceed ed. The 
Authority concluded that iron(II) – betaine compl ex, owing to the presence of nick el, is considered a skin and 
respirato ry sensitiser . It is an eye irritant, but it is non-ir ritant to the skin. The Author ity concluded that the 
substance is efficacious as a source of iron in all animal species and categor ies. The Author ity did not consider that 
there is a need for specifi c requirements of post-market monitori ng. It also verified the repor t on the method of 
analysis of the feed additive in feed, submitte d by the Reference Laboratory set up by Regulation (EC) No 1831/2003.
(5) In view of the above, the Commission considers that iron(II)– betaine compl ex satisfies the conditions provi ded for 
in Article 5 of Regulation (EC) No 1831/2003. According ly, the use of that substance should be author ised. The 
Commission further concludes that for safety reasons the additive should be incor porate d in feed via premixtures. 
In addition, the Commission considers that appropr iate prote ctive measures should be taken 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,
Offi cial Jour nal 
of the European Union EN 
L series 
2024/1055 11.4.2024
ELI: http://data.europa.eu/eli/reg_impl/2024/1055/oj 1/5(1) OJ L 268, 18.10.2003, p. 29, ELI: http://data.europa.eu/eli/reg/2003/1831/oj.
(2) EFSA Journal 2023;21(9):8250.HAS 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, 10 Apr il 2024 .
For the Commission
The President
Ursula VON DER LEYENEN OJ L, 11.4.2024 
2/5 ELI: http://data.europa.eu/eli/reg_impl/2024/1055/ojANNEX 
Identifica -
tion number 
of the feed 
additiveAdditiveComposition, chemi cal formula, descr iption, 
analytical methodSpecies or 
category of 
animalMaximum 
ageMinimum 
conten tMaximum 
conten t
Other provisionsEnd of period of 
author isationContent of the element (Fe) in 
mg/kg of complet e feed with a 
moisture content of 12 % or in 
mg element (Fe)/da y
Categor y: nutr itional additiv es. Functional group: compounds of trace elements
3b112 Iron(II) – 
betaine com ­
plexAdditiv e composition
Iron betaine compl ex with a minimum of 
14 % of iron and a minimum of 36 % of 
betaine.
Nick el: maximum 58 mg/kg.
Solid form.
Char acter isation of the activ e substances
Name: catena-[diaqua sulfato-μ2-( trimethy ­
lammonio)acetat o-iron(II)]
Chemical formula: [Fe (H2O)2((CH 3) 
3NCH 2COO)(SO 4)]n
Specif ications
Minimum of 14 % of iron,
Minimum 36 % betaine,
Sulphur: 9 %–12 %.
Maximum 5 % moisture.
Analytical methods (1)
For the quantification of total iron in the 
feed additive:
— Inductively coupled plasma-at omic 
emission spectrometr y, ICP-AES (EN 
15621 or EN 15510) or
— Atomic absor ption spectrometr y, AAS 
(ISO 6869).Ovines — — 500 mg/kg 1. The additive shall be 
incor porat ed into 
feed in the form of a 
premixture.
2. For users of the addi ­
tive and premixtures, 
feed business opera ­
tors shall establish 
operational proce ­
dures and organisa ­
tional measures to 
address the poten tial 
risks resulting from 
their use. Where those 
risks cannot be elimi ­
nated by such proce ­
dures and measures, 
the additive and pre­
mixtures shall be used 
with personal breath ­
ing, eye and skin pro­
tective equipment.1 May 2034
Bovines — — 450 mg/kg
Piglets Until one 
week 
before 
weaning— 250 mg/da y
Poultr y — — 450 mg/kg
Pets — — 600 mg/kg
Other animal 
species— — 750 mg/kgOJ L, 11.4.2024 EN 
ELI: http://data.europa.eu/eli/reg_impl/2024/1055/oj 3/5For the quantification of total iron in pre­
mixtures:
— Inductively coupled plasma-at omic 
emission spectrometr y, ICP-AES (EN 
15621 or EN 15510) or
— Atomic absor ption spectrometr y, AAS 
(ISO 6869) or
— Inductively coupled plasma-mass spec ­
trometr y, ICP-MS (EN 17053).
For the quantification of total iron in com ­
pound feed:
— Inductively coupled plasma-at omic 
emission 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 spec ­
trometr y, ICP-MS (EN 17053).
For the quantif ication of betaine in the feed 
additive:
— High performa nce liquid chromatogra ­
phy with refraction index detection 
(HPL C-RI).EN OJ L, 11.4.2024 
4/5 ELI: http://data.europa.eu/eli/reg_impl/2024/1055/ojFor the quantification of sulphur and sul­
phate in the feed additive:
— Inductively coupled plasma-at omic 
emission spectrometr y, ICP-AES (EN 
15621).
Proof of complex formation between iron, 
betaine and sulphate (2): Powder X-ra y dif­
fraction (XRD).
(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, 11.4.2024 EN 
ELI: http://data.europa.eu/eli/reg_impl/2024/1055/oj 5/5