COMMISSION IMPLEMENTING REGUL ATION (EU) 2024/1199 
of 18 Apr il 2024
concer ning the author isation of manganese(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 manganese(II) – betaine compl ex. 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 manganese(II) – betaine complex as a feed additive for all animal 
species, to be classified in the additive categor y ‘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 27 September 2023 (2)that, under 
the proposed conditions of use, manganese (II) – betaine complex is safe for all animal species, consumers and the 
environment provid ed that the maximum author ised levels for total manganese in feed are not exceed ed. In relation 
to the safety for all animal species, the Author ity concluded that based on the results of the tolerance study , the 
additive is safe for chic kens for fattening when used up to the maximum author ised levels of manganese in feed, and 
that this conclusion can be extrapolated to all animal species and categor ies provid ed that the maximum author ised 
levels in the EU for tota l manganese in feed are not exceeded. The Authority further concluded that manganese(II) – 
betaine compl ex is a skin and respirator y sensitiser , because it contains nick el. It is an eye irritant, but it is non- 
irritant to the skin. The Auth ority concluded that the substance is efficacious as a source of manga nese in all animal 
species and categor ies. It did not consider that there is a need for specifi c requirements of post-market monit oring. 
The Author ity 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 mang anese(II) – betaine complex satisfi es the conditions for 
author isation provided for in Article 5 of Regulation (EC) No 1831/2003. According ly, the use of that substance 
should be author ised. The Commission further considers that for safety reasons the additive should be added to feed 
via premixtures. In addition, the Commission considers that appropr iate prot ective 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 
2024/1199 22.4.2024
ELI: http://data.europa.eu/eli/reg_impl/2024/1199/oj 1/4(1) OJ L 268, 18.10.2003, p. 29. ELI: http://data.europa.eu/eli/reg/2003/1831/oj.
(2) EFSA Jour nal 2023;21(10):8362.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, 18 Apr il 2024 .
For the Commission
The President
Ursula VON DER LEYENEN OJ L, 22.4.2024 
2/4 ELI: http://data.europa.eu/eli/reg_impl/2024/1199/ojANNEX 
Identification 
number of the 
feed additiveAdditiveComposition, chemical formula, descr iption, analytical 
methodSpecies or 
categor y of 
animalMaxi -
mum 
ageMinimum 
contentMaximum 
content
Other provisionsEnd of period of 
author isationContent of the element (Mn) 
in mg/kg of complet e feed 
with a moisture conten t of 
12 %
Categor y: nutr itional additiv es. Functional group: compounds of trace elements
3b512 Mangan ese(II)- 
betaine com ­
plexAdditive composition:
Mang anese(II) - betaine complex with a minimum of 
17 % of manganese and a minimum of 42 % of 
betaine
Nickel: maximum 84 mg/kg
Solid form
Char acter isation of the activ e substances:
Name: catena-[μ3-sulf ato-(tr imethyl ammonio)acet ­
ato-manganese(II)]
Chemical formula: [Mn(H 2O) 2((CH3)3NCH 2COO) 
(SO 4)]n
Specifications
— Minimum of 17 % of manganese
— Minimum of 42 % betaine,
— Sulphur: 9-12 %
— Maximum of 5 % moisture
Analytical methods (1):
For the quantifi cation of total manga nese 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).Fish - - 100 1. The additive shall be in­
corporat ed into feed in 
the form of a premix ­
ture.
2. For users of the additive 
and premixtures, feed 
business operat ors shall 
establish operational 
procedures and organi­
sational measures to ad­
dress the pote ntial risks 
resulting from their use. 
Where those risks can­
not be eliminate d by 
such procedures and 
measures, the additive 
and premixtures shall be 
used with personal 
breathing, eye and skin 
protective equipment.12.5.2034
Other 
animal 
species150OJ L, 22.4.2024 EN 
ELI: http://data.europa.eu/eli/reg_impl/2024/1199/oj 3/4For the quantifi cation of total manganese 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 spectrometr y, 
ICP-MS (EN 17053).
For the quantifi cation of total manganese 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 (ISO 
6869 or Commission Regulation (EC) 
No 152/2009 - Annex IV-C) or
— Inductively coupled plasma-mass spectrometr y, 
ICP-MS (EN 17053).
For the quantific ation of betaine in the feed additive:
— High performance liquid chromat ography with 
refraction index detec tion (HPL C-RI).
For the quantifi cation of sulphur and sulphate in the 
feed additive:
— Inductively coupled plasma-at omic emission 
spectrometr y, ICP-AES (EN 15621).
Proof of compl ex formation between manga nese 
, betaine and sulphate : 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-Kα1 radiation (Johann Ge monochromat or) and a Stoe imageplat e detect or IP-PSD.EN OJ L, 22.4.2024 
4/4 ELI: http://data.europa.eu/eli/reg_impl/2024/1199/oj