Commission Implementing Regulation (EU) 2024/1199 of 18 April 2024 concerning the authorisation of manganese(II) – betaine complex as a feed additive for all animal species

• CELEX: Implementing Regulation (EU) 2024/1199
• Articles: 3

Article 1 Authorisation

The substance specified in the Annex, belonging to the additive category ‘nutritional additives’ and to the functional group ‘compounds of trace elements’, is authorised as an additive in animal nutrition subject to the conditions laid down in that Annex.

Article 2 Entry into force

This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.

Schedules & Appendices

ANNEX

ANNEX

Identification number of the feed additive

Additive

Composition, chemical formula, description, analytical method

Species or category of animal

Maximum age

Minimum content

Maximum content

Other provisions

End of period of authorisation

Content of the element (Mn) in mg/kg of complete feed with a moisture content of 12 %

Category: nutritional additives. Functional group: compounds of trace elements

3b512

Manganese(II)- betaine complex

Additive composition:

Manganese(II) - betaine complex with a minimum of 17 % of manganese and a minimum of 42 % of betaine

Nickel: maximum 84 mg/kg

Solid form

Characterisation of the active substances:

Name: catena-[μ3-sulfato-(trimethylammonio)acetato-manganese(II)]

Chemical formula: [Mn(H 2 O) 2 ((CH 3 ) 3 NCH 2 COO)(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 quantification of total manganese in the feed additive:

—

Inductively coupled plasma-atomic emission spectrometry, ICP-AES (EN 15621 or EN 15510) or

—

Atomic absorption spectrometry, AAS (ISO 6869).

For the quantification of total manganese in premixtures:

—

Inductively coupled plasma-atomic emission spectrometry, ICP-AES (EN 15621 or EN 15510) or

—

Atomic absorption spectrometry, AAS (ISO 6869) or

—

Inductively coupled plasma-mass spectrometry, ICP-MS (EN 17053).

For the quantification of total manganese in compound feed:

—

Inductively coupled plasma-atomic emission spectrometry, ICP-AES (EN 15621 or EN 15510) or

—

Atomic absorption spectrometry, AAS (ISO 6869 or Commission Regulation (EC) No 152/2009 - Annex IV-C) or

—

Inductively coupled plasma-mass spectrometry, ICP-MS (EN 17053).

For the quantification of betaine in the feed additive:

—

High performance liquid chromatography with refraction index detection (HPLC-RI).

For the quantification of sulphur and sulphate in the feed additive:

—

Inductively coupled plasma-atomic emission spectrometry, ICP-AES (EN 15621).

Proof of complex formation between manganese , betaine and sulphate: Powder X-ray diffraction (XRD)  ( 2 ) .

Fish

-

-

100

1.

The additive shall be incorporated into feed in the form of a premixture.

2.

For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address the potential 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 protective equipment.

12.5.2034

Other animal species

150

( 1 )   Details of the analytical methods are available at the following address of the Reference Laboratory: https://ec.europa.eu/jrc/en/eurl/feed-additives/evaluation-reports

( 2 )   Stoe Stadi P diffractometer in Guinier geometry using Cu-Kα1 radiation (Johann Ge monochromator) and a Stoe imageplate detector IP-PSD.