Commission Implementing Regulation (EU) 2024/265 of 17 January 2024 concerning the authorisation of zinc(II)– betaine complex as a feed additive for all animal species except aquatic animals farmed in marine aquaculture systems

• CELEX: Implementing Regulation (EU) 2024/265
• 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 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 (Zn) in mg/kg of complete feed with a moisture content of 12 %

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

3b616

Zinc(II)– betaine complex

Additive composition

Zinc betaine complex with a minimum of 20 % of zinc and a minimum of 41 % of betaine

Nickel: maximum 60 mg/kg

Solid form

Characterisation of the active substances

Name: catena-[μ3-sulphato-

(trimethylammonio)acetato-zinc(II)]

Chemical formula: [Zn((CH 3 ) 3 NCH 2 COO) (SO 4 )]n

Specifications

—

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 emission spectrometry, ICP-AES (EN 15621 or EN 15510) or

—

Atomic absorption spectrometry, AAS (ISO 6869)

For the quantification of total zinc 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 zinc in compound feed:

—

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

—

Atomic absorption spectrometry, AAS (Commission Regulation (EC) No 152/2009 (Annex IV-C) or ISO 6869) 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 sulfate in the feed additive:

—

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

Proof of complex formation between zinc, betaine and sulfate: Powder X-ray diffraction (XRD)  ( 2 )

—

Dogs

—

Cats

-

-

200

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.

7 February 2034

—

Piglets

—

Sows

—

Rabbits

—

Fish farmed in land-based aquaculture systems, other than salmonids

-

-

150

—

Calves (milk replacer)

—

Salmonids farmed in land-based aquaculture systems

-

-

180

Other species and categories except aquatic animals farmed in marine aquaculture systems

-

-

120

( 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-Κα1 radiation (Johann Gemonochromator) and a Stoe imageplate detector IP-PSD.