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Official Journal EN
of the European Union L series
2024/265 18.1.2024
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
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
Having regard to Regulation (EC) No 1831/2003 of the European Parliament and of the Council of 22 September 2003on
additives for use in animal nutrition(1), and in particular Article 9(2) thereof,
Whereas:
(1) Regulation (EC) No 1831/2003 provides for the authorisation of additives for use in animal nutrition and for the
grounds and procedures for granting such authorisation.
(2) In accordance with Article 7 of Regulation (EC) No 1831/2003, an application was submitted for the authorisation
of zinc(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 concerns the authorisation of zinc(II)– betaine complex as a feed additive for all animal species, to be
classified in the additive category ‘nutritional additives’ and in the functional group ‘compounds of trace elements’.
(4) The European Food Safety Authority (‘the Authority’) concluded in its opinion of 11 January 2023(2)that, under the
proposed conditions of use, zinc(II)– betaine complex is safe for all animal species and consumers, provided that the
maximum authorised levels for total zinc in feed are not exceeded. As regards the safety of zinc(II)– betaine complex
for the environment, the available data do not allow to conclude on its safety for the marine sediment when that
substance is used in sea cages. The Authority further concluded that zinc(II)– betaine complex is considered a skin
and respiratory sensitiser, due to the presence of nickel. It is an eye irritant, but it is non-irritant 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 specific requirements of post-market monitoring. It also verified
the report 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 above, the Commission considers that zinc(II)– betaine complex satisfies the conditions provided for
in Article 5 of Regulation (EC) No 1831/2003. Accordingly, the use of that substance should be authorised. In
addition, the Commission considers that appropriate protective measures should be taken to prevent adverse effects
on the health of the users of the additive.
(6) The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on
Plants, Animals, Food and Feed,
(1) OJ L 268, 18.10.2003, p. 29.
(2) EFSA Journal 2023;21(2):7819
ELI: http://data.europa.eu/eli/reg_impl/2024/265/oj 1/4EN
OJ L, 18.1.2024
HAS ADOPTED THIS REGULATION:
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.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 17 January 2024.
For the Commission
The President
Ursula VON DER LEYEN
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ANNEX
Minimum Maximum
content content
Identifica-
tion
Composition, chemical formula, description, Species or category of Maximum Content of the element End of period of
number Additive Other provisions
analytical method animal age (Zn) in mg/kg of authorisation
of the
complete feed with a
additive
moisture content of
12 %
Category: nutritional additives. Functional group: compounds of trace elements
3b616 Zinc(II)– Additive composition — Dogs - - 200 1. The additive shall be incorpo 7 February 2034
betaine — Cats rated into feed in the form of a
complex Zinc betaine complex with a minimum of 20 % premixture.
of zinc and a minimum of 41 % of betaine
— Piglets - - 150
Nickel: maximum 60 mg/kg 2. For users of the additive and pre
— Sows
Solid form mixtures, feed business opera
— Rabbits
tors shall establish operational
— Fish farmed in
Characterisation of the active substances
procedures and organisational
land-based aqua
measures to address the poten
culture systems,
Name: catena-[μ3-sulphato- tial risks resulting from their use.
other than salmo
(trimethylammonio)acetato-zinc(II)] Where those risks cannot be
nids
Chemical formula: [Zn((CH 3) 3NCH 2COO) eliminated by such procedures
(SO 4)]n and measures, the additive and
Specifications — Calves (milk - - 180 premixtures shall be used with
— Minimum of 20 % of zinc replacer) personal breathing eye and skin
— Minimum 41 % betaine, — Salmonids protective equipment.
— 9 %–12 % sulphur farmed in land-
— Maximum 5 % moisture based aquacul
ture systems
Analytical methods(1)
Other species and - - 120
For the quantification of total zinc in the feed categories except
additive: aquatic animals
— Inductively coupled plasma-atomic emis farmed in marine
sion spectrometry, ICP-AES (EN 15621 or aquaculture systems
EN 15510) or
— Atomic absorption spectrometry, AAS
(ISO 6869)
For the quantification of total zinc in
premixtures:
— Inductively coupled plasma-atomic emis
sion spectrometry, ICP-AES (EN 15621 or
EN 15510) or
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— Atomic absorption spectrometry, AAS
(ISO 6869) or
— Inductively coupled plasma-mass spectro
metry, ICP-MS (EN 17053)
For the quantification of total zinc in
compound feed:
— Inductively coupled plasma-atomic emis
sion 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 spectro
metry, 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 emis
sion spectrometry, ICP-AES (EN 15621)
Proof of complex formation between zinc,
betaine and sulfate: Powder X-ray diffraction
(XRD)(2)
(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.
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