Commission Implementing Regulation (EU) 2019/9 of 3 January 2019 concerning the authorisation of betaine anhydrous as a feed additive for food-producing animals except rabbits (Text with EEA relevance.)

• CELEX: Implementing Regulation (EU) 2019/9
• Articles: 3

Article 1 Authorisation

The substance specified in the Annex, belonging to the additive category ‘nutritional additives’ and to the functional group ‘vitamins, provitamins and chemically well-defined substances having a similar effect’, is authorised as a feed 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

Name of the holder of authorisation

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

mg of active substance/kg of complete feedingstuff with a moisture content of 12 %

Category of nutritional additives. Functional group: vitamins, provitamins and chemically well-defined substances having a similar effect

3a921i

AB Vista Iberia S.L.

Betaine anhydrous produced from genetically modified sugar beet

Additive composition

Betaine anhydrous

Characterisation of the active substance

Betaine C5H11NO2

CAS number: 107-43-7

Betaine anhydrous, crystalline solid form, produced by extraction from genetically modified KM-ØØØH71-4 sugar beet.

Purity criteria: min. 97 % (on anhydrous basis)

Method of Analysis

( 1 )

For the determination of betaine anhydrous (expressed as total betaine) in the feed additive, premixtures, and feedingstuffs . High Performance Liquid Chromatography method with refractive index detector (HPLC-RI).

Food-producing animals except rabbits

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1.

Betaine anhydrous may be placed on the market and used as an additive consisting of a preparation.

2.

In the directions for use of the additive and premixtures, the storage and stability to heat treatment shall be indicated.

3.

On the label of the additive and the premixture the following shall be indicated ‘Recommended not to exceed levels of: 2 000 mg of betaine/kg of complete feed (with a moisture content of 12 %)’.

4.

For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including breathing protection, safety glasses and gloves.

4 August 2028

( 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