Commission Implementing Regulation (EU) 2015/1060 of 2 July 2015 concerning the authorisation of betaine anhydrous and betaine hydrochloride as feed additives for all animal species (Text with EEA relevance)

• CELEX: Implementing Regulation (EU) 2015/1060
• Articles: 4

Article 1

The substances specified in the Annex, belonging to the additive category ‘nutritional additives’ and to the functional group ‘vitamins, pro-vitamins and chemically well-defined substances having similar effect’, are authorised as additives in animal nutrition subject to the conditions laid down in that Annex.

Article 2

1.   The substances specified in the Annex and premixtures containing these substances, which are produced and labelled before 23 January 2016 in accordance with the rules applicable before 23 July 2015 may continue to be placed on the market and used until the existing stocks are exhausted.

2.   Compound feed and feed materials containing the substances specified in the Annex which are produced and labelled before 23 July 2016 in accordance with the rules applicable before 23 July 2015 may continue to be placed on the market and used until the existing stocks are exhausted if they are intended for food-producing animals.

3.   Compound feed and feed materials containing the substances as specified in the Annex which are produced and labelled before 23 July 2017 in accordance with the rules applicable before 23 July 2015 may continue to be placed on the market and used until the existing stocks are exhausted if they are intended for non-food producing animals.

Article 3

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 % or mg of active substance/l of water

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

3a920

—

Betaine anhydrous

Additive composition:

Betaine anhydrous

Characterisation of the active substance

Betaine

C 5 H 11 NO 2

CAS number: 107-43-7

Betaine anhydrous, produced by chemical synthesis or by extraction from sugar beet molasses or vinasses by-products of sugar production.

Purity criteria: betaine anhydrous (solid form) min. 97 % (on anhydrous basis). Betaine anhydrous liquid form min 47 %.

Method of Analysis

( 1 )

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

All animal species

—

—

—

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, indicate the storage and stability conditions.

3.

The additive may be used in water for drinking.

4.

Recommended not to exceed supplemental levels of: 2 000 mg of betaine/kg of complete feed (with a moisture content of 12 %) or 1 000 mg of betaine/l of water for drinking for poultry, 700 mg of betaine/l of water for drinking for pigs and 250 mg of betaine/l of water for drinking for calves for rearing.

5.

If simultaneous use of betaine supplementation in feed and water for drinking, caution should be exercised no to exceed overall recommended levels, taking into account inherent levels in the feed.

6.

For user safety: breathing protection, safety glasses and gloves should be worn during handling.

23.7.2025

3a921

Trouw Nutrition International BV

Betaine anhydrous produced from genetically modified sugar beet.

Additive composition

Betaine anhydrous

Characterisation of the active substance

Betaine

C 5 H 11 NO 2

CAS number: 107-43-7

Betaine anhydrous, 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 in the feed additive,

premixtures, feedingstuffs and water : High Performance Liquid Chromatography method with refractive index detector (HPLC-RI).

All animal species

—

—

—

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, indicate the storage and stability conditions.

3.

The additive may be used in water for drinking.

4.

Recommended not to exceed supplemental levels of: 2 000 mg of betaine/kg of complete feed (with a moisture content of 12 %) or 1 000 mg of betaine/l of water for drinking for poultry, 700 mg of betaine/l of water for drinking for pigs and 250 mg of betaine/l of water for drinking for calves for rearing.

5.

If simultaneous use of betaine supplementation in feed and water for drinking, caution should be exercised no to exceed overall recommended levels, taking into account inherent levels in the feed.

6.

For user safety: breathing protection, safety glasses and gloves should be worn during handling.

23.10.2017

3a925

—

Betaine hydrochloride

Additive composition

Betaine hydrochloride.

Characterisation of the active substance

Betaine hydrochloride.

Chemical formula: C 5 H 11 NO 2 ·HCl

CAS number: 590-46-5

Betaine hydrochloride, solid form, produced by chemical synthesis.

Purity criteria: min. 98 % (on anhydrous basis).

Method of Analysis

( 1 )

—

For the determination of betaine hydrochloride in the feed additive:

1.

Titration with perchloric acid (US Pharmacopeia 31, Betaine hydrochloride monograph.); or

2.

High Performance Liquid Chromatography method with refractive index detector (HPLC-RI).

—

For the determination of betaine hydrochloride in premixtures, feedingstuffs and water: High-Performance Liquid Chromatography method with refractive index detector (HPLC-RI).

All animal species

—

—

—

1.

Betaine hydrochloride 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, indicate the storage and stability conditions.

3.

The additive may be used in water for drinking.

4.

Recommended not to exceed supplemental levels of: 2 000 mg of betaine/kg of complete feed (with a moisture content of 12 %) or 1 000 mg of betaine/l of water for drinking for poultry, 700 mg of betaine/l of water for drinking for pigs and 250 mg of betaine/l of water for drinking for calves for rearing.

5.

If simultaneous use of betaine supplementation in feed and water for drinking, caution should be exercised no to exceed overall recommended levels, taking into account inherent levels in the feed.

6.

For user safety: breathing protection, safety glasses and gloves should be worn during handling.

23.7.2025

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