
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.
This Regulation shall be binding in its entirety and directly applicable in all Member States.Done at Brussels, 2 July 2015.
For the Commission
The President
Jean-Claude JUNCKER
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 
Betaine anhydrous

Betaine

C5H11NO2

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 %.

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. 
Betaine anhydrous

Betaine

C5H11NO2

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)

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 
Betaine hydrochloride.

Betaine hydrochloride.

Chemical formula: C5H11NO2·HCl

CAS number: 590-46-5

Betaine hydrochloride, solid form, produced by chemical synthesis.

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


— 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
