
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 feed 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 those substances, which are produced and labelled before 2 January 2016 in accordance with the rules applicable before 2 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 2 July 2016 in accordance with the rules applicable before 2 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 specified in the Annex which are produced and labelled before 2 July 2017 in accordance with the rules applicable before 2 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, 11 June 2015.
For the Commission
The President
Jean-Claude JUNCKER
ANNEX

Identification number of the additive Name of the holder of the 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 the active substance/l of water.
Nutritional additives: Vitamins, provitamins and chemically well-defined substances having similar effect
3a820  ‘Thiamine hydrochloride’ or ‘Vitamin B1’ 
Thiamine hydrochloride

Thiamine hydrochloride

C12H17ClN4OSߦHCl

CAS No 67-03-8

Thiamine hydrochloride, solid form, produced by chemical synthesis.

Purity crieria: min. 98,5 % on anhydrous basis.

For the characterisation of thiamine hydrochloride in the feed additive:


— high performance liquid chromatography with UV detection (HPLC-UV) — US Pharmacopeia 32 (‘thiamine hydrochloride’ monograph).

For the quantification of thiamine hydrochloride in premixtures:


— ion-exchange high performance liquid chromatography coupled to UV detector (HPLC-UV) — VDLUFA Bd. III, 13.9.1, or
— reversed phase high performance liquid chromatography coupled to fluorescence detection (HPLC-FL) — decree 20.2.2006, Official Italian Journal No 50, 1.3.2006.

For the quantification of thiamine hydrochloride in feedingstuffs:


— reversed phase high performance liquid chromatography coupled to fluorescence detection (HPLC-FL) — decree 20.2.2006, Official Italian Journal No 50, 1.3.2006.

For the quantification of thiamine hydrochloride in water:


— reversed phase high performance liquid chromatography (HPLC) with post-column derivatisation and fluorescence detection.
 All animal species — — — 
1. In the directions for use of the additive and premixture, indicate the storage and the stability conditions.

2. Thiamine hydrochloride may be used via water for drinking.

3. For safety: breathing protection, safety glasses and gloves shall be worn during handling.
 2 July 2025

Identification number of the additive Name of the holder of the 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 the active substance/l of water
Nutritional additives: Vitamins, provitamins and chemically well-defined substances having similar effect
3a821  ‘Thiamine mononitrate’ or ‘Vitamin B1’ 
Thiamine mononitrate

Thiamine mononitrate

C12 H17N4OSߦNO3

CAS number: 532-43-4

Thiamine mononitrate, solid form, produced by chemical synthesis.

Purity criteria: min. 98 %, on anhydrous basis.

For the characterisation of thiamine mononitrate in the feed additive:


— high performance liquid chromatography with UV detection (HPLC-UV) — US Pharmacopeia 32 (‘thiamine mononitrate’ monograph).

For the quantification of thiamine mononitrate in premixtures:


— ion-exchange high performance liquid chromatography coupled to UV detector (HPLC-UV) — VDLUFA Bd. III, 13.9.1, or
— reversed phase high performance liquid chromatography coupled to fluorescence detection (HPLC-FL) — decree 20.2.2006, Official Italian Journal No 50, 1.3.2006.

For the quantification of thiamine mononitrate in feedingstuffs:


— reversed phase high performance liquid chromatography coupled to fluorescence detection (HPLC-FL) — decree 20.2.2006, Official Italian Journal No 50, 1.3.2006.

For the quantification of thiamine mononitrate in water:


— reversed phase high performance liquid chromatography (HPLC) with post-column derivatisation and fluorescence detection.
 All animal species — — — 
1. Thiamine mononitrate 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 premixture, indicate the storage and stability conditions.

3. Thiamine mononitrate may be used via water for drinking.

4. For safety: breathing protection, safety glasses and gloves shall be worn during handling.
 2 July 2025
