
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 these substances, which are produced and labelled before 30 June 2016 in accordance with the rules applicable before 31 December 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 31 December 2016 in accordance with the rules applicable before 31 December 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 31 December 2017 in accordance with the rules applicable before 31 December 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, 10 December 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 %
Category of nutritional additives. Functional group: vitamins, pro-vitamins and chemically well-defined substances having similar effect
3a710 — ‘Menadione sodium bisulphite’ or ‘Vitamin K3’ 
Menadione sodium bisulphite

Chromium ≤ 45 mg/kg

Menadione sodium bisulphite

C11H9NaO5S·3H2O

CAS No: 6147-37-1

Produced by chemical synthesis

Purity: min. 96 % MSB complex which corresponds to min. 50 % menadione.


— For the determination of menadione sodium bisulphite in the feed additive: a spectrophotometric method using a visible detector at 635 nm (VDLUFA -Bd.III 13.7.1).
— For the determination of menadione sodium bisulphite in premixtures and feedingstuffs: Normal Phase High-Performance Liquid Chromatograph coupled to UV detector-decree 29/04/2010, Official Italian Journal No 120 25/5/2010.
 All animal species — — — 
1. The additive shall be incorporated into feed in the form of a premixture.

2. In the directions for use of the additive and premixtures, indicate the storage and stability conditions.

3. The following equivalency shall be used if the amount of the additive is labelled: 1 mg vitamin K3 = 1 mg of menadione = 2 mg of menadione sodium bisulphite.

4. Appropriate measures shall be taken to avoid the chromium emission in the air and prevent the exposure by inhalation or by dermal route. If such measures are technically not feasible or not sufficient, protective measures shall be taken according to national regulations implementing Union legislation on health and safety at work including Council Directives 89/391/EEC, 89/656/EEC, 92/85/EEC and 98/24/EC and Directive 2004/37/EC of the European Parliament and of the Council.

5. Appropriate protective gloves, respiratory and eye protection according to Council Directive 89/686/EEC shall be worn during handling.
 31 December 2025
3a711 — ‘Menadione nicotinamide bisulphite’ or ‘Vitamin K3’ 
Menadione nicotinamide bisulphite

Chromium ≤ 142 mg/kg

Menadione nicotinamide bisulphite

C11H9O5S·C6H7N2O

CAS No: 73581-79-0

Produced by chemical synthesis

Purity: min. 96 % menadione nicotinamide bisulphite complex which corresponds to min. 43,9 % menadione and min. 31,2 % nicotinamide


— For the determination menadione nicotinamide bisulphite in the feed additive: a spectrophotometric method using a visible detector at 635 nm (VDLUFA — Bd.III 13.7.1).
— For the determination of menadione nicotinamide bisulphite in premixtures and feedingstuffs: Normal Phase High-Performance Liquid Chromatograph-decree 29/04/2010, Official Italian Journal No 120 25/5/2010.
 All animal species — — — 
1. The additive shall be incorporated into feed in the form of a premixture.

2. In the directions for use of the additive and premixtures, indicate the storage and stability conditions.

3. The following equivalency shall be used if the amount of the additive is labelled: 1 mg vitamin K3 = 1 mg of menadione = 2,27 mg of menadione nicotinamide bisulphite.

4. Appropriate measures shall be taken to avoid the chromium emission in the air and prevent the exposure by inhalation or by dermal route. If such measures are technically not feasible or not sufficient, protective measures shall be taken according to national regulations implementing Union legislation on health and safety at work including Directives 89/391/EEC, 89/656/EEC, 92/85/EEC, 98/24/EC and 2004/37/EC.

5. Appropriate protective gloves, respiratory and eye protection according to Directive 89/686/EEC shall be worn during handling.
 31 December 2025






