Commission Implementing Regulation (EU) 2015/2307 of 10 December 2015 concerning the authorisation of menadione sodium bisulphite and menadione nicotinamide bisulphite as feed additives for all animal species (Text with EEA relevance)

• CELEX: Implementing Regulation (EU) 2015/2307
• Articles: 4

Article 1 Authorisation

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 Transitional measures

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 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, pro-vitamins and chemically well-defined substances having similar effect

3a710

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‘Menadione sodium bisulphite’ or ‘Vitamin K 3 ’

Additive composition

Menadione sodium bisulphite

Chromium ≤ 45 mg/kg

Characterisation of the active substance

Menadione sodium bisulphite

C 11 H 9 NaO 5 S·3H 2 O

CAS No: 6147-37-1

Produced by chemical synthesis

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

Method of Analysis

( 1 )

—

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 K 3  = 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  ( 2 ) , 89/656/EEC  ( 3 ) , 92/85/EEC  ( 4 ) and 98/24/EC  ( 5 ) and Directive 2004/37/EC of the European Parliament and of the Council  ( 6 ) .

5.

Appropriate protective gloves, respiratory and eye protection according to Council Directive 89/686/EEC  ( 7 ) shall be worn during handling.

31 December 2025

3a711

—

‘Menadione nicotinamide bisulphite’ or ‘Vitamin K 3 ’

Additive composition

Menadione nicotinamide bisulphite

Chromium ≤ 142 mg/kg

Characterisation of the active substance

Menadione nicotinamide bisulphite

C 11 H 9 O 5 S·C 6 H 7 N 2 O

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

Method of Analysis

( 1 )

—

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 K 3  = 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

( 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

( 2 )   Council Directive 89/391/EEC of 12 June 1989 on the introduction of measures to encourage improvements in the safety and health of workers at work ( OJ L 183, 29.6.1989, p. 1 ).

( 3 )   Council Directive 89/656/EEC of 30 November 1989 on the minimum health and safety requirements for the use by workers of personal protective equipment at the workplace ( OJ L 393, 30.12.1989, p. 18 ).

( 4 )   Council Directive 92/85/EEC of 19 October 1992 on the introduction of measures to encourage improvements in the safety and health at work of pregnant workers and workers who have recently given birth or are breastfeeding ( OJ L 348, 28.11.1992, p. 1 ).

( 5 )   Council Directive 98/24/EC of 7 April 1998 on the protection of the health and safety of workers from the risks related to chemical agents at work ( OJ L 131, 5.5.1998, p. 11 ).

( 6 )   Directive 2004/37/EC of the European Parliament and of the Council of 29 April 2004 on the protection of workers from the risks related to exposure to carcinogens or mutagens at work ( OJ L 158, 30.4.2004, p. 50 ).

( 7 )   Council Directive 89/686/EEC of 21 December 1989 on the approximation of the laws of the Member States relating to personal protective equipment ( OJ L 399, 30.12.1989, p. 18 ).