The authorisation of the additive specified in the Annex, belonging to the additive category ‘nutritional additives’ and to the functional group ‘vitamins, pro-vitamins and chemical well-defined substances having a similar effect’ for all animal species, is renewed subject to the conditions laid down in that Annex.
Implementing Regulation (EU) No 515/2011 is repealed.
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
ANNEXSupplementary provisions
ANNEX
Identification number of the additive
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 additive/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
3a831
‘Pyridoxine hydrochloride’ or ‘vitamin B 6’
Additive composition
Pyridoxine hydrochloride
C 8 H 11 NO 3 ·HCl
Purity criteria: not less than 98,5 %
Characterisation of active substance
Pyridoxine hydrochloride
All animal species
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1.
In the directions for use of the additive and premixtures, the storage conditions and stability to heat treatment and in water shall be indicated.
2.
Pyridoxine hydrochloride or vitamin B 6 may be used also via water for drinking.
3.
For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks resulting from its use. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including breathing protection.
13 April 2031
Analytical method
( 1 )
For the determination of pyridoxine hydrochloride (Vitamin B 6 ) in the feed additive:
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Titration with perchloric acid (Ph. Eur. 10th edition, monograph 0245)
For the determination of pyridoxine hydrochloride (Vitamin B 6 ) in premixtures:
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Reversed phase High Performance Liquid Chromatography coupled to UV detector (RP-HPLC-UV) - VDLUFA Bd.III, 13.9.1 method
For the determination of pyridoxine hydrochloride (Vitamin B 6 ) in feedingstuffs and water:
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Reversed phase High Performance Liquid Chromatography coupled to fluorescence detector (RP-HPLC-FLD) – method based on EN14164:2008
( 1 ) Details of the analytical methods are available at the following address of the Reference Laboratory: https://ec.europa.eu/jrc/en/eurl/feed-additives/evaluation-reports