Commission Implementing Regulation (EU) 2021/507 of 23 March 2021 concerning the renewal of the authorisation of pyridoxine hydrochloride (vitamin B6) as a feed additive for all animal species and repealing Implementing Regulation (EU) No 515/2011 (Text with EEA relevance)

• CELEX: Implementing Regulation (EU) 2021/507
• Articles: 4

Article 1

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.

Article 2

Implementing Regulation (EU) No 515/2011 is repealed.

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.

Schedules & Appendices

ANNEX

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:

—

Titration with perchloric acid (Ph. Eur. 10th edition, monograph 0245)

For the determination of pyridoxine hydrochloride (Vitamin B 6 ) in premixtures:

—

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:

—

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