SCHEDULE 4Renewal of authorisation of pyridoxine hydrochloride (vitamin B6) (identification number 3a831) as a feed additive for all animal species

Regulation 3(2)

Authorisation1

The additive specified in the table in this schedule, belonging to the additive category ‘nutritional additives’ and to the functional group ‘vitamins, pro-vitamins and chemically well-defined substances having similar effect’, is authorised as an additive in animal nutrition, subject to the conditions set out in the table in this schedule27.

Table

Column 1

Column 2

Additive

Pyridoxine hydrochloride (vitamin B6)

Identification number of the additive

3a831

Authorisation holder28

Additive category

Nutritional additives

Functional group

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

Additive composition

Pyridoxine hydrochloride: C8H11NO3.HCI

Purity criteria not less than 98.5%

Characterisation of the active substance(s)

Pyridoxine hydrochloride

CAS no:58-56-029

EINECS no:200-386-230

Analytical methods31

1. For the determination of pyridoxine hydrochloride (Vitamin B6) in the feed additive:

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

2. For the determination of pyridoxine hydrochloride (Vitamin B6) in premixtures:

  • Reversed phase High Performance Liquid Chromatography coupled to UV detector (RP-HPLC-UV) in accordance with the VDLUFA Method Book, Volume III, 13.9.132

3. For the determination of pyridoxine hydrochloride (Vitamin B6) in feed and water:

  • Reversed phase High Performance Liquid Chromatography coupled to fluorescence detector (RP-HPLC-FLD) – method based in accordance with European standard EN 14164:2014 entitled “ Foodstuffs – Determination of vitamin B6 by high performance chromatography”33

Species or category of animal

All animal species

Maximum age

Not applicable

Content of Pyridoxine hydrochloride (Vitamin B6) in mg/kg of complete feed with a moisture content of 12%

Minimum content

No minimum

Maximum content

No maximum

Other provisions

1.

In the directions for use of the additive and premixtures, the storage conditions and stability to heat treatment must be indicated.

2.

Pyridoxine hydrochloride (Vitamin B 6) may be used via water for drinking.