COMMISSION IMPLEMENTING REGUL ATION (EU) 2021/507 
of 23 March 2021 
concer ning the renewal of the author isation of pyridoxine hydrochlor ide (vitamin B6) as a feed 
additiv e for all animal species and repealing Implementing Regulation (EU) No 515/2011 
(Text with EEA relevance) 
THE EUR OPEAN COMMISSION, 
Havi ng regar d to the Treaty on the Functioning of the European Union, 
Havi ng rega rd to Regulation (EC) No 1831/2003 of the European Parliament and of the Council of 22 Sept ember 2003 on 
additives for use in animal nutr ition (1), and in particular Article 9(2) thereof, 
Whereas: 
(1) Regulation (EC) No 1831/2003 provid es for the author isation of additives for use in animal nutr ition and for the 
grounds and procedures for granting and renewing such author isation. 
(2) Pyridoxine hydrochloride (vitamin B6) was author ised for 10 years as a feed additive for all animal species by 
Commission Implementing Regulation (EU) No 515/2011 (2). 
(3) In accordance with Article 14 of Regulation (EC) No 1831/2003, an application was submitte d for the renewal of 
the author isation of pyridoxine hydrochlori de as a feed additive for all animal species, requesting the additive to be 
classifie d in the additive categor y ‘nutr itional additives ’. That application was accompan ied by the particulars and 
documents required under Article 14(2) of that Regulation. 
(4) The European Food Safety Auth ority (‘the Author ity’) concluded in its opinion of 30 Sept ember 2020 (3) that the 
applicant has provi ded evidence that the additive compl ies with the existing conditions of author isation. The 
Authority concluded that pyridoxine hydrochloride under the current author ised conditions of use does not have 
an adverse effect on animal health, consumer safety or the environment. It also concluded that the additive is non- 
irritant to skin and eyes and is not a skin sensitiser but it may cause photosensitisation and in the absence of 
inhalation toxicity studies, adverse effects in the respirator y tract could not be fully excluded. Theref ore, the 
Commission considers that appropr iate prot ective measures should be take n to prevent adverse effects on human 
health, in particular as regar ds to the users of the additive. The Auth ority also concluded that there is no need for 
assessing the effic acy of the additive in the cont ext of the renewal of the author isation. 
(5) The assessment of pyridoxine hydroch loride shows that the conditions for author isation, as provided for in Article 5 
of Regulation (EC) No 1831/2003, are satisfied. According ly, the author isation of that additive should be renewed. 
(6) As a consequence of the renewal of the author isation of pyridoxine hydrochloride as a feed additive, Implemen ting 
Regulation (EU) No 515/2011 should be repealed. 
(7) The measures provid ed for in this Regulation are in accordance with the opinion of the Standing Committ ee on 
Plants, Animals, Food and Feed, 
(1)OJ L 268, 18.10.2003, p. 29.
(2)Commission Implementing Regulation (EU) No 515/2011 of 25 May 2011 concer ning the author isation of vitamin B6 as a feed 
additive for all animal species (OJ L 138, 26.5.2011, p. 40).
(3)EFSA Journal 2020;18(11):6289.EN Offi cial Jour nal of the European Union L 102/8                                                                                                                                           24.3.2021   HAS ADOPTED THIS REGUL ATION: 
Article 1 
The author isation of the additive specifi ed in the Annex, belonging to the additive categor y ‘nutr itional additives ’ and to the 
functional group ‘vitamins, pro-vitamins and chemical well-def ined 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 followi ng 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, 23 Marc h 2021.  
For the Commission 
The President 
Ursula VON DER LEYEN     EN Offi cial Jour nal of the European Union 24.3.2021                                                                                                                                           L 102/9   ANNEX 
Identification 
number of the 
additive Additive Composition, chemical formula, descr iption, analytical 
method Species or 
category of 
animal Maximum 
age Minimum 
content Maximum 
content 
Other provisions End of period of 
author isation mg of additive/kg of 
complet e feedingstuff 
with a moisture conten t 
of 12 % 
Categor y of nutr itional additiv es 
Functional group: vitamins, pro-vit amins and chemically well-def ined subst ances having similar effect 
3a831 ‘Pyridoxine 
hydrochlori de’ or 
‘vitamin B6’ Additive composition 
Pyridoxine hydroch loride 
C8H11NO 3·HCl 
Purity criteria: not less than 98,5 % 
Char acter isation of active substance 
Pyridoxine hydroch loride All 
animal 
species - - - 1. In the directions for use of the 
additive and premixtures, the sto­
rage conditions and stability to 
heat treatment and in wate r shall 
be indicated. 
2.Pyridoxine hydrochlori de or vita­
min B6 may be used also via water 
for drinking. 
3.For users of the additive and pre­
mixtures, feed business operat ors 
shall establish operational proce ­
dures and organisational mea ­
sures to address poten tial risks re­
sulting from its use. Where those 
risks cannot be eliminated or re­
duced to a minimum by such pro­
cedures and measures, the addi ­
tive and premixtures shall be 
used with personal protective 
equipment, including breathing 
prote ction. 13 Apr il 2031 
Analytical method (1) 
For the determination of pyridoxine hydrochlori de 
(Vitamin B6) in the feed additive: 
—Titration with perchlori c acid (Ph. Eur. 10th edi­
tion, monograph 0245) 
For the determination of pyridoxine hydrochlori de 
(Vitamin B6) in premixtures: 
—Reversed phase High Performance Liquid Chro ­
matog raphy coupled to UV detect or 
(RP-HPL C-UV) - VDLUF A Bd.III, 13.9.1 method 
For the determination of pyridoxine hydrochlori de 
(Vitamin B6) in feedingstuffs and water: 
—Reversed phase High Performance Liquid Chro ­
matog raphy coupled to fluorescence detect or 
(RP-HPL C-FLD) – method based on 
EN14164:2008 
(1) Details of the analytical methods are avail able at the follo wing address of the Reference Laboratory : https://ec.europa.eu/jrc/en/eurl/feed-additives/evaluation-repor tsEN Offi cial Jour nal of the European Union L 102/10                                                                                                                                         24.3.2021   