Scientific Opinion on the safety and efficacy of vitamin B6 (pyridoxine hydrochloride) as a feed additive for all animal species

Abstract

Pyridoxine hydrochloride is a form of vitamin B 6 , an essential micronutrient. Oral administration routes of pyridoxine hydrochloride via feed or water are considered as bioequivalent. Pyridoxine hydrochloride is considered to be safe for all animal species at the commercial use levels. The FEEDAP Panel concludes that the use of pyridoxine hydrochloride as a nutritional additive does not give rise to concern for consumers. Pyridoxine hydrochloride is not an irritant to skin and eyes; it is not a skin sensitizer. The Panel notes that pyridoxine hydrochloride may cause photosensitisation. The pyridoxine hydrochloride considered in this opinion has a high dusting potential. A calculation of exposure by inhalation for persons handling the substance in a premixture factory resulted in an intake of 3.1 mg/person/day. Together with exposure by food sources, total exposure would not exceed 60 % of the UL. In the absence of inhalation toxicity studies, adverse effects in the respiratory tract cannot be fully excluded. Pyridoxine occurs widely in nature (in most plant feed materials). Its use in animal nutrition is not expected to substantially increase the concentration in the environment. Therefore, a risk for the environment resulting from the use of pyridoxine in animal nutrition is not foreseen. Due to the long history of use and its established nutritional role in domestic animals, pyridoxine hydrochloride is regarded as an effective source of vitamin B 6 . © European Food SUMMARYFollowing a request from the European Commission, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on the safety and efficacy of pyridoxine hydrochloride, supplied via feed or water, as a feed additive for all animal species.Pyridoxine hydrochloride is a form of vitamin B 6 , an essential micronutrient, it occurs in the body as pyridoxal 5"-phosphate which serves as a coenzyme in transamination, decarboxylation and desamination reactions. It plays an important role in the metabolism of proteins (amino acids), fatty acids and carbohydrates, and in the synthesis of transmitters. Its major role is in neuroprotection.Oral administration routes of pyridoxine hydrochloride via feed or water are considered as bioequivalent.Pyridoxine hydrochloride is considered to be safe for all animal species at the commercial use levels.The FEEDAP Panel concludes that the use of pyridoxine hydrochloride as a nutritional additive does not give rise to concern for consumers.Pyridoxine hydrochloride is not an irritant to skin and eyes; it is not a skin sensitiser. The FEEDAP Panel notes that pyridoxine hydrochloride may cause photosensitisation. The pyridoxine hydrochloride considered in this opinion has a high dusting potential. A calculation of exposure by inhalation for persons handling the substance in a premixture factory resulted in an intake of 3.1 mg/person/day. Together with exposure by food sources, total exposure would not exceed 60 % of the UL. In the absence of inhalatio...

Assessment of a feed additive consisting of vitamin B6 (pyridoxine hydrochloride) for all animal species for the renewal of its authorisation (Kaesler Nutrition GmbH)

“…In the previous assessments of the FEEDAP Panel, the overall vitamin B 6 intake was estimated to range between 1.2 and 2.8 mg/day, with food of animal origin contributing to about 50% of the total intake from food sources. The FEEDAP Panel concluded that there was no risk to exceed the UL of 25 mg/day from food sources and that the use of vitamin B 6 as nutritional additive in feed for food producing animals is safe for the consumer (EFSA FEEDAP Panel, 2010, 2011.…”

“…The safety of pyridoxine hydrochloride for the target species, consumers, users and the environment has been evaluated in previous opinions (EFSA FEEDAP Panel, 2010, 2011. The FEEDAP Panel concluded that pyridoxine hydrochloride is considered to be safe for all animal species at the commercial use levels and that the use of pyridoxine hydrochloride as a nutritional additive does not raise safety concerns for consumers and the environment.…”

Assessment of the application for renewal of authorisation of pyridoxine hydrochloride (vitamin B6) as a feed additive for all animal species

“…The EFSA Scientific Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) issued two opinions on the safety and efficacy of vitamin B 6 , in the form of pyridoxine hydrochloride, when used as a feed additive for all animal species (EFSA FEEDAP Panel, 2010, 2011.…”

“…The safety of pyridoxine hydrochloride for the target species, consumers, users and the environment was evaluated in previous opinions (EFSA FEEDAP Panel, 2010, 2011. The FEEDAP Panel concluded that pyridoxine hydrochloride is considered to be safe for all animal species at the commercial use levels and that the use of pyridoxine hydrochloride as a nutritional additive does not give rise to concern for consumers and the environment.…”

“…In the previous assessment of the FEEDAP Panel, the overall vitamin B 6 intake was estimated to range between 1.2 and 2.8 mg/day, with food of animal origin contributing for about 50% of the total intake from food sources. The FEEDAP Panel concluded that there was no risk to exceed the UL of 25 mg/day from food sources and that the use of vitamin B 6 as nutritional additive in feed of food producing animal is safe for the consumer (EFSA FEEDAP Panel, 2011).…”