Scientific Opinion on the safety and efficacy of betaine anhydrous as a feed additive for all animal species based on a dossier submitted by Danisco Animal Nutrition

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Article
EFSA Journal 2013;11(5):3209 [20 pp.].
doi
10.2903/j.efsa.2013.3209
EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP)
Panel Members
Gabriele Aquilina, Alex Bach, Vasileios Bampidis, Maria De Lourdes Bastos, Lucio Guido Costa, Gerhard Flachowsky, Mikolaj Antoni Gralak, Christer Hogstrand, Lubomir Leng, Secundino López-Puente, Giovanna Martelli, Baltasar Mayo, Fernando Ramos, Derek Renshaw, Guido Rychen, Maria Saarela, Kristen Sejrsen, Patrick Van Beelen, Robert John Wallace and Johannes Westendorf.
Acknowledgement

The Panel wishes to thank the members of the Working Group on Vitamins, including Georges Bories, Jürgen Gropp and Alberto Mantovani, for the preparatory work on this scientific opinion.

Type
Opinion of the Scientific Committee/Scientific Panel
On Request From
European Commission
Question Number
EFSA-Q-2011-00258
Adopted
17 April 2013
Published
13 May 2013
Affiliation
European Food Safety Authority (EFSA), Parma, Italy
Note
Article (368.42 KB)368.42 KB
Abstract

Glycine betaine (betaine) acts as a methyl group donor in transmethylation reactions in organisms. Betaine occurs in numerous vertebrate tissues as an osmolyte, ensuring osmoprotection. Betaine is safe for piglets at the maximum supplementation rate of 2 000 mg/kg complete feed with a margin of safety below 5. This conclusion is extended to all pigs and extrapolated to all animal species and categories. The use of betaine as a feed additive up to a supplementation rate of 2 000 mg/kg complete feed is unlikely to pose concerns for consumer safety. Users’ inhalation exposure to betaine is expected to be minimal. Betaine anhydrous should be considered irritant to skin, eyes and mucous membranes and a skin sensitiser. It is likely to cause skin sensitisation. The supplementation of feed with betaine anhydrous does not pose a risk to the environment. Betaine has the potential to become efficacious in all animal species and categories when administered via feed or water for drinking. The FEEDAP Panel made some recommendations on (i) introduction of a maximum content for supplemental betaine in complete feed and water for drinking; (ii) avoidance of simultaneous use of betaine in feed and water for drinking; and (iii) avoidance of simultaneous inclusion of betaine and choline chloride in premixtures.

Summary

Following 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 betaine anhydrous as a nutritional additive to be used in feed and water for drinking for all animal species.

Glycine betaine (betaine) acts as a methyl group donor in transmethylation reactions in organisms. Betaine occurs in numerous vertebrate tissues as an osmolyte, ensuring osmoprotection.

Betaine is safe for piglets at the maximum supplementation rate of 2 000 mg/kg complete feed with a margin of safety below 5. This conclusion is extended to all pigs and extrapolated to all animal species and categories.

The use of betaine as a feed additive up to a supplementation rate of 2 000 mg/kg complete feed is unlikely to pose concerns for consumer safety.

Betaine anhydrous should be considered irritant to skin, eyes and mucous membranes and a skin sensitiser.

The supplementation of feed with betaine anhydrous does not pose a risk to the environment.

Betaine has the potential to become efficacious in all animal species and categories when administered via feed or water for drinking.

The FEEDAP Panel made some recommendations on (i) introduction of a maximum content for supplemental betaine in complete feed and water for drinking; (ii) avoidance of simultaneous use of betaine in feed and water for drinking; and (iii) avoidance of simultaneous inclusion of betaine and choline chloride in premixtures.
 

Keywords
Nutritional additive, vitamins and pro-vitamins, betaine anhydrous, safety
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Number of Pages
20