Safety and efficacy of a feed additive consisting of zearalenone hydrolase produced by Escherichia coli DSM 32731 for all terrestrial animal species (Biomin GmbH).
Abstract: 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 zearalenone hydrolase (ZenA) produced by DSM 32731 when used as a feed additive for all terrestrial animals. The production strain DSM 32731 is genetically modified and harbours a kanamycin resistance gene. No viable cells of the production strain were detected in the final product, but uncertainty remains on the presence of recombinant DNA in the final product. The ZenA contained in the additive is safe for all terrestrial animal species up to the maximum use levels of (in U/kg complete feed): 100 U/kg in chickens for fattening; 150 U/kg in laying hens, turkeys for fattening and rabbits; 200 U/kg in pigs; 250 U/kg in dairy cows; 400 U/kg in veal calf (milk replacer), cattle for fattening, sheep, goats, horses and cats; and 450 U/kg in dogs. Based on the ADME and toxicological data, the FEEDAP Panel considers that the use of the ZenA contained in the additive in animal nutrition is safe for the consumers. The endotoxin content in the additive poses a risk by inhalation for users handling the additive. The additive is not a skin/eye irritant nor a skin sensitiser. Due to its proteinaceous nature, the additive should be considered as a potential respiratory sensitiser. The ZenA contained in the additive and the resulting breakdown products of its enzymatic activity do not represent a safety concern for the environment. The production strain harbours an antimicrobial resistance gene and uncertainties remain on the possible presence of its recombinant DNA in the final product; therefore, the FEEDAP Panel cannot conclude on safety of the additive for the target species, the consumer, the user and the environment.
© 2022 Wiley‐VCH Verlag GmbH & Co. KgaA on behalf of the European Food Safety Authority.
Publication Date: 2022-02-24 PubMed ID: 35233253PubMed Central: PMC8867527DOI: 10.2903/j.efsa.2022.7157Google Scholar: Lookup
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Summary
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The study conducted by the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP), in response to the European Commission’s request, evaluated the safety and efficacy of the feed additive zearalenone hydrolase (ZenA), produced by genetically modified Escherichia coli (DSM 32731), for all terrestrial animals. While ZenA is considered safe for animals and consumers based on specific usage levels, it poses certain risks to people handling the additive. Questions remain about the possible presence of recombinant DNA in the final product.
ZenA as a Feed Additive
- The study focused on the feed additive zearalenone hydrolase (ZenA), which was grown in a genetically modified Escherichia coli strain (DSM 32731).
- The strain carried a kanamycin resistance gene, but no viable cells of the production strain were detected in the final product.
- However, there was uncertainty regarding the presence of the recombinant DNA (genetically engineered DNA) in the final product, which is a major safety concern.
Safety Levels for Different Animal Species
- The safe usage levels of ZenA in feed were mentioned for different terrestrial animal species. Numbers indicated the unit of ZenA (in U/kg complete feed), with limits set for various animals, ranging from 100 U/kg for chickens up to 450 U/kg for dogs.
- The allowances were based on Considerations of Absorption, Distribution, Metabolism, and Excretion (ADME) factors and toxicological data which suggest that the use of ZenA in animal feed is safe for the consumers.
Risks and Concerns
- ZenA was found to pose an inhalation risk for those who handle the feed additive due to its endotoxin content, although it is not a skin or eye irritant nor a skin sensitiser.
- Due to its proteinaceous nature however, ZenA should be considered as a potential respiratory sensitiser. This means that it can cause hypersensitivity of the airways over time.
- Despite the safety of ZenA and the breakdown products of its enzymatic activity for the environment, the presence of an antimicrobial resistance gene in the production strain and possible presence of recombinant DNA in the final product raised safety concerns. As a result, the FEEDAP Panel was unable to definitively conclude on the safety of the additive for the target species, the consumer, those handling the product, and the environment.
Cite This Article
APA
Bampidis V, Azimonti G, Bastos ML, Christensen H, Dusemund B, Fašmon Durjava M, Kouba M, López-Alonso M, López Puente S, Marcon F, Mayo B, Pechová A, Petkova M, Ramos F, Sanz Y, Villa RE, Woutersen R, Bories G, Glandorf B, Svensson K, Anguita M, Brozzi R, Galobart J, Gregoretti L, Innocenti ML, Pettenati E, Pizzo F, Tarrés-Call J, Vettori MV, López-Gálvez G.
(2022).
Safety and efficacy of a feed additive consisting of zearalenone hydrolase produced by Escherichia coli DSM 32731 for all terrestrial animal species (Biomin GmbH).
EFSA J, 20(2), e07157.
https://doi.org/10.2903/j.efsa.2022.7157 Publication
Researcher Affiliations
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Citations
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