Omneity® Pellets
All-In-One Vitamin & Mineral Pellet
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 The Equine Research Bank provides access to a large database of publicly available scientific literature. Inclusion in the Research Bank does not imply endorsement of study methods or findings by Mad Barn.
- Journal Article
Summary
This research summary has been generated with artificial intelligence and may contain errors and omissions. Refer to the original study to confirm details provided. Submit correction.
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
References
This article includes 17 references
- Cort N, Fredriksson G, Kindahl H, Edqvist LE, Rylander R. A clinical and endocrine study on the effect of orally administered bacterial endotoxin in adult pigs and goats.. Zentralbl Veterinarmed A 1990 Mar;37(2):130-7.
- EFSA FEEDAP Panel. Guidance on studies concerning the safety of use of the additive for users/workers. EFSA Journal 2012;10(1):2539, 5 pp.
- EFSA FEEDAP Panel. Scientific Opinion on the safety and efficacy of L‐lysine monohydrochloride, technically pure, produced with Escherichia coli CGMCC 3705 and L‐lysine sulphate produced with Corynebacterium glutamicum CGMCC 3704 for all animal species, based on a dossier submitted by HELM AG. EFSA Journal 2015;13(7):4156, 25 pp.
- Rychen G, Aquilina G, Azimonti G, Bampidis V, Bastos ML, Bories G, Chesson A, Cocconcelli PS, Flachowsky G, Gropp J, Kolar B, Kouba M, López-Alonso M, López Puente S, Mantovani A, Mayo B, Ramos F, Saarela M, Villa RE, Wallace RJ, Wester P, Anguita M, Galobart J, Innocenti ML. Guidance on the identity, characterisation and conditions of use of feed additives.. EFSA J 2017 Oct;15(10):e05023.
- Rychen G, Aquilina G, Azimonti G, Bampidis V, Bastos ML, Bories G, Chesson A, Cocconcelli PS, Flachowsky G, Gropp J, Kolar B, Kouba M, López-Alonso M, López Puente S, Mantovani A, Mayo B, Ramos F, Saarela M, Villa RE, Wallace RJ, Wester P, Anguita M, Galobart J, Innocenti ML, Martino L. Guidance on the assessment of the safety of feed additives for the target species.. EFSA J 2017 Oct;15(10):e05021.
- Rychen G, Aquilina G, Azimonti G, Bampidis V, Bastos ML, Bories G, Chesson A, Cocconcelli PS, Flachowsky G, Gropp J, Kolar B, Kouba M, López-Alonso M, López Puente S, Mantovani A, Mayo B, Ramos F, Saarela M, Villa RE, Wallace RJ, Wester P, Anguita M, Dujardin B, Galobart J, Innocenti ML. Guidance on the assessment of the safety of feed additives for the consumer.. EFSA J 2017 Oct;15(10):e05022.
- Rychen G, Aquilina G, Azimonti G, Bampidis V, Bastos ML, Bories G, Chesson A, Cocconcelli PS, Flachowsky G, Gropp J, Kolar B, Kouba M, López-Alonso M, López Puente S, Mantovani A, Mayo B, Ramos F, Saarela M, Villa RE, Wallace RJ, Wester P, Glandorf B, Herman L, Kärenlampi S, Aguilera J, Anguita M, Brozzi R, Galobart J. Guidance on the characterisation of microorganisms used as feed additives or as production organisms.. EFSA J 2018 Mar;16(3):e05206.
- Rychen G, Aquilina G, Azimonti G, Bampidis V, Bastos ML, Bories G, Chesson A, Cocconcelli PS, Flachowsky G, Gropp J, Kolar B, Kouba M, López-Alonso M, López Puente S, Mantovani A, Mayo B, Ramos F, Saarela M, Villa RE, Wallace RJ, Wester P, Anguita M, Galobart J, Innocenti ML, Martino L. Guidance on the assessment of the efficacy of feed additives.. EFSA J 2018 May;16(5):e05274.
- Bampidis V, Bastos M, Christensen H, Dusemund B, Kouba M, Kos Durjava M, López-Alonso M, López Puente S, Marcon F, Mayo B, Pechová A, Petkova M, Ramos F, Sanz Y, Villa RE, Woutersen R, Brock T, de Knecht J, Kolar B, van Beelen P, Padovani L, Tarrés-Call J, Vettori MV, Azimonti G. Guidance on the assessment of the safety of feed additives for the environment.. EFSA J 2019 Apr;17(4):e05648.
- Fruhauf S, Novak B, Nagl V, Hackl M, Hartinger D, Rainer V, Labudová S, Adam G, Aleschko M, Moll WD, Thamhesl M, Grenier B. Biotransformation of the Mycotoxin Zearalenone to its Metabolites Hydrolyzed Zearalenone (HZEN) and Decarboxylated Hydrolyzed Zearalenone (DHZEN) Diminishes its Estrogenicity In Vitro and In Vivo.. Toxins (Basel) 2019 Aug 20;11(8).
- Health Council of the Netherlands. Endotoxins. Health‐based recommended occupational exposure limit. Publication no 2010/04OSH, 100 pp.
- nHSE (Health and Safety Executive)n. Occupational hygiene implications of processing waste at materials recycling facilities (exposure to bioaerosol and dust). Research report RR977.
- Kakeya H, Takahashi-Ando N, Kimura M, Onose R, Yamaguchi I, Osada H. Biotransformation of the mycotoxin, zearalenone, to a non-estrogenic compound by a fungal strain of Clonostachys sp.. Biosci Biotechnol Biochem 2002 Dec;66(12):2723-6.
- OECD. Test No. 471: Bacterial Reverse Mutation Test. OECD Guidelines for the Testing of Chemicals, Section 4 OECD Publishing, Paris.
- OECD. Test No. 487: In Vitro Mammalian Cell Micronucleus Test. OECD Guidelines for the Testing of Chemicals, Section 4 OECD Publishing, Paris.
- Rylander R. Health effects among workers in sewage treatment plants.. Occup Environ Med 1999 May;56(5):354-7.
- Thorn J. The inflammatory response in humans after inhalation of bacterial endotoxin: a review.. Inflamm Res 2001 May;50(5):254-61.
Citations
This article has been cited 2 times.- Loi M, Logrieco AF, Pusztahelyi T, Leiter É, Hornok L, Pócsi I. Advanced mycotoxin control and decontamination techniques in view of an increased aflatoxin risk in Europe due to climate change. Front Microbiol 2022;13:1085891.
- De Troyer L, De Zutter N, De Saeger S, Dumoulin F, Croubels S, De Baere S, De Gelder L, Audenaert K. Actinobacteria as Promising Biocontrol Agents for In Vitro and In Planta Degradation and Detoxification of Zearalenone. Toxins (Basel) 2024 May 28;16(6).
Use Nutrition Calculator
Check if your horse's diet meets their nutrition requirements with our easy-to-use tool Check your horse's diet with our easy-to-use tool
Talk to a Nutritionist
Discuss your horse's feeding plan with our experts over a free phone consultation Discuss your horse's diet over a phone consultation
Submit Diet Evaluation
Get a customized feeding plan for your horse formulated by our equine nutritionists Get a custom feeding plan formulated by our nutritionists
