1. Safety and efficacy of a feed additive consisting of endo‐1,4‐β‐xylanase produced by Bacillus subtilis LMG S‐27588 (Beltherm MP/ML) for laying hens, minor poultry species and all avian species (Puratos NV)
- Author
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Yolanda Sanz, Fernando Ramos, Efsa Panel on Additives, Roberto Edoardo Villa, Montserrat Anguita, Giovanna Martelli, Birgit Dusemund, Noël Dierick, Alena Pechová, Mojca Fašmon Durjava, Ruud Woutersen, Henrik Christensen, Marta López-Alonso, Jaume Galobart, Lieve Herman, Mariana Petkova, Maria de Lourdes Bastos, Maryline Kouba, Baltasar Mayo, Secundino López Puente, Vasileios Bampidis, Francesca Marcon, Giovanna Azimonti, Bampidis V., Azimonti G., Bastos M.D.L., Christensen H., Dusemund B., Fasmon Durjava M., Kouba M., Lopez-Alonso M., Lopez Puente S., Marcon F., Mayo B., Pechova A., Petkova M., Ramos F., Sanz Y., Villa R.E., Woutersen R., Dierick N., Herman L., Martelli G., Galobart J., and Anguita M.
- Subjects
safety ,Veterinary (miscellaneous) ,Feed additive ,efficacy ,TP1-1185 ,Plant Science ,Bacillus subtilis ,Microbiology ,Anim2953 ,TX341-641 ,Food science ,digestibility enhancers ,Beltherm ,xylanase ,biology ,Nutrition. Foods and food supply ,Chemistry ,Chemical technology ,Endo 1 4 β xylanase ,biology.organism_classification ,zootechnical additives ,Scientific Opinion ,Xylanase ,Animal Science and Zoology ,Parasitology ,digestibility enhancer ,Food Science - Abstract
Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of an endo-1,4-β-xylanase (Beltherm MP/ML), produced by a genetically-modified Bacillus subtilis strain, as a zootechnical additive for laying hens, minor poultry species and all avian species. The additive is authorised for use in feed for poultry species for fattening or reared for laying/breeding, weaned piglets, pigs for fattening and minor porcine species for fattening. The safety and efficacy of the additive for those species have been evaluated previously by the EFSA Panelon Additives and Products or Substances used in Animal Feed (FEEDAP Panel). The current application is for an extension of use of the additive. No viable cells were detected in the additive, but the data provided to support the absence of DNA in the additive was not sufficient to conclude on the absence of recombinant DNA in the additive. However, the Panelconcluded that no safety concerns would arise from the presence of DNA from the production strain in the additive. In the current assessment, the FEEDAP Panelconcluded that the additive is safe for all avian species at the recommended level of 100 ADXU/kg feed. Similarly, the FEEDAP Panelconcluded that Beltherm MP/ML is safe for the consumer and the environment. Concerning the user safety, the FEEDAP Panelconcluded that the additive is not toxic by inhalation or irritant for skin or eyes, but it is considered a potential dermal and a respiratory sensitiser. In a previous opinion, the efficacy of the additive in poultry species for fattening was shown. However, owing to the insufficient data submitted in previous and current assessments, the Panelcould not conclude on the efficacy of the product for the target species for which the application was made.
- Published
- 2021