Safety and efficacy of a feed additive consisting of narasin (Monteban® G100) for chickens for fattening (Elanco GmbH)

Abstract Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of the coccidiostat narasin (Monteban® G100) for chickens for fattening. In a previous opinion, uncertainties remained on the identification and characterisation of th...

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Main Authors: EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP), Vasileios Bampidis, Giovanna Azimonti, Maria de Lourdes Bastos, Henrik Christensen, Birgit Dusemund, Mojca Durjava, Maryline Kouba, Marta López‐Alonso, Secundino López Puente, Francesca Marcon, Baltasar Mayo, Alena Pechová, Mariana Petkova, Fernando Ramos, Roberto Edoardo Villa, Ruud Woutersen, Antonio Finizio, Jürgen Gropp, Guido Rychen, Ivana Teodorovic, Jaume Galobart, Orsolya Holczknecht, Alberto Navarro‐Villa, Elisa Pettenati, Maria Vittoria Vettori, Barbara Rossi
Format: Article
Language:English
Published: Wiley 2024-03-01
Series:EFSA Journal
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Online Access:https://doi.org/10.2903/j.efsa.2024.8613
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author EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP)
Vasileios Bampidis
Giovanna Azimonti
Maria de Lourdes Bastos
Henrik Christensen
Birgit Dusemund
Mojca Durjava
Maryline Kouba
Marta López‐Alonso
Secundino López Puente
Francesca Marcon
Baltasar Mayo
Alena Pechová
Mariana Petkova
Fernando Ramos
Roberto Edoardo Villa
Ruud Woutersen
Antonio Finizio
Jürgen Gropp
Guido Rychen
Ivana Teodorovic
Jaume Galobart
Orsolya Holczknecht
Alberto Navarro‐Villa
Elisa Pettenati
Maria Vittoria Vettori
Barbara Rossi
author_facet EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP)
Vasileios Bampidis
Giovanna Azimonti
Maria de Lourdes Bastos
Henrik Christensen
Birgit Dusemund
Mojca Durjava
Maryline Kouba
Marta López‐Alonso
Secundino López Puente
Francesca Marcon
Baltasar Mayo
Alena Pechová
Mariana Petkova
Fernando Ramos
Roberto Edoardo Villa
Ruud Woutersen
Antonio Finizio
Jürgen Gropp
Guido Rychen
Ivana Teodorovic
Jaume Galobart
Orsolya Holczknecht
Alberto Navarro‐Villa
Elisa Pettenati
Maria Vittoria Vettori
Barbara Rossi
author_sort EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP)
collection DOAJ
description Abstract Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of the coccidiostat narasin (Monteban® G100) for chickens for fattening. In a previous opinion, uncertainties remained on the identification and characterisation of the non‐genetically modified production strain of the active substance narasin. The Panel could not conclude either on the safety of Monteban® G100 for chickens for fattening or on the efficacy of the additive at the minimum applied concentration. The FEEDAP Panel excluded risks for environment but the risk for sediment compartment could not be assessed. The applicant provided supplementary information to cover the data gaps and substituted the narasin production strain from Streptomyces spp. NRRL 8092 to Streptomyces spp. NRRL B‐67771. The information submitted to taxonomically identify the production strain did not allow to assign it to any described microbial species. Based on the information provided, the Panel concluded that the use of Monteban® G100 did not raise safety concerns as regards the production strain for the target animal, consumer, user and environment. The Panel concluded that 70 mg narasin/kg complete feed was safe for chickens for fattening with a margin of safety of 1.4; narasin from Monteban® G100 was unlikely to increase shedding of Salmonella Enteritidis, Salmonella Typhimurium and Campylobacter jejuni. Narasin, when used in chickens for fattening at 70 mg/kg feed, was not expected to pose a risk to the aquatic compartment and to sediment, while a risk for the terrestrial compartment could not be excluded. No risk for groundwater was expected, nor for secondary poisoning via the terrestrial food chain, but the risk of secondary poisoning via the aquatic food chain could not be excluded. The Panel concluded that 60 mg narasin/kg feed was efficacious in controlling coccidiosis in chickens for fattening.
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spelling doaj-art-55a6c61ae2344ebb9e9c32e3f1e2efb12025-08-20T03:14:23ZengWileyEFSA Journal1831-47322024-03-01223n/an/a10.2903/j.efsa.2024.8613Safety and efficacy of a feed additive consisting of narasin (Monteban® G100) for chickens for fattening (Elanco GmbH)EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP)Vasileios BampidisGiovanna AzimontiMaria de Lourdes BastosHenrik ChristensenBirgit DusemundMojca DurjavaMaryline KoubaMarta López‐AlonsoSecundino López PuenteFrancesca MarconBaltasar MayoAlena PechováMariana PetkovaFernando RamosRoberto Edoardo VillaRuud WoutersenAntonio FinizioJürgen GroppGuido RychenIvana TeodorovicJaume GalobartOrsolya HolczknechtAlberto Navarro‐VillaElisa PettenatiMaria Vittoria VettoriBarbara RossiAbstract Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of the coccidiostat narasin (Monteban® G100) for chickens for fattening. In a previous opinion, uncertainties remained on the identification and characterisation of the non‐genetically modified production strain of the active substance narasin. The Panel could not conclude either on the safety of Monteban® G100 for chickens for fattening or on the efficacy of the additive at the minimum applied concentration. The FEEDAP Panel excluded risks for environment but the risk for sediment compartment could not be assessed. The applicant provided supplementary information to cover the data gaps and substituted the narasin production strain from Streptomyces spp. NRRL 8092 to Streptomyces spp. NRRL B‐67771. The information submitted to taxonomically identify the production strain did not allow to assign it to any described microbial species. Based on the information provided, the Panel concluded that the use of Monteban® G100 did not raise safety concerns as regards the production strain for the target animal, consumer, user and environment. The Panel concluded that 70 mg narasin/kg complete feed was safe for chickens for fattening with a margin of safety of 1.4; narasin from Monteban® G100 was unlikely to increase shedding of Salmonella Enteritidis, Salmonella Typhimurium and Campylobacter jejuni. Narasin, when used in chickens for fattening at 70 mg/kg feed, was not expected to pose a risk to the aquatic compartment and to sediment, while a risk for the terrestrial compartment could not be excluded. No risk for groundwater was expected, nor for secondary poisoning via the terrestrial food chain, but the risk of secondary poisoning via the aquatic food chain could not be excluded. The Panel concluded that 60 mg narasin/kg feed was efficacious in controlling coccidiosis in chickens for fattening.https://doi.org/10.2903/j.efsa.2024.8613chickens for fatteningcoccidiostatsefficacyMonteban® G 100narasinsafety
spellingShingle EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP)
Vasileios Bampidis
Giovanna Azimonti
Maria de Lourdes Bastos
Henrik Christensen
Birgit Dusemund
Mojca Durjava
Maryline Kouba
Marta López‐Alonso
Secundino López Puente
Francesca Marcon
Baltasar Mayo
Alena Pechová
Mariana Petkova
Fernando Ramos
Roberto Edoardo Villa
Ruud Woutersen
Antonio Finizio
Jürgen Gropp
Guido Rychen
Ivana Teodorovic
Jaume Galobart
Orsolya Holczknecht
Alberto Navarro‐Villa
Elisa Pettenati
Maria Vittoria Vettori
Barbara Rossi
Safety and efficacy of a feed additive consisting of narasin (Monteban® G100) for chickens for fattening (Elanco GmbH)
EFSA Journal
chickens for fattening
coccidiostats
efficacy
Monteban® G 100
narasin
safety
title Safety and efficacy of a feed additive consisting of narasin (Monteban® G100) for chickens for fattening (Elanco GmbH)
title_full Safety and efficacy of a feed additive consisting of narasin (Monteban® G100) for chickens for fattening (Elanco GmbH)
title_fullStr Safety and efficacy of a feed additive consisting of narasin (Monteban® G100) for chickens for fattening (Elanco GmbH)
title_full_unstemmed Safety and efficacy of a feed additive consisting of narasin (Monteban® G100) for chickens for fattening (Elanco GmbH)
title_short Safety and efficacy of a feed additive consisting of narasin (Monteban® G100) for chickens for fattening (Elanco GmbH)
title_sort safety and efficacy of a feed additive consisting of narasin monteban r g100 for chickens for fattening elanco gmbh
topic chickens for fattening
coccidiostats
efficacy
Monteban® G 100
narasin
safety
url https://doi.org/10.2903/j.efsa.2024.8613
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