PMID- 32626196 OWN - NLM STAT- PubMed-not-MEDLINE LR - 20240328 IS - 1831-4732 (Electronic) IS - 1831-4732 (Linking) VI - 17 IP - 12 DP - 2019 Dec TI - Safety and efficacy of Elancoban((R)) G200 (monensin sodium) for chickens for fattening, chickens reared for laying and turkeys. PG - e05891 LID - 10.2903/j.efsa.2019.5891 [doi] LID - e05891 AB - The feed additive Elancoban((R)) G200, containing the active substance monensin sodium, an ionophore anticoccidial, is intended to control coccidiosis in chickens for fattening, chickens reared for laying and turkeys. The FEEDAP Panel cannot conclude on the safety of the additive for the target species, consumer, user and environment with regard to the safety of the production strain. The following conclusions apply to monensin sodium included in the additive. Based on the available data set, the FEEDAP Panel cannot conclude on the safety of Elancoban((R)) G200 for chickens for fattening. Monensin sodium is safe for turkeys for fattening with a margin of safety of 1.5. Monensin sodium is not genotoxic and not carcinogenic. The pharmacological no observed adverse effect level (NOAEL) of 0.345 mg monensin sodium/kg body weight (bw) per day was identified in dog. The acceptable daily intake (ADI) derived from this NOAEL is 0.003 mg monensin sodium/kg bw applying an uncertainty factor of 100. Elancoban((R)) G200 is safe for the consumer. The existing maximum residue limits (MRLs) ensure consumer safety, provided that the withdrawal period of 1 day is respected. Elancoban((R)) G200 is very irritant for the eye, but it is not a skin irritant. Elancoban((R)) G200 should be regarded as a potential skin and respiratory sensitiser. Inhalation exposure is considered a risk to persons handling the additive. Elancoban((R)) G200 does not pose a risk for the terrestrial compartment, the aquatic compartment and the sediment. The bioaccumulation potential of monensin in the environment is low. Monensin sodium from Elancoban((R)) G200 has the potential to effectively control coccidiosis in chickens for fattening and chickens reared for laying. The FEEDAP Panel cannot conclude on the efficacy Elancoban((R)) G200 as a coccidiostat for turkeys for fattening. CI - (c) 2019 European Food Safety Authority. EFSA Journal published by John Wiley and Sons Ltd on behalf of European Food Safety Authority. CN - EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) FAU - Bampidis, Vasileios AU - Bampidis V FAU - Azimonti, Giovanna AU - Azimonti G FAU - Bastos, Maria de Lourdes AU - Bastos ML FAU - Christensen, Henrik AU - Christensen H FAU - Dusemund, Birgit AU - Dusemund B FAU - Kos Durjava, Mojca AU - Kos Durjava M FAU - Lopez-Alonso, Marta AU - Lopez-Alonso M FAU - Lopez Puente, Secundino AU - Lopez Puente S FAU - Marcon, Francesca AU - Marcon F FAU - Mayo, Baltasar AU - Mayo B FAU - Pechova, Alena AU - Pechova A FAU - Petkova, Mariana AU - Petkova M FAU - Ramos, Fernando AU - Ramos F FAU - Sanz, Yolanda AU - Sanz Y FAU - Villa, Roberto Edoardo AU - Villa RE FAU - Woutersen, Ruud AU - Woutersen R FAU - Bories, Georges AU - Bories G FAU - Brantom, Paul AU - Brantom P FAU - Gropp, Jurgen AU - Gropp J FAU - Finizio, Antonio AU - Finizio A FAU - Focks, Andreas AU - Focks A FAU - Teodorovic, Ivana AU - Teodorovic I FAU - Glandorf, Boet AU - Glandorf B FAU - Herman, Lieve AU - Herman L FAU - Prieto Maradona, Miguel AU - Prieto Maradona M FAU - Holczknecht, Orsolya AU - Holczknecht O FAU - Tarres-Call, Jordi AU - Tarres-Call J FAU - Vettori, Maria Vittoria AU - Vettori MV FAU - Kouba, Maryline AU - Kouba M LA - eng PT - Journal Article DEP - 20191216 PL - United States TA - EFSA J JT - EFSA journal. European Food Safety Authority JID - 101642076 PMC - PMC7008793 OTO - NOTNLM OT - chickens for fattening OT - chickens reared for laying OT - coccidiostats OT - monensin sodium OT - safety and efficacy OT - turkeys EDAT- 2020/07/07 06:00 MHDA- 2020/07/07 06:01 PMCR- 2019/12/16 CRDT- 2020/07/07 06:00 PHST- 2020/07/07 06:00 [entrez] PHST- 2020/07/07 06:00 [pubmed] PHST- 2020/07/07 06:01 [medline] PHST- 2019/12/16 00:00 [pmc-release] AID - EFS25891 [pii] AID - 10.2903/j.efsa.2019.5891 [doi] PST - epublish SO - EFSA J. 2019 Dec 16;17(12):e05891. doi: 10.2903/j.efsa.2019.5891. eCollection 2019 Dec.