Safety and efficacy of a feed additive consisting of salinomycin sodium (Sacox®) for rabbits for fattening (Huvepharma N.V.)
Abstract Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of the coccidiostat salinomycin sodium (Sacox®) for rabbits for fattening. The EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) conclude...
Saved in:
| Main Authors: | , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
Wiley
2024-05-01
|
| Series: | EFSA Journal |
| Subjects: | |
| Online Access: | https://doi.org/10.2903/j.efsa.2024.8796 |
| Tags: |
Add Tag
No Tags, Be the first to tag this record!
|
| _version_ | 1850211590993870848 |
|---|---|
| author | EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) Vasileios Bampidis Giovanna Azimonti Maria de Lourdes Bastos Henrik Christensen Mojca Durjava Birgit Dusemund Maryline Kouba Marta López‐Alonso Secundino López Puente Francesca Marcon Baltasar Mayo Alena Pechová Mariana Petkova Fernando Ramos Roberto Edoardo Villa Ruud Woutersen Georges Bories Paul Brantom Pier Sandro Cocconcelli Antonio Finizio Jürgen Gropp Thomas Poiger Guido Rychen Ivana Teodorovic Jaume Galobart Alberto Navarro‐Villa Elisa Pettenati Barbara Rossi Maria Vittoria Vettori Orsolya Holczknecht |
| 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 Mojca Durjava Birgit Dusemund Maryline Kouba Marta López‐Alonso Secundino López Puente Francesca Marcon Baltasar Mayo Alena Pechová Mariana Petkova Fernando Ramos Roberto Edoardo Villa Ruud Woutersen Georges Bories Paul Brantom Pier Sandro Cocconcelli Antonio Finizio Jürgen Gropp Thomas Poiger Guido Rychen Ivana Teodorovic Jaume Galobart Alberto Navarro‐Villa Elisa Pettenati Barbara Rossi Maria Vittoria Vettori Orsolya Holczknecht |
| 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 salinomycin sodium (Sacox®) for rabbits for fattening. The EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) concluded that the use of salinomycin sodium (SAL‐Na) from Sacox® does not raise safety concerns for the target species, consumers, users and the environment with regard to the production strain. In the absence of adequate tolerance studies, the FEEDAP Panel could not conclude on the safety of SAL‐Na from Sacox® for rabbits for fattening. The FEEDAP Panel concluded that the additive is safe for the consumer when it is used at the proposed maximum level of 25 mg SAL‐Na/kg complete feed for rabbits and a withdrawal period of 1 day is respected. The following maximum residue limits (MRL) are proposed for the marker residue compound salinomycin (SAL): 0.2 and 0.03 mg SAL/kg for liver and kidney, respectively. The additive is not irritant to skin and eyes but should be considered a potential dermal and respiratory sensitiser. A risk for inhalation toxicity could not be excluded. The use of the SAL‐Na from Sacox® in feed for rabbits for fattening up to the highest proposed level will not pose a risk for the terrestrial and aquatic compartment and ground water. The risk of secondary poisoning can be excluded for worm‐eating birds and mammals, while it cannot be excluded for fish‐eating birds and mammals. The FEEDAP Panel concludes that SAL‐Na from Sacox® at the minimum concentration of 20 mg SAL‐Na/kg complete feed has the potential to control coccidiosis in rabbits for fattening. Development of resistance to SAL‐Na of field Eimeria spp. strains isolated from rabbits for fattening should be monitored. |
| format | Article |
| id | doaj-art-7c3cb1c8eb814faca4f9e42efb0d8524 |
| institution | OA Journals |
| issn | 1831-4732 |
| language | English |
| publishDate | 2024-05-01 |
| publisher | Wiley |
| record_format | Article |
| series | EFSA Journal |
| spelling | doaj-art-7c3cb1c8eb814faca4f9e42efb0d85242025-08-20T02:09:31ZengWileyEFSA Journal1831-47322024-05-01225n/an/a10.2903/j.efsa.2024.8796Safety and efficacy of a feed additive consisting of salinomycin sodium (Sacox®) for rabbits for fattening (Huvepharma N.V.)EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP)Vasileios BampidisGiovanna AzimontiMaria de Lourdes BastosHenrik ChristensenMojca DurjavaBirgit DusemundMaryline KoubaMarta López‐AlonsoSecundino López PuenteFrancesca MarconBaltasar MayoAlena PechováMariana PetkovaFernando RamosRoberto Edoardo VillaRuud WoutersenGeorges BoriesPaul BrantomPier Sandro CocconcelliAntonio FinizioJürgen GroppThomas PoigerGuido RychenIvana TeodorovicJaume GalobartAlberto Navarro‐VillaElisa PettenatiBarbara RossiMaria Vittoria VettoriOrsolya HolczknechtAbstract Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of the coccidiostat salinomycin sodium (Sacox®) for rabbits for fattening. The EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) concluded that the use of salinomycin sodium (SAL‐Na) from Sacox® does not raise safety concerns for the target species, consumers, users and the environment with regard to the production strain. In the absence of adequate tolerance studies, the FEEDAP Panel could not conclude on the safety of SAL‐Na from Sacox® for rabbits for fattening. The FEEDAP Panel concluded that the additive is safe for the consumer when it is used at the proposed maximum level of 25 mg SAL‐Na/kg complete feed for rabbits and a withdrawal period of 1 day is respected. The following maximum residue limits (MRL) are proposed for the marker residue compound salinomycin (SAL): 0.2 and 0.03 mg SAL/kg for liver and kidney, respectively. The additive is not irritant to skin and eyes but should be considered a potential dermal and respiratory sensitiser. A risk for inhalation toxicity could not be excluded. The use of the SAL‐Na from Sacox® in feed for rabbits for fattening up to the highest proposed level will not pose a risk for the terrestrial and aquatic compartment and ground water. The risk of secondary poisoning can be excluded for worm‐eating birds and mammals, while it cannot be excluded for fish‐eating birds and mammals. The FEEDAP Panel concludes that SAL‐Na from Sacox® at the minimum concentration of 20 mg SAL‐Na/kg complete feed has the potential to control coccidiosis in rabbits for fattening. Development of resistance to SAL‐Na of field Eimeria spp. strains isolated from rabbits for fattening should be monitored.https://doi.org/10.2903/j.efsa.2024.8796coccidiostatefficacyrabbits for fatteningSacoxsafetysalinomycin sodium |
| spellingShingle | EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) Vasileios Bampidis Giovanna Azimonti Maria de Lourdes Bastos Henrik Christensen Mojca Durjava Birgit Dusemund Maryline Kouba Marta López‐Alonso Secundino López Puente Francesca Marcon Baltasar Mayo Alena Pechová Mariana Petkova Fernando Ramos Roberto Edoardo Villa Ruud Woutersen Georges Bories Paul Brantom Pier Sandro Cocconcelli Antonio Finizio Jürgen Gropp Thomas Poiger Guido Rychen Ivana Teodorovic Jaume Galobart Alberto Navarro‐Villa Elisa Pettenati Barbara Rossi Maria Vittoria Vettori Orsolya Holczknecht Safety and efficacy of a feed additive consisting of salinomycin sodium (Sacox®) for rabbits for fattening (Huvepharma N.V.) EFSA Journal coccidiostat efficacy rabbits for fattening Sacox safety salinomycin sodium |
| title | Safety and efficacy of a feed additive consisting of salinomycin sodium (Sacox®) for rabbits for fattening (Huvepharma N.V.) |
| title_full | Safety and efficacy of a feed additive consisting of salinomycin sodium (Sacox®) for rabbits for fattening (Huvepharma N.V.) |
| title_fullStr | Safety and efficacy of a feed additive consisting of salinomycin sodium (Sacox®) for rabbits for fattening (Huvepharma N.V.) |
| title_full_unstemmed | Safety and efficacy of a feed additive consisting of salinomycin sodium (Sacox®) for rabbits for fattening (Huvepharma N.V.) |
| title_short | Safety and efficacy of a feed additive consisting of salinomycin sodium (Sacox®) for rabbits for fattening (Huvepharma N.V.) |
| title_sort | safety and efficacy of a feed additive consisting of salinomycin sodium sacox r for rabbits for fattening huvepharma n v |
| topic | coccidiostat efficacy rabbits for fattening Sacox safety salinomycin sodium |
| url | https://doi.org/10.2903/j.efsa.2024.8796 |
| work_keys_str_mv | AT efsapanelonadditivesandproductsorsubstancesusedinanimalfeedfeedap safetyandefficacyofafeedadditiveconsistingofsalinomycinsodiumsacoxforrabbitsforfatteninghuvepharmanv AT vasileiosbampidis safetyandefficacyofafeedadditiveconsistingofsalinomycinsodiumsacoxforrabbitsforfatteninghuvepharmanv AT giovannaazimonti safetyandefficacyofafeedadditiveconsistingofsalinomycinsodiumsacoxforrabbitsforfatteninghuvepharmanv AT mariadelourdesbastos safetyandefficacyofafeedadditiveconsistingofsalinomycinsodiumsacoxforrabbitsforfatteninghuvepharmanv AT henrikchristensen safetyandefficacyofafeedadditiveconsistingofsalinomycinsodiumsacoxforrabbitsforfatteninghuvepharmanv AT mojcadurjava safetyandefficacyofafeedadditiveconsistingofsalinomycinsodiumsacoxforrabbitsforfatteninghuvepharmanv AT birgitdusemund safetyandefficacyofafeedadditiveconsistingofsalinomycinsodiumsacoxforrabbitsforfatteninghuvepharmanv AT marylinekouba safetyandefficacyofafeedadditiveconsistingofsalinomycinsodiumsacoxforrabbitsforfatteninghuvepharmanv AT martalopezalonso safetyandefficacyofafeedadditiveconsistingofsalinomycinsodiumsacoxforrabbitsforfatteninghuvepharmanv AT secundinolopezpuente safetyandefficacyofafeedadditiveconsistingofsalinomycinsodiumsacoxforrabbitsforfatteninghuvepharmanv AT francescamarcon safetyandefficacyofafeedadditiveconsistingofsalinomycinsodiumsacoxforrabbitsforfatteninghuvepharmanv AT baltasarmayo safetyandefficacyofafeedadditiveconsistingofsalinomycinsodiumsacoxforrabbitsforfatteninghuvepharmanv AT alenapechova safetyandefficacyofafeedadditiveconsistingofsalinomycinsodiumsacoxforrabbitsforfatteninghuvepharmanv AT marianapetkova safetyandefficacyofafeedadditiveconsistingofsalinomycinsodiumsacoxforrabbitsforfatteninghuvepharmanv AT fernandoramos safetyandefficacyofafeedadditiveconsistingofsalinomycinsodiumsacoxforrabbitsforfatteninghuvepharmanv AT robertoedoardovilla safetyandefficacyofafeedadditiveconsistingofsalinomycinsodiumsacoxforrabbitsforfatteninghuvepharmanv AT ruudwoutersen safetyandefficacyofafeedadditiveconsistingofsalinomycinsodiumsacoxforrabbitsforfatteninghuvepharmanv AT georgesbories safetyandefficacyofafeedadditiveconsistingofsalinomycinsodiumsacoxforrabbitsforfatteninghuvepharmanv AT paulbrantom safetyandefficacyofafeedadditiveconsistingofsalinomycinsodiumsacoxforrabbitsforfatteninghuvepharmanv AT piersandrococconcelli safetyandefficacyofafeedadditiveconsistingofsalinomycinsodiumsacoxforrabbitsforfatteninghuvepharmanv AT antoniofinizio safetyandefficacyofafeedadditiveconsistingofsalinomycinsodiumsacoxforrabbitsforfatteninghuvepharmanv AT jurgengropp safetyandefficacyofafeedadditiveconsistingofsalinomycinsodiumsacoxforrabbitsforfatteninghuvepharmanv AT thomaspoiger safetyandefficacyofafeedadditiveconsistingofsalinomycinsodiumsacoxforrabbitsforfatteninghuvepharmanv AT guidorychen safetyandefficacyofafeedadditiveconsistingofsalinomycinsodiumsacoxforrabbitsforfatteninghuvepharmanv AT ivanateodorovic safetyandefficacyofafeedadditiveconsistingofsalinomycinsodiumsacoxforrabbitsforfatteninghuvepharmanv AT jaumegalobart safetyandefficacyofafeedadditiveconsistingofsalinomycinsodiumsacoxforrabbitsforfatteninghuvepharmanv AT albertonavarrovilla safetyandefficacyofafeedadditiveconsistingofsalinomycinsodiumsacoxforrabbitsforfatteninghuvepharmanv AT elisapettenati safetyandefficacyofafeedadditiveconsistingofsalinomycinsodiumsacoxforrabbitsforfatteninghuvepharmanv AT barbararossi safetyandefficacyofafeedadditiveconsistingofsalinomycinsodiumsacoxforrabbitsforfatteninghuvepharmanv AT mariavittoriavettori safetyandefficacyofafeedadditiveconsistingofsalinomycinsodiumsacoxforrabbitsforfatteninghuvepharmanv AT orsolyaholczknecht safetyandefficacyofafeedadditiveconsistingofsalinomycinsodiumsacoxforrabbitsforfatteninghuvepharmanv |