Safety and efficacy of a feed additive consisting of lasalocid A sodium and nicarbazin (Nilablend™ 200G) for chickens for fattening (Zoetis Belgium SA)
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 the coccidiostat Nilablend™ 200G containing lasalocid A sodium and nicarbazin. Nilablend™ 200G is not safe for chicke...
| Main Authors: | , , , , , , , , , , , , , , , , , , , , , , , , , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
Wiley
2021-03-01
|
| Series: | EFSA Journal |
| Subjects: | |
| Online Access: | https://doi.org/10.2903/j.efsa.2021.6466 |
| _version_ | 1818738492763537408 |
|---|---|
| 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 Fašmon Durjava Maryline Kouba Marta López‐Alonso Secundino López Puente Francesca Marcon Baltasar Mayo Alena Pechová Mariana Petkova Fernando Ramos Yolanda Sanz Roberto Edoardo Villa Ruud Woutersen Gabriele Aquilina Georges Bories Paul Brantom Pier Sandro Cocconcelli Jürgen Gropp Guido Rychen Orsolya Holczknecht Maria Vittoria Vettori |
| 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 Fašmon Durjava Maryline Kouba Marta López‐Alonso Secundino López Puente Francesca Marcon Baltasar Mayo Alena Pechová Mariana Petkova Fernando Ramos Yolanda Sanz Roberto Edoardo Villa Ruud Woutersen Gabriele Aquilina Georges Bories Paul Brantom Pier Sandro Cocconcelli Jürgen Gropp Guido Rychen Orsolya Holczknecht Maria Vittoria Vettori |
| 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, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on the coccidiostat Nilablend™ 200G containing lasalocid A sodium and nicarbazin. Nilablend™ 200G is not safe for chickens for fattening at the proposed maximum use level of 50 mg lasalocid A sodium + 50 mg nicarbazin/kg complete feed. Concurrent administration of Nilablend™ 200G (containing lasalocid A sodium) with tiamulin and certain other medicinal substances should be avoided. Lasalocid A sodium has antimicrobial activity against Gram‐positive bacterial species while many Enterobacteriaceae are naturally resistant. Induction of resistance and/or cross‐resistance was not observed in experimental conditions. No information on the interactions of nicarbazin with feed materials, other approved additives or medicinal products have been provided. No data were submitted on the microbiological safety of nicarbazin. The toxicological package for lasalocid A sodium and nicarbazin identified no observed adverse effect levels (NOAELs) that could be the basis for setting health‐based guidance values (e.g. an acceptable daily intake (ADI)). The Panel concluded that a concern for the genotoxicity of nicarbazin in Nilablend™ 200G cannot be excluded and that clarification on the mechanism of action of the test items would be needed. Therefore, the FEEDAP Panel is not in the position to establish an ADI for DNC on which to base the assessment of consumer safety. Nilablend™ 200G is considered toxic by inhalation, corrosive and irritant to eyes, slightly irritant to the skin but not a skin sensitiser. Inhalation exposure is considered a risk to persons handling the additive. The FEEDAP Panel cannot conclude on the safety of Nilablend™ 200G for the environment due to a possible risk for aquatic compartment (freshwater) for DNC. The efficacy of Nilablend® 200G was demonstrated. |
| first_indexed | 2024-12-18T01:09:48Z |
| format | Article |
| id | doaj.art-fe3a1fc93e454291812e6fc338ca585a |
| institution | Directory Open Access Journal |
| issn | 1831-4732 |
| language | English |
| last_indexed | 2024-12-18T01:09:48Z |
| publishDate | 2021-03-01 |
| publisher | Wiley |
| record_format | Article |
| series | EFSA Journal |
| spelling | doaj.art-fe3a1fc93e454291812e6fc338ca585a2022-12-21T21:26:09ZengWileyEFSA Journal1831-47322021-03-01193n/an/a10.2903/j.efsa.2021.6466Safety and efficacy of a feed additive consisting of lasalocid A sodium and nicarbazin (Nilablend™ 200G) for chickens for fattening (Zoetis Belgium SA)EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP)Vasileios BampidisGiovanna AzimontiMaria de Lourdes BastosHenrik ChristensenBirgit DusemundMojca Fašmon DurjavaMaryline KoubaMarta López‐AlonsoSecundino López PuenteFrancesca MarconBaltasar MayoAlena PechováMariana PetkovaFernando RamosYolanda SanzRoberto Edoardo VillaRuud WoutersenGabriele AquilinaGeorges BoriesPaul BrantomPier Sandro CocconcelliJürgen GroppGuido RychenOrsolya HolczknechtMaria Vittoria VettoriAbstract 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 the coccidiostat Nilablend™ 200G containing lasalocid A sodium and nicarbazin. Nilablend™ 200G is not safe for chickens for fattening at the proposed maximum use level of 50 mg lasalocid A sodium + 50 mg nicarbazin/kg complete feed. Concurrent administration of Nilablend™ 200G (containing lasalocid A sodium) with tiamulin and certain other medicinal substances should be avoided. Lasalocid A sodium has antimicrobial activity against Gram‐positive bacterial species while many Enterobacteriaceae are naturally resistant. Induction of resistance and/or cross‐resistance was not observed in experimental conditions. No information on the interactions of nicarbazin with feed materials, other approved additives or medicinal products have been provided. No data were submitted on the microbiological safety of nicarbazin. The toxicological package for lasalocid A sodium and nicarbazin identified no observed adverse effect levels (NOAELs) that could be the basis for setting health‐based guidance values (e.g. an acceptable daily intake (ADI)). The Panel concluded that a concern for the genotoxicity of nicarbazin in Nilablend™ 200G cannot be excluded and that clarification on the mechanism of action of the test items would be needed. Therefore, the FEEDAP Panel is not in the position to establish an ADI for DNC on which to base the assessment of consumer safety. Nilablend™ 200G is considered toxic by inhalation, corrosive and irritant to eyes, slightly irritant to the skin but not a skin sensitiser. Inhalation exposure is considered a risk to persons handling the additive. The FEEDAP Panel cannot conclude on the safety of Nilablend™ 200G for the environment due to a possible risk for aquatic compartment (freshwater) for DNC. The efficacy of Nilablend® 200G was demonstrated.https://doi.org/10.2903/j.efsa.2021.6466coccidiostatslasalocid A sodiumnicarbazinDNCHDPchickens for fattening |
| 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 Fašmon Durjava Maryline Kouba Marta López‐Alonso Secundino López Puente Francesca Marcon Baltasar Mayo Alena Pechová Mariana Petkova Fernando Ramos Yolanda Sanz Roberto Edoardo Villa Ruud Woutersen Gabriele Aquilina Georges Bories Paul Brantom Pier Sandro Cocconcelli Jürgen Gropp Guido Rychen Orsolya Holczknecht Maria Vittoria Vettori Safety and efficacy of a feed additive consisting of lasalocid A sodium and nicarbazin (Nilablend™ 200G) for chickens for fattening (Zoetis Belgium SA) EFSA Journal coccidiostats lasalocid A sodium nicarbazin DNC HDP chickens for fattening |
| title | Safety and efficacy of a feed additive consisting of lasalocid A sodium and nicarbazin (Nilablend™ 200G) for chickens for fattening (Zoetis Belgium SA) |
| title_full | Safety and efficacy of a feed additive consisting of lasalocid A sodium and nicarbazin (Nilablend™ 200G) for chickens for fattening (Zoetis Belgium SA) |
| title_fullStr | Safety and efficacy of a feed additive consisting of lasalocid A sodium and nicarbazin (Nilablend™ 200G) for chickens for fattening (Zoetis Belgium SA) |
| title_full_unstemmed | Safety and efficacy of a feed additive consisting of lasalocid A sodium and nicarbazin (Nilablend™ 200G) for chickens for fattening (Zoetis Belgium SA) |
| title_short | Safety and efficacy of a feed additive consisting of lasalocid A sodium and nicarbazin (Nilablend™ 200G) for chickens for fattening (Zoetis Belgium SA) |
| title_sort | safety and efficacy of a feed additive consisting of lasalocid a sodium and nicarbazin nilablend™ 200g for chickens for fattening zoetis belgium sa |
| topic | coccidiostats lasalocid A sodium nicarbazin DNC HDP chickens for fattening |
| url | https://doi.org/10.2903/j.efsa.2021.6466 |
| work_keys_str_mv | AT efsapanelonadditivesandproductsorsubstancesusedinanimalfeedfeedap safetyandefficacyofafeedadditiveconsistingoflasalocidasodiumandnicarbazinnilablend200gforchickensforfatteningzoetisbelgiumsa AT vasileiosbampidis safetyandefficacyofafeedadditiveconsistingoflasalocidasodiumandnicarbazinnilablend200gforchickensforfatteningzoetisbelgiumsa AT giovannaazimonti safetyandefficacyofafeedadditiveconsistingoflasalocidasodiumandnicarbazinnilablend200gforchickensforfatteningzoetisbelgiumsa AT mariadelourdesbastos safetyandefficacyofafeedadditiveconsistingoflasalocidasodiumandnicarbazinnilablend200gforchickensforfatteningzoetisbelgiumsa AT henrikchristensen safetyandefficacyofafeedadditiveconsistingoflasalocidasodiumandnicarbazinnilablend200gforchickensforfatteningzoetisbelgiumsa AT birgitdusemund safetyandefficacyofafeedadditiveconsistingoflasalocidasodiumandnicarbazinnilablend200gforchickensforfatteningzoetisbelgiumsa AT mojcafasmondurjava safetyandefficacyofafeedadditiveconsistingoflasalocidasodiumandnicarbazinnilablend200gforchickensforfatteningzoetisbelgiumsa AT marylinekouba safetyandefficacyofafeedadditiveconsistingoflasalocidasodiumandnicarbazinnilablend200gforchickensforfatteningzoetisbelgiumsa AT martalopezalonso safetyandefficacyofafeedadditiveconsistingoflasalocidasodiumandnicarbazinnilablend200gforchickensforfatteningzoetisbelgiumsa AT secundinolopezpuente safetyandefficacyofafeedadditiveconsistingoflasalocidasodiumandnicarbazinnilablend200gforchickensforfatteningzoetisbelgiumsa AT francescamarcon safetyandefficacyofafeedadditiveconsistingoflasalocidasodiumandnicarbazinnilablend200gforchickensforfatteningzoetisbelgiumsa AT baltasarmayo safetyandefficacyofafeedadditiveconsistingoflasalocidasodiumandnicarbazinnilablend200gforchickensforfatteningzoetisbelgiumsa AT alenapechova safetyandefficacyofafeedadditiveconsistingoflasalocidasodiumandnicarbazinnilablend200gforchickensforfatteningzoetisbelgiumsa AT marianapetkova safetyandefficacyofafeedadditiveconsistingoflasalocidasodiumandnicarbazinnilablend200gforchickensforfatteningzoetisbelgiumsa AT fernandoramos safetyandefficacyofafeedadditiveconsistingoflasalocidasodiumandnicarbazinnilablend200gforchickensforfatteningzoetisbelgiumsa AT yolandasanz safetyandefficacyofafeedadditiveconsistingoflasalocidasodiumandnicarbazinnilablend200gforchickensforfatteningzoetisbelgiumsa AT robertoedoardovilla safetyandefficacyofafeedadditiveconsistingoflasalocidasodiumandnicarbazinnilablend200gforchickensforfatteningzoetisbelgiumsa AT ruudwoutersen safetyandefficacyofafeedadditiveconsistingoflasalocidasodiumandnicarbazinnilablend200gforchickensforfatteningzoetisbelgiumsa AT gabrieleaquilina safetyandefficacyofafeedadditiveconsistingoflasalocidasodiumandnicarbazinnilablend200gforchickensforfatteningzoetisbelgiumsa AT georgesbories safetyandefficacyofafeedadditiveconsistingoflasalocidasodiumandnicarbazinnilablend200gforchickensforfatteningzoetisbelgiumsa AT paulbrantom safetyandefficacyofafeedadditiveconsistingoflasalocidasodiumandnicarbazinnilablend200gforchickensforfatteningzoetisbelgiumsa AT piersandrococconcelli safetyandefficacyofafeedadditiveconsistingoflasalocidasodiumandnicarbazinnilablend200gforchickensforfatteningzoetisbelgiumsa AT jurgengropp safetyandefficacyofafeedadditiveconsistingoflasalocidasodiumandnicarbazinnilablend200gforchickensforfatteningzoetisbelgiumsa AT guidorychen safetyandefficacyofafeedadditiveconsistingoflasalocidasodiumandnicarbazinnilablend200gforchickensforfatteningzoetisbelgiumsa AT orsolyaholczknecht safetyandefficacyofafeedadditiveconsistingoflasalocidasodiumandnicarbazinnilablend200gforchickensforfatteningzoetisbelgiumsa AT mariavittoriavettori safetyandefficacyofafeedadditiveconsistingoflasalocidasodiumandnicarbazinnilablend200gforchickensforfatteningzoetisbelgiumsa |