Open AccessSafety and efficacy of Robenz ® 66G (robenidine hydrochloride) for chickens for fattening and turkeys for fattening
Author(s) -
Bampidis Vasileios,
Azimonti Giovanna,
Bastos Maria de Lourdes,
Christensen Henrik,
Dusemund Birgit,
Kouba Maryline,
Kos Durjava Mojca,
LópezAlonso Marta,
López Puente Secundino,
Marcon Francesca,
Mayo Baltasar,
Pechová Alena,
Petkova Mariana,
Ramos Fernando,
Sanz Yolanda,
Villa Roberto Edoardo,
Woutersen Ruud,
Aquilina Gabriele,
Bories Georges,
Brantom Paul,
Cocconcelli Pier Sandro,
Halle Ingrid,
Kolar Boris,
Wester Pieter,
van Beelen Patrick,
Holczknecht Orsolya,
Vettori Maria Vittoria,
Gropp Jürgen
Publication year - 2019
Publication title -
efsa journal
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.076
H-Index - 97
ISSN - 1831-4732
DOI - 10.2903/j.efsa.2019.5613
Subject(s) - animal feed , feed additive , veterinary medicine , food science , zoology , chemistry , biology , medicine , broiler
Following a request from European Commission, the Panel on Additives and Products or Substances used in Animal Feed ( FEEDAP ) was asked to deliver a scientific opinion on the safety and efficacy of Robenz ® 66G (robenidine hydrochloride ( HC l)) when used as a feed additive for chickens for fattening and turkeys for fattening. The coccidiostat Robenz ® 66G is considered safe for chickens for fattening at the highest proposed level of 36 mg robenidine HC l/kg complete feed with a margin of safety of approximately 2.5. This conclusion is extrapolated to turkeys for fattening. Robenidine HC l is active against Gram‐positive but not against Gram‐negative bacteria. It is not expected that the use of robenidine HC l as a feed additive would induce resistance or cross‐resistance to antimicrobials used in human and animal therapy. The use of robenidine HC l from Robenz ® 66G at the highest proposed level of 36 mg/kg complete feed in chickens and turkeys for fattening is considered safe for the consumer. The existing maximum residues limits for both avian species are confirmed. Robenidine HC l is not a skin or eye irritant and not a skin sensitiser. The risk via inhalation is considered negligible. The use of robenidine HC l from Robenz ® in feed for chickens for fattening and turkeys for fattening up to 36 mg/kg complete feed does not pose a risk to either the terrestrial or the aquatic compartment. A risk for bioaccumulation cannot be excluded. The risk for secondary poisoning is not likely to occur. The FEEDAP Panel concludes that 36 mg robenidine HC l/kg complete feed from Robenz ® 66G has the potential to effectively control coccidiosis of chickens for fattening under field conditions but cannot conclude on the efficacy of robenidine HC l in turkeys for fattening. The existing 5‐day withdrawal period to avoid off‐flavours in edible tissues should be maintained.