Bampidis Vasileios, Azimonti Giovanna, de Lourdes Bastos Maria, Christensen Henrik, Dusemund Birgit, Kouba Maryline, Kos Durjava Mojca, López-Alonso Marta, López Puente Secundino, Marcon Francesca, Mayo Baltasar, Pechová Alena, Petkova Mariana, Ramos Fernando, Sanz Yolanda, Villa Roberto Edoardo, Woutersen Ruud, Brozzi Rosella, Galobart Jaume, Innocenti Matteo, López-Gálvez Gloria, Sofianidis Konstantinos, Vettori Maria Vittoria, Gregoretti Lucilla
EFSA J. 2019 Jun 14;17(6):e05726. doi: 10.2903/j.efsa.2019.5726. eCollection 2019 Jun.
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 modification of the terms of the authorisation of BioPlus 2B ( DSM 5749 and DSM 5750) in feeds for turkeys for fattening to allow the simultaneous use with a battery of permitted coccidiostats (diclazuril, halofuginone, monensin sodium, robenidine hydrochloride, maduramicin ammonium, lasalocid sodium) and with the preservative formic acid. The proposed modification in the conditions of the authorisation would not modify the conclusions previously drawn regarding the safety of the additive. The additive is safe for the target species, consumers and the environment. The additive should be considered a potential respiratory sensitiser, but the Panel could not conclude on the irritancy of the additive to skin and eyes or its dermal sensitisation. Conclusions previously drawn by the FEEDAP Panel on the compatibility of the additive for chickens for fattening apply to the current application provided that the maximum authorised concentration of the coccidiostats semduramycin, maduramicin ammonium, lasalocid sodium and the preservative formic acid for turkeys for fattening (when maximum authorised concentrations exist), are equal or lower than those for chickens for fattening. Considering the data submitted, the FEEDAP Panel concludes that BioPlus 2B (. DSM 5749 and . DSM 5750) is compatible with diclazuril and monensin sodium. Based on the data provided, no conclusion can be drawn for robenidine hydrochloride. In the absence of data, no conclusion can be drawn for halofuginone.
应欧盟委员会要求，动物饲料添加剂及产品或物质专家委员会（FEEDAP）被要求就肉鸡饲料中BioPlus 2B（DSM 5749和DSM 5750）授权条款的修改提供科学意见，以允许其与一系列许可的抗球虫药（地克珠利、常山酮、莫能菌素钠、盐酸氯苯胍、马杜霉素铵、拉沙洛西钠）以及防腐剂甲酸同时使用。授权条件的拟议修改不会改变先前就该添加剂安全性得出的结论。该添加剂对目标物种、消费者和环境是安全的。该添加剂应被视为潜在的呼吸道致敏原，但专家委员会无法就该添加剂对皮肤和眼睛的刺激性或其皮肤致敏性得出结论。FEEDAP专家委员会先前就育肥鸡添加剂兼容性得出的结论适用于本申请，前提是育肥火鸡的抗球虫药塞杜霉素、马杜霉素铵、拉沙洛西钠以及防腐剂甲酸的最大授权浓度（若有最大授权浓度）等于或低于育肥鸡的最大授权浓度。考虑到提交的数据，FEEDAP专家委员会得出结论，BioPlus 2B（DSM 5749和DSM 5750）与地克珠利和莫能菌素钠兼容。基于所提供的数据，无法就盐酸氯苯胍得出结论。由于缺乏数据，无法就常山酮得出结论。
