Bampidis Vasileios, Azimonti Giovanna, Bastos Maria de Lourdes, 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, Dierick Noël, Martelli Giovanna, Cocconcelli Pier Sandro, Glandorf Boet, Herman Lieve, Prieto Maradona Miguel, Saarela Maria, Anguita Montserrat, Brozzi Rosella
EFSA J. 2020 Jun 25;18(6):e06158. doi: 10.2903/j.efsa.2020.6158. eCollection 2020 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 safety and efficacy of TechnoSpore ( DSM 32016), when used as a zootechnical additive for piglets (suckling and weaned), other growing Suidae, chickens for fattening, other poultry for fattening and ornamental birds. The bacterial species present in the additive is considered suitable for the qualified presumption of safety approach to safety assessment. The identity of the active agent was established and the lack of toxigenic potential confirmed. DSM 32016 did not show resistance to antibiotics of human and veterinary importance, and therefore, was presumed safe for the target species, consumers of products derived from animals Fed the additive and the environment. Since the other components of the additive did not give rise to concerns, TechnoSpore was also considered safe for the target species, consumer and the environment. The additive is not a skin/eye irritant or a skin sensitiser but should be considered a respiratory sensitiser. TechnoSpore showed the potential to be efficacious as a zootechnical additive in weaned piglets and chickens for fattening at 1 × 10 CFU/kg complete feed. This conclusion was extended to suckling piglets and extrapolated to other growing Suidae at the same physiological stage and to other birds for fattening and ornamental birds at the same use level. DSM 32016 included in Technospore is compatible with halofuginone and diclazuril. The Panel could not conclude on the compatibility of the additive with monensin sodium, decoquinate, robenidine hydrochloride, lasalocid sodium, narasin, salinomycin sodium, maduramicin ammonium, nicarbazin and narasin/nicarbazin.
应欧盟委员会的要求，动物饲料添加剂及产品或物质专家小组（FEEDAP）被要求就TechnoSpore（DSM 32016）用作仔猪（哺乳和断奶）、其他生长阶段的猪科动物、育肥鸡、其他育肥家禽和观赏鸟的动物技术添加剂时的安全性和有效性发表科学意见。添加剂中存在的细菌种类被认为适用于安全性评估的合格假定方法。确定了活性剂的身份并确认了其无产毒潜力。DSM 32016对人和兽医领域重要的抗生素没有耐药性，因此，假定其对目标物种、食用添加该添加剂的动物产品的消费者以及环境是安全的。由于添加剂的其他成分没有引起担忧，TechnoSpore也被认为对目标物种、消费者和环境是安全的。该添加剂不是皮肤/眼睛刺激物或皮肤致敏剂，但应被视为呼吸道致敏剂。TechnoSpore在断奶仔猪和育肥鸡中以1×10 CFU/kg全价饲料用作动物技术添加剂时显示出有效潜力。这一结论扩展到哺乳仔猪，并外推至处于相同生理阶段的其他生长阶段的猪科动物以及处于相同使用水平的其他育肥鸟类和观赏鸟。TechnoSpore中包含的DSM 32016与常山酮和地克珠利相容。专家小组无法就该添加剂与莫能菌素钠、癸氧喹酯、盐酸氯苯胍、拉沙洛西钠、那拉菌素、盐霉素钠、马杜霉素铵、尼卡巴嗪以及那拉菌素/尼卡巴嗪的相容性得出结论。
