Bampidis Vasileios, Azimonti Giovanna, Bastos Maria de Lourdes, Christensen Henrik, Dusemund Birgit, Kos Durjava Mojca, Kouba Maryline, López-Alonso Marta, López Puente Secundino, Marcon Francesca, Mayo Baltasar, Pechová Alena, Petkova Mariana, Ramos Fernando, Sanz Yolanda, Villa Roberto Edoardo, Woutersen Ruud, Cocconcelli Pier Sandro, Glandorf Boet, Herman Lieve, Prieto Maradona Miguel, Saarela Maria, Anguita Montserrat, Pettenati Elisa, Brozzi Rosella
EFSA J. 2020 May 8;18(5):e06084. doi: 10.2903/j.efsa.2020.6084. eCollection 2020 May.
Following a request from the European Commission, the EFSA 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 Biacton when used as a feed additive for weaned piglets. Biacton is a preparation of viable cells of CNCM I-3740 intended to be incorporated into feed for weaned piglets at a minimum recommended application level of 1 × 10 CFU/kg complete feed. is a species considered by EFSA to be suitable for the Qualified Presumption of Safety (QPS) approach to safety assessment which requires the identity of the strain to be conclusively established and evidence that it does not show acquired resistance to antibiotics of human and veterinary importance. The strain was found to meet the criteria for the QPS approach to safety assessment and since concerns are not expected from other components of the additive, the additive is presumed safe for all target species, consumers and the environment. Biacton is not irritant to skin, eyes or to the respiratory tract, but should be considered a prespiratory sensitiser. In the absence of data, no conclusions could be drawn on the potential skin sensitisation potential of the additive. No conclusion can be drawn on the efficacy of Biacton for weaned piglets based on the data available.
应欧盟委员会的要求，欧洲食品安全局动物饲料添加剂和产品或物质专家小组（FEEDAP）被要求就Biacton用作断奶仔猪饲料添加剂时的安全性和有效性发表科学意见。Biacton是一种含有CNCM I-3740活细胞的制剂，旨在以最低推荐应用水平1×10 CFU/kg全价饲料添加到断奶仔猪饲料中。该菌株被欧洲食品安全局认为适合采用安全评估的合格假定（QPS）方法，该方法要求最终确定菌株的身份，并证明其对人和兽医重要的抗生素没有获得性耐药性。该菌株被发现符合安全评估QPS方法的标准，并且由于预计该添加剂的其他成分不会引起担忧，因此假定该添加剂对所有目标物种、消费者和环境都是安全的。Biacton对皮肤、眼睛或呼吸道无刺激性，但应被视为呼吸道致敏剂。由于缺乏数据，无法就该添加剂的潜在皮肤致敏潜力得出结论。根据现有数据，无法就Biacton对断奶仔猪的有效性得出结论。
