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 Albert, Martelli Giovanna, Galobart Jaume, Holczknecht Orsolya, Manini Paola, Pettenati Elisa, Pizzo Fabiola, Tarrés-Call Jordi, Anguita Montserrat
EFSA J. 2020 Jul 30;18(7):e06205. doi: 10.2903/j.efsa.2020.6205. eCollection 2020 Jul.
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 of 3-phytase FLF1000/FSF10000 as a feed additive for pigs for fattening and minor porcine species for growing. This additive contains 3-phytase produced by a genetically modified strain of and it is authorised in its liquid FLF1000 and solid form FSF10000 as a feed additive for chickens for fattening, laying hens, chickens reared for laying and for minor poultry species for fattening or reared for laying or for breeding. The FEEDAP Panel has adopted an opinion regarding the use of this product as a feed additive in pigs for fattening and minor porcine species for growing. In that opinion, the FEEDAP Panel concluded that the use of the product as a feed additive would raise no concerns for the consumer safety nor for the environment but that the additive should be regarded as a potential respiratory sensitizer. The Panel also concluded that the additive has a potential to be efficacious in improving the phosphorus utilisation in the target species. However, the Panel could not conclude on the safety for the target species due to the limitations identified in the data provided. The applicant has now complemented the information and made it available to the Panel. The tolerance trial was done in weaned piglets in which the animals received up to 10 times the recommended dose of 1,000 FTU/kg feed. The results showed no adverse effects of the phytase on the performance of the animals or on the haematological and biochemical parameters measured in blood. Therefore, the Panel concluded that the additive (3-phytase FLF1000 and FSF10000) is safe for pigs for fattening and minor growing porcine species at the recommended dose of 1,000 FTU/kg feed.
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3-植酸酶FLF1000/FSF10000作为育肥猪和生长中小猪品种饲料添加剂的安全性发表科学意见。这种添加剂含有由基因改造的米曲霉菌株产生的3-植酸酶,其液体形式FLF1000和固体形式FSF10000被批准作为育肥鸡、产蛋母鸡、种鸡以及育肥或产蛋或育种的小型家禽品种的饲料添加剂。FEEDAP专家小组已就该产品作为育肥猪和生长中小猪品种饲料添加剂的使用发表了意见。在该意见中,FEEDAP专家小组得出结论,将该产品用作饲料添加剂不会对消费者安全或环境造成担忧,但该添加剂应被视为潜在的呼吸道致敏剂。专家小组还得出结论,该添加剂有可能有效提高目标物种对磷的利用率。然而,由于所提供数据中存在的局限性,专家小组无法就目标物种的安全性得出结论。申请人现已补充了信息并提供给专家小组。耐受性试验在断奶仔猪中进行,动物接受的剂量高达推荐剂量1000 FTU/kg饲料的10倍。结果表明,植酸酶对动物的性能或血液中测量的血液学和生化参数没有不良影响。因此,专家小组得出结论,添加剂(3-植酸酶FLF1000和FSF10000)在推荐剂量1000 FTU/kg饲料下对育肥猪和生长中小猪品种是安全的。