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, Galobart Jaume, Holczknecht Orsolya, Manini Paola, Pizzo Fabiola, Call Jordi Tarrés, Anguita Montserrat
EFSA J. 2019 Nov 7;17(11):e05893. doi: 10.2903/j.efsa.2019.5893. eCollection 2019 Nov.
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 APSA PHYTAFEED 20,000 GR/L (6-phytase) as a feed additive turkeys for fattening, turkeys reared for breeding and minor poultry species. The additive is a preparation of 6-phytase produced by a genetically modified strain of and has been previously assessed by the FEEDAP Panel in the context of an application for its use in feed for chickens for fattening. The Panel concluded in that opinion that the production strain is safe, and that the use of the additive as a feed additive would raise no safety concerns for the consumers and the environment. The additive was also considered not to be irritant to skin or eyes or a dermal sensitiser but that should be considered as a respiratory sensitiser. The Panel considered that the new use in turkeys would not modify the previously drawn conclusions with respect to the consumers, users and the environment. A tolerance trial and a subchronic oral toxicity study were made available to support the safety for the new target species. From the results obtained, the FEEDAP Panel concluded that APSA PHYTAFEED GR/L is safe for turkeys for fattening at the recommended level of 250 U/kg feed with a wide margin of safety. This conclusion was extended to turkeys reared for breeding. The applicant submitted three efficacy trials to support the efficacy of the additive. In these trials, the utilisation of phosphorus and bone ash/phosphorus content were measured. From the results obtained, the FEEDAP Panel concluded that APSA PHYTAFEED GR/L is efficacious for turkeys for fattening, turkeys reared for breeding and minor poultry at the level of 250 U/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APSA PHYTAFEED 20,000 GR/L（6-植酸酶）作为育肥火鸡、种用火鸡和小型家禽品种的饲料添加剂的安全性和有效性发表科学意见。该添加剂是由转基因菌株生产的6-植酸酶制剂，FEEDAP小组此前已在其用于育肥鸡饲料的申请中对其进行了评估。该小组在该意见中得出结论，生产菌株是安全的，并且将该添加剂用作饲料添加剂对消费者和环境不会引起安全问题。该添加剂也被认为对皮肤或眼睛无刺激性，不是皮肤致敏剂，但应被视为呼吸道致敏剂。该小组认为，在火鸡中的新用途不会改变先前就消费者、使用者和环境得出的结论。提供了一项耐受性试验和一项亚慢性口服毒性研究以支持新目标物种的安全性。根据获得的结果，FEEDAP小组得出结论，APSA PHYTAFEED GR/L在推荐水平250 U/kg饲料下对育肥火鸡是安全的，且安全裕度较大。该结论扩展到种用火鸡。申请人提交了三项功效试验以支持该添加剂的功效。在这些试验中，测量了磷的利用率和骨灰/磷含量。根据获得的结果，FEEDAP小组得出结论，APSA PHYTAFEED GR/L在250 U/kg饲料水平下对育肥火鸡、种用火鸡和小型家禽有效。
