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, Pettenati Elisa, Pizzo Fabiola, Tarrés-Call Jordi, Anguita Montserrat
EFSA J. 2020 Jan 16;18(1):e05979. doi: 10.2903/j.efsa.2020.5979. eCollection 2020 Jan.
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 for pigs for fattening. 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 three applications for its use in different species. The Panel concluded in those opinions 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 it should be considered as a respiratory sensitiser. The Panel considered that the new use in pigs for fattening would not modify the previously drawn conclusions with respect to the consumers, users and the environment. A tolerance trial in weaned piglets and a subchronic oral toxicity study were made available to support the safety for the new target species. From the results obtained, the Panel concluded that the additive is safe for pigs for fattening at the level of 1,000 U/kg feed. The applicant submitted three efficacy trials to support the efficacy of the additive. In two trials the apparent faecal digestibility of phosphorus and bone ash/phosphorus content were measured and in the third the effects on the performance of the animals were studied. The results of the studies submitted showed an improvement on the faecal digestibility of phosphorus in two trials, with no improvements on the bone mineralisation. Significant improvements on zootechnical parameters were found in the performance of pigs for fattening that were fed 1,000 U/kg feed in the long-term trial. Since significant effects in relevant parameters were found only in one trial the FEEDAP Panel could not conclude on the efficacy of the product in pigs for fattening.
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）作为育肥猪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的 菌株生产的6-植酸酶制剂，FEEDAP小组此前已在其用于不同物种的三项申请的背景下对其进行了评估。小组在这些意见中得出结论，生产菌株是安全的，并且将该添加剂用作饲料添加剂不会对消费者和环境造成安全问题。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。小组认为，在育肥猪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。提供了一项断奶仔猪耐受性试验和一项亚慢性口服毒性研究，以支持对新目标物种的安全性。根据获得的结果，小组得出结论，该添加剂在1,000 U/kg饲料水平下对育肥猪是安全的。申请人提交了三项功效试验以支持该添加剂的功效。在两项试验中测量了磷的表观粪便消化率和骨灰/磷含量，在第三项试验中研究了对动物性能的影响。提交的研究结果显示，在两项试验中磷的粪便消化率有所提高，但骨矿化没有改善。在长期试验中，饲喂1,000 U/kg饲料的育肥猪的生产性能参数有显著改善。由于仅在一项试验中发现了相关参数的显著影响，FEEDAP小组无法就该产品在育肥猪中的功效得出结论。
