Bampidis Vasileios, Azimonti Giovanna, de Lourdes Bastos Maria, 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, Anguita Montserrat
EFSA J. 2019 Jun 18;17(6):e05730. doi: 10.2903/j.efsa.2019.5730. eCollection 2019 Jun.
The product FRA Octazyme C Dry contains eight enzymes and is intended to be used as a zootechnical additive for chickens for fattening and weaned piglets. In a previous opinion of the EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP), the additive was characterised in full, including the production strains of the enzymes, the safety and the efficacy of the product. In that assessment, the FEEDAP Panel concluded that the additive was safe for the consumers of food products obtained from animals fed with the additive and that the additive would pose no risks to the environment. Regarding the safety for the users, the Panel could not conclude on the potential of the additive to be irritant to the skin and eyes or on its skin sensitising properties, but the additive should be considered a potential respiratory sensitiser. In the trials submitted to support the safety for the target species and the efficacy of the additive, the analytical results of the enzyme activities did not confirm the intended enzyme activities and therefore the FEEDAP Panel could not draw conclusions on the tolerance and the efficacy of the additive. In the current application, the applicant has provided new analysis of the feeds used in the tolerance and efficacy trials. The data have been obtained using a modified extraction procedure which has demonstrated to permit a higher recovery of the enzyme activity in supplemented and non-supplemented feeds. However, the enzyme activities obtained in the experimental diets using the new analytical method showed increases but also decreases of the enzyme activity compared to the previously submitted data. Therefore, the change in the enzyme activities could not be ascribed to the analytical method only. The Panel concluded that the new data cannot be considered as those reflecting the actual supplementation levels of the additive in the diets and therefore could not conclude on the safety and efficacy of the target species.
产品FRA Octazyme C Dry含有八种酶，旨在用作育肥鸡和断奶仔猪的动物技术添加剂。在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）先前的一份意见中，对该添加剂进行了全面的特性描述，包括酶的生产菌株、产品的安全性和功效。在该评估中，FEEDAP小组得出结论，该添加剂对食用添加了该添加剂的动物所产食品的消费者是安全的，并且该添加剂不会对环境造成风险。关于对使用者的安全性，该小组无法就该添加剂对皮肤和眼睛的刺激性潜力或其皮肤致敏特性得出结论，但该添加剂应被视为潜在的呼吸道致敏剂。在提交的支持目标物种安全性和添加剂功效的试验中，酶活性的分析结果未证实预期的酶活性，因此FEEDAP小组无法就该添加剂的耐受性和功效得出结论。在当前的申请中，申请人提供了耐受性和功效试验中所用饲料的新分析。这些数据是使用改良的提取程序获得的，该程序已证明能够在添加和未添加添加剂的饲料中实现更高的酶活性回收率。然而，与先前提交的数据相比，使用新分析方法在实验日粮中获得的酶活性显示出增加但也有减少。因此，酶活性的变化不能仅归因于分析方法。该小组得出结论，新数据不能被视为反映日粮中添加剂实际添加水平的数据，因此无法就目标物种的安全性和功效得出结论。
