Rychen Guido, Aquilina Gabriele, Azimonti Giovanna, Bampidis Vasileios, Bastos Maria de Lourdes, Bories Georges, Chesson Andrew, Cocconcelli Pier Sandro, Flachowsky Gerhard, Gropp Jürgen, Kolar Boris, Kouba Maryline, López-Alonso Marta, López Puente Secundino, Mantovani Alberto, Mayo Baltasar, Ramos Fernando, Saarela Maria, Villa Roberto Edoardo, Wallace Robert John, Wester Pieter, Brantom Paul, Dierick Noël, Anguita Montserrat
EFSA J. 2018 May 16;16(5):e05271. doi: 10.2903/j.efsa.2018.5271. eCollection 2018 May.
Amylofeed is a feed additive that contains glucanase, xylanase and amylase activities, and it is intended to be used as a zootechnical additive for weaned piglets and minor porcine species. In previous assessments, the additive was characterised and the safety for the target species, consumers and environment was established. Considering the safety for the user, the EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) concluded that the additive should be considered as a potential skin and eye irritant and a potential skin and respiratory sensitiser. Furthermore, the Panel concluded that the additive has a potential to be efficacious in the target species. However, the efficacy at the recommended enzyme activities could not be established. In order to overcome this limitation, the applicant proposed to modify the specifications of the additive whilst keeping the recommended level of addition of 500 mg additive/kg feed. The Panel evaluated the new specifications and their impact on the relevant aspects of the safety and efficacy of the additive. The newly proposed specifications of the additive were supported by analytical data. The Panel considered that the modification proposed by the applicant on the specifications would not have an impact on the safety aspects related to the consumer, user and environment. Therefore, the conclusions previously drawn would still apply. Moreover, it was considered that the tolerance trial previously evaluated would still support the safety for the target species. The addition of the additive with the new specifications would result in higher enzyme activities than those that were found in the efficacy studies that supported the efficacy of the product. Therefore, the additive has the potential to be efficacious at the newly proposed level of enzyme activities.
淀粉消化酶是一种含有葡聚糖酶、木聚糖酶和淀粉酶活性的饲料添加剂，拟用作断奶仔猪和小型猪种的畜牧学添加剂。在之前的评估中，对该添加剂进行了特性描述，并确定了其对目标物种、消费者和环境的安全性。考虑到对使用者的安全性，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）得出结论，该添加剂应被视为潜在的皮肤和眼睛刺激物以及潜在的皮肤和呼吸道致敏剂。此外，专家小组得出结论，该添加剂在目标物种中具有潜在的有效性。然而，无法确定推荐酶活性下的有效性。为克服这一限制，申请人提议修改添加剂的规格，同时保持500毫克添加剂/千克饲料的推荐添加水平。专家小组评估了新规格及其对添加剂安全性和有效性相关方面的影响。添加剂新提议的规格得到了分析数据的支持。专家小组认为，申请人对规格提出的修改不会对与消费者、使用者和环境相关的安全方面产生影响。因此，先前得出的结论仍然适用。此外，认为先前评估的耐受性试验仍将支持对目标物种的安全性。添加新规格的添加剂将导致酶活性高于支持该产品有效性的功效研究中发现的酶活性。因此，该添加剂在新提议的酶活性水平上具有有效的潜力。
