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 Albert, Anguita Montserrat
EFSA J. 2017 Jun 19;15(6):e04856. doi: 10.2903/j.efsa.2017.4856. eCollection 2017 Jun.
Amylofeed is a preparation of endo-1,3(4)-β-glucanase, endo-1,4-β-xylanase and α-amylase aimed to be used as a feed additive for piglets and young minor porcine species. In a previous assessment, the safety of the additive for the target species, user and environment were established. However, the safety for the consumer and the efficacy of the product could not be established. In that previous assessment, the limitations on the description of the manufacturing process, the characterisation of the additive and on the toxicological studies provided did not allow the Panel to conclude on the safety for the consumer. The applicant has now provided new data/information to assess the safety for the consumer and also new studies in order to support the efficacy of the additive in the target species. The enzymes present in the product are obtained from two different strains and from two different fermentation processes. In the current assessment, the applicant provided complete and detailed information regarding the manufacturing process of the additive, including details on the composition of the intermediate products. New genotoxicity studies were submitted by the applicant and the results showed no genotoxic potential of the test items. The Panel considered that the conclusions drawn in the subchronic oral toxicity study performed and previously submitted were valid for the current assessment; the results showed no evidence for adverse effects. Consequently, the Panel concluded that the additive is safe for the consumers when used as a feed additive. For the evaluation of the efficacy of the additive, the Panel considered four long-term trials done in weaned piglets. Based on these data, the Panel concluded that the additive has a potential to be efficacious in weaned piglets at the nominal dose of 500 mg/kg feed and extrapolated this conclusion to growing minor porcine species.
淀粉消化酶是一种包含内切-1,3(4)-β-葡聚糖酶、内切-1,4-β-木聚糖酶和α-淀粉酶的制剂，旨在用作仔猪和幼年小型猪的饲料添加剂。在先前的评估中，已确定该添加剂对目标物种、使用者和环境的安全性。然而，无法确定其对消费者的安全性以及产品的功效。在先前的评估中，由于制造工艺描述、添加剂特性以及所提供的毒理学研究存在局限性，专家小组无法就其对消费者的安全性得出结论。申请人现已提供新的数据/信息以评估其对消费者的安全性，还提供了新的研究以支持该添加剂在目标物种中的功效。产品中存在的酶是通过两种不同的菌株和两种不同的发酵工艺获得的。在本次评估中，申请人提供了关于该添加剂制造工艺的完整详细信息，包括中间产品成分的细节。申请人提交了新的遗传毒性研究，结果表明测试项目无遗传毒性潜力。专家小组认为，先前进行并提交的亚慢性口服毒性研究得出的结论对本次评估有效；结果未显示出不良反应的证据。因此，专家小组得出结论，该添加剂用作饲料添加剂时对消费者是安全的。为评估该添加剂的功效，专家小组考虑了在断奶仔猪中进行的四项长期试验。基于这些数据，专家小组得出结论，该添加剂在500毫克/千克饲料的标称剂量下对断奶仔猪有潜在功效，并将这一结论外推至生长中的小型猪物种。
