Bampidis Vasileios, Azimonti Giovanna, Bastos Maria de Lourdes, Christensen Henrik, Durjava Mojca, Dusemund Birgit, Kouba Maryline, López-Alonso Marta, López Puente Secundino, Marcon Francesca, Mayo Baltasar, Pechová Alena, Petkova Mariana, Ramos Fernando, Villa Roberto Edoardo, Woutersen Ruud, Glandorf Boet, Anguita Montserrat, Innocenti Matteo Lorenzo, Pettenati Elisa
EFSA J. 2024 May 15;22(5):e8797. doi: 10.2903/j.efsa.2024.8797. eCollection 2024 May.
Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety of the feed additive consisting of endo-1,4-β-xylanase (produced with CBS 143953), subtilisin (produced with CBS 143946) and α-amylase (produced with CBS 143954) (Avizyme® 1505) as a zootechnical feed additive for all poultry species. The additive is authorised in feed for chickens and turkeys for fattening, ducks and laying hens. In 2020, the FEEDAP Panel issued an opinion for the renewal of the authorisation of the additive for the species/categories for which there is an authorisation, a reduction of the minimum recommended level in turkeys for fattening and the extension of use to all poultry species. In that assessment, the Panel could not conclude on the safety of the additive due to uncertainties on the characterisation of the production strains and the possible presence of their viable cells and DNA in the final product. Moreover, limitations were identified in the xylanase specifications and xylanase method of analysis. The applicant submitted information to address the limitations previously identified. The Panel concluded that the additive is safe for the target species under the proposed conditions of use. The use of Avizyme® 1505 in animal nutrition is considered safe for the consumer and the environment. The additive is a mild irritant to skin and eyes; it is not a dermal sensitiser but should be considered a respiratory sensitiser. The additive is efficacious in ducks at 75 U endo-1,4-β-xylanase, 1000 U subtilisin and 100 U α-amylase/kg of complete feed. In other poultry species for fattening (including turkeys), reared for breeding and reared for laying, the additive is efficacious at 187.5 U endo-1,4-β-xylanase, 2500 U subtilisin and 250 U α-amylase per kg of complete feed and at 300 U endo-1,4-β-xylanase, 4000 U subtilisin and 400 U α-amylase per kg of complete feed for all poultry species for laying (except for ducks).
应欧盟委员会的要求,欧洲食品安全局(EFSA)被要求就一种饲料添加剂的安全性发表科学意见,该添加剂由内切-1,4-β-木聚糖酶(由CBS 143953生产)、枯草杆菌蛋白酶(由CBS 143946生产)和α-淀粉酶(由CBS 143954生产)组成(爱维生1505®),用作所有家禽品种的动物营养饲料添加剂。该添加剂已获批准用于育肥鸡、育肥火鸡、鸭和产蛋鸡的饲料中。2020年,饲料添加剂和动物营养产品专家委员会(FEEDAP Panel)发布了一份意见,内容涉及对该添加剂在已有批准的物种/类别中的授权续期、降低育肥火鸡的最低推荐水平以及将其使用范围扩大到所有家禽品种。在该评估中,由于生产菌株特性以及最终产品中可能存在其活细胞和DNA方面存在不确定性,专家委员会无法就该添加剂的安全性得出结论。此外,木聚糖酶规格和木聚糖酶分析方法也存在局限性。申请人提交了相关信息以解决先前发现的局限性。专家委员会得出结论,在所提议的使用条件下,该添加剂对目标物种是安全的。爱维生1505®在动物营养中的使用被认为对消费者和环境是安全的。该添加剂对皮肤和眼睛有轻度刺激性;它不是皮肤致敏剂,但应被视为呼吸道致敏剂。该添加剂在每千克全价饲料中含有75单位内切-1,4-β-木聚糖酶、1000单位枯草杆菌蛋白酶和100单位α-淀粉酶时对鸭有效。在其他育肥家禽品种(包括火鸡)、种用家禽和蛋用家禽中,该添加剂在每千克全价饲料中含有187.5单位内切-1,4-β-木聚糖酶、2500单位枯草杆菌蛋白酶和250单位α-淀粉酶时有效,而在所有蛋用家禽品种(鸭除外)中,每千克全价饲料中含有300单位内切-1,4-β-木聚糖酶、4000单位枯草杆菌蛋白酶和400单位α-淀粉酶时有效。