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Safety and efficacy of 3‐phytase FSF10000 as a feed additive for chickens for fattening or reared for laying, laying hens and minor poultry species

机译:3-植酸酶FSF10000作为饲料添加剂或用于蛋鸡,蛋鸡和小家禽品种的饲料添加剂的安全性和有效性

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The additive 3‐phytase FSF10000 is a solid product that contains a 3‐phytase produced by a genetically modified strain of Komagataella phaffii. A liquid formulation of the additive has been previously assessed by the EFSA Panel on Additives and Products of Substances used in Animal Feed (FEEDAP) and is currently authorised as a feed additive for poultry species. The applicant requested for the use of this new formulation of the additive in chickens for fattening or reared for laying/breeding, laying hens and minor poultry species for fattening or reared for laying/breeding. Therefore, in this assessment, the new formulation of the product has been characterised and its safety and efficacy has been evaluated. The production strain and its DNA were not detected in the solid formulation. Therefore, the additive poses no concerns with regard to the genetic modification of the production strain. The Panel concluded, based on studies conducted with the liquid formulation, that the additive 3‐phytase FSF10000 is safe for the target species at 1,000 FTU/kg feed. Also, considering the production strain and composition of the final additive the Panel concluded that the additive raises no safety concerns for the consumer of products obtained from animals fed the additive or for the environment. The additive 3‐phytase FSF10000 is not irritant to skin and eyes but it is a skin dermal sensitiser and is considered to be a respiratory sensitiser. Based on studies conducted with the liquid formulation, the Panel concluded that the 3‐phytase FSF10000 has a potential to be efficacious in chickens for fattening or reared for laying and in minor poultry species for fattening or reared for laying/breeding at 500 FTU/kg feed and in laying hens at 1,000 FTU/kg feed.
机译:添加剂3-植酸酶FSF10000是一种固体产品,其中包含由Komagataella phaffii的基因改造菌株产生的3-植酸酶。 EFSA动物饲料中使用的添加剂和物质产品小组(FEEDAP)先前已经评估了添加剂的液体制剂,目前已被批准用作禽类的饲料添加剂。申请人要求使用这种新配方的添加剂在鸡中进行增肥或饲养/产蛋/育种,蛋鸡和小型家禽品种进行增肥或饲养/产蛋/育种。因此,在此评估中,已对产品的新配方进行了表征,并对其安全性和功效进行了评估。在固体制剂中未检测到生产菌株及其DNA。因此,该添加剂与生产菌株的遗传修饰无关。专家组基于对液体制剂的研究得出结论,以1,000 FTU / kg的饲料添加3植酸酶FSF10000对目标物种是安全的。此外,考虑到最终添加剂的生产应变和组成,小组得出结论认为,对于从添加剂中饲喂动物的动物或环境消费者而言,该添加剂不会引起消费者的安全问题。添加剂3-植酸酶FSF10000对皮肤和眼睛无刺激性,但它是皮肤致敏剂,被认为是呼吸道致敏剂。根据对液体制剂进行的研究,专家组得出结论:3-植酸酶FSF10000具有以500 FTU / kg的效率在鸡中进行育肥或饲养,在次要家禽品种中进行育肥或进行养殖/繁殖的功效饲料和蛋鸡1,000 FTU / kg饲料。

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