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. 2018 Mar 28;16(3):e05217. doi: 10.2903/j.efsa.2018.5217. eCollection 2018 Mar.
ECONASE XT is an enzyme preparation with endo-1,4-β-xylanase which is authorised as a feed additive for chickens for fattening or reared for laying, turkeys for fattening or reared for breeding, laying hens, weaned piglets, pigs for fattening and minor poultry species. The authorisation of the additive for pigs for fattening is at 24,000 BXU/kg feed. The applicant asked for a modification on the conditions of use in pigs for fattening, which consists in the reduction of the minimum recommended level from 24,000 BXU/kg feed to 16,000 BXU/kg feed. In previous opinions, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) assessed the safety of the product when used as a feed additive and concluded that the use of the product raises no concerns for consumer safety and no risks for the environment are expected. The Panel also concluded that the additive is non-irritant to the skin, and the liquid form is non-irritant to the eyes and is not a dermal sensitiser; however, it is considered a respiratory sensitiser. Regarding the use of the additive in pigs for fattening, the Panel concluded that under the conditions of use, the additive is safe for pigs for fattening and that it can be efficacious at 24,000 BXU/kg. In the current application, the applicant provided three efficacy trials to support the efficacy at 16,000 BXU/kg feed. Two of these studies had been previously evaluated by the FEEDAP Panel and supported the efficacy at 16,000 BXU/kg feed. The third study revealed a significant effect of the additive on the feed to gain ratio in pigs for fattening at 20,000 BXU/kg feed (analysed content). The FEEDAP Panel concluded that the additive has a potential to be efficacious in pigs for fattening as a zootechnical additive at the dose of 20,000 BXU/kg feed.
ECONASE XT是一种含有内切-1,4-β-木聚糖酶的酶制剂,被批准用作育肥鸡、产蛋鸡、育肥火鸡、种用火鸡、蛋鸡、断奶仔猪、育肥猪及小型家禽的饲料添加剂。该添加剂在育肥猪饲料中的批准用量为24,000 BXU/kg。申请人请求修改育肥猪的使用条件,即将最低推荐用量从24,000 BXU/kg饲料降至16,000 BXU/kg饲料。在之前的意见中,动物饲料添加剂和产品或物质专家委员会(FEEDAP)评估了该产品作为饲料添加剂使用时的安全性,得出该产品的使用不会对消费者安全造成担忧且预计对环境无风险的结论。专家委员会还得出该添加剂对皮肤无刺激性,其液体形式对眼睛无刺激性且不是皮肤致敏剂的结论;然而,它被认为是一种呼吸道致敏剂。关于该添加剂在育肥猪中的使用,专家委员会得出在使用条件下,该添加剂对育肥猪安全且在24,000 BXU/kg时可能有效的结论。在本次申请中,申请人提供了三项功效试验来支持16,000 BXU/kg饲料用量时的功效。其中两项研究此前已由FEEDAP专家委员会评估,并支持16,000 BXU/kg饲料用量时的功效。第三项研究表明,该添加剂在20,000 BXU/kg饲料(分析含量)时对育肥猪的料重比有显著影响。FEEDAP专家委员会得出该添加剂在20,000 BXU/kg饲料用量时作为动物营养添加剂在育肥猪中可能有效的结论。