据了解,该添加剂是由米曲霉DSM 33700生产的。经过评估,专家小组认为在建议的使用条件下该添加剂对目标物种、消费者和环境是安全的。评估小组认为,?00?00 FXU/千克全价饲料的剂量下,该添加剂可能对所有家禽和所有猪有效。部分原文报道如下:
The additive RONOZYME
?WX (CT/L) co
ntains endo-1,4-beta-xylanase produced with a genetically modified strain of the filamentous fungus Aspergillus oryzae; the additive is currently authorised for poultry for fattening, weaned piglets, pigs for fattening, lactating sows and laying hens. The applicant has requested to change the production strain, substituting strain A. oryzae DSM 26372 with A. oryzae DSM 33700, and to extend the use of the additive to all poultry species and all Suidae. RONOZYME
?WX (CT/L), manufactured with the production strain A. oryzae DSM 33700, did not give rise to safety co
ncerns with regard to the genetic modification of the production strain. No viable cells of the production strain nor its DNA were detected in an intermediate product representative of both final formulations of the additive. RONOZYME
?WX (CT/L) was co
nsidered safe for all poultry species and all Suidae at the recommended inclusion levels. The use of RONOZYME
?WX CT and L manufactured with the production strain A. oryzae DSM 33700 raised no co
ncerns for consumers. RONOZYME
?WX L is not an eye irritant; however, no co
nclusions could be drawn on the potential of RONOZYME? WX CT to be an eye irritant. Both formulations are not irritant to the skin, but due to the lack of data, the FEEDAP Panel was not able to co
nclude on the potential of both formulations of the additive to be skin sensitisers. Due to the proteinaceous nature of the active substance, the additive is co
nsidered a respiratory sensitiser. The additive manufactured by A. oryzae DSM 33700 raises no safety co
ncerns for the environment. The additive has the potential to be efficacious in all poultry species and all Suidae at 100 and 200 FXU/kg complete feed, respectively.
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