经过评估,专家小组认为在建议的使用条件下该添加剂对消费者和环境是安全的。部分原文报道如下:
Following a request from the European Commission, EFSA was asked to deliver a new scientific opinion on the coccidiostat halofuginone hydrobromide (STENOROL
?) when used as a feed additive for chickens for fattening and turkeys for fattening/reared for breeding. The Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) co
ncludes that the safety for turkeys for fattening established in its previous opinion can be extended to turkeys for breeding up to 12 weeks of age. ba
sed on the new data provided on the safety for consumer, enviro
nment and efficacy, the Panel updat
es its previous co
nclusions as follows: halofuginone hydrobromide is not genotoxic. Applying an uncertainty factor of 100 to the lowest no observed adverse effect level (NOAEL) of 0.03 mg/kg body weight (bw) per day, an acceptable daily intake (ADI) of 0.3 g halofuginone/kg bw is established. The chro
nic exposure of co
nsumers to residues of halofuginone would amount to 6C19% of the ADI after 3 days of withdrawal. Therefore, the Panel co
nsiders that the additive is safe for the co
nsumer of tissues obtained from chickens for fattening and turkeys for fattening fed the additive at a maximum level of 3 mg/kg complete feed at a 3-day withdrawal time. For co
ntrol purposes, the Panel recommends the setting of the following maximum residue limits (MRLs): liver, 50 g/kg; kidney, 40 g/kg; muscle, 3 g/kg; skin/fat, 10 g/kg wet tissue. ba
sed on an updated enviro
nmental risk assessment, no co
ncern for groundwater is expected. Halofuginone is unlikely to bioaccumulate and the risk of seco
ndary poiso
ning is not likely to occur. No safety co
ncerns are expected for terrestrial and aquatic environments. The additive has the potential to co
ntrol coccidiosis in chickens for fattening and turkeys for fattening/reared for breeding up to 12 weeks of age at a minimum level of 2 mg/kg complete feed.
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