据欧盟食品安全局(EFSA)消息,应欧盟委员会的要求,9月7日欧盟食品安全局发布了除虫脲(diflubenzuron)的农药风险同行评审结论。在此之前,瑞典对除虫脲作了农药风险同行评审,并递交了哺乳动物毒理学评估数据。
部分原文报道如下:
The conclusions of the European Food Safety Authority (EFSA) following the peer review of the initial risk assessment carried out by the competent authority of the rapporteur Member State Sweden, for the pesticide active substance diflubenzuron are reported. The context of the peer review was that requested by the European Commission following the submission and evaluation of confirmatory mammalian toxicology data. The conclusions were reached on the basis of the evaluation of the representative uses of diflubenzuron as an insecticide on apples, pears and mushrooms, and in forestry. The reliable endpoints concluded as being appropriate for use in regulatory risk assessment, derived from the available studies and literature in the dossier peer reviewed, are presented. Concerns are identified.
Diflubenzuron was included in Annex I to Directive 91/414/EEC on 1 January 2009 by Commission Directive 2008/69/EC (amended by Commission Directive 2010/39/EU), and has been deemed to be approved under Regulation (EC) No 1107/2009, in accordance with Commission Implementing Regulation (EU) No 540/2011, as amended by Commission Implementing Regulation (EU) No 541/2011. It was a specific provision of the approval that the notifier was required to submit to the European Commission further studies on the potential genotoxicity of the impurity and metabolite 4-chloroaniline (PCA) by 30 June 2011.
In accordance with the specific provision, the notifier, Chemtura Netherlands B.V, submitted an updated dossier in June 2011, which was evaluated by the designated RMS, Sweden, in the form of an Addendum to the Draft Assessment Report. In compliance with Guidance document SANCO 5634/2009 rev.3, the RMS distributed the Addendum to Member States and the EFSA for comments on 20 December 2011. The RMS collated all comments in the format of a Reporting Table, which was submitted to the European Commission in April 2012.
原文链接:<http://www.efsa.europa.eu/en/efsajournal/doc/2870.pdf>