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编译服务: 食物与营养 编译者: 潘淑春 编译时间: Jun 12, 2016 浏 览 量: 6

Commission Implementing Regulation (EU) No 844/2012 (hereinafter referred to as ‘the Regulation’) lays down the procedure for the renewal of the approval of active substances submitted under Article 14 of Regulation (EC) No 1107/2009. The list of those substances is established in Commission Implementing Regulation (EU) No 686/2012. 4-(2,4-dichlorophenoxy)butyric acid (2,4-DB) is one of the active substances listed in Regulation (EU) No 686/2012.

In accordance with Article 1 of the Regulation, the rapporteur Member State (RMS), Belgium, and co-rapporteur Member State (co-RMS), Greece, received an application from Nufarm UK Limited for the renewal of approval of the active substance 2,4-DB. Complying with Article 8 of the Regulation, the RMS checked the completeness of the dossier and informed the applicant, the co-RMS (Greece), the European Commission and the European Food Safety Authority (EFSA) about the admissibility.

The RMS provided its initial evaluation of the dossier on 2,4-DB in the renewal assessment report (RAR), which was received by EFSA on 3 June 2015. In accordance with Article 12 of the Regulation, EFSA distributed the RAR to the Member States and the applicant, Nufarm UK Limited, for comments on 30 June 2015. EFSA also provided comments. In addition, EFSA conducted a public consultation on the RAR. EFSA collated and forwarded all comments received to the European Commission on 31 August 2015.

Following consideration of the comments received on the RAR, it was concluded that additional information should be requested from the applicant and that EFSA should conduct an expert consultation in the areas of mammalian toxicology, residues and ecotoxicology.

In accordance with Article 13(1) of the Regulation, EFSA should adopt a conclusion on whether 2,4-DB can be expected to meet the approval criteria provided for in Article 4 of Regulation (EC) No 1107/2009 of the European Parliament and of the Council.

The conclusions laid down in this report were reached on the basis of the evaluation of the representative uses of 2,4-DB as a herbicide on winter and spring barley, wheat and oats, and on legumes (lucerne and clover), as proposed by the applicant. Full details of the representative uses can be found in Appendix A of this report.

The use of 2,4-DB according to the representative uses proposed at the European Union (EU) level results in a sufficient herbicidal efficacy against the target weeds.

A data gap was identified for an appropriate search of the scientific peer-reviewed open literature on the active substance and its relevant metabolites, including submission of full papers of the publications retrieved.

There are no data gaps for the section identity, physical–chemical properties of 2,4-DB or the representative formulation; however, a data gap was identified for additional validation data for the method for body fluids.

Regarding the mammalian toxicology area, data gaps were identified for the identification of the analytical methods used in each toxicity studies, interspecies comparative in vitro metabolism including human material, phototoxicity and photomutagenicity under relevant ultraviolet B (UVB) wavelength (although it is acknowledged that there is no validated test method currently available for this range of wavelength), dermal absorption study with the representative formulation, and clarification of the genotoxic potential of 2,4-DCP and of its toxicological profile relevant to consumer exposure. No critical areas of concern were identified.

  
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