Commission Regulation (EU) No 1141/2010 (hereinafter referred to as ’the Regulation’), as amended by Commission Implementing Regulation (EU) No 380/2013, lays down the procedure for the renewal of the approval of a second group of active substances and establishes the list of those substances.
2,4-D is one of the active substances listed in the Regulation. The Rapporteur Member State provided its initial evaluation of the dossier on 2,4-D in the Renewal Assessment Report (RAR), which was received by the EFSA on 4 March 2013. The peer review was initiated on 18 March 2013 by dispatching the RAR for consultation of the Member States and the applicant the European Union
2,4-D Task Force 2012.
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 and ecotoxicology, and EFSA should adopt a conclusion on whether 2,4-D can be expected to meet the conditions 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-D as a herbicide on cereals and maize, as proposed by the applicant. Full details of the representative uses can be found in Appendix A to this report.
In the area of identity, physical/chemical/technical properties and methods of analysis data gaps were identified for revised specifications for Nufarm and Makhteshim-Agan Agro Poland S.A., further validation of the analytical methods for plants and animals, and further information/data on the surface tension of the active substance.
Data gaps were identified in the mammalian toxicology area for the impurity profile of the batches used in the recently submitted studies (this also triggered a critical area of concern for the compliance of the batches tested with the current specifications), and to address the relevance of the individual impurities in comparison with the toxicity profile of the parent compound. The interim provisions of Annex II, Point 3.6.5 of Regulation (EC) No 1107/2009 concerning human health for the consideration of endocrine disrupting properties are not met. However, considering the uncertainties regarding the potential endocrine disruption potential of 2,4-D, the complete study results from the extended one-generation toxicity study and a steroidogenesis assay should be submitted, noting that further toxicological and ecotoxicological tests might be necessary (issue not finalised).
Based on the available information, the residue definition for monitoring and risk assessment was proposed as "sum of 2,4-D, its salts, esters and conjugates, expressed as 2,4-D" for plant and animal products. MRLs were proposed for some cereal commodities and for ruminant products. Based on the available data, no chronic or acute concerns were identified for the consumers.
In the area of environmental fate and behaviour, data gaps have been identified to investigate the degradation of 2,4-D in acidic soils (pH < 6) and for field dissipation studies under conditions representative of European agricultural scenarios. In addition, the aquatic exposure and risk assessment for the photolysis metabolite 1,2,4-benzenetriol could not be finalised. Furthermore, the risk by the anaerobic metabolite 4-CP to the different environmental compartments would need to be addressed for those situations where anaerobic conditions are expected to occur.
In the area of ecotoxicology, data gaps have been identified to further assess the acute and long-term dietary risk to small herbivorous mammals for the representative use in maize, as well as the risk to aquatic organisms for situations represented by the relevant FOCUS surface water scenarios considering each of the representative uses (this has also been identified as a critical area of concern). Data gaps were also identified for the impurity profile of the batches used in the recently submitted studies (this also triggered a critical area of concern for the compliance of the batches tested with the current specifications) as well as the impurity profile of some of the studies submitted for the original approval, and to address the relevance of the individual impurities in comparison with the toxicity profile of the parent compound.