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. Pendimethalin 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), the Netherlands and co-rapporteur Member State (co-RMS), Spain, received an application from ADAMA Agriculture B.V.and BASF SE for the renewal of approval of the active substance pendimethalin. Complying with Article 8 of the Regulation, the RMS checked the completeness of the dossier and informed the applicants, the co-RMS (Spain), the European Commission and the European Food Safety Authority (EFSA) about the admissibility.
The RMS provided its initial evaluation of the dossier on pendimethalin in the renewal assessment report (RAR), which was received by EFSA on 4 February 2015. In accordance with Article 12 of the Regulation, EFSA distributed the RAR to the Member States and the applicants, ADAMA Agriculture B.V. and BASF SE, for comments on 2 March 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 5 May 2015.
Following consideration of the comments received on the RAR, it was concluded that additional information should be requested from the applicants and that EFSA should conduct an expert consultation in the areas of mammalian toxicology, residues, environmental fate and behaviour and ecotoxicology.
In accordance with Article 13(1) of the Regulation, EFSA should adopt a conclusion on whether pendimethalin 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 pendimethalin as a herbicide on cereals, pulse and carrots, as proposed by the applicants. Full details of the representative uses can be found in Appendix A of this report.
Sufficient evidence of the efficacy of the formulations was provided.
In the area of identity, physical/chemical/technical properties and methods of analysis the proposed specifications were not accepted. Spectra for the relevant impurities are missing. For the formulation ‘Pendimethalin 400 SC’ a method of analysis for the relevant impurity 1,2-dichloroethane was not available. A method of analysis for body fluids and tissues was not available. A data gap was also identified for the validation of the pre-registration methods supporting the studies in the areas of mammalian toxicology, environmental fate and behaviour and ecotoxicology.
Regarding the mammalian toxicology area, a data gap was identified for the toxicological relevance of individual impurities present in the technical specification in comparison with the toxicological profile of the parent pendimethalin for both applicants (except for the impurities already identified as relevant). Considering that the technical specifications by either applicants were not accepted in the area of identity, physical/chemical/technical properties (Section 1), mainly because toxicologically relevant nitrosamines were not identified separately, it could not be established whether the batches used in the toxicological studies support the respective technical specifications and a critical area of concern was identified.
In the area of residues, data gaps were identified for one residue trial on carrot covering respectively the northern and southern zones of Europe and for additional storage stability data in high water content commodities. The consumer risk assessment from consumption of drinking water could not be finalised whilst the nature of residues in drinking water following water treatment had not been addressed.
Sufficient information is available to derive reliable end points to perform the environmental exposure assessment. FOCUS PEC GW for the uses in carrots need to be recalculated using final agreed input parameters to address the potential for groundwater exposure by the toxicologically relevant groundwater metabolite M455H001, above the parametric drinking water limit of 0.1 µg/L. Information to demonstrate that potential residues in water of substances resulting from the residues of pendimethalin and its metabolites after water treatment procedures will not have immediate or delayed harmful effects on human health is still needed.
In the section of ecotoxicology data gaps for refining the risk were identified for birds, wild mammals, and aquatic organisms. A critical area of concern was identified for aquatic organisms. Further data gaps were identified for refining the chronic risk posed by pendimethalin to honeybees, for effects on the hypopharyngeal gland (HPG), and for assessing the risk to honeybees due to exposure to metabolites in pollen and nectar. A data gap was also identified for a reliable bioaccumulation factor (BCF) value for warm water fish species and for the bioaccumulation assessment for metabolites. An additional data gap was identified as some studies from the systematic literature search were not made available to the RMS, despite a specific data requirement was set during the peer-review process. Since the technical specifications by either applicants were not accepted, mainly because toxicologically relevant nitrosamines and nitroso-pendimethalin were not addressed (see Section 1 and 2), it could not be established whether the batches used in the ecotoxicological studies support the respective technical specifications and a critical area of concern was identified.
From the available evidences it could not be excluded that pendimethalin might be considered a persistent (P) bioaccumulative (B) and toxic (T) or PBT substance. However, the assessment could not be finalised.