Diuron was included in Annex I to Directive 91/414/EEC on 01 October 2008, which is after the entry into force of Regulation (EC) No 396/2005 on 02 September 2008. EFSA is therefore required to provide a reasoned opinion on the review of the existing MRLs for that active substance in compliance with Article 12( 1) of afore mentioned regulation. In order to collect the relevant pesticide residues data, EFSA asked Denmark as the designated rapporteur Member State (RMS), to complete the Pesticide Residues Overview File (PROFile). The requested information was submitted to EFSA on 11 November 2009 and, after having considered several comments made by EFSA, the RMS provided on 14 October 2010 a revised PROFile. Based on the conclusions derived by EFSA in the framework of Directive 91/414/EEC and the additional information provided by the RMS, EFSA issued on 10 March 2011 a draft reasoned opinion that was circulated to Member State experts for consultation. Comments received by 13 May 2011 were considered for finalisation of this reasoned opinion. The following conclusions are derived. The toxicological profile of diuron was evaluated in the framework of Directive 91/414/EEC, which resulted in an ADI of 0.007 mg/kg bw/d and an ARfD of 0.016 mg/kg bw/d. Primary crop metabolism of diuron was investigated following a soil application in oranges and following a soil application in wheat and maize at pre-emergency or post-emergency, hereby covering two different crop groups and two different application methods. Confined rotational crop study investigating the uptake of residues in lettuce, turnips and wheat were also reported. Metabolic patterns in the different studies were shown to be similar and the relevant residue could be defined as parent diuron for enforcement of the above reported crops and application methods. For risk assessment the relevant residue is defined as the sum of diuron and all its metabolites containing the 3,4-dichloraniline moiety, expressed as diuron. A validated analytical method for enforcement of this residue definition with a LOQ of 0.01 mg/kg in high water content, high fat content, acidic and dry commodities is also available. For all crops supported in the framework of this review, the number of residues trials was not compliant with the minimum data requirements defined by EU guidance documents. EFSA therefore derived tentative MRL proposals and risk assessment values, and further residues trials are required. As quantifiable residues of diuron are not expected in the reported crops, there is no need to investigate the effect of industrial and/or household processing. Specific processing factors for enforcement of processed commodities are therefore not proposed. Occurrence of diuron residues in rotational crops was investigated and it was concluded that metabolic patterns in primary and succeeding crops are similar. Nevertheless, investigation of residues in rotational crops is not required because the crops supported in the framework of this review are normally not grown in rotation. Based on the uses reported by the RMS, the dietary burden was calculated for each type of livestock. As all the calculated intakes represented less than 0.1 mg/kg DM and further investigation of residues is not necessary. Significant residues in commodities of animal origin are not expected and MRLs are not proposed. Both chronic and acute consumer exposure resulting from the MRLs proposed in the framework of this review were calculated, the highest chronic exposure represented 1.8 % of the ADI (German child) and the highest acute exposure amounted to 6.1 % of the ARfD (apple). Based on the above assessment, EFSA does not recommend inclusion of this active substance in Annex IV to Regulation (EC) No 396/2005. MRL recommendations were derived in compliance with the decision tree reported in Appendix D (see table below for a summary). MRL values listed in the table are not recommended for inclusion in Annex II because they require further consideration by risk managers (see table footnotes for details). In particular, certain existing EU MRLs still need to be confirmed by submission of at least one additional trial complying with the GAPs for each crop and for each growing area. In case residues are detected, more residues trials might be necessary. [GRAPHIC]
