Propanil is one of the 84 substances of the third stage part B of the review programme covered by Commission Regulation (EC) No 1490/2002,(3) as amended by Commission Regulation (EC) No 1095/2007.(4) In accordance with Article 10(1) of the Regulation, Italy, being the designated rapporteur Member State (RMS), provided an initial evaluation of propanil in the format of a Draft Assessment Report (DAR), which was received by the EFSA on 28 November 2007. The Commission of the European Communities (hereafter referred to as, the Commission.) examined propanil in accordance with Article 11a of the Regulation and it was concluded that there were clear indications of harmful effects, leading to the adoption of a decision on non-inclusion in Annex I to Council Directive 91/414/EEC, in accordance with Articles 11f and 12 of the Regulation. Following the Commission Decision of 30 September 2008 (2008/769/EC)(5) concerning the non-inclusion of propanil in Annex I to Council Directive 91/414/EEC and the withdrawal of authorisations for plant protection products containing that substance, the applicant Propanil Data Development Consortium made a resubmission application for the inclusion of propanil in Annex I in accordance with the provisions laid down in Chapter III of Commission Regulation (EC) No. 33/2008.(6) The resubmission dossier included further data in response to the issues identified in the conclusions leading to the Decision on non-inclusion, as set out in the Review Report. In accordance with Article 18 of Commission Regulation (EC) No. 33/2008, Italy, being the designated RMS, submitted an evaluation of the additional data in the format of an Additional Report. The Additional Report was received by the EFSA on 26 February 2010. In accordance with Article 19 of Commission Regulation (EC) No. 33/2008, the EFSA distributed the Additional Report to Member States and the applicant for comments on 2 March 2010. The DAR was also distributed for comments. The EFSA collated and forwarded all comments received to the Commission on 20 April 2010. In accordance with Article 20, following consideration of the Additional Report, the comments received, and where necessary the DAR, the Commission requested the EFSA to conduct a focused peer review in the areas of mammalian toxicology, residues, fate and behaviour in the environment and ecotoxicology and deliver its conclusions on propanil. The conclusions laid down in this report were reached on the basis of the evaluation of the representative use of propanil as a herbicide on rice, 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 no critical areas of concern were identified. Data gaps were identified for one of the specifications, methods of analysis and formulation storage stability and physical properties. In the area of mammalian toxicology, two data gaps were identified: the determination of the toxicological relevance of one impurity, and information to allow the setting of reference values (ADI and ARfD) for the plant metabolite 3,4-DCA. Since the composition of the batches used in the toxicological studies was not demonstrated to cover the technical specification, this is considered as a critical area of concern. Based on the metabolism study conducted on rice the residue for monitoring and risk assessment was defined as "all compounds containing the 3,4-DCA moiety, free and conjugated". No MRL was proposed for rice, as the submitted trials were not performed according to the cGAP and a data gap was identified. A critical area of concern was identified in the residue section, as the consumer risk assessment could not be conducted. The data available on fate and behaviour in the environment are insufficient for the required environmental exposure assessments in line with the agreed EU MED-Rice (2003) guidance; therefore several data gaps were identified during the peer review. It could however be concluded that in situations represented by the scenarios in the EU MED-Rice guidance, the potential for groundwater exposure from the representative use by propanil or the metabolite 3,4-DCA above the parametric drinking water limit of 0.1 mu g/L is expected to be low. This conclusion however is based on only the limited data set available. Propanil has a potential for long-range transport through the atmosphere, therefore this was identified as a critical area of concern. Five data gaps were identified in ecotoxicology section, to further address the acute and long-term risk of propanil to birds, the long-term risk to mammals and the risk to non target-arthropods. The risk of metabolites DCNB, DCAB and TCAB to non-target species should be addressed. Acute risk to birds, long-term risk to birds, long-term risk to mammals, the risk to aquatic organisms and the risk to nontarget arthropods were identified as critical area of concerns in the ecotoxicology section.
