1-Naphthylacetic acid is one of the 295 substances of the fourth stage of the review programme covered by Commission Regulation (EC) No 2229/20043, as amended by Commission Regulation (EC) No 1095/20074. In accordance with the Regulation, at the request of the Commission of the European Communities (hereafter referred to as 'the Commission'), the EFSA organised a peer review of the initial evaluation, i. e. the Draft Assessment Report (DAR), provided by France, being the designated rapporteur Member State (RMS). The peer review process was subsequently terminated following the applicants' decision, in accordance with Article 24e, to withdraw support for the inclusion of 1-naphthylacetic acid in Annex I to Council Directive 91/414/EEC. Following the Commission Decision of 8 December 2008 (2008/941/EC) 5 concerning the noninclusion of 1-naphthylacetic acid in Annex I to Council Directive 91/414/EEC and the withdrawal of authorisations for plant protection products containing that substance, the applicants Amvac Chemical UK Limited and the 1-NAA Task Force made a resubmission application for the inclusion of 1naphthylacetic acid in Annex I in accordance with the provisions laid down in Chapter III of Commission Regulation (EC) No. 33/20086. The resubmission dossier included further data in response to the issues identified in the DAR. In accordance with Article 18 of Commission Regulation (EC) No. 33/2008, France, 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 12 March 2010. In accordance with Article 19 of Commission Regulation (EC) No. 33/2008, the EFSA distributed the Additional Report to Member States and the applicants for comments on 17 March 2010. The EFSA collated and forwarded all comments received to the Commission on 30 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 area of mammalian toxicology and deliver its conclusions on 1-naphthylacetic acid. The conclusions laid down in this report were reached on the basis of the evaluation of the representative uses of 1-naphthylacetic acid as a plant growth regulator on apple as proposed by the applicants. Full details of the representative uses can be found in Appendix A to this report. Data gaps were identified in the section on identity, physical and chemical properties and analytical methods. The technical specification for the Amvac source should be considered provisional at the time of the finalisation of the peer review (January 2011). A data gap was identified in the mammalian toxicology section. The operator, worker and bystander risk assessment could be concluded. Data gaps were identified in the section on residues. Sufficient European residue trials analysed with a validated analytical method and a new freezer storage stability study are required. The consumer risk assessment is not finalised since residue data are not available to address the use pattern that is expected to result in the most critical residue values. No critical area of concern was identified. Data gaps were identified for further information on the route and rate of degradation in soil and for information on photolysis of 1-naphthylacetic acid in soil. The potential for groundwater contamination of 1-naphthylacetic acid above the parametric drinking water limit of 0.1 ae g/ L was assessed as low for the representative use of 'Amcotone', but high for the representative uses of 'Fruitone N' and 'Obsthormon 24A'. Three data gaps were identified in the ecotoxicology section. A reproduction test is needed to address the long-term risk to birds. The risk to aquatic organisms needs to be addressed for the formulations 'Amcotone' and 'Fruitone N'. The analytical profile of the batches used in the ecotoxicology tests should be provided for the Amvac source. No critical area of concern was identified in the ecotoxicology section.
