Chemical name: Benzenamine, N-phenyl- Final regulatory action has been taken for the category: Pesticide Final regulatory action: The chemical is Banned Use or uses prohibited by the final regulatory action: All applications as a plant protection product. Pesticide use or uses that remain allowed: Not relevant The final regulatory action was based on a risk or hazard evaluation: Yes Summary of the final regulatory action: It is prohibited to place on the market or use plant protection products containing diphenylamine. Diphenylamine is not included in the list of approved active substances under Regulation (EC) No 1107/2009, which replaces Directive 91/414/EEC. As a consequence, diphenylamine is not approved for placing on the market pursuant to Regulation (EC) No 1107/2009 concerning the placing of plant protection products on the market. The reasons for the final regulatory action were relevant to: Human health Summary of known hazards and risks to human health: It was concluded that it was not demonstrated that it may be expected that, under the proposed conditions of use, plant protection products containing diphenylamine satisfy in general the requirements laid down in Article 5 (1) (a) and (b) of Directive 91/414/EEC. Based on the data provided it was not possible to perform a reliable consumer exposure assessment because information concerning residues in raw and processed apples was missing and because the presence of nitrosamines in apples could not be excluded. In particular, three metabolites could not be identified and thus their toxicological properties could not be assessed. Furthermore, the processing study submitted by the applicant was not representative of the standard hydrolytic conditions and did not allow to identify breakdown and reaction products including the three unknown metabolites. Finally, the additional evidence submitted on nitrosamines was inconclusive as the analytical method was not validated and had an insufficient resolution and a lack of selectivity. Expected effect of the final regulatory action in relation to human health: Reduction of risk from the use of plant protection products containing diphenylamine. Date of entry into force of the final regulatory action: 30/07/2012 Complete entry into force of all provisions of Regulation (EU) No 578/2012 of 29 June 2012 concerning the non-approval of the active substance diphenylamine, in accordance with Regulation (EC) No 1107/2009 was on 20 July 2012. |