Review of the existing maximum residue levels (MRLs) for diphenylamine according to Article 12 of Regulation (EC) No 396/2005

2011 EFSA Journal  
A decision not to include diphenylamine in Annex I to Directive 91/414/EEC entered into force on 21 December 2009. 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 Regulation (EC) No 396/2005. Considering that the use of diphenylamine is no longer authorised within the European Union and that no import tolerances were notified by designated rapporteur Member State Ireland, EFSA based its
more » ... ssment mainly on the conclusions derived by EFSA in the framework of Directive 91/414/EEC and the MRLs established by the Codex Alimentarius Commission. On 22 March 2011 EFSA issued a draft reasoned opinion that was circulated to Member State experts for consultation. Comments received by 27 May 2011 were considered for finalisation of this reasoned opinion. The following conclusions are derived. The toxicological profile of diphenylamine was evaluated in the framework of Directive 91/414/EEC, which resulted in an ADI of 0.075 mg/kg bw/d. This toxicological reference value was established for parent compound diphenylamine and an ARfD was not deemed necessary. Primary crop metabolism of diphenylamine was investigated following post harvest application on apple, hereby covering group of fruits and fruiting vegetables. Parent compound was always the major residue but identification of metabolites was considered insufficient by EFSA. In particular, the potential for presence or formation of nitrosamine in apple metabolism was not addressed. Consequently, the enforcement residue definition as derived by JMPR (parent compound) is considered appropriate by EFSA and validated analytical methods for enforcement of the proposed residue definition are available with a LOQ of 0.05 mg/kg. For risk assessment purposes, however, further investigation of the unidentified metabolites and the potential occurrence of nitrosamines in apples would be needed in order to confirm this residue definition at EU level. Moreover, no study investigating potential breakdown or reaction products of diphenylamine residues in processed commodities was provided. In particular, the formation of nitrosamines in processed commodities was not investigated while hydrolysis studies investigating the physical and chemical properties of the active substances indicate that, under certain pH conditions, nitrosamine compounds
doi:10.2903/j.efsa.2011.2336 fatcat:ysadvba6mrgmtf56kgd3siosna