Normativa UEOct. 9, 2012
UE: autoridad alimentaria revisa límites máximos de residuos para rimsulfuron
According to Article 12 of Regulation (EC) No 396/2005, the European Food Safety Authority (EFSA) has reviewed the Maximum Residue Levels (MRLs) currently established at European level for the pesticide active substance rimsulfuron.
In order to assess the occurrence of rimsulfuron residues in plants, processed commodities, rotational crops and livestock, EFSA considered the conclusions derived in the framework of Directive 91/414/EEC as well as European authorisations reported by Member States (incl. the supporting residues data). Based on the assessment of the available data, MRL proposals were derived and a consumer risk assessment was carried out. No information required by the regulatory framework was found to be missing and no risk to consumers was identified.
© European Food Safety Authority, 2012
Rimsulfuron was included in Annex I to Directive 91/414/EEC on 01 February 2007, which is before 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(2) of afore mentioned regulation. In order to collect the relevant pesticide residues data, EFSA asked Germany, as the designated rapporteur Member State (RMS), to complete the Pesticide Residues Overview File (PROFile). The requested information was submitted to EFSA on 09 December 2008 and, after having considered several comments made by EFSA, the RMS provided on 27 October 2009 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 17 April 2012 a draft reasoned opinion that was circulated to Member State experts for consultation. Comments received by 22 June 2012 were considered in the finalisation of this reasoned opinion. The following conclusions are derived.
The toxicological profile of rimsulfuron was evaluated in the framework of Directive 91/414/EEC, which resulted in an ADI being established at 0.1 mg/kg bw per d. An ARfD was not deemed necessary.
Primary crops metabolism of rimsulfuron was investigated following early foliar application in tomatoes, potatoes and maize, hereby covering three different crop groups. Metabolic patterns in the different studies were shown to be similar and the relevant residue for enforcement and risk assessment in all plant commodities can be defined as rimsulfuron. A validated analytical method for enforcement of the residue definition is available with an LOQ of 0.01 mg/kg in dry commodities and in high water content commodities.
Regarding the magnitude of residues, a sufficient number of supervised residue trials is available for all the GAPs reported by the RMS, which allowed EFSA to estimate the expected residue concentrations in the relevant plant commodities and to derive appropriate MRLs and risk assessment values.
As residues of rimsulfuron are not expected in treated 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 rimsulfuron residues in rotational crops was already investigated during the peer review of rimsulfuron. It was concluded that metabolic patterns in primary and succeeding crops are similar and that significant residues in rotational crops are not expected. These conclusions also apply to the GAPs supported in the framework of this review.
Based on the uses reported by the RMS, no significant intakes were calculated for the different type of livestock. Consequently, it is concluded by EFSA that no residue definition and no MRL for products of animal origin are needed.
Chronic consumer exposure resulting from the authorised uses reported in the framework of this review was calculated using revision 2 of the EFSA PRIMo. The highest chronic exposure was calculated for WHO cluster diet B, representing 0.1 % of the ADI. Acute exposure calculations were not carried out because an ARfD was not deemed necessary for this active substance.
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 of the reasoned opinion (see summary table). All MRL values listed in the table are sufficiently supported by data and are therefore proposed for inclusion in Annex II to the Regulation.
Minor deficiencies were identified in the assessment but these deficiencies are not expected to impact either on the validity of the MRLs derived or on the national authorisations. The following data are therefore considered desirable but not essential:
residue trials carried out with analytical methods achieving an LOQ of 0.01 mg/kg