Normativa UEAgo. 7, 2012
UE: autoridad alimentaria revisa límites máximos de residuo para forchlorfenuron
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 forchlorfenuron. In order to assess the occurrence of forchlorfenuron residues in plants, processed commodities, rotational crops and livestock, EFSA considered the conclusions derived in the framework of Directive 91/414/EECas well as the 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
Forchlorfenuron was included in Annex I to Directive 91/414/EEC on 01 April 2006, 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 Spain, as the designated rapporteur Member State (RMS), to complete the Pesticide Residues Overview File (PROFile). The requested information was submitted to EFSA on 18 February 2009 and, after having considered several comments made by EFSA, the RMS provided on 28 October 2009 a revised PROFile.
Based on the conclusions derived in the framework of Directive 91/414/EEC and the additional information provided by the RMS, EFSA issued on 24 May 2012 a draft reasoned opinion that was circulated to Member State experts for consultation. No comments were received by 27 July 2012 and the following conclusions are derived.
The toxicological profile of forchlorfenuron was evaluated in the framework of Directive 91/414/EEC, which resulted in an ADI of 0.05 mg/kg bw per d and an ARfD of 1 mg/kg bw.
Primary crop metabolism of forchlorfenuron was investigated following local application in kiwi and grapes. Metabolic patterns in the different studies were shown to be similar and the relevant residue for enforcement and risk assessment in these crops could be defined as forchlorfenuron. Nevertheless, investigation of the pyridine moiety is still desirable to ensure that no cleavage of the parent compound occurs before its incorporation into the biopolymer fraction. Due to the application technique and the application timings of these studies, the need for further metabolism studies at Member State level or EU level will depend on the crops and the GAP proposed for those potential new uses. A validated analytical method for enforcement of the proposed residue definition is also available, with an LOQ of 0.01 mg/kg in acidic and high water content commodities.
Regarding the magnitude of residues in all crops reported by the RMS, 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.
As quantifiable residues of forchlorfenuron are not expected in kiwi and grapes, there is no need to investigate the effect of industrial and/or household processing. In addition, the chronic exposure does not exceed 10 % of the ADI.
All crops evaluated in the framework of this MRL review are not considered relevant with regard to the potential occurrence of residues in rotational crops. Further investigation of residues in rotational crops is therefore not required and relevant residues in these crops are not expected.
Forchlorfenuron is not authorised for use on crops that might be fed to livestock. Further investigation on the occurrence of residues in commodities of animal origin is not required and the setting of MRLs in these commodities is not considered necessary.
Chronic and acute consumer exposure resulting from the uses supported in the framework of this review was calculated using revision 2 of the EFSA PRIMo. The highest chronic exposure represented less than 0.1 % of the ADI (French population) and the highest acute exposure amounted to less than 0.1 % of the ARfD (kiwi).
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 (see summary table). All MRL values listed as ‘Recommended’ in the table are sufficiently supported by data and therefore proposed for inclusion in Annex II to the Regulation.
A minor deficiency was identified in the assessment but this deficiency is not expected to impact either on the validity of the ‘Recommended’ MRLs or on the national authorisations. The following action is therefore considered desirable but not essential:
• Investigation of the metabolism of pyridine moiety in primary crops.