Normativa UEFeb. 6, 2014
UE: autoridad alimentaria revisa límites máximos de residuo para dichlorprop-P
Dichlorprop-P was included in Annex I to Directive 91/414/EEC on 01 June 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 the aforementioned regulation. In order to collect the relevant pesticide residues data, EFSA asked Denmark, as the designated rapporteur Member State (RMS), to complete the Pesticide Residues Overview File (PROFile). The requested information was submitted to EFSA on 21 April 2009 and, after having considered several comments made by EFSA, the RMS provided on 02 November 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 10 June 2011 a draft reasoned opinion that was circulated to Member State experts for consultation. Comments received by 19 August 2011 and the confirmatory data required in the framework of Directive 91/414/EEC (evaluation process finalised in October 2013) were considered in the finalisation of this reasoned opinion. The following conclusions are derived.
The toxicological profile of dichlorprop-P was evaluated in the framework of Directive 91/414/EEC, which resulted in an ADI and an ARfD being established at 0.06 mg/kg bw per d and 0.5 mg/kg bw, respectively. Both toxicological reference values were established for dichlorprop-P but they can also apply to dichlorprop which was demonstrated to have the same toxicity as dichlorprop-P.
Primary crop metabolism was investigated following foliar application on wheat and oranges, hereby covering the crop groups of fruits and cereals. The relevant residue for enforcement and risk assessment in these 2 crop groups is defined as the sum of dichlorprop (including dichlorprop-P) its salts, esters and conjugates, expressed as dichlorprop. Dichlorprop-P is also authorised for use as soil treatment in several orchards trees which would normally require an additional representative metabolism study with fruits and fruiting vegetables treated via soil application. As the DT90 values of dichlorprop-P and its soil metabolite 2,4-DCP are below the trigger value of 100 days, and as the treatment in orchard tree is performed prior to flowering, no significant residues are expected in harvested fruits. Hence EFSA proposes that the residue definition derived for foliar treatments also applies to orchard trees following soil application. Validated analytical methods for enforcement of this residue definition are available with an LOQ of 0.02 mg/kg in dry, acidic, high oil content and high water content commodities.
Regarding the magnitude of residues in all crops reported by the RMS, a sufficient number of supervised residues trials is available, which allowed EFSA to estimate the expected residue concentrations in all crops under consideration and to derive appropriate MRLs.
The effects of processing on the nature of dichlorprop-P residues have not been investigated during the peer review of the active substance and no new studies have been submitted. Nevertheless, such studies are not required as the overall chronic exposure represents less than 10 % of the ADI. Although not required, studies investigating the effect of processing on the magnitude of dichlorprop‑P residues in the processed fractions of oranges were submitted in the framework of a previous MRL application. However, as the nature of residues in processed commodities is not addressed and as only two processing studies are available, the processing factors derived from these studies are considered indicative only. With regard to the risk assessment, further processing studies are not required because they are not expected to affect the outcome of the risk assessment. If there would be the intention from risk managers to derive more processing factors for enforcement purposes, additional processing studies might be required
The DT90 values of dichlorprop-P and its soil metabolite 2,4-DCP are below the trigger value of 100 days. Further investigation of residues in rotational crops is therefore not required and relevant residues in these crops are not expected.
Based on the uses reported by the RMS, significant intakes were calculated for dairy ruminant, meat ruminants and pigs. Metabolism in lactating ruminants was sufficiently investigated and findings can be extrapolated to pigs as well. The relevant residue definition for enforcement and risk assessment in these animal products was defined as the sum of dichlorprop (including dichlorprop-P) and its salts, expressed as dichlorprop. There are indications that this residue definition can be enforced with an LOQ of 0.01 mg/kg in milk, an LOQ of 0.02 mg/kg in meat and fat, and an LOQ of 0.05 mg/kg liver and kidney, but a confirmatory method is still required. Tentative MRLs in pig and ruminant commodities were also derived from the metabolism study. For poultry products, no MRLs are required because there is no significant exposure of poultry to dichlorprop-P residues.
Chronic and acute 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 represented 1.7 % of the ADI (Dutch child) and the highest acute exposure amounted to 4 % of the ARfD (orange).
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 in the table as ‘Recommended’ are sufficiently supported by data and can in principle be proposed for inclusion in Annex II to the Regulation. The remaining MRL values listed in the table are not recommended for inclusion in Annex II because they require further consideration by risk managers (see summary table footnotes for details). In particular, some tentative MRLs need to be confirmed by the following data:
a confirmatory method for enforcement in animal commodities.
It is also noted by EFSA that the MRL proposals in cereal grains, swine kidney, ruminant liver and ruminant kidney are driven by authorisations for cereals and grass that will need to be withdrawn or modified by Member States in line with Regulation (EU) No 1166/2013. It is therefore recommended to review these MRL proposals when authorisations have been modified at national level and residue trials according to the modified GAPs (in particular for cereals) can be made available to EFSA.