Normativa UEMar. 21, 2012
UE: autoridad alimentaria revisa límites máximos de residuo para milbemectin
Milbemectin was included in Annex I to Directive 91/414/EEC on 01 December 2005, 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 The Netherlands, as the designated rapporteur Member State (RMS), to complete the Pesticide Residues Overview File (PROFile). The requested information was submitted to EFSA on 23 March 2009 and, after having considered several comments made by EFSA, the RMS provided on 20 November 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 26 September 2011 a draft reasoned opinion that was circulated to Member State experts for consultation. Comments received by 02 December 2011were considered for finalisation of this reasoned opinion. The following conclusions are derived.
The toxicological profile of milbemectin was evaluated in the framework of Directive 91/414/EEC, which resulted in an ADI of 0.03 mg/kg bw/d and an ARfD of 0.03 mg/kg bw. Both toxicological reference values were established for milbemycin A4 and milbemycin A3.
Primary crop metabolism of milbemectin was investigated following a foliar application in several fruits (apple, strawberry and orange) at maturity, hereby covering only one crop group.
Metabolic patterns in the different studies were shown to be similar and the relevant residue for enforcement and risk assessment in fruits could be defined as sum of milbemycin A4 and milbemycin A3, expressed as milbemectin. There is no metabolism study to cover the use on hops. However, as metabolism were also investigated in leaves, and as only the fruit parts of hops (cones) are consumed, the same definition of residue for enforcement and risk assessment can also apply on hops and a supplementary metabolism study is only considered desirable. If in the future, milbemectin would be supported for use on other leafy vegetables, a metabolism study would become necessary. Validated analytical methods for enforcement of this residue definition are available with an LOQ of 0.02 mg/kg in high water content (apples, pears) and acidic (oranges, strawberries) commodities, and with an LOQ of 0.2 mg/kg in hops.
Regarding the magnitude of residues in all crops reported by the RMS, a sufficient number of supervised residues trials is considered 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 residues of milbemectin are all below 0.1 mg/kg and contribution of these residues to chronic consumer exposure is generally low, investigating the effect of industrial and/or household processing was not necessary. Studies investigating the magnitude of residues in some processed products were submitted but processing factors could not be derived for enforcement because residue levels were below the LOQ in the raw agricultural commodities.
Occurrence of milbemectin residues in rotational crops was not investigated during the peer review. Strawberries may be grown in rotation with other crops. As it was demonstrated in several degradation studies that milbemectin is persistent in soil and that DT90 values exceed the trigger value of 100 days, a detailed assessment of the nature and magnitude of milbemectin residues is necessary and a rotational crop study is therefore required.
Based on the uses reported by the RMS, no significant intakes were calculated for any group of livestock, further investigation of residues as well as the setting of MRLs in commodities of animal origin is not deemed necessary.
Both 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 0.9 % of ADI (German child) and the highest acute exposure amounted to 6.5 % of the ARfD (apple).
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 table below for a summary). All MRL values listed in the table are sufficiently supported by data and therefore proposed for inclusion in Annex II to the Regulation.
It is highlighted, however, that some of the ‘Recommended’ MRLs result from a GAP in one climatic zone only, while other GAPs reported by the RMS were not fully supported by data. EFSA therefore identified the following data gaps which are not expected to impact on the validity of the recommended MRLs but which might have an impact on national authorisations:
• 8 residue trials complying with the Swedish GAP on pome fruit;
• a rotational crop study investigating the nature and the magnitude of the residue.
If the above reported data gaps are not addressed in the future, Member States are recommended to withdraw or modify the relevant authorisations at national level. When granting authorisations on strawberries, Member States are also recommended to consider the need of defining restrictions to avoid the occurrence of milbemectin in succeeding crops.
Minor deficiencies were also identified in the assessment but these deficiencies are not expected to impact either on the validity of the ‘Recommended’ MRLs or on the national authorisations. The following data are therefore considered desirable but not essential:
• an additional metabolism study to support the use on hops.