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Assessment and methodological support
Reasoned opinion on the review of the existing maximum residue levels (MRLs) for pymetrozine according to Article 12 of Regulation (EC) No 396/2005
The residue trials considered for kale was not reflecting the data submitted by MS during the Member States consultation. In order to address this omission, Table 3-2 listing the residue trials was amended, the highest residue values for kale were corrected in Tables 3-5 and 4-1 and the list of MRLs derived by EFSA in the recommendation section was updated accordingly. Detailed results of the livestock dietary burden calculation in Table 3-6 were also updated but the overall outcome remains unchanged.Affiliation: European Food Safety Authority (EFSA), Parma, Italy
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 pymetrozine. In order to assess the occurrence of pymetrozine 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 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. Some information required by the regulatory framework was found to be missing and a possible acute risk to consumers was identified. Hence, the consumer risk assessment is considered indicative only, some MRL proposals derived by EFSA still require further consideration by risk managers and measures for reduction of the consumer exposure should also be considered.
© European Food Safety Authority,2012
Pymetrozine was included in Annex I to Directive 91/414/EEC on 01 November 2001, 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 19 December 2008 and, after having considered several comments made by EFSA, the RMS provided on 05 November 2009 a revised PROFile.
Based on the conclusions derived in the framework of Directive 91/414/EEC under the supervision of the European Commission and the additional information provided by the RMS, EFSA issued on 23 January 2012 a draft reasoned opinion that was circulated to Member State experts for consultation. Comments received by 30 March 2012 were discussed in a meeting of experts, which took place on 15 June 2012, and the outcome of that meeting was considered for finalisation of this reasoned opinion. The following conclusions are derived.
The toxicological profile of pymetrozine was evaluated in the framework of Directive 91/414/EEC, which resulted in an ADI and an ARfD being established at 0.03 mg/kg bw per d and 0.1 mg/kg bw, respectively.
Primary crop metabolism of pymetrozine was investigated following a foliar application in tomatoes, potatoes, cotton and rice at different stages of application, hereby covering four different crop groups. Since the metabolic pathways were well identified and metabolic patterns in the different studies were shown to be similar, EFSA considers these data sufficient to establish the residue definition in all plant commodities. The relevant residue for enforcement and risk assessment in primary crops could be defined as pymetrozine. Validated analytical methods for enforcement of this residue definition are available with an LOQ of 0.02 mg/kg in high water content and acidic commodities, and an LOQ of 0.01 mg/kg for high oil content and dry commodities. Validated methods for enforcement of pymetrozine in hops and herbal infusion are not available.
Regarding the magnitude of residues in primary crops, a sufficient number of supervised residue trials is available for most of the GAPs reported by the RMS, except for apples, pears, okra and fresh beans without pods where no sufficient residue trials were available and no MRL or risk assessment values could be derived. Moreover, major uncertainties remain about the storage stability on high acid and high water content commodities. Consequently, except for chestnuts, hazelnuts, walnuts, dewberries, cranberries, rape seed and cotton, EFSA was only able to derive tentative MRLs in the absence of supplementary data on residue trials, analytical method for enforcement and/or storage stability.
In the framework of the peer review, the nature of residues in processed commodities was not investigated. Although not required, studies investigating the magnitude of residues in peel, pulp of citrus and cucurbits are available and allowed EFSA to derive reliable processing factors. Data on citrus juice, tomato’s products and beer are also available but no robust processing factor could be derived. Further processing studies are not required as they are not expected to affect the outcome of the risk assessment. However, if there would be the intention to derive more robust processing factors, in particular for enforcement purposes, additional processing studies would be required.
Occurrence of pymetrozine residues in rotational crops was already investigated during the peer review of pymetrozine. It is concluded that metabolic patterns in primary and succeeding crops are similar and that significant residues in rotational crops are not expected, provided that pymetrozine is applied according to the GAPs supported in the framework of this review. EFSA notes that particular attention should be paid for short cycle crops for which risk mitigation measures should be proposed.
Based on the uses reported by the RMS, significant intakes were calculated for dairy ruminants, meat ruminants and pigs. Metabolism in lactating ruminants was sufficiently investigated and findings can be extrapolated to pigs as well. In tissues, residue was defined as pymetrozine only for enforcement and the sum of pymetrozine and 6-hydroxymethyl pymetrozine, expressed as pymetrozine, for risk assessment. In milk, the relevant residue definition for both enforcement and risk assessment was therefore defined as the sum of pymetrozine, its metabolites 6-hydroxymethyl pymetrozine and its phosphate conjugate, expressed as pymetrozine. A validated analytical method for enforcement of this residue definition is also available, with an LOQ of 0.01 mg/kg in tissues, and 0.02 mg/kg in milk. Available feeding studies in livestock also demonstrated that significant residues of pymetrozine in edible matrices of ruminants and pigs are not expected, and that MRLs for these commodities can be established at the LOQ. The LOQ for milk however should be considered on a tentative basis only as further validation of the analytical method for enforcement is still required. For poultry products no MRLs are required because there is no significant exposure of poultry to pymetrozine residues.
Both chronic and acute consumer exposure resulting from the authorised uses reported in the framework of this review were calculated using revision 2 of the EFSA PRIMo. For those commodities where data were insufficient to derive an MRL, EFSA considered the existing EU MRL for an indicative calculation. For scarole, an exceedance of the ARfD was identified representing 140 % of the ARfD, respectively. Considering a fall-back MRL for this crop, the highest chronic exposure represented 6.9 % of the ADI (WHO Cluster Diet B) and the highest acute exposure amounted to 88.2 % of the ARfD (peppers).
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 as ‘Recommended’ in the table are sufficiently supported by data and are therefore 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 and existing EU MRLs need to be confirmed by the following data:
- a validated analytical methods for enforcement of residues in herbal infusions and hops;
- 8 residue trials supporting the northern GAP and 8 trials supporting the southern GAP on apples and pears;
- 4 additional residue trials supporting the northern GAP on strawberries;
- 2 additional residue trials on currants supporting the northern GAP and 6 residue trials on currants supporting the indoor GAP on blueberries, currants and/or gooseberries;
- 8 residue trials supporting the northern GAP, 4 additional trials supporting the southern GAP and 3 additional trials supporting the indoor GAP on tomatoes and aubergines;
- 8 residue trials complying with the northern GAP, 6 additional trials complying with the southern GAP and 3 additional trials complying with the indoor GAP on peppers;
- 4 residue trials supporting the indoor GAP on okra;
- 8 residue trials complying with the northern GAP, 7 additional trials complying with the southern GAP and 7 additional trials complying with the indoor GAP on cucurbits with edible peel;
- 2 additional trials complying with the southern GAP on melons, pumpkins and watermelons and 8 residue trials complying with the indoor GAP on melons and pumpkins;
- 4 residue trials supporting the northern GAP on fresh beans without pods;
- further information on the decline of residues during storage in high water content and acidic commodities;
- information on the storage condition of the residues trial samples;
- a validated analytical method for determination of residues in milk.
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. In order to comply with the MRL derived for scarole, Member States are also recommended to withdraw the indoor authorisations for this crop.
Minor deficiencies were also 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:
- 4 southern and 3 northern residue trials on apricots complying with the respective outdoor GAPs on peaches and apricots (data gap resulting from the new extrapolation rule);
- details to sort residue trials on raspberries in the right area (outdoor and indoor) and 2 additional residues trials on raspberries complying with the indoor GAP on raspberries and blackberries;
- 8 residue trials on open leaf lettuce compliant with the indoor GAP on the whole group of lettuce and other salad plants, and herbs (data gap resulting from the new extrapolation rule);
- a detailed evaluation report of analytical method for determination of pymetrozine in food of animal origin.
EFSA also emphasizes that the above risk assessment was performed disregarding the possible impact of plant and livestock metabolism on the possible isomerisation of pymetrozine and further investigation on this matter would in principle be required as well. Noting however that guidance on the consideration of isomers in the consumer risk assessment is not yet available, EFSA recommends that the impact of plant metabolism on the isomer ratio of pymetrozine is reconsidered when such guidance is available.
Pymetrozine, MRL review, Regulation (EC) No 396/2005, consumer risk assessment, pyridine, insecticide.