Normativa UEMay. 30, 2014
UE: revisan límites máximos de residuo para folpet
The toxicological profile of folpet was evaluated in the framework of Directive 91/414/EEC, which resulted in an ADI of 0.1 mg/kg bw per d and an ARfD of 0.2 mg/kg bw. Both toxicological reference values were established for folpet. The metabolite phthalimide was demonstrated to be of lower toxicity compared to folpet but data were not sufficient to derive specific reference values for this compound. It was therefore concluded that reference values for folpet can be applied to this metabolite as a worst-case assumption.
Primary crop metabolism of folpet was investigated following foliar application on wheat, potatoes and several fruit and fruiting vegetables (grapes, avocados, tomatoes). Translocation from soil application was also investigated in tomatoes. Metabolic patterns in the different studies were shown to be similar and three crop groups were covered. The relevant residue for enforcement and risk assessment in all plant commodities was therefore defined as the sum of folpet and phthalimide, expressed as folpet. Although not fully validated in all matrices, analytical methods for enforcement of the proposed residue definition are available.
The available residues trials allowed EFSA to derive MRLs and risk assessment values for all commodities under evaluation, except for bulb vegetables, kohlrabi, lettuce, scarole, spinach and fresh beans without pods. Moreover, considering the data gaps identified for analytical methods, residues trials and storage stability studies, all MRL proposals are considered tentative, except for table and wine grapes.
The hydrolysis studies demonstrate that folpet is completely degraded during processing; phthalimide is formed predominantly under conditions of pasteurisation, while levels of phthalic acid increase under conditions simulating boiling/brewing/baking and sterilisation. Considering that phthalamide was the only compound of toxicological relevance, the relevant residue for enforcement and risk assessment is processed commodities was also defined as the sum of folpet and phthalimide, expressed as folpet. Magnitude of residues in processed commodities was also investigated and robust processing factors could be derived for grapes juice, wine and beer as well as for canned tomatoes, tomato juice and tomato paste.
According to the soil degradation studies evaluated in the framework of the peer review, DT90 values of folpet, phthalimide and their relevant soil metabolites (phthalic acid and phthalamic acid) are all below the trigger value of 100 days. Further investigation of residues in rotational crops is therefore not required and relevant residues in rotational crops are not expected.
Based on the uses reported by the RMS, significant exposures are expected for dairy ruminants, meat ruminants, poultry 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 pigs and ruminants was defined as phthalimide, expressed as folpet. Analytical methods for enforcement of the proposed residue definition are available with an LOQ of 0.05 mg/kg in milk, meat, fat, liver and kidney. No livestock feeding studies were deemed necessary and, based on the available metabolism studies, MRLs and risk assessment values for the relevant commodities in ruminants and pigs can be established at the LOQ level. The nature and the magnitude of folpet residues in poultry commodities were not investigated. Further investigation on the nature and magnitude of residues in poultry commodities should be carried out in order to establish appropriate residue definitions and MRLs in these commodities.
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. For bulb vegetables, kohlrabi, lettuce, scarole, spinach and beans (fresh without pods), where data were insufficient to derive an MRL, EFSA could not consider the existing EU MRLs as they do not cover the total residue compliant with the proposed residue definition. The risk assessment for these commodities could therefore not be finalised.
In a first tier calculation, an exceedance of the ARfD was identified for wine grape, representing 105.8 % of the ARfD. The highest chronic exposure represented 22.4 % of the ADI (French population). A second tier exposure calculation was therefore performed using a refining approach for the food item “wine grapes”. The highest acute exposure was then calculated for table grapes, representing 93.3 % of the ARfD.
Apart from the MRLs evaluated in the framework of this review, internationally recommended CXLs have also been established for folpet. Additional calculations of the consumer exposure, including these CXLs, should therefore in principle be performed. Nevertheless, since the residue definitions derived by JMPR (folpet alone) and derived at EU level (sum of folpet and phtalimide, expressed as folpet) are different, and no data on the occurrence phtalimide were evaluated by the JMPR, it is not possible to perform a risk assessment with consideration of the exiting CXLs.
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. 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 or existing EU MRLs need to be confirmed by the following data:
ILVs for the determination of folpet in dry commodities and in hops as well ILVs for the determination of phtalimide in high water content, dry commodities and hops;
confirmatory methods for the determination of folpet and phtalimide in high oil content and dry commodities and for the determination of phthalimide in high water content commodities;
a storage stability study for folpet and phthalimide in high oil content commodities;
further investigation on the nature and magnitude of residues in poultry;
additional residues trials, with analysis of both folpet and phthalimide, and supporting the southern authorisations on strawberries, potatoes, tomatoes, melons, wheat (grain and straw).
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 addition, EFSA identified several crops where data were insufficient to derive tentative MRLs and where the safety of the existing EU MRL could not be demonstrated by EFSA. In order to derive MRLs in these crops, the following data would be required:
additional residue trials, with analysis of both folpet and phthalimide, and supporting authorisations on bulb vegetables, kohlrabi, lettuce, scarole, spinach and fresh beans without pods.
Meanwhile, Member States are recommended to reconsider or withdraw their national authorisations on onions, garlic, shallots, spring onions, kohlrabi, lettuce, scarole, spinach and beans (fresh without pods).
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 actions are therefore considered desirable but not essential:
a detailed evaluation report of the reported analytical method for determination of phthalimide in animal matrices;
a detailed evaluation report of the storage stability study for phthalimide in high water content, high acid content and dry commodities;
1 additional residue trial with analysis of both folpet and phthalimide, and compliant with the southern GAP on table grapes;
8 residue trials performed with a lower LOQ (at least 0.10* mg/kg), and compliant with the southern GAP on olives (table olive and olives for oil production).