According to EFSA the data are sufficient to derive MRL proposals for all crops, except apricots. Adequate multi-residue methods are available to determine formetanate and its salts in high water and high acid content matrices with a combined LOQ of 0.01 mg/kg. EFSA concludes that for the intended use on courgettes, cucumbers, strawberries, and peppers an acute consumer exposure concerns cannot be excluded and thus the intended uses cannot be supported. For all the other crops under consideration which were sufficiently supported by data EFSA concluded that the intended uses of formetanate will not result in a consumer exposure exceeding the toxicological reference values and therefore is unlikely to pose a public health concern.
Summary
In accordance with Article 6 of Regulation (EC) No 396/2005, Italy, herewith referred to as the evaluating Member State (EMS), received an application from the company Gowan Comercio Internacional e Servicos, Limitada, to modify the existing MRLs for the active substance formetanate in apricots, peaches/nectarines, table and wine grapes, strawberries, peppers, cucumbers, melons, pumpkins, watermelons, lettuce and scarole. The applicant submitted residue data for the intended GAPs for several crops (peaches, apricots, grapes, strawberries, tomatoes, peppers, aubergines cucumbers, courgettes, gherkins, melons, pumpkins watermelons, lettuce and scarole; some of the GAPs refer to crops which were already assessed in the framework of the MRL review under Article 12 of Regulation (EC) No 396/2005 and for which data gaps or consumer concerns were identified). Following the assessment of the data, the EMS concluded that due to acute consumer exposure concerns, the use on cucumbers, courgettes and gherkins cannot be supported; for the rest of the crops the EMS derived MRL proposals. The evaluation report, prepared in accordance with Article 8 of Regulation (EC) No 396/2005, was submitted to the European Commission and forwarded to EFSA on 6 January 2012. On 21 June 2012 the draft reasoned opinion of EFSA was submitted for commenting to the EU Member States. By the end of the commenting period comments were submitted by the Netherlands, Italy and France and were taken into consideration for the finalization of the reasoned opinion.
EFSA bases its assessment on the evaluation report submitted by the EMS, the Draft Assessment Report (DAR) prepared under Council Directive 91/414/EEC, the conclusion on the peer review of the pesticide risk assessment of the active substance formetanate, as well as the conclusions from the EFSA reasoned opinion on the MRL review for formetanate.
The toxicological profile of formetanate hydrochloride was assessed in the framework of the peer review under Directive 91/414/EEC and the data were sufficient to derive an ADI of 0.004 mg/kg bw per day and an ARfD of 0.005 mg/kg bw.
Primary crop metabolism of formetanate was investigated in leafy vegetables and in fruits and fruiting vegetables. The peer review concluded that the residue definition for both risk assessment and enforcement should be defined as the sum of formetanate and its salts, expressed as formetanate hydrochloride. Under Article 12 MRL review, the data gap regarding the metabolism in the third crop group was identified. Thus, the residue definitions are restricted to leafy vegetables and fruits and fruiting vegetables crop groups. For the crops under consideration the metabolism of formetanate is sufficiently elucidated and the same residue definitions as proposed by the peer review are applicable.
EFSA considers that the submitted supervised residue trials are sufficient to derive MRL proposals for all crops, except apricots. Adequate multi-residue methods are available to determine formetanate and its salts in high water and high acid content matrices with a combined LOQ of 0.01 mg/kg.
Extensive degradation of formetanate was observed under conditions simulating baking/boiling or sterilisation. Under pasteurization conditions, degradation of formetanate was less extensive. None of the metabolites identified was considered to be of toxicological concern. Thus, the peer review concluded that for processed commodities the same residue definitions as for raw primary plants are applicable. New studies to assess the magnitude of formetanate residues during the processing of the crops under consideration have not been submitted. However, data are available to derive a peeling factor for cucurbits with inedible peel (0.09).
The occurrence of formetanate residues in rotational crops was investigated in the framework of the peer review and under Article 12 MRL review. Based on the available information on the nature and magnitude of residues in succeeding crops, it was concluded that significant residue levels are unlikely to occur in rotational crops provided that the compound is used on the crops under consideration according to the proposed pattern.
Residues of formetanate in commodities of animal origin were not assessed in the framework of this application, since the crops under consideration are normally not fed to livestock.
The consumer risk assessment was performed with revision 2 of the EFSA Pesticide Residues Intake Model (PRIMo). This exposure assessment model contains the relevant European food consumption data for different sub-groups of the EU population. The comprehensive chronic exposure assessment performed in the framework of the MRL review under Article 12 of Regulation (EC) No 396/2005 was updated taking into account the intended new uses of formetanate. For this purpose, the median residue concentrations derived for the crops under consideration were included in the exposure calculation. The acute exposure assessment was performed only with regard to the crops under consideration assuming the consumption of a large portion of the food item as reported in the national food surveys containing residues at the highest level as observed in supervised field trials.
The estimated exposure was then compared with the toxicological reference values derived for formetanate.
It is noted that the long-term consumer exposure calculation is based on the conclusions and recommendations derived in the review of the existing MRLs for formetanate under Article 12 of Regulation (EC) No 396/2005. Under the assumption that the MRLs will be amended as proposed in the Article 12 review, the total calculated intake values accounted for 12.8% of the ADI (FR toddler diet). The highest individual contribution of residues to the total consumer exposure was identified from the intake of tomatoes (6.9% of the ADI; WHO Cluster diet B), wine grapes (2.0% of the ADI; FR all population diet), strawberries (1.4% ADI; FR toddler diet) and cucumbers (1.2% of the ADI; DK child diet). For other crops under consideration the contribution was below 1% of the ADI.
Acute consumer intake concerns (exceedance in percentage of ARfD) could not be excluded for cucumbers (217.5%), courgettes (172.9%), strawberries (108.5%) and peppers (102%). For other crops the calculated maximum exposure (in the percentage of the ARfD) was as follows: 98.2% for table grapes, 84.8% for tomatoes (using an empirical variability factor of 4.15), 60.7% for gherkins, 60% for aubergines, 47.8% for melons, 38.5% for watermelons, 35.6% for wine grapes and below 11% for other crops.
EFSA concludes that for the intended use on courgettes, cucumbers, strawberries and peppers acute consumer exposure concerns cannot be excluded and thus the intended uses cannot be supported. For apricots additional residue trials are required. For all the other crops under consideration EFSA concludes that the intended uses of formetanate will not result in a consumer exposure exceeding the toxicological reference values and therefore is unlikely to pose a public health concern.
