Normativa UEMar. 28, 2012
UE: autoridad alimentaria modifica límites máximos de residuos para teflubenzuron en tomates y otros
According to Article 6 of the Regulation (EC) No 396/2005, the Netherlands, herewith referred to as the Evaluating Member State (EMS), received an application from the company Exponent International Ltd. to modify the existing MRLs for the active substance teflubenzuron in tomatoes, peppers, aubergines, okra, cucumbers, gherkins and courgettes. In order to accommodate for the intended indoor use of teflubenzuron on these crops in the Netherlands, the EMS proposes to raise the existing MRLs in these crops and to delete the MRL in pome fruit, taking into account the restrictions on the use of teflubenzuron according to Commission Directive 2009/37/EC (only uses in glasshouses on artificial substrate or closed hydroponic systems can be authorized). The EMS Netherlands drafted an evaluation report according to Article 8 of Regulation (EC) No 396/2005 which was submitted to the European Commission and forwarded to EFSA on 13 September 2011.
EFSA derives the following conclusions based on the submitted evaluation report prepared by the EMS Netherlands, the Draft Assessment Report (DAR) prepared by the rapporteur Member State (RMS) United Kingdom under Directive 91/414/EEC and the EFSA conclusion on the peer review of teflubenzuron.
The toxicological profile of teflubenzuron was assessed in the framework of the peer review under Directive 91/414/EEC and the data were sufficient to derive an ADI value of 0.01 mg/kg bw/day. Due to the low acute toxicity of the active substance the setting of an ARfD was considered not necessary.
The metabolism of teflubenzuron in primary crops was investigated in fruit crops and root and tuber vegetables. Based on the results of the metabolism studies the peer review concluded on a provisional residue definition for fruit and root crops for monitoring and risk assessment as teflubenzuron only.
Residue definition according to Regulation (EC) No 396/2005 is established as parent teflubenzuron. For the uses on the crops under consideration, which belong to the group of fruits and fruiting vegetables, EFSA concludes that the metabolism of teflubenzuron is sufficiently elucidated and the provisional residue definitions agreed in the peer review are applicable. Adequate analytical enforcement methods are available to control teflubenzuron residues in the crops under consideration.
The submitted residue data are sufficient to derive the following MRL proposals in support of the intended indoor use in the Netherlands: 1.5 mg/kg in the whole group of Solanaceae, 0.5 mg/kg in courgettes and 1.5 mg/kg in gherkins. For cucumbers there is no need to modify the existing MRL of 0.5 mg/kg. The existing EU MRL of 1 mg/kg for pome fruit which is proposed for the deletion is identical to the CXL for pome fruit, established by the JMPR in 1996 in support of the southern European uses. According to the JMPR, the use of teflubenzuron is authorized also in Jordan, The United Arab Emirates (apples and pears) and in Argentina (apples only). The deletion of the CXL/EU MRL for teflubenzuron in pome fruits might affect the international trade.
The effect of processing on the nature of teflubenzuron residues has not been investigated in standard hydrolysis studies. Instead, the studies submitted for the peer review investigating the effects of processing on the magnitude of residues in heated apple pomace and canned sterilized tomatoes were considered sufficient by the peer review to demonstrate the stability of teflubenzuron under processing conditions. The effects of processing on the magnitude of teflubenzuron residues in processed tomatoes were assessed in the framework of the peer review and the relevant processing factors were derived which are now proposed for the enforcement purposes:
• Tomatoes, juice: 0.17
• Tomatoes, puree: 0.45
• Tomatoes, canned tomatoes: 0.07
Processing studies with other crops under consideration have not been performed and are not necessary given the low contribution of these commodities to the total dietary intake.
Since the proposed use of teflubenzuron is on artificial soil/hydroponic systems in glasshouse, investigations of residues in rotational crops are not relevant. The crops under consideration are not fed to livestock and therefore the nature and magnitude of teflubenzuron residues in livestock was not assessed in the framework of this application.
The consumer risk assessment was performed with revision 2 of the EFSA PRIMo. For the calculation of the chronic exposure, EFSA used the median residue values as derived from the residue trials on peppers, tomatoes, cucumbers and gherkins. The median residue value for tomatoes was used also as an input value for aubergines and okra, whereas the median residue value for cucumbers was used as an input value for courgettes. For pome fruit the median residue value was available to refine the intake calculations. For the remaining commodities of plant and animal origin the existing MRLs as established in Annex IIIA of Regulation (EC) No 396/2005 were used as input values. Acute exposure calculations were not undertaken due to the low acute toxicity of the active substance. The estimated chronic exposure was then compared with the toxicological reference value derived for teflubenzuron.
Chronic consumer intake concerns were identified for one diet incorporated in the EFSA PRIMo. The total calculated exposure accounted for up to 116% of the ADI for German child diet. The main contributor to the total exposure was apple, accounting for 58% (scenario 1).
According to Directive 2009/37/EC, the use of teflubenzuron on apples cannot anymore be authorized in the EU and therefore the MRL for teflubenzuron in apples should be deleted, e.g. set at the LOQ. EFSA thus performed a second consumer exposure calculation (scenario 2), using the LOQ of 0.01 mg/kg as an input value for apple. In this case, no long-term consumer intake concerns were identified for any of the European diets incorporated in the EFSA PRIMo. The total calculated intake values ranged from 14 to 76 % of the ADI (maximum for WHO Cluster diet B). The contribution of residues in the crops under consideration to the total consumer exposure (in the percentage of the ADI) accounted for a maximum of 10.2% for tomatoes (WHO Cluster diet B), 2.3% for peppers (WHO Cluster diet B), 1.6% for cucumbers (DK child diet) and below 1% for aubergines, okra, gherkins and courgettes. Further lowering of the chronic consumer exposure is expected when all uses not supported according to Commission Directive 2009/37/EC are withdrawn.
Provided that the existing MRL for apple is deleted, EFSA concludes that the intended use of teflubenzuron on the crops under consideration will not result in a consumer exposure exceeding the toxicological reference values and therefore will not pose a public health concern.
EFSA notes that the existing MRLs for crops which cannot be grown in glasshouses (on artificial substrate or closed hydroponic systems) and for which the existing EU MRL is above the LOQ, could be considered for deletion, taking into account the restrictions of the approval for teflubenzuron. However, the need to keep certain MRLs to accommodate for the international trade (e.g. CXLs) has to be taken into account.