Normativa UEMay. 17, 2013
UE: modifican límites máximos de residuos para 8-hydroxyquinoline en tomates
In order to accommodate for the intended indoor use of 8-hydroxyquinoline, Spain proposed to raise the existing MRL in tomatoes to 0.1 mg/kg. Spain drafted an evaluation report in accordance with Article 8 of Regulation (EC) No 396/2005, which was submitted to the European Commission and forwarded to EFSA. According to EFSA, the submitted data are sufficient to derive a MRL proposal of 0.1 mg/kg for 8-hydroxyquinoline in tomatoes which reflects the analytical LOQ of the method used to analyse residue trial samples. Based on the risk assessment results, EFSA concludes that the intended indoor use of 8-hydroxyquinoline on tomatoes will not result in a consumer exposure exceeding the toxicological reference values and therefore is unlikely to pose a public health risk.
In accordance with Article 6 of Regulation (EC) No 396/2005, Spain, hereafter referred to as the evaluating Member State (EMS), received an application from the company Probelte to modify the existing MRL for the active substance 8-hydroxyquinoline in tomatoes. In order to accommodate for the intended indoor use of 8-hydroxyquinoline, Spain proposed to raise the existing MRL in tomatoes to 0.1 mg/kg. Spain drafted an evaluation report in accordance with Article 8 of Regulation (EC) No 396/2005, which was submitted to the European Commission and forwarded to EFSA on 29 November 2011. On 21 June 2012 some data requirements were identified, which prevented EFSA to conclude on the consumer risk assessment. An updated evaluation report, addressing those data requirements, was submitted by the EMS on 22 February 2013 and taken into consideration by EFSA for finalization of this reasoned opinion.
EFSA bases its assessment on the updated evaluation report submitted by the EMS, the Draft Assessment Report (DAR) prepared under Council Directive 91/414/EEC and the conclusion of EFSA on the peer review of the pesticide risk assessment of 8-hydroxyquinoline.
The toxicological profile of 8-hydroxyquinoline 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 0.05 mg/kg bw per day and an ARfD of 0.05 mg/kg bw.
The metabolism of 8-hydroxyquinoline in tomatoes was investigated in the framework of the peer review. From these studies it was concluded to establish the residue definition for enforcement as “8-hydroxyquinoline and its salts expressed as 8-hydroxyquinoline” and for the risk assessment as “8-hydroxyquinoline free and conjugated and its salts expressed as 8-hydroxyquinoline”. These residue definitions are restricted to fruit crops only and for treatments by soil drip irrigation. The peer review, however, noted that the available freezer storage stability study was not adequate to conclude on the stability of 8-hydroxyquinoline residues in tomato samples from the metabolism study and residue trials. A new study was submitted in the framework of the current application, confirming that the results of the metabolism study are considered valid with regard to storage stability. EFSA concludes that the nature of 8-hydroxyquinoline in tomatoes is sufficiently addressed and the residue definitions as agreed in the peer review are applicable.
A sufficiently validated analytical enforcement method is available to control the residues of 8-hydroxyquinoline and its salts in high water content matrices at the LOQ of 0.01 mg/kg.
EFSA concludes that the submitted supervised residue trials are sufficient to derive a MRL proposal of 0.1 mg/kg for 8-hydroxyquinoline in tomatoes which reflects the analytical LOQ of the method used to analyse residue trial samples. It is noted, that the analytical enforcement method is more sensitive and was validated for the determination of 8-hydroxyquinoline residues in tomatoes at the LOQ of 0.01 mg/kg. The residue data are considered valid with regard to storage stability.
Specific studies investigating the nature and magnitude of 8-hydroxyquinoline residues in processed commodities are not required, since the residues expected in raw commodity are low and the total theoretical maximum daily intake (TMDI) is below the trigger value of 10% of the ADI.
Tomatoes can be grown in a crop rotation with other plants. The soil degradation studies demonstrated that the degradation rate of 8-hydroxyquinoline in soil is rapid and therefore further studies investigating the nature and magnitude of the compound uptake in rotational crops are not required.
Since tomatoes are not fed to livestock, the nature and magnitude of 8-hydroxyquinoline residues in livestock was not assessed in the framework of this application.
The consumer risk assessment was performed with revision 2 of the EFSA Pesticide Residues Intake Model (PRIMo). For the calculation of chronic exposure EFSA used the median residue value as derived from the residue trials on tomatoes, multiplied by the conversion factor of 2 for risk assessment. For the remaining commodities of plant and animal origin, the existing MRLs which are established at the default LOQ of 0.01 mg/kg were used as input values. The acute exposure assessment was performed only with regard to tomatoes assuming the consumption of a large portion of the food item as reported in the national food surveys containing residues at the highest level observed in supervised field trials.
The estimated exposure was then compared with the toxicological reference values derived for 8-hydroxyquinoline.
No long-term consumer intake concerns were identified for any of the European diets incorporated in the EFSA PRIMo. The total calculated intake accounted for up to 2.1 % of the ADI (WHO Cluster diet B). The contribution of residues in tomatoes to the total consumer exposure accounted for a maximum of 1.2% of the ADI (WHO Cluster diet B). No acute consumer risk was identified in relation to the residues in tomatoes (23.3% of the ARfD).
EFSA concludes that the intended indoor use of 8-hydroxyquinoline on tomatoes will not result in a consumer exposure exceeding the toxicological reference values and therefore is unlikely to pose a public health risk.
Thus EFSA proposes to amend the existing MRL as reported in the summary table.