Modification of the existing maximum residue level for penconazole in grapes

Abstract

In accordance with Article 6 of Regulation (EC) No 396/2005, the evaluating Member State, Italy, received an application from Syngenta to modify the existing maximum residue level (MRL) for the active substance penconazole in grapes. The data submitted in support of the request are sufficient to derive a MRL proposal of 0.4 mg/kg for the intended use on grapes. Adequate analytical enforcement methods are available to control the residues of penconazole in grapes. Based on the risk assessment results, EFSA concludes that the intended use of penconazole on grapes will not result in a consumer exposure exceeding the toxicological reference values and therefore is unlikely to pose a consumer health risk. However, these results should be considered provisional due to the fact that the risk assessment for triazole derivate metabolites is still pending. This is an open access article under the terms of the Creative Commons Attribution-NoDerivs License, which permits use and distribution in any medium, provided the original work is properly cited and no modifications or adaptations are made.The EFSA Journal is a publication of the European Food Safety Authority, an agency of the European Union. EFSA bases its assessment on the evaluation report submitted by the EMS, the draft assessment report (DAR) (and its addendum) prepared under Council Directive 91/414/EEC, the Commission review report on penconazole, the conclusion on the peer review of the pesticide risk assessment of the active substance penconazole as well as the previous EFSA reasoned opinion on penconazole in raspberries and blackberries.The toxicological profile of penconazole was assessed in the framework of the peer review under Directive 91/414/EEC and the data were sufficient to derive an acceptable daily intake (ADI) of 0.03 mg/kg body weight (bw) per day and an acute reference dose (ARfD) of 0.5 mg/kg bw.The metabolism of penconazole in primary crops was investigated in the fruit crop group (apples and tomatoes) following foliar applications. From these studies, the peer review established the residue definition for enforcement as penconazole and as sum of penconazole and its metabolites (CGA 132465, CGA 190503, CGA 127841) and the conjugates of the metabolites, expressed as penconazole for risk assessment purposes. For the uses on grapes, EFSA concludes that the metabolism of penconazole in primary crops has been addressed for the uses on grapes and the residue definitions derived are applicable. From the metabolism studies, a risk assessment conversion factor (CF) of 6 has been derived to consider the metabolites of penconazole relevant according to the reside definition for risk assessment.Adequate analytical enforcement methods are available to monitor the residues of penconazole in grapes at the validated limit of quantification (LOQ) of 0.01 mg/kg. EFSA concludes that the submitted residue trials are sufficient to derive a MRL proposal of 0.4 mg/kg on wine grapes, which can be extrapolated to table grapes.Studies investigating the natur...

Evaluation of confirmatory data following the Article 12 MRL review and modification of the existing maximum residue levels for penconazole in various crops

“…The applicant reported an adjusted northern outdoor GAP, which is supported by a complete data set on wine grapes, already assessed by EFSA in a previous MRL application (EFSA, 2017a). An MRL of 0.4 mg/kg is derived from these trials, which is lower than the existing tentative MRL of 0.5 mg/kg.…”

“…0.15 Mo: 0.09 Mo: 0.016 (tentative)PlumsNEU Mo: 4 × 0.02; 0.02 (k) ; 0.05; 0.06; 0.09 RA: no data Residue trials on plums compliant with GAP (PHI 7 days) (j) (EFSA, 2017b). 0.15 Mo: 0.09 Mo: 0.026 (tentative) Wine grapes and table grapes NEU Mo: 2 × < 0.01; 0.01; 2 × 0.02; 0.03; 0.04; 0.26 RA: no data Residue trials on wine grapes compliant with GAP and assessed in a previous MRL application (EFSA, 2017a). Extrapolation to table grapes possible. 0.4 Mo: 0.26 Mo: 0.026 (tentative)SEU Mo: < 0.01; < 0.01; 3 × 0.02; 2 × 0.03; 0.04; 0.04; 0.18 RA: no data Eight residue trials on wine grapes performed with 3 × 40 g a.s./ha (instead of 3 × 30 g a.s./ha) (EFSA, 2017b) and two new trials (< 0.01; 0.04) performed according to GAP (Germany, 2022).…”

“…For these application, the data requirements established in Regulation (EU) No 544/2011 4 and the guidance documents applicable at the date of submission of the application to the EMS are applicable (European Commission, 1997a,b,c,d,e,f,g, 2000, 2010a,b, 2017aOECD, 2011OECD, , 2013 1107/2009 is not yet finalised, the conclusions reported in this reasoned opinion may need to be reconsidered in the light of the outcome of the peer review.…”

“…EFSA based its assessment on the evaluation report submitted by the EMS (Germany, 2022), the draft assessment report (DAR) and its addendum (Germany, 2007, 2008) prepared under Council Directive 91/414/EEC, the Commission review report on penconazole (European Commission, 2021), the conclusion on the peer review of the pesticide risk assessment of the active substance penconazole (EFSA, 2008), as well as the conclusions from previous EFSA opinions on penconazole, including the reasoned opinion on the MRL review according to Article 12 of Regulation No 396/2005 (EFSA, 2017a,b).…”

“…Residue trials on wine grapes compliant with GAP and assessed in a previous MRL application (EFSA, 2017a).…”