In accordance with Article 6 of Regulation (EC) No 396/2005, Spain, herewith referred to as the evaluating Member State (EMS), received an application from Makhteshim Agan España S.A. to modify the existing MRL for the active substance propiconazole in citrus fruits. In order to accommodate for the intended post-harvest use of propiconazole, the EMS proposed to raise the existing MRL in citrus fruit from the limit of quantification (0.05 mg/kg) to 5 mg/kg. This application was notified to the European Commission and EFSA and subsequently evaluated by the EMS in accordance with Article 8 of the Regulation. After completion, the evaluation report was submitted to the European Commission who forwarded the application, the evaluation report and the supporting dossier to EFSA on 24 May 2012.
EFSA bases its assessment on the evaluation report submitted by the EMS, the Draft Assessment Report (DAR) prepared by the rapporteur Member State (RMS) Finland under Council Directive 91/414/EEC, the Commission Review Report on propiconazole as well as the previous reasoned opinions on propiconazole.
The toxicological profile of propiconazole was assessed under the peer review and the data were sufficient to conclude on an ADI value of 0.04 mg/kg bw per day and an ARfD value of 0.3 mg/kg bw.
The peer review concluded that the metabolism of propiconazole was sufficiently elucidated in primary crops and supported the residue definition for risk assessment and monitoring as parent compound. However, as propiconazole, similarly to other active substances belonging to the triazole class, when applied to plant is known to produce the degradation/metabolism products named triazole derivative metabolites (TDMs), EFSA is of the opinion that the residue definition may require to be revised pending the decision on the risk assessment methodology for all substances of the triazole chemical group. Nevertheless, as TDMs were mainly detected in the metabolism studies conducted on oilseeds and cereals with the triazole labelled propiconazole, the occurrence of TDMs in citrus fruits after post-harvest treatment is of a low relevance. Specific metabolism studies investigating the nature of propiconazole in post-harvest treatments are not available. Given the results of the available metabolism studies conducted with short PHI intervals where parent propiconazole was the main residue, a more extensive metabolism of propiconazole is unlikely in post-harvest treatment of citrus fruits. However, the need for an additional metabolism study with post-harvest application might be reconsidered in the framework of Article 12 of Regulation (EC) No 396/2005.
EFSA concludes that the submitted supervised residue trials are sufficient and according to the OECD methodology a MRL proposal of 6 mg/kg is derived for propiconazole in citrus fruits. For the supervised residue trials a minor deficiency was identified regarding the lack of storage stability data. Although studies are available to demonstrate that propiconazole residues are stable in high oil content matrices and dry matrices, the stability of residues should be also demonstrated for acidic matrices. Adequate analytical enforcement methods are available to control propiconazole residues in the crops under consideration.
A hydrolysis study simulating conditions of pasteurisation baking/brewing/boiling and sterilisation was not performed with propiconazole. The peer review did not derive specific risk assessment and enforcement residue definitions for processed commodities. Specific studies investigating the effect of processing on the magnitude of propiconazole residues in orange juice and marmalade were provided in the framework of the current application; a peeling factor was also derived. However, as the nature of propiconazole residues is not fully investigated and since the possible occurrence of TDMs in processed products should be reconsidered, EFSA does not recommend the derived processing factors for orange juice and marmalade to be included in Annex VI of Regulation (EC) No 396/2005. Further investigations, such as the performance of a hydrolysis study, are recommended.
Since the intended use refers to the post-harvest treatment of citrus fruits, the possible occurrence of propiconazole residues in rotational crops was not investigated.
Citrus pomace can be used as a livestock feed and thus a potential carry-over of residues into food of animal origin was assessed. The calculated dietary burden indicated that the trigger value of 0.1 mg/kg dry matter (DM) is exceeded for meat and dairy ruminants and is driven by the new intended use on citrus fruits. The metabolism in livestock has been sufficiently addressed in the framework of the peer review in lactating goats and laying hens. The peer review derived the risk assessment and enforcement residue definition as parent propiconazole. The calculated dietary burdens and the results of the livestock feeding studies were used to assess the occurrence of propiconazole residues in food commodities of animal origin. EFSA concluded that the existing EU MRLs for propiconazole need to be modified for ruminant kidney, fat and meat reflecting the feed intake of citrus pomace. For ruminant liver and milk the existing MRLs do not have to be modified.
The consumer risk assessment was performed with revision 2 of the EFSA Pesticides Residues Intake Model (PRIMo). For the calculation of the chronic exposure EFSA used the median residue value, multiplied by the peeling factor of 0.01, as derived from the residue trials on oranges and mandarins; this input value was used also for other citrus fruits. For ruminant meat, fat and kidney the median residue as derived from the feeding studies was used as an input value. For several commodities the median residue values were available to refine the exposure calculation. For the remaining commodities of plant and animal origin, the existing MRLs as established in Annexes II and IIIB of Regulation (EC) No 396/2005 were used as input values. The acute exposure assessment was performed only with regard to citrus fruits (considering the peeling factor) and ruminant meat, fat and kidney 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 and in livestock feeding studies (for animal commodities).
The estimated exposure was then compared with the toxicological reference values derived for propiconazole.
No long-term consumer intake concerns were identified for any of the European diets incorporated in the EFSA PRIMo. The total calculated intake values accounted for up to 5.9% of the ADI (UK toddler diet). The contribution of residues in citrus fruits to the total consumer exposure was low, being the highest for oranges (0.16% of the ADI for DE child diet). The individual contribution of residues in ruminant meat, fat and kidney to the total consumer exposure was below 0.2% of the ADI, being the highest for bovine meat (0.18% of the ADI (ES child diet)).
No acute consumer risk was identified in relation to the propiconazole residues in citrus fruits and in ruminant meat, fat and kidney. The calculated maximum exposure in percentage of the ARfD was the highest for oranges, accounting for 1%. The calculated exposure to residues from animal commodities was the highest for bovine and sheep meet (0.2% of the ARfD).
EFSA concludes that the intended use of propiconazole on citrus fruits and residues in ruminant meat, fat and kidney will not result in a consumer exposure exceeding the toxicological reference values and therefore is unlikely to pose a public health concern. The risk assessment of TDMs could not be performed. However, TDMs in citrus fruits following post-harvest treatment is of a low relevance.
Thus EFSA proposes to amend the existing MRLs as reported in the summary table.