In accordance with Article 6 of Regulation (EC) No 396/2005, Germany, hereafter referred to as the evaluating Member State (EMS), received an application from Isagro SpA to modify the existing MRLs for the active substance tetraconazole in various plant and animal commodities. Before lowering the existing MRLs on pome fruits from 0.3 mg/kg to 0.2 mg/kg, on grapes from 0.5 mg/kg to 0.07 mg/kg and on wheat from 0.1 mg/kg to and 0.04 mg/kg, Germany suggested awaiting the finalisation of the ongoing review of the existing MRLs of tetraconazole, whereas they proposed to raise the existing MRLs in the liver of swine and ruminants from 1 mg/kg to 1.5 mg/kg and 2 mg/kg, respectively. Since the existing MRL on rape seed has been recently established to the level of 0.15 mg/kg proposed by Germany, no amendment is necessary. Germany 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 1 October 2012.
EFSA bases its assessment on the evaluation report, the Draft Assessment Report (DAR) and its addendum prepared under Council Directive 91/414/EEC, the Commission review report on tetraconazole, the conclusions on the peer review of the pesticide risk assessment of the active substance tetraconazole and of previous EFSA opinions on tetraconazole.
The toxicological profile of tetraconazole 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 0.05 mg/kg bw.
The metabolism of tetraconazole in primary crops was investigated in three different crop groups following foliar application. The peer review proposed the residue definition for monitoring as tetraconazole and for risk assessment two separate residue definitions: 1) tetraconazole and 2) triazole alanine and triazole acetic acid (provisionally, awaiting information on triazole lactic acid). EFSA concludes that the residue definitions for enforcement and risk assessment proposed in the peer review are applicable also to the crops under consideration.
EFSA concludes that the submitted supervised residue trials are sufficient to derive a MRL proposal of 0.2 mg/kg on apples, of 0.07 mg/kg on grapes and of the limit of quantification (LOQ) of 0.02 mg/kg on wheat. Before the MRLs are lowered it should be confirmed that no more critical GAPs are currently authorised at EU level for these crops. Adequate analytical enforcement methods are available to control the residues of tetraconazole in the commodities under consideration at the validated LOQ of 0.01 mg/kg.
Studies investigating the nature of tetraconazole residues in processed products demonstrate that the compound is hydrolytically stable. Therefore for processed commodities the same residue definition as for raw agricultural commodities (RAC) is applicable. Several processing factors were derived for tetraconazole during the peer review and the following ones are recommended for inclusion in Annex VI of Regulation (EC) No 396/2005.
• Apple, juice: 0.35 • Grape, wine: 0.29
• Apple, pomace (dry): 4.2 • Grape, raisins: 2.28
• Grape, must: 0.49
The occurrence of tetraconazole residues in rotational crops was investigated in the framework of the peer review. Based on the available information EFSA concludes that significant residue levels of the parent compound tetraconazole are unlikely to occur in rotational crops provided that the compound is used on the crops under consideration according to the proposed GAP (Good Agricultural Practice). However, the possible occurrence of triazole derivative metabolites (TDMs) in rotational crops cannot be excluded based on the data available.
Since the apple by-product pomace and wheat and its products are used as feed products, a potential carry-over into food of animal origin was assessed. The calculated livestock dietary burden exceeded the trigger value of 0.1 mg/kg (dry matter) for ruminants and pigs. The nature of tetraconazole residues in livestock has been sufficiently investigated and the peer review proposed the residue definition for monitoring as tetraconazole and for risk assessment two separate residue definitions: 1) tetraconazole and 2) 1,2,4-triazole. From the calculated dietary burden for livestock, taking into account the intended uses of tetraconazole on the crops under consideration and the existing uses on sugar beet and rape seed, and the results of livestock feeding studies, EFSA concludes that the existing MRLs on swine and ruminant products should be revised. The existing MRLs for swine and ruminant liver should be raised to 1.5 mg/kg and 3 mg/kg, respectively. The data also support the lowering of the existing MRLs to 0.015 mg/kg in swine muscle, 0.15 mg/kg in swine fat, 0.06 mg/kg in swine kidney as well as to 0.02 mg/kg in ruminant muscle, 0.3 mg/kg in ruminant fat, 0.09 mg/kg in ruminant kidney and 0.02 mg/kg in ruminant milk.
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 values as derived from the residue trials on apples, grapes and wheat, taking into account the processing factor and the yield factor for grapes, and the input values reported in previously issued EFSA reasoned opinions. For swine and ruminant products, the estimated residue values as derived for the calculated dietary burdens from the livestock feeding study were used as input values. For the remaining commodities of plant and animal origin, the existing MRLs as established in Annexes IIIA of Regulation (EC) No 396/2005 were included in the calculation. The acute exposure assessment was performed only with regard to the commodities under consideration. The estimated exposure was then compared with the toxicological reference values derived for tetraconazole.
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 51 % of the ADI (NL child diet). From all the products under consideration the highest individual contribution to the total dietary intake was for milk and milk products (19.8 % of the ADI), apples (13 % of the ADI) and sheep liver (5 % of the ADI). The individual contribution of the other commodities to the total dietary intake was less than 5 % of the ADI. No acute consumer risk was identified in relation to the MRL proposals for the products under consideration. The calculated maximum exposure in percentage of the ARfD was 36 % for bovine liver, 24 % for apples, 5 % for bovine milk and milk products, 4.5 % for table grapes and less than 3 % for the other products of swine and ruminant origin and for wheat and wine grapes.
EFSA did not perform the chronic and acute dietary intake risk assessment for the TDMs. However, an indicative risk assessment was performed for 1,2,4-triazole considering the residues expected in products of swine and ruminant origin following the administration of tetraconazole. The estimated exposure was then compared with the toxicological reference values derived for 1,2,4-triazole. Although the exposure calculation is incomplete because it does not take into account the contribution from other sources, it provides some indications that the 1,2,4-triazole residues resulting from the use of tetraconazole do not lead to a significant consumer exposure via animal commodities. The total calculated long-term consumer intake accounted for up to 3.1 % of the ADI (FR toddler diet). The calculated maximum acute exposure resulted from the intake of bovine liver (4.4 % of the ARfD) followed by bovine milk and milk products (3.1 % of the ARfD) and goat milk and milk products (0.6 % of the ARfD) with the individual contribution of the other food items lower than 0.5 % of the ARfD.
EFSA concludes that the proposed uses of tetraconazole on the crops under consideration will not result in a consumer exposure exceeding the toxicological reference values for tetraconazole and therefore is unlikely to pose a consumer health risk.
EFSA emphasises that the consumer risk assessment should be regarded as provisional. The risk assessment for the TDMs will be performed as soon as the confirmatory data requested for triazole compounds in the framework of Regulation (EC) No 1107/2009 have been evaluated and a general methodology on the risk assessment of triazole compounds and their TDMs is available.
Thus EFSA proposes to amend the existing MRLs as reported in the summary table.