Review of the existing maximum residue levels for bitertanol according to Article 12 of Regulation (EC) No 396/2005

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Article
European Food Safety Authority
EFSA Journal
EFSA Journal 2016;14(2):4386 [15 pp.].
doi
10.2903/j.efsa.2016.4386
Acknowledgements

EFSA wishes to thank the rapporteur Member State the United Kingdom for the preparatory work on this scientific output.

Type
Reasoned Opinion
On request from
European Commission
Question Number
EFSA-Q-2009-00033
Approved
21 January 2016
Published
3 February 2016
Affiliation
European Food Safety Authority (EFSA), Parma, Italy
Note
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Abstract

According to Article 12 of Regulation (EC) No 396/2005, the European Food Safety Authority (EFSA) has reviewed the maximum residue levels (MRLs) currently established at European level for the pesticide active substance bitertanol. Although this active substance is no longer authorised within the European Union due to certain impurities of unknown toxicological relevance, MRLs established by the Codex Alimentarius Commission (CXLs) are still in place. Based on lacking toxicological characterisation of the impurities, it was not possible for EFSA to perform an assessment of these CXLs and their incorporation in European legislation cannot be recommended. Nevertheless, available data allowed EFSA to propose a marker residue and a limit of quantification (LOQ) for enforcement against potential illegal uses. 

Summary

Bitertanol was initially not included in Annex I to Directive 91/414/EEC by Commission Decision 2008/934/EC. Following a resubmission application Bitertanol was subsequently approved on 1 January 2012 by Commission Implementing Regulation (EU) No 1278/2011 of 8 December 2011 as active substance, in accordance with the provision of Regulation (EC) No 1107/2009. EFSA was therefore required to provide a reasoned opinion on the review of the existing MRLs for that active substance in compliance with Article 12(1) of the aforementioned regulation. In order to collect the relevant pesticide residues data, EFSA asked the United Kingdom, as the designated rapporteur Member State (RMS), to complete the Pesticide Residues Overview File (PROFile) and to prepare a supporting evaluation report. The PROFile and evaluation report provided by the RMS were made available to the Member States.

Meanwhile, the approval of Bitertanol was withdrawn by means of Commission Implementing Regulation (EU) No 767/2013. Consequently, authorisations reported in the PROFile were no longer relevant and the evaluation report prepared by the RMS was not relied upon by EFSA. Nevertheless, in order to verify whether import tolerances may still be in place in some Member States, a request for additional information was still addressed to the Member States in the framework of a completeness check period which was initiated by EFSA on 14 July 2015 and finalised on 14 September 2015. Member States did not contest the proposal of EFSA to disregard the evaluation report prepared by the RMS, and no further information was provided. EFSA prepared a completeness check report which was made available to all Member States on 19 October 2015.

Based on the conclusions derived by EFSA in the framework of Directive 91/414/EEC and the MRLs established by the Codex Alimentarius Commission, EFSA prepared in December 2015 a draft reasoned opinion, which was circulated to Member States for consultation via a written procedure. Comments received by 23 December 2015 were considered during the finalisation of this reasoned opinion. The following conclusions are derived.

Although the use of bitertanol is no longer authorised within the EU and uses authorised in third countries were not reported to EFSA, the Codex Limits (CXLs) for bitertanol which were previously evaluated by the JMPR (FAO, 1998, 1999, 2000) are currently still in place. Nevertheless, due to the lack of information on the toxicological relevance of certain impurities of the active substance bitertanol, it was not possible for EFSA to perform an assessment of the CXLs. Consequently, incorporation of these CXLs in European legislation is not recommended, including those that are currently still in place at EU level.

In order to assist risk managers in applying the most appropriate enforcement measures (against potential illegal uses), EFSA assessed the available data with particular attention to the analytical methods and the nature of residues in plants and livestock.

Primary crop metabolism of bitertanol was investigated was investigated in apple, tomato, cotton and peanut following foliar application and in wheat following seed treatment, while rotational crop metabolism was investigated in wheat, kale, mustard and sugar beet. Although the triazole derivative metabolites (TDM) were the most relevant compounds in seed treated cereals, they are not considered specific for the active substance. Hence, based on the available data, and given the relevance of unchanged parent compound after foliar treatment, the sum of bitertanol isomers is considered to be the most adequate marker for enforcement against the potential illegal use of bitertanol in plants. It is expected that enforcement laboratories will be able to enforce this compound with an LOQ of 0.05 mg/kg in complex matrices, 0.02 mg/kg in high oil content commodities and herbs, and 0.01 mg/kg in all other plant commodities.

Livestock metabolism of bitertanol was investigated in a lactating cow and in laying hens. Also in this case, the sum of bitertanol isomers is considered to be a valid marker for enforcement against the potential illegal use of bitertanol. It is expected that enforcement laboratories will be able to enforce these compounds with an LOQ of 0.01 mg/kg in all animal commodities. As higher concentrations were generally found in fat compared to muscle tissue, this residue is to be considered fat soluble.

Considering that the enforcement against potential illegal uses falls under the remit of risk managers, EFSA is not in a position to recommend whether the default MRL of 0.01 mg/kg, as defined by Regulation (EC) No 396/2005, or whether the setting of specific LOQ values for plant and animal commodities should apply. It is noted however that for the sum of bitertanol isomers specific LOQ values of 0.05 mg/kg in complex plant matrices, 0.02 mg/kg in high oil content commodities and herbs, and 0.01 mg/kg in all other plant and animal commodities, would provide a satisfactory level of protection for the European consumers.

Keywords
bitertanol, MRL review, Regulation (EC) No 396/2005, consumer risk assessment, triazole, fungicide
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Number of Pages
15