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

Abstract

Summary

Fluopyram was approved on 1 February 2014 by means of Commission Implementing Regulation (EU) No 802/2013 under Regulation (EC) No 1107/2009 as amended by Commission Implementing Regulations (EU) No 540/2011 and 541/2011.

As the active substance was approved after the entry into force of Regulation (EC) No 396/2005 on 2 September 2008, the European Food Safety Authority (EFSA) is required to provide a reasoned opinion on the review of the existing maximum residue levels (MRLs) for that active substance in compliance with Article 12(1) of the aforementioned regulation.

As the basis for the MRL review, on 13 October 2017 EFSA initiated the collection of data for this active substance. In a first step, Member States were invited to submit by 13 November 2017 their national Good Agricultural Practices (GAPs) in a standardised way, in the format of specific GAP forms, allowing the designated rapporteur Member State (RMS) Germany to identify the critical GAPs in the format of a specific GAP overview file. Subsequently, Member States were requested to provide residue data supporting the critical GAPs, within a period of 1 month, by 9 May 2018. On the basis of all the data submitted by Member States and by the EU Reference Laboratories for Pesticides Residues (EURL), EFSA asked the RMS to complete the Pesticide Residues Overview File (PROFile) and to prepare a supporting evaluation report. The PROFile and evaluation report, together with Pesticide Residues Intake Model (PRIMo) calculations and an updated GAP overview file, were provided by the RMS to EFSA on 27 September 2018. Subsequently, EFSA performed the completeness check of these documents with the RMS. The outcome of this exercise including the clarifications provided by the RMS, if any, was compiled in the completeness check report.

Based on the information provided by the RMS, Member States and the EURL, and taking into account the conclusions derived by EFSA in the framework of Commission Regulation (EU) No 188/2011 and the MRLs established by the Codex Alimentarius Commission, EFSA prepared in July 2019 a draft reasoned opinion, which was circulated to Member States for consultation via a written procedure. Comments received by 3 September 2019 were considered during the finalisation of this reasoned opinion. The following conclusions are derived.

The metabolism of fluopyram in plant was investigated in primary and rotational crops. According to the results of the metabolism studies, the plant residue definition for enforcement can be proposed as ‘fluopyram’ and for risk assessment as ‘sum of fluopyram and fluopyram‐benzamide (M25), expressed as fluopyram’. These residue definitions are also applicable to processed commodities. Fully validated analytical methods are available for the enforcement of the proposed residue definition in all major matrices at the limit of quantification (LOQ) of 0.01 mg/kg. According to the EURLs, the LOQ of 0.01 mg/kg is achievable by using the QuEChERS method in routine analyses.

Fluopyram is a persistent substance which may accumulate in soil following multiannual uses. To account for the potential uptake of such residues accumulated in soil in rotational crops two options were considered. Both options assumed that the most critical indoor GAP on tomatoes is restricted to growing on artificial substrates or other means to prevent carry‐over of residues from treated soil to succeeding crops. In addition to this restriction:

Option 1: assumed that adequate risk mitigation measures are in place to avoid significant residues in crops grown in rotation with crops treated with fluopyram. These measures included a plant‐back interval (PBI) of 1 year for root and tuber vegetables, and leafy vegetables; and a PBI of 120 days for cereals.

Option 2: assumed that no risk mitigation is implemented other than the above restriction on the most critical indoor GAP on tomatoes.

For Option 1, the available data are considered sufficient to derive MRL proposals as well as risk assessment values for all commodities under evaluation, except for lemons, mandarins, cherries, banana, spring onions, tomatoes, melons, watermelon, Chinese cabbage, escaroles, land cresses, red mustards, spinaches, chards/beet leaves, globe artichokes and leeks, where tentative MRLs are derived, and for lime, cherimoya and chicory roots where the available data were insufficient to derive tentative MRLs.

For Option 2, specific MRLs, considering that residues uptake in succeeding crops are not avoided, were also derived for cassava roots/manioc, sweet potatoes, yams, arrowroots, root vegetables, broccoli, cauliflower, Brussels sprouts, head cabbage, kales, kohlrabies, watercress, herbal infusions (roots), sugar beets, sweet corn, maize grain, buckwheat and millet grain, as well as tentative MRLs for chicory roots. It is underlined that MRLs values derived from rotational crop field data are subject to a high degree of uncertainty.

Tentative MRLs were also derived for cereal straw in view of the future need to set MRLs in feed items.

The effect of industrial processing and/or household preparation was assessed and robust processing factors could be derived for processed commodities from wine grapes, strawberries, tomatoes, melons, apples, bananas and rapeseeds. Tentative processing factors are also proposed for citrus, sugar beet, potato and peanuts.

Fluopyram is authorised for use on crops that might be fed to livestock. Livestock dietary burden calculations were therefore performed for different groups of livestock according to OECD guidance. Residues from primary uses without (Option 1) or with (Option 2) residues in rotational crops were considered. For both scenarios, the dietary burdens calculated for all groups of livestock were found to exceed the trigger value of 0.1 mg/kg dry matter (DM) in both cases. Behaviour of residues was therefore assessed in all commodities of animal origin.

The metabolism of fluopyram residues in livestock was investigated in lactating goats and laying hens at dose rates covering the maximum dietary burdens calculated in this review. According to the results of these studies, the residue definition for enforcement in all livestock commodities was proposed as the ‘sum of fluopyram and fluopyram‐benzamide (M25), expressed as fluopyram’ and for risk assessment as the ‘sum of fluopyram, fluopyram‐benzamide (M25), and fluopyram‐ E / Z ‐olefine (M02/M03), expressed as fluopyram’. An analytical method for the enforcement of the proposed residue definition at the LOQ of 0.02 mg/kg in all matrices is available. According to the EURLs, a combined LOQ of 0.02 mg/kg is achievable for commodities of animal origin.

Livestock feeding studies on cows and laying hens were used to derive two sets of MRL and risk assessment values in milk, eggs, and tissues of ruminants and poultry in view of the two dietary burdens (with or without rotational crops), each set corresponding to one of the 2 options described above. Since extrapolation from ruminants to pigs is acceptable, results of the livestock feeding study on ruminants were relied upon to derive the MRL and risk assessment values in pigs.

Chronic and acute consumer exposure resulting from the authorised uses reported in the framework of this review was calculated using revision 3.1 of the EFSA PRIMo. For those commodities where data were insufficient to derive a MRL, EFSA considered the existing EU MRL for an indicative calculation.

In the light of the possible contribution of residues from rotational uses to consumer exposure pending the implementation of risk mitigation measures, the two options described above were considered.

The highest chronic exposure was calculated for the Dutch toddler, representing 86% (Option 1) and 100% (Option 2) of the acceptable daily intake (ADI). The highest acute exposure was calculated for lettuce, representing 76% of the acute reference dose (ARfD) for both options.

Apart from the MRLs evaluated in the framework of this review, internationally recommended codex maximum residue limits (CXLs) have also been established for fluopyram. Additional calculations of the consumer exposure, considering these CXLs, were therefore carried out.

The highest chronic exposure was calculated for Dutch toddler, representing 110% (Option 1) and 128% (Option 2) of the ADI. The highest acute exposure was calculated for lettuce, accounting 76% of the ARfD for both options.

For Option 1, as a potential risk management option, the risk assessment was re‐calculated by considering the European animal diet for cattle and swine and thus disregarding the CXLs for these animal commodities. According to this scenario, the chronic exposure represents 92% of the ADI. Nonetheless, it is highlighted that this scenario was only provided as a potential option for risk managers to consider and does not exclude or suggest alternative options may not be available for risk managers.

For Option 2, given that the chronic exposure based on the authorised EU uses, import tolerances and the uptake of fluopyram accumulated in soil following multiannual use already accounted for 100% of the ADI (NL toddlers), and as there may be several alternative options at the discretion of risk managers to exclude a potential chronic risk, the only safe scenario assessed was that disregarding from the calculation all CXLs higher than the derived EU MRL.

Altogether, the calculations indicate a potential chronic risk to consumers if all the existing CXLs are incorporated in the assessment. For Option 1, a safe scenario could be identified, excluding the CXLs for cattle and swine tissues from the calculation. For Option 2, a safe scenario could be identified disregarding from the calculation all CXLs higher than the derived EU MRL.

Background

Regulation (EC) No 396/2005¹ (hereinafter referred to as ‘the Regulation’) establishes the rules governing the setting and the review of pesticide maximum residue levels (MRLs) at European level. Article 12(1) of that Regulation stipulates that the European Food Safety Authority (EFSA) shall provide within 12 months from the date of the inclusion or non‐inclusion of an active substance in Annex I to Directive 91/414/EEC² a reasoned opinion on the review of the existing MRLs for that active substance.

As fluopyram was approved on 1 February 2014 by means of Commission Implementing Regulation (EU) No 802/2013³ in accordance with Regulation (EC) No 1107/2009⁴ as amended by Commission Implementing Regulations (EU) No 540/2011⁵ and 541/2011⁶,EFSA initiated the review of all existing MRLs for that active substance.

By way of background information, in the framework of Commission Regulation (EU) No 188/2011⁷ Fluopyram was evaluated by Germany, designated as rapporteur Member State (RMS). Subsequently, a peer review on the initial evaluation of the RMS was conducted by EFSA, leading to the conclusions as set out in the EFSA scientific report (EFSA, 2013a).

According to the legal provisions, EFSA shall base its reasoned opinion in particular on the relevant assessment report prepared under Directive 91/414/EEC repealed by Regulation (EC) No 1107/2009. It should be noted, however, that, in the framework of Regulation (EC) No 1107/2009, only a few representative uses are evaluated, whereas MRLs set out in Regulation (EC) No 396/2005 should accommodate all uses authorised within the European Union (EU), and uses authorised in third countries that have a significant impact on international trade. The information included in the assessment report prepared under Regulation (EC) No 1107/2009 is therefore insufficient for the assessment of all existing MRLs for a given active substance.

To gain an overview of the pesticide residues data that have been considered for the setting of the existing MRLs, EFSA developed the Pesticide Residues Overview File (PROFile). The PROFile is an inventory of all pesticide residues data relevant to the risk assessment and MRL setting for a given active substance. This includes data on:

• the nature and magnitude of residues in primary crops;
• the nature and magnitude of residues in processed commodities;
• the nature and magnitude of residues in rotational crops;
• the nature and magnitude of residues in livestock commodities;
• the analytical methods for enforcement of the proposed MRLs.

As the basis for the MRL review, on 13 October 2017, EFSA initiated the collection of data for this active substance. In a first step, Member States were invited to submit by 13 November 2017 their Good Agricultural Practices (GAPs), in a standardised way, in the format of specific GAP forms. In the framework of this consultation 17 Member States provided feedback on their national authorisations of fluopyram. Based on the GAP data submitted, the designated RMS Germany was asked to identify the critical GAPs to be further considered in the assessment, in the format of a specific GAP overview file. Subsequently, in a second step, Member States were requested to provide residue data supporting the critical GAPs by 9 May 2018.

On the basis of all the data submitted by Member States and the EU Reference Laboratories for Pesticides Residues (EURL), EFSA asked Germany to complete the PROFile and to prepare a supporting evaluation report. The PROFile and the supporting evaluation report, together with the Pesticide Residues Intake Model (PRIMo) calculations and an updated GAP overview file, were submitted to EFSA on 27 September 2018. Subsequently, EFSA performed the completeness check of these documents with the RMS. The outcome of this exercise including the clarifications provided by the RMS, if any, was compiled in the completeness check report.

Considering all the available information, and taking into account the MRLs established by the Codex Alimentarius Commission (CAC) (i.e. codex maximum residue limit (CXLs)), EFSA prepared in July 2019 a draft reasoned opinion, which was circulated to Member States for commenting via a written procedure. All comments received by 3 September 2019 including additional GAPs submitted (Netherlands, 2019) were considered by EFSA during the finalisation of the reasoned opinion.

The evaluation report submitted by the RMS (Germany, 2018), taking into account also the information provided by Member States during the collection of data, the EURL report on analytical methods (EURL, 2018) and the evaluation reports received during the Member State consultation (Belgium, 2019; Netherlands, 2019) are considered as main supporting documents to this reasoned opinion and, thus, made publicly available.

In addition, further supporting documents to this reasoned opinion are the completeness check report (EFSA, 2019c) and the Member States consultation report (EFSA, 2019e). These reports are developed to address all issues raised in the course of the review, from the initial completeness check to the reasoned opinion. Furthermore, the exposure calculations for all crops reported in the framework of this review performed using the EFSA Pesticide Residues Intake Model (PRIMo) and the PROFile as well as the GAP overview file listing all authorised uses and import tolerances are key supporting documents and made publicly available as background documents to this reasoned opinion. A screenshot of the report sheet of the PRIMo is presented in Appendix C.

Terms of Reference

According to Article 12 of Regulation (EC) No 396/2005, EFSA shall provide a reasoned opinion on:

• the inclusion of the active substance in Annex IV to the Regulation, when appropriate;
• the necessity of setting new MRLs for the active substance or deleting/modifying existing MRLs set out in Annex II or III of the Regulation;
• the inclusion of the recommended MRLs in Annex II or III to the Regulation;
• the setting of specific processing factors as referred to in Article 20(2) of the Regulation.

The active substance and its use pattern

Fluopyram is the ISO common name for N‐{2‐[3‐chloro‐5‐(trifluoromethyl)‐2‐pyridyl]ethyl}‐α,α,α‐trifluoro‐o‐toluamide (IUPAC).

The chemical structure of the active substance and its main metabolites are reported in Appendix F.

The EU MRLs for fluopyram are established in Annex IIIA of Regulation (EC) No 396/2005. CXLs for fluopyram were also established by the CAC. An overview of the MRL changes that occurred since the entry into force of the Regulation mentioned above is provided below (Table 1).

For the purpose of this MRL review, all the uses of fluopyram currently authorised within the EU and in third countries as submitted by the Member States during the GAP collection, have been reported by the RMS in the GAP overview file. The critical GAPs identified in the GAP overview file were then summarised in the PROFile and considered in the assessment. The details of the authorised critical GAPs for fluopyram are given in Appendix A.

Assessment

EFSA has based its assessment on the following documents:

• the PROFile submitted by the RMS;
• the evaluation report accompanying the PROFile (Germany, 2018);
• the draft assessment report (DAR) and its addenda prepared under in the framework of Commission Regulation (EU) No 188/2011 (Germany, 2011, 2012);
• the conclusion on the peer review of the pesticide risk assessment of the active substance fluopyram (EFSA, 2013a);
• the Joint Meeting on Pesticide residues (JMPR) Evaluation report (FAO, 2010, 2012, 2014, 2015, 2017);
• the previous reasoned opinions on fluopyram (EFSA, 2011 2014 2016 2019c 2017 d).

The assessment is performed in accordance with the legal provisions of the uniform principles for evaluation and authorisation of plant protection products as set out in Commission Regulation (EU) No 546/2011⁸ and the currently applicable guidance documents relevant for the consumer risk assessment of pesticide residues (European Commission, 1997a, 1997b, 1997c, 1997d, 1997e, 1997f, 1997g, 2000, 2010a, 2010b, 2017; OECD, 2011, 2013, 2018).

More detailed information on the available data and on the conclusions derived by EFSA can be retrieved from the list of end points reported in Appendix B.

1. Residues in plants

2. Residues in livestock

Fluopyram is authorised for use on several crops that might be fed to livestock, in addition residues in feed items from crops grown in rotation cannot be ruled out. Livestock dietary burden calculations were therefore performed for different groups of livestock according to OECD guidance (OECD, 2013).

In a first scenario only the residues from primary uses were considered. In order to cover the possible contribution from rotational crops, a second calculation was carried out considering the STMR and HR values as derived in Appendix B.1.2.2.(c) based on the combined residues from primary and rotational crops. The input values for all relevant commodities, corresponding to each option, have been selected according to the recommendations of JMPR (FAO, 2009) and are summarised in Appendix D.

The calculated dietary burdens for all groups of livestock are summarised in Appendix B.2.(a) considering primary uses only (Option 1) and in Appendix B.2.(b) considering also residues from additional soil uptake (Option 2). The calculated dietary burden for ruminants nearly doubled in Option 2, driven by residues in processed potato waste, whereas it had only a minor impact the dietary burden for poultry (most critical commodity swede roots).

It is highlighted that for turnip tops, no residue data were available for primary crops. Nonetheless, residues extrapolated from rotated carrot leaves were considered in the second calculation. The animal intake of fluopyram residues via the primary use of turnip leaves has therefore not been assessed and may have been underestimated. However, this is not expected to have a major impact on the outcome of the dietary burden considering the overwhelming contribution of other feed items (e.g. cereals and potato).

The calculated dietary burdens for all groups of livestock were found to exceed the trigger value of 0.1 mg/kg dry matter (DM). Behaviour of residues was therefore assessed in all commodities of animal origin.

3. Consumer risk assessment

In the framework of this review, only the uses of fluopyram reported by the RMS in Appendix A were considered; however, the use of fluopyram was previously also assessed by the JMPR (FAO, 2010, 2012, 2014, 2015, 2017). The CXLs, resulting from these assessments by JMPR and adopted by the CAC, are now international recommendations that need to be considered by European risk managers when establishing MRLs. To facilitate consideration of these CXLs by risk managers, the consumer exposure was calculated both with and without consideration of the existing CXLs.

In the light of the possible contribution of residues from rotational uses to consumer exposure pending the implementation of risk mitigation measures, two options were considered.

In both options, it is assumed that the most critical indoor GAP on tomatoes is restricted to growing on artificial substrates or other means to prevent carry‐over of residues from treated soil to succeeding crops. In addition to this restriction:

Option 1: assumed that adequate risk mitigation measures are in place to avoid significant residues in crops grown in rotation with crops treated with fluopyram. These measures included a PBI of 1 year for root and tuber vegetables, and leafy vegetables; and a PBI of 120 days for cereals.

Option 2: assumed that no risk mitigation is implemented other than the restriction on the most critical indoor GAP on tomatoes.

Finally, it is highlighted that fluopyram‐benzamide (M25) was recently identified to be a common metabolite with flutolanil in the on‐going renewal of the latter (Netherlands, 2018). Although the MRL review for flutolanil did not assess the presence of M25 (EFSA, 2013b), as only a limited number of GAPs are authorised with relatively low existing MRLs, it can be reasonably expected that exposure to M25 from the use of flutolanil is not significant compared to the uses on fluopyram and will not impact the risk assessment performed under the present MRL review.

Conclusions

The metabolism of fluopyram in plant was investigated in primary and rotational crops. According to the results of the metabolism studies, the plant residue definition for enforcement can be proposed as ‘fluopyram’ and for risk assessment as ‘sum of fluopyram and fluopyram‐benzamide (M25), expressed as fluopyram’. These residue definitions are also applicable to processed commodities. Fully validated analytical methods are available for the enforcement of the proposed residue definition in all major matrices at the LOQ of 0.01 mg/kg. According to the EURLs the LOQ of 0.01 mg/kg is achievable by using the QuEChERS method in routine analyses.

Fluopyram is a persistent substance which may accumulate in soil following multiannual uses. To account for the potential uptake of such residues accumulated in soil in rotational crops two options were considered. Both options assumed that the most critical indoor GAP on tomatoes is restricted to growing on artificial substrates or other means to prevent carry‐over of residues from treated soil to succeeding crops. In addition to this restriction:

Option 1: assumed that adequate risk mitigation measures are in place to avoid significant residues in crops grown in rotation with crops treated with fluopyram. These measures included a plant back interval (PBI) of 1 year for root and tuber vegetables, and leafy vegetables; and a PBI of 120 days for cereals.

Option 2: assumed that no risk mitigation is implemented other than the above restriction on the most critical indoor GAP on tomatoes.

For Option 1, the available data are considered sufficient to derive MRL proposals as well as risk assessment values for all commodities under evaluation, except for lemons, mandarins, cherries, banana, spring onions, tomatoes, melons, watermelon, Chinese cabbage, escaroles, land cresses, red mustards, spinaches, chards/beet leaves, globe artichokes and leeks, where tentative MRLs are derived, and for lime, cherimoya and chicory roots where the available data were insufficient to derive tentative MRLs.

For Option 2, specific MRLs, considering that residues uptake in succeeding crops are not avoided, were also derived for cassava roots/manioc, sweet potatoes, yams, arrowroots, root vegetables, broccoli, cauliflower, Brussels sprouts, head cabbage, kales, kohlrabies, watercress, herbal infusions (roots), sugar beets, sweet corn, maize grain, buckwheat and millet grain, as well as tentative MRLs for chicory roots. It is underlined that MRLs values derived from rotational crop field data are subject to a high degree of uncertainty.

Tentative MRLs were also derived for cereal straw in view of the future need to set MRLs in feed items.

The effect of industrial processing and/or household preparation was assessed and robust processing factors could be derived for processed commodities from wine grapes, strawberries, tomatoes, melons, apples, bananas and rapeseeds. Tentative processing factors are also proposed for citrus, sugar beet, potato and peanuts.

Fluopyram is authorised for use on crops that might be fed to livestock. Livestock dietary burden calculations were therefore performed for different groups of livestock according to OECD guidance. Residues from primary uses without (Option 1) or with (Option 2) residues in rotational crops were considered. For both scenarios, the dietary burdens calculated for all groups of livestock were found to exceed the trigger value of 0.1 mg/kg DM in both cases. Behaviour of residues was therefore assessed in all commodities of animal origin.

The metabolism of fluopyram residues in livestock was investigated in lactating goats and laying hens at dose rates covering the maximum dietary burdens calculated in this review. According to the results of these studies, the residue definition for enforcement in all livestock commodities was proposed as the ‘sum of fluopyram and fluopyram‐benzamide (M25), expressed as fluopyram’ and for risk assessment as the ‘sum of fluopyram, fluopyram‐benzamide (M25), and fluopyram‐ E / Z ‐olefine (M02/M03), expressed as fluopyram’. An analytical method for the enforcement of the proposed residue definition at the LOQ of 0.02 mg/kg in all matrices is available. According to the EURLs a combined LOQ of 0.02 mg/kg is achievable for commodities of animal origin.

Livestock feeding studies on cows and laying hens were used to derive two sets of MRL and risk assessment values in milk, eggs, and tissues of ruminants and poultry in view of the two dietary burdens (with or without rotational crops), each set corresponding to one of the 2 options described above. Since extrapolation from ruminants to pigs is acceptable, results of the livestock feeding study on ruminants were relied upon to derive the MRL and risk assessment values in pigs.

Chronic and acute consumer exposure resulting from the authorised uses reported in the framework of this review was calculated using revision 3.1 of the EFSA PRIMo. For those commodities where data were insufficient to derive a MRL, EFSA considered the existing EU MRL for an indicative calculation.

In the light of the possible contribution of residues from rotational uses to consumer exposure pending the implementation of risk mitigation measures, the two options described above were considered.

The highest chronic exposure was calculated for the Dutch toddler, representing 86% (Option 1) and 100% (Option 2) of the ADI. The highest acute exposure was calculated for lettuce, representing 76% of the ARfD for both options.

Apart from the MRLs evaluated in the framework of this review, internationally recommended CXLs have also been established for fluopyram. Additional calculations of the consumer exposure, considering these CXLs, were therefore carried out.

The highest chronic exposure was calculated for Dutch toddler, representing 110% (Option 1) and 128% (Option 2) of the ADI. The highest acute exposure was calculated for lettuce, accounting 76% of the ARfD for both options.

For Option 1, as a potential risk management option, the risk assessment was re‐calculated by considering the European animal diet for cattle and swine and thus disregarding the CXLs for these animal commodities. According to this scenario, the chronic exposure represents 92% of the ADI. Nonetheless, it is highlighted that this scenario was only provided as a potential option for risk managers to consider and does not exclude or suggest alternative options may not be available for risk managers.

For Option 2, given that the chronic exposure based on the authorised EU uses, import tolerances and the uptake of fluopyram accumulated in soil following multiannual use already accounted for 100% of the ADI (NL toddlers), and as there may be several alternative options at the discretion of risk managers to exclude a potential chronic risk, the only safe scenario assessed was that disregarding from the calculation all CXLs higher than the derived EU MRL.

Altogether, the calculations indicate a potential chronic risk to consumers if all the existing CXLs are incorporated in the assessment. For Option 1, a safe scenario could be identified, excluding the CXLs for cattle and swine tissues from the calculation. For Option 2, a safe scenario could be identified disregarding from the calculation all CXLs higher than the derived EU MRL.

Recommendations

MRL recommendations were derived in compliance with the decision tree reported in Appendix E of the reasoned opinion.

Since fluopyram is highly persistent in the soil, for root, tuber and brassica vegetables as well as certain crops that may be grown in rotation but for which no primary crop use is authorised (kales, kohlrabies, watercresses, buckwheat and millet grain), it cannot be excluded that residues above the derived MRLs occur in succeeding crops, unless appropriate risk mitigation measures are in place.

Therefore, two different options were derived. In both options, it is assumed that the most critical indoor GAP on tomatoes is restricted to growing on artificial substrates or other means to prevent carry‐over of residues from treated soil to succeeding crops. In addition to this restriction:

• Option 1: assumed that adequate risk mitigation measures are in place to avoid significant residues in crops grown in rotation with crops treated with fluopyram. These measures included a PBI of 1 year for root and tuber vegetables, and leafy vegetables; and a PBI of 120 days for cereals.
• Option 2: assumed that no risk mitigation is implemented other than the restriction on the most critical indoor GAP on tomatoes.

For Option 1, all MRL values listed as ‘Recommended’ in the table are sufficiently supported by data and are therefore proposed for inclusion in Annex II to the Regulation. The remaining MRL values listed in the table are not recommended for inclusion in Annex II because they require further consideration by risk managers (see Table 2 footnotes for details). In particular, some tentative MRLs and/or existing EU MRLs need to be confirmed by the following data:

• additional residue trials on lime, mandarins, bananas, cherimoya, tomatoes, melons, watermelons, Chinese cabbage, escaroles, land cresses, red mustards, spinaches, chards/beet leaves, globe artichokes, leeks and chicory roots.

It is highlighted, however, that some of the MRLs derived result from a CXL or from a GAP in one climatic zone only, whereas other GAPs reported by the RMS were not fully supported by data. EFSA therefore identified the following data gaps which are not expected to impact on the validity of the MRLs derived but which might have an impact on national authorisations:

• additional residue trials on lemons, cherries, apricots, plums, spring onions, radishes, dry beans and peas.

If the above reported data gaps are not addressed in the future, Member States are recommended to withdraw or modify the relevant authorisations at national level.

Option 2 is presented in order to facilitate decision by risk managers but, it is underlined that all MRLs values derived from rotational crop field data are subject to a higher degree of uncertainty. They are based on a limited data set, with conservative assumptions and a very high degree of uncertainty with regards to actual concentrations of fluopyram in soil, and is also pending on the actual use pattern of fluopyram. EFSA recommends that residues uptake in succeeding crops should be avoided as much as possible. Furthermore, given that the chronic exposure based on the European authorised uses, the import tolerances and the uptake from soil accounted already for 100% of the ADI (NL toddlers), according to this option, it was not possible to consider the current CXLs higher than the derived EU MRL. As there may be several alternative options, at the discretion of risk managers, to exclude the potential chronic risk, MRLs not covering the existing CXLs require further considerations by risk managers. In particular, a chronic risk was identified if also all CXLs are considered, but it does not mean that all CXLs contribute significantly to the chronic intake and would lead to a potential intake concern. For Option 2, all MRL values listed as ‘Recommended’ in the table are sufficiently supported by data and are therefore proposed for inclusion in Annex II to the Regulation. The remaining MRL values listed in the table are not recommended for inclusion in Annex II because they require further consideration by risk managers (see Table 2 footnotes for details). In particular, some tentative MRLs and/or existing EU MRLs need to be confirmed by the following data:

• additional residue trials on lime, lemons, mandarins, bananas, cherimoyas, spring onions, tomatoes, melons, watermelons, Chinese cabbage, escaroles, land cresses, red mustards, spinaches, chards/beet leaves, globe artichokes, leeks and chicory roots.

It is highlighted, however, that some of the MRLs derived result from a GAP in one climatic zone only, whereas other GAPs reported by the RMS were not fully supported by data. EFSA therefore identified the following data gaps which are not expected to impact on the validity of the MRLs derived but which might have an impact on national authorisations:

• additional residue trials on cherries, apricots, plums, radishes, dry beans and peas.
• additional rotational field trials on fruit and fruiting vegetables.

Moreover, for bulb and stem vegetables specific data for rotational crops are not available, EFSA was not able to assess the potential uptake in succeeding crops. Although it is not expected to modify the outcome of the risk assessment, the following data should be generated if risk managers intend to set MRLs in these crops:

• 4 additional rotational field trials on bulb and stem vegetables.

Minor deficiencies were also identified in the assessment but they are not expected to impact either on the validity of the MRLs derived or on the national authorisations. The following data are therefore considered desirable but not essential:

• a fully validated analytical method for the determination of fluopyram in seed spices and an ILV of the method in hops.

Abbreviations

Appendix A – Summary of critical authorised uses considered for the review of MRLs

Appendix B – List of end points