Modification of the existing maximum residue levels and setting of import tolerances for fluopyram in various crops.

In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Bayer AG Crop Science Division submitted a request to the competent national authority in Italy to modify the existing maximum residue level (MRL) for the active substance fluopyram in kiwi. Additionally, the applicants Bayer Crop Science SA and Bayer SAS Crop Science Division submitted two applications to the competent national authority in Germany to modify the MRLs for fluopyram in certain stem vegetables, seed spices, apples and soyabeans based on intended EU uses as well as to lower the existing EU MRL in pome fruits and to raise the existing EU MRL in peanuts on the basis of authorised use of fluopyram in the USA. The data submitted in support of the request were found to be sufficient to derive MRL proposals for all the crops under assessment except for palm hearts and bamboo shoots. Adequate analytical methods for enforcement are available to control the residues of fluopyram in commodities under consideration at the validated limit of quantification (LOQ) of 0.01 mg/kg. Based on the risk assessment results, EFSA concluded that the short-term intake of residues resulting from the use of fluopyram according to the reported agricultural practices is unlikely to present a risk to consumer health. A long-term consumer intake concern is identified if the current MRL of 0.8 mg/kg in pome fruits is maintained and new MRLs for other commodities under consideration are supported, with apples being the highest contributing commodity to the diet for which exposure exceedances were noted. The chronic risk for consumers is unlikely if a lower MRL of 0.6 mg/kg in pome fruits proposed by the applicant is considered. Further risk manager considerations are required.

Modification of the existing maximum residue levels in leeks and spring onions/green onions/Welsh onions resulting from the use of potassium phosphonates.

In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant BASF Agro B.V. Arnhem (NL) Freienbach Branch submitted a request to the competent national authority in the Netherlands to modify the existing maximum residue levels (MRLs) for the active substance potassium phosphonates in leeks and spring onions/green onions/Welsh onions. The data submitted in support of the request were found to be sufficient to derive MRL proposals for the commodities under assessment. Adequate analytical methods for enforcement are available to control the residues of potassium phosphonates in accordance with the proposed residue definition 'phosphonic acid and its salts expressed as phosphonic acid' on the commodities under consideration. Based on the risk assessment results and assuming that the exiting MRLs will be amended as proposed by EFSA in previous outputs, EFSA concluded that the long-term intake of residues resulting from the use of potassium phosphonates according to the reported agricultural practices is unlikely to present a risk to consumer health. Considering the toxicological profile of the active substance, a short-term dietary risk assessment was not required. The risk assessment shall be regarded as indicative because some MRL proposals derived by EFSA in the framework of the MRL review according to Articles 12 and 43 of Regulation (EC) No 396/2005 require further consideration by risk managers.

Targeted review of maximum residue levels (MRLs) for azocyclotin and cyhexatin.

In accordance with Article 43 of Regulation (EC) 396/2005, EFSA received a request from the European Commission to review the existing maximum residue levels (MRLs) for the non-approved active substances azocyclotin and cyhexatin in view of the possible lowering of these MRLs. EFSA investigated the origin of the current EU MRLs. For existing EU MRLs that reflect previously authorised uses in the EU, or that are based on obsolete Codex Maximum Residue Limits, or import tolerances that are not required any longer, EFSA proposed the lowering to the limit of quantification. EFSA performed an indicative chronic and acute dietary risk assessment for the revised list of MRLs to allow risk managers to take the appropriate decisions. For some commodities under assessment, further risk management discussions are required to decide which of the risk management options proposed by EFSA should be implemented in the EU MRL legislation.

Setting of import tolerances for sulfoxaflor in various crops.

In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Dow AgroSciences Ltd submitted a request to the competent national authority in Greece to set an import tolerance for the active substance sulfoxaflor in various crops. The data submitted in support of the request were found to be sufficient to derive import tolerance proposals for cane fruits, blueberries, avocados, mangoes, pineapples, asparagus, globe artichokes, sunflower seeds and coffee beans. Adequate analytical methods for enforcement are available to control the residues of sulfoxaflor in plant matrices under consideration at the validated LOQ of 0.01 mg/kg. Based on the risk assessment results, EFSA concluded that the short-term and long-term intake of residues resulting from the use of sulfoxaflor according to the reported agricultural practices is unlikely to present a risk to consumer health.

Setting of import tolerance for pyraclostrobin in papayas.

In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant BASF SE submitted a request to the competent national authority in Germany to set an import tolerance for the active substance pyraclostrobin in papayas imported from Brazil. The data submitted in support of the request were found to be sufficient to derive a maximum residue level (MRL) proposal for papayas. Adequate analytical methods for enforcement are available to control the residues of pyraclostrobin on the commodity under consideration at or above the validated limit of quantification (LOQ) of 0.01 mg/kg. Based on the risk assessment results, EFSA concluded that the short-term and long-term intake of residues resulting from the use of pyraclostrobin on papayas imported from Brazil according to the reported agricultural practices is unlikely to present a risk to consumer health.

Targeted review of maximum residue levels (MRLs) for fenpropathrin.

In accordance with Article 43 of Regulation (EC) 396/2005, EFSA received a request from the European Commission to review the existing maximum residue levels (MRLs) for the non-approved active substance fenpropathrin in view of the possible lowering of the MRLs. EFSA investigated the origin of the current EU MRLs. For existing EU MRLs that reflect previously authorised uses in the EU, or that are based on obsolete Codex Maximum Residue Limits, or import tolerances that are not required any longer, EFSA proposed the lowering to the limit of quantification or to an alternative MRL. EFSA performed an indicative chronic and acute dietary risk assessment for the revised list of MRLs to allow risk managers to take the appropriate decisions.

Modification of the existing maximum residue levels for triclopyr in animal commodities.

In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Corteva Agriscience International Sàrl submitted a request to the competent national authority in the Netherlands to modify the existing maximum residue levels (MRLs) for the active substance triclopyr in animal commodities. The data submitted in support the request were found to be sufficient to derive MRL proposals for swine and ruminant edible commodities and for ruminant milks considering residue levels expected for the intended uses on grassland. Adequate analytical methods for enforcement are available to control the residues of triclopyr on the commodities under consideration at the validated limit of analytical quantification (LOQ) of 0.01 mg/kg. Based on the risk assessment results, EFSA concluded that the short-term and long-term intake of residues resulting from the uses of triclopyr according to the reported agricultural practices and the derived MRLs in products of animal origin is unlikely to present a risk to consumer health. The consumer risk assessment is indicative pending the submission of the confirmatory data requested under the MRL review.

Setting of import tolerances for metalaxyl-M in oil palms fruits and peppercorn.

In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Syngenta Crop Protection AG submitted a request to the competent national authority in Belgium to set an import tolerance for the active substance metalaxyl-M in oil palms fruits and peppercorn (black, green and white). The data submitted in support of the request were found to be sufficient to derive MRL proposals for oil palms fruits and peppercorn. Adequate analytical methods for enforcement are available to control the residues of metalaxyl-M in the commodities under consideration at the validated limit of quantification (LOQ) of 0.01 mg/kg. Based on the risk assessment results, EFSA concluded that the short-term and long-term intake of residues resulting from the use of metalaxyl-M according to the authorised agricultural practices is unlikely to present a risk to consumer health.

Modification of the existing maximum residue levels for imazalil in courgettes, cucumbers and gherkins.

In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Certis Europe B.V. submitted a request to the competent national authority in the Netherlands to modify the existing maximum residue levels (MRLs) for the active substance imazalil in cucumbers, courgettes and gherkins. The data submitted in support of the request were found to be sufficient to derive an MRL proposal of 0.08 mg/kg for the whole group of cucurbits with edible peel. It is noted that the derived MRL is proposed to replace the existing tentative MRL of 0.1 mg/kg for courgettes, thus also addressing the data gap identified in the context of the MRL review. As regards to cucumbers and gherkins, it is noted that the MRL proposal derived in the current application is covered by the MRL of 0.5 mg/kg currently in place for these commodities. Nevertheless, it is also noted that the aforementioned MRLs are based on Codex maximum residue limits (CXLs) which were revoked in 2019 following the JMPR proposal. Should this proposal be implemented in the EU regulation in the future, the proposed MRL of 0.08 mg/kg as derived in the current application would be considered an appropriate fall-back option for the whole group of cucurbits with edible peel. Further risk management considerations are therefore required. Adequate analytical methods for enforcement are available to control the residues of imazalil on the commodities under consideration at the validated limit of quantification (LOQ) of 0.005 mg/kg (QuEChERS method based on LC-MS/MS) and 0.01 mg/kg (HPLC-MS/MS method). Based on the risk assessment results, EFSA concluded that the short-term and long-term intake of residues resulting from the use of imazalil according to the reported agricultural practices is unlikely to present a risk to consumer health. However, it should be noted that a high degree of uncertainty on the overall long-term exposure calculation remains due to the data gaps identified in the context of the MRL review on full toxicological assessment of the metabolite R014821, which is expected to occur following post-harvest uses of imazalil, and animal metabolites FK-772 and FK-284.

Setting of import tolerances for fipronil in potatoes, sugar canes and commodities of animal origin.

In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant BASF SE submitted a request to the competent national authority in Austria to set an import tolerance for the active substance fipronil in potatoes, maize, rice, sugar canes and to modify the existing EU MRLs (maximum residue levels) for fipronil in commodities of animal origin. During the assessment, the applicant withdrew the import tolerance requests on maize and rice. The data submitted in support of the present assessment were found to be sufficient to derive MRL proposal for sugar canes. For potatoes, data gaps were identified which precluded the derivation of MRL proposal. The livestock exposure to fipronil residues from the intake of sugar canes molasses required the setting of MRL in fat of bovine, sheep and goat. Adequate analytical methods for enforcement are available to control the total residues of fipronil in plant and animal matrices at the validated limit of quantification (LOQ) 0.005 mg/kg. Based on the risk assessment results, EFSA concluded that consumer intake concerns are not associated with fipronil residues in food commodities under consideration: sugar canes and fat of bovine, sheep and goat. There are no EU authorisations of fipronil as well as no Codex maximum residue limits (CXLs) or import tolerances are set for fipronil in the EU MRL legislation; therefore, other plant and animal commodities were not considered in the consumer exposure assessment.

Evaluation of confirmatory data following Article 12 MRL review and modification of the existing MRLs in pome fruits for pyridaben.

In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Nissan Chemical Europe SAS submitted a request to the competent national authority in the Czech Republic to modify the existing maximum residue levels (MRLs) in pome fruits and to evaluate the confirmatory data identified in the framework of the MRL review under Article 12 of Regulation (EC) No 396/2005 as not available. To address the data gaps on residue trials, new trials according to the Good Agricultural Practices (GAPs) on apples, pears, medlars, quinces, loquats/Japanese medlars, apricots, peaches and beans with pods evaluated during the MRL review were not provided. These data gaps are not addressed. However, residue trials on apples and pears for an alternative GAP were provided and resulted by extrapolation in an MRL proposal for pome fruits lower than the current (tentative) MRL in EU legislation. The provided information may require a revision of the existing MRLs for pome fruits, apricots, peaches and beans with pods. Information on storage temperature of samples from the feeding study and a validated analytical method for animal commodities were submitted. The two data gaps on animal commodities were satisfactorily addressed. Adequate analytical methods for enforcement are available to control the residues of pyridaben in plant matrices under consideration and in all animal matrices, where currently an limit of quantification (LOQ) of 0.02 mg/kg is considered at the validated LOQ of 0.01 mg/kg. Based on the risk assessment results, EFSA concluded that the short-term and long-term intake of residues resulting from the uses of pyridaben according to the reported agricultural practices is unlikely to present a risk to consumer health.

Modification of the existing maximum residue levels for metaldehyde in flowering brassica and leafy brassica.

In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Glanzit Pfeiffer Gmbh & Co. KG submitted a request to the competent national authority in Germany to modify the existing maximum residue levels (MRLs) for the active substance metaldehyde in flowering brassica and leafy brassica. The data submitted in support of the request were found to be sufficient to derive MRL proposals for both brassica crop groups. Adequate analytical methods for enforcement are available to control the residues of metaldehyde on the commodities under consideration at the validated limit of quantification (LOQ) of 0.05 mg/kg. Based on the risk assessment results, EFSA concluded that the short-term and long-term intake of residues resulting from the intended uses of metaldehyde according to the reported agricultural practices is unlikely to present a risk to consumer health. The long-term consumer risk assessment shall be regarded as indicative only due to the data gaps identified for certain existing MRLs in the framework of the MRL review of metaldehyde according to Article 12 of Regulation (EC) No 396/2005.

Targeted review of maximum residue levels (MRLs) for bifenthrin.

In accordance with Article 43 of Regulation (EC) 396/2005, EFSA received a request from the European Commission to review the existing maximum residue levels (MRLs) for the non-approved active substance bifenthrin in view of the possible lowering of the MRLs. EFSA investigated the origin of the current EU MRLs. For existing EU MRLs that reflect previously authorised uses in the EU, or that are based on obsolete Codex maximum residue limits, or import tolerances that are not required any longer, EFSA proposed the lowering to the limit of quantification or to an alternative MRL. EFSA performed an indicative chronic and acute dietary risk assessment for the revised list of MRLs to allow risk managers to take the appropriate decisions. For some commodities, further risk management discussions are required to decide which of the risk management options proposed by EFSA should be implemented in the EU MRL legislation.

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 Syngenta Crop Protection AG submitted a request to the competent national authority in Germany to evaluate the confirmatory data that were identified for penconazole in the framework of the maximum residue level (MRL) review under Article 12 of Regulation (EC) No 396/2005 as not available. Moreover, in the application submitted to Germany, the applicant also included a request to raise the existing MRLs in pome fruits, raspberries and blackberries. To address the data gaps, detailed results on the metabolism substudy in tomato, a new storage stability on metabolites CGA127841, CGA132465 and CGA190503 and new residue trials were submitted. The data gap on metabolism was considered satisfactorily addressed. The data gap on complete sets of residue trials analysing simultaneously for monitoring and risk assessment residue definitions was considered addressed for raspberries, blackberries, pumpkins and watermelons; not addressed for pome fruits, stone fruits, grapes, gooseberries, tomatoes and aubergines. The new information provided justified an increase of the existing MRLs for pome fruits, plums, blackberries and raspberries and a revision of the risk assessment performed for penconazole. Adequate analytical methods for enforcement are available to control the residues of penconazole on the commodities under consideration at the validated limit of quantification (LOQ) of 0.01 mg/kg. Based on the risk assessment results, EFSA concluded that the short-term and long-term intake of residues resulting from the use of penconazole according to the reported agricultural practices is unlikely to present a risk to consumer health.

Modification of the existing maximum residue levels for pendimethalin in peas (with pods), beans (with pods) and leeks.

In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant BASF Agro B.V. submitted a request to the competent national authority in France to modify the existing maximum residue levels (MRLs) for the active substance pendimethalin in peas (with pods), beans (with pods) and leeks. The data submitted in support of the request were found to be sufficient to derive MRL proposals for the commodities under assessment. Adequate analytical methods for enforcement are available to control the residues of pendimethalin on the commodities under consideration at the validated LOQ of 0.01 mg/kg. Based on the risk assessment results, EFSA concluded that the short-term and long-term intake of residues resulting from the use of pendimethalin according to the reported agricultural practices is unlikely to present a risk to consumer health.

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

According to Article 12 of Regulation (EC) No 396/2005, EFSA has reviewed the maximum residue levels (MRLs) currently established at European level for the group of pesticide active substances cypermethrins. To assess the occurrence of cypermethrin, alpha-cypermethrin, zeta-cypermethrin, beta-cypermethrin residues in plants, processed commodities, rotational crops and livestock, EFSA considered the conclusions derived in the framework of Regulation (EC) No 1107/2009, the MRLs established by the Codex Alimentarius Commission (codex maximum residue limits; CXLs) for cypermethrin, alpha-cypermethrin and zeta-cypermethrin as well as the European authorisations and import tolerances reported by Member States and the UK (including the supporting residues data) for cypermethrin and zeta-cypermethrin. The toxicological profile of zeta-cypermethrin was also assessed. Based on the assessment of the available data, MRL proposals were derived, and a consumer risk assessment was carried out. Some information required by the regulatory framework was missing and a possible chronic/acute risk to consumer was identified. Hence, the consumer risk assessment is considered indicative only, all MRL proposals derived by EFSA still require further consideration by risk managers and measures for reduction of the consumer exposure should also be considered.

Evaluation of confirmatory data following the Article 12 MRL review for tebufenpyrad.

The applicant Belchim Crop Protection submitted a request to the competent national authority in Germany to evaluate the confirmatory data that were identified for tebufenpyrad in the framework of the maximum residue level (MRL) review under Article 12 of Regulation (EC) No 396/2005 as not available. To address the data gaps, new residue trials on peaches, apricots and raspberries (extrapolated to blackberries and dewberries) as well as a new analytical method for enforcement in animal commodities and its independent laboratory validation were submitted. The data gaps were considered satisfactorily addressed. The new information provided required a revision of the existing MRLs for peaches and apricots while the existing MRLs for blackberries and dewberries could be confirmed. An update of the consumer risk assessment for tebufenpyrad was performed in light of the new data submitted and it did not indicate any consumer intake concerns in relation to the chronic exposure and the acute exposure of the crops under consideration in the present assessment.

Setting of import tolerances for mandipropamid in papayas.

In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Syngenta Crop Protection AG submitted a request to the competent national authority in Austria to set an import tolerance for the active substance mandipropamid in papayas. The data submitted in support of the request were found to be sufficient to derive an maximum residue level (MRL) proposal of 0.8 mg/kg for papayas. Adequate analytical methods for enforcement are available to control the residues of mandipropamid on the commodity under consideration at the validated limit of quantification (LOQ) of 0.01 mg/kg. Based on the risk assessment results, EFSA concluded that long-term intake of residues resulting from the use of mandipropamid according to the reported agricultural practice is unlikely to present a risk to consumer health. The reliable end points, appropriate for use in regulatory risk assessment are presented.

Modification of the existing maximum residue levels for prothioconazole in garlic, onions and shallots.

In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Bayer SAS - Crop Science Division submitted a request to the competent national authority in the Netherlands to modify the existing maximum residue levels (MRLs) for the active substance prothioconazole in garlic, onions and shallots. The data submitted in support of the request were found to be sufficient to derive MRL proposals for garlic, onion and shallots. Adequate analytical methods for enforcement are available to control the residues of prothioconazole on the commodities under consideration at the validated limit of quantification (LOQ) of 0.02 mg/kg. Based on the risk assessment results, EFSA concluded that the short-term and long-term intake of residues resulting from the use of prothioconazole according to the reported agricultural practices is unlikely to present a risk to consumer health. An indicative exposure assessment to triazole derivative metabolites from the intended uses of prothioconazole did not indicate consumer intake concerns.

Setting of import tolerance for tricyclazole in rice.

In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Corteva Agriscience submitted a request to the competent national authority in Italy to set an import tolerance for the active substance tricyclazole in rice. The data submitted in support of the request were found to be sufficient to derive an maximum residue level (MRL) proposal for rice. Adequate analytical methods for enforcement are available to control the residues of tricyclazole in rice at the validated limit of quantification (LOQ) of 0.01 mg/kg. Based on the risk assessment results, EFSA concluded that the short-term and long-term intake of residues resulting from the use of tricyclazole according to the reported agricultural practice is unlikely to present a risk to consumer health.