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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. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

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 dithiocarbamates. To assess the occurrence of metiram, ziram, maneb and mancozeb residues in plants, processed commodities, rotational crops and livestock, EFSA considered the conclusions derived in the framework of Regulation (EU) No 1107/2009, the MRLs established by the Codex Alimentarius Commission (codex maximum residue limits; CXLs) as well as the European authorisations and the import tolerances reported by Member States and the UK (including the supporting residues data) for metiram and mancozeb. Propineb and thiram were not considered further in this assessment since it is expected that all uses for these compounds, including import tolerances, have been withdrawn after the lowering of all the MRLs to the limit of quantification (LOQ) following the EFSA MRLs reviews completed, respectively, in 2020 and 2021. When reviewing the MRLs for the common residue definition (determined and expressed as CS2), EFSA was requested to consider also the monitoring data from organic samples collected and made available by the EURLs, reflecting the sulfur naturally occurring in crops and not related to the uses of the dithiocarbamates. 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 consumers 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. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Landesanstalt für Landwirtschaft und Gartenbau (LLG) submitted a request to the competent national authority in Germany to modify the existing maximum residue levels (MRLs) for the active substance spirotetramat in herbs and edible flowers. The data submitted in support of the request were found to be sufficient to derive MRL proposals for the group of herbs and edible flowers. Adequate analytical methods for enforcement are available to control the residues of spirotetramat and its metabolite spirotetramat‐enol on the commodities under consideration at the validated limit of quantification (LOQ) of 0.01 mg/kg for each analyte. Based on the risk assessment results, EFSA concluded that the short‐term and long‐term intake of residues resulting from the use of spirotetramat according to the reported agricultural practice is unlikely to present a risk to consumer health. [ABSTRACT FROM AUTHOR]

The applicant Proplan Plant Protection Company submitted a request to the competent national authority in Austria (originally the United Kingdom) to evaluate the confirmatory data that were identified for paclobutrazol in the framework of the MRL review under Article 12 of Regulation (EC) No 396/2005 as not available. To address the data gaps, two new metabolism studies performed on apples were submitted. In addition, two studies on the magnitude of residues in apples and pears providing data for triazole derivative metabolites were also submitted. The data gaps were considered satisfactorily addressed. The new information provided did not require a revision of the existing MRLs for pome fruits, apricots and peaches. An update of the risk assessment was performed for paclobutrazol and for the triazole derivative metabolites in light of the new data submitted and did not indicate any consumer intake concerns. [ABSTRACT FROM AUTHOR]

In compliance with Article 43 of Regulation (EC) No 396/2005, the European Food Safety Authority (EFSA) received a mandate from the European Commission to perform a targeted review of the existing maximum residues levels (MRLs) for the active substance haloxyfop‐P to check whether the existing EU MRL in onions, sunflower seeds and soya beans (covering codex maximum residue limits (CXLs) or import tolerances) and the proposed import tolerance MRLs in linseeds, rapeseeds/canola seeds are safe for consumers and can eventually be maintained in the MRL Regulation after the expiry of the approval of the active substance. EFSA screened these MRLs considering the toxicological reference values established during the EU peer review process for the renewal of the approval of haloxyfop‐P and identified chronic consumer intake concerns for two diets when for the remaining plant and animal commodities, the input values were at the LOQ. Fall‐back MRLs could not be proposed, but the additional information provided by EURLs allowed to resolve the chronic intake concerns using lower validated LOQs for a range of plant commodities and milk. EFSA concludes that the existing EU MRLs in soya beans and onions, the CXL in sunflower seeds and the proposed import tolerances in linseed and rapeseed/canola seeds are not expected to pose a risk to consumers. However, to guarantee consumer's safety regarding the chronic exposure to haloxyfop‐P residues, the enforcement LOQs in several plant commodities and milks would have to be lowered to the levels reported by the EURLs. [ABSTRACT FROM AUTHOR]

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 pesticide active substance pyriproxyfen. To assess the occurrence of pyriproxyfen 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 as well as the import tolerances and European authorisations reported by Member States and the UK (including the supporting residues data). Based on the assessment of the available data, MRL proposals were derived and a consumer risk assessment was carried out. Although no apparent risk to consumers was identified, some information required by the regulatory framework was missing. Hence, the consumer risk assessment is considered indicative only and most MRL proposals derived by EFSA still require further consideration by risk managers. [ABSTRACT FROM AUTHOR]

In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Sumitomo Chemical Agro Europe S.A.S. submitted a request to the competent national authority in Greece to modify the existing maximum residue levels (MRLs) for the active substance pyriproxyfen in apricots and peaches. The data submitted in support of the request were found to be sufficient to derive MRL proposal of 0.4 mg/kg for apricots, whereas for peaches an MRL amendment is not necessary. Adequate analytical methods for enforcement are available to control the residues of pyriproxyfen 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 intended use of pyriproxyfen on apricots and peaches according to the reported agricultural practice is unlikely to present a risk to consumer health. [ABSTRACT FROM AUTHOR]

In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Nissan Chemical Europe S.A.S. submitted a request to the competent national authority in the Netherlands to set an import tolerance for the active substance pyridaben in grapefruits imported from the United States of America. The data submitted in support of the requests were found to be sufficient to derive an MRL proposal of 0.5 mg/kg for grapefruits. Adequate analytical methods for enforcement are available to control the residues of pyridaben on the commodity under consideration, at or above 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 on imported grapefruits from United States according to the reported agricultural practices, is unlikely to present a risk to consumer health. [ABSTRACT FROM AUTHOR]

In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Nufarm Europe Gmbh submitted a request to the competent national authority in Austria to modify the existing maximum residue levels (MRLs) for the active substance acetamiprid in honey, linseeds, poppy seeds, mustard seeds and gold of pleasure seeds. The data submitted in support of the request were found to be sufficient to derive MRL proposals for linseeds, poppy seeds, mustard seeds and gold of pleasure seeds. For honey, however, data gaps were identified by EFSA and were not fully addressed by the justification provided by the applicant. Considering the remaining uncertainties, risk managers are given the option to either accept the justification provided and the related uncertainties or to merge the provided data with a data set from a previous application to derive an MRL proposal. Adequate analytical methods for enforcement are available to control the residues of acetamiprid in plant matrices and in honey 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 acetamiprid according to the reported agricultural practices is unlikely to present a risk to consumer health. [ABSTRACT FROM AUTHOR]

In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Agriphar SA submitted a request to the competent national authority in Ireland to modify the existing maximum residue levels (MRLs) for the active substance triclopyr in oranges, lemons and mandarins. The data submitted in support of the request were found to be sufficient to derive an MRL proposal for these commodities. Adequate analytical methods for enforcement are available to control the residues of triclopyr in the 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 triclopyr according to the reported agricultural practice is unlikely to present a risk to consumer health. [ABSTRACT FROM AUTHOR]

In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Spiess‐Urania Chemicals GmbH submitted a request to the competent national authority in Austria to modify the existing maximum residue levels (MRLs) for the active substance copper compounds in the whole group of other small fruits and berries. The data submitted in support of the request were found to be sufficient to derive MRL proposals for the whole subgroup of other small fruits and berries. Adequate analytical methods for enforcement of mineral copper independently from its chemical form are available for matrices under consideration at the validated limit of quantification (LOQ) of 5 mg/kg. Based on indicative risk assessment results, EFSA concluded that the long‐term intake of copper residues resulting from the intended and existing uses, natural background levels and monitoring levels might present a risk to consumer health. Although residues in other small fruits and berries are minor contributors to the overall consumer exposure, a risk management decision has to be taken on whether it is appropriate to increase the existing MRLs for these crops, given that a potential consumer intake concern could not be excluded. [ABSTRACT FROM AUTHOR]

The applicant Syngenta Crop Protection AG submitted a request to the competent national authority in Spain to evaluate the confirmatory data that were identified for 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, a new storage stability study, new residues trials and a validated analytical enforcement method for the determination of the relevant residues in animal products were submitted. The data gaps were considered satisfactorily addressed for the plant commodities. The new information provided required a revision of the existing MRL for avocados. As regards the commodities of animal origin, the data gaps were only partially addressed and therefore further risk management considerations are required regarding the revision of the existing MRLs which were derived from Codex MRLs. The risk assessment performed for thiabendazole was also updated. No risk was identified. [ABSTRACT FROM AUTHOR]

In accordance with Article 6 of Regulation (EC) No 396/2005, the Federal Public Service (FPS) Health, Food chain Safety and Environment submitted a request on behalf of Belgium (evaluating Member State, EMS) to modify the existing maximum residue level (MRL) for the active substance pyridate in chives. The data submitted in support of the request were found to be sufficient to derive an MRL proposal for chives. Adequate analytical methods for enforcement are available to control the residues of pyridate on the commodity under consideration at the validated limit of quantification (LOQ) of 0.05 mg/kg pyridate equivalent. Based on the risk assessment results, EFSA concluded that the short‐term and long‐term intake of residues resulting from the use of pyridate according to the reported agricultural practice is unlikely to present a risk to consumer health. [ABSTRACT FROM AUTHOR]

In compliance with Article 43 of Regulation (EC) No 396/2005, EFSA received a mandate from the European Commission to perform a targeted review of the maximum residue levels (MRLs) for indoxacarb based on Codex maximum residue limits (CXLs) or on import tolerances which might still be maintained after the expire of the approval of the active substance. EFSA screened the existing MRLs based on CXLs or on import tolerances considering the new toxicological reference values established during the peer review process for the renewal of the approval of indoxacarb and identified the MRLs for which an acute risk could not be excluded and several MRLs that are unlikely to pose a risk for consumers. Fall‐back MRLs could not be proposed for the commodities exceeding the new toxicological reference values as no further data were provided during the call for data. Therefore, risk managers may consider maintaining only the MRLs identified during the screening as safe for consumers. However, for some of the proposed MRLs, further consideration by risk managers is needed due to the uncertainties identified. [ABSTRACT FROM AUTHOR]

In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant DuPont submitted a request to the competent national authority in Ireland to set an import tolerance for the active substance oxathiapiprolin in blueberries in support of an authorised use in the United States. The data submitted in support of the request were found to be sufficient to derive a maximum residue level (MRL) proposal for highbush blueberries by noting that lowbush blueberries (Vaccinium angustifolium) are excluded from the authorised use in the United States. Adequate analytical methods for enforcement are available to control the residues of oxathiapiprolin in plant matrices at the validated limit of quantification (LOQ) of 0.01 mg/kg. Based on the risk assessment results, EFSA concluded that the long‐term intake of residues resulting from the use of oxathiapiprolin according to the reported agricultural practice is unlikely to present a risk to consumer health. [ABSTRACT FROM AUTHOR]

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 Portugal to modify the existing maximum residue levels (MRLs) for the active substance prosulfocarb in herbs and edible flowers. The data submitted in support of the request were found to be sufficient to derive MRL proposals for the group of herbs and edible flowers. Adequate analytical methods for enforcement are available to control the residues of prosulfocarb 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 prosulfocarb according to the reported agricultural practice is unlikely to present a risk to consumer health. [ABSTRACT FROM AUTHOR]

In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Probelte SA submitted a request to the competent national authority in Spain to modify the existing maximum residue levels (MRLs) for the active substance folpet in lettuces. The data submitted in support of the request were found to be sufficient to derive an MRL proposal for lettuces. Adequate analytical methods for enforcement are available to control the residues of folpet and phthalimide in high water content commodities at the validated LOQ values of 0.05 mg/kg for folpet and 0.01 mg/kg for phthalimide. Based on the risk assessment results, EFSA concluded that the short‐term and long‐term intake of residues resulting from the use of folpet according to the reported agricultural practice is unlikely to present a risk to consumer health. [ABSTRACT FROM AUTHOR]

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 modify the existing maximum residue levels (MRLs) for the active substance sulfoxaflor in lettuce and salad plants (except lettuce), beans with pods and peas without pods. The data submitted in support of the request were found to be sufficient to derive MRL proposals for all crops under consideration. Adequate analytical methods for enforcement are available to control the residues of sulfoxaflor 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 sulfoxaflor according to the reported agricultural practices is unlikely to present a risk to consumer health. [ABSTRACT FROM AUTHOR]

In accordance with Article 6 of Regulation (EC) No 396/2005, the applicants FMC International and Syngenta Crop Protection submitted two requests to the competent national authority in France, respectively, to set import tolerances for the active substance cyantraniliprole in various crops and to modify the existing maximum residue levels (MRLs) in apricots. The data submitted in support of the requests were found sufficient to derive MRL proposals for apricots, potatoes, tropical root and tuber vegetables, cucurbits (inedible peel), lettuces and salad plants, Chinese cabbage and other leafy brassica (except kale), spinaches and similar leaves (except spinach), parsley and minor oilseeds. Based on the risk assessment results, EFSA concluded that the dietary intake of residues resulting from the uses of cyantraniliprole according to the reported agricultural practices is unlikely to present a risk to consumer health for the parent compound. A definitive conclusion on the risk for consumers cannot be derived for the degradation products IN‐N5M09 and IN‐F6L99 which are formed during cooking/boiling. For both compounds, the concerns on genotoxicity have been ruled out, but the general toxicity has not been addressed. The indicative exposure calculated by the EMS and EFSA for these compounds is affected by non‐standard uncertainties but can support risk managers to take an informed decision on the requested modification of the existing MRLs for the crops under assessment. [ABSTRACT FROM AUTHOR]

In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Bayer SAS submitted a request to the competent national authority in Austria to set import tolerances for the active substance deltamethrin in mangoes and papayas. The data submitted in support of the request were found to be sufficient to derive maximum residue level (MRL) proposals for mangoes and papayas. Adequate analytical methods for enforcement are available to control the residues of deltamethrin (cis‐deltamethrin) in plant matrices 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 deltamethrin according to the reported agricultural practices is unlikely to present a risk to consumer health. The risk assessment shall be regarded as indicative and affected by non‐standard uncertainties. [ABSTRACT FROM AUTHOR]

The applicant Syngenta Crop Protection AG submitted a request to the competent national authority in Sweden to evaluate the confirmatory data that were identified for diquat in the framework of the MRL review under Article 12 of Regulation (EC) No 396/2005 as not available. The applicant provided sufficient data to address the data gaps related to plant metabolism studies and analytical methods for plant and animal products. The data gap requesting further studies to investigate the nature of residues of diquat and its metabolite TOPPS in processed products was not sufficiently addressed. Considering the new studies submitted under the current application and considering that the EU uses for diquat had to be withdrawn following a decision on non‐approval, EFSA proposed the lowering of the existing MRLs to the appropriate limit of quantifications for the commodities under assessment. In addition, EFSA proposed to perform a more comprehensive review of the existing MRLs that were not subject to the current assessment, taking into account the findings and conclusions of the peer review, the consequences of the non‐approval decision and the revisions of Codex MRLs. [ABSTRACT FROM AUTHOR]

In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Agro‐Kanesho submitted a request to the competent national authority in Germany to modify the existing maximum residue level (MRL) for the active substance acequinocyl in sweet peppers/bell peppers. The data submitted in support of the request were found to be sufficient to derive MRL proposal for peppers. Adequate analytical methods for enforcement are available to control the residues of acequinocyl in peppers 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 acequinocyl according to the reported agricultural practice is unlikely to present a risk to consumer health. [ABSTRACT FROM AUTHOR]

The applicants Bayer SAS – Crop Science Division, Diachem S.p.A. and Isagro S.p.A., submitted two requests to the competent national authority in Austria to evaluate the confirmatory data identified for deltamethrin in the framework of the maximum residue level (MRL) review under Article 12 of Regulation (EC) No 396/2005 as not available. The application from Bayer SAS – Crop Science Division also included a proposal for the modification of the MRL for deltamethrin in tomatoes in accordance with Article 6 of Regulation (EC) No 396/2005. A third application was submitted by the Federal Public Service (FPS) Health, Food chain safety and Environment on behalf of Belgium, to modify the existing maximum residue level for the active substance in okra/lady's fingers. The three applications were combined by EFSA under the current assessment. The data gaps based on monitoring analytical methods were addressed; the data gaps on storage stability studies, processing trials in potatoes, metabolism studies of deltamethrin isomers in livestock and livestock feeding studies were not addressed by providing the requested experimental data; data gap on residue trials analysing simultaneously for monitoring and risk assessment residue definitions was not addressed for most of the concerned crops and requires risk managers' decisions in numerous cases. The new information provided requires a revision of certain existing MRLs. Adequate analytical methods for enforcement are available to control the residues of deltamethrin in plant and animal matrices at the validated limit of quantification (LOQ) of 0.01 mg/kg. Based on the results of the refined risk assessment following evaluation of the confirmatory data, EFSA concluded that the short‐term and long‐term intake of residues resulting from the proposed uses of deltamethrin according to the reported agricultural practices are unlikely to present a risk to consumer health. The risk assessment shall be regarded as indicative and affected by non‐standard uncertainties. [ABSTRACT FROM AUTHOR]

In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Landwirtschaftliches Technologiezentrum Augustenberg submitted a request to the competent national authority in Germany to modify the existing maximum residue levels (MRLs) for the active substance spirotetramat in crops belonging to the group of other small fruits and berries. The data submitted to support the MRL application were sufficient to derive MRL proposals for the crops concerned. Adequate analytical methods are available to enforce the proposed MRLs. Based on the risk assessment results, EFSA concluded that the short‐term and long‐term intake of residues resulting from the use of spirotetramat according to the reported agricultural practices is unlikely to present a risk to consumer health. [ABSTRACT FROM AUTHOR]

In accordance with Article 53 of Regulation (EC) 1107/2009, the United Kingdom granted two 120‐day emergency authorisations for the use of plant protection products containing the active substance cyantraniliprole in Chinese cabbages, raspberries and blackberries. The applicants (Agriculture & Horticulture Development Board (AHDB)) and FMC Agro Ltd) requested the setting of temporary maximum residue levels (MRLs) for cyantraniliprole in Chinese cabbages, raspberries and blackberries. The United Kingdom, as evaluating Member State (EMS), summarised the data provided by the applicants in two evaluation reports which were submitted to the European Commission and forwarded to EFSA. Adequate analytical methods for enforcement are available to control the residues of cyantraniliprole on the commodities under consideration at the validated limit of quantification (LOQ) of 0.01 mg/kg. Sufficient residue trials were submitted to calculate MRL proposals for the crops under assessment. Based on the risk assessment results, EFSA concluded that the long‐term intake of residues resulting from the use of parent cyantraniliprole in crops under assessment according to the reported emergency agricultural practice is unlikely to present a risk to consumer health. Due to data gaps related to the toxicological profile of degradation products generated during processing, the risk assessment for processed products could not be finalised. [ABSTRACT FROM AUTHOR]

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 modify the existing maximum residue level (MRL) for the active substance boscalid in honey and other apiculture products. The data submitted in support of the request were found to be sufficient to derive an MRL proposal for honey from field studies. This MRL proposal covers residues measured in honey samples analysed in the framework of EU National Monitoring Programmes. Adequate analytical methods for enforcement are available to control the residues of boscalid in honey at the validated limit of quantification (LOQ) of 0.01 mg/kg. Based on the risk assessment results, EFSA concluded that residues concentrations in honey at the level of the proposed MRL are unlikely to present a risk to consumer health. [ABSTRACT FROM AUTHOR]

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 pesticide active substance hymexazol. To assess the occurrence of hymexazol residues in plants, processed commodities, rotational crops and livestock, EFSA considered the conclusions derived in the framework of Commission Regulation (EC) No 33/2008 as well as the European authorisations reported by Member States (including the supporting residues data). Based on the assessment of the available data, MRL proposals were derived and a consumer risk assessment was carried out. All information required by the regulatory framework was present and a risk to consumers was not identified. [ABSTRACT FROM AUTHOR]

In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Landwirtschaftliches Technologiezentrum Augustenberg submitted a request to the competent national authority in Germany to modify the existing maximum residue level (MRL) for the active substance bifenazate in elderberries. The data submitted in support of the request were found to be sufficient to derive an MRL proposal for the crop concerned. Adequate analytical methods for enforcement are available to control the residues of bifenazate and its metabolite in elderberries at the validated limit of quantification (LOQ) of 0.01 mg/kg. Based on the risk assessment results, EFSA concluded that the dietary intake of residues resulting from the use of bifenazate according to the intended agricultural practice is unlikely to present a risk to consumer health. [ABSTRACT FROM AUTHOR]

In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant FMC Agro Ltd submitted a request to the competent national authority in the United Kingdom to set import tolerances for the active substance chlorantraniliprole in oil palms fruits and oil palms kernels. The data submitted in support of the request were found to be sufficient to derive maximum residue level (MRL) proposals for these products. Adequate analytical methods for enforcement are available to control the residues of chlorantraniliprole 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 long‐term intake of residues resulting from the use of chlorantraniliprole according to the reported agricultural practice is unlikely to present a risk to consumer health. [ABSTRACT FROM AUTHOR]

In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant H.L Hutchinson Ltd submitted a request to the competent national authority in the United Kingdom to modify the existing maximum residue level (MRL) for the active substance pyraclostrobin in sweet corn. The data submitted in support of the request were found to be sufficient to derive an MRL proposal for sweet corn. An analytical method for MRL enforcement and its independent laboratory validation, using liquid chromatography with tandem mass spectrometry (LC‐MS/MS) was sufficiently validated at a 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 pyraclostrobin according to the reported agricultural practice is unlikely to present a risk to consumer health. [ABSTRACT FROM AUTHOR]

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 pesticide active substance penflufen. To assess the occurrence of penflufen residues in plants, processed commodities, rotational crops and livestock, EFSA considered the conclusions derived in the framework of Regulation (EC) No 1107/2009 and Commission Regulation (EU) No 188/2011, as well as the European authorisations reported by Member States (including the supporting residues data). Based on the assessment of the available data, MRL proposals were derived and a consumer risk assessment was carried out. Although no apparent risk to consumers was identified, some information required by the regulatory framework was missing. Hence, the consumer risk assessment is considered indicative only and the MRL proposal for potatoes derived by EFSA still requires further consideration by risk managers. [ABSTRACT FROM AUTHOR]

The applicant DuPont de Nemours (Deutschland) GmbH submitted a request to the competent national authority in Austria to evaluate confirmatory data identified for cymoxanil in the framework of the maximum residue level (MRL) review under Article 12 of Regulation (EC) No 396/2005 and implemented in the EU MRL Regulation. To address the data gap on table and wine grapes, lettuce and spinach, the applicant submitted new residue trials for cymoxanil on these commodities. The data gap was considered satisfactorily addressed. Confirmatory data on analytical methods for enforcement in hops and herbal infusions (dried flower), and storage stability data in dry matrices were not submitted with the present application. Based on the available information, a revision of the existing MRLs for table and wine grapes, spinach and pulses should be considered by risk managers. [ABSTRACT FROM AUTHOR]

The applicant BASF SE submitted a request to the competent national authority in the Netherlands to evaluate the confirmatory data that were identified for active substance metazachlor in the framework of the review of maximum residue levels (MRLs) under Article 12 of Regulation (EC) No 396/2005 as not available. The data gaps identified during the MRL review were satisfactorily addressed for flowering brassica, head cabbages, kales and kohlrabies. The applicant no longer supported the uses on radishes, turnips, horseradishes and swedes assessed during the MRL review. In addition, in accordance with Article 6 of Regulation (EC) No 396/2005, the applicant submitted a request to modify the existing MRLs in turnips, swedes, horseradishes and leeks to reflect intended new uses. Nevertheless, the residue data submitted were not fully compliant with the currently applicable data requirements. For turnips, horseradishes and swedes, the applicant and the Netherlands requested EFSA to present the data and the deficiencies identified to allow risk managers to take an informed decision on the appropriate MRLs. A change of the existing MRLs for liver of swine and ruminants resulting from the authorised and intended uses of metazachlor is also proposed. EFSA updated the most recent consumer risk assessment for metazachlor and concluded that the long‐term and short‐term dietary intake is unlikely to present a risk to consumer health. [ABSTRACT FROM AUTHOR]

In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant BASF SE submitted an application to the competent national authority in the Netherlands to modify the existing maximum residue levels (MRLs) for bentazone in soyabeans and poppy seeds. The data submitted in support of the request were found to be sufficient to derive MRL proposals for both commodities. Adequate analytical methods for enforcement are available to control the residues of bentazone and its metabolites in plant matrices under consideration. The studies requested by EFSA in the framework of the peer review to address the toxicological properties of metabolite 6‐hydroxy‐bentazone were only partially provided. Instead of studies investigating the general toxicity of this metabolite, the applicant provided an argumentation to justify read‐across from the available information on parent bentazone and 8‐hydroxy‐bentazone. EFSA did not agree with the provided reasoning for read‐across. Therefore, the EMS asked EFSA to continue the assessment despite the data gap. EFSA performed an indicative short‐term and long‐term dietary risk assessment; the calculated dietary exposure was well below the toxicological reference values. The risk assessment however is affected by additional, non‐standard uncertainties resulting from data gap related to the toxicological properties for 6‐hydroxy‐bentazone. [ABSTRACT FROM AUTHOR]

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 pesticide active substance emamectin. To assess the occurrence of emamectin 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 as well as the European authorisations reported by Member States (including the supporting residues data). 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 acute risk to consumers was identified. Hence, the consumer risk assessment is considered indicative only, some MRL proposals derived by EFSA still require further consideration by risk managers and measures for reduction of the consumer exposure should also be considered. [ABSTRACT FROM AUTHOR]

The applicant Dow AgroSciences submitted a request to the competent national authority in France to evaluate the confirmatory data that were identified for oryzalin 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 identified, residue trials on apples were submitted which are appropriate to conclude on the residue situation in kiwi fruits; furthermore, new residue trials on asparagus and on bananas were also provided. The information submitted to address the primary crop metabolism on asparagus was considered not sufficient to elucidate the nature of residues expected in asparagus. Thus, since the data gap for asparagus was not fully addressed, risk managers may consider the deletion of the existing MRL. For kiwi fruits and bananas, the previously derived MRLs do not have to be modified. [ABSTRACT FROM AUTHOR]

In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Agro‐Kanesho submitted a request to the competent national authority in Germany to modify the existing maximum residue level (MRLs) for the active substance acequinocyl in citrus fruits. The data submitted in support of the request were found to be sufficient to derive MRL proposals for grapefruits, oranges, lemons, limes and mandarins. Adequate analytical methods for enforcement are available to control the residues of acequinocyl 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 acequinocyl according to the reported agricultural practice is unlikely to present a risk to consumer health. [ABSTRACT FROM AUTHOR]

In accordance with Article 6 of Regulation (EC) No 396/2005, the Federal Public Service Health, Food chain Safety and Environment of Belgium, submitted an application to modify the existing maximum residue levels (MRLs) for the active substance flonicamid in blueberries, cranberries, currants, gooseberries and strawberries. The data submitted in support of the request were found to be sufficient to derive MRL proposals for the crops assessed. Adequate analytical methods for enforcement are available to control the residues of flonicamid in plant matrices under consideration at the validated limit of quantification (LOQ) of 0.01 mg/kg for each analyte included in the residue definition (combined LOQ of 0.03 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 flonicamid according to the reported agricultural practices is unlikely to present a risk to consumer health. [ABSTRACT FROM AUTHOR]

In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant LAINCO S.A. submitted a request to the competent national authority in Greece to modify the existing maximum residue levels (MRLs), currently expressed as fosetyl in the MRL Regulation, resulting from the use of the active substance potassium phosphonates on apricots, cherries and plums. The data submitted in support of the request were found to be sufficient to derive MRL proposals and address the data gap for residue trials compliant with the Southern EU uses identified in the joint MRL review for cherries and plums, but insufficient for apricots. Adequate analytical methods for enforcement are available to control the residues on the commodities under consideration. Based on the risk assessment results, EFSA concluded that the long‐term intake of residues resulting from the uses of potassium phosphonates according to the intended agricultural practices is unlikely to present a risk to consumer health. [ABSTRACT FROM AUTHOR]