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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]

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]

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 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 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]

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 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 Syngenta Crop Protection AG submitted a request to the competent national authority in Austria to set an import tolerance for the active substance azoxystrobin in sugar beet roots. The data submitted in support of the request were found to be sufficient to derive maximum residue level (MRL) proposals for sugar beet roots. However, robust processing factors for Annex VI in view of monitoring of residues in processed commodities could not be derived. Adequate analytical methods for enforcement are available to control the residues of azoxystrobin in plant and animal matrices 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 azoxystrobin 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 BASF Agro BV Arnhem submitted a request to the competent national authority in Austria to set and modify the maximum residue levels (MRLs) for the active substance mefentrifluconazole in various products of plant and animal origin. The data submitted in support of the request were found to be sufficient to derive MRL proposals for pome fruits, apricots, cherries, peaches, plums, grapes, potatoes, sweet corns, maize, sunflower seeds, rapeseeds, sugar beet roots, swine liver, bovine kidney and ruminant milk. Adequate analytical methods for enforcement are available to control the residues of mefentrifluconazole in plant and animal matrices at the validated limit of quantification (LOQ) of 0.01 mg/kg. A consumer risk assessment was performed for mefentrifluconazole. The short‐term and the long‐term intake of parent mefentrifluconazole resulting from the intended uses is unlikely to present a risk to consumer health. EFSA also performed an indicative risk assessment for the following four metabolites of mefentrifluconazole, which are called triazole derivative metabolites (TDMs): triazole alanine (TA), triazole lactic acid (TLA), triazole acetic acid (TAA) and 1,2,4‐triazole (1,2,4‐T). These metabolites are common metabolites for a number of triazole fungicides. For the TDM risk assessment, EFSA took into account not only data from the intended uses of mefentrifluconazole but also the information available from various triazole pesticides previously assessed. Overall, the estimated exposure for TDMs did not exceed the toxicological reference values, noting that the consumer exposure assessments for the TDMs are affected by uncertainties related to the data gaps identified in the EU peer review of confirmatory data for TDMs. [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]