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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]

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 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]

In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant DLR‐Rheinpfalz submitted a request to the competent national authority in Germany to modify the existing maximum residue level (MRL) for the active substance oxathiapiprolin in kales, with the specific intention to derive an MRL in radish leaves (classified under the subgroup of kales), based on an intended NEU use on radishes. The residue data in radish leaves submitted in support of the request were found to be sufficient to derive MRL proposal for this commodity which could be applicable also for kales. Adequate analytical methods for enforcement are available to control the residues of oxathiapiprolin in radishes at the validated 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 on radishes 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 Agro GmbH submitted a request to the competent national authority in Germany to modify the existing maximum residue levels (MRLs) for the active substance benzovindiflupyr in fresh herbs and edible flowers. The data submitted in support of the request were found to be sufficient to derive MRL proposals for the crops under assessment. Adequate analytical methods for enforcement are available to control the residues of benzovindiflupyr 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 benzovindiflupyr 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 Syngenta Agro GmbH submitted a request to the competent national authority in Germany to modify the existing maximum residue levels (MRL) for the active substance cyprodinil in blueberries, cranberries, currants and gooseberries. The data submitted in support of the request were found to be sufficient to derive MRL proposals for blueberries, cranberries, currants and gooseberries. Adequate analytical methods for enforcement are available to control the residues of cyprodinil 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 uses of cyprodinil on blueberries, cranberries, currants and gooseberries according to the reported agricultural practices will not result in a consumer exposure exceeding the toxicological reference value and therefore 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 UPL Europe Ltd. submitted an application to the competent national authority in Germany (evaluating Member State, EMS) to raise the existing maximum residue level (MRL) to 0.15 mg/kg for the active substance phenmedipham in celeriac. The submitted residue trials are sufficient to derive a tentative MRL of 0.15 mg/kg, pending further investigation of nature of phenmedipham residues in root crops. For this assessment EFSA considered that the available sugar beet metabolism data can be extrapolated to celeriac on a tentative basis. The acceptability of such proposal shall be further considered by risk managers. Adequate analytical methods for enforcement are available to control the residues of phenmedipham in celeriac at the validated limit of quantification (LOQ) of 0.01 mg/kg. Since the current MRL application was submitted before the finalisation of the EU pesticides peer review of the renewal of the approval of phenmedipham, the consumer exposure assessment was performed according to the conclusions on the toxicity of phenmedipham from the first approval under Directive 91/414/EEC. Accordingly, the long-term intake of residues of phenmedipham resulting from the existing and the intended uses does not indicate a risk to consumer health. The present assessment does not consider the data gaps identified in the context of the renewal of the approval of phenmedipham under Regulation (EC) No 1107/2009 which prevented experts to derive toxicological reference values (TRVs) for phenmedipham, to derive the risk assessment residue definition for root crops other than sugar beet and to conclude on the toxicity of relevant metabolites. [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 phenmedipham in strawberries. Noting that at least one additional trial is missing, an MRL of 0.7 mg/kg was derived for the intended NEU use of phenmedipham on strawberries. Adequate analytical methods for enforcement are available to control the residues of phenmedipham in strawberries at the validated limit of quantification (LOQ) of 0.01 mg/kg. Since the current MRL application was submitted before the finalisation of the EU pesticides peer review of the renewal of the approval of phenmedipham, the consumer exposure assessment was performed according to the conclusions on the toxicity of phenmedipham from the first approval under Directive 91/414/EEC. Accordingly, the long‐term intake of residues of phenmedipham resulting from the existing and the intended uses is unlikely to present a risk to consumer health. EFSA notes that the present assessment does not take into account the data gaps identified in the context of the renewal of the approval of phenmedipham under Regulation (EC) No 1107/2009, which prevented experts to derive toxicological reference values (TRVs) for phenmedipham, to derive the risk assessment residue definition for fruit crops and to conclude on the toxicity of relevant metabolites. [ABSTRACT FROM AUTHOR]

In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Landesanstalt für Landwirtschaftund Gartenbau (LLG) submitted two applications to the competent national authority in Germany to modify the existing maximum residue levels (MRLs) for the active substance fluroxypyr in chives, celery leaves, parsley, thyme and basil and edible flowers. The data submitted in support of the request were found to be sufficient to derive MRL proposals for the commodities under consideration, except for thyme for which a tentative MRL proposal was derived for further risk management considerations. Adequate analytical methods for enforcement are available to control the residues of fluroxypyr 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 intake of residues resulting from the use of fluroxypyr 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, Dienstleistungszentrum Ländlicher Raum Rheinpfalz, submitted a request to the competent national authority in Germany to modify the existing maximum residue level (MRL) for the active substance picloram in flowering brassica. The data submitted in support of the request were found to be sufficient to derive an MRL proposal for broccoli, cauliflowers and other flowering brassica. Adequate analytical methods for enforcement are available to control the residues of picloram and its conjugates 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 picloram according to the reported agricultural practices 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 Indofil Industries Limited submitted a request to the competent national authority in Germany to modify the existing maximum residue levels (MRLs) for the active substance mancozeb in garlic, broccoli, cauliflowers and leeks. The data submitted in support of the request were found to be sufficient to derive MRL proposals for the crops under consideration. Based on the risk assessment results, EFSA derived recommendations for further consideration by the risk managers. Adequate analytical methods for enforcement are available to control the residues of mancozeb in the crops under consideration. [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 aclonifen in fennel seed and caraway fruit. The data submitted in support of the request were found to be sufficient to derive MRL proposals for the crops under consideration. Adequate analytical methods for enforcement are available to control the residues of aclonifen in the 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 uses of aclonifen 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 LLG Sachsen‐Anhalt, Dez. Pflanzenschutz submitted a request to the competent national authority in Germany to modify the existing maximum residue levels (MRLs) for copper compounds in herbs and edible flowers. The data submitted in support of the request were found sufficient to derive an MRL proposal of 150 mg/kg, confirming the MRL proposal of the MRL review, for copper compounds in herbs and edible flowers in support of the intended indoor use. Based on the 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 herbs and edible flowers are minor contributors to the overall consumer exposure, a risk management decision has to be taken 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 Syngenta Agro GmbH submitted a request to the competent national authority in Germany to modify the existing maximum residue level (MRL) for the active substance fludioxonil in elderberries in support of the intended NEU use. The data submitted in support of the request were found to be sufficient to derive an MRL proposal of 4 mg/kg for elderberries, as an extrapolation from red and black currants and blueberries. Adequate analytical methods for enforcement are available to control the residues of fludioxonil in the plant matrix 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 intended use of fludioxonil according to the reported agricultural practice and from the existing authorised uses 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 Tilco‐Alginure GmbH submitted a request to the competent national authority in Germany to modify the existing maximum residue levels (MRL) for the active substance potassium phosphonates in flowering brassica, Chinese cabbages, kales and spinaches. The data submitted in support of the request were found to be sufficient to derive MRL proposals for all the crops under assessment. Adequate analytical methods for enforcement are available to control residues of potassium phosphonates in the crops under assessment. Based on the risk assessment results, 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. The consumer risk assessment shall be regarded as indicative and a more realistic intake assessment will be performed in the framework of the MRL review for potassium phosphonates. 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 Syngenta Agro GmbH submitted two individual requests to the competent national authority in Germany to modify the existing maximum residue levels (MRLs) for the active substance mandipropamid in kohlrabies and in the crop group of herbs and edible flowers, respectively. The data submitted in support of the requests were found to be sufficient to derive MRL proposals for kohlrabies and for the group of herbs and edible flowers. Adequate analytical methods for enforcement are available to control the residues of mandipropamid in the crops under consideration at the validated limit of quantification (LOQ) of 0.01 mg/kg. Based on the indicative risk assessment results, EFSA concluded that the short‐term and long‐term intake of residues resulting from the use of mandipropamid according to the intended agricultural practices 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 Dow AgroSciences submitted a request to the competent national authority in Germany to evaluate the confirmatory data that were identified for fluroxypyr 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 method of analysis for plant matrices, information on metabolism in onions, revised Good Agricultural Practices (GAPs) and reside trials on apples, onions and grass, argumentation regarding the efficiency of the hydrolysis step and information on storage stability in plant matrices and products of animal origin were submitted. A ruminant metabolism study with fluroxypyr-meptyl was available and evaluated. Toxicological information on metabolites identified in the ruminant metabolism study (i.e. fluroxypyr pyridinol and its conjugates) is required to derive a final residue definition for livestock. EFSA recommends reconsideration of the existing MRLs for several plant and animal commodities. [ABSTRACT FROM AUTHOR]

In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Landesanstalt fuer Landwirtschaft und Gartenbau Sachsen‐Anhalt submitted a request to the competent national authority in Germany to modify the existing maximum residue levels (MRLs) for the active substance fluopyram in certain herbal infusions. The data submitted in support of the request were found to be sufficient to derive MRL proposals for the herbal infusions from leaves and herbs. A risk management decision needs to be taken whether the proposed MRL is considered appropriate for herbal infusions from flowers. Adequate analytical methods for enforcement are available to control the residues of fluopyram 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 dietary intake of residues resulting from the use of fluopyram 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 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 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]

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 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]