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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 conclusions of the European Food Safety Authority (EFSA) following the peer review of the initial risk assessments carried out by the competent authority of the rapporteur Member State Poland for the pesticide active substance ferric pyrophosphate are reported. The context of the peer review was that required by Regulation (EC) No 1107/2009 of the European Parliament and of the Council. The conclusions were reached on the basis of the evaluation of the representative use of ferric pyrophosphate as a molluscicide on all edible and inedible crops. The reliable end points, appropriate for use in regulatory risk assessment are presented. Missing information identified as being required by the regulatory framework is listed. Concerns are identified. [ABSTRACT FROM AUTHOR]

In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Adama Agan Ltd submitted a request to the competent national authority in Italy to modify the existing maximum residue level (MRL) for the active substance imazamox in soyabeans to support the intended use in Europe. The data submitted in support of the request were found to be sufficient to derive an MRL proposal for imazamox in soyabeans according to the existing and the revised enforcement residue definition. Adequate analytical methods for enforcement are available to control the residues of imazamox and CL 263284 in plant matrices at the individual validated limit of quantification (LOQ) of 0.01 mg/kg. The calculated livestock dietary burdens indicate no need to modify the existing EU MRLs in commodities of animal origin. EFSA proposes that the risk managers consider the modification of the existing enforcement and risk assessment residue definitions according to the conclusions of the EU pesticides peer review. Based on the risk assessment results, EFSA concluded that the proposed use of imazamox on soyabeans and the imazamox residues from the authorised uses will not result in a consumer exposure exceeding the toxicological reference values and therefore are unlikely to pose a risk to consumers’ health. [ABSTRACT FROM AUTHOR]

In accordance with Article 6 of Regulation (EC) No 396/2005, the applicants BASF SE, Landwirtschaftliches Technologiezentrum Augustenberg and Tilco Biochemie GmbH submitted a request to the competent national authorities in Greece and Germany to modify the existing maximum residue levels (MRLs) for fosetyl/phosphonic acid in various crops related to the use of potassium phosphonates. The data submitted in support of the request were found to be sufficient to derive MRL proposals for several tree nuts, pomegranates, fresh herbs and edible flowers, currants, gooseberries and blueberries. Adequate analytical methods for enforcement are available to control the residues of phosphonic acid in the plant matrices under consideration at the validated limit of quantification (LOQ) of 0.1 mg/kg in high acid content matrices and at 0.01 mg/kg in high water and high oil content matrices. Based on the risk assessment results, EFSA concluded that the intake of residues resulting from the use of potassium phosphonates is unlikely to present a risk to consumer health. [ABSTRACT FROM AUTHOR]

The applicant AgroFresh Holding France S.A.S. submitted a request to the competent national authority in the United Kingdom to evaluate the confirmatory data that were identified 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 metabolism study representative for apples was submitted. In addition, residue trials in apples and bananas were provided. For apples, residues were below the limit of quantification (LOQ), and for bananas, EFSA concluded that there is sufficient evidence to assume that quantifiable residues of 1-methylcyclopropene (1-MCP) are unlikely to occur, if bananas are treated according to the Good Agricultural Practice (GAP) reported. The new information provided did not require a revision of the existing MRLs for apples and bananas. [ABSTRACT FROM AUTHOR]

In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Adama Agan Ltd submitted a request to the competent national authority in the United Kingdom to modify the existing maximum residue levels (MRLs) for the active substance chlormequat in barley and animal commodities. The data submitted in support of the request were found to be sufficient to derive MRL proposals for barley grain, sheep muscle and sheep kidney. Adequate analytical methods for enforcement are available to control the residues of chlormequat and its salts in plant matrices at the validated limit of quantification (LOQ) of 0.01 mg/kg and in animal matrices 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 chlormequat according to the intended 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 the United Kingdom to set import tolerances for the active substance fluxapyroxad for certain root crops and for coffee beans produced in the US and Brazil. The data submitted in support of the request were found to be sufficient to derive maximum residue level (MRL) proposals for the crops assessed. Adequate analytical methods for enforcement are available to control the residues of fluxapyroxad in the products concerned 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 fluxapyroxad 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 Adama Agan Ltd submitted a request to the competent national authority in the United Kingdom to modify the existing maximum residue levels (MRLs) for the active substance chlormequat in barley and animal commodities. The data submitted in support of the request were found to be sufficient to derive MRL proposals for barley grain, sheep muscle and sheep kidney. Adequate analytical methods for enforcement are available to control the residues of chlormequat and its salts in plant matrices at the validated limit of quantification (LOQ) of 0.01 mg/kg and in animal matrices 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 chlormequat according to the intended 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 Agriculture and Horticulture Development Board (AHDB) in the United Kingdom submitted a request to the competent national authority to modify the existing maximum residue level (MRL) for the active substance cyprodinil in rhubarbs. The data submitted in support of the request were found to be sufficient to derive an MRL proposal of 2 mg/kg for rhubarbs. Adequate analytical methods for enforcement are available to control the residues of cyprodinil 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 short-term and long-term intake of residues resulting from the use of cyprodinil 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 Agriculture and Horticulture Development Board (AHDB) submitted a request to the competent national authority in the United Kingdom to modify the existing maximum residue level (MRL) for the active substance fludioxonil in rhubarbs. The data submitted in support of the request were found to be sufficient to derive an MRL proposal of 0.7 mg/kg for rhubarbs. 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 longterm intake of residues resulting from the use of fludioxonil according to the reported agricultural practice is unlikely to present a risk to consumer health. [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]

The conclusions of EFSA following the peer review of the initial risk assessment carried out by the competent authority of the rapporteur Member State, the United Kingdom, for the pesticide active substance terbuthylazine are reported. The context of the peer review was that requested by the European Commission following the submission and evaluation of confirmatory data on groundwater metabolites. The conclusions were reached on the basis of the evaluation of the representative uses of terbuthylazine as a herbicide on maize and sorghum and taking into account the scientific opinion of the EFSA Panel on Plant Protection Products and their Residues (PPR) on the setting of health-based reference values for metabolites of the active substance terbuthylazine. The reliable endpoints concluded as being appropriate for use in regulatory risk assessment, derived from the available studies and literature in the dossier peer reviewed, are presented. Concerns are identified. [ABSTRACT FROM AUTHOR]

Abstract: In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Bayer CropScience AG submitted a request to the competent national authority in Germany to modify the existing maximum residue level (MRL) for the active substance clothianidin to accommodate the use on potatoes imported from Canada. The data submitted in support of the request were found to be sufficient to derive a MRL proposal. Adequate analytical methods for enforcement are available to control clothianidin residues on the commodity under consideration. Based on the risk assessment results, EFSA concluded that the short‐term and long‐term intake of residues resulting from the use of clothianidin according to the notified agricultural practice in Canada is unlikely to present a risk to consumer health. [ABSTRACT FROM AUTHOR]

Abstract: In accordance with Article 6 of Regulation (EC) No 396/2005, the Agriculture and Horticulture Development Council submitted a request to the competent national authority in the United Kingdom to modify the existing maximum residue levels (MRL) for the active substance flonicamid in beetroots, carrots, celeriacs/turnip rooted celeries, horseradishes, Jerusalem artichokes, parsnips, parsley roots/Hamburg roots parsley, radishes, salsifies, swedes/rutabagas, turnips. The data submitted in support of the request were found to be sufficient to derive MRL proposals for the commodities concerned. Adequate analytical methods for enforcement are available to control the residues of flonicamid in the crops under consideration at the validated limit of quantification (LOQ) of 0.01 mg/kg for each analyte of the residue definition and in animal matrices at the validated LOQ of 0.01 mg/kg for each analyte of the residue definition. 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]

Abstract: In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant LTZ Augustenberg submitted a request to the competent national authority in Germany to modify the existing maximum residue levels (MRLs) for the active substance potassium phosphonates in raspberries, blackberries, currants, blueberries, gooseberries and elderberries. 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 potassium phosphonates in plant matrices under consideration. Based on the risk assessment results, EFSA concluded that the proposed uses of potassium phosphonates on raspberries, blackberries, currants, blueberries, gooseberries and elderberries will not result in a consumer exposure exceeding the toxicological reference values and therefore are unlikely to present a risk to consumers’ health. [ABSTRACT FROM AUTHOR]

Abstract: In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Dienstleistungszentrum Ländlicher Raum submitted a request to the competent national authority in Germany to modify the existing maximum residue level (MRL) for the active substance flonicamid in radishes. Furthermore, in accordance with Article 6 of Regulation (EC) No 396/2005, the applicant ISK Biosciences Europe N.V. submitted a request to the competent national authority in the Netherlands to modify the existing MRLs for the active substance flonicamid in strawberries, cane fruits, other small fruits and berries, lettuces and other salad plants, and pulses (dry beans, lentils, peas, lupins). The data submitted in support of the request were found to be sufficient to derive MRL proposals for strawberries, blackberries, raspberries, other small fruits and berries, radishes, lettuces and other salad plants, and pulses (dry beans, lentils, peas and lupins). Adequate analytical methods for enforcement are available to control the residues of flonicamid on in the commodities under consideration. 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]

Abstract: The conclusions of EFSA following the peer review of the initial risk assessments carried out by the competent authority of the rapporteur Member State Austria for the pesticide active substance sodium hydrogen carbonate are reported. The context of the peer review was that required by Regulation (EC) No 1107/2009 of the European Parliament and of the Council. The conclusions were reached on the basis of the evaluation of the representative use of sodium hydrogen carbonate as a fungicide on grapes. The reliable endpoints, appropriate for use in regulatory risk assessment are presented. [ABSTRACT FROM AUTHOR]

Abstract: The conclusions of EFSA following the peer review of the initial risk assessments carried out by the competent authorities of the rapporteur Member State Germany and co‐rapporteur Member State Hungary for the pesticide active substance beta‐cyfluthrin are reported. The context of the peer review was that required by Commission Implementing Regulation (EU) No 844/2012. The conclusions were reached on the basis of the evaluation of the representative uses of beta‐cyfluthrin as an insecticide on beet, potato, wheat and greenhouse tomato. The reliable end points, appropriate for use in regulatory risk assessment are presented. Missing information identified as being required by the regulatory framework is listed. Concerns are identified. [ABSTRACT FROM AUTHOR]

Abstract: The conclusions of EFSA following the peer review of the initial risk assessments carried out by the competent authorities of the rapporteur Member State Belgium and co‐rapporteur Member State Greece for the pesticide active substance alpha‐cypermethrin are reported. The context of the peer review was that required by Commission Implementing Regulation (EU) No 844/2012. The conclusions were reached on the basis of the evaluation of the representative uses of alpha‐cypermethrin as an insecticide on cereals, winter oilseed rape, lettuces, leafy brassica and on cucumber and courgette in permanent glasshouses. The reliable end points, appropriate for use in regulatory risk assessment and the proposed maximum residue levels (MRLs), are presented. Missing information identified as being required by the regulatory framework is listed. Concerns are identified. [ABSTRACT FROM AUTHOR]

Abstract: The conclusions of the EFSA following the peer review of the initial risk assessments carried out by the competent authority of the rapporteur Member State, Germany, for the pesticide active substance azadirachtin are reported. The context of the peer review was that required by Regulation (EC) No 1107/2009 of the European Parliament and of the Council. The conclusions were reached on the basis of the evaluation of the additional representative use of azadirachtin as an acaricide on greenhouse ornamentals. Conclusions are also represented for the representative use evaluated for the approval of azadirachtin, which was as an insecticide on potatoes. The reliable endpoints, appropriate for use in regulatory risk assessment, are presented. Missing information identified as being required by the regulatory framework is listed. Concerns are identified. [ABSTRACT FROM AUTHOR]

Abstract: The conclusions of EFSA following the peer review of the initial risk assessments carried out by the competent authority of the rapporteur Member State, France, for the pesticide active substance ABE‐IT 56 (components of lysate of Saccharomyces cerevisiae strain DDSF623) are reported. The context of the peer review was that required by Regulation (EC) No 1107/2009 of the European Parliament and of the Council. The conclusions were reached on the basis of the evaluation of the representative use of ABE‐IT 56 as a fungicide on grapes. The reliable endpoints, appropriate for use in regulatory risk assessment, are presented. Missing information identified as being required by the regulatory framework is listed. [ABSTRACT FROM AUTHOR]

The conclusions of the EFSA following the peer review of the initial risk assessments carried out by the competent authorities of the rapporteur Member State, the Netherlands and co-rapporteur Member State, Sweden, for the pesticide active substance carvone are reported. The context of the peer review was that required by Commission Implementing Regulation (EU) No 844/2012. The conclusions were reached on the basis of the evaluation of the representative use of carvone (substance evaluated dcarvone) as a plant growth regulator on seed potatoes. The reliable end points, appropriate for use in regulatory risk assessment, are presented. Missing information identified as being required by the regulatory framework is listed. [ABSTRACT FROM AUTHOR]

The conclusions of EFSA following the peer review of the initial risk assessments carried out by the competent authority of the rapporteur Member State, Italy, for the pesticide active substance florpyrauxifen-benzyl are reported. The context of the peer review was that required by Regulation (EC) No 1107/2009 of the European Parliament and of the Council. The conclusions were reached on the basis of the evaluation of the representative use of florpyrauxifen-benzyl as an herbicide on rice. The reliable endpoints, appropriate for use in regulatory risk assessment, are presented. Missing information identified as being required by the regulatory framework is listed. Concerns are identified. [ABSTRACT FROM AUTHOR]

In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Gowan Crop Protection Ltd submitted a request to the competent national authority in Greece to set an import tolerance for the active substance fenazaquin in almonds. The data submitted in support of the request were found to be sufficient to derive a maximum residue level (MRL) proposal for almonds. Adequate analytical methods for enforcement are available to control the residues of fenazaquin and its metabolites 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 fenazaquin according to the reported agricultural practices is unlikely to present a risk to European consumers. The chronic consumer risk assessment is affected by non-standard uncertainties due to the lack of information on the occurrence of the metabolite 2-(4-tert-butylphenyl) ethanol (TBPE) in crops where the use of fenazaquin is the authorised in Europe. The reliable end points, appropriate for use in regulatory risk assessment are presented. [ABSTRACT FROM AUTHOR]

The conclusions of EFSA following the peer review of the initial risk assessments carried out by the competent authority of the rapporteur Member State, the United Kingdom, for the pesticide active substance BAS 750 F (mefentrifluconazole) are reported. The context of the peer review was that required by Regulation (EC) No 1107/2009 of the European Parliament and of the Council. The conclusions were reached on the basis of the evaluation of the representative use(s) of BAS 750 F (mefentrifluconazole) as a fungicide on cereals. The reliable endpoints, appropriate for use in regulatory risk assessment are presented. Missing information identified as being required by the regulatory framework is listed. Concerns are identified. [ABSTRACT FROM AUTHOR]

The conclusions of EFSA following the peer review of the initial risk assessments carried out by the competent authorities of the rapporteur Member State the United Kingdom and the co-rapporteur Member State Portugal for the pesticide active substance 1-methylcyclopropene are reported. The context of the peer review was that required by Commission Implementing Regulation (EU) No 844/2012. The conclusions were reached on the basis of the evaluation of the representative uses of 1-methylcyclopropene as a plant growth regulator on apples. The reliable end points, appropriate for use n regulatory risk assessment, are presented. Missing information identified as being required by the regulatory framework is listed. Concerns are identified. [ABSTRACT FROM AUTHOR]

Abstract: In accordance with Article 6 of Regulation (EC) No 396/2005, the Imazalil Task Force submitted a request to the competent national authority in the Netherlands to change the existing maximum residue levels (MRLs) for the active substance imazalil in products of plant and animal origin. The evaluating Member State (EMS) proposed to modify the existing MRLs only in citrus fruits and bananas and, due to transfer of residues, in bovine and equine livers. EFSA assessed the intended uses in citrus fruits, but not the use in bananas, since compared with the previously performed MRL review no new information was provided in the context of the MRL application. For the intended uses in citrus fruits and for animal products, EFSA did not derive MRL proposals. A decision on the amendment of MRL for the intended uses needs to be postponed, until the risk assessment for the plant metabolite R014821 and for the metabolites identified in livestock (i.e. FK‐772 and FK‐284) is completed with regard to genotoxicity and general toxicity; data need to be provided to derive a conclusion whether the toxicological reference values derived for imazalil are also applicable for the metabolites. Upon conclusion on the toxicological properties of the metabolites, a decision on the residue definition for risk assessment cannot be derived which is a prerequisite to perform a reliable dietary risk assessment. [ABSTRACT FROM AUTHOR]

Abstract: In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant LSA (Landesanstalt Sachsen‐Anhalt) submitted a request to the competent national authority in Germany to modify the existing maximum residue levels (MRLs) for the active substance clomazone in chamomiles and plantains. 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 clomazone in plant matrices on the crops 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 clomazone according to the reported agricultural practice is unlikely to present a risk to consumer health. Restrictions on crop rotation as an appropriate risk mitigation measure should be taken into consideration at national level in order to avoid the occurrence of clomazone residues in rotational crops. [ABSTRACT FROM AUTHOR]

Abstract: In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Nature's Crops International submitted a request to the competent national authority in the United Kingdom to modify the existing maximum residue level (MRL) for the active substance thiacloprid in corn gromwell seeds. Furthermore, the competent national authority in Belgium compiled an application to modify the existing MRL for the active substance thiacloprid in radish. The renewal process for thiacloprid is currently ongoing; in 2015, the Committee for Risk Assessment concluded that the classification as Cat. 1B for adverse effects on development according to CLP criteria is warranted (H360FD). Considering that there is strong evidence that this active substance meets the cut‐off criteria for non‐approval defined in Article 4 of Regulation (EC) No 1107/2009, further risk management considerations have to be taken into account before a decision on the amendment of the existing MRLs is taken. The data submitted were compliant with the currently applicable legal requirement to derive MRL proposals for corn gromwell seeds and radish. The estimated exposure resulting from the residues of thiacloprid in corn gromwell seeds and radishes is not expected to exceed the toxicological reference values. [ABSTRACT FROM AUTHOR]

Abstract: In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant DuPont de Nemours (Deutschland) GmbH submitted a request to the competent national authority in France to set an import tolerance for the active substance chlorantraniliprole in hops. The data submitted in support of the request were found to be sufficient to derive an maximum residue level (MRL) proposal for hops in support of the authorised use in the USA. Adequate analytical methods for enforcement are available to control the residues of chlorantraniliprole in hops 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 existing uses and the authorised use of chlorantraniliprole 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]

Abstract: In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Belchim Crop Protection NV/SA submitted a request to the competent national authority in Hungary to modify the existing maximum residue levels (MRLs) for the active substance valifenalate in various crops. The data submitted in support of the request were found to be sufficient to derive MRL proposals for lettuces, tomatoes, aubergines, onions, shallots and garlic. Adequate analytical methods for enforcement are available to control the residues of valifenalate 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 long‐term intake of residues resulting from the use of valifenalate according to the reported agricultural practices is unlikely to present a risk to consumer health. The short‐term intake was not carried out since no acute reference dose (ARfD) is established for valifenalate. The reliable end points, appropriate for use in regulatory risk assessment are presented. [ABSTRACT FROM AUTHOR]

Abstract: In accordance with Article 6 of Regulation (EC) No 396/2005, the applicants ADAMA Agriculture Espana S.A., Sapec Agro SAU and LSA (Landesanstalt für Landwirtschaft, Forsten und Gartenbau) submitted requests to the competent national authorities in Spain and Germany, to modify the existing maximum residue levels (MRLs) for the active substance tebuconazole in olives, rice, herbs and herbal infusions (dried). The data submitted in support of the requests were found to be sufficient to derive MRL proposals for all the crops under consideration. Adequate analytical methods for enforcement are available to control the residues of tebuconazole 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 tebuconazole according to the reported agricultural practices is unlikely to present a risk to consumer health. [ABSTRACT FROM AUTHOR]

Abstract: The conclusions of EFSA following the peer review of the initial risk assessments carried out by the competent authorities of the rapporteur Member State Ireland and co‐rapporteur Member State Poland for the pesticide active substance dichlorprop‐P and the variant dichlorprop‐P‐2‐ethylhexyl and the assessment of applications for maximum residue levels (MRLs) are reported. The context of the peer review was that required by Commission Implementing Regulation (EU) No 844/2012. The conclusions were reached on the basis of the evaluation of the representative uses of dichlorprop‐P as a herbicide on cereals, grassland and grass seed crops and of the variant dichlorprop‐P‐2‐ethylhexyl as a plant growth regulator on citrus. MRLs were assessed in mandarin and lemon. The reliable end points, appropriate for use in regulatory risk assessment and the proposed MRLs, are presented. Missing information identified as being required by the regulatory framework is listed. Concerns are identified. [ABSTRACT FROM AUTHOR]

Abstract: The conclusions of the EFSA following the peer review of the initial risk assessments carried out by the competent authority of the rapporteur Member State the Netherlands, for the pesticide active substance Bacillus subtilis strain IAB/BS03 are reported. The context of the peer review was that required by Regulation (EC) No 1107/2009 of the European Parliament and of the Council. The conclusions were reached on the basis of the evaluation of the representative uses of B. subtilis strain IAB/BS03 as a fungicide on field lettuce, orchards and protected cucurbits. The reliable endpoints appropriate for use in regulatory risk assessment are presented. Missing information identified as being required by the regulatory framework is listed. Concerns are identified. [ABSTRACT FROM AUTHOR]

In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Syngenta France SAS submitted a request to the competent national authority in France to modify the existing maximum residue levels (MRL) for the active substance acibenzolar‐S‐methyl in aubergines and cucurbits with edible and inedible peel. The data submitted in support of the request were found to be sufficient to derive MRL proposals for all the commodities under consideration in this reasoned opinion. Adequate analytical methods for enforcement are available to control the residues of acibenzolar‐S‐methyl in plant matrices/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 intakes of residues resulting from the use of acibenzolar‐S‐methyl according to the reported agricultural practices are 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, Syngenta France SAS submitted a request to the competent national authority in France to modify the existing maximum residue levels (MRLs) for the active substance emamectin in leafy brassica and beans and peas with pods. The data submitted in support of the request were found to be sufficient to derive MRL proposals for the crops under consideration. An adequate analytical method for enforcement is available to control the residues of emamectin in the commodities under consideration. Based on the risk assessment results, EFSA concluded that the short‐term and long‐term intake of residues resulting from the use of emamectin benzoate 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 ‘Task Force Abamectin’, as applicant, submitted a request to the competent national authority in Spain to modify the existing maximum residue level (MRL) for the active substance abamectin in citrus fruits. The data submitted in support of the request were found to be sufficient to derive a MRL proposal of 0.04 mg/kg. Adequate analytical methods for enforcement are available to control the residues of abamectin in the crop under consideration. Based on the risk assessment results, EFSA concluded that the short‐term and long‐term intake of residues resulting from the use of abamectin 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 Dow AgroSciences submitted a request to the competent national authority in Finland, to set an import tolerance for quizalofop‐P‐ethyl in grain from genetically modified maize containing aad‐1 gene. The data submitted in support of the request were found to be sufficient to derive a maximum residue level (MRL) proposal for quizalofop‐P‐ethyl maize grain. Adequate analytical methods for enforcement are available to control the residues of quizalofop‐P‐ethyl in maize grain. Based on the risk assessment results, EFSA concluded that the authorised use of quizalofop‐P‐ethyl on genetically modified maize containing aad‐1 gene and the subsequent import of maize grain in Europe will not result in a consumer exposure exceeding the toxicological reference value and therefore is unlikely to pose a risk to consumers' health. [ABSTRACT FROM AUTHOR]

In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant ADAMA Agriculture BV submitted an application to the competent national authority in Belgium (evaluating Member State (EMS)) to modify the existing maximum residue levels (MRLs) for the active substance prochloraz in sugar beet root and in liver and kidney of swine and ruminant. The data submitted in support of the request were found to be sufficient to derive an MRL proposal for sugar beet root. Residues in sugar beet tops from the new use were found to contribute significantly to the livestock exposure. As the dietary burden needs to be calculated including all feed items and since not all information is available at the moment, EFSA proposes to assess the magnitude of prochloraz residues in animal commodities under the currently ongoing review of prochloraz MRLs according to Article 12 of Regulation (EC) No 396/2005. Adequate analytical methods are available to control the residues of prochloraz residues in plant and animal matrices. The risk assessment performed by EFSA gave an indication that residues of prochloraz may lead to an exceedance of the acceptable daily intake (ADI). Thus, before the MRL for sugar beet is amended, it is necessary that a comprehensive, refined risk assessment is performed, taking into account all existing uses of prochloraz and the intended new use on sugar beet. Considering that the MRL review for prochloraz is currently ongoing, the results of the comprehensive risk assessment will be available in due time. [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 France, to modify the existing maximum residue levels (MRLs) for the active substance fenpyrazamine in lamb's lettuces, lettuces, escaroles, dandelions, cresses, land cresses, rucola, red mustards, spinaches, purslanes and chards/beet leaves. The data submitted in support of the request were found to be sufficient to derive MRL proposals for lamb's lettuces/corn salads, lettuces, escaroles/broad-leaved endives (including dandelions), cresses, land cresses, roman rocket/rucola, red mustards, spinaches, purslanes and chards/beet leaves. Adequate analytical methods for enforcement are available to control the residues of fenpyrazamine in the crops assessed in this application according to the enforcement residue definition. The methods enable quantification of residues in the crops assessed at or above 0.01 mg/kg (limit of quantification (LOQ)). Based on the risk assessment results, EFSA concluded that the short-term and long-term intake of residues resulting from the use of fenpyrazamine on lamb's lettuces/corn salads, lettuces, cresses, land cresses, roman rocket/rucola, red mustards, spinaches, purslanes and chards/beet leaves according to the reported agricultural practice is unlikely to present a risk to consumer health. According to the internationally agreed methodology for short-term exposure estimation (IESTI), the acute reference dose (ARfD) was not exceeded for the intended use of fenpyrazamine on escaroles (97.6%), and thus, there is a narrow safety margin. [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 level (MRL) for the active substance fluazifop-P in tomato. The data submitted in support of the request were found to be sufficient to derive MRL proposal for tomato. An adequate analytical method for enforcement is available to control the residues of fluazifop-P in tomato 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 fluazifop-P according to the reported agricultural practice is unlikely to present a risk to consumer health. [ABSTRACT FROM AUTHOR]

The conclusions of EFSA following the peer review of the initial risk assessments carried out by the competent authority of the rapporteur Member State, the United Kingdom, for the pesticide active substance asulam and the assessment of applications for maximum residue levels (MRLs) are reported. The context of the peer review was that required by Regulation (EC) No 1107/2009 of the European Parliament and of the Council. The conclusions were reached on the basis of the evaluation of the representative use of asulam (variant evaluated asulam‐sodium) as a herbicide on spinach and tulip, hyacinth and lily for bulb production. MRLs were assessed in spinach. The reliable endpoints, appropriate for use in regulatory risk assessment and the proposed MRLs, are presented. Missing information identified as being required by the regulatory framework is listed. Concerns are identified. [ABSTRACT FROM AUTHOR]

The conclusions of EFSA following the peer review of the initial risk assessments carried out by the competent authority of the rapporteur Member State, the Netherlands, for the pesticide active substance Beauveria bassiana strain PPRI 5339 are reported. The context of the peer review was that required by Regulation (EC) No 1107/2009 of the European Parliament and of the Council. The conclusions were reached on the basis of the evaluation of the representative uses of Beauveria bassiana strain PPRI 5339 as an insecticide in protected Solanaceae (tomato, sweet pepper, aubergine, edible and processed fruits), in protected Cucurbitaceae (cucumber, edible and processed fruits) and in protected ornamentals. The reliable endpoints, appropriate for use in regulatory risk assessment are presented. Missing information identified as being required by the regulatory framework is listed. Concerns are identified. [ABSTRACT FROM AUTHOR]

The conclusions of EFSA following the peer review of the initial risk assessments carried out by the competent authorities of the rapporteur Member State Germany and co-rapporteur Member State Bulgaria for the pesticide active substance dimethenamid-P and the assessment of applications for maximum residue levels (MRLs) are reported. The context of the peer review was that required by Commission Implementing Regulation (EU) No 844/2012. The conclusions were reached on the basis of the evaluation of the representative uses of dimethenamid-P as a herbicide on annual monocotyledonous and dicotyledonous weeds in winter oilseed rape, maize, sweet corn, soya bean, sunflower and sugar beet. The reliable end points, appropriate for use in regulatory risk assessment and the proposed MRLs, are presented. Missing information identified as being required by the regulatory framework is listed. Concerns are identified. [ABSTRACT FROM AUTHOR]

The conclusions of EFSA following the peer review of the initial risk assessments carried out by the competent authorities of the rapporteur Member State, Lithuania, and co-rapporteur Member State Latvia for the pesticide active substance trinexapac and the assessment of applications for maximum residue levels (MRLs) are reported. The context of the peer review was that required by Commission Implementing Regulation (EU) No 844/2012. The conclusions were reached on the basis of the evaluation of the representative use of trinexapac as a plant growth regulator on barley (winter and spring) and wheat (winter). MRLs were assessed in rye. The reliable end points, appropriate for use in regulatory risk assessment and the proposed MRLs, are presented. The confirmatory data following the review of existing MRLs according to Article 12 of Regulation (EC) No 396/2005 were also assessed under this conclusion. Missing information identified as being required by the regulatory framework is listed. Concerns are identified. [ABSTRACT FROM AUTHOR]

In accordance with Article 6 of Regulation (EC) No 396/2005, the applicants Bayer CropScience Europe and Oxon Italia S.p.A. submitted requests to the competent national authority in Spain and Italy, respectively, to modify the existing maximum residue levels (MRLs) for fosetyl in peach and potato from the intended southern Europe (SEU) uses of fosetyl‐Al. The applicants Adama Agriculture B.V., Fitosanitarios Bajo Riesgo AIE and Almond Board of California submitted each an application to the competent national authority in France to modify the MRLs for fosetyl‐Al in pome fruits, peaches and tree nuts (except coconut) for the intended/authorised uses of the active substance potassium phosphonates. The data submitted in support of the requests were found to be sufficient to derive MRL proposals for all the crops under consideration. Adequate analytical methods for enforcement are available to control the residues of fosetyl‐Al and phosphonic acid in plant matrices under consideration. EFSA concluded that the proposed use of fosetyl‐Al on potatoes and the proposed uses of potassium phosphonates on pome fruits and peaches and the authorised use of potassium phosphonates on tree nuts in the United States are unlikely to result in a consumer exposure exceeding the toxicological reference values for phosphonic acid and fosetyl and therefore are unlikely to pose a risk to consumers’ health. However, the risk assessment is considered to be tentative and has to be updated as soon as the approval of the renewal of fosetyl and the review of existing uses of potassium phosphonates and disodium phosphonate is finalised. [ABSTRACT FROM AUTHOR]

In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Arysta LifeScience Benelux SPRL submitted a request to the competent national authority in Italy, to modify the existing maximum residue level (MRL) for the active substance pyrimethanil in cucurbits with edible peel. The data submitted in support of the request were found to be sufficient to derive a MRL proposal for cucurbits with edible peel. Adequate analytical methods for enforcement are available to control the residues of pyrimethanil 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 pyrimethanil according to the reported agricultural practice is unlikely to present a risk to consumer health. [ABSTRACT FROM AUTHOR]

In accordance with the Article 53 of the Regulation (EC) 1107/2009, Greece granted a 120-day emergency authorisation for the use of mepiquat in cotton following an application by the Hellenic Ministry of Rural Development and Food. To accommodate for the use of mepiquat according to the authorised good agricultural practices, Greece submitted an application to set a temporary maximum residue level (tMRL) for the active substance mepiquat in cotton seed in line with Article 16(1) in conjunction with Article 14 of Regulation (EC) No 396/2005. Greece, as evaluating Member State (EMS), drafted an evaluation report in accordance with Article 8 of Regulation (EC) No 396/2005, which was submitted to the European Commission and forwarded to EFSA. EFSA has assessed the available data and performed a risk assessment as regards the risks to consumers related to the exposure of mepiquat chloride in cotton seed. Several risk management options were derived in response to the request to amend the existing MRL for cotton seed. EFSA did not confirm the need to modify the existing MRLs for animal products as suggested by Greece. [ABSTRACT FROM AUTHOR]