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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 Bacillus pumilus QST 2808. To assess the occurrence of Bacillus pumilus QST 2808 residues in primary crops, processed commodities, rotational crops and livestock, EFSA considered the conclusions derived in the framework of 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 cannot be derived and are deemed not to be necessary. A consumer risk assessment cannot be performed quantitatively. Although no apparent risk to consumers was identified, some information required by the regulatory framework was missing. The outcome of the assessment was compared to the criteria defined by the European Commission for inclusion of pesticide active substances in Annex IV of the Regulation. A proposal for inclusion of Bacillus pumilus QST 2808 into Annex IV of Regulation (EC) No 396/2005 is derived by EFSA. [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 fluopyram. To assess the occurrence of fluopyram residues in plants, processed commodities, rotational crops and livestock, EFSA considered the conclusions derived in the framework of Commission Regulation (EU) No 188/2011, the MRLs established by the Codex Alimentarius Commission as well as the import tolerances and 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 chronic 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. Hence, the consumer risk assessment is considered indicative only and some MRL proposals derived by EFSA still require further consideration by risk managers. [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 spinetoram. To assess the occurrence of spinetoram residues in plants, processed commodities, rotational crops and livestock, EFSA considered the conclusions derived in the framework of Commission Regulation (EU) No 188/2011, 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]

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 level (MRL) for the active substance fludioxonil in certain oilseeds. The data submitted in support of the request were found to be sufficient to derive MRL proposals of 0.3 mg/kg for linseeds, sesame seeds, rapeseeds, mustard seeds, borage seeds, gold of pleasure seeds, hemp seeds and 0.02 mg/kg for cattle milk. 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. From the chronic risk assessment performed by EFSA, it is concluded that the intake of residues resulting from the use of fludioxonil according to the reported agricultural practices is unlikely to present a risk to consumer health. The risk assessment is affected by additional, non‐standard uncertainties because experimental data on the magnitude of certain metabolites included in the risk assessment residue definition are not available for the oilseeds under assessment. [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]

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 tefluthrin. To assess the occurrence of tefluthrin residues in plants, processed commodities, rotational crops and livestock, EFSA considered the conclusions derived 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. 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 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]

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 bixafen. To assess the occurrence of bixafen 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 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 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]

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 metamitron. To assess the occurrence of metamitron residues in plants, processed commodities, rotational crops and livestock, EFSA considered the conclusions derived in the framework of Directive 91/414/EEC as well as the import tolerances and 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 some MRL proposals derived by EFSA still require further consideration by risk managers [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 ipconazole. To assess the occurrence of ipconazole residues in plants, processed commodities, rotational crops and livestock, EFSA considered the conclusions derived in the framework of Regulation (EC) No 1107/2009 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 for ipconazole 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. Regarding triazole derivative metabolites (TDMs), separate indicative exposure assessments were performed for triazole alanine and triazole acetic acid and no risk to consumers was identified for what regards these two metabolites individually. However, TDMs may be generated by several pesticides belonging to the group of triazole fungicides, and a comprehensive risk assessment has thus to be performed that covers all existing European uses for all pesticides belonging to the class of triazole fungicides. EFSA recommended to elaborate together with risk managers a strategy to ensure that the required data are made available to finalise the overall risk assessment for triazole fungicides. [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]

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 diclofop. To assess the occurrence of diclofop 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. 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 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 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]

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 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]

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 thiencarbazone‐methyl. To assess the occurrence of thiencarbazone‐methyl residues in plants, processed commodities, rotational crops and livestock, EFSA considered the conclusions derived in the framework of 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. 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 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]

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]

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]

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 benalaxyl-M. To assess the occurrence of benalaxyl-M residues in plants, processed commodities, rotational crops and livestock, EFSA considered the conclusions derived in the framework of Commission Regulation (EU) No 188/2011, the European authorisations for benalaxyl-M reported by Member States (including the supporting residues data) and also the authorised uses of benalaxyl reviewed by EFSA in the past (as they may generate common residues with benalaxyl-M) and the MRLs established for benalaxyl by the Codex Alimentarius Commission. 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 all MRL proposals derived by EFSA still require further consideration by risk managers. [ABSTRACT FROM AUTHOR]

The applicant Syngenta submitted a request to the competent national authority in France 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. The applicant provided residue trials on strawberries representative for an adjusted Good Agricultural Practice (GAP) and a new feeding study in ruminants. The data gaps identified in the MRL review were considered satisfactorily addressed, except for the southern adjusted GAP on strawberries. The new residue data confirm the existing tentative MRL for strawberries; EFSA proposed - based on the new feeding study in ruminants - amendments of the existing MRLs for certain animal products for further risk management consideration. EFSA updated the most recent consumer risk assessment for fludioxonil and concluded that the long-term dietary intake 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 pyridalyl. To assess the occurrence of pyridalyl residues in plants, processed commodities, rotational crops and livestock, EFSA considered the conclusions derived in the framework of 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. All information required by the regulatory framework was present and a risk to consumers was not identified. [ABSTRACT FROM AUTHOR]

The reaction of ethylenediamine (EDA) with ortho and/or para halogenated benzonitriles did not lead to the imidazolines expected: a competitive aromatic nucleophilic substitution (SNAr) was observed instead. The selective synthesis of these imidazolines was performed by nucleophilic addition of EDA to thiobenzamide derivatives. The difference in reactivity between the nitrile and thioamide derivatives was estimated by a frontier orbital approach at the RHF/6-31G** level which predicted a greater reactivity of substituted thiobenzamides towards the nucleophilic addition of EDA. [Copyright &y& Elsevier]

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 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]

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 dimethyl disulfide 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 dimethyl disulfide as a nematicide, fungicide and herbicide on carrot (field use) and on tomato (greenhouse application). 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 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 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]

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 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 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]

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]

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 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]

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]

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 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 Du Pont de Nemours GmbH submitted two requests to the competent national authority in Ireland to modify the existing EU maximum residue levels (MRLs) and to set import tolerances for oxathiapiprolin in various plant commodities in order to accommodate the intended EU uses and the authorised uses of this active substance in China, Canada and the United States. The data submitted in support of the request were found to be sufficient to derive MRL proposals for all crops under consideration, except for Brussels sprouts and peas (without pods), for which residue data were either not submitted or were insufficient to support the use. Adequate analytical methods for enforcement are available to control the residues of oxathiapiprolin in commodities under consideration at the validated limit of quantification (LOQ) of 0.01 mg/kg. Based on the risk assessment results, EFSA concluded that, taking into account the existing and the intended uses, the long‐term intake of residues of oxathiapiprolin 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 bupirimate. To assess the occurrence of bupirimate 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. 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 some MRL proposals derived by EFSA still require further consideration by risk managers. [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 Netherlands and co‐rapporteur Member State Spain for the pesticide active substance pyriproxyfen 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 pyriproxyfen as an insecticide on citrus fruit, pome fruit (apple, pears), tomatoes, ornamentals (field use) and tomatoes, ornamentals (greenhouse application). MRLs were assessed in citrus fruits. 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]

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 fluopicolide. To assess the occurrence of fluopicolide residues in plants, processed commodities, rotational crops and livestock, EFSA considered the conclusions derived in the framework of Directive 91/414/EEC, the MRLs established by the Codex Alimentarius Commission as well as the import tolerances and 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]