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In accordance with Article 6 of Regulation (EC) No 396/2005, the evaluating Member State (EMS) Greece received an application from Dow AgroSciences to set an import tolerance for the active substance 2,4-D in genetically modified (GM) maize imported from Canada and the USA. The modification confers tolerance to the herbicide 2,4-D. Greece 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. According to EFSA, the data submitted are sufficient to conclude that a change of the existing maximum residue level (MRL) set at the limit of quantification (LOQ) of 0.05 mg/kg in maize is not required. Analytical enforcement methods are available to control the residues of 2,4-D in cereals and no risk for consumers was identified for the notified use on GM maize expressing the aryloxyalkanoate dioxygenase 1 (AAD-1) protein imported from Canada and the USA. [ABSTRACT FROM AUTHOR]

In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Dow AgroSciences submitted an application to the competent national authority in Spain (evaluating Member State (EMS)) to modify maximum residue levels (MRLs) for the active substance chlorpyrifos‐methyl in kaki/Japanese persimmons and granate apples/pomegranates. The data submitted in support of this MRL application were found to be sufficient to derive MRL proposals for chlorpyrifos‐methyl and for the optional residue definition that refers to 3,5,6‐trichloropyridinol (3,5,6‐TCP) in the fruits under consideration. Adequate analytical methods for enforcement are available to control the residues of chlorpyrifos‐methyl in plant matrices under consideration. For the enforcement of 3,5,6‐TCP residues in the crops under consideration, the applicant has to perform validation of the hydrolysis step of analytical enforcement method and to submit an independent laboratory validation (ILV) for high acid content matrices. Based on the risk assessment results and provided that the conclusions of the MRL review are taken into consideration, EFSA concludes that the long‐term and short‐term intake of residues of chlorpyrifos‐methyl and metabolite 3,5,6‐TCP resulting from the existing and the intended uses 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 bromadiolone. Considering that this active substance is not authorised for use on edible crops within the EU, that no MRLs are established by the Codex Alimentarius Commission (codex maximum residue limits) and that no import tolerances were notified to EFSA, residues of bromadiolone are not expected to occur in any plant or animal commodity. Even though information on the limit of quantification (LOQ) of bromadiolone was provided by the European Union Reference Laboratories for Pesticide Residues, the available data were not sufficient to derive a residue definition for enforcement against potential illegal uses. [ABSTRACT FROM AUTHOR]

In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Nufarm España S.A. submitted an application to the competent national authority in Spain to modify the existing maximum residue levels (MRL) for the active substance dichlorprop‐P in citrus fruits (except oranges). 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 dichlorprop‐P in citrus fruits. Based on the risk assessment results, EFSA concluded that the short‐term and long‐term intake of residues resulting from the use of dichlorprop‐P 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 Irvita N.V. submitted a request to the competent national authority in Denmark to modify the existing maximum residue levels (MRLs) for the active substance tau‐fluvalinate in citrus fruits. The data submitted in support of the request were found to be sufficient to derive a MRL proposal of 0.4 mg/kg for citrus fruit under consideration. Adequate analytical methods for enforcement are available to control the residues of tau‐fluvalinate 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 tau‐fluvalinate on citrus fruits 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 evaluating Member State, Italy, received an application from Syngenta to modify the existing maximum residue level (MRL) for the active substance penconazole in grapes. The data submitted in support of the request are sufficient to derive a MRL proposal of 0.4 mg/kg for the intended use on grapes. Adequate analytical enforcement methods are available to control the residues of penconazole in grapes. Based on the risk assessment results, EFSA concludes that the intended use of penconazole on grapes will not result in a consumer exposure exceeding the toxicological reference values and therefore is unlikely to pose a consumer health risk. However, these results should be considered provisional due to the fact that the risk assessment for triazole derivate metabolites is still pending. [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 triflumuron. To assess the occurrence of triflumuron 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 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 all 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 evaluating Member State (EMS), the Netherlands, received an application from Arysta LifeScience Great Britain Limited to modify the existing maximum residue levels (MRLs) for the active substance etridiazole in various crops. To accommodate for the intended uses of etridiazole, the Netherlands proposed to raise the existing MRLs from the limit of quantification (LOQ) of 0.05* mg/kg to 0.4 mg/kg in gherkin, courgette and other cucurbits with edible peel, and to raise the existing MRL value of 0.1 mg/kg to 0.4 mg/kg in cucumber. The Netherlands 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. Although the intended uses on gherkin, courgette and other cucurbits with edible peel are supported by residue trials, EFSA did not derive MRL proposals because appropriate information on the toxicological profile and on the relevance of the major plant metabolites 5-hydroxyethoxyetridiazole acid and 3-hydroxymethyletridiazole has not been provided. Thus, the tentative risk assessment is affected by a high degree of uncertainty. [ABSTRACT FROM AUTHOR]

In accordance with Article 6 of Regulation (EC) No 396/2005, the evaluating Member State (EMS), the Netherlands, received two applications from ISK Biosciences Europe N.V. to modify the existing maximum residue levels (MRLs) for the active substance flonicamid in various commodities. EFSA concludes that the data submitted were sufficient to derive MRL proposals of 0.3 mg/kg for apricots, 0.5 mg/kg for head cabbage, and 1.5 mg/kg for beans and peas with pods. No change of the existing MRL set at the limit of quantification (LOQ) of 0.03 mg/kg was required for sugar beet. Furthermore, EFSA derived new MRL proposals for some commodities of animal origin. Adequate analytical enforcement methods are available to control the residues of flonicamid on the commodities under consideration. Based on the risk assessment results, EFSA concludes that the proposed use of flonicamid on the commodities under consideration will not result in a consumer exposure exceeding the toxicological reference values and therefore is unlikely to pose a consumer health risk. [ABSTRACT FROM AUTHOR]

In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Bayer CropScience submitted a request to the competent national authority in Spain to modify the existing maximum residue level (MRL) for the active substance ethephon in kaki/Japanese persimmons. The data submitted in support of the request are sufficient to derive a MRL proposal for the crop under consideration. An adequate analytical method for enforcement is available to control the residues of ethephon in kaki/Japanese persimmon fruits. Based on the risk assessment results, EFSA concluded that the short-term and long-term intake of residues resulting from the use of ethephon 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 Sumitomo Chemical Agro Europe S.A.S submitted a request to the competent national authority of Finland to modify the existing maximum residue level (MRL) for the active substance tolclofos-methyl in potatoes. The data submitted in support of the request were found to be sufficient to derive an MRL proposal of 0.2 mg/kg. An amendment of the existing MRLs for food of animal origin was not found necessary. Adequate analytical enforcement methods are available to control the residues of tolclofos-methyl in potatoes. Based on the risk assessment results, EFSA concluded that the proposed use of tolclofos-methyl on potatoes will not result in a consumer exposure exceeding the toxicological reference value and therefore is unlikely to pose a consumer health risk. [ABSTRACT FROM AUTHOR]

The aim of the current study was to investigate effects of temperature and a mixture of herbicides on the physiological status of the bivalve Mya arenaria. Bivalves acclimated to two temperatures (7 and 18°C) were exposed for 28 d to 0.01 mg/L of a pesticide formulation containing dichlorophenoxyacetic acid (2,4-D), 2-(2-methyl-4-chlorophenoxy) propionic acid (mecoprop), and 3,6-dichloro-2-methoxybenzoic acid (dicamba). At days 7, 14, and 28, mortality, immune parameters (hemocyte number, phagocytic activity, and efficiency), biomarkers of oxidative stress (catalase [CAT] and superoxide dismutase [SOD] activities and malondialdehyde [MDA] content), the metabolic enzyme cytochrome C oxidase (CCO), a biomarker of pesticide exposure (acetylcholinesterase [AChE]), and the activity of an enzyme related to gametogenesis (aspartate transcarbamylase [ATCase]) were monitored in clam tissues. Gonadosomatic index (GSI), condition factor (CF), and sex were also assessed. In clams acclimated to 7°C, exposure to pesticide enhanced CCO activity and CF and decreased MDA content, hemocyte number, CAT, and SOD activities. In clams kept at 18°C, pesticide effects appeared minor compared with samples kept at 7°C. In bivalves acclimated to 18°C, CCO, SOD, and ATCase activity and MDA content were enhanced, and hemocyte number, CAT, and AchE activities and phagocytosis were suppressed. In samples exposed to pesticides, increased temperature enhanced MDA content and CCO and SOD activity and suppressed hemocyte number and CAT and AchE activity. A gradual sexual maturation was observed in both sexes through experimental time, but females had a higher sensitivity to temperature and pesticides compared to males. Increased temperature altered the ability of the sentinel species Mya arenaria to respond to pesticide exposures. Further work is needed to understand the impacts of increasing temperature on the whole St. Lawrence estuary ecosystem. Environ. Toxicol. Chem. 2011;30:132-141. © 2010 SETAC [ABSTRACT FROM AUTHOR]

In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Landesanstalt fuer Landwirtschaft und Gartenbau Sachsen‐Anhalt submitted a request to the competent national authority in Germany to modify the existing maximum residue levels (MRLs) for the active substance fluopyram in certain herbal infusions. The data submitted in support of the request were found to be sufficient to derive MRL proposals for the herbal infusions from leaves and herbs. A risk management decision needs to be taken whether the proposed MRL is considered appropriate for herbal infusions from flowers. Adequate analytical methods for enforcement are available to control the residues of fluopyram in the commodities under consideration at the validated limit of quantification (LOQ) of 0.01 mg/kg. Based on the risk assessment results, EFSA concluded that the dietary intake of residues resulting from the use of fluopyram according to the reported agricultural practice is unlikely to present a risk to consumer health. [ABSTRACT FROM AUTHOR]

In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant BASF SE submitted a request to the competent national authority in Germany to modify the existing maximum residue level (MRL) for the active substance boscalid in honey and other apiculture products. The data submitted in support of the request were found to be sufficient to derive an MRL proposal for honey from field studies. This MRL proposal covers residues measured in honey samples analysed in the framework of EU National Monitoring Programmes. Adequate analytical methods for enforcement are available to control the residues of boscalid in honey at the validated limit of quantification (LOQ) of 0.01 mg/kg. Based on the risk assessment results, EFSA concluded that residues concentrations in honey at the level of the proposed MRL are unlikely to present a risk to consumer health. [ABSTRACT FROM AUTHOR]

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

According to Article 12 of Regulation (EC) No 396/2005, EFSA has reviewed the maximum residue levels (MRLs) currently established at European level for the pesticide active substance hymexazol. To assess the occurrence of hymexazol residues in plants, processed commodities, rotational crops and livestock, EFSA considered the conclusions derived in the framework of Commission Regulation (EC) No 33/2008 as well as the European authorisations reported by Member States (including the supporting residues data). Based on the assessment of the available data, MRL proposals were derived and a consumer risk assessment was carried out. All information required by the regulatory framework was present and a risk to consumers was not identified. [ABSTRACT FROM AUTHOR]

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

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

In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant FMC Agro Ltd submitted a request to the competent national authority in the United Kingdom to set import tolerances for the active substance chlorantraniliprole in oil palms fruits and oil palms kernels. The data submitted in support of the request were found to be sufficient to derive maximum residue level (MRL) proposals for these products. Adequate analytical methods for enforcement are available to control the residues of chlorantraniliprole in the commodities under consideration at the validated limit of quantification (LOQ) of 0.01 mg/kg. Based on the risk assessment results, EFSA concluded that the long‐term intake of residues resulting from the use of chlorantraniliprole according to the reported agricultural practice is unlikely to present a risk to consumer health. [ABSTRACT FROM AUTHOR]

In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant H.L Hutchinson Ltd submitted a request to the competent national authority in the United Kingdom to modify the existing maximum residue level (MRL) for the active substance pyraclostrobin in sweet corn. The data submitted in support of the request were found to be sufficient to derive an MRL proposal for sweet corn. An analytical method for MRL enforcement and its independent laboratory validation, using liquid chromatography with tandem mass spectrometry (LC‐MS/MS) was sufficiently validated at a limit of quantification (LOQ) of 0.02 mg/kg. Based on the risk assessment results, EFSA concluded that the short‐term and long‐term intake of residues resulting from the use of pyraclostrobin according to the reported agricultural practice is unlikely to present a risk to consumer health. [ABSTRACT FROM AUTHOR]

According to Article 12 of Regulation (EC) No 396/2005, EFSA has reviewed the maximum residue levels (MRLs) currently established at European level for the pesticide active substance penflufen. To assess the occurrence of penflufen residues in plants, processed commodities, rotational crops and livestock, EFSA considered the conclusions derived in the framework of Regulation (EC) No 1107/2009 and Commission Regulation (EU) No 188/2011, as well as the European authorisations reported by Member States (including the supporting residues data). Based on the assessment of the available data, MRL proposals were derived and a consumer risk assessment was carried out. Although no apparent risk to consumers was identified, some information required by the regulatory framework was missing. Hence, the consumer risk assessment is considered indicative only and the MRL proposal for potatoes derived by EFSA still requires further consideration by risk managers. [ABSTRACT FROM AUTHOR]

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

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

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

According to Article 12 of Regulation (EC) No 396/2005, EFSA has reviewed the maximum residue levels (MRLs) currently established at European level for the pesticide active substance emamectin. To assess the occurrence of emamectin residues in plants, processed commodities, rotational crops and livestock, EFSA considered the conclusions derived in the framework of Regulation (EC) No 1107/2009, the MRLs established by the Codex Alimentarius Commission as well as the European authorisations reported by Member States (including the supporting residues data). Based on the assessment of the available data, MRL proposals were derived and a consumer risk assessment was carried out. Some information required by the regulatory framework was missing and a possible acute risk to consumers was identified. Hence, the consumer risk assessment is considered indicative only, some MRL proposals derived by EFSA still require further consideration by risk managers and measures for reduction of the consumer exposure should also be considered. [ABSTRACT FROM AUTHOR]

The applicant Dow AgroSciences submitted a request to the competent national authority in France to evaluate the confirmatory data that were identified for oryzalin in the framework of the maximum residue level (MRL) review under Article 12 of Regulation (EC) No 396/2005 as not available. To address the data gaps identified, residue trials on apples were submitted which are appropriate to conclude on the residue situation in kiwi fruits; furthermore, new residue trials on asparagus and on bananas were also provided. The information submitted to address the primary crop metabolism on asparagus was considered not sufficient to elucidate the nature of residues expected in asparagus. Thus, since the data gap for asparagus was not fully addressed, risk managers may consider the deletion of the existing MRL. For kiwi fruits and bananas, the previously derived MRLs do not have to be modified. [ABSTRACT FROM AUTHOR]

In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Agro‐Kanesho submitted a request to the competent national authority in Germany to modify the existing maximum residue level (MRLs) for the active substance acequinocyl in citrus fruits. The data submitted in support of the request were found to be sufficient to derive MRL proposals for grapefruits, oranges, lemons, limes and mandarins. Adequate analytical methods for enforcement are available to control the residues of acequinocyl in the commodities under consideration at the validated limit of quantification (LOQ) of 0.01 mg/kg. Based on the risk assessment results, EFSA concluded that the short‐term and long‐term intake of residues resulting from the use of acequinocyl according to the reported agricultural practice is unlikely to present a risk to consumer health. [ABSTRACT FROM AUTHOR]

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

In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant 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 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]

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]

In accordance with Article 6 of Regulation (EC) No 396/2005, Finland, hereafter referred to as the evaluating Member State (EMS), received an application from BASF SE to modify the temporary maximum residue level (MRL) for the active substance mepiquat in cultivated fungi based on monitoring data. Mepiquat residues in mushrooms do not result from the use of the active substance on mushrooms, but from the uptake of residues via the growth substrate composed of cereal straw that has been treated with mepiquat. Based on a total of 74 samples on oyster mushrooms, three different MRL proposals were derived. A risk management decision is required, considering the acceptable non‐compliance rate, in order to decide which temporary MRL is the most appropriate to cover the presence of mepiquat chloride residues in oyster mushrooms. The exposure to residues of mepiquat chloride at the levels observed in the monitoring data on cultivated oyster mushrooms, which were the basis for deriving the MRL proposals, 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 Italy to modify the existing maximum residue levels (MRLs) for propaquizafop/quizalofop in lettuces and salad plants to accommodate the intended SEU use of propaquizafop. The data submitted in support of the request were found to be sufficient to derive MRL proposals of 0.15 mg/kg for the intended SEU use of propaquizafop for the crops belonging to the crop group of lettuces and salad plants. The MRL proposals are expressed for a common residue definition that covers quizalofop and propaquizafop. Since the EU MRL is set at a higher level of 0.20 mg/kg, no modification of the MRL is currently required for the intended use. Adequate analytical methods for enforcement are available to control the residues of propaquizafop, expressed as quizalofop, in plant matrices under consideration. Based on the risk assessment results, EFSA concluded that the long‐term and short‐term intake of residues occurring in food from the existing uses of quizalofop‐P‐ethyl, quizalofop‐P‐tefuryl and propaquizafop and from the intended use of propaquizafop on lettuces and other salad plants, is unlikely to present a risk to consumer health. [ABSTRACT FROM AUTHOR]

In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Syngenta (France SAS) submitted a request to the competent national authority in France to modify the existing maximum residue level (MRL) for the active substance emamectin in peaches. A second request was submitted by Syngenta Italia S.p.a to the competent national authority in Italy to modify the MRL emamectin in kiwi. The data submitted in support of the request were found to be sufficient to derive MRL proposals for kiwi and peaches. Adequate analytical methods for enforcement are available to enforce the residues resulting from the use of emamectin benzoate on the commodities under consideration at the validated limit of quantification (LOQ) of 0.001 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 emamectin benzoate according to the reported agricultural practices is unlikely to present a risk to consumer health. [ABSTRACT FROM AUTHOR]

In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Syngenta France SAS submitted a request to the competent national authority in France to modify the existing maximum residue level (MRL) for the active substance acibenzolar‐S‐methyl in hazelnuts. The data submitted in support of the request were found to be sufficient to derive an MRL proposal for hazelnuts/cobnuts. Adequate analytical methods for enforcement are available to control residues of acibenzolar‐S‐methyl 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 acibenzolar‐S‐methyl according to the reported agricultural practice is unlikely to present a risk to consumer health. [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 bentazone 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 livestock feeding study and storage stability data for bentazone and 6‐hydroxy bentazone in animal matrices were submitted. To address the data gap for potatoes, adjusted less critical good agricultural practices (GAPs) were reported and supporting residue data were provided. The data gap related to analytical methods in fat and herbal infusions were addressed in the framework of the peer review. The data gap for residue trials on leek has not been addressed. Further confirmation from the applicant/Member States are needed for the clarification of the GAP for herbal infusions. Based on the information submitted in support of the confirmatory data request, the existing EU MRLs for bentazone need to be modified for potato and leek, for swine fat and kidney and for bovine, equine, goat and sheep fat, liver and milk. The consumer risk assessment performed in the MRL review was updated, using new toxicological reference values derived by the peer review. No consumer intake concerns were identified. [ABSTRACT FROM AUTHOR]

In accordance with Article 6 of Regulation (EC) No 396/2005, the applicants Luxembourg Industries (Pamol) Ltd and De Sangosse SAS submitted a request to the competent national authority in France to modify the existing maximum residue level (MRL) for fosetyl/phosphonic acid related to the use of potassium phosphonates on potatoes, wheat and some animal commodities. The data submitted in support of the request were found to be sufficient to derive MRL proposals for the crops under assessments and for animal commodities. Adequate analytical methods for enforcement are available to control the residues of phosphonic acid on the commodities under consideration at the validated limit of quantification (LOQ) of 0.01 mg/kg for high water‐ and dry matrices and at LOQ of 0.1 mg/kg in high acid matrices and in animal matrices and eggs at the validated LOQ of 0.05 mg/kg and in milk at the validated LOQ of 0.01 mg/kg. Based on the risk assessment results, EFSA concluded that the intake of residues resulting from the use of potassium phosphonates according to the reported agricultural practices is unlikely to present a risk to consumers. [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 clethodim. To assess the occurrence of clethodim 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 and European authorisations reported by Member States (including the supporting residues data). Based on the assessment of the available data, MRL could not be proposed because an overall consumer risk assessment could not be finalised. Risk managers should be made aware that the genotoxic potential of the clethodim metabolite 3‐chloroallyl alcohol, the aglycon of 3‐chlorolallyl alcohol glucoside (M14A/M15A) could not be concluded and no toxicological reference values could be derived for this metabolite. Until a conclusion on the toxicological properties of the metabolite is reached, a decision on the residue definition for risk assessment cannot be made which is a prerequisite to perform a reliable dietary risk assessment. [ABSTRACT FROM AUTHOR]

In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Belgium Federal Public Service for Health, Food chain safety and Environment (Belgium FPS Health) submitted a request to modify the existing maximum residue level (MRL) for the active substance fludioxonil in Florence fennels. The data submitted in support of the request were found to be sufficient to derive an MRL proposal of 1.5 mg/kg for Florence fennels. Adequate analytical methods for enforcement are available to control the residues of fludioxonil on the commodity under consideration at the validated limit of quantification (LOQ) of 0.01 mg/kg. Based on the risk assessment results, EFSA concluded that the long‐term 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 applicant Dow AgroSciences submitted a request to the competent national authority in Greece to set an import tolerance for the active substance 2,4‐D in genetically modified (GM) soyabeans imported from Canada and the USA. The genetic modification confers tolerance to the herbicide 2,4‐D. The data submitted in support of the request provided sufficient evidence to conclude that residues of parent 2,4‐D and of the metabolite 2,4‐dichlorophenol (2,4‐DCP), which was found in the GM soybeans treated with 2,4‐D, are unlikely to present a risk for consumers. Sufficiently validated analytical methods are available to enforce the proposed maximum residue level (MRL) in soybeans. [ABSTRACT FROM AUTHOR]

The applicant BASF SE submitted a request to the competent national authority in Germany to evaluate the confirmatory data that were identified for dimethenamid‐P in the framework of the maximum residue level (MRL) review under Article 12 of Regulation (EC) No 396/2005 as not available. The data gap refers to the submission of a plant metabolism study investigating the fate of dimethenamid‐P following foliar treatment with a short preharvest interval (PHI) in a leafy or bulb vegetable crop. The confirmatory data requirement is considered sufficiently addressed according to the conclusions of the peer review, which, based on available metabolism studies, proposed to modify the existing enforcement and risk assessment residue definitions in all plant commodities, by including additional dimethenamid‐P metabolites ((2RS)‐3‐(2‐{(2,4‐dimethylthiophen‐3‐yl)[(2S)‐1‐methoxypropan‐2‐yl]amino}‐2‐oxoethanesulfinyl)‐2‐hydroxypropanoic acid (M30) and (2RS)‐3‐[(2‐{(2,4‐dimethylthiophen‐3‐yl)[(2S)‐1‐methoxypropan‐2‐yl]amino}‐2‐oxoethyl)sulfanyl]‐2‐hydroxypropanoic acid (M26). The residue data of metabolites M26 and M30 are currently not available for all authorised uses assessed in the MRL review. Should risk managers decide amending residue definitions, the existing EU MRLs would need to be revised accordingly. The consumer exposure as calculated by the MRL review was updated in two scenarios, using the existing and the new toxicological reference values as derived by the peer review. For the crops under consideration (spring onions, lettuce, escarole and herbs), indicative conversion factors were applied to account for possible metabolite burden. No consumer intake concerns were identified. [ABSTRACT FROM AUTHOR]

According to Regulation (EC) No 396/2005 on maximum residue levels of pesticides in or on food and feed, Member States have to monitor pesticide residue levels in food samples and submit the monitoring results to EFSA and the European Commission. The Standard Sample Description (SSD, version 1) is the data model used for reporting the data on analytical measurements of chemical substances occurring in food, feed and water to EFSA. This document is a consolidated version of the past four years' guidance defining the appropriate SSD codes to describe the samples and the analytical results and it gives directions for the reporting of the pesticide residues monitoring data starting with the data generated in 2018 onwards. These provisions take into account the experience of both the previous reporting seasons and the new legislation applicable in 2018. This EFSA Guidance will not be applicable for the 2019 data collection provided to EFSA in 2020. In 2020, all data on annual monitoring will be transmitted in SSD2 format only. [ABSTRACT FROM AUTHOR]