Search

In accordance with Article 6 of Regulation (EC) No 396/2005, the Federal Public Service (FPS) Health, Food chain Safety and Environment submitted a request on behalf of Belgium (evaluating Member State, EMS) to modify the existing maximum residue level (MRL) for the active substance methoxyfenozide in aubergines/eggplants. The data submitted in support of the request were found to be sufficient to derive an MRL proposal for aubergines/eggplants. Adequate analytical methods for enforcement are available to control the residues of methoxyfenozide in the commodity under consideration at the validated limit of quantification (LOQ) of 0.01 mg/kg. Based on the risk assessment results, the EFSA concluded that the short‐term and long‐term intake of residues resulting from the indoor use of methoxyfenozide 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 applicants De Sangosse SAS and Tilco‐Alginure submitted two requests, respectively, to the competent national authorities in France and Germany to modify the existing maximum residue levels (MRLs) for the active substance potassium phosphonates in various plant commodities. The data submitted in support of the requests were found to be sufficient to derive MRL proposals for the commodities under assessment. For the derived MRL on baby leaf crops, further risk manager consideration is required to decide between two MRL options. Adequate analytical methods for enforcement are available to control the residues of potassium phosphonates in accordance with the residue definition 'phosphonic acid and its salts expressed as phosphonic acid' in the commodities under consideration. Based on the risk assessment results and assuming that the existing MRLs will be amended as proposed by EFSA in previous outputs, EFSA concluded that the long‐term intake of residues resulting from the existing uses of fosetyl and phosphonates (previously assessed in a joint MRL review) and new proposed uses of potassium phosphonates is unlikely to present a risk to consumer health. Considering the toxicological profile of the active substance, a short‐term dietary risk assessment was not required. The risk assessment shall be regarded as indicative because some MRL proposals derived by EFSA in the framework of the MRL review according to Articles 12 and 43 of Regulation (EC) No 396/2005 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 gamma‐cyhalothrin. To assess the occurrence of gamma‐cyhalothrin 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) in the framework of this review. Based on the assessment of the available data, MRL proposals were derived, and a consumer risk assessment was carried out. Although no risk to consumers was identified, some information required by the regulatory framework was missing. The residue definition for monitoring (lambda‐cyhalothrin (includes gamma‐cyhalothrin) (sum of R, S and S, R isomers)) covers both lambda‐ and gamma‐cyhalothrin. Appropriate enantioselective techniques, which are not commonly used in routine analysis, are required to differentiate gamma‐cyhalothrin residues from lambda‐cyhalothrin. According to the available data, it is expected that the MRLs currently set in Regulation (EC) No 396/2005 will cover the uses of gamma‐cyhalothrin assessed in the present review. Therefore, risk managers can consider maintaining the existing EU MRLs. [ABSTRACT FROM AUTHOR]

The applicant Corteva Agriscience submitted a request to the competent national authority in Austria to evaluate the confirmatory data that were identified for myclobutanil in the framework of the MRL review under Article 12 of Regulation (EC) No 396/2005 as not available. To address the data gap related to the lack of information on the triazole derivative metabolites (TDMs), new residue trials analysing for TDMs were submitted on apples, grapes, strawberries, tomatoes and melons. Following the assessment of the submitted data, EFSA concluded that Article 12 confirmatory data gaps are considered addressed for pome fruits, grapes, cucurbits with inedible peel, strawberries and tomatoes. The new information provided required the assessment of consumer exposure to TDMs, which identified no consumer intake concerns for the crops under consideration. No information was provided to address the Article 12 confirmatory data referred to in Regulation (EU) 2020/770 for blackberries, gooseberries, bananas, aubergines/eggplants, lamb's lettuces/corn salads, beans (with pods), globe artichokes, hops, sugar beet roots and products of animal origin. For these commodities, the existing EU MRL could be lowered to the enforcement limit of quantification (LOQ). For kaki/Japanese persimmon and azararoles/mediterranean medlars, the existing EU MRL is set on the basis of Codex MRL in pome fruits. The applicant did not request maintaining a Codex MRL in these commodities, but should risk managers decide otherwise, the Article 12 data gap is considered addressed for kaki/Japanese persimmon while for azaroles/Mediterranean medlars, a risk management decision might be required. No consumer intake concerns were identified. [ABSTRACT FROM AUTHOR]

In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant BASF SE submitted two requests to the competent national authority in Spain and Ireland to modify the existing maximum residue levels (MRLs) for the active substance fluxapyroxad in kaki/Japanese persimmons and in cultivated fungi, respectively. The data submitted in support of the requests were found to be sufficient to derive MRL proposals for kaki/Japanese persimmons and cultivated fungi. Adequate analytical methods for enforcement are available to control the residues of fluxapyroxad on the commodities under consideration 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 fluxapyroxad, according to the reported agricultural practices, is unlikely to present a risk to consumer health. The long‐term consumer risk assessment is indicative, pending the submission of the confirmatory data requested under the MRL review. [ABSTRACT FROM AUTHOR]

The applicant Arysta Life Science Great Britain Limited submitted a request to the competent national authority in Croatia to evaluate the confirmatory data that were identified for quizalofop‐P‐tefuryl in the framework of the maximum residue level (MRL) review under Article 12 of Regulation (EC) No 396/2005 as not available. Since Article 12 data gaps were also set for the two other quizalofop‐P variants sharing the same residue definitions for risk assessment and monitoring, EFSA included in the present assessment all quizalofop‐P variants: quizalofop‐P‐ethyl, quizalofop‐P‐tefuryl and propaquizafop. Moreover, in the application submitted to Croatia, the applicant also included a request to modify the existing MRLs for quizalofop‐P‐tefuryl in grapes, sunflower seeds and soyabeans in accordance with Article 6 of Regulation (EC) No 396/2005. To address the data gaps, new data on hydrolysis efficiency of quizalofop‐P‐tefuryl, quizalofop acid, quizalofop‐pentanoic acid and quizalofop‐P‐glycerate in different matrices of animal origin in accordance with the guidance document SANTE/2020/12830 Rev.1 were submitted, along with a validated analytical method for animal commodities. EFSA concluded that the data gap on validation of the efficiency of the extraction and hydrolysis included in the enforcement method of residues in livestock animal commodities was only fully addressed for muscle, poultry liver and eggs. Regarding plant commodities, the remaining data gaps were not addressed. EFSA also considered data gaps for quizalofop‐p‐ethyl in caraway as sufficiently addressed in the context of a previous MRL application. In general, the new information provided required a revision of the existing MRLs for several commodities of plant and animal origin. Further risk management considerations are required. Based on the risk assessment results, EFSA concluded that the short‐term and long‐term intake of residues resulting from the use of quizalofop‐P‐tefuryl 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 Corteva Agriscience International Sàrl submitted a request to the competent national authority in Finland to modify the existing maximum residue levels (MRLs) for the active substance clopyralid in honey. The data submitted in support of the request were found to be sufficient to derive MRL proposals for honey. Adequate analytical methods for enforcement are available to control the residues of clopyralid (including potential conjugates) in honey 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 clopyralid residues in honey, resulting from the authorised use of clopyralid on oilseed rape notified in the present MRL assessment, is unlikely to present a risk to consumer health. [ABSTRACT FROM AUTHOR]

The applicant Syngenta Crop Protection AG submitted a request to the competent national authority in Sweden to evaluate the confirmatory data that were identified for diquat in the framework of the MRL review under Article 12 of Regulation (EC) No 396/2005 as not available. The applicant provided sufficient data to address the data gaps related to plant metabolism studies and analytical methods for plant and animal products. The data gap requesting further studies to investigate the nature of residues of diquat and its metabolite TOPPS in processed products was not sufficiently addressed. Considering the new studies submitted under the current application and considering that the EU uses for diquat had to be withdrawn following a decision on non‐approval, EFSA proposed the lowering of the existing MRLs to the appropriate limit of quantifications for the commodities under assessment. In addition, EFSA proposed to perform a more comprehensive review of the existing MRLs that were not subject to the current assessment, taking into account the findings and conclusions of the peer review, the consequences of the non‐approval decision and the revisions of Codex MRLs. [ABSTRACT FROM AUTHOR]

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

The applicants Bayer SAS – Crop Science Division, Diachem S.p.A. and Isagro S.p.A., submitted two requests to the competent national authority in Austria to evaluate the confirmatory data identified for deltamethrin in the framework of the maximum residue level (MRL) review under Article 12 of Regulation (EC) No 396/2005 as not available. The application from Bayer SAS – Crop Science Division also included a proposal for the modification of the MRL for deltamethrin in tomatoes in accordance with Article 6 of Regulation (EC) No 396/2005. A third application was submitted by the Federal Public Service (FPS) Health, Food chain safety and Environment on behalf of Belgium, to modify the existing maximum residue level for the active substance in okra/lady's fingers. The three applications were combined by EFSA under the current assessment. The data gaps based on monitoring analytical methods were addressed; the data gaps on storage stability studies, processing trials in potatoes, metabolism studies of deltamethrin isomers in livestock and livestock feeding studies were not addressed by providing the requested experimental data; data gap on residue trials analysing simultaneously for monitoring and risk assessment residue definitions was not addressed for most of the concerned crops and requires risk managers' decisions in numerous cases. The new information provided requires a revision of certain existing MRLs. Adequate analytical methods for enforcement are available to control the residues of deltamethrin in plant and animal matrices at the validated limit of quantification (LOQ) of 0.01 mg/kg. Based on the results of the refined risk assessment following evaluation of the confirmatory data, EFSA concluded that the short‐term and long‐term intake of residues resulting from the proposed uses of deltamethrin according to the reported agricultural practices are unlikely to present a risk to consumer health. The risk assessment shall be regarded as indicative and affected by non‐standard uncertainties. [ABSTRACT FROM AUTHOR]

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 tetraconazole. To assess the occurrence of tetraconazole 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 and the UK (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, with the exception of the MRL proposal for kaki, all MRL proposals derived by EFSA still require further consideration by risk managers. Regarding triazole derivative metabolites (TDMs), separate indicative exposure assessments were performed and no risk to consumers was identified for what regards these 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]

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 isoxaben. To assess the occurrence of isoxaben 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 and the UK (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. Although this active substance is not authorised within the European Union, MRLs were established by the Codex Alimentarius Commission (codex maximum residue limits; CXLs) and import tolerances were reported by Member States and the UK (including the supporting residues data). Considering that no toxicological reference values are currently established in Europe for novaluron because the peer review for the approval was terminated before an EFSA conclusion was issued, the toxicological profile of novaluron was also assessed, in order to be able to perform the consumer risk assessment in the framework of the art 12 MRL review. Based on the assessment of the available data, toxicological reference values were derived, and a consumer risk assessment was carried out for the existing CXLs and import tolerances. All CXLs and import tolerances were found to be supported by inadequate data and a possible chronic risk to consumers was identified. Hence, further consideration by risk managers is needed. [ABSTRACT FROM AUTHOR]

In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Industrias Afrasa SA – Albaugh TKI d.o.o. – Lainco S.A. submitted a request to the competent national authority in Greece to modify the existing maximum residue levels (MRLs) for the active substance azoxystrobin in rapeseeds and linseeds. The data submitted in support of the request were found to be sufficient to derive an MRL proposal for rapeseeds. No modification of the existing EU MRL was proposed for linseeds. Adequate analytical methods for enforcement are available to control the residues of azoxystrobin in the commodities under consideration at the validated limit of quantification (LOQ) of 0.01 mg/kg. Based on the risk assessment results, noting that an acute risk assessment was not deemed necessary for azoxystrobin, EFSA concluded that the long‐term intake of residues resulting from the use of azoxystrobin 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 DLR‐Rheinpfalz submitted a request to the competent national authority in Germany to modify the existing maximum residue level (MRL) for the active substance oxathiapiprolin in kales, with the specific intention to derive an MRL in radish leaves (classified under the subgroup of kales), based on an intended NEU use on radishes. The residue data in radish leaves submitted in support of the request were found to be sufficient to derive MRL proposal for this commodity which could be applicable also for kales. Adequate analytical methods for enforcement are available to control the residues of oxathiapiprolin in radishes at the validated LOQ of 0.01 mg/kg. Based on the risk assessment results, EFSA concluded that the long‐term intake of residues resulting from the use of oxathiapiprolin on radishes according to the reported agricultural practice is unlikely to present a risk to consumer health. [ABSTRACT FROM AUTHOR]

The applicant Syngenta Crop Protection AG submitted a request to the competent national authority in Belgium to evaluate the confirmatory data that were identified for metalaxyl‐M in the framework of the MRL review under Article 43 and Article 12 of Regulation (EC) No 396/2005 as not available. To address the data gaps new data regarding analytical methods for enforcement (validation data for hops and cocoa beans, ILV for fat) and several residue trials data supporting adjusted GAPs for metalaxyl‐M on apples, pears, broccoli, cauliflower, herbs and edible flowers, soya beans and cocoa beans were submitted. Two data gaps concerning analytical methods for enforcement (validation data for hops and cocoa beans, ILV for fat) were considered satisfactorily addressed. However, the data gap on validation of the efficiency of the extraction, hydrolysis and derivatisation steps included in the proposed analytical method for enforcement of residues in livestock was not addressed. The data gap for residue trials supporting authorisations of metalaxyl‐M was partially addressed. The data gap for residue trials supporting authorisations of metalaxyl was not addressed. The new information provided may require a revision of the existing MRLs for several commodities of plant and animal origin. Further risk management considerations are required. [ABSTRACT FROM AUTHOR]

In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Nissan Chemical Europe S.A.S. submitted a request to the competent national authority in Finland to modify the existing maximum residue level (MRL) for quizalofop in caraway to accommodate the intended NEU use of quizalop‐P‐ethyl for this commodity. The data submitted in support of the request were found to be sufficient to derive an MRL proposal for caraway. Adequate analytical methods for enforcement are available to control the residues of quizalofop, resulting from the use of quizalofop‐P‐ethyl, 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 short‐term and long‐term intake of residues resulting from the use of quizalofop‐P‐ethyl 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 ADAMA Agriculture BV on behalf of ADAMA Makhteshim Ltd submitted a request to the competent national authority in Denmark to modify the existing maximum residue levels (MRL) for the active substance tau-fluvalinate in tomatoes and watermelons. The data submitted in support of the request were found to be sufficient to derive an MRL proposal for tomatoes. For watermelons, a change of the MRL recently set in the EU legislation is not required. 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 intended uses of tau-fluvalinate according to the reported agricultural practices is unlikely to present a risk to consumer health. The risk assessment shall be regarded as indicative. [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 pinoxaden. To assess the occurrence of pinoxaden 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 and the UK (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, the applicant Nisso Chemical Europe GmbH submitted a request to the competent national authority in Greece to set an import tolerance for the active substance cyflufenamid 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; however, further risk management considerations are required to decide on the appropriate MRL values considering that the MRL in the country of origin is lower than the MRL proposal derived from the residue trials. Adequate analytical methods for enforcement are available to control the residues of cyflufenamid in the crop under consideration at the validated limit of quantification (LOQ) of 0.01 mg/kg. Based on the consumer risk assessment results, EFSA concluded that the short-term and long-term intake of residues resulting from the use of cyflufenamid according to the reported agricultural practice in the country of origin is unlikely to present a risk to consumer health. This conclusion shall be regarded as indicative considering that some MRL proposals derived by EFSA during the MRL review require further confirmatory data. [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 cyproconazole. Considering that no application was received to support the renewal of the approval of cyproconazole and considering the expiry date for its approval on 31 May 2021, and that the import tolerances identified were not supported by sufficient data, and are not forming the basis of any existing EU MRLs, but correspond to existing MRLs established by the Codex Alimentarius Commission (codex maximum residue limits; CXLs), the current assessment is limited to CXLs. To assess the occurrence of cyproconazole 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 MRLs established by the Codex Alimentarius Commission. Based on the assessment of the available data, EFSA assessed the CXLs 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 applicant Landwirtschaftliches Technologiezentrum Augustenberg submitted a request to the competent national authority in Germany to modify the existing maximum residue level (MRL) for the active substance phenmedipham in strawberries. Noting that at least one additional trial is missing, an MRL of 0.7 mg/kg was derived for the intended NEU use of phenmedipham on strawberries. Adequate analytical methods for enforcement are available to control the residues of phenmedipham in strawberries at the validated limit of quantification (LOQ) of 0.01 mg/kg. Since the current MRL application was submitted before the finalisation of the EU pesticides peer review of the renewal of the approval of phenmedipham, the consumer exposure assessment was performed according to the conclusions on the toxicity of phenmedipham from the first approval under Directive 91/414/EEC. Accordingly, the long‐term intake of residues of phenmedipham resulting from the existing and the intended uses is unlikely to present a risk to consumer health. EFSA notes that the present assessment does not take into account the data gaps identified in the context of the renewal of the approval of phenmedipham under Regulation (EC) No 1107/2009, which prevented experts to derive toxicological reference values (TRVs) for phenmedipham, to derive the risk assessment residue definition for fruit crops and to conclude on the toxicity of relevant metabolites. [ABSTRACT FROM AUTHOR]

In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant FMC Agro Limited submitted a request to the competent national authority in the UK to set import tolerances for the active substance chlorantraniliprole in strawberries and the whole category pulses (beans, lentils, peas and lupins/lupini beans). The data submitted in support of the request were found to be sufficient to derive an maximum residue level (MRL) proposal for the whole category pulses. The available data are not sufficient to derive an import tolerance for strawberries and no modification of the current EU MRL is required. 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. 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 Bayer SAS - Crop Science Division submitted a request to the competent national authority in the Netherlands to modify the existing maximum residue levels (MRL) for the active substance flupyradifurone and its metabolite DFA in rapeseeds/canola seeds and mustard seeds. The data submitted in support of the request were found sufficient to derive MRL proposals for both compounds in rapeseeds and mustard seeds. Adequate analytical methods for enforcement are available to control the relevant residues in plant matrices under consideration. Based on the risk assessment results, EFSA concluded that the short-term and long-term intake of residues of flupyradifurone and of its metabolite DFA resulting from the use of flupyradifurone is unlikely to present a risk to consumer health. [ABSTRACT FROM AUTHOR]

In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant, Dienstleistungszentrum Ländlicher Raum Rheinpfalz, submitted a request to the competent national authority in Germany to modify the existing maximum residue level (MRL) for the active substance picloram in flowering brassica. The data submitted in support of the request were found to be sufficient to derive an MRL proposal for broccoli, cauliflowers and other flowering brassica. Adequate analytical methods for enforcement are available to control the residues of picloram and its conjugates in plant matrices under consideration at the validated limit of quantification (LOQ) of 0.01 mg/kg. Based on the risk assessment results, EFSA concluded that the short‐term and long‐term intake of residues resulting from the use of picloram according to the reported agricultural practices is unlikely to present a risk to consumer health. The reliable end points, appropriate for use in regulatory risk assessment, are presented. [ABSTRACT FROM AUTHOR]

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 oxyfluorfen. To assess the occurrence of oxyfluorfen 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 one existing European MRL still requires 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 pyroxsulam. To assess the occurrence of pyroxsulam 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. 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]

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 quinmerac. To assess the occurrence of quinmerac residues in plants, processed commodities, rotational crops and livestock, EFSA considered the conclusions derived in the framework of Commission Regulation (EC) No 33/2008, 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, the applicant Corteva submitted a request to the competent national authority in Italy to modify the existing maximum residue levels (MRLs) for the active substance penthiopyrad in Florence fennels and celeries. The data submitted in support of the request were found to be sufficient to derive MRL proposals for Florence fennels and celeries. Adequate analytical methods for enforcement are available to control the residues of penthiopyrad 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 penthiopyrad residues and of its metabolite PAM, resulting from the use of penthiopyrad 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 applicants Tilco‐Alginure GmbH, ADAMA Agriculture BV, Lainco S.A., Exclusivas Sarabia S.A., Biovert S.L. and Landwirtschaftskammer Steiermark submitted requests to the competent national authorities in Germany, France, Greece and Austria to modify the existing maximum residue levels (MRLs) for the active substance potassium phosphonates in various crops. The data submitted in support of the different requests were found to be sufficient to derive MRL proposals for all crops under assessment. Adequate analytical methods for enforcement are available to control the residues of potassium phosphonates in the crops under assessment. Based on the risk assessment results, EFSA concluded that the long‐term intake of residues resulting from the use of potassium phosphonates according to the reported agricultural practices is unlikely to present a risk to consumer health. The consumer risk assessment shall be regarded as indicative and a more realistic intake assessment will be performed in the framework of the joint review of MRLs for fosetyl and phosphonates. 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 Streptomyces lydicus strain WYEC 108. Considering the information provided by Member States, neither EU uses nor import tolerances are currently authorised for Streptomyces lydicus strain WYEC 108 within the EU. Furthermore, no MRLs are established by the Codex Alimentarius Commission (codex maximum residue limits) for this active substance. Therefore, residues of Streptomyces lydicus strain WYEC 108 are not expected to occur in any plant or animal commodity and therefore a consumer risk assessment is not required. Nevertheless, the available information allowed EFSA to propose a marker residue definition noting that methods for identification and quantification of Streptomyces lydicus strain WYEC 108 are available; however, a method for enforcement fully validated at a specific limit of quantification (LOQ) was not provided. An inclusion of Streptomyces lydicus strain WYEC 108 in Annex IV of (EC) No 396/2005 is not recommended. [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 Greece to modify the existing maximum residue level (MRL) for the active substance boscalid in granate apples/pomegranates. The data submitted in support of the request were found to be sufficient to derive an MRL proposal for pomegranates. Adequate analytical methods for enforcement are available to control the residues of boscalid in 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 boscalid 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]

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 chlorantraniliprole. To assess the occurrence of chlorantraniliprole 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. 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 Pseudomonas sp. strain DSMZ 13134. To assess the occurrence of Pseudomonas sp. strain DSMZ 13134 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 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 would still be desirable. 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 Pseudomonas sp. strain DSMZ 13134 into Annex IV of Regulation (EC) No 396/2005 is derived by EFSA based on the authorised uses of this Art. 12 review. [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 6‐benzyladenine. To assess the occurrence of 6‐benzyladenine 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 Syngenta Agro GmbH submitted a request to the competent national authority in Germany to modify the existing maximum residue level (MRL) for the active substance fludioxonil in elderberries in support of the intended NEU use. The data submitted in support of the request were found to be sufficient to derive an MRL proposal of 4 mg/kg for elderberries, as an extrapolation from red and black currants and blueberries. Adequate analytical methods for enforcement are available to control the residues of fludioxonil in the plant matrix under consideration at the validated limit of quantification (LOQ) of 0.01 mg/kg. Based on the risk assessment results, EFSA concluded that the long‐term intake of residues resulting from the intended use of fludioxonil according to the reported agricultural practice and from the existing authorised uses is unlikely to present a risk to consumer health. [ABSTRACT FROM AUTHOR]

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 amisulbrom. To assess the occurrence of amisulbrom 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 applicant ISK Biosciences Europe N.V, submitted a request to the competent national authority in Finland to evaluate the confirmatory data that were identified for flonicamid in the framework of the maximum residue level (MRL) review under Article 12 of Regulation (EC) No 396/2005 as not available. In order to address the data gaps, the applicant provided method validation data for hops, residue trials on cherries, plums, tomatoes and melons and referred to results from trials in cucumbers and storage stability and hydrolysis studies which have been assessed in previous EFSA outputs. The provided information was considered sufficient to address the confirmatory data gaps for hops, cherries, plums, tomatoes and aubergines, courgettes and cucurbits with inedible peel. EFSA updated the most recent consumer risk assessment for flonicamid and concluded that for the crops under assessment, the long‐term and short‐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 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]

The applicant Bayer Crop Science submitted a request to the competent national authority in the Netherlands to evaluate the confirmatory data that were identified for aclonifen 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, an analytical method for enforcement in complex/no group matrices (spices) and additional four residue trials supporting SEU authorisation on peppers were submitted. The data gaps were considered satisfactorily addressed and the tentative MRLs can be confirmed in peppers, in seed and fruit spices and in flowers and leaves and herbs of herbal infusions. The previous consumer intake assessment remains valid. [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]

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 spirotetramat. To assess the occurrence of spirotetramat residues in plants, processed commodities, rotational crops and livestock, EFSA considered the conclusions derived in the framework of Directive 91/414/EEC, Regulation (EC) No 1107/2009 and 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 residue 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 terbuthylazine. To assess the occurrence of terbuthylazine 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 applicant Syngenta Crop Protection submitted a request to the competent national authority in the Netherlands to evaluate the confirmatory data addressing information that was identified as not available for abamectin in the framework of the maximum residue level (MRL) review under Article 12 of Regulation (EC) No 396/2005. In addition, in accordance with Article 6 of Regulation (EC) No 396/2005, the applicant submitted a request to modify the existing MRLs for abamectin in lamb’s lettuces, lettuces, escaroles, cresses and other sprouts/shoots, roman rocket/rucola, baby leaf crops, celery leaves, spinaches and similar leaves, beans with pods and peas with pods. The data gap on the validation for the enforcement analytical method was satisfactorily addressed; in addition, the requested residue trials to support the indoor winter use on lamb’s lettuces were provided. For pome fruits and tomatoes, lower MRLs were derived based on alternative good agricultural practices (GAPs) already assessed by EFSA. Among the intended new uses requested in the MRL application, the residue data were sufficient to support an MRL proposal for the indoor winter use on lamb’s lettuces and baby leaf crops, the outdoor Southern Europe use on lamb’s lettuces, escaroles, cresses and other sprouts/shoots, roman rocket/rucola, baby leaf crops, spinaches and similar leaves, celery leaves and the indoor winter use on peas with pods. For lettuces and beans with pods, the supporting data were not fully compliant with the data requirements, and further risk management discussions are recommended to decide whether a modification of the existing MRLs would be appropriate. EFSA updated the most recent consumer risk assessment for abamectin and concluded that the long-term dietary intake is unlikely to present a risk to consumer health. According to the internationally agreed methodology, an acute consumer risk was not identified in relation to the uses assessed. [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]

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]