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Abstract In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant ISK Biosciences Europe N.V. submitted a request to the competent national authority in Finland to modify the existing maximum residue level (MRL) for the active substance flonicamid in honey. The data submitted in support of the request were not found appropriate to derive an MRL proposal for honey. The assessment was complemented by an analysis of the monitoring data available from the EU monitoring programmes (conducted during 2009–2023). The results from the monitoring data analysis suggest that the current MRL is still sufficient to account for the residue uptake in honey resulting from plant protection products uses of flonicamid on melliferious crops. Adequate analytical methods for enforcement are available to control the residues of flonicamid in honey according to the residue definition as the sum of flonicamid, TFNA and TFNG, expressed as flonicamid at the validated limit of quantification (LOQ) of 0.01 mg/kg for each compound. Based on the risk assessment results, EFSA concluded that the short‐term and long‐term intake of residues in honey at a level of 0.05 mg/kg according to the monitoring data is unlikely to present a risk to consumer health.

Abstract The conclusions of the European Food Safety Authority (EFSA) following the peer review of the initial risk assessments carried out by the competent authorities of the rapporteur Member State, Italy, and co‐rapporteur Member State, Poland, for the pesticide active substance penoxsulam are reported. The context of the peer review was that required by Commission Implementing Regulation (EU) No 844/2012, as amended by Commission Implementing Regulation (EU) No 2018/1659. The conclusions were reached on the basis of the evaluation of the representative uses of penoxsulam as a herbicide on rice and chicory. The reliable end points, appropriate for use in regulatory risk assessment, are presented. Missing information identified as being required by the regulatory framework is listed. Concerns are reported where identified.

Abstract The conclusions of the European Food Safety Authority (EFSA) following the peer review of the initial risk assessments carried out by the competent authority of the rapporteur Member State Austria for the pesticide active substance elemental iron and the considerations as regards the inclusion of the substance in Annex IV of Regulation (EC) No 396/2005 are reported. The context of the peer review was that required by Regulation (EC) No 1107/2009 of the European Parliament and of the Council. The conclusions were reached on the basis of the evaluation of the representative uses of elemental iron in field and greenhouses (permanent and non‐permanent structures) via granule application by spreading on all edible and non‐edible crops, ornamental plants and amenity grassland to control molluscs. The reliable endpoints, appropriate for use in regulatory risk assessment, are presented. Missing information identified as being required by the regulatory framework is listed.

Abstract 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 the Netherlands to modify the existing maximum residue levels (MRLs) in certain animal commodities (fat and liver) and honey. The data submitted in support of the request were found to be sufficient to derive an MRL proposal for honey. Adequate analytical methods for enforcement are available to control the residues according to the residue definition for enforcement proposed as ‘picloram, free and conjugated, expressed as picloram’ in honey at the validated limit of quantification (LOQ) of 0.01 mg/kg. For the commodities of animal origin, although the submitted data were found to be sufficient, EFSA concluded that no change of the existing MRLs was necessary. Based on the risk assessment results, EFSA concluded that the short‐term and long‐term intake of residues expected in honey, resulting from the existing uses of picloram on melliferous crops, is unlikely to present a risk to consumer health.

Abstract The conclusions of the European Food Safety Authority (EFSA) following the peer review of the initial risk assessments carried out by the competent authority of the rapporteur Member State, The Netherlands for the pesticide active substance bixlozone are reported. The context of the peer review was that required by Regulation (EC) No 1107/2009 of the European Parliament and of the Council. The conclusions were reached on the basis of the evaluation of the representative uses of bixlozone as an herbicide on winter cereals (wheat and barley), winter oilseed rape and maize via soil broadcast spray application in field. The reliable endpoints, appropriate for use in regulatory risk assessment are presented. Missing information identified as being required by the regulatory framework is listed. Concerns are identified.

Abstract The conclusions of the European Food Safety Authority (EFSA) following the peer review of the initial risk assessments carried out by the competent authorities of the rapporteur Member State Czech Republic and co‐rapporteur Member State Austria for the pesticide active substance pyrimethanil and of confirmatory data following the maximum residue limit (MRL) review under Article 12 of Regulation (EC) No 396/2005 are reported. The context of the peer review was that required by Commission Implementing Regulation (EU) No 844/2012, as amended by Commission Implementing Regulation (EU) No 2018/1659. The conclusions were reached on the basis of the evaluation of the representative uses of pyrimethanil as a fungicide on grapevine and pome fruit (field uses), strawberry and lettuce (field and greenhouse uses). The reliable end points, appropriate for use in regulatory risk assessment are presented. Missing information identified as being required by the regulatory framework is listed. Concerns are identified.

Abstract In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Nufarm Crop Products UK Ltd. submitted a request to the competent national authority in Italy to modify the existing maximum residue levels (MRLs) for the active substance dichlorprop‐P in barley, oat, rye and wheat grain. The data submitted in support of the request were found to be sufficient to derive MRL proposals for these cereal grains. Adequate analytical methods for enforcement are available to control the residues of dichlorprop‐P in the commodities under consideration at the validated limit of quantification (LOQ) of 0.01 mg/kg and in animal matrices at the validated LOQ of 0.01 mg/kg. Based on the risk assessment results, the European Food Safety Authority (EFSA) concluded that the short‐term and long‐term intake of residues resulting from the use of dichlorprop‐P‐2‐ethylhexyl (dichlorprop‐P 2‐EHE) according to the reported agricultural practices is unlikely to present a risk to consumer health.

Abstract The conclusions of the European Food Safety Authority (EFSA) following the peer review of the initial risk assessments carried out by the competent authorities of the rapporteur Member State Sweden for the pesticide active substance pirimicarb are reported. The context of the peer review was that required by Commission Implementing Regulation (EU) No 844/2012, as amended by Commission Implementing Regulation (EU) No 2018/1659. The conclusions were reached on the basis of the evaluation of the representative use(s) of pirimicarb as an insecticide on winter and spring wheat and sugar beet via foliar spray application and on ornamental pot plants in permanent greenhouses. The reliable end points, appropriate for use in regulatory risk assessment are presented. Missing information identified as being required by the regulatory framework is listed. Concerns are identified.

Abstract The conclusions of the European Food Safety Authority (EFSA) following the peer review of the initial risk assessments carried out by the competent authority of the rapporteur Member State the Netherlands for the pesticide active substance Bacillus subtilis strain RTI477 are reported. The context of the peer review was that required by Regulation (EC) No 1107/2009 of the European Parliament and of the Council. The conclusions were reached on the basis of the evaluation of the representative uses of B. subtilis strain RTI477 as a fungicide for the control of soil‐borne diseases in greenhouses (permanent) and walk‐in tunnels and field crops; by drip and drench irrigation on lettuce, cucurbit and solanaceous vegetables; field application by treating tubers whilst laying in furrow on potato; seed treatment application on maize, sunflower, sugar beet and winter oilseed rape. The reliable endpoints, appropriate for use in regulatory risk assessment, are presented. Missing information identified as being required by the regulatory framework is listed. Concerns are reported when identified.

Abstract The conclusions of the European Food Safety Authority (EFSA) following the peer review of the initial risk assessments carried out by the competent authority of the rapporteur Member State The Netherlands for the pesticide active substance Bacillus velezensis strain RTI301 are reported. The context of the peer review was that required by Regulation (EC) No 1107/2009 of the European Parliament and of the Council. The conclusions were reached on the basis of the evaluation of the representative uses of B. velezensis strain RTI301 as a fungicide for the control of soil‐borne diseases in greenhouses (permanent) and walk‐in tunnels (non‐permanent) and field crops; by drip and drench irrigation on lettuce, cucurbit and solanaceous vegetables; field application by treating tubers whilst laying in furrow on potato; seed treatment application on maize, sunflower, sugar beet and winter oilseed rape. The reliable endpoints, appropriate for use in regulatory risk assessment, are presented. Missing information identified as being required by the regulatory framework is listed. Concerns are reported when identified.

Abstract The conclusions of the European Food Safety Authority (EFSA) following the peer review of the initial risk assessments carried out by the competent authorities of the rapporteur Member State, Finland, and co‐rapporteur Member State, Croatia, for the pesticide active substance amidosulfuron and the assessment of confirmatory data following the Article 12 MRL review are reported. The context of the peer review was that required by Commission Implementing Regulation (EU) No 844/2012, as amended by Commission Implementing Regulation (EU) No 2018/1659. The conclusions were reached on the basis of the evaluation of the representative uses of amidosulfuron as a post‐emergence herbicide on winter cereals, spring cereals, flax and grass/pasture (all field uses). The reliable end points, appropriate for use in regulatory risk assessment are presented. Missing information identified as being required by the regulatory framework is listed. Concerns are reported where identified.

Abstract In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant BASF SE submitted a request to the competent national authority in the Netherlands to modify the existing maximum residue levels (MRLs) for the active substance cycloxydim in pome fruits, apricots/peaches, peas (with pods), maize/corn, sugar beet roots and milk (sheep). The data submitted in support of the request were found to be sufficient to derive MRL proposals for pome fruits, peas (with pods), maize/corn and sugar beet roots while for apricots, peaches and sheep milk no changes to the existing MRLs were considered necessary. Adequate analytical methods for enforcement are available to control the residues of cycloxydim according to the current enforcement residue definition 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 uses of cycloxydim according to the reported agricultural practices is unlikely to present a risk to consumer health.

Abstract The conclusions of the European Food Safety Authority (EFSA) following the peer review of the initial risk assessments carried out by the competent authorities of the rapporteur Member State Poland and co‐rapporteur Member State France for the pesticide active substance flufenacet are reported. In addition, the assessment of the confirmatory data following the Article 12 maximum residue limit (MRL) review of Regulation (EC) No 396/2005 is also reported. The context of the peer review was that required by Commission Implementing Regulation (EU) No 844/2012. The conclusions were reached on the basis of the evaluation of the representative use of flufenacet as a herbicide on winter cereals. Confirmatory data following the Article 12 MRL review were assessed. The reliable end points, appropriate for use in regulatory risk assessment and the assessment of confirmatory data following the Article 12 MRL review, are presented. Missing information identified as being required by the regulatory framework is listed. Concerns are reported where identified.

Abstract The conclusions of the European Food Safety Authority (EFSA) following the peer review of the initial risk assessments carried out by the competent authorities of the rapporteur Member State Italy and co‐rapporteur Member State Spain for the pesticide active substance bensulfuron‐methyl are reported. The context of the peer review was that required by Commission Implementing Regulation (EU) No 844/2012, as amended by Commission Implementing Regulation (EU) No 2018/1659. The conclusions were reached on the basis of the evaluation of the representative uses of bensulfuron‐methyl as an herbicide on rice and spring cereals (spring wheat, spring barley, oat, rye, triticale). The reliable end points, appropriate for use in regulatory risk assessment are presented. Missing information identified as being required by the regulatory framework is listed. Concerns are identified.

Abstract The conclusions of EFSA following the peer review of the initial risk assessments carried out by the competent authority of the rapporteur Member State Belgium for the pesticide active substance Pythium oligandrum strain B301 and the considerations as regards the inclusion of the substance in Annex IV of Regulation (EC) No 396/2005 are reported. The context of the peer review was that required by Regulation (EC) No 1107/2009 of the European Parliament and of the Council. The conclusions were reached on the basis of the evaluation of the representative uses of Pythium oligandrum strain B301 as a resistance inducer/elicitor to control trunk diseases on grapevines. The reliable endpoints, appropriate for use in regulatory risk assessment, are presented. Missing information identified as being required by the regulatory framework is listed. Concerns are reported where identified.

Abstract 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 difenoconazole. To assess the occurrence of difenoconazole residues in plants, processed commodities, rotational crops and livestock, EFSA considered the conclusions derived in the framework of Council Directive 91/414/EEC, 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. 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 The conclusions of the European Food Safety Authority (EFSA) following the peer review of the initial risk assessments carried out by the competent authority of the rapporteur Member State The Netherlands for the pesticide active substance 1‐methylcyclopropene are reported. The context of the peer review was that required by Regulation (EC) No 1107/2009 of the European Parliament and of the Council for an amendment in approval conditions. The current approval of 1‐methylcyclopropene includes the specific provision ‘Only uses as plant growth regulator for post‐harvest storage in sealable warehouse may be authorised’. The applicant AgroFresh Holding France SAS submitted, in accordance with Article 7 of Reg. (EC) 1107/2009, an application to remove this specific provision in order to allow member states to authorise the use of products containing 1‐methylcyclopropene on outdoor crops pre‐harvest. The conclusions were reached on the basis of the evaluation of the representative use(s) of 1‐methylcyclopropene as a plant growth regulator via spray application on pome fruit. The reliable endpoints, appropriate for use in regulatory risk assessment are presented. Missing information identified as being required by the regulatory framework is listed. Concerns are reported where identified.

Abstract The conclusions of the European Food Safety Authority (EFSA) following the peer review of the initial risk assessments carried out by the competent authority of the rapporteur Member State, The Netherlands for the pesticide active substance Phthorimaea operculella granulovirus are reported. The context of the peer review was that required by Regulation (EC) No 1107/2009 of the European Parliament and of the Council. The conclusions were reached on the basis of the evaluation of the representative uses of Phthorimaea operculella granulovirus as an insecticide on tomato (field and greenhouse uses) and on potato (field use) via spraying (tractor drawn or knapsack sprayers) or overhead irrigation. The reliable endpoints, appropriate for use in regulatory risk assessment are presented. Missing information identified as being required by the regulatory framework is listed.

Abstract 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 The conclusions of the European Food Safety Authority (EFSA) following the peer review of the initial risk assessments carried out by the competent authorities of the rapporteur Member State, Greece, and co‐rapporteur Member State, France, for the pesticide active substance paraffin oil are reported. The context of the peer review was that required by Commission Implementing Regulation (EU) No 844/2012, as amended by Commission Implementing Regulation (EU) No 2018/1659. The conclusions were reached on the basis of the evaluation of the representative uses of paraffin oil as an acaricide and insecticide on potatoes, ornamentals (flower bulbs) and orchards (pear/apple), on pome fruit and stone fruit, on field and permanent protected fruiting vegetables and on field and permanent protected roses and on citrus. The reliable end points appropriate for use in regulatory risk assessment are presented. Missing information identified as being required by the regulatory framework is listed. Concerns are reported where identified.

Abstract The conclusions of the EFSA following the peer review of the initial risk assessment carried out by the competent authority of the rapporteur Member State, Spain, for the pesticide active substance difenoconazole are reported. The context of the peer review was that requested by the European Commission following the submission and evaluation of confirmatory information with regard to the consumer risk assessment. The conclusions were reached on the basis of the evaluation of the representative uses of difenoconazole as a fungicide on pome fruit, carrot, wheat, barley, triticale, rye and oats. The reliable endpoints concluded as being appropriate for use in regulatory risk assessment, derived from the available studies and/or literature in the dossier peer reviewed, are presented. Concerns were not identified.

Abstract The conclusions of the EFSA following the peer review of the initial risk assessments carried out by the competent authorities of the rapporteur Member State, Finland, and co‐rapporteur Member State, Estonia, for the pesticide active substance mepiquat (evaluated variant mepiquat chloride) are reported. The context of the peer review was that required by Commission Implementing Regulation (EU) No 844/2012, as amended by Commission Implementing Regulation (EU) No 2018/1659. The conclusions were reached on the basis of the evaluation of the representative uses of mepiquat chloride as a plant growth regulator on cereals and grass (field uses). The reliable end points, appropriate for use in regulatory risk assessment, are presented. Missing information identified as being required by the regulatory framework is listed. Concerns are identified.

Abstract The conclusions of the European Food Safety Authority (EFSA) following the peer review of the initial risk assessments carried out by the competent authorities of the rapporteur Member State, Belgium, and co‐rapporteur Member State, Austria, for the pesticide active substance lenacil are reported. The context of the peer review was that required by Commission Implementing Regulation (EU) No 844/2012, as amended by Commission Implementing Regulation (EU) No 2018/1659. The conclusions were reached on the basis of the evaluation of the representative uses of lenacil as a herbicide on sugar and fodder beet (field use). The reliable end points, appropriate for use in regulatory risk assessment, are presented. Missing information identified as being required by the regulatory framework is listed. Concerns are reported where identified.

Abstract 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 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 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 The conclusions of the EFSA following the peer review of the initial risk assessments carried out by the competent authority of the rapporteur Member State, Malta, for the pesticide active substance clove oil are reported. The context of the peer review was that required by Regulation (EC) No 1107/2009 of the European Parliament and of the Council. The conclusions for the amendment of approval were reached on the basis of the evaluation of the representative use of clove oil as a preharvest nematicide on tomatoes and cucumbers (permanent greenhouse use). The representative use evaluated for the renewal of approval of clove oil was as post‐harvest fungicide and bactericide on apples, pears and peaches (indoor uses). The reliable endpoints appropriate for use in regulatory risk assessment are presented. Endpoints not relevant to the scope of the proposed amendment of approval conditions will be addressed in the context of the renewal of approval procedure of clove oil running in parallel (AIR IV, EFSA Q‐2016‐00809). Missing information identified as being required by the regulatory framework is listed. Concerns are reported where identified.

Abstract 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 The conclusions of the EFSA following the peer review of the initial risk assessments carried out by the competent authorities of the rapporteur Member State, Ireland, and co‐rapporteur Member State, Poland, for the pesticide active substance dichlorprop‐P and the variant dichlorprop‐P‐2‐ethylhexyl and the assessment of applications for maximum residue levels (MRLs) are reported. The context of the peer review was that required by Commission Implementing Regulation (EU) No 844/2012. The conclusions were reached on the basis of the evaluation of the representative uses of dichlorprop‐P as a herbicide on cereals, grassland and grass seed crops and of the variant dichlorprop‐P‐2‐ethylhexyl as a plant growth regulator on citrus. MRLs were assessed in mandarin and lemon. The conclusions from 2018 were updated in 2024 following the request from the European Commission with regard to the endocrine‐disrupting properties. The reliable end points, appropriate for use in regulatory risk assessment and the proposed MRLs, are presented. Missing information identified as being required by the regulatory framework is listed. Concerns are reported where identified.

Abstract The conclusions of the European Food Safety Authority (EFSA) following the peer review of the initial risk assessments carried out by the competent authorities of the rapporteur Member State, Spain, and co‐rapporteur Member State, the Netherlands, for the pesticide active substance quinolin‐8‐ol are reported. The context of the peer review was that required by Commission Implementing Regulation (EU) No 844/2012. The conclusions were reached on the basis of the evaluation of the representative use of quinolin‐8‐ol as a fungicide and bactericide against soil‐borne pathogens in tomato cultivation in permanent greenhouses applied by drip irrigation. The reliable end points, appropriate for use in regulatory risk assessment are presented. Missing information identified as being required by the regulatory framework is listed. Concerns are reported where identified.

Abstract 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 In compliance with Article 43 of Regulation (EC) No 396/2005, EFSA received from the European Commission in 2020 a mandate to provide its reasoned opinion on the toxicological properties and maximum residue levels (MRLs) for the benzimidazole substances carbendazim and thiophanate‐methyl. Specifically, EFSA was asked to assess whether thiophanate‐methyl or carbendazim has clastogenic potential and, in case clastogenic potential can be excluded, to derive toxicological reference values necessary for consumer risk assessment and assessment of maximum residue levels (MRLs). Although these active substances are no longer authorised within the European Union, MRLs were established by the Codex Alimentarius Commission (codex maximum residue limits; CXLs), and import tolerances are in place. Based on the assessment of the available data, toxicological reference values and MRL proposals were derived and a consumer risk assessment was carried out. Some information required by the regulatory framework was found to be missing and a possible acute risk to consumers was identified. Hence, the consumer risk assessment was considered indicative only and all MRL proposals derived by EFSA still require further consideration by risk managers. In October 2022, to ensure that MRLs derived by EFSA in its assessment of 2021 are safe for consumers also in view of endocrine‐disrupting properties, EFSA was requested to carry out a follow‐up assessment taking into account the scientific criteria for identifying endocrine disruptors (ED). Based on the outcome of the assessment, the experts agreed that the reference values are also covering the concern related to the identified hazards indicative of endocrine disruption for thiophanate‐methyl. No further considerations on the impact of the ED assessment on the current reference values were needed for carbendazim since the ED criteria are not met for this substance. Therefore, the risk assessment and the MRL recommendations derived in 2021 are confirmed.

Abstract 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 In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant ISK Biosciences Europe N.V. submitted two requests to the competent national authority in Finland and Belgium, respectively, to modify the existing maximum residue levels (MRLs) for the active substance flonicamid in potatoes and in various crops. The data submitted in support of the requests were found to be sufficient to derive MRL proposals for potatoes, lettuces and salad plants, spinaches and similar leaves, beans (without pods), cardoons, celeries, Florence fennels and rhubarbs. Adequate analytical methods for enforcement are available to control the residues according to the residue definition as of the sum of flonicamid, TFNA and TFNG, expressed as flonicamid in the plant matrices under consideration at the validated limit of quantification (LOQ) of 0.01 mg/kg for each compound. Based on the risk assessment results, EFSA concluded that the short‐term and long‐term intake of residues resulting from the uses of flonicamid according to the reported agricultural practices is unlikely to present a risk to consumer health.

Abstract The conclusions of the EFSA following the peer review of the initial risk assessments carried out by the competent authority of the rapporteur Member State, France, and co‐rapporteur Member State, Austria, for the pesticide active substance pydiflumetofen and the assessment of applications for maximum residue levels (MRLs) are reported. The context of the peer review was that required by Regulation (EC) No 1107/2009 of the European Parliament and of the Council. The conclusions were reached on the basis of the evaluation of the representative uses of pydiflumetofen as a fungicide field application on pome fruits, grapes, potato, fruiting vegetables, cucurbits and Brassica vegetables and updated following the request from Commission to consider additional information submitted and review the risk assessment. The reliable endpoints, appropriate for use in regulatory risk assessment and the proposed MRLs, are presented. Missing information identified as being required by the regulatory framework is listed. Concerns are reported where identified.