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In accordance with Article 6 of Regulation (EC) No 396/2005, the original evaluating Member State (EMS), the United Kingdom, received an application from Bayer CropScience to set an import tolerance for the non‐approved active substance ethiprole in rice. In the framework of the assessment process, the application was re‐allocated to the Netherlands and the purpose of the application was changed to only set European residue definitions and toxicological reference values for the active substance ethiprole. Based on the assessment of the available toxicological data, an acceptable daily intake of 0.002 mg/kg bw per day and an acute reference dose of 0.005 mg/kg bw were derived. The data submitted in support of the request were found to be sufficient to derive residue definitions in primary crops and in processed commodities. The residue definition for enforcement was derived as 'ethiprole'. Adequate analytical methods for enforcement are available to control the residues of ethiprole in dry commodities at the validated LOQ of 0.002 mg/kg. A residue definition for risk assessment was derived as the 'sum of ethiprole, ethiprole‐sulfone (RPA097973) and ethiprole‐amide (RPA112916), expressed as ethiprole'. This residue definition is applicable for foliar treatment in all primary crops, for both foliar and soil treatments in cereals crops, and is also valid for processed commodities. [ABSTRACT FROM AUTHOR]

EFSA updated its previous work on the establishment of specific effects that are considered relevant for grouping pesticide residues targeting the thyroid and for performing the retrospective assessment of dietary cumulative risk (CRA). The two specific effects already selected in 2019 leading to the two cumulative assessment groups (CAGs) 'hypothyroidism' and 'C‐cell hypertrophy, hyperplasia and neoplasia' were reconfirmed. Compared to 2019, the list of indicators that can be used to identify these specific effects was refined to only include histopathological changes. In a second phase of the work, data will be extracted on indicators of the specific effects from the dossiers on active substances (a.s.) used as plant protection products. The criteria for including a.s. into CAGs were also updated, together with the hazard characterisation methodology and the lines of evidence for assessing CAG‐membership probabilities. The tasks related to the data extraction and the establishment of the CAGs on hypothyroidism and on C‐cell hypertrophy, hyperplasia and neoplasia are beyond the scope of this report. This part of the CRA process has been outsourced and will be the subject of a separate report. [ABSTRACT FROM AUTHOR]

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 FROM AUTHOR]

In accordance with Article 43 of Regulation (EC) 396/2005, EFSA received a request from the European Commission to review the existing maximum residue levels (MRLs) for the non‐approved active substance profenofos in view of the possible lowering of the MRL. EFSA investigated the origin of the current EU MRLs. Existing EU MRLs are based on Codex Maximum Residue Limits still in place or reflect temporary MRLs set from monitoring data. EFSA performed an indicative chronic and acute dietary risk assessment for the list of MRLs to allow risk managers to take the appropriate decisions. For some commodities, further risk management discussions are required to decide which of the risk management options proposed by EFSA should be implemented in the EU MRL legislation. [ABSTRACT FROM AUTHOR]

In accordance with Article 43 of Regulation (EC) 396/2005, EFSA received a request from the European Commission to review the existing maximum residue levels (MRLs) for the non‐approved active substance chlorfenapyr in view of the possible lowering of the MRL set for tea. This current EU MRL is based on an import tolerance established in 2007. EFSA reviewed the toxicological data assessed by other scientific bodies, proposing toxicological reference values to be used for an indicative risk assessment, noting that the values are affected by additional, non‐standard uncertainties. According to the indicative chronic and acute dietary risk assessment the existing MRL for tea does not pose an unacceptable risk for consumers. Further risk management discussions are required to decide which of the risk management options proposed by EFSA should be implemented in the EU MRL legislation. [ABSTRACT FROM AUTHOR]

In accordance with Article 43 of Regulation (EC) 396/2005, EFSA received a request from the European Commission to review the existing maximum residue levels (MRLs) for the non‐approved active substance diazinon in view of the possible lowering of the MRL. EFSA investigated the origin of the current EU MRLs. For existing EU MRLs that reflect previously authorised uses in the EU, or that are based on obsolete Codex MRLs, or import tolerances that are not required any longer, EFSA proposed the lowering to the limit of quantification. EFSA performed an indicative chronic and acute dietary risk assessment for the revised list of MRLs to allow risk managers to take the appropriate decisions. For some commodities, further risk management discussions are required to decide which of the risk management options proposed by EFSA should be implemented in the EU MRL legislation. [ABSTRACT FROM AUTHOR]

The conclusions of EFSA following the peer review of the initial risk assessments carried out by the Assessment Group on Glyphosate (AGG), consisting of the competent authorities of France, the Netherlands, Sweden and Hungary, acting jointly as rapporteur Member State for the pesticide active substance glyphosate 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 glyphosate as a herbicide as proposed by the applicants, covering uses pre‐sowing, pre‐planting and pre‐emergence plus post‐harvest in vegetables and sugar beet; post‐emergence of weeds in orchards, vineyards, row vegetables, railway tracks against emerged annual, biennial and perennial weeds. Moreover, uses as spot treatment against invasive species in agricultural and non‐agricultural areas, and in vegetables and sugar beet against couch grass are also included. 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 FROM AUTHOR]

In accordance with Article 43 of Regulation (EC) 396/2005, EFSA received a request from the European Commission to review the existing maximum residue levels (MRLs) for the non‐approved active substance endosulfan in view of the possible lowering of the MRLs. EFSA investigated the origin of the current EU MRLs. For existing EU MRLs that reflect previously authorised uses in the EU, or that are based on obsolete Codex maximum residue limits, or import tolerances that are not required any longer, EFSA proposed the lowering to the limit of quantification or to an alternative MRL. EFSA performed an indicative chronic and acute dietary risk assessment for the revised list of MRLs to allow risk managers to take the appropriate decisions. For all commodities, further risk management discussions are required to decide which of the risk management options proposed by EFSA should be implemented in the EU MRL legislation. [ABSTRACT FROM AUTHOR]

In accordance with Article 43 of Regulation (EC) 396/2005, EFSA received a request from the European Commission to review the existing maximum residue levels (MRLs) for the non‐approved active substance fenarimol in view of the possible lowering of the MRLs. EFSA investigated the origin of the current EU MRLs. For existing EU MRLs that reflect previously authorised uses in the EU, or that are based on obsolete Codex maximum residue limits, or import tolerances that are not required any longer, EFSA proposed the lowering to the limit of quantification. EFSA performed a chronic and acute dietary risk assessment for the revised list of MRLs to allow risk managers to take the appropriate decisions. For some commodities, further risk management discussions are required to decide which of the risk management options proposed by EFSA should be implemented in the EU MRL legislation. [ABSTRACT FROM AUTHOR]

In accordance with Article 43 of Regulation (EC) 396/2005, EFSA received a request from the European Commission to review the existing maximum residue levels (MRLs) for the non‐approved active substances azocyclotin and cyhexatin in view of the possible lowering of these MRLs. EFSA investigated the origin of the current EU MRLs. For existing EU MRLs that reflect previously authorised uses in the EU, or that are based on obsolete Codex Maximum Residue Limits, or import tolerances that are not required any longer, EFSA proposed the lowering to the limit of quantification. EFSA performed an indicative chronic and acute dietary risk assessment for the revised list of MRLs to allow risk managers to take the appropriate decisions. For some commodities under assessment, further risk management discussions are required to decide which of the risk management options proposed by EFSA should be implemented in the EU MRL legislation. [ABSTRACT FROM AUTHOR]

In accordance with Article 43 of Regulation (EC) 396/2005, EFSA received a request from the European Commission to review the existing maximum residue levels (MRLs) for the non‐approved active substance bifenthrin in view of the possible lowering of the MRLs. EFSA investigated the origin of the current EU MRLs. For existing EU MRLs that reflect previously authorised uses in the EU, or that are based on obsolete Codex maximum residue limits, or import tolerances that are not required any longer, EFSA proposed the lowering to the limit of quantification or to an alternative MRL. EFSA performed an indicative chronic and acute dietary risk assessment for the revised list of MRLs to allow risk managers to take the appropriate decisions. For some commodities, further risk management discussions are required to decide which of the risk management options proposed by EFSA should be implemented in the EU MRL legislation. [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 group of pesticide active substances cypermethrins. To assess the occurrence of cypermethrin, alpha‐cypermethrin, zeta‐cypermethrin, beta‐cypermethrin residues in plants, processed commodities, rotational crops and livestock, EFSA considered the conclusions derived in the framework of Regulation (EC) No 1107/2009, the MRLs established by the Codex Alimentarius Commission (codex maximum residue limits; CXLs) for cypermethrin, alpha‐cypermethrin and zeta‐cypermethrin as well as the European authorisations and import tolerances reported by Member States and the UK (including the supporting residues data) for cypermethrin and zeta‐cypermethrin. The toxicological profile of zeta‐cypermethrin was also assessed. 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/acute risk to consumer was identified. Hence, the consumer risk assessment is considered indicative only, all MRL proposals derived by EFSA still require further consideration by risk managers and measures for reduction of the consumer exposure should also be considered. [ABSTRACT FROM AUTHOR]

Development of adverse outcome pathways (AOPs) for uterine adenocarcinoma can provide a practical tool to implement the EFSA‐ECHA Guidance (2018) for the identification of endocrine disruptors in the context of Regulations (EU) No 528/2012 and (EC) No 1107/2009. AOPs can give indications about the strength of the relationship between an adverse outcome (intended as a human health outcome) and chemicals (pesticides but not only) affecting the pathways. In this scientific opinion, the PPR Panel explored the development of AOPs for uterine adenocarcinoma. An evidence‐based approach methodology was applied, and literature reviews were produced using a structured framework assuring transparency, objectivity, and comprehensiveness. Several AOPs were developed; these converged to a common critical node, that is increased estradiol availability in the uterus followed by estrogen receptor activation in the endometrium; therefore, a putative AOP network was considered. An uncertainty analysis and a probabilistic quantification of the weight of evidence have been carried out via expert knowledge elicitation for each set of MIEs/KEs/KERs included in individual AOPs. The collected data on the AOP network were evaluated qualitatively, whereas a quantitative uncertainty analysis for weight of the AOP network certainty has not been performed. Recommendations are provided, including exploring further the uncertainties identified in the AOPs and putative AOP network; further methodological developments for quantifying the certainty of the KERs and of the overall AOPs and AOP network; and investigating of NAMs applications in the context of some of the MIEs/KEs currently part of the putative AOP network developed. This publication is linked to the following EFSA Supporting Publications article: http://onlinelibrary.wiley.com/doi/10.2903/sp.efsa.2023.EN-7748/full [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 dithianon. To assess the occurrence of dithianon 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 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. Given that a data gap as regards the magnitude of residues of the metabolites 1,4‐naphthoquinone and phthalic acid was identified in the peer review for dithianon in light of confirmatory data, the toxicological profile of these metabolites was also assessed in the framework of the Article 12 MRL review. 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. In particular, it is highlighted that the toxicological reference values derived for the metabolite 1,4‐naphthoquinone are provisional only, pending a conclusion on the mutagenicity potential. 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 France SAS submitted a request to the competent national authority in France to modify the existing maximum residue level (MRL) for the active substance sedaxane in potatoes. The data submitted in support of the request were found to be sufficient to derive an MRL proposal for potatoes. Adequate analytical methods for enforcement are available to control the residues of sedaxane 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 sedaxane according to the intended agricultural practice is unlikely to present a risk to consumer health. [ABSTRACT FROM AUTHOR]

The GMO Panel has previously assessed genetically modified (GM) cotton DAS‐24236‐5 × DAS‐21Ø23‐5 and concluded that it is as safe as its conventional counterpart and other appropriate comparators with respect to potential effects on human and animal health and the environment in the context of its intended uses. On 17 November 2020, the European Commission requested EFSA to evaluate new DNA sequence information and updated bioinformatics data for cotton DAS‐24236‐5 × DAS‐21Ø23‐5 and to indicate whether the conclusions of the GMO Panel on the previously assessed cotton DAS‐24236‐5 × DAS‐21Ø23‐5 remain valid. The new sequence data of DAS‐24236‐5 showed the change of one nucleotide that results in one amino acid substitution, in the newly expressed Cry1F (synpro_L620Q) compared to the sequence originally reported. The GMO Panel concludes that this amino acid substitution in the protein is a mutation. Nonetheless with the exception of the bioinformatics analysis, the studies performed for the risk assessment of Cry1F in cotton DAS‐24236‐5 × DAS‐21Ø23‐5 remain valid. In addition, the new sequencing data showed a change in one nucleotide in the 5′ flanking region of DAS‐21Ø23‐5 compared to the original sequence reported on the stack cotton DAS‐24236‐5 × DAS‐21Ø23‐5. The bioinformatic analyses of the newly sequenced DAS‐21Ø23‐5 event in the stack DAS‐24236‐5 × DAS‐21Ø23‐5 shows that the nucleotide difference is in the 5′ flanking region outside the ORFs that span the 5′ junction and is therefore not considered further in the safety assessment. Based on the information provided, the GMO Panel concludes that the corrected sequence does not give rise to any safety concerns, and therefore, the original risk assessment of cotton DAS‐24236‐5 × DAS‐21Ø23‐5 remains valid. [ABSTRACT FROM AUTHOR]

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 thiabendazole 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 endocrine disruption potential of the substance. The conclusions were reached on the basis of the evaluation of the representative uses of thiabendazole as a fungicide on seed potato, apple and pear and citrus. Assessments not finalised together with the missing information identified as being required by the mandate are listed. Concerns are identified. [ABSTRACT FROM AUTHOR]

Tinea capitis is a dermatophyte infection of the scalp that most commonly affects children and is relatively rare in adults. In this case, a 66-year-old Italian woman presented with chronic diffuse papulopustular lesions on the scalp. Personal medical history was positive for itching, repeatedly treated with oral antibiotics without improvement. Trichoscopy observed broken hairs, fine desquamation, signs of scalp inflammation, and folliculitis. A punch biopsy of the scalp revealed a moderately dense mixed inflammatory infiltrate with edema and dilated capillaries. Periodic acid-Schiff stain revealed arthroconidia in the hair shaft and in the inner root sheath of the hair follicle. It was additionally noted that arthroconidia were not present in hair follicles in the telogen phase. The fungal culture subsequently showed Trichophyton tonsurans. Therefore, the patient was diagnosed with an endothrix tinea capitis infection and was treated with oral terbinafine, oral corticosteroids, as well as topical ciclopirox and naftifine creams. Considering the relative lack of specific literature regarding the hair cycle involvement of arthroconidia in endothrix tinea capitis infections and the fact that the sources found cited the presence of arthroconidia in both anagen and telogen phase follicles, we present this case of telogen-sparing arthroconidia involvement in an adult with an endothrix tinea capitis infection. [ABSTRACT FROM AUTHOR]

The conclusions of the European Food Safety Authority (EFSA) following the peer review of the initial risk assessments carried out by the competent authorities of the rapporteur Member State France and co-rapporteur Member State Bulgaria for the pesticide active substance cyprodinil 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 cyprodinil as a fungicide on apples and barley. 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., (© 2025 European Food Safety Authority. EFSA Journal published by Wiley‐VCH GmbH on behalf of European Food Safety Authority.)

The European Commission mandated EFSA to assess the toxicity of bromide, the existing maximum residue levels (MRLs), and possible transfer from feed into food of animal origin. The critical effects of bromide in experimental animals are on the thyroid and central nervous system. Changes in thyroid hormone homeostasis could result in neurodevelopmental toxicity, among other adverse effects. Changes in thyroid hormone concentrations and neurophysiological parameters have also been observed in experimental human studies, but the evidence was limited. Dose-response modelling of decreased blood thyroxine concentrations in rats resulted in a reference point of 40 mg/kg body weight (bw) per day. The Scientific Committee established a tolerable daily intake (TDI) of 0.4 mg/kg bw per day and an acute reference dose (ARfD) of 0.4 mg/kg bw per day to protect against adverse neurodevelopmental effects. The TDI value is supported by the results of experimental human studies with a NOAEL of 4 mg/kg bw per day and 10-fold interindividual variability. The TDI and ARfD are considered as conservative with 90% certainty. Insufficient evidence related to the toxicological effects of bromide was available for animals, with the exception of dogs. Therefore, the reference point of 40 mg/kg bw per day was extrapolated to maximum safe concentrations of bromide in complete feed for other animal species. Bromide can transfer from feed to food of animal origin, but, from the limited data, it was not possible to quantify the transfer rate. Monitoring data exceeded the current MRLs for some food commodities, generally with a low frequency. A conservative safety screening of the MRLs indicated that the TDI and ARfD are exceeded for some EU diets. Dietary exposure assessment for animals was not feasible due to insufficient data. The Scientific Committee recommends data be generated to allow robust dietary exposure assessments in the future, and data that support the risk assessment., (© 2025 European Food Safety Authority. EFSA Journal published by Wiley‐VCH GmbH on behalf of European Food Safety Authority.)

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, the Netherlands, and co-rapporteur Member State, France, for the pesticide active substance spinosad 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 spinosad as insecticide on bulb/dry onions, maize (fodder and grain), sweet corn, grapes (table and wine), lettuce, potato, aubergine, pepper and tomato. MRLs were assessed in field leek and field and greenhouse strawberries, cane fruits, lettuce & plants salad (others), spinach and similar leaves (others), herbs and edible flowers (others), cardoons, rhubarb and animal commodities. 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., (© 2025 European Food Safety Authority. EFSA Journal published by Wiley‐VCH GmbH on behalf of European Food Safety Authority.)

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 lysate of Willaertia magna C2c Maky 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 use of lysate of Willaertia magna C2c Maky as a fungicide against downy mildew ( Plasmopara viticola ) on grapevines and table grapes. The reliable endpoints, appropriate for use in regulatory risk assessment, are presented. Missing information identified as being required by the regulatory framework is listed. Concerns were not identified., (© 2025 European Food Safety Authority. EFSA Journal published by Wiley‐VCH GmbH on behalf of European Food Safety Authority.)

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 Germany for the pesticide active substance phosphine 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 phosphine as a post-harvest indoor insecticide to control insects infesting stored grains (barley, oat, rye, wheat), cacao and coffee beans, tree nuts and oilseeds and dried fruit via gassing application (gas-tight rooms/container). 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., (© 2025 European Food Safety Authority. EFSA Journal published by Wiley‐VCH GmbH on behalf of European Food Safety Authority.)

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 Slovenia and co-rapporteur Member State Slovakia for the pesticide active substance gibberellic acid 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 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 of gibberellic acid as a plant growth regulator on seedless grapes (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 when identified., (© 2024 European Food Safety Authority. EFSA Journal published by Wiley‐VCH GmbH on behalf of European Food Safety Authority.)

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 Slovenia and co-rapporteur Member State Slovakia for the pesticide active substance gibberellins (GA4/GA7) 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 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 gibberellins (GA4/GA7) as a plant growth regulator on apple and pear (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 when identified., (© 2024 European Food Safety Authority. EFSA Journal published by Wiley‐VCH GmbH on behalf of European Food Safety Authority.)

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 Austria and co-rapporteur Member State Finland for the pesticide active substance fenoxaprop-P-ethyl 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 fenoxaprop-P-ethyl as a post-emergence herbicide in wheat, durum wheat, rye, triticale and barley to control annual monocotyledonous weeds. 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., Competing Interests: If you wish to access the declaration of interests of any expert contributing to an EFSA scientific assessment, please contact interestmanagement@efsa.europa.eu., (© 2024 European Food Safety Authority. EFSA Journal published by Wiley‐VCH GmbH on behalf of European Food Safety Authority.)

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., (© 2024 European Food Safety Authority. EFSA Journal published by Wiley‐VCH GmbH on behalf of European Food Safety Authority.)

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., Competing Interests: If you wish to access the declaration of interests of any expert contributing to an EFSA scientific assessment, please contact interestmanagement@efsa.europa.eu., (© 2024 European Food Safety Authority. EFSA Journal published by Wiley‐VCH GmbH on behalf of European Food Safety Authority.)

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., Competing Interests: If you wish to access the declaration of interests of any expert contributing to an EFSA scientific assessment, please contact interestmanagement@efsa.europa.eu., (© 2024 European Food Safety Authority. EFSA Journal published by Wiley‐VCH GmbH on behalf of European Food Safety Authority.)

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., Competing Interests: If you wish to access the declaration of interests of any expert contributing to an EFSA scientific assessment, please contact interestmanagement@efsa.europa.eu., (© 2024 European Food Safety Authority. EFSA Journal published by Wiley‐VCH GmbH on behalf of European Food Safety Authority.)

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., Competing Interests: If you wish to access the declaration of interests of any expert contributing to an EFSA scientific assessment, please contact interestmanagement@efsa.europa.eu., (© 2024 European Food Safety Authority. EFSA Journal published by Wiley‐VCH GmbH on behalf of European Food Safety Authority.)

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 Hungary for the pesticide active substance triclopyr (variant triclopyr-butotyl) 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, 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 triclopyr (variant triclopyr-butotyl) as a herbicide on established pasture and non-recreational amenity grassland (field use). MRLs were assessed in rice. 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., Competing Interests: If you wish to access the declaration of interests of any expert contributing to an EFSA scientific assessment, please contact interestmanagement@efsa.europa.eu., (© 2024 European Food Safety Authority. EFSA Journal published by Wiley‐VCH GmbH on behalf of European Food Safety Authority.)

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., Competing Interests: If you wish to access the declaration of interests of any expert contributing to an EFSA scientific assessment, please contact interestmanagement@efsa.europa.eu., (© 2024 European Food Safety Authority. EFSA Journal published by Wiley‐VCH GmbH on behalf of European Food Safety Authority.)

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., Competing Interests: If you wish to access the declaration of interests of any expert contributing to an EFSA scientific assessment, please contact interestmanagement@efsa.europa.eu., (© 2024 European Food Safety Authority. EFSA Journal published by Wiley‐VCH GmbH on behalf of European Food Safety Authority.)

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., Competing Interests: If you wish to access the declaration of interests of any expert contributing to an EFSA scientific assessment, please contact interestmanagement@efsa.europa.eu., (© 2024 European Food Safety Authority. EFSA Journal published by Wiley‐VCH GmbH on behalf of European Food Safety Authority.)

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., Competing Interests: If you wish to access the declaration of interests of any expert contributing to an EFSA scientific assessment, please contact interestmanagement@efsa.europa.eu., (© 2024 European Food Safety Authority. EFSA Journal published by Wiley‐VCH GmbH on behalf of European Food Safety Authority.)

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., Competing Interests: If you wish to access the declaration of interests of any expert contributing to an EFSA scientific assessment, please contact interestmanagement@efsa.europa.eu., (© 2024 European Food Safety Authority. EFSA Journal published by Wiley‐VCH GmbH on behalf of European Food Safety Authority.)

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., Competing Interests: If you wish to access the declaration of interests of any expert contributing to an EFSA scientific assessment, please contact interestmanagement@efsa.europa.eu., (© 2024 European Food Safety Authority. EFSA Journal published by Wiley‐VCH GmbH on behalf of European Food Safety Authority.)