Peer review of the pesticide risk assessment of the active substance mancozeb.

The conclusions of EFSA following the peer review of the initial risk assessments carried out by the competent authorities of the rapporteur Member State the United Kingdom and co-rapporteur Member State Greece for the pesticide active substance mancozeb 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 mancozeb as a fungicide on wheat (winter/spring), grapevine, potatoes and tomatoes. 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.

Evaluation of confirmatory data following the Article 12 MRL review and modification of the existing maximum residue levels for prothioconazole in celeriacs and rapeseeds.

In accordance with Article 6 of Regulation (EC) No 396/2005, the applicants Bayer SAS Crop Science and the Agriculture and Horticulture Development Board submitted two requests to the competent national authority in the United Kingdom to modify the existing maximum residue levels (MRLs) for prothioconazole in rapeseeds and celeriacs, respectively. The data submitted in support of the requests were found to be sufficient to derive MRL proposals for these crops. The applicant Bayer SAS Crop Science additionally submitted a request to the competent national authority in the United Kingdom to evaluate the confirmatory data identified in the framework of the MRL review under Article 12 of Regulation (EC) No 396/2005 as not available. To address the data gaps, residue trials on carrots, onions, rapeseeds and wheat, and storage stability studies were submitted. The data gaps are considered fully addressed for the root and tuber vegetables, the oilseeds concerned and wheat. The data gaps have been partially addressed for onions, shallots, flowering brassica, Brussels sprouts, head cabbages, leeks, rye, barely and oat. The data gaps were not addressed for pulses and grass. Based on the risk assessment results, EFSA concluded that the short-term and long-term intake of residues resulting from the existing and intended uses of prothioconazole according to the reported agricultural practices is unlikely to present a risk to consumer health. For the triazole derivative metabolites (TDMs), only an indicative exposure assessment was performed considering celeriacs and rapeseeds; the results showed that the expected exposure to TDMs in these commodities is well below the toxicological reference values derived for the TDMs.

Peer review of the pesticide risk assessment of the active substance blood meal.

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 Lithuania for the pesticide active substance blood meal 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 blood meal as a game repellent on deciduous and coniferous trees in forestry, orchard trees and ornamental plants and as a vole repellent on deciduous and coniferous trees in forestry (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. No concerns are identified.

Modification of the existing maximum residue level for pyridaben in sweet pepper/bell pepper and setting of an import tolerance in tree nuts.

In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Nissan Chemical Europe S.A.S. submitted two requests to the competent national authority in the Netherlands, respectively to modify the existing maximum residue level (MRL) in sweet pepper/bell pepper and to set an import tolerance in tree nuts for the active substance pyridaben. The data submitted in support of the requests were found to be sufficient to derive the MRL proposals of 0.3 mg/kg for sweet peppers/bell peppers and of 0.05* mg/kg for tree nuts. Adequate analytical methods for enforcement are available to control the residues of pyridaben in the commodities under consideration, at or above the validated limits of quantification (LOQs) 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 pyridaben on imported tree nuts from United States and from the indoor use on sweet peppers/bell peppers 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.

Peer review of the pesticide risk assessment of the active substance lavandulylsenecioate.

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 Italy for the pesticide active substance lavandulylsenecioateare 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 evaluated as a pheromone comprising manual applications to control Planococcusficus (vine mealybug) populations by mating disruption in table grape, wine grape, raisins and any other crops where P. ficus may be a pest in Southern Europe. The reliable endpoints,appropriate for use in regulatory risk assessmentare presented. Missing information identified as being required by the regulatory framework is listed.Concerns are identified.

Peer review of the pesticide risk assessment of the active substance chloropicrin.

The conclusions of EFSA following the peer review of the initial risk assessments carried out by the competent authority of the initial rapporteur Member State the United Kingdom and the new rapporteur Member State Italy for the pesticide active substance chloropicrin 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 chloropicrin as a soil fumigant on strawberries, tomatoes, peppers, cucurbits (field and greenhouse applications) and tree crops: pome fruit, stone fruit, citrus, olives (field applications). 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.

Peer review of the pesticide risk assessment for the active substance sulfoxaflor in light of confirmatory data submitted.

The conclusions of EFSA following the peer review of the initial risk assessment carried out by the competent authority of the co-rapporteur Member State, the Czech Republic, for the pesticide active substance sulfoxaflor are reported. The context of the peer review was that requested by the European Commission following the submission and evaluation of confirmatory ecotoxicology data. The conclusions were reached on the basis of the evaluation of the representative uses of sulfoxaflor as an insecticide on fruiting vegetables (field and greenhouse application), cucurbits (field and greenhouse application), spring and winter cereals (field application) and cotton (field application). The reliable endpoints concluded as being appropriate for use in regulatory risk assessment, derived from the available studies and literature in the dossier peer reviewed, are presented. For the field and non-permanent structure greenhouses, a high risk to honeybees and bumble bees was identified related to some pertinent scenarios (treated crop scenario except after flowering period, weed scenario, field margin scenario). A low risk was concluded for honeybees, bumble bees and solitary bees in case of permanent structure greenhouse provided the low exposure in such scenarios. The European Commission mandated EFSA to complete the assessment of the spray drift reducing measures necessary to protect bumblebees and solitary bees in field margins from exposure to sulfoxaflor and to complete the assessment of the risk to bees from puddle water.

Peer review of the pesticide risk assessment of the active substance kieselgur (diatomaceous earth).

The conclusions of 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 Greece for the pesticide active substance kieselgur (diatomaceous earth) 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 kieselgur (diatomaceous earth) as an insecticide and acaricide on stored cereals, empty storage rooms and storage rooms, mills and warehouses (with stored goods). 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.

Evaluation of confirmatory data following the Article 12 MRL review for sodium 5-nitroguaiacolate, sodium o-nitrophenolate and sodium p-nitrophenolate (sodium nitrocompounds).

The applicant Asahi Chemical Europe s.r.o. submitted a request to the competent national authority in the Netherlands to evaluate the confirmatory data that were identified for the pesticide active substances sodium 5-nitroguaiacolate, sodium o-nitrophenolate and sodium p-nitrophenolate (sodium nitrocompounds) 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 gap related to validated analytical enforcement method, the validation data of a method for the determination of sodium nitrocompounds in high acid content commodities, dry commodities and hops (dried) was submitted. The data gap was considered satisfactorily addressed. The new information provided does not require a revision of the existing MRLs; the risk assessment performed for the three active substances sodium 5-nitroguaiacolate, sodium o-nitrophenolate and sodium p-nitrophenolate in the framework of the MRL review remains valid.

Review of the existing maximum residue levels for fluopyram according to Article 12 of Regulation (EC) No 396/2005.

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.

Peer review of the pesticide risk assessment of the active substance beta-cyfluthrin.

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, Germany, and co-rapporteur Member State, Hungary, for the pesticide active substance beta-cyfluthrin 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 beta-cyfluthrin as an insecticide on beet, potato, wheat and greenhouse tomato. In addition, this conclusion also addresses the request received from the European Commission during the decision-making phase following completion of the peer review with regard to the risk to non-target arthropods. 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.

Reasoned opinion on the setting of temporary maximum residue levels for chlorpropham in potatoes.

EFSA received from the European Commission a mandate to deliver a reasoned opinion according to Article 43 of Regulation (EC) No 396/2005 on the safety of a proposed temporary maximum residue level (tMRL) for chlorpropham in potatoes to consumers. Sprout inhibitors based on the active substance chlorpropham have been widely used in commercial storage facilities in Europe over multiple seasons. Following the non-renewal of approval of chlorpropham, representatives of potato trade organisations and manufacturers of chlorpropham reported an issue of cross-contamination above the limit of quantification (LOQ) of untreated potatoes stored in facilities with a history of applications of chlorpropham as a post-harvest treatment. The evaluating Member State (EMS) the Netherlands, in accordance with Articles 6(2) and 16 (1)(a) of Regulation (EC) No 396/2005, submitted an application for the setting of a tMRL for chlorpropham in potatoes in order to address the cross-contamination in commercial storages. The EMS proposed to set a tMRL for the active substance at a level ranging between 0.3 and 0.5 mg/kg. Based on the assessment of the available data and information with different methodologies, optional tMRL proposals of 0.3, 0.4 and 0.5 mg/kg were derived, and an indicative consumer risk assessment was carried out. The tMRL proposals require further consideration by risk managers, mainly with regard to identified uncertainties, and measures for further reduction of occurrence of chlorpropham residues will also need to be considered. With this prospect, EFSA concluded that the short-term and long-term intake of residues of chlorpropham and 3-chloroaniline resulting from cross-contamination in potatoes is unlikely to present a risk to consumer health.

Modification of the existing maximum residue levels for lambda-cyhalothrin in seed and fruit spices.

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 lambda-cyhalothrin in seed and fruit spices. The data submitted in support of the request were found to be sufficient to derive MRL proposals in seed spices and in fruit spices. Since the general data gap related to toxicity of degradation products formed under sterilisation conditions and identified in the framework of the MRL review has not yet been addressed, a risk management decision is required whether it is appropriate to take over the proposed MRLs in the MRL legislation. Adequate analytical enforcement methods are available to control the residues of lambda-cyhalothrin in the commodities under consideration. Based on the risk assessment results, EFSA concluded that the short-term and long-term intake of residues resulting from the use of lambda-cyhalothrin on spices according to the reported agricultural practice is unlikely to present a risk to consumer health. However, the consumer exposure calculation shall be considered provisional, pending the toxicological assessment of the compounds formed under sterilisation conditions.

Peer review of the pesticide risk assessment of the active substance garlic extract.

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, Denmark, for the pesticide active substance garlic extract 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 garlic extract as a repellent, insecticide and nematicide on a wide range of crops in agriculture, horticulture, amenity. 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.

Peer review of the pesticide risk assessment of the active substance Akanthomyces muscarius strain Ve6, formerly Lecanicillium muscarium strain Ve6.

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 Akanthomyces muscarius strain Ve6 formerly Lecanicillium muscarium strain Ve6 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 Akanthomyces muscarius strain Ve6 as an insecticide on fruiting vegetables of cucurbitaceae with edible and inedible peel, fruiting vegetables of solanaceae, strawberries, floriculture crops (except roses), cut roses and tree nursery. 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.

Review of the existing maximum residue levels for metaflumizone according to Article 12 of Regulation (EC) No 396/2005.

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 metaflumizone. To assess the occurrence of metaflumizone 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 and the European authorisations reported by Member States (including the supporting residues data). Based on the assessment of the available data, MRL proposals were derived and a consumer risk assessment was carried out. Some information required by the regulatory framework was missing and a possible acute risk to consumers was identified. Hence, the consumer risk assessment is considered indicative only, some MRL proposals derived by EFSA still require further consideration by risk managers and measures for reduction of the consumer exposure should also be considered.

Peer review of the pesticide risk assessment of the active substance 24-epibrassinolide.

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 24-epibrassinolide 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 24-epibrassinolide as an elicitor on grapes, leafy vegetables, sugar beet and as plant activator on grapes and cucurbits. The reliable endpoints, appropriate for use in regulatory risk assessment are presented. Missing information identified as being required by the regulatory framework is listed. No concerns are identified.

Setting of import tolerances, modification of existing maximum residue levels and evaluation of confirmatory data following the Article 12 MRL review for flupyradifurone and DFA.

In accordance with Article 6 of Regulation (EC) No 396/2005, the applicants Bayer CropScience AG and Bayer SAS submitted two requests to the competent national authority in the Netherlands to set import tolerances and to modify existing EU maximum residue levels (MRLs) for the active substance flupyradifurone and its metabolite difluoroacetic acid (DFA) in various crops. The application also included the request to evaluate the confirmatory data related to residues that were identified in the framework of the peer review of flupyradifurone under Regulation (EC) No 1107/2009 as not available. The data submitted in support of intended and authorised uses were found to be sufficient to derive MRL proposals for flupyradifurone and DFA in all crops under consideration except for prickly pear and hops; for grapefruit, pome fruits, grape leaves and witloof, further risk management discussion is recommended to decide on the appropriate MRL. Furthermore, EFSA recommended risk management discussion to examine different options to deal with DFA residues in crops that can be grown in crop rotation. The calculated livestock dietary burdens indicated that existing EU MRLs for flupyradifurone and DFA in animal commodities need to be modified. Adequate analytical methods for enforcement are available to control the residues of flupyradifurone and the DFA in plant and animal matrices. The submitted data are considered sufficient to address the data gaps related to residues which were identified in the framework of the EU pesticides peer review, and thus, the footnotes set for DFA and flupyradifurone MRLs in the Commission Regulation (EU) 2016/1902 can be deleted. Based on the consumer exposure assessment, acute consumer exposure concerns could not be excluded for tomatoes, melons, celery and processed escaroles. Hence, the raising of the existing MRLs for flupyradifurone in these crops is not recommended. For these four crops, MRL proposals for DFA were derived, which reflect the uptake of residues via soil resulting from previous use of flupyradifurone. For the remaining commodities of plant and animal origin, EFSA concludes that the intended EU uses and authorised US and Canadian uses of flupyradifurone and resulting residues of DFA will not result in chronic or acute consumer exposure exceeding the toxicological reference values and therefore is unlikely to pose a risk to consumers' health.

Setting of import tolerances for flonicamid in various crops and products of animal origin.

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 set an import tolerance for the active substance flonicamid in various crops and products of animal origin on the basis of the authorised use of flonicamid in the USA. The data submitted in support of the request were found to be sufficient to derive maximum residue level (MRL) proposals for all crops under assessment. Based on the results of the feeding studies and the updated animal burden calculations, no need for new MRL proposals on products of animal origin was identified. Adequate analytical methods for enforcement are available to control the residues of flonicamid in plant and animal matrices. EFSA updated the most recent consumer risk assessment for flonicamid and concluded that the authorised USA uses of flonicamid will not result in acute or chronic consumer exposure exceeding the toxicological reference values and, therefore, is unlikely to pose a risk to consumers' health.

Review of the existing maximum residue levels for flubendiamide according to Article 12 of Regulation (EC) No 396/2005.

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 flubendiamide. To assess the occurrence of flubendiamide 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 (including the supporting residues data). No European authorisation was reported by Member States. 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 requires further consideration by risk managers and measures for reduction of the consumer exposure should also be considered.