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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 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, 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 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, 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 FROM AUTHOR]

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.

According to Article 12 of Regulation (EC) No 396/2005, EFSA has reviewed the maximum residue levels (MRLs) currently established at European level for the pesticide active substance gamma‐cyhalothrin. To assess the occurrence of gamma‐cyhalothrin residues in plants, processed commodities, rotational crops and livestock, EFSA considered the conclusions derived in the framework of Commission Regulation (EU) No 188/2011, as well as the European authorisations reported by Member States (including the supporting residues data) in the framework of this review. Based on the assessment of the available data, MRL proposals were derived, and a consumer risk assessment was carried out. Although no risk to consumers was identified, some information required by the regulatory framework was missing. The residue definition for monitoring (lambda‐cyhalothrin (includes gamma‐cyhalothrin) (sum of R, S and S, R isomers)) covers both lambda‐ and gamma‐cyhalothrin. Appropriate enantioselective techniques, which are not commonly used in routine analysis, are required to differentiate gamma‐cyhalothrin residues from lambda‐cyhalothrin. According to the available data, it is expected that the MRLs currently set in Regulation (EC) No 396/2005 will cover the uses of gamma‐cyhalothrin assessed in the present review. Therefore, risk managers can consider maintaining the existing EU MRLs. [ABSTRACT FROM AUTHOR]

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.

In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant DLR‐Rheinpfalz submitted a request to the competent national authority in Germany to modify the existing maximum residue levels (MRLs) for the active substance flonicamid in Chinese cabbages, kales and kohlrabies. The data submitted in support of the request were found to be sufficient to derive MRL proposals for the commodities under assessment. Adequate analytical methods for enforcement are available to control the residues of flonicamid, 4‐trifluoromethylnicotinic acid (TFNA) and N‐(4‐trifluoromethylnicotinoyl) glycine (TFNG) (sum expressed as flonicamid) in the commodities under consideration at the validated combined limit of quantification (LOQ) of 0.03 mg/kg and the residues of flonicamid and TFNA‐AM in animal matrices at the validated combined LOQ of 0.02 mg/kg. Based on the risk assessment results, EFSA concluded that the short‐term and long‐term intake of residues resulting from the use of flonicamid according to the reported agricultural practices is unlikely to present a risk to consumer health. [ABSTRACT FROM AUTHOR]

The conclusions of the European Food Safety Authority (EFSA) following the peer review of the initial risk assessment carried out by the competent authorities of the rapporteur Member State, Germany, and co‐rapporteur Member State, the Netherlands, for the pesticide active substance milbemectin 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 milbemectin as an acaricide and insecticide in strawberry (field and greenhouse), berries and black and white currant (field and greenhouse), apple, pear, cherry and plum (field) and ornamentals (field and greenhouse). 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 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]

Abstract In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant DLR‐Rheinpfalz submitted a request to the competent national authority in Germany to modify the existing maximum residue levels (MRLs) for the active substance flonicamid in Chinese cabbages, kales and kohlrabies. The data submitted in support of the request were found to be sufficient to derive MRL proposals for the commodities under assessment. Adequate analytical methods for enforcement are available to control the residues of flonicamid, 4‐trifluoromethylnicotinic acid (TFNA) and N‐(4‐trifluoromethylnicotinoyl) glycine (TFNG) (sum expressed as flonicamid) in the commodities under consideration at the validated combined limit of quantification (LOQ) of 0.03 mg/kg and the residues of flonicamid and TFNA‐AM in animal matrices at the validated combined LOQ of 0.02 mg/kg. Based on the risk assessment results, EFSA concluded that the short‐term and long‐term intake of residues resulting from the use of flonicamid 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 assessment carried out by the competent authorities of the rapporteur Member State, Germany, and co‐rapporteur Member State, the Netherlands, for the pesticide active substance milbemectin 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 milbemectin as an acaricide and insecticide in strawberry (field and greenhouse), berries and black and white currant (field and greenhouse), apple, pear, cherry and plum (field) and ornamentals (field and greenhouse). 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 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.

On 26 August 2022, the European Commission asked EFSA to provide scientific and technical assistance according to Article 21(2) of Regulation (EC) No 1107/2009 concerning the review of the approval of the active substance pirimicarb and to deliver a statement on whether the applicable approval criteria may still be considered fulfilled, taking into consideration the information submitted by the applicant and the assessment of the rapporteur Member State, Sweden and, where applicable, the results of a discussion with experts from Member States. The current statement contains a summary of the main findings of the assessment of the risks to consumers from the exposure to metabolites of pirimicarb through dietary intake, the risks to human health through non‐dietary exposure and the acute risk to birds from the representative uses of pirimicarb assessed for the first approval and additionally, from the representative uses as submitted as part of the renewal of approval. Concerns are reported where identified. [ABSTRACT FROM AUTHOR]

Abstract On 26 August 2022, the European Commission asked EFSA to provide scientific and technical assistance according to Article 21(2) of Regulation (EC) No 1107/2009 concerning the review of the approval of the active substance pirimicarb and to deliver a statement on whether the applicable approval criteria may still be considered fulfilled, taking into consideration the information submitted by the applicant and the assessment of the rapporteur Member State, Sweden and, where applicable, the results of a discussion with experts from Member States. The current statement contains a summary of the main findings of the assessment of the risks to consumers from the exposure to metabolites of pirimicarb through dietary intake, the risks to human health through non‐dietary exposure and the acute risk to birds from the representative uses of pirimicarb assessed for the first approval and additionally, from the representative uses as submitted as part of the renewal of approval. Concerns are reported where identified.

The conclusions of 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 the Netherlands for the pesticide active substance Cydia pomonella granulovirus (CpGV) 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 CpGV as an insecticide on pome fruit (apple, pear, quince, nashi pears, medlars), stone fruit (peach, apricot, nectarine, almond, plum trees), walnut trees (field foliar spray applications, professional and non‐professional 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. [ABSTRACT FROM AUTHOR]

In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Sumitomo Chemical Agro Europe S.A.S. submitted a request to the competent national authority in Greece to modify the existing maximum residue levels (MRLs) for the active substance pyriproxyfen in apricots and peaches. The data submitted in support of the request were found to be sufficient to derive MRL proposal of 0.4 mg/kg for apricots, whereas for peaches an MRL amendment is not necessary. Adequate analytical methods for enforcement are available to control the residues of pyriproxyfen on the commodities under consideration at the validated limit of quantification (LOQ) of 0.01 mg/kg. Based on the risk assessment results, EFSA concluded that the short-term and long-term intake of residues resulting from the intended use of pyriproxyfen on apricots and peaches according to the reported agricultural practice is unlikely to present a risk to consumer health. [ABSTRACT FROM AUTHOR]

Abstract The conclusions of 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 the Netherlands for the pesticide active substance Cydia pomonella granulovirus (CpGV) 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 CpGV as an insecticide on pome fruit (apple, pear, quince, nashi pears, medlars), stone fruit (peach, apricot, nectarine, almond, plum trees), walnut trees (field foliar spray applications, professional and non‐professional 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.

Abstract In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Sumitomo Chemical Agro Europe S.A.S. submitted a request to the competent national authority in Greece to modify the existing maximum residue levels (MRLs) for the active substance pyriproxyfen in apricots and peaches. The data submitted in support of the request were found to be sufficient to derive MRL proposal of 0.4 mg/kg for apricots, whereas for peaches an MRL amendment is not necessary. Adequate analytical methods for enforcement are available to control the residues of pyriproxyfen on the commodities under consideration at the validated limit of quantification (LOQ) of 0.01 mg/kg. Based on the risk assessment results, EFSA concluded that the short‐term and long‐term intake of residues resulting from the intended use of pyriproxyfen on apricots and peaches according to the reported agricultural practice is unlikely to present a risk to consumer health.

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 Malta for the pesticide active substance abamectin 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 abamectin as an insecticide and acaricide on tomato and strawberry, and updated following the request from Commission to review the exposure and risk assessments as regards birds and mammals, aquatic organisms and soil macroorganisms. The risk assessment to bees and non‐target arthropods was also updated. 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 FROM AUTHOR]

According to Article 12 of Regulation (EC) No 396/2005, EFSA has reviewed the maximum residue levels (MRLs) currently established at European level for the pesticide active substance phosmet. Although this active substance is no longer authorised within the European Union, MRLs were established by the Codex Alimentarius Commission (codex maximum residue limits; CXLs). Based on the available data, EFSA assessed the CXLs and a consumer risk assessment was carried out. The CXLs were found to be supported by inadequate data and a possible chronic and acute risk to consumers was identified for several commodities. Hence, further consideration by risk managers is needed. [ABSTRACT FROM AUTHOR]

Abstract 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 Malta for the pesticide active substance abamectin 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 abamectin as an insecticide and acaricide on tomato and strawberry, and updated following the request from Commission to review the exposure and risk assessments as regards birds and mammals, aquatic organisms and soil macroorganisms. The risk assessment to bees and non‐target arthropods was also updated. 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 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 phosmet. Although this active substance is no longer authorised within the European Union, MRLs were established by the Codex Alimentarius Commission (codex maximum residue limits; CXLs). Based on the available data, EFSA assessed the CXLs and a consumer risk assessment was carried out. The CXLs were found to be supported by inadequate data and a possible chronic and acute risk to consumers was identified for several commodities. Hence, further consideration by risk managers is needed.

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 Netherlands and co‐rapporteur Member State Finland for the pesticide active substance rape seed oil 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 professional and non‐professional uses of rape seed oil as an acaricide on pome fruit trees (field use), berries, vegetables, ornamentals (greenhouse and field uses) and as an insecticide on potatoes (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. [ABSTRACT FROM AUTHOR]

In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Dow AgroSciences Ltd submitted a request to the competent national authority in Greece to modify the existing maximum residue levels (MRLs) for the active substance sulfoxaflor in lettuce and salad plants (except lettuce), beans with pods and peas without pods. The data submitted in support of the request were found to be sufficient to derive MRL proposals for all crops under consideration. Adequate analytical methods for enforcement are available to control the residues of sulfoxaflor in the commodities under consideration at the validated limit of quantification (LOQ) of 0.01 mg/kg. Based on the risk assessment results, EFSA concluded that the short‐term and long‐term intake of residues resulting from the use of sulfoxaflor according to the reported agricultural practices is unlikely to present a risk to consumer health. [ABSTRACT FROM AUTHOR]

Abstract 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 Netherlands and co‐rapporteur Member State Finland for the pesticide active substance rape seed oil 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 professional and non‐professional uses of rape seed oil as an acaricide on pome fruit trees (field use), berries, vegetables, ornamentals (greenhouse and field uses) and as an insecticide on potatoes (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.

Abstract In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Dow AgroSciences Ltd submitted a request to the competent national authority in Greece to modify the existing maximum residue levels (MRLs) for the active substance sulfoxaflor in lettuce and salad plants (except lettuce), beans with pods and peas without pods. The data submitted in support of the request were found to be sufficient to derive MRL proposals for all crops under consideration. Adequate analytical methods for enforcement are available to control the residues of sulfoxaflor in the commodities under consideration at the validated limit of quantification (LOQ) of 0.01 mg/kg. Based on the risk assessment results, EFSA concluded that the short‐term and long‐term intake of residues resulting from the use of sulfoxaflor according to the reported agricultural practices is unlikely to present a risk to consumer health.

According to Article 12 of Regulation (EC) No 396/2005, EFSA has reviewed the maximum residue levels (MRLs) currently established at European level for the pesticide active substance. Although this active substance is not authorised within the European Union, MRLs were established by the Codex Alimentarius Commission (codex maximum residue limits; CXLs) and import tolerances were reported by Member States and the UK (including the supporting residues data). Considering that no toxicological reference values are currently established in Europe for novaluron because the peer review for the approval was terminated before an EFSA conclusion was issued, the toxicological profile of novaluron was also assessed, in order to be able to perform the consumer risk assessment in the framework of the art 12 MRL review. Based on the assessment of the available data, toxicological reference values were derived, and a consumer risk assessment was carried out for the existing CXLs and import tolerances. All CXLs and import tolerances were found to be supported by inadequate data and a possible chronic risk to consumers was identified. Hence, further consideration by risk managers is needed. [ABSTRACT FROM AUTHOR]

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

In 2018, the risk assessment for tebufenozide in light of confirmatory data requested following approval in accordance with Article 6(1) of Directive 91/414/EEC and Article 6(f) of Regulation (EC) No 1107/2009 concluded that based on the submitted data, the metabolite RH-2651 has to be considered as a relevant groundwater metabolite since the absence of genotoxic potential in vivo was not fully demonstrated. Following further considerations during the decision-making process, the European Commission asked EFSA on 14 July 2021 to provide its scientific view on the genotoxic potential of the metabolite RH-2651 following consideration of new experimental data submitted by the applicant under Article 21(2) of Regulation (EC) No 1107/2009. Based on the available data, it is concluded that metabolite RH-2651 does not have genotoxic potential and therefore is not automatically considered a relevant groundwater metabolite. [ABSTRACT FROM AUTHOR]

According to Article 12 of Regulation (EC) No 396/2005, EFSA has reviewed the maximum residue levels (MRLs) currently established at European level for the pesticide active substance spirodiclofen. Although this active substance is no longer authorised within the European Union, MRLs were established by the Codex Alimentarius Commission (codex maximum residue limits; CXLs) and import tolerances were reported by Member States (including the supporting residues data). Based on the assessment of the available data, EFSA assessed the CXLs and import tolerances requested, and a consumer risk assessment was carried out. Although no apparent risk to consumers was identified, as spirodiclofen is classified as carcinogenic 1B with threshold, all MRL proposals derived by EFSA still require further consideration by risk managers. [ABSTRACT FROM AUTHOR]

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, Denmark, and co-rapporteur Member State, the Netherlands, for the pesticide active substance Bacillus thuringiensis subsp. kurstaki strain ABTS-351 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 Bacillus thuringiensis subsp. kurstaki strain ABTS-351 as an insecticide on cabbage (field use) and tomato (permanent greenhouse and walk-in tunnel 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 FROM AUTHOR]

The conclusions of EFSA following the peer review of the initial efficacy assessment and consideration of the effects of water treatment used for the production of drinking water on any residues that might be in raw water carried out by the competent authority of the rapporteur Member State Greece for the pesticide active substances paraffin oils (CAS 64742-46-7, 72623-86-0 and 97862-82-3) 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 conclusions were reached on the basis of the evaluation of the efficacy of paraffin oils (CAS 64742-46-7, 72623-86-0 and 97862-82-3) as a fungicide. The reliable endpoints are presented. [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 authority of the rapporteur Member State, Spain, for the pesticide active substance Spodoptera exigua multicapsid nucleopolyhedrovirus 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 Spodoptera exigua multicapsid nucleopolyhedrovirus as an insecticide on pepper and leafy vegetables (lettuce crops) (field, greenhouse and walk-in tunnel uses). 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 FROM AUTHOR]

The conclusions of EFSA following the peer review of the initial efficacy assessment and consideration of the effects of water treatment used for the production of drinking water on any residues that might be in raw water carried out by the competent authority of the rapporteur Member State Greece for the pesticide active substances paraffin oils (CAS 64742-46-7, 72623-86-0 and 97862-82-3) 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 conclusions were reached on the basis of the evaluation of the efficacy of paraffin oils (CAS 64742-46-7, 72623-86-0 and 97862-82-3) as a fungicide. The reliable endpoints are presented. [ABSTRACT FROM AUTHOR]

According to Article 12 of Regulation (EC) No 396/2005, EFSA has reviewed the maximum residue levels (MRLs) currently established at European level for the pesticide active substances Beta-cyfluthrin and Cyfluthrin. Although these active substances are no longer authorised for use on edible crops within the European Union, MRLs were established by the Codex Alimentarius Commission (codex maximum residue limits (CXLs)) and import tolerances were reported by Member States (including the supporting residues data). Based on the assessment of the available data, EFSA assessed the CXLs and import tolerances requested, and a consumer risk assessment was carried out. All CXLs were found to be sufficiently supported by data, whereas some import tolerances were not supported by adequate data. Hence, the consumer risk assessment is considered indicative only and further consideration by risk managers is needed. Apart from a possible acute risk to consumers for a CXL higher than the existing MRL, no risk to consumers was identified. [ABSTRACT FROM AUTHOR]

In accordance with Article 6 of Regulation (EC) No 396/2005, the applicants Nisso Chemical Europe GmbH and Sipcam Italia S.p.A. submitted requests to the competent national authority in the Netherlands and in Italy, respectively, to modify the existing maximum residue levels (MRLs) for the active substance acetamiprid in various crops. The data submitted in support of these requests were found to be sufficient to derive MRL proposals for plums, aubergines, peppers, cucumbers, courgettes, other cucurbits with edible peel, poppy seeds, mustard seeds, pomegranates and honey. Adequate analytical methods for enforcement are available to control the residues of acetamiprid in the commodities under consideration at the validated limit of quantification (LOQ) of 0.01 mg/kg. Based on the risk assessment results, EFSA concluded that the short-term and long-term intake of residues resulting from the use of acetamiprid according to the reported agricultural practices is unlikely to present a risk to consumer health. [ABSTRACT FROM AUTHOR]

Abstract In 2018, the risk assessment for tebufenozide in light of confirmatory data requested following approval in accordance with Article 6(1) of Directive 91/414/EEC and Article 6(f) of Regulation (EC) No 1107/2009 concluded that based on the submitted data, the metabolite RH‐2651 has to be considered as a relevant groundwater metabolite since the absence of genotoxic potential in vivo was not fully demonstrated. Following further considerations during the decision‐making process, the European Commission asked EFSA on 14 July 2021 to provide its scientific view on the genotoxic potential of the metabolite RH‐2651 following consideration of new experimental data submitted by the applicant under Article 21(2) of Regulation (EC) No 1107/2009. Based on the available data, it is concluded that metabolite RH‐2651 does not have genotoxic potential and therefore is not automatically considered a relevant groundwater metabolite.

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 spirodiclofen. Although this active substance is no longer authorised within the European Union, MRLs were established by the Codex Alimentarius Commission (codex maximum residue limits; CXLs) and import tolerances were reported by Member States (including the supporting residues data). Based on the assessment of the available data, EFSA assessed the CXLs and import tolerances requested, and a consumer risk assessment was carried out. Although no apparent risk to consumers was identified, as spirodiclofen is classified as carcinogenic 1B with threshold, all MRL proposals derived by EFSA still require further consideration by risk managers.

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, Denmark, and co‐rapporteur Member State, the Netherlands, for the pesticide active substance Bacillus thuringiensis subsp. kurstaki strain ABTS‐351 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 Bacillus thuringiensis subsp. kurstaki strain ABTS‐351 as an insecticide on cabbage (field use) and tomato (permanent greenhouse and walk‐in tunnel 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 authority of the rapporteur Member State, Spain, for the pesticide active substance Spodoptera exigua multicapsid nucleopolyhedrovirus 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 Spodoptera exigua multicapsid nucleopolyhedrovirus as an insecticide on pepper and leafy vegetables (lettuce crops) (field, greenhouse and walk‐in tunnel uses). 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 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 substances Beta‐cyfluthrin and Cyfluthrin. Although these active substances are no longer authorised for use on edible crops within the European Union, MRLs were established by the Codex Alimentarius Commission (codex maximum residue limits (CXLs)) and import tolerances were reported by Member States (including the supporting residues data). Based on the assessment of the available data, EFSA assessed the CXLs and import tolerances requested, and a consumer risk assessment was carried out. All CXLs were found to be sufficiently supported by data, whereas some import tolerances were not supported by adequate data. Hence, the consumer risk assessment is considered indicative only and further consideration by risk managers is needed. Apart from a possible acute risk to consumers for a CXL higher than the existing MRL, no risk to consumers was identified

Abstract In accordance with Article 6 of Regulation (EC) No 396/2005, the applicants Nisso Chemical Europe GmbH and Sipcam Italia S.p.A. submitted requests to the competent national authority in the Netherlands and in Italy, respectively, to modify the existing maximum residue levels (MRLs) for the active substance acetamiprid in various crops. The data submitted in support of these requests were found to be sufficient to derive MRL proposals for plums, aubergines, peppers, cucumbers, courgettes, other cucurbits with edible peel, poppy seeds, mustard seeds, pomegranates and honey. Adequate analytical methods for enforcement are available to control the residues of acetamiprid in the commodities under consideration at the validated limit of quantification (LOQ) of 0.01 mg/kg. Based on the risk assessment results, EFSA concluded that the short‐term and long‐term intake of residues resulting from the use of acetamiprid according to the reported agricultural practices is unlikely to present a risk to consumer health.

Abstract In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Syngenta France S.A.S. submitted a request to the competent national authority in France to modify the existing maximum residue levels (MRLs) for emamectin. The data submitted in support of the request were found to be sufficient to derive MRL proposals for apricots, cherries, spinaches and similar leaves and herbal infusions from leaves and herbs, whereas a change of the existing MRL is not necessary for pome fruits. Adequate analytical methods for enforcement are available to control the residues of emamectin B1a on 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 emamectin benzoate according to the intended agricultural practices are unlikely to present a risk to consumer health. The consumer risk assessment shall be regarded as indicative since affected by uncertainty related to the data gaps identified in the MRL review.

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, France, and co‐rapporteur Member State, Austria, for the pesticide active substance carbon dioxide 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 carbon dioxide as an insecticide and acaricide on stored cereal grains, oilseeds, medicinal plants, cereal products, spices, tobacco, tea, dried fruits and other stored plant products (except semolina and oilseed meal) (all indoor uses). The reliable end points, appropriate for use in regulatory risk assessment, are presented.

In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Syngenta France S.A.S. submitted a request to the competent national authority in France to modify the existing maximum residue levels (MRLs) for emamectin. The data submitted in support of the request were found to be sufficient to derive MRL proposals for apricots, cherries, spinaches and similar leaves and herbal infusions from leaves and herbs, whereas a change of the existing MRL is not necessary for pome fruits. Adequate analytical methods for enforcement are available to control the residues of emamectin B1a on 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 emamectin benzoate according to the intended agricultural practices are unlikely to present a risk to consumer health. The consumer risk assessment shall be regarded as indicative since affected by uncertainty related to the data gaps identified in the MRL review. [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 corapporteur Member State, Austria, for the pesticide active substance carbon dioxide 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 carbon dioxide as an insecticide and acaricide on stored cereal grains, oilseeds, medicinal plants, cereal products, spices, tobacco, tea, dried fruits and other stored plant products (except semolina and oilseed meal) (all indoor uses). The reliable end points, appropriate for use in regulatory risk assessment, are presented. [ABSTRACT FROM AUTHOR]

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, Denmark, and co‐rapporteur Member State, the Netherlands, for the pesticide active substance Bacillus thuringiensis subsp. kurstaki strain PB 54 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 Bacillus thuringiensis subsp. kurstaki strain PB 54 as an insecticide on stone fruit and ornamentals (field uses) and tomato (field, permanent greenhouse and walk‐in tunnel 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, Denmark, and co‐rapporteur Member State, the Netherlands, for the pesticide active substance Bacillus thuringiensis subsp. kurstaki strain EG2348 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 Bacillus thuringiensis kurstaki strain EG2348 as an insecticide on pome fruits (field use), solanaceous fruiting vegetables (uses in permanent greenhouse and walk‐in tunnel) and ornamentals (field, permanent greenhouse and walk‐in tunnel 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 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, Greece, for the pesticide active substance phosmet 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 phosmet as an insecticide on citrus fruits, pome fruits, peaches/nectarines and potatoes (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 risk assessment for gamma‐cyhalothrin in light of confirmatory data requested following approval in accordance with Article 6(1) of Directive 91/414/EEC and Article 6(f) of Regulation (EC) No 1107/2009 concluded that the long‐term risk to wild mammals from the proposed representative uses of gamma‐cyhalothrin was not fully addressed. Following further considerations during the decision‐making process, the European Commission asked EFSA to update the risk assessment for wild mammals and consider a restriction to the proposed good agricultural practice (GAP). The outcome of the updated peer review of the risk assessment for wild mammals is presented.