Modification of the existing maximum residue levels for dichlorprop-P in cereal grains.

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

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

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

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

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

Modification of the existing maximum residue levels for cycloxydim in various crops.

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

Peer review of the pesticide risk assessment of the active substance bensulfuron-methyl.

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

Peer review of the pesticide risk assessment of the active substance Bacillus velezensis RTI301.

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

Peer review of the pesticide risk assessment of the active substance Bacillus subtilis strain RTI477.

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

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

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.

Review of the existing maximum residue levels for difenoconazole 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 difenoconazole. To assess the occurrence of difenoconazole residues in plants, processed commodities, rotational crops and livestock, EFSA considered the conclusions derived in the framework of Council Directive 91/414/EEC, the MRLs established by the Codex Alimentarius Commission as well as the European authorisations reported by Member States and the UK (including the supporting residues data). Based on the assessment of the available data, MRL proposals were derived, and a consumer risk assessment was carried out. Some information required by the regulatory framework was missing and a possible acute risk to consumers was identified. Hence, the consumer risk assessment is considered indicative only, some MRL proposals derived by EFSA still require further consideration by risk managers and measures for reduction of the consumer exposure should also be considered.

Peer review of the pesticide risk assessment of the active substance Phthorimaea operculella granulovirus.

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

Peer review of the pesticide risk assessment of the active substance triclopyr (variant triclopyr-butotyl).

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.

Peer review of the pesticide risk assessment of the active substance Pythium oligandrum strain B301.

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

Peer review of the pesticide risk assessment of the active substance 1-methylcyclopropene.

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.

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

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.

Peer review of the pesticide risk assessment of the active substance paraffin oil (CAS 8042-47-5, chain lengths C17-C31).

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.

Modification of the existing maximum residue level for methoxyfenozide in aubergines.

In accordance with Article 6 of Regulation (EC) No 396/2005, the Federal Public Service (FPS) Health, Food chain Safety and Environment submitted a request on behalf of Belgium (evaluating Member State, EMS) to modify the existing maximum residue level (MRL) for the active substance methoxyfenozide in aubergines/eggplants. The data submitted in support of the request were found to be sufficient to derive an MRL proposal for aubergines/eggplants. Adequate analytical methods for enforcement are available to control the residues of methoxyfenozide in the commodity under consideration at the validated limit of quantification (LOQ) of 0.01 mg/kg. Based on the risk assessment results, the EFSA concluded that the short-term and long-term intake of residues resulting from the indoor use of methoxyfenozide according to the reported agricultural practice is unlikely to present a risk to consumer health.

Peer review of the pesticide risk assessment of the active substance mepiquat (evaluated variant mepiquat chloride).

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.

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

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.

Modification of the existing maximum residue levels in various plant commodities resulting from the use of potassium phosphonates.

In accordance with Article 6 of Regulation (EC) No 396/2005, the applicants De Sangosse SAS and Tilco-Alginure submitted two requests, respectively, to the competent national authorities in France and Germany to modify the existing maximum residue levels (MRLs) for the active substance potassium phosphonates in various plant commodities. The data submitted in support of the requests were found to be sufficient to derive MRL proposals for the commodities under assessment. For the derived MRL on baby leaf crops, further risk manager consideration is required to decide between two MRL options. Adequate analytical methods for enforcement are available to control the residues of potassium phosphonates in accordance with the residue definition 'phosphonic acid and its salts expressed as phosphonic acid' in the commodities under consideration. Based on the risk assessment results and assuming that the existing MRLs will be amended as proposed by EFSA in previous outputs, EFSA concluded that the long-term intake of residues resulting from the existing uses of fosetyl and phosphonates (previously assessed in a joint MRL review) and new proposed uses of potassium phosphonates is unlikely to present a risk to consumer health. Considering the toxicological profile of the active substance, a short-term dietary risk assessment was not required. The risk assessment shall be regarded as indicative because some MRL proposals derived by EFSA in the framework of the MRL review according to Articles 12 and 43 of Regulation (EC) No 396/2005 require further consideration by risk managers.

Review of the existing maximum residue levels for gamma-cyhalothrin 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 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.