Renata Leuschner

Peer review of the pesticide risk assessment for the triazole derivative metabolites in light of confirmatory data submitted

Abstract The conclusions of EFSA following the peer review of the initial risk assessment carried out by the competent authority of the rapporteur Member State, the United Kingdom, for the pesticide risk assessment for the triazole derivative metabolites are reported. The context of the peer review was that requested by the European Commission following the submission and evaluation of confirmatory data in relation to mammalian toxicology, metabolism and residue data. The conclusions were reached on the basis of the evaluation of various uses for a number of triazole fungicides. Recommendations are proposed. Missing information identified as being required by the regulatory framework is listed. Concerns are identified.

Peer review of the targeted hazard assessment of the pesticide active substance quinoxyfen

Abstract The conclusions of EFSA following the peer review of the initial assessments carried out by the competent authorities of the rapporteur Member State, the United Kingdom, and co‐rapporteur Member State, Austria, for the pesticide active substance quinoxyfen 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 information targeted at the assessment of the potential persistent, bioaccumulative and toxic (PBT), very persistent and very bioaccumulative (vPvB) and persistent organic pollutant (POP) properties of quinoxyfen according to Article 11(2) of Regulation (EC) No 1107/2009. The reliable end points, appropriate for use in these regulatory hazard cut off assessments are presented. Missing information identified as being required by the regulatory framework is listed. The concern is identified that quinoxyfen may be considered to exhibit the hazard properties of both a PBT and vPvB substance considering the triggers specified in Annex II of Regulation (EC) No 1107/2009.

Modification of a maximum residue level for mepiquat in cotton seeds

Abstract In accordance with the Article 53 of the Regulation (EC) 1107/2009, Greece granted a 120‐day emergency authorisation for the use of mepiquat in cotton following an application by the Hellenic Ministry of Rural Development and Food. To accommodate for the use of mepiquat according to the authorised good agricultural practices, Greece submitted an application to set a temporary maximum residue level (tMRL) for the active substance mepiquat in cotton seed in line with Article 16(1) in conjunction with Article 14 of Regulation (EC) No 396/2005. Greece, as evaluating Member State (EMS), drafted an evaluation report in accordance with Article 8 of Regulation (EC) No 396/2005, which was submitted to the European Commission and forwarded to EFSA. EFSA has assessed the available data and performed a risk assessment as regards the risks to consumers related to the exposure of mepiquat chloride in cotton seed. Several risk management options were derived in response to the request to amend the existing MRL for cotton seed. EFSA did not confirm the need to modify the existing MRLs for animal products as suggested by Greece.

Modification of the existing maximum residue levels for fosetyl‐Al in tree nuts, pome fruit, peach and potato

Abstract In accordance with Article 6 of Regulation (EC) No 396/2005, the applicants Bayer CropScience Europe and Oxon Italia S.p.A. submitted requests to the competent national authority in Spain and Italy, respectively, to modify the existing maximum residue levels (MRLs) for fosetyl in peach and potato from the intended southern Europe (SEU) uses of fosetyl‐Al. The applicants Adama Agriculture B.V., Fitosanitarios Bajo Riesgo AIE and Almond Board of California submitted each an application to the competent national authority in France to modify the MRLs for fosetyl‐Al in pome fruits, peaches and tree nuts (except coconut) for the intended/authorised uses of the active substance potassium phosphonates. The data submitted in support of the requests were found to be sufficient to derive MRL proposals for all the crops under consideration. Adequate analytical methods for enforcement are available to control the residues of fosetyl‐Al and phosphonic acid in plant matrices under consideration. EFSA concluded that the proposed use of fosetyl‐Al on potatoes and the proposed uses of potassium phosphonates on pome fruits and peaches and the authorised use of potassium phosphonates on tree nuts in the United States are unlikely to result in a consumer exposure exceeding the toxicological reference values for phosphonic acid and fosetyl and therefore are unlikely to pose a risk to consumers’ health. However, the risk assessment is considered to be tentative and has to be updated as soon as the approval of the renewal of fosetyl and the review of existing uses of potassium phosphonates and disodium phosphonate is finalised.

Modification of the existing maximum residue levels for mandestrobin in apricots, cherries, peaches/nectarines and plums

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 France, to modify the existing maximum residue levels (MRL) for the active substance mandestrobin in apricots, cherries, peaches/nectarines and plums. The data submitted in support of the request were found to be sufficient to derive MRL proposals for apricots, cherries, peaches/nectarines and plums. Adequate analytical methods for enforcement are available to control the residues of mandestrobin in the commodities under consideration at the validated limit of quantification (LOQ) of 0.01 mg/kg. A short‐term dietary risk assessment was not required. Based on the long‐term risk assessment results, EFSA concluded that the long‐term intake of residues resulting from the use of mandestrobin according to the agricultural practices reported in the good agricultural practice (GAP) for applications at growth stages BBCH 77–87 is unlikely to present a risk to consumer health. The GAP for applications at growth stages BBCH 57–69 is not adequately supported by residue trials data. The reliable end points appropriate for use in regulatory risk assessment are presented.

Modification of the existing maximum residue level for flonicamid in various crops

Abstract In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Dienstleistungszentrum Ländlicher Raum submitted a request to the competent national authority in Germany to modify the existing maximum residue level (MRL) for the active substance flonicamid in radishes. Furthermore, 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 the Netherlands to modify the existing MRLs for the active substance flonicamid in strawberries, cane fruits, other small fruits and berries, lettuces and other salad plants, and pulses (dry beans, lentils, peas, lupins). The data submitted in support of the request were found to be sufficient to derive MRL proposals for strawberries, blackberries, raspberries, other small fruits and berries, radishes, lettuces and other salad plants, and pulses (dry beans, lentils, peas and lupins). Adequate analytical methods for enforcement are available to control the residues of flonicamid on 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 flonicamid according to the reported agricultural practices is unlikely to present a risk to consumer health.

Modification of the existing maximum residue levels for prochloraz in various commodities

Abstract In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant ADAMA Agriculture BV submitted an application to the competent national authority in Belgium (evaluating Member State (EMS)) to modify the existing maximum residue levels (MRLs) for the active substance prochloraz in sugar beet root and in liver and kidney of swine and ruminant. The data submitted in support of the request were found to be sufficient to derive an MRL proposal for sugar beet root. Residues in sugar beet tops from the new use were found to contribute significantly to the livestock exposure. As the dietary burden needs to be calculated including all feed items and since not all information is available at the moment, EFSA proposes to assess the magnitude of prochloraz residues in animal commodities under the currently ongoing review of prochloraz MRLs according to Article 12 of Regulation (EC) No 396/2005. Adequate analytical methods are available to control the residues of prochloraz residues in plant and animal matrices. The risk assessment performed by EFSA gave an indication that residues of prochloraz may lead to an exceedance of the acceptable daily intake (ADI). Thus, before the MRL for sugar beet is amended, it is necessary that a comprehensive, refined risk assessment is performed, taking into account all existing uses of prochloraz and the intended new use on sugar beet. Considering that the MRL review for prochloraz is currently ongoing, the results of the comprehensive risk assessment will be available in due time.

Peer review of the pesticide risk assessment of the active substance pethoxamid

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, Austria, and co‐rapporteur Member State, the Czech Republic, for the pesticide active substance pethoxamid 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 pethoxamid as a herbicide on maize and soya bean. 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 of the active substance mepanipyrim

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, Belgium, and co‐rapporteur Member State, Greece, for the pesticide active substance mepanipyrim 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 mepanipyrim as a fungicide on table and wine grapes, and in field and protected strawberries 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.

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

Abstract The conclusions of EFSA following the peer review of the initial risk assessment carried out by the competent authority of the rapporteur Member State, the United Kingdom, for the pesticide active substance metazachlor are reported. The context of the peer review was that requested by the European Commission following the submission and evaluation of confirmatory data regarding the groundwater exposure of metabolites and their toxicological relevance triggering an assessment. The conclusions were reached on the basis of the evaluation of the representative uses of metazachlor as a herbicide on winter and spring rapeseed and on ornamental trees and shrubs. 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. Concerns are identified.