Suchergebnisse

In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Bayer CropScience submitted two applications to the competent national authorities appointed in the United Kingdom and Greece to modify the existing maximum residue levels (MRLs) for the active substance trifloxystrobin in various crops and in sweet peppers/bell peppers, respectively. Moreover, in the application submitted to the United Kingdom, the applicant also included a request 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. In the framework of the assessment process, these applications were re‐allocated to the Netherlands. The data submitted in support of the requests were found to be sufficient to derive MRL proposals for sweet peppers/bell peppers, kales, escaroles, herbs and edible flowers, beans with pods, oat and chicory roots. Since the data gaps identified in the MRL review were not addressed, risk managers might consider lowering the tentative MRLs in passion fruits/maracujas and leafy brassica other than kales to the limit of quantification (LOQ), and the implementation of the Codex MRL (CXL) in the EU legislation for cucumbers and gherkins. The new intended use on witloof/Belgian endives was not adequately supported by residue data and therefore an MRL proposal cannot be derived. Adequate analytical methods for enforcement are available to control the residues of trifloxystrobin on the commodities under consideration. Based on the results of the risk assessment performed, considering the exposure to residues of trifloxystrobin and its metabolites CGA 321113 (apart for passion fruits), EFSA concluded that the short‐term and long‐term intake of residues resulting from the uses of trifloxystrobin under consideration is unlikely to present a risk to consumer health, except for escaroles. For the intended indoor use on escaroles, a risk from short‐term intake cannot be excluded, hence a modification of the existing EU MRL is not ...

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
In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Gowan Crop Protection Limited submitted a request to the competent national authority in Finland to set an import tolerance for the active substance hexythiazox in blackberries and raspberries. The data submitted in support of the request were found to be sufficient to derive maximum residue level (MRL) proposals of 3 mg/kg for raspberries and blackberries. Adequate analytical methods for enforcement are available to control the residues of hexythiazox in the plant matrices under consideration at the validated limit of quantification (LOQ) of 0.01 mg/kg. Based on the risk assessment results, EFSA concluded that the intake of residues resulting from the use of hexythiazox 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 Federal Public Service (FPS) Health, Food chain Safety and Environment submitted a request to the competent national authority in Belgium (evaluating Member State, EMS) to modify the existing maximum residue levels (MRLs) for the active substance propamocarb in radishes for the residues occurring in radish roots and in small radish leaves (proposed to be classified under the subgroup of Roman rocket/rucola). The data submitted in support of the request were found to be sufficient to derive MRL proposals for radishes and small radish leaves. Adequate analytical methods for enforcement are available to control the residues of propamocarb 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 use of propamocarb according to the reported agricultural practice is unlikely to present a risk to consumer health. The chronic consumer risk assessment shall be regarded as indicative since affected by uncertainty related to the data gaps identified in the MRL review.

Abstract
In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Corteva Agriscience International Sàrl submitted a request to the competent national authority in the Netherlands to modify the existing maximum residue levels (MRLs) in certain animal commodities (fat and liver) and honey. The data submitted in support of the request were found to be sufficient to derive an MRL proposal for honey. Adequate analytical methods for enforcement are available to control the residues according to the residue definition for enforcement proposed as 'picloram, free and conjugated, expressed as picloram' in honey at the validated limit of quantification (LOQ) of 0.01 mg/kg. For the commodities of animal origin, although the submitted data were found to be sufficient, EFSA concluded that no change of the existing MRLs was necessary. Based on the risk assessment results, EFSA concluded that the short‐term and long‐term intake of residues expected in honey, resulting from the existing uses of picloram on melliferous crops, is unlikely to present a risk to consumer health.

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 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.

Abstract
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.

Abstract
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.

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

In compliance with Article 43 of Regulation (EC) No 396/2005, EFSA received from the European Commission a mandate to provide its reasoned opinion on the toxicological properties and maximum residue levels (MRLs) for the benzimidazole substances carbendazim and thiophanate‐methyl. Specifically, EFSA was asked to assess whether thiophanate‐methyl or carbendazim have clastogenic potential and, in case clastogenic potential can be excluded, to derive toxicological reference values necessary for consumer risk assessment and assessment of maximum residue levels (MRLs). Although these active substances are no longer authorised within the European Union, MRLs were established by the Codex Alimentarius Commission (codex maximum residue limits; CXLs), and import tolerances are in place. Based on the assessment of the available data, toxicological reference values and MRL proposals were derived and a consumer risk assessment was carried out. Some information required by the regulatory framework was found to be missing and a possible acute risk to consumers was identified. Hence, the consumer risk assessment 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.

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.