Reasoned opinion on the modification of the existing MRLs for dimethomorph in several vegetable crops

<p>In accordance with Article 6 of Regulation (EC) No 396/2005, Germany received three applications from BASF SE to modify or set MRLs for the active substance dimethomorph. In order to accommodate for the intended uses of dimethomorph, Germany proposed to raise the existing MRL from the LOQ of 0.05 mg/kg to 3 mg/kg in leafy brassica, from 1 mg/kg to 5 mg/kg on scarole, whereas an amendment of the existing MRLs was not necessary for cress and land cress, and to set import tolerances at 4 mg/kg on flowering brassica, 15 mg/kg on lettuce and celery and 0.6 mg/kg on garlic, onions and shallots. Germany drafted three separate evaluation reports according to Article 8 of Regulation (EC) No 396/2005 which were submitted to the European Commission and forwarded to EFSA, which addressed these applications in a single reasoned opinion. According to EFSA the data are sufficient to derive MRL proposals of 3 mg/kg for leafy brassica, 6 mg/kg for scarole (outdoor use in Southern Europe), while the existing MRL of 10 mg/kg supports the intended indoor/outdoor uses on cress and land cress and no amendment is necessary. The following import tolerances are proposed: 0.6 mg/kg for onion, garlic and shallot, 15 mg/kg for lettuce and celery. The values of 7 mg/kg and 5 mg/kg for head cabbage and broccoli, respectively, are proposed assuming that the modification of the GAP authorised in the USA will be approved. Adequate analytical methods are available to monitor the residues of dimethomorph in the commodities under consideration at the validated LOQ of 0.01 mg/kg. Based on the risk assessment results, EFSA concludes that the proposed uses under consideration (except the indoor use on scarole) will not result in a consumer exposure exceeding the toxicological reference values and therefore will not pose a public health concern.</p&gt

Statement on the dietary risk assessment for proposed temporary maximum residue levels (t-MRLs) for fosetyl-Al in certain crops

In accordance with Article 43 of Regulation (EC) No 396/2005, the European Commission requested EFSA to perform a dietary risk assessment of the proposed temporary MRLs for fosetyl-Al. These temporary MRLs should accommodate for residues found in different commodities which are according to food business operators most likely resulting from the use of foliar phosphorous fertilizers which could mimic the treatment with fosetyl-Al. The European Commission proposed to raise the existing MRLs as a proportionate risk management measure on a temporary basis to avoid market disruptions, provided that the proposed temporary MRLs do not pose a consumer heath risk. EFSA concludes that the overall dietary exposure to fosetyl-Al (sum of fosetyl and phosphonic acid and their salts expressed as fosetyl) linked to the proposed temporary MRLs for the crops under assessment and the existing MRLs for other commodities covered by the EU MRL legislation is not expected to result in a consumer exposure exceeding the toxicological reference values for fosetyl. Considering that the exposure assessment was performed with a conservative approach which is likely to overestimate the real exposure, EFSA concludes that the proposed temporary MRLs are unlikely to pose a consumer health risk. Since the source of the occurrence of the residues in the crops under consideration is not clarified, the conclusions of the risk assessment are restricted to the identified residues of phosphonic acid. EFSA derived several recommendations to be considered by risk managers to identify the source of the contamination aiming to reduce the uncertainties of the risk assessment

Reasoned opinion on the modification of the existing MRLs for pyraclostrobin in cucumbers and Jerusalem artichokes

In accordance with Article 6 of Regulation (EC) No 396/2005, Belgium, hereafter referred to as the evaluating Member State (EMS), compiled an application to modify the existing MRLs for the active substance pyraclostrobin in cucumbers and Jerusalem artichokes. In order to accommodate for the intended uses of pyraclostrobin, Belgium proposed to raise the existing MRL for cucumbers to 0.5 mg/kg; for Jerusalem artichokes the EMS proposed to raise the existing MRL, which is set at the limit of quantification (0.02 mg/kg), to 0.1 mg/kg. Belgium 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. According to EFSA the submitted data fully support the MRL proposals of 0.5 mg/kg on cucumbers. The MRL proposal of 0.09 mg/kg on Jerusalem artichokes is derived by extrapolation from overdosed trials on carrots, given that this crop is classified as very minor. Alternatively, EFSA derived a tentative MRL of 0.06 mg/kg by applying the proportionality approach. Adequate enforcement analytical methods are available to control the residues of pyraclostrobin in the commodities under consideration. Based on the risk assessment results, EFSA concludes that the proposed uses of pyraclostrobin on cucumbers and Jerusalem artichokes in Belgium will not result in a consumer exposure exceeding the toxicological reference values and therefore are unlikely to pose a consumer health risk

Reasoned opinion on the review of the existing maximum residue levels (MRLs) for metrafenone according to Article 12 of Regulation (EC) No 396/2005

According to Article 12 of Regulation (EC) No 396/2005, the European Food Safety Authority (EFSA) has reviewed the Maximum Residue Levels (MRLs) currently established at European level for the pesticide active substance metrafenone. In order to assess the occurrence of metrafenone residues in plants, processed commodities, rotational crops and livestock, EFSA considered the conclusions derived in the framework of Directive 91/414/EEC as well as the import tolerances and European authorisations reported by Member States (incl. the supporting residues data). Based on the assessment of the available data, MRL proposals were derived and a consumer risk assessment was carried out. Although no apparent risk to consumers was identified, some information required by the regulatory framework was found to be missing. Hence, the consumer risk assessment is considered indicative only and some MRL proposals derived by EFSA still require further consideration by risk managers

Conclusion on the peer review of the pesticide risk assessment of confirmatory data submitted for the active substance diflubenzuron

<p>The conclusions of the European Food Safety Authority (EFSA) following the peer review of the initial risk assessment carried out by the competent authority of the rapporteur Member State Sweden, for the pesticide active substance diflubenzuron are reported. The context of the peer review was that requested by the European Commission following the submission and evaluation of confirmatory mammalian toxicology data. The conclusions were reached on the basis of the evaluation of the representative uses of diflubenzuron as an insecticide on apples, pears and mushrooms, and in forestry. 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.</p&gt