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 fluroxypyr 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 fluroxypyr. In order to assess the occurrence of fluroxypyr 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 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 all MRL proposals derived by EFSA still require further consideration by risk managers

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

Multi-country outbreak of Salmonella Stanley infections Update

No abstract availabl

Reasoned opinion on the modification of the existing MRLs for difenoconazole in raspberries, blackberries and cucurbits (edible peel)

<p>In accordance with Article 6 of Regulation (EC) No 396/2005, Germany, hereafter referred to as the evaluating Member State (EMS), received an application from TSGE Deutschland GmbH to modify the existing MRLs for difenoconazole in raspberries and blackberries. Germany also received an application from Landwirtschaftskammer NRW Pflanzenschutzdienst to modify the existing MRLs for difenoconazole in cucurbits with (edible peel). In order to accommodate the intended NEU outdoor use on raspberries and blackberries and the intended indoor use on cucurbits (edible peel), the EMS proposed to raise the existing MRLs in these berries from 0.3 mg/kg to 1.5 mg/kg and in cucurbits (edible peel) from 0.1 mg/kg to 0.3 mg/kg. The EMS drafted two evaluation reports in accordance with Article 8 of Regulation (EC) No 396/2005, which were submitted to the European Commission and forwarded to EFSA. According to EFSA, the applications are sufficiently supported by data and EFSA confirmed the MRL proposals made by the EMS. Adequate analytical enforcement methods are available to control the residues of difenoconazole in the crops under consideration. The risk assessment demonstrated that the intended use of difenoconazole on the crops under consideration will not result in a consumer exposure exceeding the toxicological reference values and therefore is unlikely to pose a public health concern.</p&gt

Reasoned opinion on the modification of the existing MRLs for thiacloprid in spinach and similar leaves

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 thiacloprid in spinach and similar leaves crop group. In order to accommodate the intended indoor and outdoor uses of thiacloprid in Belgium, the EMS proposed to raise the existing MRLs for thiacloprid in spinach and similar leaves group or only in spinach and beet leaves to 0.15 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 residue trials data on lettuce are not sufficient to support the residue data extrapolation to the whole group of spinach and similar leaves. Alternatively, the EMS proposed to extrapolate four outdoor residue trials data on open leaf lettuce to spinach and beet leaves only. Although this extrapolation is not explicitly mentioned in the European guidance document, EFSA is of the opinion that the proposal is acceptable, considering the morphological similarities between spinach/beet leaves and open leave varieties of lettuce and taking into account that spinach and beet leaves are minor crops. Thus, a MRL proposal of 0.15 mg/kg is derived. Based on the risk assessment results EFSA concludes that the intended use of thiacloprid on spinach and beet leaves will not result in a consumer exposure exceeding the toxicological reference values and therefore is unlikely to pose a public health concern

Reasoned opinion on the modification of the existing MRLs for mepiquat in oats, wheat and food commodities of animal origin

In accordance with Article 6 of Regulation (EC) No 396/2005, United Kingdom received an application from BASF to modify the existing MRLs for the active substance mepiquat in oats, wheat and food commodities of animal origin. In order to accommodate the intended uses of mepiquat, United Kingdom proposed to raise the existing MRLs from the limit of quantification to 0.1 mg/kg for meat (except poultry meat), to 0.5 mg/kg for liver (except poultry liver), to 0.8 mg/kg for kidney and offal (except poultry kidney and offal), and from 2 mg/kg to 3 mg/kg for oats and wheat. United Kingdom 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 considers that the submitted supervised residue trials are sufficient to derive MRL proposals of 3 mg/kg for the proposed uses on wheat (existing and new residue definition); for oats the MRL does not have to be modified for the existing residue definition, but needs to be raised to 3 mg/kg for the new residue definition. Adequate analytical enforcement methods are available to control the residues of mepiquat in dry content commodities (oat and wheat) under consideration at the validated LOQ of 0.05 mg/kg. For certain food commodities of animal origin the MRLs have to be modified as well. Based on the risk assessment results, EFSA concludes that the proposed use of mepiquat on oats and wheat and the resulting residues in food of animal origin will not result in a consumer exposure exceeding the toxicological reference values and therefore is unlikely to pose a consumer health risk

Conclusion on the peer review of the pesticide risk assessment of confirmatory data submitted for the active substance dichlorprop-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 Denmark, for the pesticide active substance dichlorprop-P are reported. The context of the peer review was that requested by the European Commission following the submission and evaluation of confirmatory data concerning the risk assessment in the areas of consumer exposure and birds and mammals. The conclusions were reached on the basis of the evaluation of the representative uses of dichlorprop-P as a herbicide on cereals, grassland and grass seed crops. 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