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

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

Scientific Opinion on safety and efficacy of hydroxy-analogue of selenomethionine as feed additive for all species

The additive hydroxy-analogue of selenomethionine consists of synthetic R,S-2-hydroxy-4-methylselenobutanoic acid (HMSeBA) and is intended to be used as a source of the essential trace element selenium for all animal species/categories. Based on data from tolerance studies in chickens and turkeys for fattening and piglets, the additive is considered as safe for all species/categories up to the maximum authorised total selenium level in complete feed. After being absorbed, HMSeBA is metabolised to selenomethionine; consequently, no residues of the compound itself occur in animal tissues and products. Compared with inorganic selenium sources, the use of HMSeBA in animal nutrition would result in a similar increase in selenium deposition in animal tissues/products as that resulting from selenised yeast. To ensure consumer safety from consumption of food originating from animals supplemented with HMSeBA, the FEEDAP Panel concluded that selenium supplementation from the additive should not exceed a maximum of 0.2 mg Se/kg complete feed. The additive should be regarded as an eye irritant, but should not be classified as skin irritant or skin sensitiser. Inhalation exposure poses a hazard to users; the FEEDAP Panel concludes, therefore, that the formulation and conditions of use of the solid form of the additive should minimise user exposure by inhalation. The use of HMSeBA in feed does not pose an additional risk to the environment, compared to other sources of selenium for which it will substitute, as long as the maximum authorised content in feedingstuffs is not exceeded. Based on the response of plasma glutathione peroxidase activity and the plasma/liver concentration of selenium in chickens for fattening and pigs for fattening, the FEEDAP Panel considers that HMSeBA is an efficaceous source of selenium for all animal species/categories. HMSeBA does not modify the quality of meat as measured by physico-chemical properties

Reasoned opinion on the modification of the existing MRLs for bixafen in oilseed rape, linseed, poppy seed and mustard seed

<p>In accordance with Article 6 of Regulation (EC) No 396/2005, the United Kingdom, herewith referred to as the evaluating Member State (EMS), received an application from Bayer CropScience Limited to modify the existing MRLs for the active substance bixafen in oilseed rape, linseed, poppy seed and mustard seed. In order to accommodate for the intended use of bixafen in France, the United Kingdom proposed to raise the existing MRL for these crops from the value of 0.015 mg/kg to 0.1 mg/kg. The United Kingdom drafted an evaluation report according to Article 8 of Regulation (EC) No 396/2005, which was submitted to the European Commission and forwarded to EFSA. According to EFSA the available residues trials data are insufficient to propose MRLs for the proposed use in France on these oilseed crops. Adequate analytical enforcement methods are available to control the residues of bixafen in plant matrices under consideration at the validated LOQ of 0.01 mg/kg. EFSA concludes that the data available are insufficient to make a proposal to change any MRL.</p&gt

Conclusion on the peer review of the pesticide risk assessment of the active substance pyridalyl

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 pyridalyl are reported. The context of the peer review was that required by Commission Regulation (EU)No 188/2011. The conclusions were reached on the basis of the evaluation of the representative uses of pyridalyl as an insecticide on field and glasshouse tomato, aubergine, sweet and chilli pepper, and on field cucurbits, lettuce and cotton. 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. Missing information identified as being required by the regulatory framework is listed. Concerns are identified

Scientific opinion on the safety of smoke flavouring Primary Product SmokEz C-10 - 2012 Update

<p>The EFSA CEF Panel updated the safety assessment of the smoke flavouring Primary Product SmokEz C-10. In 2009, the Panel concluded that the margins of safety for this Primary Product were insufficient and the proposed use levels were considered of safety concern. After the opinion of 2009 the Panel received new data, i.e. new use levels, chemical data and a new 90-day toxicity study, which resulted in this update of the previous opinion. The new chemical data provided demonstrate that the test material used in the new 90-day toxicity study is representative of the Primary Product evaluated by EFSA. Based on the findings from the 90-day study submitted in 2009 and from the newly submitted one, the Panel derived a NOAEL for Primary Product SmokEz C-10 of 535 mg/kg bw/day based on body weight changes, relative kidney weight changes and changes in parameters indicative for changes in kidney function at dietary concentrations of 1350 mg/kg feed (equal to 801 mg/kg bw/day in males) and higher. Based on newly submitted normal use levels, the margins of safety are 56 and 68 (total dietary exposure) and 58 and 80 (use in traditionally smoke foods only) depending on the exposure scenario used. Given that these margins of safety are based on a 90-day toxicity studies, and given the absence of data on reproduction, developmental toxicity and of long term studies, it is concluded that the uses and use levels of Primary Product would require a larger margin of safety. The Panel concluded that the proposed use of the Primary Product at the uses and use levels specified is of safety concern.</p&gt