Reasoned opinion on the modification of the existing MRLs for cyflufenamid in pome fruits, cucurbits (inedible peel) and gherkins

In accordance with Article 6 of Regulation (EC) No 396/2005, France, hereafter referred to as the evaluating Member State (EMS), received an application from the company Nisso Chemical Europe GmbH to modify the existing MRLs for the active substance cyflufenamid in pome fruit (quinces, medlar, loquat), cucurbits with inedible peel (pumpkins, watermelons) and gherkins. In order to accommodate for the intended uses of cyflufenamid, France proposed to raise the existing MRLs from the limit of quantification of 0.02 mg/kg to 0.05 mg/kg in pome fruit and gherkins and 0.04 mg/kg in cucurbits with inedible peel. France 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 data are sufficient to derive a MRL proposal of 0.06 mg/kg for the intended use on quinces, medlar and loquat in France, 0.05 mg/kg for the intended use on pumpkins and watermelons in France and 0.08 mg/kg for the intended use on gherkins in France. Alternatively, the existing MRLs of 0.05 mg/kg on apples and pears and 0.04 mg/kg on melons, which were derived from the same residue data using the previous valid statistically-based calculation method, could be extrapolated to the whole group of pome fruit and cucurbits with inedible peel, respectively. Adequate analytical enforcement methods are available to control the residues of cyflufenamid in the commodities under consideration. Based on the risk assessment results, EFSA concludes that the proposed use of cyflufenamid on quinces, medlar, loquat, pumpkins, watermelons and gherkins will not result in a consumer exposure exceeding the toxicological reference values and therefore is unlikely to pose a public health concern

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

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 the United Kingdom, for the pesticide active substance dimethoate are reported. The context of the peer review was that requested by the European Commission following the submission and evaluation of confirmatory mammalian toxicology, residues and ecotoxicology data. The conclusions were reached on the basis of the evaluation of the representative uses of dimethoate as an insecticide on sugar beet and protected lettuce. Concerns are identified

Guidance on the Use of Probabilistic Methodology for Modelling Dietary Exposure to Pesticide Residues

No abstract availabl

Scientific Opinion on the revised exposure assessment of steviol glycosides (E 960) for the proposed uses as a food additive

Following a request from the European Commission, the European Food Safety Authority (EFSA) carried out an exposure assessment of steviol glycosides (E 960) from its use as a food additive, taking into account the proposed extension of uses. In 2010, the EFSA Panel on Food Additives and Nutrient Sources added to Food (ANS) adopted a scientific opinion on the safety of steviol glycosides (E 960) and established an Acceptable Daily Intake (ADI) of 4 mg/kg body weight (bw) per day. Conservative estimates of exposure, both in adults and children, suggested that it is likely that the ADI would be exceeded at the maximum proposed use level. In 2011, EFSA carried out a revised exposure assessment for steviol glycosides based on revised proposed uses and concluded that high level dietary exposure in children may still exceed the ADI. The current refined exposure estimates are based on the currently authorised uses, the proposed extension, and the EFSA Comprehensive Food Consumption Database. The mean dietary exposure to steviol glycosides ranges from 0.1 mg/kg bw/day in adults and the elderly, to 2.4 mg/kg bw/day in toddlers. Estimates at the 95th percentile of exposure range from 0.3 to 4.3 mg/kg bw/day in the elderly and toddlers, respectively. The Panel concluded that dietary exposure to steviol glycosides is considerably lower than that in the previous exposure assessment. Overall, the revised exposure estimates for all age groups remain below the ADI, except for toddlers at the upper range of the high level (95th percentile) estimates, in one country. Moreover, the Panel noted that table top sweeteners may represent an important source of exposure and therefore a MPL with a numerical value, rather than quantum satis, would be preferable, to allow for a more precise estimation of the potential maximum level of exposure from table top sweeteners

Scientific Opinion on the safety assessment of the process ILPA, based on Starlinger Decon technology, used to recycle post-consumer PET into food contact materials

This scientific opinion of the EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids deals with the safety assessment of the recycling process ILPA (EU register No RECYC105) which is based on the Starlinger Decon technology. The input of the process is hot caustic washed and dried PET flakes originating from collected post-consumer PET containers, mainly bottles and trays, containing no more than 5 % of PET from non-food consumer applications. Through this technology washed and dried PET flakes are pre-heated before being solid state polymerised (SSP) in a continuous reactor at high temperature under vacuum and gas flow. Having examined the challenge test provided, the Panel concluded that the pre-heating (step 2) and the decontamination in the continuous SSP reactor (step 3) are the critical steps that determine the decontamination efficiency of the process. The operating parameters to control their performance are well defined and are the temperature, the pressure, the residence time and the gas flow for step 2 and 3. Under these conditions, it was demonstated that the recycling process under evaluation, is able to ensure that the level of migration of potential unknown contaminants into food is below a conservatively modelled migration of 0.1 μg/kg food. Therefore, the recycled PET obtained from this process intended to be used up to 100 % for the manufacture of materials and articles for contact with all types of foodstuffs for long term storage at room temperature, with or without hotfill, is not considered of safety concern

Scientific Opinion on the safety assessment of the process APPE supercycle CP used to recycle post-consumer PET into food contact materials

This scientific opinion of the EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids deals with the safety evaluation of the recycling process APPE Supercycle CP (EU register No RECYC066). The input of the process is hot caustic washed and dried PET flakes originating from collected post-consumer PET containers, mainly bottles, containing no more than 5 % of PET from non-food consumer applications. Through this process, washed and dried PET flakes are extruded under vacuum and pelletised (step 2). The pellets are crystallised at high temperature under vacuum (step 3) and further decontaminated in a solid state polymerisation reactor (SSP) at high temperature under vacuum. Having examined the challenge test provided, the Panel concluded that the three steps, the extrusion (step 2), the crystallisation (step 3) and the decontamination in the SSP reactor (step 4) are the critical steps for the decontamination efficiency of the process. The operating parameters to control their performance are the temperature, the gas flow, the pressure and the residence time. The operating parameters of these steps in the process are at least as severe as those obtained from the challenge test. Under these conditions, it was demonstrated that the recycling process is able to ensure that the level of migration of potential unknown contaminants into food is below a conservatively modelled migration of 0.1 μg/kg food. Therefore the Panel concluded that the recycled PET obtained from this process intended to be used at up to 100 % for the manufacture of materials and articles for contact with all types of foodstuffs for long term storage at room temperature, with or without hotfill is not considered of safety concern

Scientific Opinion on the safety evaluation of the process “RPET Nosinyec”, used to recycle post-consumer PET into food contact materials

This scientific opinion of the EFSA Panel on food contact materials, enzymes, flavourings and processing aids deals with the safety evaluation of the recycling process RPET Nosinyec, EC register number RECYC082. The input of the process is washed and dried PET flakes originating from collected post-consumer PET bottles containing no more than 5% of PET from non-food consumer applications. Through this process, washed and dried flakes are extruded into pellets, pre-crystallised then pre-crystallised pellets are fed into a reactor at high temperature under vacuum in which they are further crystallised and solid-state polymerised (SSP). After having examined the challenge test provided, the Panel concluded that the two steps, the extrusion and the decontamination in the batch SSP reactor are the critical steps that determine the decontamination efficiency of the process. The operating parameters to control the performance of these critical steps are well defined and are the temperature, the pressure and the residence time both for the extrusion (step 2) and the SSP (step 4). The operating parameters of these steps in the process are at least as severe as those obtained from the challenge test. Under these conditions, it was demonstrated that the recycling process is able to ensure that the level of migration of potential unknown contaminants into food is below a conservatively modelled migration of 0.1 μg/kg food. Therefore the Panel concluded that the recycled PET obtained from this process intended for the manufacture of materials and articles for contact with all types of foodstuffs for long term storage at room temperature, with or without hotfill is not considered of safety concern

Survey of the prevalence of Salmonella species on laying hen farms in Kosovo

A survey on the prevalence of Salmonella (S.) species was carried out on 39 layer farms in Kosovo between April and September 2012. In total 367 samples, comprising feces, dust, eggs, and internal organs from dead birds, were investigated using bacteriological culture methods. Additionally, data on the location of the farm, the total number of birds on the farm, age of birds, and laying performance were collected. Salmonella were isolated from 38 samples obtained from 19 (49%) farms. The most common serovar identified was Salmonella enteritidis, found on 18 farms. The most common S. enteritidis phage type was PT29 followed by PT6, PT7, PT21, PT13a, PT8, PT14b, and PT4. One S. enteritidis isolate was not typable. Six farms had more than one phage type. Furthermore, serovar S. Bovismorbificans also was found in samples from 3 farms. Flock size or production stage was not associated with the probability of isolating Salmonella. The only flock factor found to be significantly associated was percent hen/day production: It was 2.8 times more likely to isolate Salmonella from flocks with production above 80% hen/day production compared to flocks producing at a lower level. Analysis of antimicrobial resistance patterns of 30 isolates revealed that all isolates were sensitive to gentamicin, ampicillin, sulphamethoxazole trimethoprim, and oxytetracycline, and 29 (97%) were sensitive to ciprofloxacin. All isolates showed intermediate resistance or were resistant to minocycline and cloxacillin. Twenty-six isolates (86%) had intermediate resistance to amoxicillin and 27 isolates (90%) were fully resistant to streptomycin. The present survey revealed a high prevalence of Salmonella enteritidis in layer flocks in Kosovo, indicating that table eggs have to be suspected as an important source of human salmone-llosis