Scientific and technical assistance on the provisional results of the study on genetic resistance to Classical scrapie in goats in Cyprus

This EFSA Scientific Report reviews and discusses the provisional results of a study (EURL/Cypriot study) on genetic resistance to Classical scrapie in goats in Cyprus. It is concluded that the provisional results obtained in the study further support the lower susceptibility to Classical scrapie in goats carrying the D146 and S146 alleles compared to wild type (N146N) goats. The results from intracerebral challenge are not compatible with a level of resistance as high as the one observed in sheep carrying the ARR allele or in goats carrying the K222 allele. Final results from the oral challenge will be crucial in determining the level of resistance associated with the D146 and S146 alleles. Furthermore, it is concluded that the provisional results obtained in the study are compatible with the possibility to use the D146 and S146 alleles to build a genetic strategy to control and eradicate Classical scrapie in goats in Cyprus. However, the success of such a strategy will be determined by the level of resistance associated with the D146 and S146 alleles against infection with all the different TSE agents proved to be circulating in Cyprus, which at this stage of the EURL/Cypriot study remains to be definitively assessed. In addition, as compared to the results of the model developed in the study, it is concluded that the efficiency of the implementation in the field of a breeding strategy selecting for the D146 and S146 alleles may be lower due to potential practical constraints related to the management of genetic diversity, to the selection for production and health traits and to the need of moving animals for breeding purposes in Cyprus. Recommendations on aspects that may be considered when completing the study are formulated

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 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

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 and efficacy of Natugrain^® TS (endo-1,4-beta-xylanase and endo-1,4-beta-glucanase) as a feed additive for pigs for fattening

Natugrain® TS is an enzyme preparation that contains endo-1,4-beta-xylanase and endo-1,4-beta-glucanase, produced by two genetically modified strains of Aspergillus niger. This product is currently authorised for use in piglets (weaned), poultry species and ornamental birds as a zootechnical additive under the functional group of digestibility enhancers. The applicant is now seeking for the extension of its use as a zootechnical additive for pigs for fattening at a dose range of 560 to 840 TXU (thermostable xylanase units) and 250 to 375 TGU (thermostable glucanase units) per kg feed. Since the product has been demonstrated to be  safe in piglets at the maximum recommended dose, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) considers that this conclusion can be extended to pigs for fattening, provided that the same maximum dose applies. In two long-term trials, Natugrain® TS significantly improved the performance of the pigs for fattening at the minimum recommended dose (560 TXU and 250 TGU/kg feed). In a balance trial, the metabolisable energy content of the diet was significantly improved by the addition of Natugrain® TS in feed at the minimum recommended dose. Therefore, the FEEDAP Panel concludes that Natugrain® TS at the minimum recommended dose (560 TXU and 250 TGU/kg feed) has the potential to be efficacious in pigs for fattening