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In April and May of 2016, Norway con firmed two cases of chronic wasting disease (CWD) in a wildreindeer and a wild moose, respectively. In the light of this emerging issue, the European Commissionrequested EFSA to recommend surveillance act ivities and, if necessary, additional animal healthrisk-based measures to prevent the introduction of the disease and the spread into/withi n the EU,specifically Estonia, Finland, Iceland, Latvia, Lithuania, Norway, Poland and Sweden, and consideringseven wild, semidomesticated and farmed cervid species (Eurasian tundra reindeer, Finnish (Eurasian)forest reindeer, moose, roe deer, white-tailed deer, red deer and fallow deer). It was also asked toassess any new evidence on possible public health risks related to CWD. A 3-year surveillance systemis proposed, differing for farmed and wild or semidomesticated cervids, with a two-stage samplingprogramme at the farm/geographically based population unit level (random samp ling) and individuallevel (convenience sampling targeting high-risk animals). The current derogations of CommissionImplementing Decision (EU) 2016/1918 present a risk of introduction of CWD into the EU. Measures toprevent the spread of CWD within the EU are dependent upon the assumption that the disease isalready present; this is currently unknown. The measures listed are intended to contain (limit thegeographic extent of a focus) and/or to contro l (acti vely stabilise/reduce infection rates in an affectedherd or population) the disease where it occurs. With regard to the zoonotic potential, the humanspecies barrier for CWD prions does not appear to be absolute. These prions are present in theskeletal muscle and other edible tissues, so humans may consume infected material in enzootic areas.Epidemiological investigations carried out to date make no association between the occurrence ofsporadic Creutzfeldt–Jakob disease in humans and exposure to CWD prions

Under current European hygiene legislation, food businesses are obliged to develop and implement food safety management systems (FSMS) including prerequisite programme (PRP) activities and hazard analysis and critical control point principles. This requirement is especially challenging for small food retail establishments, where a lack of expertise and other resources may limit the development and implementation of effective FSMS. In this opinion, a simplified approach to food safety management is developed and presented based on a fundamental understanding of processing stages (flow diagram) and the activities contributing to increased occurrence of the hazards (biological, chemical (including allergens) or physical) that may occur. The need to understand and apply hazard or risk ranking within the hazard analysis is removed and control is achieved using PRP activities as recently described in the European Commission Notice 2016/C278, but with the addition of a PRP activity covering ‘product information and customer awareness’. Where required, critical limits, monitoring and record keeping are also included. Examples of the simplified approach are presented for five types of retail establishments: butcher, grocery, bakery, fish and ice cream shop.

EFSA is requested to assess the safety of a broad range of biological agents in the context of notification formarket authorisation as sources of food and feed additives, food enzymes and plant protection products.The qualified presumption of safety (QPS) assessment was developed to provide a harmonised generic pre-assessment to support safety risk assessments performed by EFSA’sscientific Panels. The safety ofunambiguously defined biological agents (at the highest taxonomic unit appropriate for the purpose forwhich an application is intended), and the completeness of the body of knowledge are assessed. Identifiedsafety concerns for a taxonomic unit are, where possible and reasonable in number, reflected as‘qualifications’in connection with a recommendation for a QPS status. The list of QPS recommendedbiological agents was reviewed and updated in the current opinion and therefore becomes the valid list.The 2016 update reviews previously assessed microorganisms including bacteria, yeasts and viruses usedfor plant protection purposes following an Extensive Literature Search strategy. The taxonomic units relatedto the new notifications received since the 2013 QPS opinion, were periodically evaluated for a QPS statusand the results published as Statements of the BIOHAZ Panel.Carnobacterium divergens,Lactobacillusdiolivorans,Microbacterium imperiale,Pasteuria nishizawae,Pediococcus parvulus, Bacillusflexus,Bacillus smithii, Xanthomonas campestrisandCandida cylindraceawere recommended for the QPS list. Alltaxonomic units previously recommended for the 2013 QPS list had their status reconfirmed as well theirqualifications with the exception ofPasteuria nishizawaefor which the qualification was removed. Theexclusion offilamentous fungi and enterococci from the QPS evaluations was reconsidered but monitoringwill be maintained and the status will be re-evaluated in the next QPS Opinion update. Evaluation ofbacteriophages should remain as a case-by-case procedure and should no

Breeding programmes to promote resistance to classical scrapie, similar to those for sheep in existingtransmissible spongiform encephalopathies (TSE) regulations, have not been established in goats. TheEuropean Commission requested a scientific opinion from EFSA on the current knowledge of geneticresistance to TSE in goats. An evaluation tool, which considers both the weight of evidence andstrength of resistance to classical scrapie of alleles in the goatPRNPgene, was developed and appliedto nine selected alleles of interest. Using the tool, the quality and certainty of thefield andexperimental data are considered robust enough to conclude that the K222, D146 and S146 allelesboth confer genetic resistance against classical scrapie strains known to occur naturally in the EU goatpopulation, with which they have been challenged both experimentally and underfield conditions. Theweight of evidence for K222 is greater than that currently available for the D146 and S146 alleles andfor the ARR allele in sheep in 2001. Breeding for resistance can be an effective tool for controllingclassical scrapie in goats and it could be an option available to member states, both at herd andpopulation levels. There is insufficient evidence to assess the impact of K222, D146 and S146 alleleson susceptibility to atypical scrapie and bovine spongiform encephalopathy (BSE), or on health andproduction traits. These alleles are heterogeneously distributed across the EU Member States and goatbreeds, but often at low frequencies (<10%). Given these low frequencies, high selection pressuremay have an adverse effect on genetic diversity so any breeding for resistance programmes should bedeveloped at Member States, rather than EU level and their impact monitored, with particular attentionto the potential for any negative impact in rare or small population breeds

Sixty bovine spongiform encephalopathy (BSE) cases of Classical or unknown type (BARB-60 cases)were born after the date of entry into force of the EU total feed ban on 1 January 2001. The EuropeanCommission has requested EFSA to provide a scientific opinion on the most likely origin(s) of theseBARB-60 cases; whether feeding with material contaminated with the BSE agent can be excluded asthe origin of any of these cases and, if so, whether there is enough scientific evidence to conclude thatsuch cases had a spontaneous origin. The source of infection cannot be ascertained at the individuallevel for any BSE case, including these BARB-60 cases, so uncertainty remains high about the origin ofdisease in each of these animals, but when compared with other biologically plausible sources ofinfection (maternal, environmental, genetic, iatrogenic), feed-borne exposure is the most likely. Thisexposure was apparently excluded for only one of these BARB-60 cases. However, there isconsiderable uncertainty associated with the data collected through thefield investigation of thesecases, due to a time span of several years between the potential exposure of the animal and theconfirmation of disease, recall difficulty, and the general paucity of documented objective evidenceavailable in the farms at the time of the investigation. Thus, feeding with material contaminated withthe BSE agent cannot be excluded as the origin of any of the BARB-60 cases, nor is it possible todefinitively attribute feed as the cause of any of the BARB-60 cases. A case of disease is classified asspontaneous by a process of elimination, excluding all other definable possibilities; with regard to theBARB-60 cases, it is not possible to conclude that any of them had a spontaneous origin.

On 22 January 2015, Croatia submitted to the European Commission (EC) a request to revise its bovine spongiform encephalopathy (BSE) monitoring programme. The EC requested the European Food Safety Authority (EFSA) to provide scientific and technical assistance on an assessment of the capacity of the proposed revised monitoring programme in Croatia to allow the detection of BSE, both classical and atypical strains, with a design prevalence of at least one case per 100,000 animals in the adult cattle population of the EU26 group (EU25 and Croatia). Under this revision Croatia would stop testing all healthy slaughtered cattle and would test all ‘at risk’ cattle of active surveillance above 36 months of age. The EC resolved that the EU26 should be considered as a unique epidemiological unit for this assessment. Data related to the EU26 were updated to run the Cattle Transmissible Spongiform Encephalopathies Monitoring Model (C-TSEMM), previously applied to similar assessments. This model allows the estimation of the design prevalence of the same surveillance regime applied by a group of countries. Using data up to 2014, the current EU25 surveillance regime would allow the detection of BSE in the EU25 with a design prevalence of at least 1 per 3,769,555 of the cattle adult population, lower (i.e. more sensitive) than the minimum requirement of 1 case per 100,000. The addition of Croatia to the EU25 epidemiological unit (EU26) assuming the current EU25 surveillance regime resulted in an ability in EU26 to detect BSE with a design prevalence of at least 1 per 3,789,838 of the adult cattle population. It is recommended: [1] to run the C-TSEMM model on an annual basis with updated data; [2] to monitor MS data in order to evaluate the surveillance coverage and [3] to identify any shortcomings affecting the overall sensitivity of the surveillance system.

The Bacillus cereus group, also known as B. cereus sensu lato, is a subdivision of the Bacillus genus that consists of eight formally recognised species: B. cereus sensu stricto, B. anthracis, B. thuringiensis, B. weihenstephanensis, B. mycoides, B. pseudomycoides, B. cytotoxicus and B. toyonensis. The current taxonomy of the B. cereus group and the status of separate species mainly rely on phenotypic characteristics. Bacillus thuringiensis strains display a similar repertoire of the potential virulence genes on the chromosome as B. cereus sensu stricto strains and it has been shown that these genes can also be actively expressed in B. thuringiensis strains. Bacillus cereus and B. thuringiensis strains are usually not discriminated in clinical diagnostics or food microbiology. Thus, the actual contribution of the two species to gastrointestinal and non-gastrointestinal diseases is currently unknown. Most cases of food-borne outbreaks caused by the B. cereus group have been associated with concentrations above 105 CFU/g. However, cases of both emetic and diarrhoeal illness have been reported involving lower levels of B. cereus. The levels of B. cereus that can be considered as a risk for consumers are also valid for B. thuringiensis. There is no evidence that B. thuringiensis has the genetic determinants for the emetic toxin cereulide. The Panel has recommended the application of whole genome sequencing to provide unambiguous identification of strains used as biopesticides and the detailed characterisation of outbreak strains allowing discrimination of B. thuringiensis from B. cereus. Data gaps include: dose–response and behavioural characteristics of B. cereus group strains and specifically of B. thuringiensis. Field studies after application of B. thuringiensis biopesticides are needed to enable the establishment of pre-harvest intervals.