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International audience ; A methodology based on the combination of two complementary approaches to rank microbiological risks in foods is presented. In the forward approach data on the pathogenicity of hazards and their behaviour in food during processing and following steps, up to consumption, are used in decision trees to qualitatively estimate the risk associated with foods. In the backward approach risks are evaluated based on the analysis of data available on the past occurrence of hazards and food-borne outbreaks. The categorisation of foods using the forward approach should prevail, and whenever it leads to a likely risk for a given food, the risk can be further qualified with the results from the backward approach. The methodology developed was applied to rank the public health risk posed by certain composite products, which contain both processed products of animal origin and products of plant origin (e.g., bread, cakes, chocolate). Despite limitations in the data available for these foods, valuable results were obtained. The method is therefore considered suitable for application with success to other types of food, and is proposed as a tool for risk managers to rank foods based on their potential food safety risks. Introduction In the World Trade Organization (WTO) Agreement on the Application of Sanitary and Phytosanitary (SPS) Measures it is stated that sanitary measures should be based on an assessment of the risks to humans, taking into account risk assessment techniques. In the European Union (EU), the general principles governing food and feed safety are laid down in Regulation (EC) No 178/2002 (General

International audience ; A methodology based on the combination of two complementary approaches to rank microbiological risks in foods is presented. In the forward approach data on the pathogenicity of hazards and their behaviour in food during processing and following steps, up to consumption, are used in decision trees to qualitatively estimate the risk associated with foods. In the backward approach risks are evaluated based on the analysis of data available on the past occurrence of hazards and food-borne outbreaks. The categorisation of foods using the forward approach should prevail, and whenever it leads to a likely risk for a given food, the risk can be further qualified with the results from the backward approach. The methodology developed was applied to rank the public health risk posed by certain composite products, which contain both processed products of animal origin and products of plant origin (e.g., bread, cakes, chocolate). Despite limitations in the data available for these foods, valuable results were obtained. The method is therefore considered suitable for application with success to other types of food, and is proposed as a tool for risk managers to rank foods based on their potential food safety risks. Introduction In the World Trade Organization (WTO) Agreement on the Application of Sanitary and Phytosanitary (SPS) Measures it is stated that sanitary measures should be based on an assessment of the risks to humans, taking into account risk assessment techniques. In the European Union (EU), the general principles governing food and feed safety are laid down in Regulation (EC) No 178/2002 (General

International audience ; A methodology based on the combination of two complementary approaches to rank microbiological risks in foods is presented. In the forward approach data on the pathogenicity of hazards and their behaviour in food during processing and following steps, up to consumption, are used in decision trees to qualitatively estimate the risk associated with foods. In the backward approach risks are evaluated based on the analysis of data available on the past occurrence of hazards and food-borne outbreaks. The categorisation of foods using the forward approach should prevail, and whenever it leads to a likely risk for a given food, the risk can be further qualified with the results from the backward approach. The methodology developed was applied to rank the public health risk posed by certain composite products, which contain both processed products of animal origin and products of plant origin (e.g., bread, cakes, chocolate). Despite limitations in the data available for these foods, valuable results were obtained. The method is therefore considered suitable for application with success to other types of food, and is proposed as a tool for risk managers to rank foods based on their potential food safety risks. Introduction In the World Trade Organization (WTO) Agreement on the Application of Sanitary and Phytosanitary (SPS) Measures it is stated that sanitary measures should be based on an assessment of the risks to humans, taking into account risk assessment techniques. In the European Union (EU), the general principles governing food and feed safety are laid down in Regulation (EC) No 178/2002 (General

The European Commission asked EFSA for a Scientific Opinion: to revise the state of knowledge about the differences between the chronic wasting disease (CWD) strains found in North America (NA) and Europe and within Europe; to review new scientific evidence on the zoonotic potential of CWD and to provide recommendations to address the potential risks and to identify risk factors for the spread of CWD in the European Union. Full characterisation of European isolates is being pursued, whereas most NA CWD isolates have not been characterised in this way. The differing surveillance programmes in these continents result in biases in the types of cases that can be detected. Preliminary data support the contention that the CWD strains identified in Europe and NA are different and suggest the presence of strain diversity in European cervids. Current data do not allow any conclusion on the implications of strain diversity on transmissibility, pathogenesis or prevalence. Available data do not allow any conclusion on the zoonotic potential of NA or European CWD isolates. The risk of CWD to humans through consumption of meat cannot be directly assessed. At individual level, consumers of meat, meat products and offal derived from CWD‐infected cervids will be exposed to the CWD agent(s). Measures to reduce human dietary exposure could be applied, but exclusion from the food chain of whole carcasses of infected animals would be required to eliminate exposure. Based on NA experiences, all the risk factors identified for the spread of CWD may be associated with animals accumulating infectivity in both the peripheral tissues and the central nervous system. A subset of risk factors is relevant for infected animals without involvement of peripheral tissues. All the risk factors should be taken into account due to the potential co‐localisation of animals presenting with different disease phenotypes.

The European Commission asked EFSA for a Scientific Opinion: to revise the state of knowledge about the differences between the chronic wasting disease (CWD) strains found in North America (NA) and Europe and within Europe; to review new scientific evidence on the zoonotic potential of CWD and to provide recommendations to address the potential risks and to identify risk factors for the spread of CWD in the European Union. Full characterisation of European isolates is being pursued, whereas most NA CWD isolates have not been characterised in this way. The differing surveillance programmes in these continents result in biases in the types of cases that can be detected. Preliminary data support the contention that the CWD strains identified in Europe and NA are different and suggest the presence of strain diversity in European cervids. Current data do not allow any conclusion on the implications of strain diversity on transmissibility, pathogenesis or prevalence. Available data do not allow any conclusion on the zoonotic potential of NA or European CWD isolates. The risk of CWD to humans through consumption of meat cannot be directly assessed. At individual level, consumers of meat, meat products and offal derived from CWD‐infected cervids will be exposed to the CWD agent(s). Measures to reduce human dietary exposure could be applied, but exclusion from the food chain of whole carcasses of infected animals would be required to eliminate exposure. Based on NA experiences, all the risk factors identified for the spread of CWD may be associated with animals accumulating infectivity in both the peripheral tissues and the central nervous system. A subset of risk factors is relevant for infected animals without involvement of peripheral tissues. All the risk factors should be taken into account due to the potential co‐localisation of animals presenting with different disease phenotypes.

EFSA received an application from the Dutch Competent Authority, under Article 20 of Regulation (EC)No 1069/2009 and Regulation (EU) No 142/2011, for the evaluation of an alternative method fortreatment of Category 3 animal by-products (ABP). It consists of the hydrolysis of the material to short-carbon chains, resulting in medium-chain fatty acids that may contain up to 1% hydrolysed protein, foruse in animal feed. A physical process, with ultrafiltration followed by nanofiltration to remove hazards, isalso used. Process efficacy has been evaluated based on the ability of the membrane barriers to retainpotential biological hazards present. Small viruses passing the ultrafiltration membrane will be retained atthe nanofiltration step, which represents a Critical Control Point (CCP) in the process. This step requiresthe Applicant to validate and provide certification for the specific use of the nanofiltration membranesused. Continuous monitoring and membrane integrity tests should be included as control measures in theHACCP plan. The ultrafiltration and nanofiltration techniques are able to remove particles of the size ofvirus, bacteria and parasites from liquids. If used under controlled and appropriate conditions, theprocessing methods proposed should reduce the risk in the end product to a degree which is at leastequivalent to that achieved with the processing standards laid down in the Regulation for Category 3material. The possible presence of small bacterial toxins produced during the fermentation steps cannotbe avoided by the nanofiltration step and this hazard should be controlled by a CCP elsewhere in theprocess. The limitations specified in the current legislation and any future modifications in relation to theend use of the product also apply to this alternative process, and no hydrolysed protein of ruminantorigin (except ruminant hides and skins) can be included in feed for farmed animals or for aquaculture. ; publishedVersion

Abstract The European Parliament requested EFSA to develop a holistic risk assessment of multiple stressors in honey bees. To this end, a systems-based approach that is composed of two core components: a monitoring system and a modelling system are put forward with honey bees taken as a showcase. Key developments in the current scientific opinion (including systematic data collection from sentinel beehives and an agent-based simulation) have the potential to substantially contribute to future development of environmental risk assessments of multiple stressors at larger spatial and temporal scales. For the monitoring, sentinel hives would be placed across representative climatic zones and landscapes in the EU and connected to a platform for data storage and analysis. Data on bee health status, chemical residues and the immediate or broader landscape around the hives would be collected in a harmonised and standardised manner, and would be used to inform stakeholders, and the modelling system, ApisRAM, which simulates as accurately as possible a honey bee colony. ApisRAM would be calibrated and continuously updated with incoming monitoring data and emerging scientific knowledge from research. It will be a supportive tool for beekeeping, farming, research, risk assessment and risk management, and it will benefit the wider society. A societal outlook on the proposed approach is included and this was conducted with targeted social science research with 64 beekeepers from eight EU Member States and with members of the EU Bee Partnership. Gaps and opportunities are identified to further implement the approach. Conclusions and recommendations are made on a way forward, both for the application of the approach and its use in a broader context.