Raw drinking milk (RDM) has a diverse microbial flora which can include pathogens transmissible to humans. The main microbiological hazards associated with RDM from cows, sheep and goats, horses and donkeys and camels were identified using a decision tree approach. This considered evidence of milk-borne infection and the hazard being present in the European Union (EU), the impact of the hazard on human health and whether there was evidence for RDM as an important risk factor in the EU. The main hazards were Campylobacter spp., Salmonella spp., shigatoxin-producing Escherichia coli (STEC), Brucella melitensis, Mycobacterium bovis and tick-borne encephalitis virus, and there are clear links between drinking raw milk and human illness associated with these hazards. A quantitative microbiological risk assessment for these hazards could not be undertaken because country and EU-wide data are limited. Antimicrobial resistance has been reported in several EU countries in some of the main bacterial hazards isolated from raw milk or associated equipment and may be significant for public health. Sale of RDM through vending machines is permitted in some EU countries, although consumers purchasing such milk are usually instructed to boil the milk before consumption, which would eliminate microbiological risks. With respect to internet sales of RDM, there is a need for microbiological, temperature and storage time data to assess the impact of this distribution route. Intrinsic contamination of RDM with pathogens can arise from animals with systemic infection as well as from localised infections such as mastitis. Extrinsic contamination can arise from faecal contamination and from the wider farm environment. It was not possible to rank control options as no single step could be identified which would significantly reduce risk relative to a baseline of expected good practice, although potential for an increase in risk was also noted. Improved risk communication to consumers is recommended. SUMMARYFollowing a request from the European Food Safety Authority (EFSA), the EFSA Panel on Biological Hazards (BIOHAZ) was asked to deliver a scientific opinion on the public health risks related to the consumption of raw drinking milk (RDM). In particular, the BIOHAZ Panel was requested to identify the main microbiological hazards of public health significance that may occur in RDM from different animal species, to assess the public health risk arising from the consumption of RDM, to assess the likelihood of RDM being a significant source of antimicrobial resistant bacteria/resistance genes, to assess the additional risks associated with the sale of RDM through vending machines and via the internet and to identify and rank potential control options to reduce public health risks arising from consumption of RDM.According to European Union (EU) legislation, "raw milk" is defined as milk produced by the secretion of the mammary gland of farmed animals that has not been heated to more than 40 °C or undergone any treatment that has an e...

An alternative method to the HTST treatment (High Temperature Short Time pasteurisation at 72 °C for at least 15 seconds or equivalent pasteurisation effect achieving a negative reaction to a phosphatase test), approved for the treatment of bovine colostrum (Category 3 material), was assessed. The purpose of the alternative method, based on a series of filtration steps, is the production of Colostrinov, a product whose main ingredient is bovine colostrum, to be used for foal nutrition. Since the filtration techniques used are known to eliminate particles of the size of bacteria, fungi and protozoa from liquids, it is reasonable to assume that the microfiltration process reduces these contaminants to a level at least equivalent to the treatment required by the legislation. Owing to their small size, viruses are not retained by the mechanical effect of the filters but they may be retained by physico‐chemical interactions with the surface of the filter, depending on the surface properties of the viruses and those of the filter, as well as on the properties of the surrounding liquid. From the information provided by the applicant, it cannot be concluded whether or not the microfiltration process reduces the relevant viral contaminants to a level at least equivalent to a single HTST treatment as required by the legislation.

Eight tools relevant to risk ranking of biological hazards in food were identified and assessed using two case studies. Differences in their performance were observed, related to the risk metrics, data requirements, ranking approach, model type, model variables and data integration. Quantitative stochastic models are the most reliable for risk ranking. However, this approach needs good characterisation of input parameters. The use of deterministic models that ignore variability may result in risk ranking errors. The ordinal scoring approaches in semi-quantitative models provide ranking with more errors than the deterministic approaches. FDA (Food and Drug Administration)-iRISK was identified as the most appropriate tool for risk ranking of microbiological hazards. The Burden of Communicable Diseases in Europe (BCoDE) toolkit can be used in combination with the outputs from FDA-iRISK or as a top-down tool to rank pathogens. Uncertainty needs to be addressed and communicated to decision makers and stakeholders as one of the outcomes of the risk ranking process. Uncertainty and variability can be represented by means of probability distributions. Techniques such as the NUSAP (numeral, unit, spread, assessment and pedigree) approach can also be used to prioritise factors for sensitivity and scenario analysis or stochastic modelling. Quantitative risk ranking models are preferred over semi-quantitative models. When data and time constraints do not allow quantitative risk ranking, semiquantitative models could be used, but the limitations of these approaches linked to the selection and integration of the ordinal scores should be made explicit. Decision trees should be used only to show how decisions are made about classifying food-pathogen combinations into broad categories. BCoDE and FDA-iRISK, in combination with a network of available predictive microbiology tools, databases and information sources, can form a risk ranking toolbox and be applied based on a "fit for purpose" approach supporting timely and transparent risk ranking. for the support provided to this scientific opinion. Development of a risk ranking toolbox for the EFSA BIOHAZ Panel EFSA Journal 2015;13(1):3939 2 SUMMARY The European Food Safety Authority (EFSA) asked the Panel on Biological Hazards (BIOHAZ) (i) to evaluate the performance and data requirements of the available risk ranking tools; (ii) to investigate methodologies for introducing uncertainty and variability in the risk ranking models; and (iii) to design and develop a risk ranking toolbox for the EFSA BIOHAZ Panel. The BIOHAZ Panel identified eight tools relevant to risk ranking applications of biological hazards in food: decision trees; the United States Food and Drug Administration (US-FDA) risk ranking tool: the pathogen-produce pair attribution risk ranking tool (P 3 ARRT); the EFSA food of non-animal origin risk ranking tool (EFoNAO-RRT); Risk Ranger; microHibro; swift quantitative microbiological risk assessment (sQMRA); FDA-iRISK; and the European Centre for Disease Prevention and...