* This record is given in both English and Spanish. Regulation (EC) No. 853/2004, laying down specific hygiene rules for food of animal origin, allows placing on the market raw milk for direct human consumption. Moreover, it determines that the Member States of the European Union can regulate by means of specific rules, prohibit or limit the placing on the market of raw milk intended for direct human consumption. The current situation in Spain allows placing on the market raw milk without any additional requirements to the aforementioned Regulation. Despite being authorised, in terms of risk assessment, the scientific reports of the European Food Safety Authority (EFSA, 2015), and the AESAN Scientific Committee (AESAN, 2015) show that the consumption of raw milk involve a risk to the health of consumers. AESAN (Spanish Agency for Food Safety and Nutrition) requests its Scientific Committee to prepare a report assessing whether the risk management measures related to raw milk intended for direct human consumption, are adequate to provide a high level of consumer protection. Or if, alternatively, it is necessary to prohibit the placing on the market of raw milk intended for direct human consumption in Spain. These proposals will be incorporated into the draft Royal Decree regulating certain conditions for applying the provisions of the European Union in the area of production hygiene and marketing of foodstuffs and regulating activities excluded from its scope. The proposed risk management measures related to raw milk intended for direct human consumption (microbiological criteria, mandatory packaging of milk and indicating on the label: “Raw milk not heat-treated: boil before consumption” and “Store in refrigeration between 1 and 4 oC”) may be considered, provided all of them are met, adequate to provide a high level of protection to consumers of this product. The evaluation of the growth kinetics of the pathogens considered at 4, 6 and 7 oC based on bibliographic data show that with the predicted latency period, in the most unfavourable case, growth would be lower than authorised levels (taking Listeria monocytogenes as the reference microorganism). It is therefore recommended that the shelf life is set at 3 days. There are numerous microbiological risks that may be present in raw milk, so raw milk is considered a dangerous food for the health of the consumer if the established criteria are not strictly fulfilled, especially refrigeration and boiling process, before consumption. It is also recommended the inclusion of a warning to avoid that the consumption of raw milk without following the required measures poses a health risk.

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