According to Article 14 of the Regulation (EC)No 178/2002 of the European Parliament and of the Council, food shall not

be placed on the market if it is unsafe. Food shall be deemed to be unsafe if it is considered to be injurious to health. Shortly after the VitroBurgers were put on the market, a series of strange diseases occurred, which seemed to be caused by them, although the connection could not immediately be established. Article 14 further says that if there are no specific community provisions, food should be deemed to be safe when it conforms to the specific provisions of national food law of the member state in whose territory the food is marketed. Article 6 of the Regulation (EC)No 178/2002 says the food law shall be based on risk analysis in order to achieve the general objective of a high level of protection of human health and life. Risk assessment shall be based on the available scientific evidence and undertaken in an independent objective and transparent manner. Risk management shall take into account the results of risk assessment and in particular the opinions of the Authority referred to in Article 22, other factors legitimate to the matter under consideration and the precautionary principle. Article 7 says that in specific circumstances where, following an assessment of available information, the possibility of harmful effects on health is identified but scientific uncertainty persists, provisional risks management measures, necessary to ensure the high level of health protection, chosen in the community may be adopted, pending further scientific information for a more comprehensive risk assessment. According to Article 50, if any member of the network of rapid alert system, which includes member states, the Commission and the Authority, has any information relating to the existence of a serious direct or indirect risk to human health deriving from food, this information shall be immediately notified to the Commission under the rapid alert system. So, in case of VitroBurgers, a member states should notified the commission about the possible risk for human health. Article 53 says that, if it is evident that food is likely to constitute a serious risk to human health and that such risk cannot be contained satisfactorily by means of measures taken by the Member state concerned, the commission shall immediately adapt one or more of the following measures, depending on the gravity of the situation: 1. Suspension of the placing on the market or use of the food in question 2. Laying down special conditions for the food in question 3. Any other appropriate interim measure According to article 55, the Commission shall draw up in close cooperation with the Authority and the Member states a general plan for crisis management in the field of the safety of food (general plan). The

general plan shall specify the types of situation involving direct or indirect risks to human health deriving from food which are not likely to be prevented, eliminated or reduced to an acceptable level by provisions in place or cannot adequately be managed solely by way of the application of Articles 53 and 54. According to Article 19 of the Regulation (EC)No 178/2002, if a food business operator (producer of VitroBurgers) considers or has reason to believe that a food which it has imported, produced, processed, manufactured or distributed is not in compliance with the food safety requirements, it shall immediately initiate procedures to withdraw the food in question from the market where the food has left the immediate control of that food business operator and shall inform the competent authorities thereof. Since the strange diseases that occurred seem to be caused by the VitroBurger it can be considered that a food business operator has reason to believe that a food which it has produced is not in compliance with food safety requirements. So, it is supposed to withdraw the food from the market. Other responsibilities of the food business operator according to article 19 are: Since the product has reached the consumer, the operator shall effectively and accurately inform the consumer of the reasons for its withdrawal and recall from consumers products already supplied to them. A food business operator shall immediately inform the competent authorities if it considers or has reason to believe that a food which it has place on the market may be injurious to human health. Operator shall inform the competent authorities of the action taken to prevent risks for the final consumer and shall not prevent or discourage any person from cooperation with competent authorities where this may prevent, reduce or eliminate a risk arising from a food. Food business operator shall collaborate with competent authorities on actions taken to avoid or reduce risks posed by a food which they have supplied.