The role of the concept of "history of safe use" in the safety assessment of novel foods and novel food ingredients. Opinion of the Senate Commission on Food Safety (SKLM) of the German Research Foundation (DFG).

The Council of the European Union has proposed a revision on the EU regulation on novel foods and novel food ingredients concerning safety assessment of traditional foods from non-EU countries and their introduction onto the EU market. The proposal stipulates that such foods may be placed on the EU market if their history of safe use in the country of origin is appropriately documented. The present statement of the SKLM gives an overview on current discussions on practical implementation of the "history of safe use" concept as well as examples of its application. The SKLM, in principle, agrees with these concepts, underscores, however, in connection with convincing evidence for a "history of safe use" the need for a range of additional information to achieve a comprehensive risk assessment. In the opinion of the SKLM such information must comprise compositional data as well as experience on adverse effects. A list of questions considered essential is presented. The following opinion was adopted on December 23rd 2010.