MNF REPORT 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) à Karl-Heinz Engel, Rudi F. Vogel, Dietrich Knorr, Michael Habermeyer, Barbara Kochte-Clemens and Gerhard Eisenbrand Department of Food Chemistry and Toxicology, University of Kaiserslautern, Kaiserslautern, Germany Received: March 23, 2011 Revised: March 23, 2011 Accepted: March 29, 2011 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. Keywords: Food safety / History of safe use / Novel foods / Qualified presumption of safety / Safety assessment 1 Introduction The proposed revision of the EU regulation on novel foods and novel food ingredients [1] [available at: www.eur- oparl.europa.eu/sides/getDoc.do?type 5 TA&language 5 EN &reference 5 P6-TA-2009-0171] foresees that traditional foods from third countries may be placed on the Commu- nity market under conditions that correspond to those for which the history of safe use has been demonstrated if they are included in the list of traditional foods from third countries. As regards the safety assessment and manage- ment of traditional foods from third countries, their history of safe food use in the third country of origin should be à The Senate Commission on Food Safety (SKLM) of the Deutsche Forschungsgemeinschaft (DFG) advises authorities and the government on the safety for health of foodstuffs. For further information on the SKLM activity profile, see Eisenbrand, G., The DFG-Senate Commission on Food Safety (SKLM). Mol. Nutr. Food Res. 2005, 49, 285–288. Further detailed information on the work of the DFG-Senate Commission on Food Safety can be obtained from Professor Dr. Gerhard Eisenbrand, Food Chemistry and Toxicology, University of Kaiserslautern or by the Scientific Office of the SKLM: S. Guth and M. Habermeyer, e-mail: sklm@rhrk.uni-kl.de and also by Dr. A. Krawisch, DFG-administrative headquarters, e-mail: sklm@dfg.de. Abbreviations: ACNFP, Advisory Committee on Novel Foods and Processes; EFSA, European Food Safety Authority; NNT, Nordic Working Group on Food Toxicology and Risk Evaluation QPS, qualified presumption of safety Correspondence: Professor Gerhard Eisenbrand, University of Kaiserslautern, Dept. of Chemistry, Food Chemistry and Toxi- cology, Erwin-Schroedinger-StraXe 52, D-67663 Kaiserslautern, Germany E-mail: sklm@rhrk.uni-kl.de Fax: 149-631-205-4005 & 2011 WILEY-VCH Verlag GmbH & Co. KGaA, Weinheim www.mnf-journal.com Mol. Nutr. Food Res. 2011, 55, 957–963 957 DOI 10.1002/mnfr.201100206