EFSA has responsibility across all EU countries for regulating nutrition and health claims on foods including probiotic and prebiotic products. EFSA is not a decision maker, Seppo Salminen explained. Rather, it is an independent risk assessment and scientific advice authority. The role of EFSA in the scientific substantiation of nutrition and health claims is based on a 2006 European Parliament regulation.7 Prior to the 2006 regulations, claims were regulated through directives, with each member state acting independently.
While the new EU claim regulation addresses free and fair trade of goods, including foods, and promotion of innovation, its most important principle is consumer protection: “Nutrition and health claims on food must be substantiated by scientific evidence.” The regulation creates several new challenges for claim applicants. First, evidence should be collected from a population that is representative of the generally healthy population or from which results can be extrapolated to the general population, which Salminen noted varies even within Europe (e.g., there are significant differences in microbiota composition and activity in individuals from northern versus southern Europe). Second, the evidence must be considered “generally accepted science,” which Salminen noted is a difficult criterion for microbiota research. Finally, scientific assessment of proposed claims must address causality. Salminen referred to the comments of many previous speakers and workshop participants on the issue of causality (i.e., that most of the evidence on diet-microbiome-health relationships is associational, not causal).
Because of these challenges, EFSA issued a guidance document to assist applicants in preparing and presenting their applications for authorization (EFSA, 2011a). The guidance document addresses both format and criteria for substantiation. Salminen noted that it is constantly being reviewed and updated and that EFSA also conducts stakeholder consultations. EFSA also published an additional and more specific guidance document on the scientific requirements for claims on gut health and immunity (EFSA, 2011b). The document summarizes experience from earlier assessments, gives guidance on factors associated with gut health and immunity, summarizes beneficial effects or beneficial implications that have already been considered, attempts to explain why some studies are applicable and others are not, and provides some outcome measures. The guidance is not exhaustive, Salminen warned. That would be impossible. Evaluations are conducted on a case-
6 This section summarizes the presentation of Seppo Salminen.
7 Regulation on Nutrition and Health Claims Made on Foods, EC No. 1924/2006 of the European Parliament and of the Council (December 20, 2006).