ANNEGRET NIELSEN
Analyze&realize GmbH, Berlin, Germany

Abstract

The Nutrition and Health Claims Regulation (NHCR) went into effect on July 2007. Originally intended to end the potential misuse of unregulated health claims on product labels and to bring clarity for the consumer, it has arguably led to a stagnation of innovation in many food product categories.

INTRODUCTION

The implementation of the NHCR has had a tremendous impact on the marketing of food supplements, as the use of health claims has become strictly regulated. Over the years, a lot of the claims that were submitted for innovative ingredients (Art. 13.5 of the NHCR) received a negative opinion from the European Food Safety Authority (EFSA).

Overall the number of refused health claim applications is high, as shown in the table below (Table 1). In the beginning, the low acceptance rate could in part be explained by the fact that the scientific criteria used by EFSA to evaluate the applications were somewhat of a black box. This situation resulted in the publication of various guidance papers (Table 2) intended to assist applicants in designing an EFSA-conforming trial and reporting the study results in an appropriate way. Indeed, it was these guidance papers, together with a number of published health claim opinions, that shed light on the requirements EFSA has for the substantiation of a health claim.

This might be one reason why nowadays more companies are once again willing to invest time and money in order ...