STEFFI DUDEK 
analyze & realize GmbH, Berlin, Germany

Abstract

The new Novel Food Regulation (EU) 2015/2283 that entered into force on January 1, 2018 will hopefully ease the route to market for many food business operators. Although the requirements for applicants are strict, hopes are high that the application procedure will take less time to an authorization than before. A Union List of authorized food ingredients was established that contains the foods and food ingredients that were authorized under Article 4 of (EC) 258/97 or that were substantially equivalent according to Article 5 and that will be amended by authorizations and notifications under the new regulation. All authorizations will be generic unless the applicant requested data protection. A simplified procedure is expected to facilitate easier market access for traditional foods from countries outside the EU.

INTRODUCTION

Foods and food ingredients that have not been consumed in the EU to a significant extent prior to May 15, 1997 face the risk to be considered ‘novel foods’ and to require a pre-market authorization. Being classified as novel food was often perceived as the ultimate showstopper for the introduction of innovative ingredients to the EU market. The authorization procedure for novel foods, according to Regulation (EC) 258/97, was complicated, not very transparent, led to an unnecessary bureaucratic burden for manufacturers and authorities alike, and did not sufficiently accommodate the technological progress that took place in the food industry during the last two decades. Thus, a revision was overdue. 

As of January 1, 2018, the new Novel Food Regulation (EU) 2015/2283 (NFR) entered into force, with the aim to facilitate the entry of new and innovative foods into the EU market while maintaining a high level of food safety for European consumers. Under this new regulation, the responsibilities of food business operators (FBO) are strengthened, a centralized assessment and authorization procedure repea ...