In order to update the legislation regarding novel food which has been in place for almost 20 years, the European Parliament adopted on November 16, 2015 a new regulation 2015/2283 in order to respond to the food industry’s wish for more unified decisions across Europe and fewer regulatory hurdles blocking innovation. The Regulation will come into force from January 1, 2018.
“Novel food” is defined as any food product which was not generally consumed in the European Union before 1997 (date of the first European legislation on this subject) or innovative food developed using new technologies.
Until now, substantial funding and patience was required when embarking on the long and expensive national procedure for the authorization to commercialize novel food. Only 90 novel foods were authorized between 1997 and 2014.
With this new Regulation, applicants will be able to avoid screenings by national authorities. For French companies, this will avoid having to seek the approval of the French Directorate General for Competition, Consumer Affairs and Repression of Fraud (DGCCRF) and the French National Agency for Sanitary Safety of Food, Environment and Labor (ANSES ). Applicants will be able to present their application, with supporting scientific evidence, directly to the European Commission which will then consult the European Food Safety Administration (EFSA), which is responsible for assessing the risks of novel foods. While the cost of an approval process will certainly remain substantial, processing requests should now, according to the European Commission, take no longer than 18 months (compared to a 3 year average before). Novel foods may not be approved for placing on the European Union market unless they present no public health risks and, if they are intended to replace another food, differ from that food in a way that would not be nutritionally disadvantageous for the consumer.
Any Member State may, however, provisionally suspend or restrict the marketing and sale of a novel food if that State took the view that it presents a health risk. In this case, the Member State’s authorities must inform the European Commission which will then conduct an investigation.
The Regulation also includes provisions on data protection. Once a novel food is authorized, the most recent scientific evidence or proprietary data which were provided with the application may not be used by any competitor for the needs of a separate application for 5 years. These provisions help protect the interests of the applicants that develop these products and should encourage real innovation in the food sector.