Since 1 January 2018, Regulation (EU) 2015/2283 of the European Parliament and of the Council of 25 November 2015 on novel foods has applied. We provide a first overview of the major changes and new regulations.

The Novel Food Regulation replaces Regulation (EC) No. 258/97 of the European Parliament and of the Council as well as Commission Regulation (EC) No. 1852/2001. With that, after almost 20 years, the European legislator wanted to adjust the regulations on novel foods to the most recent developments in Union law as well as to technological progress. In addition, it was intended to simplify the authorization procedure that has so far been mandatory.

Novel Food

As well as the previous regulations, the new Novel Food Regulation also concerns the placing of novel foods on the market within the European Union. According to the reformed and, in comparison to the previous regulation, more clearly worded definitions, any food that was not used for human consumption to a significant degree within the Union before 15 May 1997, irrespective of the dates of accession of Member States to the Union, and that falls under at least one of the categories listed in the new Novel Food Regulation, shall be novel food. Examples include food consisting of, isolated from or produced from microorganisms, fungi or algae. Practical examples are algae oil (oil from the micro algae ulcenia sp.) as an ingredient for pastries, cooking fats and oils, bar products and beverages, parts of the Stevia rebaudiana Bertoni plant as sweetener or chia seeds. Due to the inclusion of food consisting of animals or animal parts, insects may now also fall within the scope of the Novel Food Regulation.

Authorization of Novel Food and Union List

Placing novel food on the market within the European Union continues to require an authorization procedure. The requirement for the provision of authorization, in particular, is that the food does not pose a safety risk for human health and the consumers are not mislead by the intended use.

Anyone wanting to place a novel food on the market now has to apply directly to the European Commission, which may request an opinion of the European Food Safety Authority. With that, the requirement has been dropped to first file an application in the Member State where the novel food is supposed to be placed on the market for the first time. The associated initial assessment on Member State level is no longer intended.

Contrary to the previous regulation, there will be a general authorization and not, as was the case in the past, applicant-related. Moreover, there is the option to suspend the authorization procedure.

The so-called Union List, in which the European Commission will include all novel food that have been authorized, was also newly introduced. Novel food that have already been authorized will be transferred to the Union List. Only authorized foods mentioned in this list may be placed on the market.

Special Provisions for Traditional Foods from Third Countries

For food from a third country for which safe use has been confirmed there, special provisions apply according to the new Novel Food Regulation. It is required that the food has a history of safe food use in a third country for at least 25 years. For this purpose, it has to be a component of the customary diet of a significant number of people in at least one third country. If this is the case, the notification of the food being placed on the market to the Commission suffices in the first place. Only if the notification procedure was not successful since there are sufficiently justified circumstances that question the safety of the traditional food, an application for an authorization of the food has to be filed.

Assessment and Outlook

Overall, the new Novel Food Regulation significantly goes beyond the previous acts with regard to degree of regulation. An accelerated and simplified authorization procedure has in fact been set up. This applies in particular with regard to the facilitations for traditional foods from third countries. It remains to be seen whether the new definition and the procedures stand the test of practice.

Sandra Fröhlich, Lawyer
Hamburg