This article was originally published on March 7 in Food Navigator.

In the latest in a series of articles drilling down into the European novel food legislative framework, Katia Merten-Lentz, partner at international law firm Keller and Heckman, suggests that changes to novel food rules lay the groundwork for a step-change in innovation.

From the beginning of this year, the new Novel Food Regulation 2015/2283[1] became applicable in all Member States of the European Union. Thanks to this new legislation, food business operators are now equipped with tools facilitating innovation.

The new Regulation significantly differs from its predecessor[2], which was full of restrictions.

Since 1997, the European legislation has always defined a Novel Food based on two cumulative criteria.[3] First, it should be “novel”. This means that the given ingredient was not used for human consumption to a significant degree within the European Union before the introduction of the legislation on the 15th of May 1997. Second, the Novel Food Regulation only applies to those ingredients falling in one of the categories explicitly mentioned by this Regulation.

Although in the new regulation those two criteria remain unchanged, the scope of the regulation has expanded. The number of the categories of novel food covered by the Regulation increased from four to ten. For instance, food of mineral origin, cell culture or nanomaterials shall now be considered as novel food – of course provided that they were not consumed to a significant degree within the EU before 1997.

In addition, some categories have been made more detailed. For instance, the previous Regulation only covered “part of animals”, whereas the updated corresponding category includes “food consisting of, isolated from or produced from animal or their parts”. As a result, whole insects used for human consumption now fall into the scope of the Novel Food rules.

It is crucial to determine whether a food or an ingredient is a Novel Food because that determines whether a pre-market authorisation is required. The responsibility of verifying if the food or an ingredient which is intended to be placed on the market as a novel food relies on food business operators.

It is sometimes thorny to distinguish between what is a novel food and what is not. To help business operators with this sensitive task, the European Commission has made available various tools, such as a guidance on information to be provided to substantiate the “human consumption to a significant degree before 1997 within the EU” of a given food.

Furthermore, the European Commission had issued the “Novel Food catalogue”, which gives information on the history of use of some products, based on information provided by EU Member States. Article 4 of the new Regulation 2015/2283 also introduces a genuine consultation process to determine whether a new ingredient falls within of the scope of the Novel Food regulation.

The consultation process is likely to be detailed by an Implementing Regulation of the Commission[4], which is about to be adopted. In a nutshell, food business operators can consult the Member State where they first intend to market a product when they are uncertain about its status. After consulting (if needed) the other Member States and the Commission, the national authorities of the concerned Member State will assess the status of the specific food.

In the meantime, per article 5 of the new Regulation, the Commission is also able to determine by means of implementing acts, whether a food falls within the definition of novel food, either on its own initiative or upon a request by a Member State. This new competence should avoid multiple national interpretations and ensure European harmonization.

Last, the new consultation process also takes into account the very sensitive issue of data protection. Of interest, the last draft of the implementing regulation, already approved by the Standing Committee on Plants, Animals, Food and Feed, includes the right for applicants to ask for a confidential treatment of certain information submitted as part of their consultation request.

This provision was not included in the first draft, and this “update” is likely to restore the effectiveness of the whole consultation process, by providing a more effective protection to innovative food business operators.