What needs to happen for novel food approval?

The Commission recently approved the use of the house cricket as a novel food. The application for this was submitted 3 years ago. Why does this take so much time? To better understand this process, we list the novel food approval process.

The rules for placing novel foods on the market are set out in Regulation (EU) 2015/2283. First, you must determine whether you are actually dealing with a novel food. If this is indeed the case, the authorization procedure can be initiated. The procedure starts by submitting an application to the European Commission. If the Commission deems it necessary, the European Food Safety Authority (EFSA) gives an opinion on the safety of the food product. Once the authorization procedure is complete, the food product is included in the Union list in the Annex to Implementing Regulation (EU) 2017/2470.

Definition of novel food

Novel foods are: foods that were not used for human consumption to a significant degree within the Union before May 15, 1997. However, these foods must fall into one of the categories listed in Article 2(a) of Regulation (EU) 2015/2283. Among others, you can think of foods made from microorganisms, animals, plants, fungi and algae. Examples include "frozen, dried and powdered forms of mealworm" and "pasteurized Akkermansia muciniphila" (bacteria). The first foodstuff involves the larva of the insect species Tenebrio molitor (mealworm). The second foodstuff is produced by a particular strain of bacteria.

Traditional foods from a third country

A distinction is made between "novel food" and "traditional food from a third country. A traditional food from a third country meets the definition of a novel food. However, traditional food from a third country exempts some categories from Article 2(a) of Regulation (EU) 2015/2283. In addition, a traditional food from a third country must have a history of safe food use in a third country. An example of an approved traditional food from a third country is "dried berry pulp" from coffee berries. This food product has a history of safe use in Yemen, Ethiopia and Bolivia.

Conditions of application

The authorisation procedure of a novel food starts with the submission of an application to the European Commission. The application must provide sufficient scientific evidence showing that the food meets the following conditions:

the food does not pose a safety risk to human health;
the intended use of the food is not misleading to the consumer, especially if the food is intended to replace another food and its nutritional value undergoes a significant change;
if the food is intended to replace another food, it does not differ from it to such an extent that its normal consumption is nutritionally disadvantageous to the consumer.

Property rights

The applicant may request to authorize the novel food only on a proprietary basis, protecting the scientific data from the application. During the data protection period, the food product may only be marketed by the applicant. Other producers need permission from the original applicant, or must submit a new application without referring to the protected data.

Review application

The European Commission assesses whether an application for a novel food meets the requirements. If desired, the Commission may ask EFSA to prepare a scientific opinion on the safety of the intended food. The authorization procedure ends with the adoption of an implementing act, adding the novel food to the Union list. Before this implementing act can be adopted, the Commission again requests an opinion. This opinion must this time come from the Standing Committee on Plants, Animals, Food and Feed. Only if the Committee gives a positive opinion, the novel food can be added to the Union list.