Innovation is everywhere – including in the food industry. New ingredients, products, and technologies are emerging at a rapid pace. Think of cell-cultured meat alternatives, microalgae, or CBD oil used in food supplements. However, before such products can be sold within the European Union (EU), they must comply with a comprehensive legal framework. These products fall under the category of “novel foods.”
A novel food is any food or ingredient that was not consumed to a significant degree within the EU before 15 May 1997. This may include:
– Foods with a new or deliberately modified molecular structure;
– Ingredients derived from microorganisms, fungi, algae, mineral sources, plants, or animals;
– Products based on cell or tissue cultures from animals, plants, microorganisms, fungi, or algae;
– Foods produced using innovative manufacturing methods that were not used before 1997;
– Technically produced nanomaterials;
– Vitamins, minerals, or other substances now used in different applications than previously allowed, and foods that were once only used in food supplements.
Certain categories are explicitly excluded from this definition, such as genetically modified foods, food additives, flavourings, and extraction solvents.
The main legal basis is Regulation (EU) 2015/2283, which sets the conditions under which novel foods may be placed on the market. In addition, Implementing Regulation (EU) 2017/2470 establishes the official Union List of authorised novel foods.
Other implementing regulations further define this framework. For instance:
– (EU) 2017/2468 describes the notification procedure for traditional foods from third countries;
– (EU) 2017/2469 outlines the application procedure for novel food authorisation;
– (EU) 2018/456 details the consultation procedure used to determine whether a product qualifies as a “novel food.”
A novel food can only be marketed if it is included in the Union List and complies with the relevant conditions. In the Netherlands, these rules are further elaborated in the Warenwetbesluit nieuwe voedingsmiddelen en genetisch gemodificeerde levensmiddelen (Decree on Novel and Genetically Modified Foods).
Anyone acting in violation of these rules commits an economic offence under the Dutch Economic Offences Act (Wet op de economische delicten – WED). Sanctions may include imprisonment, community service, or substantial fines, as well as product seizure or destruction.
Companies that wish to introduce an innovative food product must first determine whether their product qualifies as a “novel food.”
The first step is to check the product was consumed to a significant extent before 15 May 1997. Evidence may include invoices, literature, packaging, or other documentation. Next, the product’s status can be checked in the Union List or in the European Commission’s Novel Food Catalogue. If listed as a novel food, authorisation is required. Even if it is not listed, the product may still be considered novel, as the catalogue is not exhaustive
If there is uncertainty about a product’s status, the business may consult the Member State where the product will first be placed on the market. In the Netherlands, this assessment is carried out by the Bureau Nieuwe Voedingsmiddelen (part of the Medicines Evaluation Board, CBG). The final decision is made by the Minister of Health, Welfare and Sport (VWS), and the European Commission subsequently publishes the outcome.
If the product is determined to be a novel food, an authorisation procedure must be completed before it can be marketed. There are two possible routes:
1. An authorisation application for a completely new food, resulting in an update to the Union List;
2. A notification procedure for a traditional food from a third country that has been safely consumed for at least 25 years, also resulting in an update to the Union List.
Applications are submitted to the European Commission, which requests a safety assessment from the European Food Safety Authority (EFSA). The EFSA evaluates whether the product is safe for human consumption. After a positive opinion, the product is added to the Union List and can be marketed by anyone, provided all listed conditions are met.
The EFSA regularly issues guidance documents for applicants, explaining both content and evaluation criteria. In its most recent version, the requirements have been significantly tightened. Applicants must now provide a comprehensive technical dossier, including:
– Information about the production process and composition;
– Chemical, nutritional, and microbiological specifications;
– History of use and expected intake;
– Data on absorption, metabolism, toxicology, and potential allergens;
– An assessment of possible health risks and uncertainties.
Each dossier must demonstrate that the novel food is as safe as comparable products already available in the EU.
The food market is changing faster than ever. New technologies offer great opportunities but also entail risks. Therefore, it is essential that innovation in the food industry goes hand in hand with safety, transparency, and thorough assessment.
Anyone who wants to bring an innovative food product to market must understand the applicable rules, the boundaries, and the authorisation process. Only then can innovation thrive without endangering consumers or public health.
While every care has been taken in the preparation of this publication, Customs Knowledge accepts no liability for any errors or omissions, nor for their consequences. This article is not intended as specific advice. Please also refer to the General Terms and Conditions of Customs Knowledge BV.
