The demand for innovative, science-backed supplements is higher than ever – and many of the most exciting ingredients fall under the EU’s “novel food” regulation. If you’re developing new formulations or working with exotic extracts, understanding this framework is essential to stay compliant and bring your products to market without delay. Below, you will find the most important info – from the novel food definition to a list of useful links.
WHAT IS THE NOVEL FOOD DEFINITION?
Novel foods are foods that were not widely consumed by the population in the EU before 15 May 1997, when the first Novel Food Regulation came into force.
They may, for example, include foods that have been produced with new technologies or foods that have traditionally been eaten in countries outside the European Union.
Novel foods must be safe for consumers and therefore require pre-market approval. This means that you cannot just pack and sell such products, but must first obtain the necessary documentation.
WHAT ARE THE EXAMPLES OF NOVEL FOODS?
The EU’s list of authorised novel foods includes a wide variety of ingredients relevant to supplement manufacturing, such as:
- Chia seeds: Now widely used in supplements and foods, chia seeds have been authorized as a novel food in the EU since 2009.
- Some non-traditional berries: Certain berries (such as acai and goji) have been authorized as novel foods, but not all. Authorization depends on the specific berry and its processing method.
- Specific probiotics and postbiotics: Only particular strains or preparations not previously used in EU foods are considered novel and require authorization. For example, some inactivated bacteria (postbiotics) have been authorized, but most probiotics are not classified as novel unless they are new to the EU.
- Heat-treated dairy products fermented with Bacteroides xylanisolvens: This specific product has been authorized as a novel food.
- UV-treated milk and mushrooms: Both have been authorized for enhanced vitamin D content.
- Insect-derived proteins: Several insect proteins, such as yellow mealworm and house cricket powder, are authorized as novel foods and permitted in food supplements.
- Fermented or cultivated mycelium extracts: Some mycelium-based ingredients have been authorized, but the status depends on the species and processing method. Always check the Union list for the specific extract or application.
- Precision-fermented nutrients: Some nutrients produced by precision fermentation (such as certain vitamins and proteins) have been authorized or are under review, but not all are currently permitted. Each ingredient is assessed individually.
Even familiar substances-such as ashwagandha, curcumin, or ginseng-can be considered novel if extracted or processed using new technologies, or if a new part of the plant or a new use is introduced to the EU market.
HOW DOES THE NOVEL FOOD AUTHORISATION WORK?
The placing of a novel food on the EU market must be authorised by the European Commission. Here’s a simple breakdown of how that works:
1. Submit an application with full details
You (or your ingredient supplier) must prepare a comprehensive dossier that includes:
- What the ingredient is (identity and characterization)
- How it’s made (production process)
- What it’s made of (composition and specifications)
- How it will be used (proposed uses and use levels)
- How much people are expected to consume (anticipated intake)
- Why it’s safe (all safety studies, including toxicology, nutrition, allergenicity, and any potential health hazards)
All scientific studies-favorable or unfavorable-must be included, especially if commissioned after March 27, 2021.
2. Application check by the European Commission
The European Commission reviews the application to ensure all required information is present. If anything is missing, the process will not proceed until the dossier is complete.
3. Safety review by EFSA
Once validated, the application goes to the European Food Safety Authority (EFSA), which conducts a scientific risk assessment. They look closely at ingredient quality and composition, how it’s produced, nutritional value, potential health risks or allergens, and whether it’s safe for intended populations.
EFSA may ask for more info if something is unclear, which can delay things. EFSA aims to deliver its opinion within nine months of receiving a valid application, not counting any time taken to provide extra data
4. Final decision and approval
After EFSA gives their opinion, the European Commission drafts a decision. This draft is reviewed by the Standing Committee on Plants, Animals, Food and Feed.
If the Committee gives a positive opinion, the Commission adopts an implementing act, officially adding the ingredient to the Union List of Novel Foods.
The Commission may set specific conditions of use, maximum levels, labeling requirements, or post-market monitoring as needed. Once approved, the novel food can be marketed in the EU under the listed conditions.
Tip: If the ingredient has been safely consumed for at least 25 years outside the EU, you may use a simplified “traditional food” notification procedure. If no safety objections are raised by EU Member States or EFSA, these foods can be authorized more quickly.
DOES YOUT INGREDIENT QUALIFY AS A NOVEL FOOD?
Here’s a quick checklist for supplement brand owners:
- Is the ingredient listed in the EU Novel Food Catalogue?
- Was it consumed in the EU before May 1997 in food or supplements?
- Is the ingredient synthetically produced, fermented, or nano-processed?
- Has it already been authorised, or do you need to apply for approval?
If there’s uncertainty, you should consult with your manufacturer or regulatory expert. An experienced partner can help with navigating authorisation pathways, providing necessary documentation (such as certificates or dossiers), and avoiding hidden delays due to regulatory red flags.
USEFUL RESOURCES
These links might be useful if you are looking for more information:
- EU Novel Food Catalogue
- Union list of novel foods
- Novel food regulation
- Website of the European Commission on novel foods
- Information on e-submission
Updated updated on 27 February 2025