EU Novel Food Regulation: Which Supplement Ingredients Are Affected?

A US supplement brand approached us with a product containing nicotinamide riboside (NR) — a popular NAD+ precursor with strong US sales. Their question: can they sell it in the EU? The answer was yes, but only under specific conditions, because NR is a Novel Food in the EU. Understanding the Novel Food framework is essential for any brand bringing innovative supplement ingredients to the European market.

What Is the EU Novel Food Regulation?

Regulation (EU) 2015/2283 on novel foods defines a novel food as any food that was not used for human consumption to a significant degree within the EU before 15 May 1997. The regulation applies to foods and food ingredients, including those used in food supplements.

The key date — 15 May 1997 — is the date the original Novel Food Regulation (EC) No 258/97 came into force. Ingredients that were in widespread use in EU food supplements before that date are not novel foods. Ingredients that were not, or that were introduced after that date, may be novel foods requiring authorisation before they can be sold in the EU.

Which Supplement Ingredients Are Novel Foods?

The European Commission maintains a Novel Food Catalogue — a searchable database at ec.europa.eu/food/safety/novel-food/catalogue — that lists the novel food status of specific ingredients. However, the catalogue is not exhaustive, and the novel food status of many ingredients is uncertain.

Confirmed Novel Foods in Supplements

Nicotinamide riboside (NR): Authorised as a Novel Food in 2019. Permitted in food supplements for the general adult population at a maximum of 300 mg/day. Not permitted in supplements for pregnant or breastfeeding women without further assessment.

Cannabidiol (CBD): Novel Food status confirmed by the European Commission in 2019. CBD products require Novel Food authorisation before they can be legally sold in the EU. As of 2026, several CBD applications are under EFSA evaluation, but no CBD product has received full Novel Food authorisation. Products sold before the novel food status was confirmed may continue under transitional measures in some member states.

Astaxanthin (synthetic): Synthetic astaxanthin is a Novel Food. Natural astaxanthin from Haematococcus pluvialis algae has been authorised as a Novel Food.

Lacto-N-neotetraose (LNnT) and 2’-fucosyllactose (2’-FL): Human milk oligosaccharides (HMOs) used in infant formula and supplements. Several have been authorised as Novel Foods.

Chia seeds (Salvia hispanica): Authorised as a Novel Food for use in various food products including supplements.

Noni juice (Morinda citrifolia): Authorised as a Novel Food.

Lutein from Tagetes erecta: Authorised as a Novel Food for use in food supplements.

Phytosterols/phytostanols: Authorised as Novel Foods with specific conditions and maximum levels.

Potentially Novel Ingredients Requiring Assessment

Many ingredients commonly used in US supplements have uncertain novel food status in the EU:

• Certain botanical extracts: Extracts from plants not traditionally consumed in Europe before 1997
• Synthetic versions of naturally occurring compounds: Even if the natural form is permitted, a synthetic version may be novel
• Fermentation-derived ingredients: Ingredients produced through novel fermentation processes
• Nano-formulations: Nano-forms of otherwise permitted ingredients may be novel

How to Determine If Your Ingredient Is a Novel Food

The process for determining novel food status:

1. Check the Novel Food Catalogue: Search the European Commission’s Novel Food Catalogue for your ingredient. If it’s listed as authorised, check the conditions of use. If it’s listed as novel (not authorised), you need authorisation.

2. Check the history of consumption: If your ingredient is not in the catalogue, assess whether it was consumed to a significant degree in the EU before 15 May 1997. This requires evidence — historical records, literature, traditional use documentation.

3. Consult EFSA or a national authority: For uncertain cases, you can request a consultation with EFSA or the competent authority of an EU member state (in France, ANSES) to clarify the novel food status.

4. Submit a history of safe use notification: If you believe your ingredient has a history of safe use as a food in a third country (not the EU), you may be eligible for a simplified notification procedure rather than a full authorisation.

How to Get Novel Food Authorisation

The Novel Food authorisation process under Regulation (EU) 2015/2283:

Step 1: Pre-Submission Consultation

Before submitting a formal application, it is strongly recommended to consult with EFSA or a national competent authority. EFSA offers pre-submission meetings to discuss the application dossier and identify any gaps in the evidence package.

Step 2: Application Submission

The application is submitted to the European Commission through a dedicated online system. The application dossier must include:

• Administrative information (applicant details, description of the novel food)
• Scientific data demonstrating safety:
  • Characterisation of the novel food (composition, physical and chemical properties)
  • History of use (if applicable)
  • Proposed conditions of use and labelling requirements
  • Toxicological data (acute toxicity, sub-chronic toxicity, genotoxicity, reproductive toxicity, allergenicity)
  • Nutritional information
  • Proposed analytical methods for detection and identification

Step 3: EFSA Safety Assessment

EFSA evaluates the application and issues a scientific opinion on the safety of the novel food. The evaluation typically takes 9 months for applications with complete data packages. Applications with data gaps receive requests for supplementary information, which extend the timeline.

Step 4: Commission Authorisation

If EFSA’s opinion is positive, the European Commission adds the novel food to the EU list of authorised novel foods through an implementing regulation. This step typically takes 6 to 12 months after the EFSA opinion.

Total timeline: 18 to 36 months for a complete application with no data gaps. Applications with data gaps or complex safety questions can take 3 to 5 years.

Cost: Preparing a complete Novel Food application dossier typically costs €50,000 to €200,000 in consultant and testing fees, plus EFSA’s assessment fee.

The Simplified Notification for Traditional Foods from Third Countries

For foods with a documented history of safe use as food in a third country (outside the EU), a simplified notification procedure is available. This procedure is faster (approximately 18 months) and less costly than full authorisation, but it requires:

• Documentation of the history of safe use in the third country (at least 25 years of use as part of the customary diet of a significant number of people)
• No safety concerns raised by EU member states or EFSA

This procedure is particularly relevant for traditional foods from Asian, African, or South American countries that are being introduced to the EU market for the first time.

Practical Implications for Supplement Brands

For supplement brands entering the EU market, the Novel Food framework requires:

1. Ingredient audit: Review every ingredient in your formulation against the Novel Food Catalogue and assess novel food status
2. Authorisation check: For ingredients with Novel Food status, verify they are authorised and check the conditions of use (maximum levels, permitted product categories, labelling requirements)
3. Reformulation or authorisation: For ingredients that are novel and not yet authorised, either reformulate to remove the ingredient or pursue Novel Food authorisation
4. Monitoring: Novel food status changes — new ingredients are added to the authorised list, and new ingredients are identified as novel. Establish a monitoring programme.

At Care Europe, we conduct Novel Food status assessments for supplement brands entering the EU market and support Novel Food authorisation applications. Contact us at [email protected].