What Is Novel Food in the EU?
Introduction
Finding out if an ingredient is a "novel food" under EU law is one of the most important compliance hurdles for any business making drinks, functional meals, or dietary supplements. If so, you must go through a formal pre-market authorization process with the European Commission and EFSA before you may lawfully market it.
Simply put, a component that was not commonly used in the EU before to May 15, 1997, is referred to as a "novel food." It might be a novel extract, a plant cultivated in a different way, a synthetic substance, or even something that was once thought of as traditional but is now utilized in a different way.
BF-EssE explains in this tutorial how to determine whether your ingredient is unique, how to deal with approvals, and what the consequences are if you make a mistake. We'll also demonstrate how to use a green, blue, and red flag system to evaluate EFSA's recommendations and provide real-world examples such as CBD, NMN, and peptides.
Simply put, a component that was not commonly used in the EU before to May 15, 1997, is referred to as a "novel food." It might be a novel extract, a plant cultivated in a different way, a synthetic substance, or even something that was once thought of as traditional but is now utilized in a different way.
BF-EssE explains in this tutorial how to determine whether your ingredient is unique, how to deal with approvals, and what the consequences are if you make a mistake. We'll also demonstrate how to use a green, blue, and red flag system to evaluate EFSA's recommendations and provide real-world examples such as CBD, NMN, and peptides.
What Counts as Novel Food in the EU?
According to Regulation (EU) 2015/2283, a food or ingredient is considered novel if it was not consumed “significantly” by humans in the EU before May 15, 1997.
But "significantly" doesn't mean just sold — it means widespread, documented consumption. That includes things like:
But "significantly" doesn't mean just sold — it means widespread, documented consumption. That includes things like:
- Not used in any food product
- Used only outside the EU
- Used medicinally or experimentally, but not as food
Examples of Novelty Criteria
An ingredient may be considered novel if it:
An ingredient may be considered novel if it:
- is derived from a new source (e.g., fungi, algae, insects)
- Is produced using a new extraction method (e.g., nanoencapsulation)
- Contains synthetic versions of known compounds
- Is modified to a new molecular structure
- Is fermented, cultured, or bioengineered in a way that didn’t exist pre-1997
Novel Food Flag System: How Risky Is Your Ingredient?
To help navigate uncertainty, use this traffic-light approach:
Novel Food database
How the status looks in EFSA novel-food database
GREEN FLAG — Ingredient is NOT novel
Widely consumed before 1997
Listed in EU Novel Food Catalogue as “not novel”
Already used in approved supplements across the EU
Example:
Widely consumed before 1997
Listed in EU Novel Food Catalogue as “not novel”
Already used in approved supplements across the EU
Example:
- Vitamin B12 (cyanocobalamin)
- Magnesium citrate
BLUE FLAG — Borderline / Inconclusive / On Hold
May not have clear status
Limited documentation before 1997
Depends on form, source, or production method
Example:
May not have clear status
Limited documentation before 1997
Depends on form, source, or production method
Example:
- Algae-based EPA/DHA not on positive list
- Postbiotic blends or heat-killed strains
RED FLAG — Ingredient is Novel
Clearly listed as novel
EFSA has evaluated and marked it as requiring authorisation
Already rejected or blocked in at least one EU country
Example:
Clearly listed as novel
EFSA has evaluated and marked it as requiring authorisation
Already rejected or blocked in at least one EU country
Example:
- CBD (Cannabidiol)
- NMN (Nicotinamide Mononucleotide)
- Synthetic peptides
- 3D-printed protein materials
Do You Need Novel Food Approval?
If you're unsure about your ingredient, follow this simplified pathway:
Was it consumed in the EU before 15 May 1997?
Yes → likely not novel
No → proceed to step 2
Has EFSA evaluated it or is it in the Novel Food Catalogue?
Yes, and marked “Not novel” → you're safe
No clear status → proceed to step 3
Submit an Article 4 Consultation
EU authorities will assess and publish your product’s legal status
If the answer is “novel food,” a full EFSA dossier required
Was it consumed in the EU before 15 May 1997?
Yes → likely not novel
No → proceed to step 2
Has EFSA evaluated it or is it in the Novel Food Catalogue?
Yes, and marked “Not novel” → you're safe
No clear status → proceed to step 3
Submit an Article 4 Consultation
EU authorities will assess and publish your product’s legal status
If the answer is “novel food,” a full EFSA dossier required
What Happens If You Ignore Novel Food Law?
Marketing a novel ingredient without approval can result in:
Product delisting from e-commerce platforms (e.g., Amazon)
Border seizures or customs blockages
Fines from national authorities
Brand credibility damage
This isn’t just a paperwork issue—it’s a market access risk.
Product delisting from e-commerce platforms (e.g., Amazon)
Border seizures or customs blockages
Fines from national authorities
Brand credibility damage
This isn’t just a paperwork issue—it’s a market access risk.
How BF‑EssE Helps Brands Navigate Novel Food Compliance
BF-EssE is more than just a manufacturer under contract.
We assist customers:
Determine whether the ingredients are new or not.
Work closely with national authorities in the EU
Verify that formulas only contain compliant, market-ready components.
We will assist you in evaluating it before you run afoul of regulations, regardless of whether you have doubts about a plant, a fermentation byproduct, or a novel isolate.
We assist customers:
Determine whether the ingredients are new or not.
Work closely with national authorities in the EU
Verify that formulas only contain compliant, market-ready components.
We will assist you in evaluating it before you run afoul of regulations, regardless of whether you have doubts about a plant, a fermentation byproduct, or a novel isolate.
How BF‑Esse Helps You Stay Compliant
Contact BF‑EssE’s regulatory team for tailored support.
Contact BF‑EssE’s regulatory team for tailored support.
What BF-EssE can do for you
BF-EssE can help you with the complete clearance procedure, whether your ingredient is confirmed to be novel or you're developing new extracts, isolates, or biotechnologies.
If your ingredient is confirmed as novel — or you're innovating with new extracts, isolates, or biotechnologies — BF‑EssE can guide you through the entire approval process.
We offer complete technical and regulatory support for:
To make sure your innovative food concept satisfies the highest requirements and has the best chance of being approved, we collaborate with regulatory advisors, food scientists, and EU legal specialists.
We offer complete technical and regulatory support for:
- Scientific dossier preparation (identity, composition, safety, history of use)
- Pre-submission consultations with authorities
- EFSA submission coordination
- Compliance review and reformulation if needed
To make sure your innovative food concept satisfies the highest requirements and has the best chance of being approved, we collaborate with regulatory advisors, food scientists, and EU legal specialists.
We’ve Done It Before: Pine Needle Extract
BF‑EsseE is one of the very few EU-based contract manufacturers to have successfully completed a novel food consultation and health claim submission — starting with Pinus sylvestris (Scots pine).
Read how we made pine extract non-novel and submitted an EU health claim →
When you're ready to take a novel ingredient from concept to compliant market launch, we’re here to support you every step of the way.
Frequently Asked Questions About Novel Food in the EU
A novel food is any food or ingredient that was not significantly consumed in the EU before 15 May 1997, including new sources (e.g., algae, insects), processes (e.g., nanotech), or bioengineered ingredients.
Use the EU Novel Food Catalogue. If it’s listed as “novel,” you must apply for pre-market authorisation before selling it.
Yes. Even if an ingredient is not novel in food, its use in concentrated or isolated forms in supplements may still require assessment. The rules apply to both food and food supplements.
The product may be delisted, seized at customs, or penalized by national food authorities. Platforms like Amazon may also block your listing for non-compliance.
The full process typically takes 9–24 months, including EFSA's scientific review and the European Commission’s decision
Yes. BF‑EssE supports clients with ingredient evaluation, consultation requests, dossier preparation, and submission coordination — from first inquiry to full authorisation.
Useful link list:
- EU Novel Food Catalogue (Search Tool)
- Regulation (EU) 2015/2283 – Novel Foods Framework
- EFSA Novel Food Topic Page
- EFSA Guidance on Novel Food Applications
- Implementing Regulation (EU) 2018/456 – Consultation Procedure (Article 4)
- EFSA’s Register of Questions – Novel Food Applications
- Example: Pinus sylvestris Consultation Outcome (PDF)
Disclaimer
The information provided on this page is for informational purposes only and does not constitute legal or regulatory advice. While BF‑Esse makes every effort to ensure the accuracy of its content based on current EU regulations and EFSA guidelines, businesses are responsible for conducting their own due diligence and consulting with qualified regulatory professionals or competent authorities where appropriate.
The European Commission, EFSA, and national food authorities are the official bodies responsible for determining the novel food status and compliance of any ingredient. Regulatory requirements may evolve, and interpretations can vary by member state.
The European Commission, EFSA, and national food authorities are the official bodies responsible for determining the novel food status and compliance of any ingredient. Regulatory requirements may evolve, and interpretations can vary by member state.