Novel Food application: understanding EU regulation and securing market access
BY TOXI PLAN YOUR REGULATION EXPERT
The market for innovative food ingredients and dietary supplements is expanding rapidly: new plant extracts, precision fermentation proteins and biotechnology-derived compounds.
However, every innovation quickly faces a key regulatory question:
👉🏼 Is this ingredient a Novel Food?
If the answer is yes, companies must submit a Novel Food application before the ingredient can legally be placed on the European market.
Understanding how to prepare a Novel Food application early in development is essential to avoid regulatory delays and costly reformulations.
The regulatory framework for Novel Food in Europe
The Novel Food regulation is defined by Regulation (EU) 2015/2283.
An ingredient is considered a Novel Food if it “was not consumed to a significant degree in the European Union before 15 May 1997.” This date is the regulatory reference point used to determine whether a Novel Food application is required.
If an ingredient falls under the Novel Food category, it must obtain EU authorisation before being marketed.
1. What can make an ingredient a Novel Food?
Several criteria can lead to classifying an ingredient as a Novel Food, and these criteria are also crucial in the analysis of Novel Food status.
a new plant, algae, fungus or microorganism
a different part of a plant (leaf, root, seed, bark)
a different chemical form
an innovative production process such as fermentation or biotechnology
a higher concentration of active compounds
a new species or microbial strain
lack of documented consumption in the EU before 1997
- CBD extracts
- highly concentrated botanical extracts
- precision fermentation proteins
- collagen from new sources
- non-traditional algae
- edible insects
- new fungi or yeast strains
- authorised vitamins and minerals
- traditionally consumed plants
- common herbs and spices
- ingredients widely consumed in Europe before 1997
⚠️ One essential point is that the ingredient name alone does not determine its Novel Food status. Authorities assess the plant part used, the manufacturing process as well as the concentration of compounds and evidence of historical consumption. As a result, the same plant can be non-Novel Food in its traditional form, or Novel Food when produced as a concentrated extract.
2. The Novel Food authorisation process
1. Determining Novel Food status
The first step is assessing whether the ingredient qualifies as Novel Food.
This includes:
- analysing ingredient composition
- reviewing scientific literature
- identifying evidence of consumption before 1997
- comparing manufacturing processes
documenting historical use.
👉🏼 If sufficient evidence cannot be demonstrated, then a Novel Food application becomes necessary.
2. Preparing the Novel Food application
The Novel Food application is a comprehensive scientific submission,ubmitted through the European Commission portal, and including:
- detailed description of the ingredient
- full manufacturing process
- qualitative and quantitative composition
- specifications
- stability data
- proposed conditions of use
- nutritional data
- toxicological data
- ADME studies when required.
3. Scientific evaluation by EFSA
The application is evaluated by the European Food Safety Authority (EFSA).
EFSA reviews:
- ingredient characterisation
- toxicological safety
- consumer exposure
- target populations
- safety margins.
Requests for additional data are common during this phase.
4. Authorisation decision
Based on EFSA’s scientific opinion:
the European Commission makes the final decision
the ingredient may be added to the Union list of authorised Novel Foods
specific conditions of use may apply.
Without approval, the ingredient cannot be marketed in the EU!
3. The role of the toxicologist at each step
The toxicologist is involved throughout the entire process.
In a Novel Food application, safety assessment is the central element, as it is required to obtain marketing authorization in the European Union. The involvement of a toxicologist is therefore essential to analyze the scientific data, define the assessment strategy, and demonstrate the ingredient’s safety to the authorities. At Toxi Plan, this expertise supports companies at every stage of the Novel Food process to ensure a strong regulatory dossier and maximize the chances of authorization. (Discover our services)
Determining Novel Food status
- Process and composition analysis
- Exposure level assessment
- Comparison with historical uses
- Scientific support for decision-making: Novel/non-Novel
Preparing the Novel Food application
- Definition of the toxicological strategy
- Identification of necessary data
- Interpretation of existing studies
- Choice of required or unnecessary tests
- Scientific justification of hypotheses
During EFSA evaluation
- calculating safety margins
- supporting exposure assessments
- responding to EFSA questions
- analysing additional data requests.
After authorisation
- supporting companies using the ingredient
- defining safe conditions of use
- ensuring consistency with labelling and claims
- integrating the ingredient into finished product assessments.
4. Why toxicological expertise is essential?
A successful Novel Food application relies on a robust safety demonstration. As much as an accurate exposure assessment and a strong scientific justification.
Without toxicological expertise:
- applications may be incomplete
- data may be poorly interpreted
- EFSA questions increase
- timelines become longer
- the risk of rejection rises significantly.
Toxicologists help transform innovative ingredients into regulatory-compliant food ingredients.
Un ingrédient innovant ne peut être commercialisé en Europe qu’après avoir démontré scientifiquement sa sécurité dans le cadre de la réglementation Novel Food.
FAQ – Novel Food
What is the difference between a Novel Food and a food supplement?
A Novel Food refers to a new ingredient requiring regulatory approval.
A food supplement is a product category intended to complement the diet. A supplement may contain a Novel Food ingredient only if it has been authorised.
How long does a Novel Food authorisation take in Europe?
Obtaining authorisation typically takes 18 to 36 months, depending on the complexity of the Novel Food applicationand the number of additional questions from the European Food Safety Authority.
Can a Novel Food be sold without authorisation in the EU?
No. Any ingredient classified as Novel Food must be authorised before being placed on the EU market. Selling unauthorised Novel Food ingredients can lead to regulatory sanctions and product withdrawals.
What is the difference between a Novel Food and a food supplement?
A Novel Food refers to a new ingredient requiring regulatory approval.
A food supplement is a product category intended to complement the diet. A supplement may contain a Novel Food ingredient only if it has been authorised.
Need an evaluation of a Novel Food dossier?
Toxi Plan supports you in regulatory compliance and securing your products. Contact our experts to anticipate regulatory requirements.
Novel Food regulation is not simply an administrative constraint. It is a structured regulatory framework designed to ensure that food innovation remains safe for consumers.
Understanding the Novel Food application process, anticipating regulatory expectations and working with experienced toxicology experts are essential to:
- secure investment
- control development timelines
- gain sustainable access to the European market.
Disclaimer:
The information provided in this article is for informational and educational purposes only. It does not constitute legal advice nor a personalized regulatory consultation. Despite the care taken in drafting this article and verifying its sources, regulations evolve regularly and may be subject to differing interpretations depending on the specific context of each company, product, or market.
Toxi Plan®, its directors, and its employees shall not be held liable for any use made of the information contained in this article without further analysis tailored to a specific situation. Any regulatory or strategic decision should be based on a specific assessment carried out by a qualified professional, with due regard to the applicable regulations, including any provisions or regulatory practices entering into force after the date of publication.