How to Determine if Your Ingredient Is a Novel Food ?

When a company develops a new ingredient, whether it is a concentrated plant extract, a biotech-derived ferment, a processed algae or a “functional” mushroom, one recurring question always arises: is a Novel Food procedure required before marketing the ingredient within the EU? 

This question often emerges when the project is already well advanced: the formulation is nearly finalized, the marketing identity is ready, the first commercial discussions have started… and suddenly, regulatory uncertainty arises. This can cause a serious slowdown, or even block market entry, if the question has not been addressed early on. 

The reality is that innovation does not take place solely in the laboratory or through marketing arguments. An essential part of success lies in the regulatory qualification of the ingredient, particularly regarding its possible classification as a Novel Food under the criteria defined by the European Union. 

What “Novel Food” Really Means 

The term Novel Food does not imply a risk or a restriction. It refers to a regulatory concept: a Novel Food is simply a food or ingredient that was not consumed to a significant degree before 15 May 1997 by the European population, or that results from an innovative process altering its composition or bioavailability. 

Since safety cannot be justified through long-term, significant consumption, it must instead be demonstrated through toxicological safety studies. 

Therefore, Novel Food status is not a judgment of immediate safety, but rather an invitation to demonstrate safety in an official dossier, evaluated by EFSA and validated at the European level. Being classified as Novel Food does not mean “impossible to market”, but rather “requires prior authorization”. 

A Quick Test to Know if Your Ingredient Falls Within the Novel Food Scope 

Here are a few simple points of attention. If several of these statements apply to your ingredient, a Novel Food status analysis is likely necessary. 

• Your ingredient has not been the subject of documented consumption in Europe before 1997.  

• You use an innovative process that modifies the concentration, structure, or metabolites of the raw material.  

• The ingredient is fermented using a strain or a technique that is not part of Europe’s food tradition.  

• The source comes from a species rarely consumed in the EU (specific microalga, medicinal mushroom, microorganism, cell culture, etc.).  

• The final chemical profile is no longer comparable to the traditional raw material. 

If you identify with one or more of these cases, a regulatory screening is recommended before any commercial communication or product launch. 

Common, and Often Underestimated, Situations 

Many companies believe they fall outside the scope of the Novel Food Regulation because the ingredient exists naturally or is consumed in other parts of the world. However, the reality is quite different. 

example, while curcuminoids extracted from Curcuma longa root and standardized to 95% curcumin are authorized in Europe for use in food supplements, curcumin itself is considered a Novel Food. 

Regulatory Solutions to Confirm the Status of Your Ingredient 

The Novel Food Regulation allows, in cases where an ingredient’s status is unclear, to consult the competent authorities through a formal consultation procedure designed to officially determine the status of an ingredient. 

This procedure gives an EU Member State the responsibility, based on data provided by the applicant, to decide on the ingredient’s classification. It is an optional procedure, with both advantages and disadvantages that should be carefully assessed before submission. 

What Changes When an Ingredient Is a Novel Food 

When an ingredient is considered a Novel Food, the regulatory approach changes. It is no longer simply a matter of verifying compliance with a positive list, but of providing scientific evidence of safety for European consumers under realistic conditions of use (dose, formulation, target population, cumulative exposure, etc.). 

The evaluation covers: 

• The exact composition, including impurities, possible nanoparticles, solvents, or residues 

• Technical specifications (natural variability, stability) 

• Manufacturing processes 

• Dietary exposure of different population groups 

• Available toxicological data 

• The ability to demonstrate absence of risk under intended conditions of use 

The Importance of Anticipation 

The earlier the status is assessed, the more secure the time-to-market will be. Conversely, discovering a potential Novel Food issue once formulations are finalized and commercial partners are engaged can lead to multi-year delays, time needed to compile a dossier, conduct or gather the required studies, submit to the competent authorities, and wait for their evaluation. 

This is why more and more companies are integrating a Novel Food regulatory screening early in the development phase, even before finalizing the product positioning. 

CEHTRA, Supporting You to Decide Quickly and Wisely 

At CEHTRA, we support project leaders, manufacturers, and start-ups during this critical qualification phase. The goal is not only to prepare a dossier later, but to help you make

the right decisions quickly: 

• Verify whether the ingredient falls under the scope of the Novel Food Regulation 

• Identify the elements to be documented (consumption history, equivalence, composition, etc.) 

• Build a realistic and progressive safety assessment strategy 

• Develop a clear, well-argued, and robust dossier in case of official submission 

Our approach aims to secure your innovation without unnecessary obstacles. 

In Conclusion 

Determining whether an ingredient is a Novel Food is not a mere administrative formality, it is a strategic step that defines commercial feasibility, cost anticipation, and credibility with partners. 

The earlier the verification is carried out, the smoother, more controlled, and transparent the innovation path will be, both internally and with investors, clients, and distributors. 

To discuss your specific case or request a Novel Food status assessment, you can contact Marie Liamin, Food Products Market Manager at CEHTRA. 

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