The market for innovative ingredients has never been so dynamic: alternative proteins, biomass derived from fermentation, extracts of exotic plants, edible insects. Behind each launch lies a crucial regulatory question: does the ingredient qualify as a Novel Food ? If so, its introduction to the European market is impossible without prior authorization, the granting of which largely depends on a robust scientific analysis dossier.
This topic is more relevant than ever. The guide to scientific requirements for authorization applications was updated in early 2025, and the EFSA administrative guidelines were revised at the end of 2025. Meanwhile, the list of insects authorized for human consumption continues to expand as the European authority issues favorable opinions. For manufacturers and importers, anticipating the Novel Food process and the associated range of analyses has become a strategic imperative.
YesWeLab supports food, nutraceutical and animal nutrition manufacturers in carrying out the analyses required for this type of case, relying on a network of more than 200 accredited partner laboratories.
Table of Contents
What is a Novel Food?
Novel Food status is defined by Regulation (EU) 2015/2283. A novel food is any foodstuff or ingredient that does not have a significant history of consumption within the European Union before May 15, 1997.This date is the sole reference point for determining an ingredient's status.
The concept of significant consumption history (often abbreviated HoC, for history of consumption) is central. An ingredient consumed in negligible or non-existent quantities before 1997 falls within the scope of Novel Food, regardless of the accession date of the Member States concerned.
A fundamental, and frequently misunderstood, point deserves emphasis: it is never the name of the ingredient that determines its status, but its precise nature. The part of the plant used, the production process, the concentration, and the form (extract, isolate, powder) all come into play. The same plant can be considered non-novel in a traditional form and novel in a concentrated form or one obtained through a novel process. Similarly, an ingredient that is not considered novel in a common food can become a Novel Food when used in isolated form in a food supplement.
Which categories of ingredients are affected?
The regulation covers a wide range of situations. These include, in particular:
- The new ingredients, of which insects are the most emblematic example.
- Foods from new sources, such as omega-3 rich oil extracted from krill.
- New substances used to enrich food, such as plant sterols and stanols.
- Foods produced using new technologies, for example ultraviolet-treated milk or ingredients obtained through precision fermentation.
Several ingredients in high demand today fall under this framework and illustrate the areas of vigilance: cannabinoids, including CBD, are considered Novel Food and cannot be marketed in supplements without prior authorization; nicotinamide mononucleotide (NMN), a star of the longevity market, is also classified as a novel food; and many alternative proteins must be evaluated according to their source and extraction process.
One particular subcategory deserves attention: traditional foods from third countries. These are foodstuffs that have been safely consumed for at least 25 years outside the Union (chia seeds, baobab fruit, certain insects). These products remain legally "new" within the meaning of the regulation, but benefit from a simplified notification procedure, based on proof of this documented safe use.
The authorization procedure: steps, deadlines and challenges
Since January 1, 2018, the authorization of novel foods has followed a centralized procedure. The European Commission is responsible for the final decision and can task the EFSA (European Food Safety Authority) with carrying out the scientific risk assessment. This centralization has simplified the previous system, where each application first had to undergo a national assessment.
EFSA examines each dossier from several perspectives: toxicological safety, nutritional quality, conditions of use, and consumer exposure. When a novel food is intended to replace an existing one, the authority also verifies that its consumption is not nutritionally disadvantageous. A novel food is only included on the Union's list of authorized novel foods if it poses no health risks and does not lead to nutritional imbalances.
For operators, two parameters are crucial:
- The time frame. The complete procedure generally takes between 18 and 36 months, depending on the complexity of the case, the toxicological data available and any requests for additional information from the EFSA (the famous clock stops, which are very frequent).
- The risks of non-compliance. A Novel Food ingredient marketed without authorization is subject to sanctions, product recalls, and customs seizures. Anticipation is therefore an economic as well as a regulatory necessity.
Note that an incentive mechanism exists: when a case is based on proprietary scientific data, this data can benefit from five years of protection, preventing a competitor from using it to obtain a similar authorization.
The analyses necessary for compiling a file
This is where the analytical dimension becomes crucial. The updated guide to scientific requirements has brought the expectations for Novel Foods closer to those applicable to food additives and enzymes: the applicant must compile a safety dossier with a comparable level of analysis. The analyses to be provided vary depending on the type of novel food, but are structured around several main areas.
Characterization and composition
The ingredient's identity must be established unambiguously: detailed composition, nutrient profile, and identification of major and minor constituents. This characterization forms the basis of the dossier, as it determines the interpretation of all safety data.
Purity and contaminants
The purity profile must demonstrate the absence of chemical and microbiological risks. Analyses typically focus on heavy metals, mycotoxins, extraction solvent residues, process contaminants, and microbiological quality. For ingredients of plant or fungal origin, testing for pesticides and natural toxins may also be required.
Stability
Stability data documents the behavior of the ingredient over time and under the intended conditions of use (temperature, humidity, light), as well as its stability in the matrix of the finished product.
Toxicological studies and exposure
The toxicological component is central to the safety assessment. Depending on the nature of the ingredient and its history, it may involve genotoxicity studies, subchronic toxicity studies, and other targeted tests. This is complemented by an estimate of dietary exposure, calculated based on the intended conditions of use and the different population groups. These conditions of use must therefore be clearly defined beforehand.
Special cases depending on the source
- Novel Foods derived from microorganisms (fermentation). The EFSA guide now distinguishes three statuses: biomass (inactive material in the final product),active agent (active microorganism in the final product), and production strain. Genetic characterization of the strain, using sequencing techniques, is becoming a key element of the dossier. For further information, see our article comparing Sanger sequencing and NGS.
- Insects. The assessment must cover the biological, chemical, allergenic and environmental hazards specific to each species and its farming method.
- Protein ingredients. Characterization of the amino acid profile and nutritional quality (notably via PDCAAS) usefully supports the demonstration of nutritional non-inferiority.
Novel Food, food additive or food supplement: do not confuse the categories
A recurring difficulty lies in the blurring of regulatory boundaries. The same ingredient may, depending on its use, fall under the Novel Food Regulation (2015/2283), the Food Additives Regulation (1333/2008), or the Food Supplements Regulation. The classification depends on the actual technological function and the conditions of use. Determining the correct regulatory regime upstream of product development avoids costly reformulations and application rejections. This is one of the first questions to resolve before initiating any analytical program.
Pending the publication of this new standard, the Australian standard AS 5810 and the French standard NF T51-800 are the most commonly used to assess compostability in home composting. The parameters covered by AS 5810 are largely identical to those of EN 13432, with the most notable differences concerning the biodegradation conditions and permitted decomposition times.
The acceptance criteria for home compostable packaging are as follows. Characterization requires a minimum of 50% volatile solids and a heavy metal content not exceeding the specified thresholds, identical to those of EN 13432. Biodegradability requires that at least 90% (by mass) of the material degrades under aerobic conditions within twelve months at 25 ± 5 °C, with tests conducted in accordance with EN 14855. Disintegration requires that after 180 days in a controlled composting environment, at least 90% (by mass) of the material passes through a 2 mm sieve, with any residue being indistinguishable from the compost to the naked eye at a distance of 500 mm. Finally, the resulting compost must not negatively affect plant growth or worm survival. As with industrial testing, each component of the material must meet these requirements in order for the whole to be labeled home compostable.
The behavior of a bio-based material depends closely on its structure and composition: upstream characterization of polymers often allows for better anticipation of the results of compostability tests
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How YesWeLab supports you
Compiling a Novel Food dossier requires a wide range of analyses, often distributed across several specialized laboratories: compositional characterization, contaminant testing, stability studies, strain sequencing, and toxicological studies. Coordinating these services, selecting the appropriate methods for each type of ingredient, and ensuring laboratory accreditation represents a considerable undertaking for internal teams.
As a one-stop shop, YesWeLab centralizes these needs through its digital platform and its network of more than 200 ISO 17025 accredited laboratories. We help you identify the relevant panel of analyses for your project, select the right methods according to the nature of your new food, and manage all your analyses from a single point of entry — in order to secure your file and optimize your time to market.
Are you developing an innovative ingredient and want to assess the analyses required for your Novel Food dossier?
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