Innovative ingredient or Novel Food? What to check before using a new ingredient

New extracts, fermentation products and ingredients with a specific intended function often enter product development accompanied by persuasive application data. Whether they may lawfully be used in the intended food turns on a narrower question: does food law already cover this particular ingredient, in this particular form and for this particular use? Supplier statements and database results are starting points. A defensible release decision requires the identity, manufacture, consumption history, scope of authorisation and target market to be assessed together.

Executive summary:

With innovative ingredients, the status assessment must be completed before the product itself is released. What matters is the precise identity, source, manufacture, composition and intended use of the ingredient. For the EU, the question is whether significant consumption before 15 May 1997 can be documented or whether an authorisation on the Union list covers the material. The Novel Food Status Catalogue is a useful research tool, but it is neither binding nor exhaustive. Even an authorised Novel Food may be used only within the limits of its specifications, food categories, maximum levels, target groups and labelling requirements. Germany and Austria operate under the common EU framework; Switzerland requires a separate assessment of its authorisation and recognition rules. Beyond classification, the commercial decision must establish which defensible regulatory and supply route can take the specific product to market.

Regulatory status is part of an ingredient’s identity

In innovation projects, an ingredient is often described first by its intended role: a protein source, a polyphenol-rich extract, a postbiotic preparation, a fat produced by fermentation, or an ingredient intended to support a particular claim. Such descriptions rarely suffice for regulatory classification. Two ingredients sold under the same trade name may come from different species, plant parts or microorganisms, be manufactured by different processes, and be standardised for different constituents. Those differences can change both their Novel Food classification and the scope of an existing authorisation.

The Novel Food Regulation covers foods that were not used for human consumption to a significant degree within the Union before 15 May 1997 and fall within at least one of its statutory categories. These include, among others, products from microorganisms, fungi or algae, plants or animals, cell or tissue cultures, novel production processes and engineered nanomaterials. A substance with a long history of use can also fall within the Regulation if a new process or a substantial change in composition creates a different food. Certain other categories — including genetically modified foods, additives, flavourings, enzymes and extraction solvents — are excluded from its scope and must be assessed under their own rules. [1]

This leads to a clear sequence for project work. First, define the material being assessed: its taxonomic identity or production strain; the organism or plant part used; the starting material; manufacturing and purification methods; standardisation; carriers; relevant residues; particle characteristics; and specification limits. Then define the intended use, including food category, use level, target population and daily exposure. Only once that object is defined can its consumption history or an authorisation be assessed reliably.

An earlier Food Essentials article on product classification explained how the choice between an ordinary food, a fortified food and a food supplement sets the regulatory parameters for a project. With innovative ingredients, the finished-product category alone is insufficient. Ingredient status and product category interact: a use documented or authorised for food supplements may fall outside that scope when the ingredient is used in a drink, snack or food for a particular group of consumers.

Consumption history is a question of evidence

“On the market for years” does not answer the cut-off-date question. What matters is significant human consumption in the EU before 15 May 1997. Commission guidance identifies the nature and purpose of use, quantities consumed, duration and continuity, geographical spread and number of consumers as relevant factors. Contemporary written records generally carry more weight than later recollections or current marketing statements. [2]

The comparability of the historical food is equally important. Documented consumption of a fruit does not automatically establish consumption of its peel, root or a concentrated extract. Consumption of a whole fermented product does not, without further justification, establish the status of a fraction isolated from it. Different extraction solvents, degrees of enrichment or processing conditions may likewise create a different material for assessment. For microorganisms and fermentation products, the strain, viability, biomass or isolated metabolite, and the way the production organism is handled must be recorded separately.

Supplier dossiers on consumption history often contain market surveys, literature references, invoices or product images. For release, the evidence must show what material was actually sold, in which Member State, in what quantities and in which food category. Evidence of cosmetic, pharmaceutical or feed use does not establish human food consumption. Product listings dating from after the cut-off do not fill the historical gap either. If identity, dates or the extent of use remain unclear, a conclusion of “not novel” goes further than the evidence supports.

The Catalogue, consultation and Union list answer different questions

The European Commission’s Novel Food Status Catalogue brings together information from the Member States and is an important starting point for research. The Commission expressly describes it as non-binding and non-exhaustive. It also notes that food business operators must substantiate the relevant consumption history and that historical consumption documented only for food supplements does not cover new uses in other foods. [3]

A Catalogue entry should therefore be read as a result with a defined scope. The scientific name, organism or plant part, preparation, production process and notes on use all matter. Absence from the Catalogue proves neither novelty nor lawful marketability. A green or positive status for a plant cannot be extended to every extract and enriched fraction without comparing their identities. Conversely, an adverse status entry may be limited to a narrowly described preparation.

If a food business operator remains uncertain after its own assessment, Article 4 of the Novel Food Regulation provides for consultation with the competent authority of the Member State where the food is intended to be placed on the market first. The implementing regulation governing consultation requires a technically adequate description of the food, a justification of the proposed category, available information on status and the relevant evidence of consumption history. The Commission publishes the reasoned outcomes. [4] A consultation request is therefore no substitute for preparatory work; it subjects that work to official scrutiny.

The Union list has a different function. It is the positive list of Novel Foods authorised in the EU. A food listed there may be placed on the market under the conditions specified in its entry. Entries contain specifications and, depending on the case, permitted food categories, maximum levels, specific labelling, restrictions concerning target populations and other requirements. Authorisations are generally generic. During a period of protection for proprietary scientific data, however, use may be restricted to the named applicant. [5]

A supplier’s statement that an ingredient is “EU authorised” must therefore point to a specific entry. The next step is to check whether the supplied material meets the entry’s identity and specifications, whether the proposed product category is included, whether the dose remains within the permitted level, and whether labelling or target-population requirements have been incorporated into the product concept. Where data protection applies, entitlement to use that supply route must also be examined. An authorisation for a comparable ingredient or another manufacturer supports the project only if the entry is genuinely open to use and the specific material falls within its specifications.

A practical example: pomegranate is not pomegranate extract

An Article 4 decision published in 2026 illustrates the limits of a status assessment. It concerned a water–ethanol extract of the whole pomegranate fruit, including seeds and peel, standardised to approximately 40% punicalagin. After consulting the other Member States and the Commission, the competent Finnish authority concluded that the extract was not novel in food supplements. The evidence concerned the use of similar extracts in that product category. It did not substantiate the additional proposed use in other foods; the published status expressly states “not novel in food supplements”. [6] This decision addresses only the Novel Food status of the described extract in food supplements. It neither establishes a health benefit nor assesses whether health-related advertising is permissible.

A company wishing to use the same extract in capsules and in a drink therefore faces two regulatory paths. For the food supplement, it must still determine whether its actual material is comparable to the extract assessed and meets all other applicable food-law requirements. For the drink, it cannot simply carry across a consumption history limited to food supplements. A formulation decision for that use needs its own sound status or authorisation basis.

The example also shows why concentration figures and manufacturing parameters belong in the ingredient dossier. The fact that pomegranates have been consumed as fruit says nothing, by itself, about the composition of an extract standardised for punicalagin or the resulting exposure. The assessment must make that distance between the starting food and the offered ingredient visible.

Supplier evidence must reach the batch level

A useful supplier declaration identifies the regulatory route and explains why it applies to the material being sold. For an ingredient considered not novel, this includes a description of its identity and the evidence supporting its consumption history. For an authorised Novel Food, the specific Union-list entry, conformity with its specifications, permitted uses and, where relevant, entitlement during the data-protection period must be documented. The contract should treat changes in starting material, production strain, process, specifications and production site as events requiring reassessment before release.

A status decision does not replace ingredient qualification. Specifications, certificates of analysis, test methods, contaminant and microbiological risks, allergens, traceability, stability and technical function remain separate release matters. They are particularly important for a Novel Food because the marketed batch must remain within the legally defined identity. A broad internal purchasing specification can be problematic if it permits characteristics outside those of the Union-list entry.

If authorisation is required, a separate development programme begins. EU administrative requirements cover, among other things, a full description of the Novel Food, its manufacturing process, composition data, specifications, proposed uses and anticipated intake. [7] Current EFSA guidance requires a scientifically sound characterisation and safety assessment. Depending on the ingredient, stability, production organisms, nutritional aspects, metabolism, toxicology and allergenicity may be decisive. Since 2021, the transparency rules and pre-notification of commissioned studies must also be built into the plan. [8] The regulatory route thus shapes pilot batches, analytical work, study planning, budgets and launch timing from an early stage.

DACH needs a shared evidence base and separate market decisions

Germany and Austria apply the EU definition, consultation procedure, authorisation process and Union list. In Germany, an Article 4 consultation can be requested from the Federal Office of Consumer Protection and Food Safety. The Federal Institute for Risk Assessment also explains the roles of EFSA’s central safety assessment and the Commission’s authorisation. [9] In Austria, the Federal Ministry of Labour, Social Affairs, Health, Care and Consumer Protection is the competent consultation authority. Austrian government guidance expressly points to the food business operator’s responsibility and the need for supporting status documentation. [10]

Switzerland has its own authorisation system, with broadly comparable cut-off-date and category rules. According to current guidance from the Federal Food Safety and Veterinary Office, Novel Food status must be documented for each product as part of the operator’s self-monitoring obligations. The status of a starting product does not automatically extend to extracts or other derived products. Novel Foods authorised in the EU can generally be marketed in Switzerland under the conditions specified there, whereas an individual Swiss authorisation does not apply in the EU. Special considerations include products derived from genetically modified microorganisms. [11] A shared supplier dossier can therefore provide the factual basis, but EU and Swiss market-release decisions must be documented separately.

Early status assessment protects the commercial decision

An unresolved Novel Food status becomes costly when it surfaces only after formulation optimisation, packaging development or a sales commitment. Regulatory uncertainty then competes with launch plans and investments already made. The status assessment belongs at the beginning of ingredient screening. It can lead to several commercially sensible outcomes: use within a documented food category; selection of material already authorised and compliant with its specifications; a switch to an ingredient with a clearer regulatory route; an initial launch limited to one target market; or a dedicated authorisation project.

Food Essentials’ assessment connects three layers. The status file records why the particular material is treated as not novel, authorised or requiring authorisation. The use file applies that status to product category, dose, target population and labelling. The supplier and batch file confirms that the material actually purchased matches the identity assessed. Together, these provide a defensible basis for formulation, costing, product trials and market release.

Conclusion

For innovative ingredients, the precision with which the material is defined determines the quality of the release decision. An ingredient name, a Catalogue symbol or a general assurance of authorisation is too broad if plant part, strain, process, standardisation, use and target market do not match. Consumption history, an official status decision and an authorisation are distinct legal routes, each with its own scope.

In practice, the assessment pays off before formulation work begins. It prevents technical development and marketing from relying on a supply route that does not support the intended use. It also provides the foundation for the next topic, Product and Supplier Readiness: an innovative ingredient becomes viable for a project only when regulatory status, specifications, data quality, supply capability and change control align.

Food Essentials supports food businesses and ingredient suppliers with structured Novel Food status assessments, comparisons against the Union list and the translation of regulatory conditions into sound development and supplier dossiers.

Where the status of a new extract, fermentation-derived ingredient or ingredient with a specific intended function remains unclear for its proposed use, Food Essentials can identify the gaps that matter before the formulation is fixed, a customer gives approval or the product enters the market.

Wishing you a pleasant Sunday, Andreas Gebhart

References

All sources checked on 11 September 2026.

1. Regulation (EU) 2015/2283, Articles 2–4.
2. European Commission: Human Consumption to a Significant Degree.
3. European Commission: Novel Food Status Catalogue.
4. Implementing Regulation (EU) 2018/456, Articles 3–6 and Annexes I–II and European Commission: published Article 4 consultations.
5. Regulation (EU) 2015/2283, Articles 6–12 and 26–27 and Implementing Regulation (EU) 2017/2470, Annex.
6. Finnish Food Authority: Article 4 decision on pomegranate extract with 40% punicalagin, 26 May 2026.
7. Implementing Regulation (EU) 2017/2469, Articles 3–5 and Annex.
8. EFSA: Novel Food application procedure and scientific guidance.
9. BfR: Novel Foods and German federal portal: Article 4 consultation procedure at the BVL.
10. Austrian Federal Ministry: Novel Foods and AGES: Novel Foods.
11. Swiss Foodstuffs and Utility Articles Ordinance, Articles 15–17, Swiss Ordinance on Novel Foods, Annexes 1–2 and FSVO: Authorisation of Novel Foods.

Note: This article provides technical information and does not constitute legal advice. The specific ingredient, its manufacture and specifications, intended use, target markets and the law in force at the time of the decision remain decisive. Picture: KI-generated.