Novel food status of microbial products in the EU

Microbial ingredients are moving fast, and EU market access still hinges on one deceptively simple question: was the product consumed to a significant degree in the EU before 15 May 1997? If the answer is unclear, the product may fall under the EU Novel Food Regulation and require authorisation before it can be placed on the market.

The EU Novel Food Catalogue is often the first reference point. It provides guidance on novelty status for specific foods and ingredients, including microorganisms and fermentation derived products. The Catalogue is helpful for orientation, yet it is not legally binding. The binding list is the Union list of authorised novel foods, set out in the EU Implementing Regulation that establishes the list of novel foods, alongside the authorisations and conditions of use.

This article explains how novelty is assessed for microbial products, and why strain identity, intended use, and evidence of historic consumption decide the outcome.

The EU Novel Food Catalogue provides guidance (and only that, being non-legally binding) on whether specific foods or ingredients, including microbes and fermentation-derived products, were consumed significantly in the EU before 15 May 1997. Below we present key microbial products (bacteria, yeasts, fungi, algae, and their fermentation products) and their novel food status – Novel, Not Novel, or Not Novel (in supplements only) – with justifications and references to EU regulations or opinions. All authorised novel foods in the EU are listed in the Implementing Regulation establishing the list of novel foods.

The basic rule: history of consumption decides novelty

Historic use in the EU before 1997 → Not Novel

Microorganisms or microbial ingredients with a demonstrable history of consumption in the EU before 1997 are typically treated as not novel.

For example, the cheese bacterium Brevibacterium casei and algae like Spirulina were in use pre-1997, so they do not require novel food authorisation. Where the evidence base is strong, products can often proceed without a novel food authorisation, although other regulatory requirements may still apply depending on the product category and claims.

No proven pre-1997 consumption → Novel Food

Microbial species, specific strains, or fermentation derived ingredients without demonstrable significant consumption in the EU before the cut-off date are generally treated as novel foods. In those cases, authorisation is required, including a safety assessment.

A common pattern is that a traditional organism has a history of use, while a new format, isolate, or strain does not.

For instance, the use of fungal mycelium powders from mushrooms not traditionally consumed in that form, such as dehydrated mycelium of Ganoderma lucidum (Reishi), has been classified as novel. While the fruiting bodies of these mushrooms may have a history of use, the isolated mycelium does not and therefore requires a separate evaluation under the Novel Food Regulation. Similarly, Saccharomyces cerevisiae protein and dried yeast fermentate are not considered as novel foods, but iron-enriched yeast is considered a novel food because consumption to a significant degree prior to May 1997 has not been demonstrated.

Supplement only history of use → Conditional

Some microbial ingredients have evidence of use in food supplements before 1997 yet lack evidence for use in conventional foods. In practice, this often leads to a conditional position: not novel for supplements, while novel for other food categories. This distinction becomes crucial when a company expands from supplements into foods such as dairy, beverages, bakery, or ready to eat products. Bacillus clausii and Bacillus subtilis subsp. natto are examples – allowed in supplements, but novel in other foods.

Novel Foods: novel or not, that's the question

Here’s a closer look at some of the most illustrative cases.

Why strain level matters: the Quorn mycoprotein example

Quorn’s mycoprotein illustrates a key point in EU novelty assessments: novelty can be strain specific. In the case of Quorn’s mycoprotein small changes in microbial production shifted a product’s regulatory status.

The original Quorn products are made from the filamentous fungus Fusarium venenatum strain A3/5. This strain was introduced in the UK in the 1980s and had gained significant market presence across the EU by 1997. Because of this established history of consumption, the European Commission does not consider it a novel food.

However, when a new strain of the same species, Fusarium venenatum NRRL 26228, was proposed for use in food, it triggered a different regulatory outcome. Despite being the same species, the new strain had no documented history of consumption in the EU before the 1997 cut-off date. As a result, it was effectively classified as a novel food under Article 3(2)(a)(ii) of Regulation (EU) 2015/2283 (food consisting of, isolated from or produced from microorganisms, fungi or algae). This means it must undergo a full safety assessment and receive authorization before being placed on the market. For companies, the practical takeaway is straightforward: species level familiarity does not automatically transfer to a new strain. Evidence needs to be built around the exact production organism and the exact food use.

Supplement status does not automatically extend to foods

A second recurring issue is the boundary between supplements and foods.

Some microbial products fall into a grey area where they are not considered novel when used in food supplements but would be novel if used in other food categories. This distinction is critical for companies looking to expand the use of their ingredients.

Take Bacillus coagulans (also known as Heyndrickxia coagulans). This bacterium has been used in food supplements in the EU prior to 1997, which exempts it from novel food authorization in that context. However, when a company submitted a consultation to use B. coagulans as an ingredient in fresh greens (like ready-to-eat lettuce), the European Commission concluded that this would constitute a novel food. The reasoning was that natural presence of the bacterium on vegetables does not equate to intentional consumption, and no evidence was provided to show that B. coagulans had been deliberately added to foods before 1997. Therefore, while it remains non-novel in supplements, its use in general foods requires authorisation.

A similar logic has applied to other ingredients that appear in the supplement space, like fungi. Ophiocordyceps sinensis, a parasitic fungus known as “caterpillar fungus,” is not novel when used in food supplements. However, its use in other food forms would be considered novel due to the lack of historical consumption data in those contexts.

Recent consultations: how the EU draws the line for microbes

The 2025 updates to the Novel Food Catalogue and Article 4 consultations brought several microbial products under scrutiny. Recent updates and consultations in the Novel Food Catalogue have reinforced consistent patterns in decision making:

Probiotic candidates without a food use history tend to be treated as novel when significant EU consumption is not demonstrated.
- Streptococcus salivarius was classified as a novel food. The strain in question was not commonly used in food fermentation and lacked a history of consumption in the EU. As such, it must undergo a full safety assessment before it can be marketed.
Traditional dairy cultures, on the other hand, with long standing EU use tend to be treated as not novel.
- Streptococcus thermophilus was confirmed as not novel. This bacterium is a staple in traditional dairy fermentation, especially in yogurt and cheese production. Its long-standing use in the EU food supply made its status clear.
Lactic acid bacteria remain strain and use dependent. Even within familiar genera, a specific strain may still be novel.
- Limosilactobacillus vaginalis BC17 was deemed a novel food. Despite being a lactic acid bacterium, it had no documented food use in the EU prior to 1997. This reflects the broader principle that even familiar genera like Lactobacillus or Bifidobacterium can yield novel foods if the specific strain or application is new.
When the evidence package is solid, the authorisation route is viable .
- Clostridium butyricum TO-A was authorised as a novel food in 2025. EFSA’s scientific opinion concluded that it was safe for use in food supplements at specific daily intake levels for different age groups. This case illustrates how a novel food can gain market access through the proper regulatory channels, provided safety is demonstrated.
Taxonomy also matters in practice. When species names change, continuity of evidence can matter more than the label.
- Lactobacillus paragasseri was identified as a new species name for strains previously classified under L. gasseri. Because L. gasseri had known use in EU supplements pre-1997, the Commission confirmed L. paragasseri is “not novel” for supplement use, essentially treating the species as a continuum with its predecessor.

What this means for product developers

For food businesses and researchers working with microbial ingredients, novelty status determines whether a product can launched directly into commercialisation or needs a novel food strategy first, which can require a lengthy and costly authorisation process.

The most common triggers for a novel food requirement are:

A new strain without documented pre 1997 EU consumption
A shift from supplement use into conventional foods
A new product form where historic consumption evidence does not cover the isolate, fraction, or format
A new fermentation derived ingredient where the history of use is limited or the production process changes key characteristics

A structured novelty assessment early in development often saves time later. If a project enters dossier preparation before novelty is clear, course correction can become expensive.

EU novelty decisions for microbial products rest on documented history of consumption, tied to the exact organism, strain, product form, and intended use. The Novel Food Catalogue helps orient the discussion, while authorisations and conditions of use sit in the Union list. The Quorn case shows why strain identity can decide novelty. Supplement history shows why intended use can decide novelty.

If you are developing a novel probiotic, a fermentation derived ingredient, fungal mycelium, microalgae, or a microbial biomass product, a clear view on novelty status is the first step toward a predictable regulatory path.