Microalgae to market: Regulatory essentials for food innovators

Microalgae are gaining ground as sustainable and functional ingredients. To reach the market, developers must meet demanding safety and compliance expectations. This overview focuses on the European Union pathway with a brief comparison to the United States. It highlights real regulatory cases and the core data that authorities expect today.

Microalgae: traditional use versus novel status

A few microalgae, such as Spirulina and Chlorella, have a history of safe use in Europe and are not considered novel under the Novel Food Regulation (EU) 2015/2283 when used in traditional forms. Most other species are novel and require authorisation before placement on the EU market. The Union List of authorised novel foods contains several microalgae and microalgae-derived ingredients, but each new ingredient must pass a full safety assessment.

A few microalgae, like Spirulina and Chlorella, have a history of safe use and are not considered novel foods in the EU. Most other species are novel and require authorisation under Regulation (EU) 2015/2283. Each new ingredient must pass scientific scrutiny before reaching consumers.

Microalgae are microscopic, mostly single-celled organisms found in freshwater or seawater. They can be cultivated to produce nutritious biomass or high-value extracts. While Spirulina and Chlorella are well-known as supplements, microalgae are increasingly used in mainstream foods, such as powders in snacks, natural colourants, and fermentation-derived oils rich in omega-3s.

Regulatory pathways in brief: EU and US

European Union

In the EU, any microalgae not widely consumed before May 1997 is considered a novel food and must be authorised under the Novel Food Regulation. The Union List of authorised novel foods now includes several microalgae-based ingredients. Since 2018, the regulatory process has become more demanding, with a strong emphasis on scientific evidence and safety data.

United States

In the US, there is no direct equivalent to the EU’s novel food regulation. Instead, companies rely on the GRAS (Generally Recognized as Safe) notification process or food additive petitions. A history of safe use can help, but new ingredients must still be supported by robust safety and manufacturing data. The Food and Drug Administration (FDA) reviews GRAS notices and may issue a “no questions” letter or may cease to evaluate if information is insufficient.

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Case studies: successes and setbacks

Euglena gracilis is a standout example of a successful EU application. In 2020, EFSA gave a positive opinion for dried Euglena powder for use in foods such as bakery products, drinks, and supplements. The application was supported by comprehensive genomic identification and toxicological studies, despite the fact that Euglena gained EFSA’s QPS (Qualified Presumption of Safety) status in 2019. The company demonstrated that the final product contained no viable cells and had a clean safety profile, including a 90-day rat study showing no adverse effects even at high doses.

Schizochytrium sp. is another success story, especially since Schizochytrium limacinum (now Aurantiochytrium limacinum) gained QPS status. This marine microalga is used to produce DHA-rich oils, which are now authorised for use in foods including infant formula. Each new strain or production process has required its own safety assessment. For example, a recent approval involved demonstrating the taxonomic identity of the strain, that the final oil contained no live algal cells and that its composition was consistent and free from contaminants, and these data were granted data protection according to Article 26 of the Regulation (EU) 2015/2283 on novel foods

Haematococcus pluvialis (now Haematococcus lacustris, QPS-listed species) is best known for its astaxanthin pigment. Extracts have been authorised as novel foods. The regulatory focus has been on ensuring the absence of unwanted contaminants and verifying that the ingredient is safe at proposed use levels.

Not all applications succeed and not all microalgae gain QPS status.

Phaeodactylum tricornutum, a marine diatom rich in omega-3 EPA, faced a setback in 2023 when EFSA rejected an application for a supplement extract. The panel cited incomplete characterisation of the extract, concerns about potential toxins (such as pheophorbide A), and adverse effects observed in animal studies. This case highlights that microalgae can pose risks if not thoroughly characterised and tested.

Galdieria sulphuraria is under EFSA review as a high-protein, blue-pigmented alga. Its approval could open the door for more innovative microalgae foods. Meanwhile, Chlamydomonas reinhardtii is being developed for plant-based meat applications, but EFSA could not establish safety. Dried biomass of C. reinhardtii received an FDA “no questions” letter in 2019 for certain uses. A later notice was not pursued to completion, and the FDA issued a cease-to-evaluate letter. Safety expectations may differ between jurisdictions and the quality of applications and data are crucial for success.

For a broader context across algal taxa, see our article Algae in the food chain. It summarises the Netherlands Commission on Genetic Modification COGEM’s large-scale taxonomy and risk classification work, explains the red/green/grey categories, and outlines why strain identity and conditions of use drive safety assessments, with links to the underlying reports.

Key safety data: what regulators expect

Whether in the EU or the US, authorities expect a coherent data package that links identity, manufacturing, composition, exposure and toxicological data to a clear safety conclusion.

Identity

Unambiguous taxonomic identification supported by whole genome sequencing where appropriate
The absence of genes of concern, including production of antimicrobials
Evidence that no viable microalgal cells remain the product where relevant

Production process

Detailed description of cultivation and processing, including controls to prevent contamination
Techniques used to remove/inactivate viable cells during downstream processing

Compositional data

Using validated methods and addressing compositional variability
Impurities, residues, contaminants, proximate analyses, nutritionally relevant constituents

Stability and specifications

To assure compositional integrity and safety
Chemical, physiochemical, nutritional and microbiological parameters

History of use

A comprehensive literature review

Proposed uses and intake

Proposed food categories, use levels, and population groups
Dietary exposure estimates

ADME and Toxicology

Tiered approach
In vitro studies and literature evaluation where sufficient
Allergenicity considerations where proteins are present

QPS

QPS recommendations can streamline assessment
QPS does not remove the need to characterise the final ingredient, its composition, and its intended uses
Novel microalgae require a full data package

How Biosafe supports microalgae dossiers

Biosafe helps innovators build compliant data packages and manage submissions. We operate as an extension of your R&D and regulatory team from early feasibility through authorisation.

In-house and partner services aligned with EFSA and FDA expectations

Service	Regulatory purpose
Whole genome sequencing and bioinformatics	Taxonomic identification and screening for genes of concern and allergenicity
Absence of viable cells testing	Required for biomasses and non-QPS species, QPS-species with qualification “for production purposed only”, and GM production strains
Antimicrobial activity testing	Confirms absence of antimicrobial compounds when relevant
Toxicology study design and coordination	OECD-compliant studies and weight-of-evidence reviews
Dossier preparation and submission	EU novel food, food enzymes and feed additives, FDA GRAS and NDI
Post-submission support	Handling authority questions and updates to the dossier

Microalgae offer real opportunities for nutrition and sustainability. Market access depends on rigorous identity, process control, composition, contaminant assessment, exposure estimates, and a fit-for-purpose toxicology strategy. Recent EU and US cases show that well-characterised ingredients with complete data can succeed, while gaps in characterisation or safety reasoning can delay or halt progress.

If you are planning a microalgae ingredient or formulation, involve regulatory support early. Biosafe can help you prioritise studies, avoid common pitfalls, and assemble a dossier that aligns with EFSA and FDA expectations.