As the world leans toward sustainable and functional foods, mycoproteins—proteins derived from fungi—are emerging as major contenders. Known for their environmental benefits and nutrient profiles, these fungi-based proteins are increasingly being utilized in food products, from plant-based meats to dairy alternatives. However, mycoproteins occupy a complex regulatory landscape. Here’s a breakdown of key legal considerations for companies aiming to bring these products to market, from food law expert insights to specific international regulatory precedents.
Image courtesy: Enifer
Navigating the Regulatory Landscape for Fungi Ingredients
Not all fungi are equally recognized in food regulation. In fact, only a handful of fungal species have the green light for human consumption across various regions. While fungi like Neurospora crassa and Fusarium venenatum (used in products like Rhiza and Quorn) are authorized, newer strains face a longer path to approval. Regulatory distinctions arise due to fungi's diverse applications, which include uses as food additives, dietary supplements, and technological aids. Companies exploring mycoproteins must align their products within these classifications and understand which applications necessitate pre-market approval.
1. Understand Nomenclature and Classification
Fungi-derived products face distinct regulations depending on their intended use, especially in jurisdictions where pre-market approval is mandatory for novel foods, such as the U.S., European Union, and Singapore. For example, both Nature’s Fynd and The Protein Brewery submitted extensive dossiers for pre-market approval across multiple markets. Mycoprotein products are frequently classified as “novel foods” under EU and U.S. regulations, meaning they require rigorous assessment to validate safety and nutritional claims before they can reach consumers.
The European Union’s Novel Food Regulation (EU) 2015/2283 sets particularly stringent standards for these approvals. Applicants must provide comprehensive safety assessments, including studies on the strain's genetic stability and allergenic potential, which requires extensive resources and time. In the U.S., the FDA’s GRAS (Generally Recognized as Safe) designation allows some flexibility; companies can self-affirm GRAS status if there is sufficient scientific evidence.
Image courtesy: Quorn
2. Allergen Awareness: A Legal Requirement
While most jurisdictions do not classify mycoprotein or fungi-based ingredients as allergens, they do require clear labelling to mitigate potential health risks. Allergen labelling remains a cornerstone of food safety regulations, particularly for products containing ingredients like milk, eggs, or nuts, which are legally mandated to be displayed in bold in ingredient lists. This labelling helps protect consumers from cross-reactivity, a phenomenon where proteins in fungi might trigger allergies similar to those caused by mould, due to structural similarities in protein makeup.
For instance, researchers have found that people with mould allergies may have sensitivities to some fungi-derived proteins, given their shared properties. A study published in The Journal of Allergy and Clinical Immunology suggests that certain fungi proteins can prompt an immune response, indicating that companies should clearly communicate the potential for cross-reactivity, especially as consumer awareness grows around allergens.
Image courtesy: Revo Foods
3. Nutrition and Health Claims: Proceed with Caution
Despite the potential health benefits associated with mycoprotein, companies face significant restrictions on health claims. In the European Union, for example, any statement suggesting specific health benefits requires authorization under the EU Nutrition and Health Claims Regulation (NHCR). Yet, no health claims for mycoprotein have gained approval, even after several submissions. Claims such as “mycoprotein helps maintain normal cholesterol levels” and “satisfies appetite for longer” were ultimately denied.
Similar restrictions apply in other markets: the U.S. FDA evaluates health claims rigorously under the Food Labeling Guide, and Singapore’s Health Promotion Board monitors nutritional and health claims closely. Companies marketing mycoprotein need to ensure that any statements on packaging or promotional materials are well-supported by scientifically validated data, or risk facing regulatory pushback.
Image courtesy: Quorn
4. Adapting to Regional Regulatory Nuances
Every market introduces its own set of regulatory nuances, requiring companies to tailor their approach. For instance, Singapore has become a major hub for alternative proteins, with the Singapore Food Agency (SFA) approving products like The Better Meat Co’s Rhiza mycoprotein. However, navigating SFA’s process involves a thorough evaluation of the ingredient’s safety, nutritional composition, and functional properties.
In comparison, the European Union, known for its precautionary regulatory stance, subjects novel foods to exhaustive scrutiny. Under EU law, only foods with a history of consumption prior to 1997 avoid the lengthy novel food authorization process. U.S. regulations are comparatively lenient, with the GRAS pathway providing an avenue for faster market entry, though companies must ensure their scientific evidence meets FDA standards.
5. Ensuring Compliance with Sustainability and Ethical Standards
Given that sustainability is a core appeal of mycoproteins, companies must ensure their product claims align with ethical standards set by certifying bodies like the International Organization for Standardization (ISO) and Global Food Safety Initiative (GFSI). While these bodies do not regulate fungi directly, they provide frameworks for companies to follow, especially as consumers demand transparency on environmental impact.
As the alternative protein sector expands, regulatory bodies are placing greater emphasis on supply chain transparency, carbon footprint reduction, and environmental sustainability. Certifications such as B Corporation status or compliance with ISO 14001 for environmental management are becoming increasingly relevant for mycoprotein companies aiming to appeal to eco-conscious consumers.
Looking Ahead: Mycoproteins in a Rapidly Evolving Regulatory Landscape
As the mycoprotein sector gains traction, regulatory bodies will likely adapt to provide clearer pathways for fungi-based foods. Recent advancements, such as The Protein Brewery’s and Nature’s Fynd’s successful entries into the US and Asian markets, demonstrate that with robust safety data and regulatory foresight, mycoproteins can navigate these regulatory complexities. For companies looking to establish a foothold in this emerging sector, working closely with regulatory authorities and investing in comprehensive safety assessments will be crucial to ensuring a smooth market entry.
Contributing Author: Mathilde Do Chi
Mathilde is Managing Director at Forward Food Law BV and consultant at MycoStories. She's also a public speaker, board member and impact investment committee member. She has international experience in both the private and public sectors (ADM, FAO, law & IP firms, lobbying).