As the popularity of functional mushrooms such as Reishi, Lion’s Mane, Cordyceps, and Turkey Tail continues to grow, it is becoming clear that they will need to follow the same regulatory path as CBD in the UK. Predicting their future in the market, it is expected that the Food Standards Agency (FSA) will require these mushrooms to undergo the novel food process.
This regulation ensures that any food not widely consumed in Europe before May 1997 is subject to safety assessments before market approval. Despite their use in traditional medicine, functional mushrooms were not commonly consumed in Europe before this date, meaning they fall under the category of novel foods.
The Role of Extraction Methods
A key factor in why functional mushrooms will require novel food approval is the use of modern extraction methods. Functional mushrooms are processed through methods like hot water extraction, alcohol extraction, or dual extraction. These processes are used to concentrate specific bioactive compounds like beta-glucans, polysaccharides, and triterpenes, which are known for their potential health benefits. However, the concentration of these compounds means that they are no longer in their natural state and could introduce risks related to potency or interactions with other substances.
For example, a consumer taking a powdered extract of Lion’s Mane could be ingesting significantly higher levels of its active compounds than would be consumed by eating the whole mushroom. As with CBD, these concentrated forms of functional mushrooms require careful evaluation to ensure they do not pose health risks. This is why the novel food process is so essential—it ensures that products are safe before they enter the market.
CBD’s Regulatory Path: A Comparison
The novel food process has already been applied to CBD, which offers an instructive comparison. CBD, whether derived from cannabis plants or produced synthetically, must undergo the same rigorous evaluation. Extraction processes for CBD, like CO2 or ethanol extraction, isolate cannabidiol in highly concentrated forms. Moreover, CBD can also be synthesized in a lab, completely bypassing the plant. Synthetic CBD is chemically identical to its plant-derived counterpart, but it must still pass the same safety assessments under the novel food regulation to ensure consumer protection.
This highlights the FSA’s consistent approach to novel foods: any substance not widely consumed before 1997, especially in its extracted or synthesized form, must prove it is safe. Functional mushrooms, particularly when sold as extracts or in concentrated products, face the same requirements as CBD to undergo a full risk assessment.
Safety Concerns with Functional Mushrooms and CBD
The primary goal of the novel food process is to ensure the safety of new or emerging food products. In the case of functional mushrooms, safety assessments will focus on several key areas:
Toxicology: The FSA will evaluate whether concentrated doses of mushroom extracts pose any toxic risks. The potential for interactions with other supplements or medications is another area of concern, especially given the heightened potency of extracts.
Contaminants: Just like with CBD, safety testing will also look at potential contamination from heavy metals, pesticides, or harmful microbial presence. For functional mushrooms, especially those grown outside the UK, contamination risks are a serious consideration.
Serving Size and Potency: The novel food process will assess the appropriate serving sizes of functional mushroom extracts. Given the concentration of bioactive compounds in extracted forms, the FSA will establish guidelines for safe serving sizes to avoid overconsumption.
Long-term Use: Since functional mushrooms are often consumed for their purported long-term health benefits, understanding the effects of prolonged use is essential. Safety studies will help ensure that regular consumption doesn’t result in adverse side effects over time.
For CBD, similar safety concerns regarding serving sizes, potency, and potential contaminants have already been addressed. As with CBD, the FSA’s assessment will help ensure that functional mushrooms are safe for consumers and meet high regulatory standards before they are approved for sale.
Why the Novel Food Process is Essential
The novel food process is vital for both CBD and functional mushrooms due to the high concentration of bioactive compounds in these products. Extracting these compounds from their natural state can increase their potency, but it also raises safety concerns. This process evaluates potential health risks, determines safe serving sizes, and ensures that products are free from harmful contaminants. For consumers, this means the assurance that the products they are using have been tested and are safe for daily consumption.
As the wellness industry expands, consumers are increasingly turning to supplements and functional foods that claim to offer cognitive or immune-boosting benefits. While these products may provide significant advantages, it is crucial to remember that concentrated extracts can also carry risks. The FSA’s novel food process acts as a safeguard to predict and mitigate these risks before they reach the market.
Finally
Functional mushrooms are likely to undergo the same rigorous novel food approval process as CBD due to their relatively recent introduction to the European market and the use of extraction techniques that alter their natural state. By concentrating their bioactive compounds, functional mushroom products need to demonstrate their safety through toxicology tests, contaminant screening, and serving size evaluations. Just as CBD faced similar hurdles, functional mushrooms will need to pass the FSA’s stringent standards to ensure they are safe for consumers.
As both CBD and functional mushroom markets continue to grow, the novel food process will remain essential for protecting consumers while allowing these innovative products to thrive in the wellness sector. By ensuring that safety standards are met, the FSA helps balance consumer demand for new, functional products with the need to protect public health.
Published 16th April 2025
