Mushroom-based supplements, long used in traditional medicine, are gaining popularity in Europe. However, navigating the regulatory landscape surrounding these supplements is no easy task. With the introduction of the EU’s “Novel Food” Regulation, the process of getting health claims approved for mushroom supplements has become more complex and expensive.
What Makes Mushrooms Special in the EU?
In Europe, mushrooms are classified as food supplements. This means they are regulated similarly to other supplements like vitamins or minerals, but there are additional challenges. Many mushroom-based supplements are considered "novel foods" under Regulation (EU) n°2015/2283, meaning they were not widely consumed before 1997. This status requires strict safety assessments before they can be marketed, making it harder for companies to introduce new products. As of now, only Shiitake and Cordyceps sinensis mycelia have been approved for use.
Health Claims: A Long and Expensive Process
Health claims on supplements help consumers make informed choices, but getting approval is a lengthy and costly process. The European Food Safety Authority (EFSA) evaluates claims for accuracy and scientific backing. However, out of thousands of applications, only a few hundred claims (mostly related to vitamins and minerals) have been approved. Mushroom supplements face additional hurdles due to the lack of human studies and high costs, making it difficult for companies to substantiate claims like “boosts immunity” or “supports natural defenses.”
Mushroom Supplements and Ongoing Claims
Despite the challenges, there are ongoing efforts to gain approval for mushroom-related health claims. Some mushrooms like Reishi, Cordyceps, and Maitake are waiting for EFSA’s decision on claims related to immune support, energy enhancement, and other benefits. However, most claims are stalled due to the need for more human studies and clearer scientific data.
The Future of Mushroom Supplements
Looking ahead, the mushroom supplement industry faces an uphill battle. The costs and risks of applying for health claims are significant, and the EU’s rigorous approval process doesn’t make it easy. Yet, there is hope. Companies like Hifas da Terra continue to invest in research, and the increasing scientific interest in mushrooms could lead to breakthroughs that satisfy EFSA’s requirements.
As research into mushroom-based supplements grows, the industry might see more concrete evidence supporting health claims, making it easier for companies to navigate EU regulations and bring their products to market.
In the meantime, consumers should remain cautious about the health claims on mushroom supplements and look for certified products to ensure quality and safety.he Future of Mushroom-Based Supplements in the European Union: A Complex Road Ahead
Mushroom-based supplements, long used in traditional medicine, are gaining popularity in Europe. However, navigating the regulatory landscape surrounding these supplements is no easy task. With the introduction of the EU’s “Novel Food” Regulation, the process of getting health claims approved for mushroom supplements has become more complex and expensive.
What Makes Mushrooms Special in the EU?
In Europe, mushrooms are classified as food supplements. This means they are regulated similarly to other supplements like vitamins or minerals, but there are additional challenges. Many mushroom-based supplements are considered "novel foods" under Regulation (EU) n°2015/2283, meaning they were not widely consumed before 1997. This status requires strict safety assessments before they can be marketed, making it harder for companies to introduce new products. As of now, only Shiitake and Cordyceps sinensis mycelia have been approved for use.
Health Claims: A Long and Expensive Process
Health claims on supplements help consumers make informed choices, but getting approval is a lengthy and costly process. The European Food Safety Authority (EFSA) evaluates claims for accuracy and scientific backing. However, out of thousands of applications, only a few hundred claims (mostly related to vitamins and minerals) have been approved. Mushroom supplements face additional hurdles due to the lack of human studies and high costs, making it difficult for companies to substantiate claims like “boosts immunity” or “supports natural defenses.”
Mushroom Supplements and Ongoing Claims
Despite the challenges, there are ongoing efforts to gain approval for mushroom-related health claims. Some mushrooms like Reishi, Cordyceps, and Maitake are waiting for EFSA’s decision on claims related to immune support, energy enhancement, and other benefits. However, most claims are stalled due to the need for more human studies and clearer scientific data.
The Future of Mushroom Supplements
Looking ahead, the mushroom supplement industry faces an uphill battle. The costs and risks of applying for health claims are significant, and the EU’s rigorous approval process doesn’t make it easy. Yet, there is hope. Companies like Hifas da Terra continue to invest in research, and the increasing scientific interest in mushrooms could lead to breakthroughs that satisfy EFSA’s requirements.
As research into mushroom-based supplements grows, the industry might see more concrete evidence supporting health claims, making it easier for companies to navigate EU regulations and bring their products to market.
In the meantime, consumers should remain cautious about the health claims on mushroom supplements and look for certified products to ensure quality and safety.
Reference: https://hifasdaterra.com/en/blog/novel-food/
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