What is Serrapeptase?
Serrapeptase, also known as serratiopeptidase, is a proteolytic enzyme, meaning it breaks down proteins [1.7.1]. It was originally isolated from a species of bacteria called Serratia E15 found in the digestive tract of silkworms (Bombyx mori) [1.4.2, 1.7.3]. The enzyme's natural function is to dissolve the silkworm's tough cocoon, allowing the moth to emerge [1.4.2]. For decades, particularly in Japan and parts of Europe, it was used therapeutically for its purported anti-inflammatory, pain-reducing, and mucolytic (mucus-thinning) properties [1.4.3, 1.4.4]. It has been marketed for a wide range of conditions, from post-surgical swelling to chronic respiratory diseases [1.7.1, 1.7.3].
The Central Question: Banned or Just Unauthorised?
The answer to 'Is serrapeptase banned in Europe?' is nuanced. It is not banned in the sense of being an illegal, controlled substance. However, for it to be sold as a food supplement for human consumption in the European Union and the UK, it must have authorization. This is where serrapeptase runs into a major regulatory hurdle: it is classified as an unauthorised novel food [1.5.1, 1.3.5].
A 'novel food' is defined as a food that had not been consumed to a significant degree by humans in the EU before May 15, 1997 [1.5.1]. Because authorities like the UK's Food Standards Scotland (FSS) could not find evidence of a significant history of consumption before this date, serrapeptase falls into this category [1.5.1]. To be legally marketed, all novel foods must undergo a rigorous pre-market safety assessment and receive authorization from the European Commission, a process now managed by the European Food Safety Authority (EFSA) [1.5.1, 1.5.6].
As serrapeptase has not received this authorization, placing it on the market as a food or dietary supplement is illegal under EU and UK regulations [1.2.5, 1.3.1]. This has led to withdrawal notices and enforcement actions, effectively removing it from the legitimate supplement market for humans [1.5.1, 1.5.4]. Some products may still be sold for veterinary use, a distinction some sellers make explicit [1.2.3, 1.3.4].
The Scientific Evidence: A History of Doubt
The regulatory status is closely linked to the scientific evidence for its effectiveness, which has been found lacking. A pivotal moment came in 2011 when Takeda, a major pharmaceutical manufacturer, voluntarily withdrew its serrapeptase drug, Dasen, from the market in Japan [1.6.1, 1.6.6]. This decision was made after postmarketing clinical trials—required to re-evaluate older drugs—failed to demonstrate a significant clinical benefit over a placebo for its approved indications [1.7.3, 1.6.6].
Subsequent systematic reviews and analyses of existing clinical trials have highlighted significant weaknesses in the research supporting serrapeptase [1.7.2, 1.7.3]. Many studies are old, have small sample sizes, poor methodological quality, and conflicting results [1.7.2, 1.7.3].
- Anti-inflammatory Effects: While some small studies on post-operative swelling (e.g., after dental surgery) suggested a benefit, other, higher-quality trials for conditions like sprained ankles found no difference between serrapeptase and a placebo [1.7.1, 1.7.3].
- Pain Relief: Evidence for pain reduction is similarly conflicting and not well-established [1.4.1, 1.7.2].
- Mucolytic (Mucus-Thinning) Effects: Some studies suggested serrapeptase could reduce mucus viscosity in chronic respiratory diseases, but a large postmarketing study for chronic bronchitis found it no better than a placebo [1.7.1, 1.7.3].
This lack of robust, high-quality evidence makes it difficult for regulatory bodies to justify its approval as a medicine or authorize it as a safe food supplement [1.6.6, 1.7.2].
Comparison Table: Serrapeptase vs. Nattokinase
Another enzyme supplement, Nattokinase, is often discussed alongside Serrapeptase. Here’s how they compare:
| Feature | Serrapeptase (Serratiopeptidase) | Nattokinase |
|---|---|---|
| Origin | Bacteria from silkworm intestines (Serratia E15) [1.4.2] | Fermented soybeans (Nattō) [1.9.4] |
| Primary Claimed Action | Anti-inflammatory, mucolytic (mucus-thinning), breaks down dead/damaged tissue [1.7.1, 1.9.5] | Fibrinolytic (breaks down fibrin/blood clots), supports circulation and blood pressure [1.9.1, 1.9.2] |
| Main Area of Use | Historically for pain, inflammation, respiratory conditions [1.4.3] | Primarily for cardiovascular and circulatory health [1.9.1, 1.9.5] |
| EU/UK Regulatory Status | Unauthorised novel food; illegal to sell for human consumption [1.5.1, 1.5.2] | Varies; often sold as a food supplement, but individual member states may have own rules. |
| Key Scientific Finding | Efficacy not well-established in high-quality trials; voluntarily withdrawn as a drug in Japan due to lack of efficacy [1.7.3, 1.6.6] | Some clinical studies suggest benefits for managing atherosclerosis and hyperlipidemia [1.9.2] |
Safety and Side Effects
While often tolerated in short-term studies, serrapeptase is not without potential side effects. Reported issues include skin reactions, muscle and joint pain, nausea, and coughing [1.8.1]. A more significant concern is its potential to interfere with blood clotting [1.8.1]. Individuals taking anticoagulant (blood-thinner) medications like warfarin or antiplatelet drugs like aspirin are advised to avoid serrapeptase, as it may increase the risk of bleeding and bruising [1.4.5, 1.8.2]. Rare but serious side effects like eosinophilic pneumonitis (a type of lung inflammation) have also been reported [1.7.3, 1.8.5].
Conclusion
While serrapeptase is not 'banned' in Europe in the way a narcotic is, its sale for human use is illegal in the EU and UK because it is classified as an 'unauthorised novel food' [1.5.1]. This regulatory stance is underpinned by a lack of strong scientific evidence for its effectiveness, a conclusion supported by its withdrawal from the Japanese market [1.6.6]. Consumers should be aware that any serrapeptase products sold online for human consumption in this region are not legally compliant and have not passed the required safety assessments.
For more information on the novel food regulation, you can visit the European Commission's Food Safety website.
