Historical Context of Serratiopeptidase in Europe
Serratiopeptidase, also known as serrapeptase, is a proteolytic enzyme originally derived from a species of bacteria, Serratia E-15, found in the intestines of silkworms. The enzyme's natural function is to help the silkmoth dissolve its cocoon to emerge. Isolated and developed for therapeutic purposes in Japan during the 1960s, it gained widespread use in medical practice throughout Europe and Asia starting in the 1970s and 1980s. It was employed for its anti-inflammatory, anti-edema, analgesic, and fibrinolytic properties. Historically, European clinicians and patients used serratiopeptidase for a wide variety of conditions, including:
- Surgery and Trauma: To reduce postoperative and traumatic swelling.
- Otolaryngology: For ear, nose, and throat inflammation, including sinusitis and bronchitis.
- Orthopedics: To alleviate pain and inflammation in conditions like arthritis and carpal tunnel syndrome.
- Gynecology: In the treatment of breast engorgement.
- Dentistry: For post-dental surgery inflammation and pain.
For many years, it was a commonly used prescription drug or nutritional supplement in many European countries.
The Novel Food Regulation: A Turning Point for European Availability
The legal status of serratiopeptidase in Europe was fundamentally altered by the introduction and implementation of EU food safety regulations. Under EU Regulation 2015/2283 on novel foods, any food or food ingredient not consumed to a significant degree in the EU before May 15, 1997, is considered a 'novel food'. To be legally sold within the European Union, a novel food must undergo a mandatory pre-market safety assessment and receive specific authorization.
Because manufacturers could not provide sufficient evidence of significant consumption of serratiopeptidase in the EU prior to the cutoff date, it was classified as an unauthorized novel food. This triggered a significant shift in its availability across the European market.
- Regulatory Enforcement: National food standards agencies, such as Food Standards Scotland, issued official notices advising the withdrawal of products containing serratiopeptidase intended for human consumption.
- Market Removal: Many retailers and manufacturers in the EU and the UK (under the retained EU law) ceased the sale of serratiopeptidase supplements.
- Ongoing Restrictions: As of late 2024, the status remains unchanged. Notifications by EU authorities continue to identify online sales of unauthorized serratiopeptidase supplements as a potential risk.
It is important to note that this regulation applies specifically to its use as a food or food supplement. When used for a different technical purpose as a food enzyme, it is permitted under different regulations.
How Serratiopeptidase Works and Its Evidence
Serratiopeptidase's purported therapeutic effects stem from its proteolytic activity—its ability to break down proteins. Its mechanisms of action include:
- Anti-inflammatory: It reduces swelling by thinning fluids in inflamed tissues and facilitates the absorption of decomposed proteins through blood and lymphatics.
- Analgesic: It may help alleviate pain by inhibiting the release of pain-inducing amines like bradykinin.
- Anti-biofilm: The enzyme may help break down bacterial biofilms, which are a protective coating that makes bacteria resistant to antibiotics. Combining serratiopeptidase with antibiotics may enhance their effectiveness against infections.
- Fibrinolytic: It can break down fibrin and other damaged tissue, which has led to anecdotal claims of benefit for cardiovascular conditions by dissolving blood clots and plaque in arteries.
Despite decades of use, a 2013 systematic review highlighted the poor methodological quality of many clinical studies on serratiopeptidase. Researchers found that while there is some evidence supporting its anti-inflammatory and analgesic roles, the clinical evidence is insufficient to fully support its widespread use as an analgesic and health supplement. Crucially, data on long-term safety and tolerability are also lacking.
Regulatory Status: Europe vs. The Rest of the World
Serratiopeptidase's regulatory status differs significantly across international markets, as shown in the table below:
| Aspect | Europe (EU & UK) | United States (US) | Canada | India |
|---|---|---|---|---|
| Current Legal Status | Unauthorized Novel Food for human consumption as a supplement. | Generally considered a dietary supplement. | Approved as a natural health product. | Approved as a pharmaceutical ingredient (often combined with NSAIDs). |
| Availability | Not legally available for human consumption. | Widely available as a supplement. | Available as a natural health product. | Widely prescribed as a medication. |
| Regulatory Body | European Commission, national food agencies. | U.S. Food & Drug Administration (FDA). | Health Canada. | Central Drugs Standard Control Organisation. |
| Authorization for Use | Requires a pre-market safety assessment and authorization. | Allowed under New Dietary Ingredient Notification process. | Permitted once authorized. | Licensed for specific pharmaceutical applications. |
Safety Concerns and Potential Alternatives
While often marketed as a natural product, serratiopeptidase is not without potential risks, and its long-term safety profile is not well-documented. Reported side effects have included gastric disturbances like stomach upset and nausea, allergic skin reactions, and an increased risk of bleeding. Due to its effects on blood clotting, it is strongly advised that individuals on blood-thinning medication, such as warfarin or aspirin, should not take serratiopeptidase. It is also recommended to stop taking it at least two weeks before any scheduled surgery.
For those seeking alternatives in Europe, particularly for anti-inflammatory effects, several other enzyme-based or natural options exist:
- Bromelain: A proteolytic enzyme derived from pineapple, used historically alongside or as an alternative to serratiopeptidase.
- Papain: A protein-digesting enzyme from papaya, often used in conjunction with bromelain.
- Turmeric/Curcumin: A well-known anti-inflammatory compound with a long history of traditional use.
Conclusion: The Present and Future of Serratiopeptidase
The history of what is serratiopeptidase in Europe? has been a journey from a widely used anti-inflammatory drug to its current state as an unavailable food supplement. The shift in legal classification, based on the EU's Novel Food Regulation, has effectively removed it from the human supplement market within the EU and UK. The key reason for this change is not necessarily a sudden safety discovery but rather a lack of documented evidence of significant use in Europe before May 1997, as required by law.
For European consumers, this means that while historical use and anecdotal benefits exist, there are no legally approved food supplements containing serratiopeptidase available for purchase. The potential for future availability hinges on a successful application process and demonstration of safety under the novel food framework. In the interim, consumers should be cautious of any online vendors illegally selling these products and instead consider legally approved alternatives for managing inflammation and pain, after consulting with a healthcare professional. For further research into proteolytic enzymes and their therapeutic applications, resources like the National Institutes of Health provide valuable scientific insights.
