Bespoke nattokinase supplement manufacturing
British VitaTech is a nattokinase supplement manufacturer that develops and makes custom nattokinase capsules, tablets and powders for brands worldwide, from formulation to finished product, and the brand owns the formula.
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Nattokinase supplements dosed in FU, not by weight
We work as a nattokinase supplement manufacturer at our UK facility, taking custom nattokinase supplements for brands from formulation to finished product: hard capsules, film-coated and enteric-coated tablets, and powders in sachets and stick packs. We build them on nattokinase standardised by enzyme activity, use the authorised fermented soybean extract for UK and EU products at up to 100 mg a day, and prepare each product for UK, EU and US launch. You receive a certificate of analysis with the enzyme activity and vitamin K2 results for every batch. Your formula is yours.
Nattokinase is an enzyme from natto, the Japanese food made by fermenting soybeans with Bacillus subtilis var. natto. It is a serine protease of 275 amino acids (EFSA, 2016). Brands sell it for heart-health positioning, and it sits within our healthy ageing and longevity supplement manufacturing, next to NAD+ and NMN and urolithin A in longevity ranges. We also make muscle health formulas for those ranges.
Nattokinase is dosed by activity, not by weight. Potency is declared in fibrin degradation units (FU), the unit of a standard laboratory assay of enzyme activity. FU describes the strength of the ingredient in that assay, not an effect in the body, so we use it to specify, release and label every lot.
| Grade | What it is | Where it fits |
|---|---|---|
| Fermented soybean extract | The authorised novel food: a powder of 30% fermented soybean extract and 70% resistant dextrin, containing nattokinase, with vitamin K2 removed | Every UK and EU product, in capsules, tablets and powders |
| Nattokinase powders standardised in FU | Extracts declared by activity, with vitamin K2 removed and soy declared as an allergen | US products, with activity declared in FU on the Supplement Facts panel |
The authorised specification standardises the extract to 20,000 to 28,000 FU per gram and limits vitamin K2, which is removed during manufacture, to 0.1 mg per kg (EFSA, 2016). We specify both on every lot: activity, so the dose on the label is real, and vitamin K2, so every lot matches the authorised description.
Hard capsules, coated tablets and stick packs of nattokinase
We make every format at our UK facility, which is ISO 9001, HACCP and GMP certified by BSI, and FDA registered.
- Capsules: the standard format, hard capsules filled by weight and checked for activity, GMP certified. See capsule and tablet manufacturing.
- Tablets: film-coated or enteric-coated, with activity checked after compression and coating.
- Powders, sachets and stick packs: a measured daily dose in moisture-barrier film, for brands that pair nattokinase with other actives in one serving. See powder supplement manufacturing.
Combination formulas pair nattokinase with nutrients that carry authorised claims, such as thiamine or omega-3, and we check each active's status in every market the product will be sold in. Development starts with bench samples of your formula, with activity measured after each process step, so we know where activity is lost before the first production batch.
Why we keep nattokinase out of gummies and drinks
100 mg of extract and the FU it delivers
In the UK and EU, the authorisation caps fermented soybean extract at 100 mg a day, for adults excluding pregnant and breastfeeding women. Across the authorised activity range, 100 mg delivers 2,000 to 2,800 FU, and EFSA's assessment put the maximum intake at 2,800 FU a day (EFSA, 2016). A three-year trial in 265 healthy adults used 2,000 FU (Hodis and colleagues, 2021). We build UK and EU products to the 100 mg cap with the activity declared, and US products at the activity your evidence supports. As a worked example, a 100 mg serving of extract at 20,000 FU per gram delivers 2,000 FU at release; the FU on the label is the figure our real-time stability data support at the end of shelf life.
An open question, and enteric coating
How much active enzyme the body absorbs is an open question: EFSA found that the data it reviewed did not allow conclusions on the absorption of active nattokinase (EFSA, 2016). Where a brand wants the enzyme carried past stomach acid, we make enteric-coated tablets and capsules, and keep any delivery claim tied to data on your own product.
Heat, moisture and lost activity
Nattokinase is a protein, and heat and moisture cost it activity. We keep processing cool and dry, check activity after compression and coating, pack with desiccants in moisture-barrier packs, and set the label claim from real-time stability data, measured in FU at every stability point. For the same reason, nattokinase goes into capsules, tablets and powders rather than cooked gummies, liquids or drinks; in the UK and EU those forms also sit outside the authorisation, which covers capsules, tablets and powders.
Labelling and allergens
In the UK and EU, labels name the ingredient "fermented soybean extract" and carry the statement that "persons taking medication should only consume the product under medical supervision". We carry the same statement on US labels as standard. Soybeans are a declared allergen in the UK and EU, and soy is a major food allergen in the US, so every label declares it and the extract is handled under our allergen management plan with yellow colour coding.
Fermented soybean extract: the UK and EU name, cap and warning
As of October 2026, nattokinase can be sold in supplements in the UK, EU and US, and the UK and EU set the tighter conditions. No authorised health claim names nattokinase in the UK or EU, so claims come from nutrients in the formula, each at least at a source level and in exact register wording.
| Market | What the product needs | Claims you can use |
|---|---|---|
| United Kingdom | Fermented soybean extract in capsules, tablets or powders, up to 100 mg a day, for adults excluding pregnant and breastfeeding women; named "fermented soybean extract", with the medication statement and soy declared. | Nutrient claims such as "Thiamine contributes to the normal function of the heart", or "EPA and DHA contribute to the normal function of the heart" for a source of EPA and DHA, with the effect stated at 250 mg a day. |
| European Union | The same conditions and label statements. | The same nutrient claims. |
| United States | A new dietary ingredient basis for the nattokinase used, activity declared in FU and soy declared as a major food allergen. | Structure and function claims backed by competent and reliable scientific evidence, notified to FDA and carrying FDA's standard disclaimer, written conservatively to the human evidence. |
The authorised conditions are on the FSA's register entry for fermented soybean extract. Our claims and regulation page explains how we write claims for each market, and our regulation watch tracks changes to these conditions.
FU per serving beside the extract weight
For each market we prepare the label text and claims wording, the product specification, certificates of analysis with the FU and vitamin K2 results for every batch, a stability summary and allergen statements, so retailers, marketplaces and importers get the documents they ask for. Labels state the activity in FU per serving alongside the weight of extract, so buyers compare products on activity.
Nattokinase processed cool and dry, with activity rechecked
- Specify. We set the dose in FU, the format, the markets and the claims with you.
- Approve and receive. Extract comes from suppliers that have passed our supplier approval, reviewed annually. Each lot arrives with a certificate of analysis for activity, vitamin K2, microbiology and contaminants, and we confirm its activity before use.
- Weigh and blend. Materials are weighed and blended cool and dry, under our allergen management plan with yellow colour coding, because the extract contains soy.
- Fill or compress. Capsules are filled and checked by weight; tablets are compressed and coated, then rechecked for activity; powders are sealed into moisture-barrier sachets and stick packs.
- Pack, label and release. Packs carry desiccants. Label verification on every batch is the critical control point in our HACCP plan, CCP-01; three retained samples are kept for shelf life plus one year; and quality control releases each batch against its specification.
How a nattokinase supplement manufacturer proves the FU on the label
Ask how the FU on the label is proved. Every batch is tested by accredited partner laboratories (ISO/IEC 17025), and batch testing is part of every order.
| Test | Typical method | Why it matters |
|---|---|---|
| Enzyme activity | Fibrin degradation assay, in which one FU is the amount of enzyme that raises the absorbance of the reaction at 275 nm by 0.01 a minute (EFSA, 2016) | Proves the FU on the label, at release and through shelf life |
| Vitamin K2 | HPLC, against the 0.1 mg per kg limit | Confirms the extract matches its specification |
| Microbiology | Total viable count, yeasts and moulds, and pathogens | A fermented ingredient stays within specification |
| Heavy metals | ICP-MS | Lead, cadmium, mercury and arsenic within limits |
| Disintegration | USP <2040>; Ph. Eur. 2.9.1, with an acid stage for enteric-coated products | The unit opens where it is designed to |
| Stability | ICH Q1A(R2) storage, with activity at every point | Sets the shelf life and the FU claim |
Our quality system adds a HACCP study per product type, reviewed annually, and a full mock recall, forward and backward with mass balance, in seconds. Nothing is dispatched without quality control sign-off. Our testing and batch release and stability and shelf life testing pages explain each method.
Research and development is a paid stage that can be included with an order of the right size. Start your project with your markets and positioning, and we will propose the dose in FU, the format and the claims for each.
References: EFSA NDA Panel, safety of a fermented soybean extract as a novel food (2016); Food Standards Agency, register of authorised novel foods, NOVEL-57, fermented soybean extract (2025); Commission Implementing Decision (EU) 2017/115 (2017); Commission Implementing Regulation (EU) 2017/2470, Union list of novel foods (2017); Hodis and colleagues, Clinical Hemorheology and Microcirculation (2021); Commission Regulation (EU) No 432/2012 (2012); Regulation (EU) No 1169/2011 on food information to consumers (2011).
Where it can be sold
-
UK
Permitted with conditionsAs of October 2026, fermented soybean extract is authorised in capsule, tablet or powder food supplements for adults, excluding pregnant and breastfeeding women, at up to 100 mg a day, with a medication statement on the label.
-
EU
Permitted with conditionsAs of October 2026, the EU authorises the same extract on the same conditions: capsule, tablet or powder food supplements for adults, excluding pregnant and breastfeeding women, at up to 100 mg a day.
-
US
Permitted with conditionsAs of October 2026, nattokinase is sold in US dietary supplements with its activity declared in FU, and the new dietary ingredient rules apply.
Where this is going
To 2030
Up: heart-health positioning keeps search and sales rising
To 2036
Flat: needs larger trials to move beyond a niche
What to watch
Thin clinical base outside one branded ingredient
Questions brands ask
Can nattokinase be sold in the UK and EU?
Yes, as the authorised novel food "fermented soybean extract". As of October 2026, the UK and EU allow it in food supplements in capsule, tablet or powder form, at up to 100 mg a day, for adults excluding pregnant and breastfeeding women. Labels name it "fermented soybean extract" and state that "persons taking medication should only consume the product under medical supervision". We build UK and EU formulas to these conditions.
What does FU mean on a nattokinase label?
FU stands for fibrin degradation units, the unit of the laboratory assay that measures nattokinase's enzyme activity. In the assay EFSA cites, one FU is the amount of enzyme that raises the absorbance of the reaction at 275 nm by 0.01 a minute. FU describes the ingredient's strength, not an effect in the body. The authorised extract carries 20,000 to 28,000 FU per gram, so a 100 mg serving delivers 2,000 to 2,800 FU.
What dose of nattokinase do products use?
In the UK and EU, up to 100 mg of fermented soybean extract a day, as of October 2026, which EFSA's assessment put at a maximum of 2,800 FU a day. A three-year trial in 265 healthy adults used 2,000 FU. US products declare activity in FU on the Supplement Facts panel. We set the dose with you, declare it in FU and confirm it on every batch, at release and through shelf life.
Which formats suit nattokinase?
Capsules, tablets and powders. They keep the enzyme dry and cool, and in the UK and EU they are the forms the authorisation covers. We make hard capsules, film-coated and enteric-coated tablets, and sachets and stick packs in moisture-barrier film. Cooked gummies, liquids and drinks cost the enzyme activity through heat and water, so we keep nattokinase in dry formats and check activity after compression and coating before any batch is released.
What claims can a nattokinase supplement make?
In the UK and EU, claims come from nutrients in the formula, because no authorised health claim names nattokinase as of October 2026. A formula with thiamine at a source level can say "Thiamine contributes to the normal function of the heart". In the US, structure and function claims need competent and reliable scientific evidence, a notification to FDA and the standard disclaimer, and we write them conservatively to the evidence.
How do you test nattokinase supplements?
Every batch is tested by accredited partner laboratories (ISO/IEC 17025) as part of every order. Enzyme activity is measured in FU by a fibrin degradation assay at release and at every stability point, vitamin K2 is checked against its specification, and microbiology, heavy metals and disintegration complete the panel. Quality control releases every batch against its specification, and nothing is dispatched without its sign-off.
Does nattokinase need allergen labelling?
Yes, because it comes from fermented soybeans. Soybeans are a declared allergen in the UK and EU, and soy is a major food allergen in the US, so every label we prepare declares it. We handle the extract under our allergen management plan with yellow colour coding and check each combination formula for other allergens. In the UK and EU, the ingredient is also named "fermented soybean extract" on the label.