Bespoke Akkermansia and next-generation probiotic manufacturing
British VitaTech is an Akkermansia supplement manufacturer that develops and makes custom pasteurised Akkermansia and next-generation strain supplements for brands worldwide, and the brand owns the formula.
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Pasteurised Akkermansia and other next-generation strains, by market
Pasteurised Akkermansia, dosed by certified cell count at up to 34 billion cells a day for adults in the EU, is what we formulate and make as an Akkermansia supplement manufacturer: custom capsules, stick packs, gummies and liquid shots for premium wellness brands, in our UK facility. We build next-generation strain formulas market by market, from Clostridium butyricum CBM 588 for GB and EU brands to live Akkermansia for US programmes. You receive the specification, a certificate of analysis for every batch and the ingredient documents for each market. Akkermansia sits within our gut health supplement manufacturing range, beside the live strains on our probiotic supplement manufacturing page.
Next-generation probiotics are gut species with little or no history of use in food, studied for defined effects rather than general gut health. Akkermansia muciniphila is a mucin-degrading gut bacterium described in 2004 (Derrien and colleagues, 2004). Its pasteurised form is authorised in EU food supplements for adults and, since 2026, for adolescents, and US dietary supplements carry both live and pasteurised forms.
Pasteurised Akkermansia muciniphila
The authorised EU ingredient is strain ATCC BAA-835, grown without oxygen, then pasteurised, concentrated, cryopreserved and lyophilised. Its specification sets a total count of 25 billion to 2.5 trillion cells per gram, viable cells below 10 CFU per gram and limits for ten microbiological criteria. Because the cells are inactivated, the ingredient fits the ISAPP definition of a postbiotic (Vinderola and colleagues, 2023), as our postbiotic supplement manufacturing page explains. Until 1 March 2027, EU products may use only the authorisation holder's material, and we source accordingly.
Live Akkermansia
Live Akkermansia is an anaerobe, so it is grown, dried and packed without oxygen and counted as live cells to the end of shelf life. US brands sell it in dietary supplements; GB and the EU have not authorised it. A 2025 randomised, placebo-controlled trial in 58 adults used live cells (Zhang and colleagues, Cell Metabolism, 2025), and its benefits tracked colonisation, so its results do not transfer to pasteurised cells, which cannot colonise.
Other next-generation strains
- Clostridium butyricum. A spore-forming butyrate producer, and a next-generation option GB and EU brands can use today: strain CBM 588 is authorised in food supplements in both, at up to 135 million CFU a day. We count it in colony forming units to the end of shelf life.
- Anaerostipes caccae. A butyrate-producing gut species. In 2025 one strain was self-affirmed as generally recognised as safe (GRAS) for the US market, as reported by NutraIngredients; GB and the EU have not authorised it.
- Faecalibacterium prausnitzii. A butyrate producer studied widely in research, not authorised in GB or the EU.
Bacteriophages
Bacteriophages are viruses that target specific bacteria. ISAPP does not count viruses as living microorganisms, so phages are neither probiotics nor postbiotics. In a 2019 randomised, placebo-controlled crossover trial in 36 adults reporting gut discomfort, a blend of four phages targeting E. coli lowered faecal E. coli without changing overall microbiota diversity (Febvre and colleagues, Nutrients, 2019). Phage blends are a US product: they have been sold in US dietary supplements since at least 2019, and GB and the EU have authorised none.
The EU's 34 billion cell ceiling and the baseline question
The EU ceiling and fill weights by count
The EU sets the ceiling. Food supplements may supply up to 34 billion cells a day for adults, 30 billion for adolescents from 14 and 21 billion from 12, and are not for pregnant or lactating women, under the EU's conditions of use. With 25 billion to 2.5 trillion cells per gram allowed in the ingredient, the same dose can weigh from about 14 mg to about 1.4 g, so we set fill weights from each lot's certified cell count, never from a standard weight. The 2019 pilot study used 10 billion cells a day: in the 32 adults who completed three months, live and pasteurised cells were safe and well tolerated, and pasteurised cells improved several metabolic markers against placebo (Depommier and colleagues, Nature Medicine, 2019).
Who benefits: the baseline question
The 2025 trial points to precision use: participants who started with low levels of Akkermansia were colonised efficiently and showed benefits, while those with high levels showed poor colonisation and no significant improvement (Zhang and colleagues, 2025). Measuring baseline levels is the logical next step, but consumer microbiome tests are not yet consistent: when NIST sent the same reference sample to seven direct-to-consumer services, results varied between providers about as much as between different people (NIST, 2024).
Dry pasteurised cells, oxygen-free live ones
Pasteurised cells need no viability, and long shelf lives are readily achieved for inactivated microorganisms (Salminen and colleagues, 2021). Moisture still matters: we keep the blend dry with low-moisture excipients, pack it high-barrier with desiccant, and confirm the cell count in real-time studies through our stability and shelf life testing programme. Live cells need more: oxygen and moisture both cut the count, so live formats are filled and packed under nitrogen, and the label count is the count we measure at the end of shelf life.
Fibre and chromium beside Akkermansia
Akkermansia feeds on the gut's mucus layer rather than on dietary fibre, but brands can pair it with a fibre such as inulin in a stick pack, and with nutrients that carry authorised claims, such as chromium, which "contributes to normal macronutrient metabolism" where the product is a source of chromium.
Akkermansia for EU supplements, and both forms for the US
What a brand can sell and say, as of October 2026. We design every formula to the rules of the markets you sell in, and our supplement regulation watch tracks changes every quarter.
| Market | What you can sell | What the label carries |
|---|---|---|
| Great Britain | No form of Akkermansia. Next-generation formulas use authorised strains such as Clostridium butyricum CBM 588. | The authorised strain's designation, such as "Clostridium butyricum (CBM 588)". |
| Northern Ireland | As in the EU. | As in the EU. |
| European Union | Pasteurised Akkermansia in food supplements, at the doses above; live Akkermansia is not authorised. | The designation "pasteurised Akkermansia muciniphila"; a statement that pregnant and lactating women, and children below the age the dose allows, should not consume it; the cells per daily portion. |
| United States | Live and pasteurised Akkermansia in dietary supplements. A strain or form new to the market needs a new dietary ingredient notification to FDA unless it is already in the food supply unaltered. | Structure and function claims backed by competent and reliable scientific evidence, notified to FDA, with its standard disclaimer. |
Designation, count and the words EU labels avoid
GB advertising rules and the European Commission regard "probiotic" as a health claim, and none is authorised for supplements; pasteurised cells are not alive, so the word is inaccurate for them too, and no health claim is authorised for Akkermansia. EU labels therefore carry the designation, the cell count and the required statement, and take claims from added nutrients, such as the chromium claim above. They never say "probiotic", "live" or "colonises", and make no medical claim. US labels can describe pasteurised cells as a postbiotic and carry structure and function claims with FDA's disclaimer. Our claims and regulation page sets out the wording rules by market.
Capsules, sticks, gummies or shots, and nitrogen for live cells
Pasteurised Akkermansia works in every dose form a food supplement can take, and we make each one in our UK facility, which is ISO 9001, HACCP and GMP certified by BSI.
- Capsules are the reference format: HPMC shells, a dry blend and high-barrier bottles or blisters with desiccant. Capsules are GMP certified. See capsule manufacturing.
- Stick packs carry one daily dose with a fibre, sealed in foil laminate. See sachet and stick pack manufacturing.
- Gummies and liquid shots suit pasteurised cells far better than live ones, with the cell count confirmed after processing. Gummies get an active assay on every batch as standard, and gummies and liquids are GMP certified. In the EU they are sold as food supplements, since the authorisation does not cover everyday foods and drinks.
- Live Akkermansia for US programmes goes into capsules filled and packed under nitrogen, with oxygen absorbers in the pack.
Designation and cell count verified on every Akkermansia label
Development starts from your brief: we confirm your markets, form and dose, build the formula by cell count, run pilot batches and put the formula on stability before full production. R&D is a paid stage that can be included with an order of the right size. The ingredient comes from its authorised producer, which makes it to the EU specification and certifies each lot, and every supplier passes our approval process before any material is used. Production runs in six steps:
- Goods-in. The certificate of analysis is checked against the EU specification: total cell count, viable cells below 10 CFU per gram and the microbiological limits.
- Dispensing. The fill weight is calculated from the lot's cell count and recorded in the batch record.
- Blending. The ingredient is blended with dry, low-moisture excipients, or with a fibre for stick packs, in a set order for a uniform mix.
- Encapsulation. HPMC capsules are filled and weight-checked.
- Packing. Capsules are sealed in high-barrier bottles or blisters with desiccant.
- Label check and release. The designation, cell count and statement on who should not consume the product are verified on every batch, the critical control point in our HACCP plan.
The critical steps are dose accuracy by cell count, moisture control and label accuracy. Each product type has its own HACCP study, reviewed every year, and our allergen management plan, with yellow colour coding, controls any allergen a fibre or carrier brings.
Two counts an Akkermansia supplement manufacturer should report
Ask how the cell count on the label is measured, and how the manufacturer proves the cells are pasteurised. Every batch is tested by accredited partner laboratories (ISO/IEC 17025) as part of every order, as our testing and batch release page explains.
- Total cell count by flow cytometry, in the finished product and at the end of shelf life.
- Viable count: below 10 CFU per gram for pasteurised products, the limit in the EU specification; for live US products, a live count to the end of shelf life.
- Identity: strain identity from the producer's file.
- Microbiology: every limit in the specification, from aerobic count, Enterobacteriaceae, yeasts and moulds to Salmonella, Listeria and E. coli.
- Moisture and water activity of the blend and the finished product.
You receive the documents buyers and marketplaces ask for: a certificate of analysis and batch release confirmation for every batch, the product specification, the stability report and the ingredient documents for each market, from the authorisation holder's supply documents for the EU to the dietary ingredient file for the US.
Quality control releases every batch against its specification, and nothing is dispatched without quality control sign-off. We keep three retained samples per batch for shelf life plus one year, and a full mock recall, forward and backward with mass balance, runs in seconds. We are ISO 9001, HACCP and GMP certified by BSI, and FDA registered. BRCGS implementation under way, certification expected in early 2027. Your formula is yours, including its specification and stability data. Start your project with your form, dose and markets, and we build the formula around them.
References: Derrien and colleagues, International Journal of Systematic and Evolutionary Microbiology (2004); Depommier and colleagues, Nature Medicine (2019); Zhang and colleagues, Cell Metabolism (2025); Febvre and colleagues, Nutrients (2019); Vinderola and colleagues, Frontiers in Pharmacology (2023); Commission Implementing Regulation (EU) 2022/168 (2022); Commission Implementing Regulation (EU) 2026/391 (2026); Commission Implementing Decision 2014/907/EU (2014).
Where it can be sold
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UK
Not permittedAs of October 2026, no form of Akkermansia muciniphila is authorised as a novel food in Great Britain, so it cannot be sold there.
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EU
Permitted with conditionsAs of October 2026, pasteurised Akkermansia is authorised in food supplements at up to 34 billion cells a day for adults, with lower limits from age 12, and live Akkermansia is not authorised.
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US
Permitted with conditionsAs of October 2026, live and pasteurised Akkermansia are sold in dietary supplements, and a strain or form new to the market needs a new dietary ingredient notification to FDA unless it is already in the food supply unaltered.
Where this is going
To 2030
Up: next-generation probiotics gain approvals and trials, led by precision use
To 2036
Up: a mainstream metabolic-microbiome ingredient if trials confirm benefits in low-baseline users
What to watch
Benefit seen only in people with low baseline Akkermansia; novel-food barriers
Questions brands ask
Can Akkermansia supplements be sold in the UK?
Not in Great Britain as of October 2026: no form of Akkermansia is authorised there, so GB brands build next-generation formulas on authorised strains such as Clostridium butyricum CBM 588. Northern Ireland follows the EU rules, where pasteurised Akkermansia is authorised in food supplements. We make Akkermansia products for EU and US brands, and our regulation watch reviews the GB position every quarter.
What dose of pasteurised Akkermansia does the EU allow?
As of October 2026, food supplements can supply up to 34 billion cells a day for adults, 30 billion for adolescents from 14 and 21 billion from 12. Pregnant and lactating women, infants and younger children are excluded, and the label must say so. Until 1 March 2027, EU products may use only the authorisation holder's material, so we source from it and set every fill weight by certified cell count.
Does Akkermansia benefit everyone who takes it?
The evidence says no. In a 2025 randomised, placebo-controlled trial in 58 adults, the groups did not differ overall; participants who started with low levels of Akkermansia were colonised efficiently and showed benefits, while those with high levels did not. That trial used live cells, so its results do not transfer directly to pasteurised cells. So we build Akkermansia labels on the designation and cell count, and never promise a benefit for everyone.
Can an Akkermansia supplement be called a probiotic?
Not in GB or the EU. GB advertising rules and the European Commission regard "probiotic" as a health claim, and as of October 2026 none is authorised for supplements; pasteurised cells are also not alive, so the word is inaccurate for them. EU labels carry the designation "pasteurised Akkermansia muciniphila", the cell count per daily portion, the required statement on who should not consume it and authorised claims from added nutrients. US labels can carry structure and function claims with FDA's disclaimer.
Can bacteriophage supplements be sold in the UK and EU?
Not as of October 2026: GB and the EU have authorised no bacteriophage preparation, so phage blends are a US product. They have been sold in US dietary supplements since at least 2019, and a 2019 crossover trial found a four-phage blend lowered faecal E. coli without changing overall microbiota diversity. Phages are viruses, so they are neither probiotics nor postbiotics.
How do you test Akkermansia supplements?
We count total cells by flow cytometry and confirm pasteurisation with a viable count below 10 CFU per gram, the limit in the EU specification, on every batch. Microbiology covers every limit in the specification, from aerobic count and Enterobacteriaceae to Salmonella, Listeria and E. coli, and stability studies confirm the count to the end of shelf life. Every batch is tested by accredited partner laboratories (ISO/IEC 17025) as part of every order.
Do you make private label Akkermansia supplements?
We develop bespoke Akkermansia supplements rather than relabelling stock formulas. A bespoke formula lets you choose the form, dose, pairing, format and label for each market, built on the authorised ingredient and a specification set by cell count. R&D is a paid stage that can be included with an order of the right size, and your formula is yours, including its specification and stability data.