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PROBIOTIC & FIBRE
B. lactis
strain Bl-04
IN 1 OF THE 29 FORMULAS NO AUTHORISED CLAIM

Bifidobacterium lactis

A bifidobacterium, strain Bl-04. It is in one of our formulas, Digestion & microbiome, and it carries no authorised EU health claim. What it does have is a place on EFSA's safety list for microorganisms used in food, which is a different thing, and we keep the two apart.

FORM WE USE Strain Bl-04, no supplier grade on fileStrain Bl-04
NRV —
OUR RANGE 5 billion CFU, in one formula5 billion CFU
EFSA UPPER LIMIT Not established
APPEARS IN 1 formula
AUTHORISED CLAIMS None under Reg. 432/2012

WHAT WE ARE ALLOWED TO SAY

No authorised claim. A safety status instead.

There is no health claim for Bifidobacterium lactis on the EU register, so there is no wording to quote here, and we are not going to write a sentence that sounds like one. What it does have is a place on EFSA's QPS list, the qualified presumption of safety for microorganisms used in food, where it appears as Bifidobacterium animalis subsp. lactis. That tells you it is considered safe to take. It does not tell you what it does for you.There is no health claim for Bifidobacterium lactis on the EU register. What it has is a place on EFSA's QPS safety list, which is not a claim.

AND WHAT THAT MEANS

In Digestion & microbiome, the one authorised claim on the page belongs to zinc, not to the bacteria. Our file also describes how this strain works: it settles in the small and large intestine and ferments carbohydrates we cannot digest into lactic and acetic acid, which lowers the pH of the gut contents. Our file goes further than that, but none of it is an authorised claim, and EU law does not let us present it as an effect, so you will not read it here as a promise.

WHY STRAIN Bl-04

No salt to choose. A strain instead.

Bacteria do not come in chemical forms, so there is no oxide or citrate to weigh up here, and our file records none. It is used as it comes, a standardised strain. Ours is Bl-04, the strain named in the studies on our dose record, and the species sits on EFSA's QPS safety list. The strain is not a claim argument, and we do not use it as one.

WHAT IT ISA bifidobacterium

A probiotic that ferments carbohydrates we cannot digest into lactic and acetic acid. Our file records it settling in the small and large intestine. It is not absorbed into the blood: it passes through the gut and leaves with it.

WHERE IT COMES FROMTypically grown on milk

Our file records that strains like this one are typically cultured in a dairy medium. So milk allergy, lactose intolerance and a vegan diet are on its warning list. A lactose-free strain is still to be confirmed for ours.

HOW FASTWeeks, not hours

Our file puts the onset at one to two weeks, and records the bacteria as viable for 24 – 48 hours on their way through. That fits a base formula taken every morning and held for eight weeks, not a dose you would expect to feel the same day.

THE HONEST VERSION

Our file on this strain is still a short one, and it says so: deeper research is pending. It has the mechanism, the safety status and one dose record, but no supplier grade, no confirmed lactose-free strain and no figure for how much of it survives the stomach. Until it does, treat the strain in our formula as possibly milk-derived, and read the allergen on the label if you are allergic to milk or cannot take lactose.Our file on this strain is still a short one. No supplier grade or lactose-free strain is on record yet, so treat it as possibly milk-derived and read the label.

WHERE IT APPEARS

One of the twenty-nine carries it.

It sits second in Digestion & microbiome, next to Lactobacillus acidophilus, pasteurised Akkermansia, inulin, GOS and zinc, taken 15 – 30 minutes before breakfast, on an empty stomach so that more of it gets past the stomach acid. At 5 billion CFU it sits within the 1 – 10 billion CFU a day used in the Bl-04 studies named in our file, and above the 1 billion CFU a day on our dose record.

FORMULATYPEDOSEWINDOWWHY IT IS IN THERE
Digestion & microbiome CORE 5 billion CFU
5 billion CFU Morning Morning · Second of three bacterial strains, next to the inulin and GOS that feed it, before breakfast

THE CEILING

No upper limit has been set.

EFSA has not set a tolerable upper intake level for B. lactis, and its QPS listing comes without a number to count against, so there is no ceiling to draw here. Bacteria are counted in colony-forming units (CFU), not milligrams. Our file records 1 billion CFU once a day as the recommended dose for adults, and the Bl-04 studies it names used 1 – 10 billion CFU a day. The formula carries 5 billion.EFSA has not set an upper intake level for B. lactis. Our file records 1 billion CFU a day for adults; the Bl-04 studies used 1 – 10 billion. The formula carries 5 billion.

HOW IT IS COUNTEDIn CFU, not milligrams

Our library records this strain in colony-forming units: 1 billion CFU a day on our dose record, 5 billion in Digestion & microbiome. No other VION formula carries it today, so there is nothing to add it to.

HOW LONGHeld for 8 weeks, then reviewed

The formula is taken for at least 8 weeks, with no forced break, and your digestive symptoms are reassessed at 8 weeks. If SIBO is diagnosed, the formula comes out and a different one takes its slot.

NEVER FORWho should not take it

Small intestinal bacterial overgrowth (SIBO) or severe immunosuppression: the formula that carries it is not for either. Ask a health professional first if you are immunocompromised, a cancer patient on chemotherapy, or have a central venous catheter. Milk allergy, as our file records that strains like this are typically grown on dairy, and care with lactose intolerance. It is marked as not suitable for a vegan diet. And the usual three: do not exceed the daily dose, it does not replace a varied and balanced diet, and keep it out of reach of young children.

WHAT IT REACTS WITH

No documented pairs yet. Two fibres, one allergen.

B. lactis is one of the 140 ingredients in our library, so it has 139 possible partners. None of them is among the 443 pairs we have documented so far, and no medicine is on file against it either. What we do have is a note in two other ingredients' files, and an allergen on its label.

SHARES A DOSEInulin and GOS

Not entries in our interaction table, but our inulin file lists Bifidobacterium among the probiotics it feeds, and our GOS file names bifidobacteria among the bacteria that ferment it. EFSA rejected the health claims filed for GOS on gut discomfort and pathogens, so what our file records here is a description, not a promise. In Digestion & microbiome the three are served together, before breakfast.

POSSIBLE ALLERGENMilk

Our file records that this strain is typically grown on dairy, so milk is listed as an allergen and lactose intolerance as a related intolerance. Read the label if either applies to you.

NOT CHECKED YETMedicines and everything else

No pair with another ingredient or with a medicine is documented for B. lactis, and our pharmacokinetic file found nothing on liver enzymes, half-life or bioavailability. That is an open question, not a clean result.

WHAT WE HAVE NOT CHECKED YET

443 of the 9,730 possible pairs in our library are documented, which is 4.55%, and none of them involves B. lactis. The rest are not "safe", they are simply unchecked, and we would rather write that down than let the number look like a badge.443 of the 9,730 possible pairs in our library are documented, which is 4.55%, and none of them involves B. lactis. The rest are not safe, they are simply unchecked.

SOURCES

Everything on this page, with its reference.

EFSA QPS EFSA — Qualified Presumption of Safety (QPS) list, 2024 — Bifidobacterium animalis subsp. lactis safety status, not a claim; no numeric upper limit
REGULATION Regulation (EU) 432/2012 — the EU list of authorised health claims B. lactis not included
REGULATION Directive 2002/46/EC, Art. 6.3 — labelling of food supplements standard label warnings
EFSA EFSA Journal 2011;9(6):2060 — opinion on health claims related to galacto-oligosaccharides (GOS); EFSA Journal 2011 (doi 10.2903/j.efsa.2011.2333) is the opinion on the 'reduce gastrointestinal discomfort' claim GI discomfort and pathogen claims for GOS rejected
VION FILE Internal dose record, Bl-04 studies (Stadlbauer 2014, Eskesen 2015), references still to be attached 1 billion CFU a day; studies at 1 – 10 billion
VION FILE Internal pharmacokinetic file for B. lactis onset 1 – 2 weeks; no half-life, bioavailability or liver-enzyme data found

Reviewed by VION nutrition team · last reviewed 16 September 2026

140 INGREDIENTS · 64 IN USE TODAY

Every one of them has a page like this.

What it is, what we are allowed to say about it, which formulas carry it, what it reacts with and where each of those statements comes from. No proprietary blends, no hidden amounts.