THE SCIENCE BEHIND IT
Only one of these six has an authorised claim at this dose.
In the EU, only a short list of health claims is authorised. Two of our six ingredients have one, but inulin's needs four times the amount this formula carries, so we do not use it. The three bacteria rest on safety approvals, which say they are considered safe to take, not what they do for you, and the Akkermansia dose here sits above the level its approval sets.
Lactobacillus acidophilus
NO AUTHORISED CLAIM
WHAT WE ARE ALLOWED TO SAY
Nothing. We are not allowed to attribute an effect to it, so we do not.
Strain NCFM. The species is on EFSA's QPS list, the qualified presumption of safety for microorganisms used in food. That tells you it is considered safe to take. It does not let us promise anything about your gut.
EFSA QPS list 2024 · 1 source on file · not a claim
Bifidobacterium lactis
NO AUTHORISED CLAIM
WHAT WE ARE ALLOWED TO SAY
Nothing. We are not allowed to attribute an effect to it, so we do not.
Strain Bl-04, listed by EFSA as Bifidobacterium animalis subsp. lactis on the same QPS safety list. A safety status, not a claim. Strains like this are typically grown on dairy, which is why milk allergy and lactose intolerance are on the warning list below.
EFSA QPS list 2024 · 1 source on file · not a claim
Akkermansia muciniphila
NO AUTHORISED CLAIM
WHAT WE ARE ALLOWED TO SAY
Nothing. Its EU authorisation covers safety, not an effect.
Pasteurised Akkermansia muciniphila was assessed by EFSA and authorised in the EU as a novel food in 2021, for up to 3.4 billion cells a day in adults. That limit is written in cells, because pasteurised bacteria are not alive; our composition table records this ingredient in CFU, the unit we use for the two live strains. The reference dose in this formula is 10 billion, about three times that maximum, so we do not present the authorisation as covering it: the dose is flagged for clinical and regulatory review. And even within the limit, a novel food authorisation is permission to sell it as a food, not permission to say what it does for you, so we do not.
EFSA Journal 2021;19(9):6780 · up to 3.4 billion cells a day · 2 sources on file · not a claim
Inulin
NO AUTHORISED CLAIM
WHAT WE ARE ALLOWED TO SAY
Not at this dose. The authorised claim needs 12 g a day, and this formula carries 3 g.
Native chicory inulin does have an authorised EU claim on bowel function, but only at 12 g a day. We did not raise the dose to reach it, and we will not borrow the claim at a quarter of it. It is here as a prebiotic fibre alongside the bacteria.
EFSA Journal 2015;13(1):3951 · 9 sources on file · claim not applicable
Galactooligosaccharides (GOS)
NO AUTHORISED CLAIM
WHAT WE ARE ALLOWED TO SAY
Nothing. EFSA looked at the claims made for GOS and rejected them.
The claims submitted for GOS on digestive discomfort and on pathogens were rejected, and GOS is not on the authorised list. It is included as a second prebiotic fibre, and its dose is the first thing reviewed if this formula leaves you bloated.
EFSA Journal 2011;9(6):2060 · 2 sources on file · claim rejected
Zinc
AUTHORISED CLAIM
WHAT WE ARE ALLOWED TO SAY
“Zinc contributes to normal protein synthesis.”
Regulation (EU) 432/2012, which only allows the claim on a product that is at least a source of zinc. This formula carries 5 mg, 50% of the NRV, and stays well under the 25 mg upper limit.
Reg. 432/2012 · EFSA Journal 2010;8(10):1819 · NRV 10 mg · 14 sources on file