Risk assessment of probiotics in infant formula

The Norwegian Food Safety Authority has asked VKM to assess whether there may be health risks associated with giving infants (up to 12 months) infant formula supplemented with a specific probiotic bacterium (Bifidobacterium breve M-16V).

Background

"Probiotics" generally refers to health products containing live microorganisms, usually bacteria. Currently, some infant formulas outside Norway are supplemented with freeze-dried probiotic bacteria. The bacterium Bifidobacterium breve M-16V (B. breve M-16V) in given concentrations is considered safe in the USA and EU for use in food, but this status is regularly reviewed in the EU and may change if negative health effects are discovered. In infants, the intestinal microbiota (composition of microorganisms) and immune system are not fully developed, and it is uncertain whether the addition of high doses of probiotic bacteria during infancy may have unintended long-term effects.

Background for the risk assessment

A company has applied to the Norwegian Food Safety Authority to market two specific infant formulas in Norway: one peptide-based and another amino acid-based. The products are intended for infants having allergies and are regulated as foods for special medical purposes. Both products are supplemented with the probiotic bacterium B. breve M-16V. The Norwegian Food Safety Authority has asked VKM to assess whether there may be health risks associated with giving infants these products specifically, and infant formula supplemented with B. breve M-16V in general.

VKM’s methodology

A multidisciplinary project group appointed by VKM has reviewed documentation from the company. The group has also conducted a systematic literature review of health effects reported in studies where infants received infant formula supplemented with B. breve M-16V and calculated the possible intake of infant formula and B. breve M-16V among Norwegian infants. VKM has only assessed the risk of negative health effects based on the assignment and according to guidelines for probiotics in food, not as a medicinal product. The assessment has been approved by a multidisciplinary approval group, also appointed by VKM.

Findings

VKM has not found any unwanted properties of B. breve M-16V based on reported laboratory studies and animal experiments. VKM has also not found negative health effects in 13 clinical studies involving a total of 1580 children, of whom 836 received infant formula supplemented with B. breve M-16V (test) and the rest received infant formula without B. breve M-16V (control). The studies lasted from 6 weeks to 12 months (median 16 weeks). VKM found no consistent differences between test and control groups in reported side effects, children's growth, or symptoms from the gastrointestinal tract, skin, or respiratory system as long as the studies were ongoing (short-term). VKM has found only two studies of long-term effects in children one year (development of asthma symptoms) or 3-5 years (neurocognitive outcomes) after they received infant formula with B. breve M-16V. This is too little to draw conclusions about long-term effects.

VKM provides independent scientific assessments of issues that affect the environment and food safety. VKM does not give advice or take a position on how the risk should be managed. We can assess the consequences of different courses of action, but it is the commissioner who decides on the management.