The assessment is conducted with emphasis on the age groups 4-6 months, 6-12 months and 1-3 years.

Clinical studies with B. lactis Bb12 added to baby foods have not been found in the available literature. The benefit and risk assessment is therefore based on studies where B. lactis Bb12 is added to infant formula or follow-on formula.

It is however important to note that in most of these studies B. lactis Bb12 was added in combination with other probiotic strains. Serious negative health effects have not been reported from infant formula with B. lactis Bb12 in the clinical studies that have been reviewed.

Scientific evidence of positive effects lacking

However, long term daily intake of infant formula with B. lactis Bb12 has not been studied for the age groups in question. Some studies have shown a certain effect of baby food with probiotics, also B. lactis Bb12, in situations with diarrhea and atopic eczema, while other studies show no effect.

Thus scientific evidence of positive effects is weak or totally lacking. No studies showed positive effect of processed cereal-based baby foods with added B. lactis Bb12 in these age groups.

Several health claims related to products with added probiotic bacteria have been assessed by EFSA, including claims of reduction of gastro-intestinal ailments, normal functioning of the digestive system, building of the natural intestinal barrier, improvement of the general immune system, mental and cognitive developments in children and immune system of children during growth.

EFSA has concluded that a cause and effect relationship has not been established between the consumption of the probiotic containing products and the claimed effect. None of the products assessed so far contained B. lactis Bb12 (November 1st 2009).

Potential unwanted health effects with daily intake

Commercially produced cereals are frequently given to infants and small children in Norway from an early age, and this is particularly important for the establishment of the intestinal bacterial flora and the development of the intestinal mucosal immune system. According to the notifier, one portion (25 gram) of the cereal powder contains 1 x 109 cfu B. lactis Bb12 in monoculture.

Taking into consideration that the daily intake is often greater than one portion of cereals, even in infants below 6 months of age, this would represent a daily intake of 1-2 x 109 cfu B. lactis Bb12 for an infant 4-6 months and even more in infants above 6 months. If a considerable amount of the B. lactis Bb12 survives the transport to the small intestine, it would represent a dominating and monocultural supply, often several times a day, to the small intestine.

The immaturity and vulnerability of the intestinal microbiota and the immune system makes the two lowest age groups, 4 – 6 and 6 – 12 months, at the highest risk of unwanted health effects due to the daily intake of probiotics.

The assessment is based on a review of literature sent by the notifier and MEDLINE literature search.

The VKM Panel on Nutrition, Dietetic products, Novel food and Allergy and the Panel on Biological Hazards were responsible for this benefit and risk assessment.