Child’s play: EFSA approves immune and metabolism health claims, rejects colic discomfort

Published on Friday, the approved claims read:

• “Vitamin D contributes to the normal function of the immune system.”​ ​​
• “Niacin contributes to normal energy-yielding metabolism.”​ ​​
• “Biotin contributes to normal energy-yielding metabolism.”​ ​​

The target population for all three claims submitted by trade group Specialised Nutrition Europe was infants and young children up to three years of age.

Meanwhile the panel on Dietetic Products, Nutrition and Allergies (NDA) concluded that the evidence provided for lactase enzyme beta-galactosidase produced by controlled fermentation of yeast Kluyveromyces lactis ​​​and the reduction of gastrointestinal​​ discomfort was “insufficient​”.​ 

The application from Cross Vetpharm Group UK sought the approval of the claim that its product Colief “reduces the lactose load of the infant’s feed and improves the consequences of lactose maldigestion in colicky infants unable to effectively digest all the lactose in their feed”.​ 

The proposed target population was infants prior to weaning, aged up to 4-5 months with signs of colic like excessive crying.

While the panel said a reduction of gastrointestinal discomfort was a beneficial physiological effect for infants and young children, the two human studies submitted failed to establish a cause and effect relationship between the product and the health outcome.

From general to specific ​

The three approved claims built on previously approved dossiers for the same nutrients and health outcomes for the general population.

The approval came with the condition that if used on follow-on formula the product must comply with the 2006 EU directive on the sector​​.

Other foods intended for infants and young children like processed cereal-based foods and baby foods must provide at least 15% of the Nutrient Reference Values set out in this directive.

If it is used in foods for special medical purpose for infants and young children, it must comply with a separate directive​​ on these foods intended for the exclusive or partial feeding of people whose nutritional requirements cannot be met by 'normal' foods.

EFSA set Tolerable Upper Intake Levels for vitamin D at 25 microgram (µg) per day for infants and 50 µg/day for children aged 1–10 years. For free nicotinic acid this was 2 mg/day and 150 mg/day for nicotinamide for children aged one to three years. No such limit has been set for biotin.