Allergenicity assessment of hydrolyzed cow's milk based infant formula

Hypoallergenic infant formulas are commonly used for genetically predisposed children and infants diagnosed with cow's milk allergy. Hypoallergenic formulas are generally categorized as par tial and extensive hydrolysates based on the degree of hydrolysis. According to the EC-directive on infant formulas and follow-on formulas, it is required that objective and scientifically verified data are available as proof of the claimed hypoallergenicity. For safety reasons, the hypoallergenicity of hydrolysed infant formulas needs to be assessed by showing that the hypoallergenic formulas are not able to sensitize animals to the protein source they are derived from. We present a strategy for comprehensive and detailed analyses of the potential allergenicity of whey-based hydrolysed infant formulas using both in vitro and in vivo approaches. By assessing the sensitizing capacity in an in vivo mouse model using oral sensitization in combination with the capacity to cross-link chimeric humanized IgE antibodies using the rat basophilic leukaemia cell line RBL-2H3 stably transfected with the α-chain of human IgE receptor (FcεRI) in vitro, both the sensation and challenge phase of the allergic response can be studied. Data will be presented of different ring trial studies aiming to validate the mouse model as well as the RBL-2H3 assay to assess the potential allergenicity of hydrolysed infant formulas. This combination of assays is proposed as a strategy for the screening of new hypoallergenic formulas aimed at preventing sensitization in atopic children and avoiding clinical symptoms in infants suffering from cow's milk allergy.