13.1.5.2

Dietary foods for babies and young children for special medical purposes as defined in Directive 1999/21/EC

Number 13.1.5.2
Name Dietary foods for babies and young children for special medical purposes as defined in Directive 1999/21/EC
Details The additives of category 13.1.3 are applicable, except for E 270, E 333, E 341
Parent Category Dietary foods for infants and young children for special medical purposes as defined by Commission Directive 1999/21/EC (20) and special formulae for infants

Authorized additives

E Number Maximum Level (mg/l or mg/kg as appropriate) Details Restrictions/exceptions
1 000From four months onwards in special food products with adapted composition, required for metabolic disorders and for general tube-feeding
10 000From birth onwards in products in liquid formulae containing hydrolysed proteins, peptides or amino acids
10 000From birth onwards in products for the dietary management of metabolic disorders
10 000From birth onwards in products for reduction of gastro-oesophageal reflux
9 000only when sold as liquid; From birth onwards
20 000 
200From 12 months onwards in specialised diets intended for young children who have cow’s milk intolerance or inborn errors of metabolism
7 500only when sold as powder; From birth onwards
10 000From birth onwards in products used in case of gastro-intestinal disorders
5 000From birth onwards in specialised diets, particularly those devoid of proteins
1 200From birth onwards for use in products based on amino acids or peptides for use with patients who have problems with impairment of the gastrointestinal tract, protein mal-absorption or inborn errors of metabolism
120only products containing hydrolysed proteins, peptides and amino acids