13.1.5.1

Dietary foods for infants for special medical purposes and special formulae for infants

Number 13.1.5.1
Name Dietary foods for infants for special medical purposes and special formulae for infants
Details The additives of categories 13.1.1 and 13.1.2 are applicable
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
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
1 000The additives may be added individually or in combination The maximum level is expressed as P2O5only for pH adjustment
1 000The additives may be added individually or in combination The maximum level is expressed as P2O5 E 339, E 340 and E 341 are authorised individually or in combination 
7 500only when sold as powder; From birth onwards
120only products containing hydrolysed proteins, peptides and amino acids
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 for reduction of gastro-oesophageal reflux
9 000only when sold as liquid; From birth onwards
quantum satis 
200From 12 months onwards in specialised diets intended for young children who have cow’s milk intolerance or inborn errors of metabolism
quantum satisonly as rising agent
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
20 000only in infant formulae and follow-on formulae
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
quantum satisonly for pH adjustment