Table 3.
MPLs of SSOS (E 1450) in foods for infants below 16 weeks of age according to the Annex II and Annex III to Regulation (EC) No 1333/2008
| Food category number | Food category name | E‐number | Restrictions/exception | MPL (mg/L or mg/kg as appropriate) |
|---|---|---|---|---|
| 13.1.5.1a | Dietary foods for infants for special medical purposes and special formulae for infants | E 1450 | Only in infant formulae and follow‐on formulae | 20,000 |
| 13.1.5.2b | Dietary foods for babies and young children for special medical purposes as defined in Directive 1999/21/EC | E 1450 | Only processed cereal‐based foods and baby foods | 50,000 |
| 13.1.5.2b | Dietary foods for babies and young children for special medical purposes as defined in Directive 1999/21/EC | E 1450 | Except processed cereal‐based foods and baby foods | 20,000 |
| Food category | E‐number | Nutrient to which the food additive may be added | ||
| Annex III, Part 5 Section B | In nutrients intended to be used in foodstuffs for infants and young children listed in point 13.1 of Part E of Annex II | E 1450 | Vitamin preparations | Carry‐over 100c |
| Polyunsaturated fatty acid preparations | Carry‐over 1,000c |
MPL: maximum permitted level.
This category covers dietary foods for infants for special medical purposes and special formulae such as premature infant formulae, hospital discharge formulae, low and very low birth weight formulae, and human breast milk fortifiers.
This category covers foods specially processed or formulated and intended for the dietary management of babies and young children, to be used under medical supervision. This includes, for example the dietary management of infants and young children with metabolic or gastrointestinal disorders, or single or multiple food allergies or intolerances (e.g. cow's milk protein allergy, protein mal‐absorption) and for general tube feeding. Baby foods are foodstuffs destined to children of at least 4 months (see Article 8 of Commission Directive 2006/125).
Two preparations can contain E 1450 as carry‐over. In the final formula, it is in theory possible that carry‐over from both preparations are present. Therefore, for the regulatory exposure scenario, a maximum carry‐over level of 1,100 mg/L or mg/kg as appropriate was used.