13.1.5.1 Dietary foods for infants for special medical purposes and special formulae for infants
GB food category, from assimilated Regulation (EC) No 1333/2008, Annex II, Part D, as at 28 June 2024.
In Great Britain an additive may be used only in the foods and under the conditions listed for them. Since 1 April 2025 those conditions are Annex II as it stood on 28 June 2024, read with the FSA and FSS register of authorisations. This page shows what is listed for this category. It does not infer anything from broader categories: where Annex II extends a broader category's provisions to its subcategories, it says so in that category's own listing. See the broader category 13.1.5.
Listed for this category
| Additive | Maximum level | Conditions | Citation |
|---|---|---|---|
| Calcium carbonate E170 | quantum satis | — | Assimilated Regulation (EC) No 1333/2008, Annex II (as at 28 June 2024) |
| Calcium citrate E333 | quantum satis | Authorised under E 333, Calcium citrates. | Assimilated Regulation (EC) No 1333/2008, Annex II (as at 28 June 2024), under E 333, Calcium citrates |
| Calcium hydrogen phosphate E341 | 1,000 mg/kg or mg/l | Authorised under E 341, Calcium phosphates. Note (1): The additives may be added individually or in combination. Note (4): The maximum level is expressed as P 2 O 5. Note (20): E 339, E 340 and E 341 are authorised individually or in combination. | Assimilated Regulation (EC) No 1333/2008, Annex II (as at 28 June 2024), under E 341, Calcium phosphates |
| Calcium hydroxide E526 | quantum satis | only for pH adjustment. | Assimilated Regulation (EC) No 1333/2008, Annex II (as at 28 June 2024) |
| Calcium phosphate E341 | 1,000 mg/kg or mg/l | Authorised under E 341, Calcium phosphates. Note (1): The additives may be added individually or in combination. Note (4): The maximum level is expressed as P 2 O 5. Note (20): E 339, E 340 and E 341 are authorised individually or in combination. | Assimilated Regulation (EC) No 1333/2008, Annex II (as at 28 June 2024), under E 341, Calcium phosphates |
| Carob bean gum E410 | 10,000 mg/kg or mg/l | From birth onwards in products for reduction of gastro-oesophageal reflux. | Assimilated Regulation (EC) No 1333/2008, Annex II (as at 28 June 2024) |
| Citric and fatty acid esters of glycerol E472c | — | (1) ML 7500: only when sold as powder; From birth onwards; (2) ML 9000: only when sold as liquid; From birth onwards. | Assimilated Regulation (EC) No 1333/2008, Annex II (as at 28 June 2024) |
| Dicalcium citrate E333(ii) | quantum satis | Authorised under E 333, Calcium citrates. | Assimilated Regulation (EC) No 1333/2008, Annex II (as at 28 June 2024), under E 333, Calcium citrates |
| Dipotassium phosphate E340 | 1,000 mg/kg or mg/l | Authorised under E 340, Potassium phosphates. Note (1): The additives may be added individually or in combination. Note (4): The maximum level is expressed as P 2 O 5. Note (20): E 339, E 340 and E 341 are authorised individually or in combination. | Assimilated Regulation (EC) No 1333/2008, Annex II (as at 28 June 2024), under E 340, Potassium phosphates |
| Disodium citrate E331(ii) | quantum satis | Authorised under E 331, Sodium citrates. | Assimilated Regulation (EC) No 1333/2008, Annex II (as at 28 June 2024), under E 331, Sodium citrates |
| Disodium phosphate E339 | 1,000 mg/kg or mg/l | Authorised under E 339, Sodium phosphates. Note (1): The additives may be added individually or in combination. Note (4): The maximum level is expressed as P 2 O 5. Note (20): E 339, E 340 and E 341 are authorised individually or in combination. | Assimilated Regulation (EC) No 1333/2008, Annex II (as at 28 June 2024), under E 339, Sodium phosphates |
| Guar gum E412 | 10,000 mg/kg or mg/l | From birth onwards in products in liquid formulae containing hydrolysed proteins, peptides or amino acids. | Assimilated Regulation (EC) No 1333/2008, Annex II (as at 28 June 2024) |
| Hydrochloric acid E507 | quantum satis | only as rising agent. | Assimilated Regulation (EC) No 1333/2008, Annex II (as at 28 June 2024) |
| Mono- and di-glycerides of fatty acids E471 | 5,000 mg/kg or mg/l | From birth onwards in specialised diets, particularly those devoid of proteins. | Assimilated Regulation (EC) No 1333/2008, Annex II (as at 28 June 2024) |
| Monobasic calcium phosphate E341 | 1,000 mg/kg or mg/l | Authorised under E 341, Calcium phosphates. Note (1): The additives may be added individually or in combination. Note (4): The maximum level is expressed as P 2 O 5. Note (20): E 339, E 340 and E 341 are authorised individually or in combination. | Assimilated Regulation (EC) No 1333/2008, Annex II (as at 28 June 2024), under E 341, Calcium phosphates |
| Monocalcium citrate E333(i) | quantum satis | Authorised under E 333, Calcium citrates. | Assimilated Regulation (EC) No 1333/2008, Annex II (as at 28 June 2024), under E 333, Calcium citrates |
| Pectins E440 | 10,000 mg/kg or mg/l | From birth onwards in products used in case of gastro-intestinal disorders. | Assimilated Regulation (EC) No 1333/2008, Annex II (as at 28 June 2024) |
| Phosphoric acid E338 | 1,000 mg/kg or mg/l | only for pH adjustment. Note (1): The additives may be added individually or in combination. Note (4): The maximum level is expressed as P 2 O 5. | Assimilated Regulation (EC) No 1333/2008, Annex II (as at 28 June 2024) |
| Potassium bicarbonate E501 | quantum satis | Authorised under E 501, Potassium carbonates. only as rising agent. | Assimilated Regulation (EC) No 1333/2008, Annex II (as at 28 June 2024), under E 501, Potassium carbonates |
| Potassium carbonate E501 | quantum satis | Authorised under E 501, Potassium carbonates. only as rising agent. | Assimilated Regulation (EC) No 1333/2008, Annex II (as at 28 June 2024), under E 501, Potassium carbonates |
| Potassium citrates E332 | quantum satis | Authorised under E 332, Potassium citrates. | Assimilated Regulation (EC) No 1333/2008, Annex II (as at 28 June 2024), under E 332, Potassium citrates |
| Potassium dihydrogen citrate INS 332(i) | quantum satis | Authorised under E 332, Potassium citrates. | Assimilated Regulation (EC) No 1333/2008, Annex II (as at 28 June 2024), under E 332, Potassium citrates |
| Potassium dihydrogen phosphate INS 340(i) | 1,000 mg/kg or mg/l | Authorised under E 340, Potassium phosphates. Note (1): The additives may be added individually or in combination. Note (4): The maximum level is expressed as P 2 O 5. Note (20): E 339, E 340 and E 341 are authorised individually or in combination. | Assimilated Regulation (EC) No 1333/2008, Annex II (as at 28 June 2024), under E 340, Potassium phosphates |
| Potassium hydroxide E525 | quantum satis | only for pH adjustment. | Assimilated Regulation (EC) No 1333/2008, Annex II (as at 28 June 2024) |
| Propylene glycol alginate E405 | 200 mg/kg or mg/l | From 12 months onwards in specialised diets intended for young children who have cow’s milk intolerance or inborn errors of metabolism. | Assimilated Regulation (EC) No 1333/2008, Annex II (as at 28 June 2024) |
| Sodium acid phosphate INS 339(i) | 1,000 mg/kg or mg/l | Authorised under E 339, Sodium phosphates. Note (1): The additives may be added individually or in combination. Note (4): The maximum level is expressed as P 2 O 5. Note (20): E 339, E 340 and E 341 are authorised individually or in combination. | Assimilated Regulation (EC) No 1333/2008, Annex II (as at 28 June 2024), under E 339, Sodium phosphates |
| Sodium alginate E401 | 1,000 mg/kg or mg/l | From four months onwards in special food products with adapted composition, required for metabolic disorders and for general tube-feeding. | Assimilated Regulation (EC) No 1333/2008, Annex II (as at 28 June 2024) |
| Sodium bicarbonate E500 | quantum satis | Authorised under E 500, Sodium carbonates. only as rising agent. | Assimilated Regulation (EC) No 1333/2008, Annex II (as at 28 June 2024), under E 500, Sodium carbonates |
| Sodium carbonate E500 | quantum satis | Authorised under E 500, Sodium carbonates. only as rising agent. | Assimilated Regulation (EC) No 1333/2008, Annex II (as at 28 June 2024), under E 500, Sodium carbonates |
| Sodium carboxymethylcellulose E466 | 10,000 mg/kg or mg/l | From birth onwards in products for the dietary management of metabolic disorders. | Assimilated Regulation (EC) No 1333/2008, Annex II (as at 28 June 2024) |
| Sodium citrate INS 331(iii) | quantum satis | Authorised under E 331, Sodium citrates. | Assimilated Regulation (EC) No 1333/2008, Annex II (as at 28 June 2024), under E 331, Sodium citrates |
| Sodium citrates E331 | quantum satis | Authorised under E 331, Sodium citrates. | Assimilated Regulation (EC) No 1333/2008, Annex II (as at 28 June 2024), under E 331, Sodium citrates |
| Sodium dihydrogen citrate INS 331(i) | quantum satis | Authorised under E 331, Sodium citrates. | Assimilated Regulation (EC) No 1333/2008, Annex II (as at 28 June 2024), under E 331, Sodium citrates |
| Sodium hydroxide E524 | quantum satis | only for pH adjustment. | Assimilated Regulation (EC) No 1333/2008, Annex II (as at 28 June 2024) |
| Sodium sesquicarbonate INS 500(iii) | quantum satis | Authorised under E 500, Sodium carbonates. only as rising agent. | Assimilated Regulation (EC) No 1333/2008, Annex II (as at 28 June 2024), under E 500, Sodium carbonates |
| Starch sodium octenyl succinate E1450 | 20,000 mg/kg or mg/l | only in infant formulae and follow-on formulae. | Assimilated Regulation (EC) No 1333/2008, Annex II (as at 28 June 2024) |
| Sucrose esters of fatty acids E473 | 120 mg/kg or mg/l | only products containing hydrolysed proteins, peptides and amino acids. | Assimilated Regulation (EC) No 1333/2008, Annex II (as at 28 June 2024) |
| Tripotassium citrate INS 332(ii) | quantum satis | Authorised under E 332, Potassium citrates. | Assimilated Regulation (EC) No 1333/2008, Annex II (as at 28 June 2024), under E 332, Potassium citrates |
| Tripotassium phosphate INS 340(iii) | 1,000 mg/kg or mg/l | Authorised under E 340, Potassium phosphates. Note (1): The additives may be added individually or in combination. Note (4): The maximum level is expressed as P 2 O 5. Note (20): E 339, E 340 and E 341 are authorised individually or in combination. | Assimilated Regulation (EC) No 1333/2008, Annex II (as at 28 June 2024), under E 340, Potassium phosphates |
| Trisodium phosphate INS 339(iii) | 1,000 mg/kg or mg/l | Authorised under E 339, Sodium phosphates. Note (1): The additives may be added individually or in combination. Note (4): The maximum level is expressed as P 2 O 5. Note (20): E 339, E 340 and E 341 are authorised individually or in combination. | Assimilated Regulation (EC) No 1333/2008, Annex II (as at 28 June 2024), under E 339, Sodium phosphates |
| Xanthan gum E415 | 1,200 mg/kg or mg/l | From 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. | Assimilated Regulation (EC) No 1333/2008, Annex II (as at 28 June 2024) |