13.1.5.1 Foods for special medical purposes as defined by Regulation (EU) No 609/2013, intended for infants

EU food category, from Regulation (EC) No 1333/2008, Annex II, Part D.

Under Annex II, an additive may be used only in the foods and under the conditions listed for them. 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

AdditiveMaximum levelConditionsCitation
Ascorbyl palmitate E304100 mg/kg—Regulation (EC) No 1333/2008, Annex II, as amended by (EU) No 1129/2011
Calcium carbonate E170quantum satis—Regulation (EC) No 1333/2008, Annex II, as amended by (EU) No 1129/2011
Calcium citrate E333quantum satis

Authorised under E 333, Calcium citrates.

Regulation (EC) No 1333/2008, Annex II, under E 333, Calcium citrates
Calcium hydrogen phosphate E3411,000 mg/kg

Authorised under E 341, Calcium phosphates. Note 1: The additives may be added individually or in combination.

Regulation (EC) No 1333/2008, Annex II, as amended by (EU) No 1129/2011, under E 341, Calcium phosphates
Calcium hydroxide E526quantum satis

only for pH adjustment.

Regulation (EC) No 1333/2008, Annex II, as amended by (EU) No 1129/2011
Calcium phosphate E3411,000 mg/kg

Authorised under E 341, Calcium phosphates. Note 1: The additives may be added individually or in combination.

Regulation (EC) No 1333/2008, Annex II, as amended by (EU) No 1129/2011, under E 341, Calcium phosphates
Carob bean gum E41010,000 mg/kg

From birth onwards in products for reduction of gastro-oesophageal reflux.

Regulation (EC) No 1333/2008, Annex II, as amended by (EU) No 1129/2011
Citric and fatty acid esters of glycerol E472c7,500 mg/kg

only when sold as powder; From birth onwards.

Regulation (EC) No 1333/2008, Annex II, as amended by (EU) No 1129/2011
Dicalcium citrate E333(ii)quantum satis

Authorised under E 333, Calcium citrates.

Regulation (EC) No 1333/2008, Annex II, under E 333, Calcium citrates
Dipotassium phosphate E3401,000 mg/kg

Authorised under E 340, Potassium phosphates. Note 1: The additives may be added individually or in combination.

Regulation (EC) No 1333/2008, Annex II, as amended by (EU) No 1129/2011, under E 340, Potassium phosphates
Disodium citrate E331(ii)quantum satis

Authorised under E 331, Sodium citrates.

Regulation (EC) No 1333/2008, Annex II, under E 331, Sodium citrates
Disodium phosphate E3391,000 mg/kg

Authorised under E 339, Sodium phosphates. Note 1: The additives may be added individually or in combination.

Regulation (EC) No 1333/2008, Annex II, as amended by (EU) No 1129/2011, under E 339, Sodium phosphates
Guar gum E41210,000 mg/kg

From birth onwards in products in liquid formulae containing hydrolysed proteins, peptides or amino acids.

Regulation (EC) No 1333/2008, Annex II
Hydrochloric acid E507quantum satis

only as rising agent.

Regulation (EC) No 1333/2008, Annex II, as amended by (EU) No 1129/2011
Mono- and di-glycerides of fatty acids E4715,000 mg/kg

From birth onwards in specialised diets, particularly those devoid of proteins.

Regulation (EC) No 1333/2008, Annex II, as amended by (EU) No 1129/2011
Monobasic calcium phosphate E3411,000 mg/kg

Authorised under E 341, Calcium phosphates. Note 1: The additives may be added individually or in combination.

Regulation (EC) No 1333/2008, Annex II, as amended by (EU) No 1129/2011, under E 341, Calcium phosphates
Monocalcium citrate E333(i)quantum satis

Authorised under E 333, Calcium citrates.

Regulation (EC) No 1333/2008, Annex II, under E 333, Calcium citrates
Pectins E44010,000 mg/kg

From birth onwards in products used in case of gastro-intestinal disorders.

Regulation (EC) No 1333/2008, Annex II, as amended by (EU) No 1129/2011
Phosphoric acid E3381,000 mg/kg

only for pH adjustment,. Note 1: The additives may be added individually or in combination.

Regulation (EC) No 1333/2008, Annex II, as amended by (EU) No 1129/2011
Potassium bicarbonate E501quantum satis

Authorised under E 501, Potassium carbonate. only as rising agent.

Regulation (EC) No 1333/2008, Annex II, as amended by (EU) No 1129/2011, under E 501, Potassium carbonate
Potassium carbonate E501quantum satis

Authorised under E 501, Potassium carbonate. only as rising agent.

Regulation (EC) No 1333/2008, Annex II, as amended by (EU) No 1129/2011, under E 501, Potassium carbonate
Potassium citrates E332quantum satis

Authorised under E 332, Potassium citrates.

Regulation (EC) No 1333/2008, Annex II, under E 332, Potassium citrates
Potassium dihydrogen citrate INS 332(i)quantum satis

Authorised under E 332, Potassium citrates.

Regulation (EC) No 1333/2008, Annex II, under E 332, Potassium citrates
Potassium dihydrogen phosphate INS 340(i)1,000 mg/kg

Authorised under E 340, Potassium phosphates. Note 1: The additives may be added individually or in combination.

Regulation (EC) No 1333/2008, Annex II, as amended by (EU) No 1129/2011, under E 340, Potassium phosphates
Potassium hydroxide E525quantum satis

only for pH adjustment.

Regulation (EC) No 1333/2008, Annex II, as amended by (EU) No 1129/2011
Propylene glycol alginate E405200 mg/kg

From 12 months onwards in specialised diets intended for young children who have cow's milk intolerance or inborn errors of metabolism.

Regulation (EC) No 1333/2008, Annex II, as amended by (EU) No 1129/2011
Sodium acid phosphate INS 339(i)1,000 mg/kg

Authorised under E 339, Sodium phosphates. Note 1: The additives may be added individually or in combination.

Regulation (EC) No 1333/2008, Annex II, as amended by (EU) No 1129/2011, under E 339, Sodium phosphates
Sodium alginate E4011,000 mg/kg

from four months onwards in special food products with adapted composition, required for metabolic disorders and for general tube-feeding.

Regulation (EC) No 1333/2008, Annex II, as amended by (EU) No 1129/2011
Sodium bicarbonate E500quantum satis

Authorised under E 500, Sodium carbonates. only as rising agent.

Regulation (EC) No 1333/2008, Annex II, under E 500, Sodium carbonates
Sodium carbonate E500quantum satis

Authorised under E 500, Sodium carbonates. only as rising agent.

Regulation (EC) No 1333/2008, Annex II, under E 500, Sodium carbonates
Sodium carboxymethylcellulose E46610,000 mg/kg

From birth onwards in products for the dietary management of metabolic disorders.

Regulation (EC) No 1333/2008, Annex II
Sodium citrate INS 331(iii)quantum satis

Authorised under E 331, Sodium citrates.

Regulation (EC) No 1333/2008, Annex II, under E 331, Sodium citrates
Sodium citrates E331quantum satis

Authorised under E 331, Sodium citrates.

Regulation (EC) No 1333/2008, Annex II, under E 331, Sodium citrates
Sodium dihydrogen citrate INS 331(i)quantum satis

Authorised under E 331, Sodium citrates.

Regulation (EC) No 1333/2008, Annex II, under E 331, Sodium citrates
Sodium hydroxide E524quantum satis

only for pH adjustment.

Regulation (EC) No 1333/2008, Annex II, as amended by (EU) No 1129/2011
Sodium sesquicarbonate INS 500(iii)quantum satis

Authorised under E 500, Sodium carbonates. only as rising agent.

Regulation (EC) No 1333/2008, Annex II, under E 500, Sodium carbonates
Starch sodium octenyl succinate E145020,000 mg/kg

only in infant formulae and follow-on formulae.

Regulation (EC) No 1333/2008, Annex II, as amended by (EU) No 1129/2011
Sucrose esters of fatty acids E473120 mg/kg

only products containing hydrolysed proteins, peptides and amino acids.

Regulation (EC) No 1333/2008, Annex II, as amended by (EU) No 1129/2011
Tripotassium citrate INS 332(ii)quantum satis

Authorised under E 332, Potassium citrates.

Regulation (EC) No 1333/2008, Annex II, under E 332, Potassium citrates
Tripotassium phosphate INS 340(iii)1,000 mg/kg

Authorised under E 340, Potassium phosphates. Note 1: The additives may be added individually or in combination.

Regulation (EC) No 1333/2008, Annex II, as amended by (EU) No 1129/2011, under E 340, Potassium phosphates
Trisodium phosphate INS 339(iii)1,000 mg/kg

Authorised under E 339, Sodium phosphates. Note 1: The additives may be added individually or in combination.

Regulation (EC) No 1333/2008, Annex II, as amended by (EU) No 1129/2011, under E 339, Sodium phosphates
Xanthan gum E4151,200 mg/kg

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.

Regulation (EC) No 1333/2008, Annex II, as amended by (EU) No 1129/2011