Additives permitted in infant formula

Infant formula, follow-on formula and formulae for infants with special medical needs.

This comparison is a starting point, not an equivalence. The four systems here do not share a vocabulary, so the categories shown for each are this site's reading of where a food in this group falls. The systems agree on roughly this group of foods but cut it up differently. These are the most tightly restricted categories in the EU, GB and Codex systems: only the additives expressly listed for them may be used, the EU and GB infer nothing into them from any broader category, and Codex's provisions for 13.1 are written for these products alone rather than carried down from 13.0. Codex's 13.1 reaches this site's data with its name mis-parsed from the standard's PDF as '- 13.4 and 13.6'; it is kept because it is the parent through which Codex inheritance runs. The EU and GB differ only in the instrument named — the EU's 13.1.1 cites Regulation (EU) No 609/2013 where GB's copy, frozen at 28 June 2024, still cites Directive 2006/141/EC. In Australia and New Zealand, Standard 2.9.1 applies in Australia only: New Zealand applies its own infant formula standard, and every Schedule 15 row in class 13.1 says so.

What each system calls it

EU food categories

13.1.1 infant formulae as defined by Regulation (EU) No 609/2013, 13.1.2 follow-on formulae as defined by by Regulation (EU) No 609/2013, 13.1.5 Foods for special medical purposes, as defined by Regulation (EU) No 609/2013, intended for infants and young children, 13.1.5.1 Foods for special medical purposes as defined by Regulation (EU) No 609/2013, intended for infants, 13.1.5.2 Foods for special medical purposes, as defined by Regulation (EU) No 609/2013, intended for infants as from four months of age and for young children — 51 additives

Great Britain food categories

13.1.1 Infant formulae as defined by Commission Directive 2006/141/EC, 13.1.2 Follow-on formulae as defined by Directive 2006/141/EC, 13.1.5 Dietary foods for infants and young children for special medical purposes as defined by Commission Directive 1999/21/EC and special formulae for infants, 13.1.5.1 Dietary foods for infants for special medical purposes and special formulae for infants, 13.1.5.2 Dietary foods for babies and young children for special medical purposes as defined in Directive 1999/21/EC — 50 additives

Codex food categories

13.1 - 13.4 and 13.6, 13.1.1 Infant formulae, 13.1.2 Follow-up formulae, 13.1.3 Formulae for special medical purposes for infants — 68 additives

Australia and New Zealand food categories

13.1 Infant formula products, 13.1.1 Special medical purpose product for infants — 53 additives

Canada, Japan, South Korea and the United States are not here. Canada writes its permissions against foods named in prose, Japan's and South Korea's standards of use name foods in their own language rather than by a category code, and the US permits most substances for use in food generally rather than by category. Their pages carry what this site holds.

Where they differ

• 1 permitted by EU and not by GB
• 18 permitted by EU and not by Codex
• 11 permitted by EU and not by ANZ
• 18 permitted by GB and not by Codex
• 11 permitted by GB and not by ANZ
• 35 permitted by Codex and not by EU
• 36 permitted by Codex and not by GB
• 24 permitted by Codex and not by ANZ
• 13 permitted by ANZ and not by EU
• 14 permitted by ANZ and not by GB
• 9 permitted by ANZ and not by Codex

A difference is not a disagreement about safety. A regulator may permit a substance in a neighbouring category, regulate it under another instrument, or simply never have been asked. Open an additive to see what each regulator actually says.

Where the ceilings differ

Permitting a substance and permitting the same amount of it are different questions. These are the additives in this group whose most permissive figure differs by a factor of four or more between systems. The category each figure comes from is shown, because a group maps to several categories in each system and the most permissive figure often belongs to one narrow food inside it. See how much is permitted.

• Carob bean gum

  • EU10,000 mg/kg — 13.1.5.2 Foods for special medical purposes, as defined by Regulation (EU) No 609/2013, intended for infants as from four months of age and for young children
  • GB10,000 mg/kg — 13.1.5.2 Dietary foods for babies and young children for special medical purposes as defined in Directive 1999/21/EC
  • Codex1,000 mg/kg — 13.1.3 Formulae for special medical purposes for infants
  • ANZ5,000 mg/kg — 13.1.1 Special medical purpose product for infants

• Guar gum

  • EU10,000 mg/kg — 13.1.5.2 Foods for special medical purposes, as defined by Regulation (EU) No 609/2013, intended for infants as from four months of age and for young children
  • GB10,000 mg/kg — 13.1.5.2 Dietary foods for babies and young children for special medical purposes as defined in Directive 1999/21/EC
  • Codex1,000 mg/kg — 13.1.2 Follow-up formulae
  • ANZ10,000 mg/kg — 13.1.1 Special medical purpose product for infants

• Acetylated distarch adipate, Acetylated distarch phosphate, Distarch phosphate, Phosphated distarch phosphate

  • Codex5,000 mg/kg — 13.1.2 Follow-up formulae
  • ANZ25,000 mg/kg — 13.1.1 Special medical purpose product for infants

• Lecithin

  • EU1,000 mg/kg — 13.1.2 follow-on formulae as defined by by Regulation (EU) No 609/2013
  • GB1,000 mg/kg — 13.1.2 Follow-on formulae as defined by Directive 2006/141/EC
  • Codex5,000 mg/kg — 13.1.3 Formulae for special medical purposes for infants
  • ANZ5,000 mg/kg — 13.1 Infant formula products

88 additives, side by side

● a permission this site matched to one of the categories above ○ none found there. Levels and conditions differ between them; each category page has the detail.