EU Additives Regulation: new requirements for products intended for vulnerable populations
On January 29, 2026, Commission Regulations (EU) 2026/189 and 2026/196 were published in the Official Journal of the European Union. These acts introduce technical amendments to the two pillars of EU food additive legislation:
- Regulation (EC) No 1333/2008, which establishes the Union list of food additives approved for use in foods and their conditions of use.
- Commission Regulation (EU) No 231/2012, laying down specifications for food additives.
Based on EFSA scientific opinions, the new regulations introduce significant restrictions on the use of additives in product categories intended for vulnerable populations: infants, young children, and patients requiring Foods for Special Medical Purposes (FSMP).
The update includes a revision of maximum levels (MLs) and categories of use for several additives, the revocation of Guar Gum in infant formulae and specific FSMPs, stricter purity specifications including lower limits for heavy metals, more rigorous microbiological criteria, and terminological updates.
The Regulations entered into force on February 18, 2026, requiring an immediate compliance check and potential formula revisions, in accordance with the compliance deadlines set between August 2026 and February 2028.
Key Amendments to Regulation (EC) No 1333/2008
- Guar Gum (E 412)
- Categories 13.1.1 (Infant formulae) and 1.5.1 (Dietary foods for infants for special medical purposes and special formulae for infants): authorization is revoked. Production and import of products containing E 412 in these categories must cease by August 18, 2026.
- Category 13.1.5.2 (Dietary foods for infants from four months onwards and young children for special medical purposes): use remains permitted (limit 10,000 mg/kg) until April 27, 2027, after which the revocation becomes definitive.
- Locust Bean Gum (E 410)
In categories 13.1.5.1 and 13.1.5.2, the maximum permitted level is reduced to 5,300 mg/kg. - Pectins (E 440)
In categories 13.1.5.1 and 13.1.5.2, the maximum permitted level is reduced to 4,000 mg/kg. - Starch Sodium Octenyl Succinate (E 1450)
In categories 13.1.5.1 and 13.1.5.2, the maximum level is reduced to 10,000 mg/kg, with a final compliance deadline of February 18, 2028. - Management of Multiple Hydrocolloids (Note X)
For “Milk-based drinks and similar products for young children” (Cat. 01.10), the combined use of multiple thickeners (e.g., E 407, 410, 412, 414, 415, 440) requires a proportional reduction of the maximum levels for each (Note X). The previous Note (21) is deleted. - Shellac (E 904)
Authorization is extended to category 13.2 (Dietary foods for special medical purposes), specifically for tablets and coated tablets [Reg. (EU) 2026/189].
Key Changes to Commission Regulation (EU) No 231/2012
- Terminology Update: in the solubility parameter for Locust bean gum (E 410), Guar gum (E 412), Acacia gum (gum arabic) (E 414), Xanthan gum (E 415), Pectin (E 440 (i)), and Starch sodium octenyl succinate (E 1450), the terms “soluble/solution” are replaced by the terms “dispersible/dispersion.
- Absence of Gluten: starch sodium octenyl succinate (E 1450) must not contain gluten when used in infant formulae and follow-on formulae.
- Microbiological criteria: Microbiological criteria are introduced for Locust bean gum (E 410), Guar gum (E 412), Pectin and Amidated pectin (E 440 (i), E 440 (ii)), and Starch sodium octenyl succinate (E 1450); additional microbiological criteria are added for Acacia gum (gum arabic) (E 414) and Xanthan gum (E 415).
- Heavy Metals and Contaminants: general reduction of specification limits, for example for Locust bean gum (E 410) lead is reduced to 0.4 mg/kg. For Starch sodium octenyl succinate (E 1450) residual sulphur dioxide is reduced to 10 mg/kg, on a dry basis.
What to do
To ensure compliance by the deadlines (August 2026 – February 2028), Food Business Operators (FBOs) should verify whether their products fall within the limits and specifications imposed by the new regulations and align with the new requirements.
>>> Complife offers regulatory and analytical support in compliance with the Regulations.
See also the article on the update of the EFSA guidelines “Guidance on the scientific data requirements for an application for authorisation of a food additive submitted under Regulation (EC) No 1331/2008”
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