The operational question is not “are gums banned?”, but in which category, at what level, in which combination and against which specification. Commission Regulation (EU) 2026/196 of 28 January 2026 (CELEX 32026R0196) amends Annex II to Regulation (EC) No 1333/2008 and the Annex to Regulation (EU) No 231/2012. It applies from 18 August 2026. EFSA re-evaluations and follow-ups underpin the measure; a scientific opinion is not a market decision — the Commission changes the Union list of uses and the purity criteria.
1. What the act changes
Commission Regulation (EU) 2026/196 (OJ L, 2026/196, 29.1.2026; ELI: http://data.europa.eu/eli/reg/2026/196/oj; CELEX 32026R0196) amends:
- Article 1 / Annex I — Part E of Annex II to Regulation (EC) No 1333/2008 (conditions of use);
- Article 2 / Annex II — the Annex to Regulation (EU) No 231/2012 (specifications for E 410, E 412, E 414, E 415, E 440, E 1450 — including toxic elements, microbiology and “fully dispersible” wording).
Additives covered for uses: E 407, E 410, E 412, E 414, E 415, E 440, E 1450. Priority categories: 01.10, 13.1.1, 13.1.5.1 and 13.1.5.2 under Regulation (EU) No 609/2013 definitions.
2. EFSA re-evaluation ≠ market authorisation
The recitals cite EFSA opinions on locust bean gum E 410 (2017; 2023 follow-up DOI 10.2903/j.efsa.2023.7775), guar gum E 412 (2017 DOI 10.2903/j.efsa.2017.4669; 2024 follow-up DOI 10.2903/j.efsa.2024.8748), gum arabic, xanthan, pectins and modified starches including E 1450 (2017 DOI 10.2903/j.efsa.2017.4911). For E 412, EFSA concluded that submitted data were not sufficient to demonstrate safety in infant formula and FSMP categories 13.1.1, 13.1.5.1 or 13.1.5.2 — hence deletion or time-limited use in the Commission act.
3. Category 01.10 — maxima and footnote (X)
| Additive | Maximum level | Note |
|---|---|---|
| E 407 carrageenan | 300 mg/kg | footnote (X) |
| E 410, E 412, E 414, E 415 | 10,000 mg/kg each | footnote (X) |
| E 440 pectins | 5,000 mg/kg | footnote (X) |
Footnote (X): if more than one of E 407, E 410, E 412, E 414, E 415 and E 440 is added, each maximum is lowered by the relative part of the others present in that foodstuff. Full individual maxima cannot be stacked.
4. Infant formula and FSMP
4.1. E 412 deleted in 13.1.1 and 13.1.5.1
In 13.1.1 (infant formulae) the E 412 entry is deleted. In 13.1.5.1 (FSMP intended for infants) E 412 is also deleted; the opening sentence states that additives of categories 13.1.1 and 13.1.2 apply, except for E 412.
4.2. Category 13.1.5.2
- E 410 — 5,300 mg/kg from birth onwards only in products for reduction of gastro-oesophageal reflux;
- E 412 — 10,000 mg/kg from birth onwards only in liquid formulae containing hydrolysed proteins, peptides or amino acids; period of application until 27 April 2027;
- E 440 — 4,000 mg/kg from birth onwards in products used in case of gastro-intestinal disorders;
- E 1450 — 20,000 mg/kg until 18 February 2028, then 10,000 mg/kg.
Parallel E 410 / E 440 / E 1450 entries (with conditions) apply in 13.1.5.1; E 1450 there is limited to infant formulae and follow-on formulae within that FSMP category.
5. Specifications (Reg. 231/2012)
Annex II updates definitions and purity criteria (lower Pb/As/Hg/Cd limits, microbiological criteria, dispersibility wording, Kjeldahl method where relevant). A recipe can meet a numerical use level and still fail if the additive lot does not meet the revised specification.
6. Transitional rules (Article 3)
- Additive stock — E 410, E 412, E 414, E 415, E 440 and E 1450 lawfully placed on the market before 18 August 2026 may be added to food under Annexes II and III to 1333/2008 until stocks are exhausted.
- Foods containing that stock — may be placed on the market until MDD / use-by.
- Foods not complying with Annex I — lawfully placed on the market before 18 August 2026 (or before 18 February 2028 if they contain E 1450) may continue until MDD / use-by.
- E 412 in 13.1.1 and 13.1.5.1 — foods lawfully marketed before 18 August 2026 may continue until MDD / use-by.
- E 412 in 13.1.5.2 — foods lawfully marketed before 27 April 2027 may continue until MDD / use-by.
7. Compliance checklist
- Confirm food category and FSMP status (609/2013).
- Apply use maxima, purpose restrictions and footnote (X).
- Verify CoAs against amended 231/2012 specifications.
- Document Article 3 transitions separately for additives and foods.
- Do not treat additive status as a health-claim basis (1924/2006).
Glossary
- FSMP
- Food for special medical purposes — Regulation (EU) No 609/2013.
- IF
- Infant formulae — category 13.1.1.
- Footnote (X)
- Proportional reduction of maxima when E 407/410/412/414/415/440 are combined in category 01.10.
- Specification
- Identity and purity criteria in Regulation (EU) No 231/2012.
Conclusion
Since 18 August 2026, Regulation (EU) 2026/196 tightens and clarifies selected hydrocolloid and E 1450 uses in young-child and FSMP foods while updating specifications. The decisive operational points are E 412 deletion from IF and infant FSMP, combined limits in 01.10, purpose-bound E 410/E 440 uses, and the E 412 / E 1450 clocks. EFSA opinions justify the measure; the Commission sets the market rule.
Primary sources
- Commission Regulation (EU) 2026/196 — CELEX 32026R0196; ELI eli/reg/2026/196/oj. Applies from 18.08.2026.
- Regulation (EC) No 1333/2008 — food additives.
- Regulation (EU) No 231/2012 — specifications.
- Regulation (EU) No 609/2013 — infant food and FSMP.
- EFSA 2017 — guar gum E 412; follow-up 2024 e8748.
- EFSA 2023 — locust bean gum E 410 follow-up.
- EFSA 2017 — modified starches including E 1450.
- Regulation (EC) No 1924/2006 — nutrition and health claims.