1. Commission Regulation (EU) 2026/196
1.1. Food additives affected
The additives concerned mainly belong to the group of hydrocolloids and modified starches, widely used by the food industry as thickeners, stabilisers or texturising agents:- Carrageenans (E 407)
- Locust bean gum (E 410)
- Guar gum (E 412)
- Gum arabic (E 414)
- Xanthan gum (E 415)
- Pectins (E 440 i and ii)
- Sodium starch octenyl succinate (E 1450)
1.2. Key regulatory changes
The Regulation introduces targeted restrictions and clarifications aimed at reducing exposure in vulnerable populations, updating additive specifications and strengthening safety requirements.1.3. Infant milk drinks
Within category 01.10 (milk-based drinks and similar products intended for young children), the authorisation of several hydrocolloids is maintained, but a new mandatory footnote is introduced. When E 407, E 410, E 412, E 414, E 415 and/or E 440 are used in combination, the maximum level of each additive must be reduced proportionally according to the presence of the others. This measure aims to limit cumulative exposure to hydrocolloids in products intended for infants and young children.1.4. Withdrawal and restrictions on guar gum (E 412)
One of the most significant changes is the progressive withdrawal of the authorisation of guar gum (E 412) in sensitive food categories:- Infant formulae (13.1.1)
- Foods for special medical purposes intended for infants (13.1.5.1)
1.5. Specific restrictions on other hydrocolloids
- Locust bean gum (E 410): permitted in FSMP intended for infants only in products designed to reduce gastro-oesophageal reflux, with reduced maximum levels.
- Pectins (E 440): use limited to products intended for gastrointestinal disorders, with lower maximum levels.
- Sodium starch octenyl succinate (E 1450): maximum permitted level reduced from 20,000 mg/kg to 10,000 mg/kg as from 18 February 2028 due to concerns regarding infant exposure.
1.6. Revision of technical specifications
The Regulation introduces a comprehensive revision of additive specifications, with a strong focus on protecting vulnerable populations.Definitions
- Replacement of the terms “soluble/solution” with “dispersible/dispersion”, reflecting the true colloidal nature of these substances.
- Greater detail on manufacturing processes, particularly for vegetable gums and modified starches.
Stricter contaminant limits
Lower maximum limits are established for:- Lead
- Arsenic
- Mercury
- Cadmium
Microbiological criteria
Mandatory microbiological criteria are introduced, including:- Total plate count
- Yeasts and moulds
- Absence of Salmonella spp.
- Absence of Cronobacter spp. in additives intended for infant foods
1.7. Key dates and transitional periods
- Additives and foods lawfully placed on the market before 18 August 2026 may continue to be marketed until stocks are exhausted.
- For E 1450, the transitional period extends until 18 February 2028.
- Specific deadlines apply for the withdrawal of E 412, extending until April 2027.
2. Commission Regulation (EU) 2026/189
2.1. Newly authorised use of shellac (E 904)
The Regulation authorises the use of shellac (E 904) as a coating agent in foods for special medical purposes, exclusively in tablet and dragee form, under category 13.2 (excluding products under category 13.1.5). The maximum authorised level is 46,000 mg/kg, in line with its technological function as a protective coating ensuring appropriate release of active substances in the intestinal tract.2.2. Modification of technical specifications
The technical specifications for shellac (E 904) are updated to improve clarity and safety:- Removal of references to shellac with waxes.
- Redefinition as bleached shellac without waxes.
- Introduction of a maximum wax content of 0.2%.
- Adjustment of the definition to reflect the product placed on the market.
Conclusions and impact for the agri-food sector
These legislative changes represent a significant strengthening of the EU regulatory framework for food additives, particularly for products intended for infants and young children.- Need to review formulations, especially for infant foods and FSMP.
- Updating technical specifications and quality control systems.
- Increased requirements for microbiological safety and contaminant control.
- Importance of early planning to comply within transitional periods.
