New maximum levels for sodium ascorbate in infant formulae and follow-on formulae
Regulation of sodium ascorbate as an additive in vitamin A preparations
August 2025. On 11 June 2025, the European Commission adopted Regulation (EU) 2025/1150, amending Annex III of Regulation (EC) No 1333/2008 concerning food additives. The amendment aims to regulate the use of the sodium ascorbate additive (E 301) more precisely in vitamin A preparations for infant and follow-on formulae.
We will provide you with a compact overview of the key changes, explaining their significance and outlining how we can support you in complying with the new legal requirements.
Overview of the key changes
The new Regulation (EU) 2025/1150 explicitly regulates the use of sodium ascorbate in microencapsulated vitamin A preparations in Annex III. The following regulations will apply in future to sodium ascorbate used in microencapsulated vitamin A preparations for infant and follow-on formulae:
- 50,000 mg/kg in the microencapsulated vitamin A preparation
- Maximum residual content in the final food: 1 mg/l
For sodium ascorbate used in coatings of nutrient preparations containing polyunsaturated fatty acids, as well as in foods for infants and young children, a total residual content of 75 mg/l applies.
The new regulation has been in force since 2 July 2025. No specific transitional periods have been defined for the changes it contains.
Importance of the changes
According to the new regulation, manufacturers of infant and follow-on formulae must adjust the composition of their vitamin A preparations to comply with the new maximum levels. As there are no transitional periods defined in the new regulation, manufacturers must comply with the new maximum levels for new productions immediately. Products manufactured before the ordinance came into force may continue to be marketed, provided they comply with previous regulations.
The clearly defined maximum residue concentration is intended to strengthen food safety and enable innovations, such as microencapsulated preparations, in the future. These preparations maintain safety limits for consumers.
Sodium ascorbate in vitamin D preparations
Annex III of Regulation (EC) No 1333/2008 on food additives contains a list of authorised additives and their permitted uses. Sodium ascorbate (E 301) was previously authorised for use in vitamin D preparations, as well as in the coatings of other food products, under broadly defined conditions. For vitamin D preparations, the maximum residual content permitted is 100,000 mg/kg in the preparation and 1 mg/litre in the final foodstuff. The new regulation supplements these requirements, which were primarily related to vitamin D preparations and residual levels in coatings.
Contact us
The Eurofins laboratories for food and feed analysis in Germany support you with a comprehensive range of analyses for your food supplements to ensure that you comply with legal maximum levels and fulfil legal requirements.
Do you have any questions about analysing sodium ascorbate or other food additives? Please feel free to contact your personal account manager at any time or get in touch with our experts for food supplements directly.
