Commission authorizes the use of sodium ascorbate  as an antioxidant in microencapsulated vitamin A preparations for infant formulae and follow-on formulae

With the implementation of Regulation (EU) 2025/1150 of 11 June 2025, the Commission amending Annex III to Regulation (EC) No 1333/2008 of the European Parliament and of the Council as regards the use of sodium ascorbate (E 301) in vitamin A preparations intended for infant formula and follow-on formula.

In October 2023, an application was submitted to the Commission for the authorisation of use of sodium ascorbate (E 301) as an antioxidant at the maximum level of 50 000 mg/kg in microencapsulated vitamin A preparations for infant formula and follow-on formula, resulting in a maximum carry-over in those foods of 1 mg/l of sodium ascorbate (E 301). The application was subsequently made available to Member States pursuant to Article 4 of Regulation (EC) No 1331/2008.

Microencapsulation is commonly used to protect vitamin A from degradation. In this context, sodium ascorbate (E 301), when used as an antioxidant, ensures the stability of the protective matrix encapsulating vitamin A during the production process and in the final product. The increased stability of vitamin A allows the dose to be better controlled and less overage is required to guarantee the correct vitamin A amount in the final product.

The requested use of sodium ascorbate (E 301) in microencapsulated vitamin A preparations results in the same maximum carry-over level to infant formula and follow-on formula as the level assessed by the Authority in 2010. Moreover, the maximum amounts for vitamin C and sodium authorised in infant formula and follow-on formula cover their presence from all sources, including carry-over of food additives. Therefore, the proposed extension of use of sodium ascorbate (E 301) is not liable to have an effect on human health.

Therefore, it is appropriate to authorise the use of sodium ascorbate (E 301) as an antioxidant in microencapsulated vitamin A preparations for infant formula and follow-on formula at the maximum level of 50 000 mg/kg and the maximum carry-over level of 1 mg/l in those foods.

For further information (in English), click on the Link