Food additives: sodium ascorbate (E 301)
- Food additives
Summary
The European Union (EU) has authorised the use of sodium ascorbate (E 301) as an antioxidant in microencapsulated vitamin A preparations intended for infant formula and follow-on formula. This Regulation amends Annex III of Regulation (EC) No 1333/2008.
EU authorises use of sodium ascorbate (E 301) in vitamin A preparations for infant formula
Commission Regulation (EU) 2025/1150 of 11 June 2025 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
Update
The European Union (EU) has authorised the use of sodium ascorbate (E 301) as an antioxidant in microencapsulated vitamin A preparations intended for infant formula and follow-on formula. This Regulation amends Annex III of Regulation (EC) No 1333/2008.
Impacted Products
Food additives, infant formula, follow-on formula
What is changing?
The EU has authorised the use of E 301 in microencapsulated vitamin A preparations at a maximum level of 50,000 mg/kg, resulting in a maximum carry-over of 1 mg/l in the final formula.
Why?
Prior to this Regulation, E 301 had been authorised for use in vitamin D preparations for infant formula. Following an application for its use in vitamin A preparations for such products, the European Commission decided that, in light of a previous assessment of vitamin A by the European Food Safety Authority (EFSA 2010) and established maximum levels for sodium and vitamin C in infant formula, the requested extended use is not expected to pose any risk to human health.
The use of E 301 in microencapsulated vitamin A preparations is intended to improve their stability and avoid loss of vitamin A. This reduces the need to “overdose” vitamin A during production to ensure sufficient vitamin A content.
Timeline
The new use of E 301 is permitted from 2 July 2025.
What are the major implications for exporting countries?
Operators can now use vitamin A preparations containing sodium ascorbate (E 301) in infant and follow-on formula exports to the EU, provided the carry-over does not exceed 1 mg/l and all conditions of use are respected.
Background
Annex III of Regulation 1333/2008 sets out a list of food additives approved for use in food additives, food enzymes, food flavourings, and nutrients, and sets out conditions of use for each additive. Sodium ascorbate (E 301) is already authorised for use in vitamin D preparations for infant formula at a maximum carry-over level of 1 mg/l. It is also allowed as a source of vitamin C in infant formula. The minimum and maximum amounts of vitamin C and sodium in infant formula and follow-on formula are specified in Regulation 2016/127.
Infant formula and follow-on formula products are defined by Regulation 609/2013.
Resources
Commission Delegated Regulation 2016/127 supplementing Regulation (EU) No 609/2013 as regards the specific compositional and information requirements for infant formula and follow-on formula and as regards requirements on information relating to infant and young child feeding
Regulation 609/2013 on food intended for infants and young children, food for special medical purposes, and total diet replacement for weight control
Regulation 1333/2008 on food additives
EFSA (2010) Scientific Opinion on the use of sodium ascorbate as a food additive in vitamin D preparations intended to be used in formulae and weaning food for infants and young children. EFSA Journal, 8(12): 1942.
Sources
Commission Regulation (EU) 2025/1150 amending Annex III to Regulation (EC) No 1333/2008 as regards the use of sodium ascorbate (E 301) in vitamin A preparations intended for infant formula and follow-on formula
Disclaimer: Under no circumstances shall COLEAD be liable for any loss, damage, liability or expense incurred or suffered that is claimed to have resulted from the use of information available on this website or any link to external sites. The use of the website is at the user’s sole risk and responsibility. This information platform was created and maintained with the financial support of the European Union. Its contents do not, however, reflect the views of the European Union.
EU authorises use of sodium ascorbate (E 301) in vitamin A preparations for infant formula
Commission Regulation (EU) 2025/1150 amending Annex III to Regulation (EC) No 1333/2008 as regards the use of sodium ascorbate (E 301) in vitamin A preparations intended for infant formula and follow-on formula
What is changing and why?
E 301 is now permitted in vitamin A preparations at a maximum level of 50,000 mg/kg, with a maximum carry-over of 1 mg/l in infant formula and follow-on formula. The use of E 301 in microencapsulated vitamin A preparations improves their stability and avoids loss of vitamin A. This reduces the need to “overdose” vitamin A during production to ensure sufficient vitamin A content in infant formula.
Actions
Operators can now use vitamin A preparations containing sodium ascorbate (E 301) in infant and follow-on formula exports to the EU, provided the carry-over does not exceed 1 mg/l and all conditions of use are respected.
Timeline
The new use of E 301 is permitted from 2 July 2025.
Disclaimer: Under no circumstances shall COLEAD be liable for any loss, damage, liability or expense incurred or suffered that is claimed to have resulted from the use of information available on this website or any link to external sites. The use of the website is at the user’s sole risk and responsibility. This information platform was created and maintained with the financial support of the European Union. Its contents do not, however, reflect the views of the European Union.