(fra kommisjonsforordningen)

(1) Annex III to Regulation (EC) No 1333/2008 lays down a Union list of food additives approved for use in food additives, food enzymes, food flavourings, nutrients and their conditions of use. 

(2) The Union list of food additives may be updated in accordance with the common procedure referred to in Article 3(1) of Regulation (EC) No 1331/2008, either on the initiative of the Commission or following an application from a Member State or an interested party. 

(3) 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. 

(4) Pursuant to Annex III to Regulation (EC) No 1333/2008, sodium ascorbate (E 301) is currently authorised as a food additive in, among other uses, vitamin D preparations for infant formula and follow-on formula at the maximum level of 100 000 mg/kg and the maximum carry-over in those foods of 1 mg/l. This authorisation is based on the scientific opinion of the European Food Safety Authority (‘the Authority’), issued on 22 December 2010, concluding that the use of food additive sodium ascorbate (E 301) as an antioxidant for the vitamin D preparations for use in infant formula and follow on formula is not of safety concern as the maximum carry-over of 1 mg/l of sodium ascorbate would only marginally contribute to the vitamin C and sodium content in infant formula and follow-on formula. 

(5) Furthermore, pursuant to the Annex to Regulation (EU) No 609/2013 of the European Parliament and of the Council4 , sodium ascorbate may be added to infant formula and follow-on formula as a source of vitamin C. The minimum and maximum amounts of vitamin C and sodium in infant formula and follow-on formula are specified in Commission Delegated Regulation (EU) 2016/127. 

(6) 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. 

(7) Pursuant to Article 3(2) of Regulation (EC) No 1331/2008, the Commission has to seek the opinion of the Authority in order to update the Union list of food additives set out in Annex III to Regulation (EC) No 1333/2008, except where the update in question is not liable to have an effect on human health. 

(8) 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 followon 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. 

(9) 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 carryover level of 1 mg/l in those foods. 

(10) Regulation (EC) No 1333/2008 should therefore be amended accordingly. 

(11) The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed,