ANNEX IISupplementary provisions
ANNEX II Annex III to Regulation (EC) No 1333/2008 is amended as follows: (1) in the definitions, point 1 is replaced by the following: ‘1. “nutrients” for the purposes of this Annex means vitamins, minerals and other substances added for nutritional purposes, as well as substances added for physiological purposes as covered by Regulation (EC) No 1925/2006 of the European Parliament and of the Council ( *1 ) , Directive 2002/46/EC and Regulation (EU) No 609/2013. ( *1 ) OJ L 404, 30.12.2006, p. 26 , ELI: http://data.europa.eu/eli/reg/2006/1925/oj .’;" (2) in Part 5, Section A, the introductory wording is replaced by the following: ‘— Food additives added in nutrients except in nutrients intended to be used in foodstuffs listed in Part E, point 01.10, of Annex II and foodstuffs for infants and young children listed in Part E, point 13.1, of Annex II:’; (3) in Part 5, Section B, the introductory wording is replaced by the following: ‘— Food additives added in nutrients intended to be used in foodstuffs listed in Part E, point 01.10, of Annex II and foodstuffs for infants and young children listed in Part E, point 13.1, of Annex II:’; (4) in Part 5, Section B, the table is replaced by the following: ‘E number of the food additive Name of the food additive Maximum level Nutrient to which the food additive may be added Food category E 301 Sodium ascorbate 100 000 mg/kg in vitamin D preparation and 1 mg/l maximum carry-over in final food Vitamin D preparations Infant formulae and follow-on formulae as defined by Regulation (EU) No 609/2013 50 000 mg/kg in microencapsulated vitamin A preparation and 1 mg/l maximum carry-over in final food Microencapsulated vitamin A preparations Infant formula and follow-on formula as defined by Regulation (EU) No 609/2013 Total carry-over 75 mg/l Coatings of nutrient preparations containing polyunsaturated fatty acids Foods for infants and young children, and foods mentioned in Part E, point 01.10, of Annex II E 304(i) Ascorbyl palmitate For uses in nutrient preparations under the condition that the maximum level in foods mentioned in Part E, points 01.10 and 13.1, of Annex II is not exceeded All nutrients Foods for infants and young children, and foods mentioned in Part E, point 01.10, of Annex II E 306 E 307 E 308 E 309 Tocopherol-rich extract Alpha-tocopherol Gamma-tocopherol Delta-tocopherol For uses in nutrient preparations under the condition that the maximum level in foods mentioned in Part E, points 01.10 and 13.1, of Annex II is not exceeded All nutrients Foods for infants and young children, and foods mentioned in Part E, point 01.10, of Annex II E 322 Lecithins For uses in nutrient preparations under the condition that the maximum level in foods mentioned in Part E, points 01.10 and 13.1, of Annex II is not exceeded All nutrients Foods for infants and young children, and foods mentioned in Part E, point 01.10, of Annex II E 330 Citric acid quantum satis All nutrients Foods for infants and young children, and foods mentioned in Part E, point 01.10, of Annex II E 331 Sodium citrates For uses in nutrient preparations under the condition that the maximum level in foods mentioned in Part E, points 01.10 and 13.1, of Annex II is not exceeded and the conditions of use specified therein are respected All nutrients Foods for infants and young children and foods mentioned in Part E, point 01.10, of Annex II E 332 Potassium citrates For uses in nutrient preparations under the condition that the maximum level in foods mentioned in Part E, points 01.10 and 13.1, of Annex II is not exceeded and the conditions of use specified therein are respected All nutrients Food for infants and young children and foods mentioned in Part E, point 01.10, of Annex II E 333 Calcium citrates Total carry-over 0,1 mg/kg expressed as calcium and within the limit of calcium level and calcium/phosphorus ratio as set for the food category All nutrients Foods for infants and young children, and foods mentioned in Part E, point 01.10, of Annex II E 341(iii) Tricalcium phosphate Maximum carry-over of 150 mg/kg expressed as P 2 O 5 and within the limit for calcium, phosphorus, and the calcium:phosphorus ratio as set in Delegated Regulation (EU) 2016/127 All nutrients Infant formulae and follow-on formulae as defined by Regulation (EU) No 609/2013 Maximum level of 1 000 mg/kg expressed as P 2 O 5 from all uses in final food mentioned in Part E, point 13.1.3, of Annex II is respected All nutrients Processed cereal-based foods and baby foods for infants and young children as defined by Regulation (EU) No 609/2013 E 401 Sodium alginate For uses in nutrient preparations under the condition that the maximum level in foods mentioned in point 13.1.3 of Part E of Annex II is not exceeded All nutrients Processed cereal-based foods and baby foods for infants and young children as defined by Regulation (EU) No 609/2013 E 402 Potassium alginate For uses in nutrient preparations under the condition that the maximum level in foods mentioned in Part E, points 01.10 and 13.1.3, of Annex II is not exceeded All nutrients Processed cereal-based foods and baby foods for infants and young children as defined by Regulation (EU) No 609/2013 E 404 Calcium alginate For uses in nutrient preparations under the condition that the maximum level in foods mentioned in point 13.1.3 of Part E of Annex II is not exceeded All nutrients Processed cereal-based foods and baby foods for infants and young children as defined by Regulation (EU) No 609/2013 E 414 Gum arabic (acacia gum) 150 000 mg/kg in the nutrient preparation and 10 mg/kg carry-over in final product All nutrients Foods for infants and young children, and foods mentioned in Part E, point 01.10, of Annex II E 415 Xanthan gum For uses in nutrient preparations under the condition that the maximum level in foods mentioned in point 13.1.3 of Part E of Annex II is not exceeded All nutrients Processed cereal-based foods and baby foods for infants and young children as defined by Regulation (EU) No 609/2013 E 421 Mannitol 1 000 times more than vitamin B12, 3 mg/kg total carry-over As carrier for vitamin B12 Foods for infants and young children, and foods mentioned in Part E, point 01.10, of Annex II E 440 Pectins For uses in nutrient preparations under the condition that the maximum level in foods mentioned in point 13.1 of Part E of Annex II is not exceeded All nutrients Follow-on formulae and processed cereal-based foods and baby foods for infants and young children as defined Regulation (EU) No 609/2013 E 466 Sodium carboxy methyl cellulose, cellulose gum For uses in nutrient preparations under the condition that the maximum level in foods mentioned in point 13.1.5 of Part E of Annex II is not exceeded Only until 26 April 2027 ( 1 ) All nutrients Food for special medical purposes, as defined by Regulation (EU) No 609/2013, intended for infants and young children E 471 Mono- and diglycerides of fatty acids For uses in nutrient preparations under the condition that the maximum level in foods mentioned in Part E, points 01.10 and 13.1, of Annex II is not exceeded and the conditions of use specified therein are respected All nutrients Foods for infants and young children and foods mentioned in Part E, point 01.10, of Annex II E 472c Citric acid esters of mono- and diglycerides of fatty acids For uses in nutrient preparations under the condition that the maximum level in foods mentioned in Part E, points 01.10 and 13.1, of Annex II is not exceeded All nutrients Infant formulae and follow-on formulae for infants and young children in good health E 551 Silicon dioxide 10 000 mg/kg in nutrient preparations Dry powdered nutrient preparations Foods for infants and young children and foods mentioned in Part E, point 01.10, of Annex II E 1420 Acetylated starch For uses in nutrient preparations under the condition that the maximum level in foods mentioned in point 13.1.3 of Part E of Annex II is not exceeded All nutrients Processed cereal-based foods and baby foods for infants and young children as defined by Regulation (EU) No 609/2013 E 1450 Starch sodium octenyl succinate Carry-over 100 mg/kg Vitamin preparations Foods for infants and young children and foods mentioned in Part E, point 01.10, of Annex II Carry-over 1 000 mg/kg Polyunsaturated fatty acid preparations E 1451 Acetylated oxidised starch For uses in nutrient preparations under the condition that the maximum level in foods mentioned in point 13.1.3 of Part E of Annex II is not exceeded All nutrients Processed cereal-based foods and baby foods for infants and young children as defined by Regulation (EU) No 609/2013 ( *1 ) OJ L 404, 30.12.2006, p. 26 , ELI: http://data.europa.eu/eli/reg/2006/1925/oj .’;” ( 1 ) OJ L, 2025/666, 7.4.2025, ELI: http://data.europa.eu/eli/reg/2025/666/oj ’.