ANNEX ISupplementary provisions
ANNEX I COMPOSITIONAL REQUIREMENTS REFERRED TO IN ARTICLE 2(3) PART A Food for special medical purposes developed to satisfy the nutritional requirements of infants 1. Products referred to in Article 2(1)(a) developed to satisfy the nutritional requirements of infants shall contain the vitamins and mineral substances as specified in Table 1. 2. Products referred to in Article 2(1)(b) developed to satisfy the nutritional requirements of infants shall contain the vitamins and mineral substances as specified in Table 1, without prejudice to modifications for one or more of these nutrients rendered necessary by the intended use of the product. 3. Maximum levels of vitamins and mineral substances present in products referred to in Article 2(1)(c) developed to satisfy the nutritional requirements of infants shall not exceed those specified in Table 1, without prejudice to modifications for one or more of these nutrients rendered necessary by the intended use of the product. 4. Where this is not contrary to the requirements dictated by the intended use, food for special medical purposes developed to satisfy the nutritional requirements of infants shall comply with the provisions relating to other nutrients applicable to infant formula and follow-on formula, as the case may be, laid down in Commission Delegated Regulation (EU) 2016/127 ( 1 ) . Table 1 Values for vitamins and minerals in food for special medical purposes developed to satisfy the nutritional requirements of infants Per 100 kJ Per 100 kcal Minimum Maximum Minimum Maximum Vitamins Vitamin A (μg-RE) ( 2 ) 16,7 43 70 180 Vitamin D (μg) 0,48 0,72 2 3 Vitamin K (μg) 0,24 6 1 25 Vitamin C (mg) 0,96 7,2 4 30 Thiamin (μg) 9,6 72 40 300 Riboflavin (μg) 14,3 107 60 450 Vitamin B 6 (μg) 4,8 72 20 300 Niacin (mg) ( 3 ) 0,1 0,72 0,4 3 Folate (μg-DFE) ( 4 ) 3,6 11,4 15 47,6 Vitamin B 12 (μg) 0,02 0,12 0,1 0,5 Panthotenic Acid (mg) 0,1 0,48 0,4 2 Biotin (μg) 0,24 4,8 1 20 Vitamin E (mg α-tocopherol) ( 5 ) 0,14 1,2 0,6 5 Minerals Sodium (mg) 6 14,3 25 60 Chloride (mg) 14,3 38,2 60 160 Potassium (mg) 19,1 38,2 80 160 Calcium (mg) ( 6 ) 12 60 50 250 Phosphorus (mg) ( 7 ) 6 24 25 100 Magnesium (mg) 1,2 3,6 5 15 Iron (mg) 0,07 0,6 0,3 2,5 Zinc (mg) 0,12 0,6 0,5 2,4 Copper (μg) 14,3 29 60 120 Iodine (μg) 3,6 8,4 15 35 Selenium (μg) 0,72 2 3 8,6 Manganese (μg) 0,24 24 1 100 Chromium (μg) — 2,4 — 10 Molybdenum (μg) — 3,3 — 14 Fluoride (μg) — 47,8 — 200 PART B Food for special medical purposes other than that developed to satisfy the nutritional requirements of infants 1. Products referred to in Article 2(1)(a) other than those developed to satisfy the nutritional requirements of infants shall contain the vitamins and mineral substances as specified in Table 2. 2. Products referred to in Article 2(1)(b) other than those developed to satisfy the nutritional requirements of infants shall contain the vitamins and mineral substances as specified in Table 2, without prejudice to modifications for one or more of these nutrients rendered necessary by the intended use of the product. 3. Maximum levels of vitamins and mineral substances present in products referred to in Article 2(1)(c) other than those developed to satisfy the nutritional requirements of infants shall not exceed those specified in Table 2, without prejudice to modifications for one or more of these nutrients rendered necessary by the intended use of the product. Table 2 Values for vitamins and minerals in food for special medical purposes other than that developed to satisfy the nutritional requirements of infants Per 100 kJ Per 100 kcal Minimum Maximum Minimum Maximum Vitamins Vitamin A (μg-RE) 8,4 43 35 180 Vitamin D (μg) 0,12 0,65/0,75 ( 8 ) 0,5 2,5/3 ( 8 ) Vitamin K (μg) 0,85 5 3,5 20 Vitamin C (mg) 0,54 5,25 2,25 22 Thiamin (mg) 0,015 0,12 0,06 0,5 Riboflavin (mg) 0,02 0,12 0,08 0,5 Vitamin B 6 (mg) 0,02 0,12 0,08 0,5 Niacin (mg NE) 0,22 0,75 0,9 3 Folic Acid (μg) 2,5 12,5 10 50 Vitamin B 12 (μg) 0,017 0,17 0,07 0,7 Panthotenic Acid (mg) 0,035 0,35 0,15 1,5 Biotin (μg) 0,18 1,8 0,75 7,5 Vitamin E (mg α-TE) 0,5/g of polyunsaturated fatty acids expressed as linoleic acid but in no case less than 0,1 mg per 100 available kJ 0,75 0,5/g of polyunsaturated fatty acids expressed as linoleic acid but in no case less than 0,5 mg per 100 available kcal 3 Minerals Sodium (mg) 7,2 42 30 175 Chloride (mg) 7,2 42 30 175 Potassium (mg) 19 70 80 295 Calcium (mg) 8,4/12 ( 8 ) 42/60 ( 8 ) 35/50 ( 8 ) 175/250 ( 8 ) Phosphorus (mg) 7,2 19 30 80 Magnesium (mg) 1,8 6 7,5 25 Iron (mg) 0,12 0,5 0,5 2 Zinc (mg) 0,12 0,36 0,5 1,5 Copper (μg) 15 125 60 500 Iodine (μg) 1,55 8,4 6,5 35 Selenium (μg) 0,6 2,5 2,5 10 Manganese (mg) 0,012 0,12 0,05 0,5 Chromium (μg) 0,3 3,6 1,25 15 Molybdenum (μg) 0,84 4,3 3,5 18 Fluoride (mg) — 0,05 — 0,2 ( 1 ) Commission Delegated Regulation (EU) 2016/127 of 25 September 2015 supplementing Regulation (EU) No 609/2013 of the European Parliament and of the Council 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 (see page 1 of this Official Journal). ( 2 ) Preformed vitamin A; RE = all trans retinol equivalent. ( 3 ) Preformed niacin. ( 4 ) Dietary folate equivalent: 1 μg DFE = 1 μg food folate = 0,6 μg folic acid from food for special medical purposes. ( 5 ) Based on vitamin E activity of RRR-α-tocopherol. ( 6 ) The calcium:available phosphorus molar ratio shall not be less than 1 nor greater than 2. ( 7 ) Total phosphorus. ( 8 ) For products intended for children of 1 to 10 years of age.