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Commission Delegated Regulation (EU) 2016/128Show full title
Commission Delegated Regulation (EU) 2016/128 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 food for special medical purposes (Text with EEA relevance)
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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
| a Preformed vitamin A; RE = all trans retinol equivalent. | ||||
| b Preformed niacin. | ||||
| c Dietary folate equivalent: 1 μg DFE = 1 μg food folate = 0,6 μg folic acid from food for special medical purposes. | ||||
| d Based on vitamin E activity of RRR-α-tocopherol. | ||||
| e The calcium:available phosphorus molar ratio shall not be less than 1 nor greater than 2. | ||||
| f Total phosphorus. | ||||
| Per 100 kJ | Per 100 kcal | |||
|---|---|---|---|---|
| Minimum | Maximum | Minimum | Maximum | |
| Vitamins | ||||
| Vitamin A (μg-RE)a | 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 B6 (μg) | 4,8 | 72 | 20 | 300 |
| Niacin (mg)b | 0,1 | 0,72 | 0,4 | 3 |
| Folate (μg-DFE)c | 3,6 | 11,4 | 15 | 47,6 |
| Vitamin B12 (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)d | 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)e | 12 | 60 | 50 | 250 |
| Phosphorus (mg)f | 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 |
(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).
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