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)
Article 1
Placing on the market
Article 2
Compositional requirements
Article 3
Requirements on pesticides in food for special medical purposes developed to satisfy the nutritional requirements of infants and young children
Article 4
Name of the food
Article 5
Specific requirements on food information
Article 6
Specific requirements on the nutrition declaration
Article 7
Nutrition and health claims
Article 8
Specific requirements for food for special medical purposes developed to satisfy the nutritional requirements of infants
Article 9
Notification
Article 10
Directive 1999/21/EC
Article 11
Entry into force and application
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
|
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 B6 (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 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)(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
|
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 B6 (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 B12 (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 |
ANNEX II
ACTIVE SUBSTANCES REFERRED TO IN ARTICLE 3(3)
Chemical name of the substance |
Maximum residue level (mg/kg) |
Cadusafos |
0,006 |
Demeton-S-methyl/demeton-S-methyl sulfone/oxydemeton-methyl (individually or combined, expressed as demeton-S-methyl) |
0,006 |
Ethoprophos |
0,008 |
Fipronil (sum of fipronil and fipronil-desulfinyl, expressed as fipronil) |
0,004 |
Propineb/propylenethiourea (sum of propineb and propylenethiourea) |
0,006 |