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)
Modified by
- Commission Delegated Regulation (EU) 2020/566of 17 February 2020correcting certain language versions of Delegated Regulation (EU) 2016/128 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), 32020R0566, April 24, 2020
- Commission Delegated Regulation (EU) 2021/1040of 16 April 2021amending Delegated Regulation (EU) 2016/128 as regards the requirements on pesticides in food for special medical purposes developed to satisfy the nutritional requirements of infants and young children(Text with EEA relevance), 32021R1040, June 25, 2021
(a) nutritionally complete food with a standard nutrient formulation which, used in accordance with the manufacturer's instructions, may constitute the sole source of nourishment for the persons for whom it is intended; (b) nutritionally complete food with a nutrient-adapted formulation specific for a disease, disorder or medical condition which, used in accordance with the manufacturer's instructions, may constitute the sole source of nourishment for the persons for whom it is intended; (c) nutritionally incomplete food with a standard formulation or a nutrient-adapted formulation specific for a disease, disorder or medical condition which is not suitable to be used as the sole source of nourishment.
(a) a statement that the product must be used under medical supervision; (b) a statement whether the product is suitable for use as the sole source of nourishment; (c) a statement that the product is intended for a specific age group, as appropriate; (d) where appropriate, a statement that the product poses a health hazard when consumed by persons who do not have the disease, disorder or medical condition for which the product is intended; (e) the statement "For the dietary management of …" where the blank shall be filled in with the disease, disorder or medical condition for which the product is intended; (f) where appropriate, a statement concerning adequate precautions and contra-indications; (g) a description of the properties and/or characteristics that make the product useful in relation to the disease, disorder or medical condition for the dietary management of which the product is intended, in particular, as the case may be, relating to the special processing and formulation, the nutrients which have been increased, reduced, eliminated or otherwise modified and the rationale of the use of the product; (h) where appropriate, a warning that the product is not for parenteral use; (i) instructions for appropriate preparation, use and storage of the product after the opening of the container, as appropriate.
(a) the amount of each mineral substance and of each vitamin listed in Annex I to this Regulation and present in the product; (b) the amount of components of protein, carbohydrate, fat and/or of other nutrients and their components, the declaration of which would be necessary for the appropriate intended use of the product; (c) information on the osmolality or the osmolarity of the product where appropriate; (d) information on the source and the nature of the protein and/or protein hydrolysates contained in the product.
| Per 100 kJ | Per 100 kcal | |||
|---|---|---|---|---|
| Minimum | Maximum | Minimum | Maximum | |
| Vitamin A (μg-RE) | 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 | 4,8 | 72 | 20 | 300 |
| Niacin (mg) | 0,1 | 0,72 | 0,4 | 3 |
| Folate (μg-DFE) | 3,6 | 11,4 | 15 | 47,6 |
| Vitamin B | 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) | 0,14 | 1,2 | 0,6 | 5 |
| 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) | 12 | 60 | 50 | 250 |
| Phosphorus (mg) | 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 |
| Per 100 kJ | Per 100 kcal | |||
|---|---|---|---|---|
| Minimum | Maximum | Minimum | Maximum | |
| Vitamin A (μg-RE) | 8,4 | 43 | 35 | 180 |
| Vitamin D (μg) | 0,12 | 0,65/0,75 | 0,5 | 2,5/3 |
| 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 | 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 | 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 |
| 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 | 42/60 | 35/50 | 175/250 |
| 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 |
| Chemical name of the parent compound of the substance | Maximum residue level (mg/kg) |
|---|---|
| Cadusafos | 0,006 |
| 0,006 | |
| Ethoprophos | 0,008 |
| Fipronil | 0,004 |
| Propineb | 0,006 |
| Chemical name of the parent compound of the substance |
|---|
in Bulgarian: "Храни за специални медицински цели", in Spanish: "Alimento para usos médicos especiales", in Czech: "Potravina pro zvláštní lékařské účely", in Danish: "Fødevare til særlige medicinske formål", in German: "Lebensmittel für besondere medizinische Zwecke (bilanzierte Diät)", in Estonian: "Meditsiinilisel näidustusel kasutamiseks ettenähtud toit", in Greek: "Τρόφιμα για ειδικούς ιατρικούς σκοπούς", in English: "Food for special medical purposes", in French: "Denrée alimentaire destinée à des fins médicales spéciales", in Croatian: "Hrana za posebne medicinske potrebe", in Italian: "Alimento a fini medici speciali", in Latvian: "Īpašiem medicīniskiem nolūkiem paredzēta pārtika", in Lithuanian: "Specialios medicininės paskirties maisto produktai", in Hungarian: "Speciális gyógyászati célra szánt élelmiszer", in Maltese: "Ikel għal skopijiet mediċi speċjali", in Dutch: "Voeding voor medisch gebruik", in Polish: "Żywność specjalnego przeznaczenia medycznego", in Portuguese: "Alimento para fins medicinais específicos", in Romanian: "Alimente destinate unor scopuri medicale speciale", in Slovak: "Potraviny na osobitné lekárske účely", in Slovenian: "Živila za posebne zdravstvene namene", in Finnish: "Erityisiin lääkinnällisiin tarkoituksiin tarkoitettu elintarvike (kliininen ravintovalmiste)", in Swedish: "Livsmedel för speciella medicinska ändamål".
(a) nutritionally complete food with a standard nutrient formulation which, used in accordance with the manufacturer's instructions, may constitute the sole source of nourishment for the persons for whom it is intended; (b) nutritionally complete food with a nutrient-adapted formulation specific for a disease, disorder or medical condition which, used in accordance with the manufacturer's instructions, may constitute the sole source of nourishment for the persons for whom it is intended; (c) nutritionally incomplete food with a standard formulation or a nutrient-adapted formulation specific for a disease, disorder or medical condition which is not suitable to be used as the sole source of nourishment.
(a) a statement that the product must be used under medical supervision; (b) a statement whether the product is suitable for use as the sole source of nourishment; (c) a statement that the product is intended for a specific age group, as appropriate; (d) where appropriate, a statement that the product poses a health hazard when consumed by persons who do not have the disease, disorder or medical condition for which the product is intended; (e) the statement "For the dietary management of …" where the blank shall be filled in with the disease, disorder or medical condition for which the product is intended; (f) where appropriate, a statement concerning adequate precautions and contra-indications; (g) a description of the properties and/or characteristics that make the product useful in relation to the disease, disorder or medical condition for the dietary management of which the product is intended, in particular, as the case may be, relating to the special processing and formulation, the nutrients which have been increased, reduced, eliminated or otherwise modified and the rationale of the use of the product; (h) where appropriate, a warning that the product is not for parenteral use; (i) instructions for appropriate preparation, use and storage of the product after the opening of the container, as appropriate.
(a) the amount of each mineral substance and of each vitamin listed in Annex I to this Regulation and present in the product; (b) the amount of components of protein, carbohydrate, fat and/or of other nutrients and their components, the declaration of which would be necessary for the appropriate intended use of the product; (c) information on the osmolality or the osmolarity of the product where appropriate; (d) information on the source and the nature of the protein and/or protein hydrolysates contained in the product.
| Per 100 kJ | Per 100 kcal | |||
|---|---|---|---|---|
| Minimum | Maximum | Minimum | Maximum | |
| Vitamin A (μg-RE) | 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 | 4,8 | 72 | 20 | 300 |
| Niacin (mg) | 0,1 | 0,72 | 0,4 | 3 |
| Folate (μg-DFE) | 3,6 | 11,4 | 15 | 47,6 |
| Vitamin B | 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) | 0,14 | 1,2 | 0,6 | 5 |
| 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) | 12 | 60 | 50 | 250 |
| Phosphorus (mg) | 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 |
| Per 100 kJ | Per 100 kcal | |||
|---|---|---|---|---|
| Minimum | Maximum | Minimum | Maximum | |
| Vitamin A (μg-RE) | 8,4 | 43 | 35 | 180 |
| Vitamin D (μg) | 0,12 | 0,65/0,75 | 0,5 | 2,5/3 |
| 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 | 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 | 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 |
| 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 | 42/60 | 35/50 | 175/250 |
| 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 |
| Chemical name of the parent compound of the substance | Maximum residue level (mg/kg) |
|---|---|
| Cadusafos | 0,006 |
| 0,006 | |
| Ethoprophos | 0,008 |
| Fipronil | 0,004 |
| Propineb | 0,006 |
| Chemical name of the parent compound of the substance |
|---|
in Bulgarian: "Храни за специални медицински цели", in Spanish: "Alimento para usos médicos especiales", in Czech: "Potravina pro zvláštní lékařské účely", in Danish: "Fødevare til særlige medicinske formål", in German: "Lebensmittel für besondere medizinische Zwecke (bilanzierte Diät)", in Estonian: "Meditsiinilisel näidustusel kasutamiseks ettenähtud toit", in Greek: "Τρόφιμα για ειδικούς ιατρικούς σκοπούς", in English: "Food for special medical purposes", in French: "Denrée alimentaire destinée à des fins médicales spéciales", in Croatian: "Hrana za posebne medicinske potrebe", in Italian: "Alimento a fini medici speciali", in Latvian: "Īpašiem medicīniskiem nolūkiem paredzēta pārtika", in Lithuanian: "Specialios medicininės paskirties maisto produktai", in Hungarian: "Speciális gyógyászati célra szánt élelmiszer", in Maltese: "Ikel għal skopijiet mediċi speċjali", in Dutch: "Voeding voor medisch gebruik", in Polish: "Żywność specjalnego przeznaczenia medycznego", in Portuguese: "Alimento para fins medicinais específicos", in Romanian: "Alimente destinate unor scopuri medicale speciale", in Slovak: "Potraviny na osobitné lekárske účely", in Slovenian: "Živila za posebne zdravstvene namene", in Finnish: "Erityisiin lääkinnällisiin tarkoituksiin tarkoitettu elintarvike (kliininen ravintovalmiste)", in Swedish: "Livsmedel för speciella medicinska ändamål".