[13.1.5 | Dietary foods for infants and young children for special medical purposes as defined by Directive 1999/21/EC and special formulae for infants |
13.1.5.1 | Dietary foods for infants for special medical purposes and special formulae for infants |
The additives of categories 13.1.1 and 13.1.2 are applicable |
E 170 | Calcium carbonate | quantum satis | | |
E 304(i) | L-ascorbyl palmitate | 100 | | |
E 331 | Sodium citrates | quantum satis | | |
E 332 | Potassium citrates | quantum satis | | |
E 333 | Calcium citrates | quantum satis | | |
E 338 | Phosphoric acid | 1 000 | (1) (4) | only for pH adjustment |
E 339 | Sodium phosphates | 1 000 | (1) (4) (20) | |
E 340 | Potassium phosphates | 1 000 | (1) (4) (20) | |
E 341 | Calcium phosphates | 1 000 | (1) (4) (20) | |
E 401 | Sodium alginate | 1 000 | | From four months onwards in special food products with adapted composition, required for metabolic disorders and for general tube-feeding |
E 405 | Propane-1, 2-diol alginate | 200 | | From 12 months onwards in specialised diets intended for young children who have cow’s milk intolerance or inborn errors of metabolism |
E 410 | Locust bean gum | 10 000 | | From birth onwards in products for reduction of gastro-oesophageal reflux |
E 412 | Guar gum | 10 000 | | From birth onwards in products in liquid formulae containing hydrolysed proteins, peptides or amino acids |
E 415 | Xanthan gum | 1 200 | | From birth onwards for use in products based on amino acids or peptides for use with patients who have problems with impairment of the gastrointestinal tract, protein mal-absorption or inborn errors of metabolism |
E 440 | Pectins | 10 000 | | From birth onwards in products used in case of gastro-intestinal disorders |
[E 466 | Sodium carboxy methyl cellulose, Cellulose gum | 10 000 | | From birth onwards in products for the dietary management of metabolic disorders] |
E 471 | Mono- and diglycerides of fatty acids | 5 000 | | From birth onwards in specialised diets, particularly those devoid of proteins |
E 472c | Citric acid esters of mono- and diglycerides of fatty acids | 7 500 | | only when sold as powder; From birth onwards |
E 472c | Citric acid esters of mono- and diglycerides of fatty acids | 9 000 | | only when sold as liquid; From birth onwards |
E 473 | Sucrose esters of fatty acids | 120 | | only products containing hydrolysed proteins, peptides and amino acids |
E 500 | Sodium carbonates | quantum satis | | only as rising agent |
E 501 | Potassium carbonates | quantum satis | | only as rising agent |
E 507 | Hydrochloric acid | quantum satis | | only as rising agent |
E 524 | Sodium hydroxide | quantum satis | | only for pH adjustment |
E 525 | Potassium hydroxide | quantum satis | | only for pH adjustment |
E 526 | Calcium hydroxide | quantum satis | | only for pH adjustment |
E 1450 | Starch sodium octenyl succinate | 20 000 | | only in infant formulae and follow-on formulae |
(1): The additives may be added individually or in combination |
(4): The maximum level is expressed as P 2 O 5 |
(20): E 339, E 340 and E 341 are authorised individually or in combination |
13.1.5.2 | Dietary foods for babies and young children for special medical purposes as defined in Directive 1999/21/EC |
[The additives of categories 13.1.2 and 13.1.3 are applicable, except for E 270, E 333, E 341] |
E 401 | Sodium alginate | 1 000 | | From four months onwards in special food products with adapted composition, required for metabolic disorders and for general tube-feeding |
E 405 | Propane-1, 2-diol alginate | 200 | | From 12 months onwards in specialised diets intended for young children who have cow’s milk intolerance or inborn errors of metabolism |
E 410 | Locust bean gum | 10 000 | | From birth onwards in products for reduction of gastro-oesophageal reflux |
E 412 | Guar gum | 10 000 | | From birth onwards in products in liquid formulae containing hydrolysed proteins, peptides or amino acids |
E 415 | Xanthan gum | 1 200 | | From birth onwards for use in products based on amino acids or peptides for use with patients who have problems with impairment of the gastrointestinal tract, protein mal-absorption or inborn errors of metabolism |
E 440 | Pectins | 10 000 | | From birth onwards in products used in case of gastro-intestinal disorders |
[E 466 | Sodium carboxy methyl cellulose, Cellulose gum | 10 000 | | From birth onwards in products for the dietary management of metabolic disorders] |
E 471 | Mono- and diglycerides of fatty acids | 5 000 | | From birth onwards in specialised diets, particularly those devoid of proteins |
E 472c | Citric acid esters of mono- and diglycerides of fatty acids | 7 500 | | only when sold as powder; From birth onwards |
E 472c | Citric acid esters of mono- and diglycerides of fatty acids | 9 000 | | only when sold as liquid; From birth onwards |
E 473 | Sucrose esters of fatty acids | 120 | | only products containing hydrolysed proteins, peptides and amino acids |
E 1450 | Starch sodium octenyl succinate | 20 000 | | |
13.2 | Dietary foods for special medical purposes defined in Directive 1999/21/EC (excluding products from food category 13.1.5) |
Products in this category can also contain additives that are allowed in the corresponding food categories |
Group I | Additives | | | |
Group II | Colours at quantum satis | quantum satis | | |
[Group III | Colours with combined maximum limit | 50 | (88) | ] |
Group IV | Polyols | quantum satis | | |
[E 104 | Quinoline Yellow | 10 | (61) | |
E 110 | Sunset Yellow FCF/Orange Yellow S | 10 | (61) | |
E 124 | Ponceau 4R, Cochineal Red A | 10 | (61) | ] |
E 160d | Lycopene | 30 | | |
E 200-213 | Sorbic acid — sorbates; Benzoic acid — benzoates | 1 500 | (1) (2) | |
E 338-452 | Phosphoric acid — phosphates — di-, tri- and polyphosphates | 5 000 | (1) (4) | |
E 405 | Propane-1, 2-diol alginate | 1 200 | | |
E 406 | Agar | quantum satis | | only foods in tablet and coated tablet form |
E 432-436 | Polysorbates | 1 000 | (1) | |
E 473-474 | Sucrose esters of fatty acids — sucroglycerides | 5 000 | (1) | |
E 475 | Polyglycerol esters of fatty acids | 5 000 | | |
E 477 | Propane-1,2-diol esters of fatty acids | 1 000 | | |
E 481-482 | Stearoyl-2-lactylates | 2 000 | (1) | |
E 491-495 | Sorbitan esters | 5 000 | (1) | |
E 950 | Acesulfame K | 450 | | |
E 951 | Aspartame | 1 000 | | |
E 952 | Cyclamic acid and its Na and Ca salts | 400 | (51) | |
E 954 | Saccharin and its Na, K and Ca salts | 200 | (52) | |
E 955 | Sucralose | 400 | | |
E 959 | Neohesperidine DC | 100 | | |
[E 960 | Steviol glycosides | 330 | (60) | ] |
E 961 | Neotame | 32 | | |
E 962 | Salt of aspartame-acesulfame | 450 | (11)a (49) (50) | |
[E 960 | Advantame | 10 | | ] |
(1): The additives may be added individually or in combination |
(2): The maximum level is applicable to the sum and the levels are expressed as the free acid |
(4): The maximum level is expressed as P 2 O 5 |
(11): Limits are expressed as (a) acesulfame K equivalent or (b) aspartame equivalent |
(49): The maximum usable levels are derived from the maximum usable levels for its constituent parts, aspartame (E 951) and acesulfame-K (E 950) |
(50): The levels for both E 951 and E 950 are not to be exceeded by use of the salt of aspartame-acesulfame, either alone or in combination with E 950 or E 951 |
(51): Maximum usable levels are expressed in free acid |
(52): Maximum usable levels are expressed in free imide |
[(60): Expressed as steviol equivalents] |
[(61): The total quantity of E 104, E 110, E 124 and the colours in Group III shall not exceed the maximum listed for Group III] |
[(88): Maximum limit for aluminium coming from aluminium lakes of E 120 cochineal, carminic acid, carmines 3 mg/kg only in liquid heat-treated products. No other aluminium lakes may be used. For the purposes of Article 22(1)(g) of Regulation (EC) No 1333/2008 that limit shall apply from 1 February 2013] |
13.3 | Dietary foods for weight control diets intended to replace total daily food intake or an individual meal (the whole or part of the total daily diet) |
Group I | Additives | | | |
Group II | Colours at quantum satis | quantum satis | | |
Group III | Colours with combined maximum limit | 50 | | |
Group IV | Polyols | quantum satis | | |
[E 104 | Quinoline Yellow | 10 | (61) | |
E 110 | Sunset Yellow FCF/Orange Yellow S | 10 | (61) | |
E 124 | Ponceau 4R, Cochineal Red A | 10 | (61) | ] |
E 160d | Lycopene | 30 | | |
E 200-213 | Sorbic acid — sorbates; Benzoic acid — benzoates | 1 500 | (1) (2) | |
E 338-452 | Phosphoric acid — phosphates — di-, tri- and polyphosphates | 5 000 | (1) (4) | |
E 405 | Propane-1, 2-diol alginate | 1 200 | | |
E 432-436 | Polysorbates | 1 000 | (1) | |
E 473-474 | Sucrose esters of fatty acids — sucroglycerides | 5 000 | (1) | |
E 475 | Polyglycerol esters of fatty acids | 5 000 | | |
E 477 | Propane-1,2-diol esters of fatty acids | 1 000 | | |
E 481-482 | Stearoyl-2-lactylates | 2 000 | (1) | |
E 491-495 | Sorbitan esters | 5 000 | (1) | |
E 950 | Acesulfame K | 450 | | |
E 951 | Aspartame | 800 | | |
E 952 | Cyclamic acid and its Na and Ca salts | 400 | (51) | |
E 954 | Saccharin and its Na, K and Ca salts | 240 | (52) | |
E 955 | Sucralose | 320 | | |
E 959 | Neohesperidine DC | 100 | | |
[E 960 | Steviol glycosides | 270 | (60) | ] |
E 961 | Neotame | 26 | | |
E 962 | Salt of aspartame-acesulfame | 450 | (11)a (49) (50) | |
[E 960 | Advantame | 8 | | ] |
(1): The additives may be added individually or in combination |
(2): The maximum level is applicable to the sum and the levels are expressed as the free acid |
(4): The maximum level is expressed as P 2 O 5 |
(11): Limits are expressed as (a) acesulfame K equivalent or (b) aspartame equivalent |
(49): The maximum usable levels are derived from the maximum usable levels for its constituent parts, aspartame (E 951) and acesulfame-K (E 950) |
(50): The levels for both E 951 and E 950 are not to be exceeded by use of the salt of aspartame-acesulfame, either alone or in combination with E 950 or E 951 |
(51): Maximum usable levels are expressed in free acid |
(52): Maximum usable levels are expressed in free imide |
[(60): Expressed as steviol equivalents] |
[(61): The total quantity of E 104, E 110, E 124 and the colours in Group III shall not exceed the maximum listed for Group III] |
13.4 | Foods suitable for people intolerant to gluten as defined by Regulation (EC) No 41/2009 |
Products in this category can also use additives that are allowed in the corresponding food counterparts categories |
Group I | Additives | | | including dry pasta |
Group II | Colours at quantum satis | quantum satis | | |
Group IV | Polyols | quantum satis | | |
E 338-452 | Phosphoric acid — phosphates — di-, tri- and polyphosphates | 5 000 | (1) (4) | |
In addition, all additives in the gluten containing counterparts are authorised |
| (1): The additives may be added individually or in combination |
| (4): The maximum level is expressed as P 2 O 5 |
14 | Beverages |
14.1 | Non-alcoholic beverages |
14.1.1 | Water, including natural mineral water as defined in Directive 2009/54/EC and spring water and all other bottled or packed waters |
E 338-452 | Phosphoric acid — phosphates — di-, tri- and polyphosphates | 500 | (1) (4) | only prepared table waters |
(1): The additives may be added individually or in combination |
(4): The maximum level is expressed as P 2 O 5 |
(48): Mineral salts added to prepared table waters for standardisation are not classified as additives |
14.1.2 | Fruit juices as defined by Directive 2001/112/EC and vegetable juices |
Group I | Additives | | | only vegetable juices |
E 170 | Calcium carbonate | quantum satis | | only grape juice |
E 200-203 | Sorbic acid — sorbates | 500 | (1) (2) | only Sød … saft and sødet … saft |
E 200-213 | Sorbic acid — sorbates; Benzoic acid — benzoates | 2 000 | (1) (2) | only grape juice, unfermented, for sacramental use |
E 210-213 | Benzoic acid — benzoates | 200 | (1) (2) | only Sød … saft and sødet … saft |
E 220-228 | Sulphur dioxide — sulphites | 2 000 | (3) | only concentrated grape juice for home wine-making |
E 220-228 | Sulphur dioxide — sulphites | 50 | (3) | only orange, grapefruit, apple and pineapple juice for bulk dispensing in catering establishments |
E 220-228 | Sulphur dioxide — sulphites | 350 | (3) | only lime and lemon juice |
E 220-228 | Sulphur dioxide — sulphites | 70 | (3) | only grape juice, unfermented, for sacramental use |
E 296 | Malic acid | 3 000 | | only pineapple juice |
E 300 | Ascorbic acid | quantum satis | | |
E 330 | Citric acid | 3 000 | | |
E 336 | Potassium tartrates | quantum satis | | only grape juice |
E 440 | Pectins | 3 000 | | only pineapple and passion fruit juice |
E 900 | Dimethyl polysiloxane | 10 | | only pineapple juice and Sød … saft and sødet … saft |
(1): The additives may be added individually or in combination |
(2): The maximum level is applicable to the sum and the levels are expressed as the free acid |
(3): Maximum levels are expressed as SO 2 relate to the total quantity, available from all sources, an SO 2 content of not more than 10 mg/kg or 10 mg/l is not considered to be present |
14.1.3 | Fruit nectars as defined by Directive 2001/112/EC and vegetable nectars and similar products |
Group I | Additives | | | only vegetable nectars, E 420, E421, E 953, E965, E 966, E 967 and E 968 may not be used |
E 200-203 | Sorbic acid — sorbates | 300 | (1) (2) | only traditional Swedish and Finnish fruit syrups |
E 200-203 | Sorbic acid — sorbates | 250 | (1) (2) | only traditional Swedish fruit syrups, maximum applies if E 210-213, benzoic acid — benzoates, have also been used is |
E 210-213 | Benzoic acid — benzoates | 150 | (1) (2) | only traditional Swedish and Finnish fruit syrups |
E 270 | Lactic acid | 5 000 | | |
E 296 | Malic acid | quantum satis | | only traditional Swedish and Finnish fruit syrups |
E 300 | Ascorbic acid | quantum satis | | |
E 330 | Citric acid | 5 000 | | |
E 440 | Pectins | 3 000 | | only pineapple and passion fruit |
[E 466 | Sodium carboxy methyl cellulose, Cellulose gum | quantum satis | | only traditional Swedish and Finnish fruit syrups from citrus] |
E 950 | Acesulfame K | 350 | | only energy-reduced or with no added sugar |
E 951 | Aspartame | 600 | | only energy-reduced or with no added sugar |
E 952 | Cyclamic acid and its Na and Ca salts | 250 | (51) | only energy-reduced or with no added sugar |
E 954 | Saccharin and its Na, K and Ca salts | 80 | (52) | only energy-reduced or with no added sugar |
E 955 | Sucralose | 300 | | only energy-reduced or with no added sugar |
E 959 | Neohesperidine DC | 30 | | only energy-reduced or with no added sugar |
[E 960 | Steviol glycosides | 100 | (60) | only energy-reduced or with no added sugar] |
E 961 | Neotame | 20 | | only energy-reduced or with no added sugar |
E 962 | Salt of aspartame-acesulfame | 350 | (11)a (49) (50) | only energy-reduced or with no added sugar |
[E 969 | Advantame | 6 | | only energy-reduced or with no added sugar] |
(11): Limits are expressed as (a) acesulfame K equivalent or (b) aspartame equivalent |
(49): The maximum usable levels are derived from the maximum usable levels for its constituent parts, aspartame (E 951) and acesulfame-K (E 950) |
(50): The levels for both E 951 and E 950 are not to be exceeded by use of the salt of aspartame-acesulfame, either alone or in combination with E 950 or E 951 |
(51): Maximum usable levels are expressed in free acid |
(52): Maximum usable levels are expressed in free imide |
[(60): Expressed as steviol equivalents] |
14.1.4 | Flavoured drinks |
[Group I | Additives | | | E 420, E 421, E 953, E 965, E 966 and E 967 may not be used
E 968 may not be used except where specifically provided for in this food category]
|
[Group II | Colours at quantum satis | quantum satis | | excluding chocolate milk and malt products
Period of application:
until 31 July 2014
|
Group II | Colours at quantum satis | quantum satis | (74) | excluding chocolate milk and malt products
Period of application:
from 1 August 2014]
|
[Group III | Colours with combined maximum limit | 100 | (25) | excluding chocolate milk and malt products
Period of application:
until 31 July 2014
|
Group III | Colours with combined maximum limit | 100 | (25) (74) | excluding chocolate milk and malt products
Period of application:
from 1 August 2014]
|
[E 104 | Quinoline Yellow | 10 | (61) | excluding chocolate milk and malt products |
E 110 | Sunset Yellow FCF/Orange Yellow S | 20 | (61) | excluding chocolate milk and malt products |
E 124 | Ponceau 4R, Cochineal Red A | 10 | (61) | excluding chocolate milk and malt products] |
E 160d | Lycopene | 12 | | excluding dilutable drinks |
E 200-203 | Sorbic acid — sorbates | 300 | (1) (2) | excluding dairy-based drinks |
E 200-203 | Sorbic acid — sorbates | 250 | (1) (2) | maximum applies if E 210-213, benzoic acid — benzoates, have also been used is |
E 210-213 | Benzoic acid — benzoates | 150 | (1) (2) | excluding dairy-based drinks |
E 220-228 | Sulphur dioxide — sulphites | 20 | (3) | only carry over from concentrates in non-alcoholic flavoured drinks containing fruit juice |
E 220-228 | Sulphur dioxide — sulphites | 50 | (3) | only non-alcoholic flavoured drinks containing at least 235 g/l glucose syrup |
E 220-228 | Sulphur dioxide — sulphites | 350 | (3) | only concentrates based on fruit juice and containing not less than 2,5 % barley (barley water) |
E 220-228 | Sulphur dioxide — sulphites | 250 | (3) | only other concentrates based on fruit juice or comminuted fruit; capilé, groselha |
E 242 | Dimethyl dicarbonate | 250 | (24) | |
E 297 | Fumaric acid | 1 000 | | only instant powders for fruit-based drinks |
E 338-452 | Phosphoric acid — phosphates — di-, tri- and polyphosphates | 700 | (1) (4) | |
E 338-452 | Phosphoric acid — phosphates — di-, tri- and polyphosphates | 500 | (1) (4) | only sport drinks |
E 338-452 | Phosphoric acid — phosphates — di-, tri- and polyphosphates | 4 000 | (1) (4) | only whey protein containing sport drinks |
E 338-452 | Phosphoric acid — phosphates — di-, tri- and polyphosphates | 20 000 | (1) (4) | only vegetable protein drinks |
E 338-452 | Phosphoric acid — phosphates — di-, tri- and polyphosphates | 2 000 | (1) (4) | only chocolate and malt dairy-based drinks |
E 355-357 | Adipic acid — adipates | 10 000 | (1) | only powders for home preparation of drinks |
E 363 | Succinic acid | 3 000 | | only powders for home preparation of drinks |
E 405 | Propane-1, 2-diol alginate | 300 | | |
[E 423 | Octenyl succinic acid modified gum arabic | 1 000 | only in energy drinks and in drinks containing fruit juice | ] |
E 426 | Soybean hemicellulose | 5 000 | | only dairy-based drinks intended for retail sale |
E 444 | Sucrose acetate isobutyrate | 300 | | only cloudy drinks |
E 445 | Glycerol esters of wood rosins | 100 | | only cloudy drinks |
E 459 | Beta-cyclodextrin | 500 | | only flavoured powdered instant drinks |
E 473-474 | Sucrose esters of fatty acids — sucroglycerides | 5 000 | (1) | only aniseed-based, dairy-based, coconut and almond drinks |
E 473-474 | Sucrose esters of fatty acids — sucroglycerides | 10 000 | (1) | only powders for the preparation of hot beverages |
E 481-482 | Sodium and Calcium stearoyl-2-lactylates | 2 000 | (1) | only powders for the preparation of hot beverages |
E 900 | Dimethyl polysiloxane | 10 | | |
E 950 | Acesulfame K | 350 | | only energy-reduced or with no added sugar |
E 951 | Aspartame | 600 | | only energy-reduced or with no added sugar |
E 952 | Cyclamic acid and its Na and Ca salts | 250 | (51) | only energy-reduced or with no added sugar |
E 954 | Saccharin and its Na, K and Ca salts | 80 | (52) | only energy-reduced or with no added sugar |
E 954 | Saccharin and its Na, K and Ca salts | 100 | (52) | only ‘ gaseosa ’ energy-reduced or with no added sugar |
E 955 | Sucralose | 300 | | only energy-reduced or with no added sugar |
E 959 | Neohesperidine DC | 30 | | only energy-reduced or with no added sugar, except milk and milk derivative based flavoured drinks |
E 959 | Neohesperidine DC | 50 | | only milk and milk derivative based flavoured drinks, energy-reduced or with no added sugar |
E 957 | Thaumatin | 0,5 | | only water based flavoured non-alcoholic drinks, as flavour enhancer only |
[E 960 | Steviol glycosides | 80 | (60) | only energy reduced or with no added sugar] |
E 961 | Neotame | 20 | | only energy-reduced or with no added sugar |
E 961 | Neotame | 2 | | only energy-reduced or with no added sugar, as flavour enhancer |
E 962 | Salt of aspartame-acesulfame | 350 | (11)a (49) (50) | only energy-reduced or with no added sugar |
[E 968 | Erythritol | 16 000 | | only energy-reduced or with no added sugars, as flavour enhancer only] |
[E 969 | Advantame | 6 | | only energy reduced or with no added sugar] |
E 999 | Quillaia extract | 200 | (45) | |
(1): The additives may be added individually or in combination |
(2): The maximum level is applicable to the sum and the levels are expressed as the free acid |
(3): Maximum levels are expressed as SO 2 relate to the total quantity, available from all sources, an SO 2 content of not more than 10 mg/kg or 10 mg/l is not considered to be present |
(4): The maximum level is expressed as P 2 O 5 |
(11): Limits are expressed as (a) acesulfame K equivalent or (b) aspartame equivalent |
(49): The maximum usable levels are derived from the maximum usable levels for its constituent parts, aspartame (E 951) and acesulfame-K (E 950) |
(50): The levels for both E 951 and E 950 are not to be exceeded by use of the salt of aspartame-acesulfame, either alone or in combination with E 950 or E 951 |
(51): Maximum usable levels are expressed in free acid |
(52): Maximum usable levels are expressed in free imide |
(24): Ingoing amount, residues not detectable] |