Annex II to Regulation (EC) No 1333/2008 is amended as follows:
In Part B, in Table 2 ‘Sweeteners’, the following new entry is inserted after the entry for food additive E 968 Erythritol:
| ‘E 969 | Advantame’ |
In Part E, the following entries for E 969 are inserted in numerical order in the food categories referred to:
| Category number | E -Number | Name | Maximum level (mg/l or mg/kg as appropriate) | Footnotes | restrictions/exception |
|---|---|---|---|---|---|
| 01.4 | Flavoured fermented milk products including heat-treated products | ||||
| ‘E 969 | Advantame | 10 | only energy-reduced products or with no added sugar’ | ||
| 03 | Edible ices | ||||
| ‘E 969 | Advantame | 10 | only energy-reduced or with no added sugar’ | ||
| 04.2.2 | Fruit and vegetables in vinegar, oil, or brine | ||||
| ‘E 969 | Advantame | 3 | only sweet-sour preserves of fruit and vegetables’ | ||
| 04.2.3 | Canned or bottled fruit and vegetables | ||||
| ‘E 969 | Advantame | 10 | only fruit energy-reduced or with no added sugar’ | ||
| 04.2.4.1 | Fruit and vegetable preparations excluding compote | ||||
| ‘E 969 | Advantame | 10 | only energy-reduced’ | ||
| 04.2.5.1 | Extra jam and extra jelly as defined by Directive 2001/113/EC | ||||
| ‘E 969 | Advantame | 10 | only energy-reduced jams jellies and marmalades’ | ||
| 04.2.5.2 | Jam, jellies and marmalades and sweetened chestnut puree as defined by Directive 2001/113/EC | ||||
| ‘E 969 | Advantame | 10 | only energy-reduced jams, jellies and marmalades’ | ||
| 04.2.5.3 | Other similar fruit or vegetable spreads | ||||
| ‘E 969 | Advantame | 10 | only dried-fruit-based sandwich spreads, energy-reduced or with no added sugar’ | ||
| 05.1 | Cocoa and Chocolate products as covered by Directive 2000/36/EC | ||||
| ‘E 969 | Advantame | 20 | only energy-reduced or with no added sugars’ | ||
| 05.2 | Other confectionery including breath refreshening microsweets | ||||
| ‘E 969 | Advantame | 20 | only cocoa or dried fruit based, energy reduced or with no added sugar | ||
| E 969 | Advantame | 10 | only cocoa, milk, dried fruit or fat based sandwich spreads, energy-reduced or with no added sugar | ||
| E 969 | Advantame | 20 | only starch based confectionary energy reduced or with no added sugar | ||
| E 969 | Advantame | 10 | only confectionary with no added sugar | ||
| E 969 | Advantame | 60 | only breath-freshening micro-sweets, with no added sugar | ||
| E 969 | Advantame | 20 | only strongly flavoured freshening throat pastilles with no added sugar’ | ||
| 05.3 | Chewing gum | ||||
| ‘E 969 | Advantame | 200 | only with added sugars or polyols, as flavour enhancer | ||
| E 969 | Advantame | 400 | only with no added sugar’ | ||
| 05.4 | Decorations, coatings and fillings, except fruit based fillings covered by category 4.2.4 | ||||
| ‘E 969 | Advantame | 20 | only starch based confectionary energy reduced or with no added sugar | ||
| E 969 | Advantame | 10 | only confectionary with no added sugar | ||
| E 969 | Advantame | 20 | only cocoa or dried fruit based, energy reduced or with no added sugar | ||
| E 969 | Advantame | 4 | only sauces’ | ||
| 06.3 | Breakfast cereals | ||||
| ‘E 969 | Advantame | 10 | only breakfast cereals with a fibre content of more than 15 %, and containing at least 20 % bran, energy reduced or with no added sugar’ | ||
| 07.2 | Fine bakery wares | ||||
| ‘E 969 | Advantame | 10 | only essoblaten — wafer paper | ||
| E 969 | Advantame | 17 | only fine bakery products for special nutritional uses’ | ||
| 09.2. | Processed fish and fishery products including mollusks and crustaceans | ||||
| ‘E 969 | Advantame | 3 | only sweet-sour preserves and semi preserves of fish and marinades of fish, crustaceans and molluscs’ | ||
| 11.4.1 | Table Top Sweeteners in liquid form | ||||
| ‘E 969 | Advantame | quantum satis’ | |||
| 11.4.2 | Table Top Sweeteners in powder form | ||||
| ‘E 969 | Advantame | quantum satis'’ | |||
| 11.4.3 | Table Top Sweeteners in tablets | ||||
| ‘E 969 | Advantame | quantum satis’ | |||
| 12.4 | Mustard | ||||
| ‘E 969 | Advantame | 4’ | |||
| 12.5 | Soups and broths | ||||
| ‘E 969 | Advantame | 2 | only energy-reduced soups’ | ||
| 12.6 | Sauces | ||||
| ‘E 969 | Advantame | 4’ | |||
| 12.7 | Salads and savoury based sandwich spreads | ||||
| ‘E 969 | Advantame | 4 | only Feinkostsalat’ | ||
| 13.2 | Dietary foods for special medical purposes defined in Directive 1999/21/EC (excluding products from food category 13.1.5) | ||||
| ‘E 960 | Advantame | 10’ | |||
| 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) | ||||
| ‘E 960 | Advantame | 8’ | |||
| 14.1.3 | Fruit nectars as defined by Council Directive 2001/112/EC and vegetable nectars and similar products | ||||
| ‘E 969 | Advantame | 6 | only energy-reduced or with no added sugar’ | ||
| 14.1.4 | Flavoured drinks | ||||
| ‘E 969 | Advantame | 6 | only energy reduced or with no added sugar’ | ||
| 14.2.1 | Beer and malt beverages | ||||
| ‘E 969 | Advantame | 6 | only alcohol-free beer or with an alcohol content not exceeding 1,2 % vol; “Bière de table/Tafelbier/Table beer” (original wort content less than 6 %) except for “Obergäriges Einfachbier”; Beers with a minimum acidity of 30 milli-equivalents expressed as NaOH; Brown beers of the “oud bruin” type | ||
| E 969 | Advantame | 0,5 | only energy-reduced beer’ | ||
| 14.2.3 | Cider and perry | ||||
| ‘E 969 | Advantame | 6’ | |||
| 14.2.8 | Other alcholic drinks including spirits with less than 15 % of alcohol and mixtures of alcoholic drinks with non-alcoholic drinks | ||||
| ‘E 969 | Advantame | 6’ | |||
| 15.1 | Potato-, cereal-, flour- or starch-based snacks | ||||
| ‘E 969 | Advantame | 5’ | |||
| 15.2 | Processed nuts | ||||
| ‘E 969 | Advantame | 5’ | |||
| 16. | Desserts excluding products covered in category 1, 3 and 4 | ||||
| ‘E 969 | Advantame | 10 | only energy-reduced or with no added sugar’ | ||
| 17.1 | Food supplements supplied in a solid form including capsules and tablets and similar forms | ||||
| ‘E 969 | Advantame | 20’ | |||
| 17.2 | Food supplements supplied in a liquid form | ||||
| ‘E 969 | Advantame | 6’ | |||
| 17.3 | Food supplements supplied in a syrup-type or chewable form | ||||
| ‘E 969 | Advantame | 55’ | |||
In the Annex to Regulation (EU) No 231/2012, the following new entry is inserted after the entry for food additive E 968:
| Synonyms | |
| Definition | Advantame (ANS9801) is produced by chemical synthesis in a three-step process; production of the principal manufacturing intermediate, 3-hydroxy-4-methoxycinnamaldehyde (HMCA), followed by hydrogenation to form 3-(3-hydroxy-4-methoxyphenyl) propionaldehyde (HMPA). In the final step, the HMPA methanol solution (filtrate) is combined with aspartame to give the imine that under selective hydrogenation forms advantame. The solution is allowed to crystallise and crude crystals are washed. The product is re-crystallised and crystals are separated, washed and dried. |
| CAS No. | 714229-20-6 |
| Chemical name | N-[N-[3-(3-hydroxy-4-methoxyphenyl) propyl]-α-aspartyl]-L-phenylalanine 1-methyl ester, monohydrate (IUPAC); L-phenylalanine, N-[3-(3-hydroxy-4-methoxyphenyl)propyl]-L-alpha-aspartyl-, 2-methyl ester, monohydrate (CA) |
| Molecular formula | C24H30N2O7·H2O |
| Molecular weight | 476,52 g/mol (monohydrate) |
| Assay | Not less than 97,0 % and not more than 102,0 % on an anhydrous basis |
| Description | White to yellow powder |
| Identification | |
| Melting Point | 101,5 °C |
| Purity | |
| N-[N-[3-(3-hydroxy-4-methoxyphenyl)propyl-α-aspartyl]-L-phenylalanine (ANS9801-acid) | Not more than 1,0 % |
| Total other related substances | Not more than 1,5 % |
| Residual Solvents | Isopropyl acetate: Not more than 2 000 mg/kg Methyl acetate: Not more than 500 mg/kg Methanol: Not more than 500 mg/kg 2-Propanol: Not more than 500 mg/kg |
| Water content | Not more than 5,0 % (Karl Fischer method) |
| Residue on ignition | Not more than 0,2 % |
| Arsenic | Not more than 2 mg/kg |
| Lead | Not more than 1 mg/kg |
| Palladium | Not more than 5,3 mg/kg |
| Platinum | Not more than 1,7 mg/kg’ |