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Commission Regulation (EU) No 497/2014Show full title

Commission Regulation (EU) No 497/2014 of 14 May 2014 amending Annex II to Regulation (EC) No 1333/2008 of the European Parliament and of the Council and the Annex to Commission Regulation (EU) No 231/2012 as regards the use of Advantame as a sweetener (Text with EEA relevance)

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ANNEX IU.K.

Annex II to Regulation (EC) No 1333/2008 is amended as follows:

(1)

In Part B, in Table 2 ‘Sweeteners’, the following new entry is inserted after the entry for food additive E 968 Erythritol:

E 969Advantame
(2)

In Part E, the following entries for E 969 are inserted in numerical order in the food categories referred to:

PART E: AUTHORISED FOOD ADDITIVES AND CONDITIONS OF USE IN FOOD CATEGORIESU.K.

Category numberE -NumberNameMaximum level (mg/l or mg/kg as appropriate)Footnotesrestrictions/exception
01.4 Flavoured fermented milk products including heat-treated products
‘E 969Advantame10only energy-reduced products or with no added sugar’
03 Edible ices
‘E 969Advantame10only energy-reduced or with no added sugar’
04.2.2 Fruit and vegetables in vinegar, oil, or brine
‘E 969Advantame3only sweet-sour preserves of fruit and vegetables’
04.2.3 Canned or bottled fruit and vegetables
‘E 969Advantame10only fruit energy-reduced or with no added sugar’
04.2.4.1 Fruit and vegetable preparations excluding compote
‘E 969Advantame10only energy-reduced’
04.2.5.1 Extra jam and extra jelly as defined by Directive 2001/113/EC
‘E 969Advantame10only 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 969Advantame10only energy-reduced jams, jellies and marmalades’
04.2.5.3 Other similar fruit or vegetable spreads
‘E 969Advantame10only 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 969Advantame20only energy-reduced or with no added sugars’
05.2 Other confectionery including breath refreshening microsweets
‘E 969Advantame20only cocoa or dried fruit based, energy reduced or with no added sugar
E 969Advantame10only cocoa, milk, dried fruit or fat based sandwich spreads, energy-reduced or with no added sugar
E 969Advantame20only starch based confectionary energy reduced or with no added sugar
E 969Advantame10only confectionary with no added sugar
E 969Advantame60only breath-freshening micro-sweets, with no added sugar
E 969Advantame20only strongly flavoured freshening throat pastilles with no added sugar’
05.3 Chewing gum
‘E 969Advantame200only with added sugars or polyols, as flavour enhancer
E 969Advantame400only with no added sugar’
05.4 Decorations, coatings and fillings, except fruit based fillings covered by category 4.2.4
‘E 969Advantame20only starch based confectionary energy reduced or with no added sugar
E 969Advantame10only confectionary with no added sugar
E 969Advantame20only cocoa or dried fruit based, energy reduced or with no added sugar
E 969Advantame4only sauces’
06.3 Breakfast cereals
‘E 969Advantame10only 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 969Advantame10only essoblaten — wafer paper
E 969Advantame17only fine bakery products for special nutritional uses’
09.2. Processed fish and fishery products including mollusks and crustaceans
‘E 969Advantame3only 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 969Advantame quantum satis’
11.4.2 Table Top Sweeteners in powder form
‘E 969Advantame quantum satis'’
11.4.3 Table Top Sweeteners in tablets
‘E 969Advantame quantum satis’
12.4 Mustard
‘E 969Advantame4’
12.5 Soups and broths
‘E 969Advantame2only energy-reduced soups’
12.6 Sauces
‘E 969Advantame4’
12.7 Salads and savoury based sandwich spreads
‘E 969Advantame4only Feinkostsalat
13.2 Dietary foods for special medical purposes defined in Directive 1999/21/EC (excluding products from food category 13.1.5)
‘E 960Advantame10’
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 960Advantame8’
14.1.3 Fruit nectars as defined by Council Directive 2001/112/EC and vegetable nectars and similar products
‘E 969Advantame6only energy-reduced or with no added sugar’
14.1.4 Flavoured drinks
‘E 969Advantame6only energy reduced or with no added sugar’
14.2.1 Beer and malt beverages
‘E 969Advantame6only 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 969Advantame0,5only energy-reduced beer’
14.2.3 Cider and perry
‘E 969Advantame6’
14.2.8 Other alcholic drinks including spirits with less than 15 % of alcohol and mixtures of alcoholic drinks with non-alcoholic drinks
‘E 969Advantame6’
15.1 Potato-, cereal-, flour- or starch-based snacks
‘E 969Advantame5’
15.2 Processed nuts
‘E 969Advantame5’
16. Desserts excluding products covered in category 1, 3 and 4
‘E 969Advantame10only energy-reduced or with no added sugar’
17.1 Food supplements supplied in a solid form including capsules and tablets and similar forms
‘E 969Advantame20’
17.2 Food supplements supplied in a liquid form
‘E 969Advantame6’
17.3 Food supplements supplied in a syrup-type or chewable form
‘E 969Advantame55’

ANNEX IIU.K.

In the Annex to Regulation (EU) No 231/2012, the following new entry is inserted after the entry for food additive E 968:

E 969 ADVANTAME

Synonyms
DefinitionAdvantame (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 formulaC24H30N2O7·H2O
Molecular weight476,52 g/mol (monohydrate)
AssayNot less than 97,0 % and not more than 102,0 % on an anhydrous basis
DescriptionWhite to yellow powder
Identification
Melting Point101,5 °C
Purity
N-[N-[3-(3-hydroxy-4-methoxyphenyl)propyl-α-aspartyl]-L-phenylalanine (ANS9801-acid)Not more than 1,0 %
Total other related substancesNot 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 contentNot more than 5,0 % (Karl Fischer method)
Residue on ignitionNot more than 0,2 %
ArsenicNot more than 2 mg/kg
LeadNot more than 1 mg/kg
PalladiumNot more than 5,3 mg/kg
PlatinumNot more than 1,7 mg/kg

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