ANNEX IISupplementary provisions
ANNEX II 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 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·H 2 O 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’