# 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), Annex II

Extent: E+W+S+N.I.

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·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
’

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Source: https://www.legislation.gov.uk/eur/2014/497/annex/II (the official version)
Page: https://openlegislation.uk/eu-regulation-2014-497/annex-II
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.