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Commission Directive 2010/37/EU (repealed)Show full title
Commission Directive 2010/37/EU of 17 June 2010 amending Directive 2008/60/EC laying down specific purity criteria on sweeteners (Text with EEA relevance) (repealed)
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ANNEX
In Annex I to Directive 2008/60/EC the following entry E 961 is inserted after the entry E 959:
| ‘E 961 — NEOTAME | |
|---|---|
| Synonyms | N-[N-(3,3-dimethylbutyl)-L-α-aspartyl]-L-phenylalanine 1-methyl ester, N(3,3-dimethylbutyl)-L-aspartyl-L-phenylalanine methyl ester |
| Definition | Neotame is manufactured by reaction under hydrogen pressure of aspartame with 3,3,-dimethylbutyraldehyde in methanol in presence of a palladium/carbon catalyst. It is isolated and purified by filtration, where diatomaceous earth may be used. After solvent removal via distillation, neotame is washed with water, isolated by centrifugation and finally vacuum dried |
| CAS No | 165450-17-9 |
| Chemical name | N-[N-(3,3-dimethylbutyl)-L-α-aspartyl]-L-phenylalanine 1-methyl ester |
| Chemical formula | C20H30N2O5 |
| Molecular weight | 378,47 |
| Description | white to off-white powder |
| Assay | Not less than 97,0 % on the dried basis |
| Identification | |
| Solubility | 4,75 % (w/w) at 60 °C in water, soluble in ethanol and ethyl acetate |
| Purity | |
| Water content | Not more than 5 % (Karl Fischer, sample size 25 ± 5 mg) |
| pH | 5,0 – 7,0 (0,5 % aqueous solution) |
| Melting range | 81 °C to 84 °C |
| N-[(3,3-dimethylbutyl)-L-α-aspartyl]-L-phenylalanine | Not more than 1,5 % |
| Lead | Not more than 1 mg/kg’ |
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