Amendment of the principal Regulation
3. Schedule 1 to the principal Regulations shall be amended as follows:—
(a)in Part I (permitted Sweeteners) after the item relating to “Isomalt” there shall be inserted—
| In Column 1 | In Column 2 |
| (Name of Sweetener) | (Serial Number) |
| “Lactitol ... ... ... ...” | “ ... ... ... ...”; |
(b)in Part II, (specific purity criteria for permitted sweeteners) after the item relating to “Isomalt” there shall be inserted—
| “Lactitol | |
| Synonyms | Lactit, Lactositol, Lactobiosit. |
| Chemical name | 4-0-(β-D-galactopyranosyl)-D-glucitol |
| Empirical formula | C12H24O11. |
| Molecular weight | 344.32. |
| Specific rotation [7agr;] 20°C/D | + 13° to + 15° (using a 10% weight to volume aqueous solution). |
| Water | Lactitol monohydrate not more than 5.5% |
| (Karl Fischer). | |
| Lactitol dihydrate not more than 10.5% | |
| (Karl Fischer). | |
| Description | Colourless, aqueous syrup with a sweet taste. When dried, the resulting products, lactitol monohydrate and lactitol dihydrate, are white, odourless and crystalline. |
| Content | Not less than 97.5% 4-0-(β-D-galactopyranosyl)-D-glucitol on a dry weight basis. |
| Other polyols | Not more than 2.5% on a dry weight basis. |
| Reducing sugars | Not more than 0.2% on a dry weight basis, expressed as lactose. |
| Chlorides | Not more than 100 mg/kg on a dry weight basis, expressed as C1. |
| Sulphate | Not more than 100 mg/kg on a dry weight basis, expressed as SO4. |
| Arsenic | Not more than 1 mg/kg on a dry weight basis, expressed as As. |
| Nickel | Not more than 1 mg/kg on a dry weight basis, expressed as Ni. |
| Lead | Not more than 1 mg/kg on a dry weight basis, expressed as Pb. |
| Ash | Not more than 0.1% after ignition at 800 ± 25°C calculated on a dry weight basis.”. |