Regulation 3 Amendment of the principal Regulations

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, [α] 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 Cl.
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.

”.

Lactitol
Synonyms…	Lactit, Lactositol, Lactobiosit.
Chemical name…	4-0-(β:-D-galactopyranosyl)-D-glucitol.
Empirical formula…	C₁₂H₂₄O₁₁.
Molecular weight…	344.32.
Specific rotation, [α] 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 Cl.
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.