Regulation 3 Amendment of the principal Regulation

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.

”.

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.