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Ashwani Maindola, New Delhi November 30 , 2015
Following the publishing of proposed amendment to food products standards and food additives norms and Central government taking in to consideration objections and suggestions received from the public, the apex food regulator has issued Food Safety and Standards (Food Products Standards and Food Additives) (Amendment) Regulations, 2015, with respect to the sweetener steviol glycoside or stevia used in various food products.

The FSSAI through this amendment has reframed the regulations with respect to the usage of stevia, which was earlier termed as artificial sweetener. Now steviol glycoside will be called as non-nutritive sweetener.  However, the FSSAI has also defined the articles of food and the limits for use.

FSSAI (Food Safety and Standards Authority of India) has proposed that in the regulation relating to “artificial sweetener,” the word shall be replaced by - Use of Non Nutritive Sweetener. According to the final draft, the non-nutritive sweetener mentioned in column (2) of the able below may be used only in the food articles mentioned in column (3) and in quantities not exceeding the limits mentioned in column (4) and as per the provisions contained in these regulations:

Sl.No. Name of
non-nutritive sweetener
Articles of food Maximum level (mg/kg)
(steviol equivalent)
(1) (2) (3) (4)
1 Steviol Glycoside Dairy-based drinks flavoured 200

Dairy-based desserts (ice cream, frozen desserts, cream toppings) 330

Yoghurt 200

Fruit nectars 200

Non-carbonated water- based
beverages (non-alcoholic)
200

Ice lollies or edible ice 270

Jams, jellies, marmalades 360

Ready-to-eat cereals 350

Carbonated water 200

Soft drink concentrate 200 (in the final product after reconstitution)

Chewing gum 3500



The draft says provided further that steviol glycoside may be marketed as a table top sweetener in tablet form powder and liquid which may contain seven mg as steviol equivalent per 100 mg.

Steviol glycoside, according to the definition put up by FSSAI, is a white to light yellow powder, odourless or having a slight characteristic odour. About 200-300 times sweeter than sucrose. The product is obtained from the leaves of stevia rebaudiana bertoni. The leaves are extracted with hot water and the aqueous extract is passed through an adsorption resin to trap and concentrate the component steviol glycosides. The resin is washed with a solvent alcohol to release the glycosides and the product is recrystallised from methanol or aqueous ethanol. Ion exchange resins may be used in the purification process. The final product may be spray-dried. Stevioside and rebaudioside A are the component glycosides of principal interest for their sweetening property. Associated glycosides include rebaudioside B, rebaudioside C, rebaudioside D, rebaudioside F, dulcoside A, rubusoside and steviolbioside which are generally present in preparations of steviol glycosides at levels lower than stevioside or rebaudioside A.

Steviol glycoside—
Synonym             INS No. 960

Chemical name     Stevioside:13-[(2-O-ß-D-glucopyranosyl-ß glucopyranosyl)oxy] kaur-16-en-18-oic acid, ß-D-glucopyranosyl ester

Rebaudioside A:13-[(2-O-ß-D-glucopyranosyl-3-O-ß-D-glucopyranosyl-ß-D-glucopyranosyl)oxy]kaur-16-en-18-oic acid, ß-D-glucopyranosyl ester

Empirical formula
Formula weight
Solubility
pH
Purity Total ash
Loss on drying
Residual solvents
Arsenic
Lead

Stevioside: C38H60O18
Rebaudioside A: C44H70O23

Stevioside: 804.88
Rebaudioside A: 967.03

Freely soluble in water Stevioside and rebaudioside A

The main peak in the chromatogram obtained by following the procedure in Method of Assay corresponds to either stevioside or rebaudioside A
Between 4.5 and 7.0 (1 in 100 solution)

Not more than per cent
Not more than 6 per cent (105°, 2h)

Not more than 200 mg/kg methanol and not more than 5000 mg/kg ethanol (Method I in Vol. 4, General Methods, Organic Components, Residual Solvents)

Not more than 1 mg/kg Determine by the atomic absorption hydride technique [Use Method II to prepare the test (sample) solution]

Not more than 1 mg/kg

Determine using an AAS/ICP-AES technique appropriate to the specified level. The selection of sample size and method of sample preparation may be based on the principles of the
methods described in Vol. 4 (under “General Methods, Metallic Impurities”)

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