In the recently concluded 16th Authority meeting, FSSAI, the apex regulator had proposed approval for Steviol Glycoside as additive in particular foods as a non nutritive sweetener. Through a notification dated 6th February 2015 the FSSAI has now issued a draft regulation for the same inviting objections and suggestions. Once published in the Official Gazette these regulations would be called Food Safety and Standards (Food Products Standards and Food Additives Amendment) Regulations, 2015 and would be effective 30 days after publication.
The existing regulations on food additives would get amended upon the implementation of this notification in the following manner:
In the FSSR, 3.1.3 relating to “Artificial Sweetener”, after sub regulation (5), the following sub regulation shall be inserted;
“(6) Use of Non Nutritive Sweetener.- The non nutritive sweetener mentioned in column (2) of the Table 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.
S. No. | Name of non-nutritive sweetener | Food Category | Based on JECFA ADI of 1-4mg/kg bw as per codex) |
---|---|---|---|
!. | Steviol Glycoside | Dairy based drinks flavoured | 200 |
Dairy based deserts (ice cream, frozen desserts, cream toppings) | 330 | ||
Yoghurt | 200 | ||
Fruit nectars | 200 | ||
Non carbonated water based beverages (non alcoholic) | 200 | ||
Ice Lollies, Edible ice | 270 | ||
Jams, jellies, marmalade | 360 | ||
Ready to eat cereals | 350 | ||
Carbonated water | 200 | ||
Soft drink concentrate | 200* | ||
Chewing gum | 3500 |
* In soft drink the maximum level mentioned is for final product after reconstitution.
Provided further that the Steviol Glycoside may be marketed as table top sweetener in tablet, powder and liquid form which may contain seven mg as Steviol equivalent per 100 mg with carrier or filler as mentioned in the second proviso of Explanation II of sub-regulation (1) of regulation 3.1.3”. (FBOs can refer this from FSS Act, Rules & Regulations)
The draft notification further proposes standards for Steviol Glycoside and the same will be reflected under FSSR as;
“3.2.2 Sweetener: – The standards for various sweeteners with characteristics are–
Steviol Glycoside – 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 re-crystallized 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
Synonyms: INS no.960.
Chemical name
Stevioside: 13-[(2-O-β-D-glucopyranosyl-β glucopyranosyl)oxy] kaur-16-en- 18-oic acid, β-D-glucopyranosyl ester.
Rebaudioside A: 13-[(2-O-β-D-glucopyranosy1-3-O-β-D-glucopyranosyl-β-D- glucopyranosyl)oxy]kaur-16-en-18-oic acid, β-D-glucopyranosyl ester.
Empirical formula: Stevioside: C₃₈H₆₀ O₁₈, Rebaudioside A: C₄₄H₇₀O₂₃
Formula weight: Stevioside: 804.88, Rebaudioside A: 967.03.
Solubility:
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
pH: Between 4.5 and 7.0 (1 in 100 solution)
PURITY
Total ash: Not more than per cent
Loss on drying: Not more than 6 per cent (105°, 2h).
Residual solvents:
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)
Arsenic: Not more than 1 mg/kg Determine by the atomic absorption hydride technique (Use Method II to prepare the test (sample) solution)
Lead: 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”).”
To view Original Notification: http://www.fssai.gov.in/Portals/0/Pdf/Draft_Notification_Steviol.pdf
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