Date: 2015-02-09Category: Extra OrdinaryState: Union GovernmentCountry: India
Draft regulations. These regulations may be called the Food Safety and Standards (Food Products Standards and Food Additives) (Amendment) Regulations, 2015.
Executive Summary:
This notification from the Food Safety and Standards Authority of India proposes amendments to the Food Safety and Standards (Food Products Standards and Food Additives) Regulations, 2011, regarding artificial sweeteners. It publishes draft regulations for public feedback, with a 30-day period for objections or suggestions following the availability of the Official Gazette. The notification was issued on February 6, 2015.
Key Points / Main Content:
Artificial Sweetener Regulation:
* A new sub-regulation 6 is inserted after sub-regulation 5 in regulation 3.1.3, concerning the "Use of Non-Nutritive Sweetener."
* Specifies that non-nutritive sweeteners can only be used in certain food articles within specified limits.
* Sets maximum levels (mg/kg) for steviol equivalents in various food items, including dairy drinks, desserts, yogurt, fruit nectars, beverages, ice lollies, jams, cereals, carbonated water, soft drink concentrates, and chewing gum.
* Steviol Glycoside may be marketed as a table top sweetener in tablet form, containing 7mg Steviol equivalent per 100mg.
Standards for Food Additives:
* A new sub-regulation 3.2.2 is inserted after sub-regulation 3.2.1 in regulation 3.2, concerning "Sweetener" standards.
* Establishes standards for Steviol Glycoside, defining it as a white to light yellow powder derived from Stevia rebaudiana bertoni leaves.
* Specifies extraction and purification processes involving hot water, adsorption resin, solvent alcohol, methanol or aqueous ethanol, and potentially ion exchange resins.
* Lists component glycosides, including Stevioside and Rebaudioside A, along with associated glycosides.
* Includes synonyms (INS no. 960) and chemical names for Stevioside and Rebaudioside A.
* Defines empirical formulas (C38H60O18 for Stevioside; C44H70O23 for Rebaudioside A) and formula weights (804.88 for Stevioside; 967.03 for Rebaudioside A).
* Specifies solubility (freely soluble in water) and pH (between 4.5 and 7.0 in 1 in 100 solution).
* Sets purity standards: Total ash not more than 1%, Loss on drying not more than 6% at 105°C for 2 hours, Residual solvents not more than 200 mg/kg methanol and 5000 mg/kg ethanol.
* Limits for Arsenic (not more than 1 mg/kg) and Lead (not more than 1 mg/kg) are specified.
Impact Analysis:
Food Manufacturers:
* Impact: Must comply with the new regulations regarding the use of non-nutritive sweeteners and the specified limits in various food products.
* Action Required: Reformulate products as necessary to meet the new standards for steviol glycoside and other non-nutritive sweeteners, ensuring compliance with the stipulated maximum levels.
Food Safety and Standards Authority of India:
* Impact: Responsible for considering objections and suggestions from the public regarding the draft regulations.
* Action Required: Review and address any feedback received during the 30-day comment period, and finalize the amendment regulations.
Consumers:
* Impact: Will have access to food products that adhere to the revised standards for non-nutritive sweeteners.
* Action Required: Be aware of the new regulations and provide feedback to the Food Safety and Standards Authority of India during the comment period if they have any concerns or suggestions.
Stakeholders involved in Food and Drug Administration:
* Impact: They need to be aware of the changes and prepared to help implement the new changes.
* Action Required: Become familiar with the changes, implement them where necessary, and prepare to help others with implementation.
Key Entities Referenced
Food Safety and Standards Authority of India: An authority responsible for food safety and standards in India. It proposes amendments to regulations.
Food Safety and Standards Act, 2006: The Act under which the Food Safety and Standards Authority of India exercises its powers to regulate food safety.
Food Safety and Standards Food Products Standards and Food Additives Regulations, 2011: The regulations being amended by this notification. They pertain to food product standards and food additives.
Central Government: The governing body that provides previous approval for the amendments proposed by the Food Safety and Standards Authority of India.
Steviol Glycoside: A non-nutritive sweetener derived from Stevia rebaudiana bertoni leaves, with specifications and usage limits defined in the regulation.
New Delhi: The city where the notification is issued and the location of the Food Safety and Standards Authority of India's office.
YUDHVIR SINGH MALIK: The Chief Executive Officer of the Food Safety and Standards Authority of India.
Food and Drug Administration Bhawan, Kotla Road, New Delhi-110002: Address of Food Safety and Standards Authority of India
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PART III —Section 4
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((((भभभभााााररररततततीीीीयययय खखखखाााा(cid:3)(cid:3)(cid:3)(cid:3) ससससुरुरुरुर(cid:7)(cid:7)(cid:7)(cid:7)ाााा औऔऔऔरररर ममममााााननननकककक (cid:8)(cid:8)(cid:8)(cid:8)ााााििििधधधधककककररररणणणण))))
अअअअििििधधधधससससचचूूचचूू ननननाााा
नई (cid:1)द(cid:3)ली, 6 फरवरी, 2015
फफफफाााा.... सससस..ंं..ंं पपपपीीीी.... 11115555000022225555////222200008888////2222000011113333----पपपपीीीीएएएए////एएएएफफफफएएएएससससएएएएससससएएएएआआआआईईईई.—खा(cid:8) सुर(cid:12)ा और मानक (खा(cid:8) उ(cid:15)प ाद मानक और खा(cid:8) उपभो(cid:23)य )
िविनयम, 2011 का और संशोधन करने के िलए, कितपय िविनयम(cid:27) का िन(cid:28)िलिखत (cid:30)(cid:31)प, भारतीय खा(cid:8) सुर(cid:12)ा और मानक (cid:30)ािधकरण
के#$ीय सरकार के पूव& अनुमोदन से, खा(cid:8) सुर(cid:12)ा और मानक अिधिनयम, 2006 (2006 का 34) क’ धारा 16 के साथ प(ठत धारा 92 क’
उपधारा (2) के खंड (ङ) *ारा (cid:30)द+ शि-य(cid:27) का (cid:30)योग करते /ए बनाने का (cid:30)2ताव करती ह,ै उन सभी 5ि-य(cid:27) क’ जानकारी के िलए
उ6 त उपधारा (1) क’ अपे(cid:12)ानुसार (cid:30)कािशत (cid:1)कया जाता है, िजनके उससे (cid:30)भािवत होने क’ संभावना है और यह सूचना दी जाती है (cid:1)क
उ- (cid:30)ा(cid:31)प िविनयम(cid:27) पर उस तारीख से, िजसको उस राजप9 क’ (cid:30)ितया,ं िजसम ; यह अिधसूचना (cid:30)कािशत क’ जाती है, जनता को
उपल<ध करा दी जाती ह,ै तीस (cid:1)दन(cid:27) क’ अविध क’ समाि= के प>ात ्िवचार (cid:1)कया जाएगा ;
आ(cid:12)ेप या सुझाव, य(cid:1)द कोई ह(cid:27), मुAय काय&कारी अिधकारी, भारतीय खा(cid:8) सुर(cid:12)ा और मानक (cid:30)ािधकरण, खा(cid:8) और vkSषिध
(cid:30)शासन भवन, कोटला रोड, नई (cid:1)द(cid:3)ली-110002 को भेजे जा सक;गे ।
उ6 त (cid:30)ा(cid:31)प िविनयम(cid:27) के संबंध म ;(cid:1)कसी 5ि- से (cid:30)ा= आ(cid:12)ेप(cid:27) और सुझाव(cid:27) पर िविनCदD अविध के अवसान से पूव& खा(cid:8) (cid:30)ािधकरण
*ारा िवचार (cid:1)कया जाएगा ;
(cid:8)(cid:8)(cid:8)(cid:8)ाााा(cid:13)(cid:13)(cid:13)(cid:13)पपपप ििििववववििििननननययययमममम
1. (1) इन िविनयम(cid:27) का संि(cid:12)= नाम खा(cid:8) सुर(cid:12)ा और मानक (खा(cid:8) उ(cid:15)प ाद मानक और खा(cid:8) सहयो(cid:23)य ) (संशोधन) िविनयम,
2015 ह ै।
2. खा(cid:8) सुर(cid:12)ा और मानक (खा(cid:8) उ(cid:15) पाद मानक और खा(cid:8) सहयो(cid:23)य ) िविनयम, 2011 म,;-
(क) "कृि9म मधुरक" से संबंिधत िविनयम 3.1.3 म; उप िविनयम (5) के पFच ात् िनमन् िलिखत उप-िविनयम अंत:2थ ािपत (cid:1)कया
जाएगा, अथा&त:्-
"(6) गगगगैरैरैरैर----पपपपौौौौिििि(cid:21)(cid:21)(cid:21)(cid:21)टट टट कककक ममममधधधधुरुरुरुरकककक ककककाााा उउउउपपपपययययोोोोगगगग,- नीचे दी गई सारणी के 2त ंभ (2) म; वIणत गैर-पौिKट क मधुरक का उपयोग केवल 2त भं (3)
म; वIणत चीज(cid:27) म; और 2 तभं (4) म; वIणत सीमाM से अनिधक मा9ाM म; तथा इन िविनयम(cid:27) म; अंतIवKट उपबंध(cid:27) के अनुसार ही (cid:1)कया जा
सकेगा :
702 GI/2015 (1)2 THE GAZETTE OF INDIA : EXTRAORDINARY [PART III—SEC. 4]
ससससााााररररणणणणीीीी
Oम स.ं गैर पौिK टक मधुरक खा(cid:8) चीज ; अिधकतम 2त र
का उपयोग (िमलीPाम/(cid:1)कलोPाम) (2ट ीिवयोल
समतु(cid:3)य )
(1) (2) (3) (4)
1 2 टीिवयोल सुवा2 य डेयरी आधा(रत पेय 200
Q लीकोसाइड
डेयरी आधा(रत डेजSस& (आइसO’म (cid:30)शीितत डेजट&, O’म 330
टोTपQस
योगाट& 200
फल ने6 टर 200
अकाब&नीकृत जल आधा(रत सुपेय (गैर अ(cid:3)क ोहिलक) 200
आइसलोलीज या खा(cid:8) बफ& 270
जैम, जैली, मामा&लेVस 360
खाने के िलए तैयार अनाज 350
काब&िनकृत जल 200
साWट TX6 स सां$ 200 (पुनग&ठन के पFच ात् अंितम
उ(cid:15)प ाद म;
Yयुइंगम 3500
परंतु यह और (cid:1)क 2 टीिवयोल Q लीकोसाइड का िवपणन टेबलेट के (cid:31)प म; टेबल टॉप मधुरक के (cid:31)प म; (cid:1)कया जा सकेगा िजसम;
िविनयम 3.1.3 के उप-िविनयम (1) के 2 पK टीकरण II के दसू रे परंतुक म; वIणत कै(रयर या (cid:1)फ(cid:3)ल र के साथ (cid:30)ित सौ िमिलPाम म ;
2 टीिवयोल समतु(cid:3) य 7 िमिलPाम अंतIवK ट हो सकेगा" ।
(ख) "खा(cid:8) अिभयो(cid:23) य(cid:27) के मानक" से संबंिधत िविनयम 3.2 म; उप-िविनयम 3.2.1 के पFच ात् िन[न िलिखत उप-िविनयम
अंत:2 थिपत (cid:1)कया जाएगा, अथा&त:्-
"3.2.2 मधुरक:- अिभल(cid:12)ण(cid:27) के साथ िविभ# न मधुरक(cid:27) के िलए मानक इस (cid:30)कार ह \–
(1) (cid:23)(cid:23)(cid:23)(cid:23)टट टट ीीीीििििववववययययोोोोलललल (cid:27)(cid:27)(cid:27)(cid:27)लल लल ीीीीककककोोोोससससााााइइइइडडडड –सफेद से ह(cid:3) का पीला पाउडर, गंधहीन या ह(cid:3)क ’ चा(रि9क गंध । सुOोज से 200-300 गुणा मधुर । इस
उ(cid:15) पाद को 2 टेिवया रेबाउिडयाना बटोनी के प(cid:15) त(cid:27) से अिभ(cid:30)ा^त (cid:1)कया जाता ह ै। प(cid:15)त (cid:27) को गम& जल से िनKक Iषत (cid:1)कया जाता है और जलीय
िनK कष&ण को 2 टीिवयोल Q लीकोसाइड संघटक के सांaण को (cid:30)ा^त करने के िलए एक एडसो^श&न से गुजारा जाता ह ै । रेTजन को
Q लूीकोसाइड को मु6 त करने के िलए एक घोलक ए(cid:3) कोहल से धोया जाता ह ै और उ(cid:15)प ाद को मेिथनोल या ए6उ अस इथनोल से पुन:
(cid:1)O2 टलीकृत (cid:1)कया जाता ह ै आयोन ए6 सच;ज रेिजन का उपयोग शुbकरण (cid:30)(cid:1)Oया म; (cid:1)कया जा सकता ह ै । अंितम उ(cid:15)प ाद को 2(cid:30) े शुिKक त
(cid:1)कया जा सकेगा । 2 टीिवयोसाइड और (रबाउिडयोसाइड A संघटक Qल ीकोसाइड उनके मधुरक गुणधम& के कारण मुAय िहत क’ व2त ु ह ै ।
सहबb Q लीकोसाइड म; (रबाउिडयोसाइड बी, (रबाउिडयोसाइड C, (रबाउिडयोसाइड D, (रबाउिडयोसाइड एफ, ड(cid:3) कोसाइड A,
cबोसोसाइड और 2 टीिवयोल वायोसाइड जो साधारणतया 2ट ीिवयोल Q लुकोसाइड क’ िनIमितय(cid:27) म; 2ट ीिवयोसाइड या (रबाउिडयोसाइड
A से कम 2 तर पर िव(cid:8)मान होते ह \।
समानाथd आईएनएस सं. 960
रासायिनक नाम 2 टीिवयोसाइड: 13-[(2-O-β-D Qल कु ोपायरेनोसाइल-β
Q लकु ोपायरेनोसाइल) आ6स ी] कोर -16 ईएन 18 ओआईसी अ[ल β- D- Qल ुकोपायरेनोसाइल
ई2 टर
(रेबोिडयोसाइड A: 13- [2(O- β -D Qल ुकोपायरेनोसाइड-3-ओ- β- D Qल ुकोपायरेनोसाइल- β-
D Q लकु ोपायरेनोसाइल) आ6स ी ] कोर-16-ईएन-18-ओआईसी अ[ल - β- D Qल ुकोपायरेनोसाइल
ई2 टर
मू(cid:3) य परक सू9 2 टीिवयोसाइड C- H O
38 60 18;
(रबाउिडयोसाइड A: C- H O
44 70 23;
सू9 भार 2 टीिवयोसाइड 804.88 (रबाउिडयोसाइड A:967.03¹Hkkx IIIµ[k.M 4º Hkkjr dk jkti=k % vlk/kj.k 3
घुलनशीलता जल म; मु6 त (cid:31)प से घुलनशील
2 टीिवयोसाइड और
(रबाउिडयोसाइड A
6लोरोमेटोPाम म; मुAय चरम सीमा परख िविध क’ (cid:30)(cid:1)Oया का 2ट ीिवयोसाइड या
(रबाउिडयोसाइड A का अनुसरण करके (cid:30)ा= क’ जाती ह ै।
pH 4.5 और 7.0 (100 घोलक(cid:27) म; से 1) के बीच
शुbता
कुल भ2म
(cid:30)ितशत से अिधक नहg
शुKकन पर नुकसान 6 (cid:30)ितशत से अिधक नहg (105 िडPी, 2h)
अविशD घोलक मेथनोल 200 एमजी/केजी से अिधक नहg और इथनोल 5000 एमजी/केजी से अिधक नहg
(मेथनोल I खंड 4 म,; साधारण िविधयां, काब&िनक संघटक, अविशKट घोलक
असhिनक 1 एमजी/केजी से अिधक नहg
आणिवक अवशोषण हाइXाइड तकनीक *ारा अवधा(रत (परी(cid:12)ण तैयार करने के िलए िविध II
(नमूना) घोलक)
सीसा 1 एमजी/केजी से अिधक नहg
िविनCदK ट 2त र के िलए उपयु6त AAS/ICP-AES तकनीक का उपयोग करके अवधा(रत ।
नमूना आकार और नमूना तैयार करने क’ िविध खंड 4 (''साधारण िविधयां, धाि(cid:15)व क अशुbताएं
के अधीन) म; वIणत िसbातं (cid:27) के आधार पर आधा(रत हो सकेगा")।''
युbवीर Tसह मिलक, मुAय काय&कारी अिधकारी
foKkiu& vlk vks
[ III/4/ ./187- /14]
(cid:28)(cid:28)(cid:28)(cid:28)टटटट(cid:29)(cid:29)(cid:29)(cid:29)पपपपणणणण :::: मूल िविनयम भारत के राजप9, असाधारण, भाग III, खंड 4 म; अिधसूचना सं. 2-15015/30/2010 तारीख 1 अग2त, 2011
*ारा (cid:30)कािशत (cid:1)कए गए थे और उनका प>ातवतd संशोधन िन(cid:28)िलिखत अिधसूचना संAयांक(cid:27) *ारा (cid:1)कया गयाः-
1. फा. सं. 4/15015/30/2011 तारीख 7 जून, 2013 ।
2. फा. सं. पी.15014/2011-पीएफए/एफएसएसएआई, तारीख 27 जून, 2013 ।
3. फा. सं. 5/15015/30/2012 तारीख 12 जुलाई, 2013 ।
4. फा. सं. पी.15025/262/2013-पीए/एफएसएसएआई, 5, (cid:1)दसंबर, 2014
MINISTRY OF HEALTH AND FAMILY WELFARE
(Food Safety and Standards Authority of India)
NOTIFICATION
New Delhi, the 6th February, 2015
F. No P. 15025/208/2013-PA/FSSAI.—The following draft of certain regulations further to amend the Food
Safety and Standards (Food Products Standards and Food Additives) Regulations, 2011, which the Food Safety and
Standards Authority of India proposes to make with the previous approval of Central Government, in exercise of the
powers conferred by clause (e) of sub-section (2) of section 92 read with section 16 of the Food Safety and Standards
Act, 2006 (34 of 2006), hereby publishes as required by sub-section (1) of section 92 of the said Act, for the information
of all persons likely to be affected thereby, and notice is hereby given that the said draft regulations shall be taken into
consideration after the expiry of the period of thirty days from the date on which the copies of the Official Gazette in
which this notification is published are made available to the public;
Objections or suggestions, if any, may be addressed to the Chief Executive Officer, Food Safety and Standards
Authority of India, Food and Drug Administration Bhawan, Kotla Road, New Delhi-110002;
Any objections or suggestions, which may be received from any person with respect to the said draft regulation
before the expiry of the period so specified, shall be considered by the Food Authority.4 THE GAZETTE OF INDIA : EXTRAORDINARY [PART III—SEC. 4]
Draft regulations
1. (1) These regulations may be called the Food Safety and Standards (Food Products Standards and Food Additives)
(Amendment) Regulations, 2015.
2. In the Food Safety and Standards (Food Products Standards and Food Additives) Regulations, 2011,-
(a) in regulation 3.1.3 relating to “Artificial Sweetener”, after sub regulation (5), the following sub-regulation shall be
inserted, namely:-
“(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:
TABLE
Sl.No. Name of non-nutritive Articles of food Maximum level (mg/kg)
sweetener (steviol equivalent)
(1) (2) (3) (4)
1 Steviol Glycoside Dairy based drinks flavored 200
Dairy based desserts (ice-cream, frozen desserts, 330
cream toppings)
Yoghurt 200
Fruit Nectars 200
Non carbonated water based beverages (non 200
alcoholic)
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
Provided further that the Steviol Glycoside may be marketed as table top sweetener in tablet 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”.
(b) In regulation 3.2 relating to “Standards of food additives”, after sub-regulation 3.2.1 the following sub-regulation
shall be inserted, namely:-
“3.2.2 Sweetener:- The standards for various sweeteners with characteristics are –
(1) Steviol Glycoside- White to light yellow powder, odorless or having a slight characteristic odor. 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-glucopyranosyl-3-O-β-D-glucopyranosyl-β-D-
glucopyranosyl)oxy]kaur-16-en-18-oic acid, β-D-glucopyranosyl ester.
Empirical formula Stevioside: C H O
38 60 18
Rebaudioside A: C H O
44 70 23
Formula weight Stevioside: 804.88
Rebaudioside A: 967.03.¹Hkkx IIIµ[k.M 4º Hkkjr dk jkti=k % vlk/kj.k 5
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”).”
YUDHVIR SINGH MALIK, Chief Executive Officer
[ADVT. III/4/Exty./187-O/14]
Note: - The principal regulations were published in the Gazette of India, Extraordinary, Part III, Section 4, vide
notification number F. No: 2-15015/30/2010, dated 1st August, 2010 and subsequently amended vide notification
numbers:
(i) F.No. 4/15015/30/2011, dated the 7th June, 2013.
(ii) F.No. P.15014/1/2011-PFA/FSSAI, dated the 27th June, 2013
(iii) F.No. 5/15015/30/2012, dated the 12th July, 2013 and
(iv) F.No. P.15025/262/13-PA/FSSAI dated the 5th, December, 2014
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