Home India Ministry of Health and Family Welfare Whereas the draft of the Food Safety and Standards Food Prod...
Date: 2016-12-06 Category: Extra Ordinary State: Union Government Country: India

Whereas the draft of the Food Safety and Standards Food Products Standards and Food Additives

Issued by Ministry of Health and Family Welfare · Food Safety and Standards Authority

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Executive Summary & Key Takeaways

Executive Summary: This notification from the Food Safety and Standards Authority of India announces the Food Safety and Standards (Food Products Standards and Food Additives) Thirteenth Amendment Regulations, 2016. These regulations amend the 2011 regulations, introducing standards for caffeinated beverages and allowing blue tint in certain plastic containers for water packaging. The regulations come into force on the date of publication in the Official Gazette, with Food Business Operators required to comply by July 1, 2017. Key Points / Main Content: * **Amendment Title:** Food Safety and Standards (Food Products Standards and Food Additives) Thirteenth Amendment Regulations, 2016. * **Effective Date:** Regulations are effective from the date of publication in the Official Gazette. * **Compliance Deadline:** Food Business Operators must comply with all provisions by July 1, 2017. **Caffeinated Beverages Standards:** * **Water Quality:** Water used must meet packaged drinking water standards as per regulation 2.10.8 of the 2011 regulations. * **Caffeine Content:** Must contain between 145mg and 300mg of total caffeine per liter. * **Optional Ingredients:** May contain additional substances approved by the Food Authority after safety assessment. * **Daily Consumption:** A label declaration stating "consume not more than 500 ml per day" is required. * **Vitamins:** Thiamine, riboflavin, niacin, vitamin B6, and vitamin B12 may be added at one Recommended Daily Allowance level. * **Other Standards:** Must conform to standards for carbonated water regarding ingredients, flavors, sweeteners, food additives, contaminants, and microbiological requirements. * **Labeling Requirements:** Must comply with general labeling requirements, including: * "High Caffeine: X mg/serving size" where X is the caffeine amount. * Cautionary statement: "Not recommended for children, pregnant or lactating women, persons sensitive to caffeine." **Packaging Standards:** * **Blue Tint for Water Packaging:** Allows blue tint in polycarbonate and Poly Ethylene Terephthalate (PET) plastic containers (five liters and above) used for packaging mineral water and packaged drinking water. * **Pigment Migration Limit:** Overall migration of pigment/color used in containers must not exceed 60 mg/liter as per IS: 9845. Impact Analysis: Food Business Operators: * Impact: Must comply with the new standards for caffeinated beverages, including composition, labeling, and any modifications to packaging requirements for water products. * Action Required: Update product formulations, labels, and packaging to meet the new regulations by July 1, 2017. Consumers: * Impact: Will have access to caffeinated beverages that adhere to specific safety and quality standards, and benefit from clearer labeling regarding caffeine content and consumption recommendations. * Action Required: Be aware of the caffeine content and recommended consumption limits of caffeinated beverages. Food Safety and Standards Authority of India: * Impact: Responsible for enforcing the new regulations and assessing the safety of any additional ingredients proposed for caffeinated beverages. * Action Required: Implement and monitor compliance with the new regulations, and review any applications for additional ingredients in caffeinated beverages.

Key Entities Referenced

Food Safety and Standards Authority of India: An authority that is responsible for food safety and standards in India and is publishing the notification. Food Safety and Standards Act, 2006: The act under which the Food Safety and Standards Authority of India is established and functions. Food Safety and Standards Food Products Standards and Food Additives Regulations, 2011: A set of regulations related to food product standards and food additives, which are being amended by this notification. Food Safety and Standards Food Products Standards and Food Additives Amendment Regulations, 2013: Amendment regulations that were published for inviting suggestions and objections Food Safety and Standards Food Products Standards and Food Additives Thirteenth Amendment Regulations, 2016: The title of the regulations being introduced through this notification. New Delhi: The city where the notification is issued. Official Gazette: The official publication in which the regulations are published. Ministry of Health and Family Welfare: The ministry under which the Food Safety and Standards Authority of India operates.
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jftLVªh laö Mhö ,yö&33004@99 REGD. NO. D. L.-33004/99 vlk/kj.k EXTRAORDINARY Hkkx III—[k.M 4 PART III—Section 4 izkf/dkj ls izdkf'kr PUBLISHED BY AUTHORITY la- 446] ubZ fnYyh] eaxyokj] fnlEcj 6] 2016@vxzgk;.k 15] 1938 No. 446] NEW DELHI, TUESDAY DECEMBER 6, 2016/AGRAHAYANA 15, 1938 (cid:7021)वा(cid:7021)(cid:7005)य और प(cid:7407)रवार क(cid:7016)याण म(cid:7074)ं ालय (भारतीय खा(cid:7378) सुर(cid:6979)ा और मानक (cid:7079)ािधकरण) अिधसचू ना नई (cid:7408)द(cid:7016)ली, 2 (cid:7408)दस(cid:7013)बर, 2016 एफ.स.ं पी./15025/93/2011-पीएफ़ए/एफ़एसएसएआई.—खा(cid:7378) सुर(cid:6979)ा और मानक (खा(cid:7378) उ(cid:7004)पाद मानक और खा(cid:7378) सहयो(cid:6996)य) संशोधन िविनयम, 2013 का (cid:7079)ा(cid:7272)प खा(cid:7378) सरु (cid:6979)ा और मानक अिधिनयम, 2006 (2006 का 34) क(cid:7409) धारा 92 क(cid:7409) उप-धारा (1) क(cid:7409) अपे(cid:6979)ानुसार, भारतीय खा(cid:7378) सुर(cid:6979)ा और मानक (cid:7079)ािधकरण क(cid:7409) अिधसूचना सं. एफ.स. 5/15015/30/2011 तारीख 18 अ(cid:7079)ैल, 2013 (cid:7367)ारा भारत के राजप(cid:7074), असाधारण, भाग III, खंड 4 म (cid:7286) (cid:7079)कािशत (cid:7408)कया गया था िजसम(cid:7286) उन (cid:7390)ि(cid:7334)य(cid:7298) स,े िजनके उसस े (cid:7079)भािवत होन े क(cid:7409) संभावना थी, उस तारीख स े िजसको उ(cid:7334) अिधसूचना वाले राजप(cid:7074) क(cid:7409) (cid:7079)ितया ं जनता को उपल(cid:7011)ध करा दी गय(cid:7277) थी, तीस (cid:7408)दन(cid:7298) क(cid:7409) अविध क(cid:7409) समाि(cid:7385) के पूव(cid:6981) आ(cid:6979)पे और सुझाव आमंि(cid:7074)त (cid:7408)कए गए थे ; और उ(cid:7334) राजप(cid:7074) क(cid:7409) (cid:7079)ितयां जनता को 18 अ(cid:7079)लै , 2013 को उपल(cid:7011)ध करा दी गई थ(cid:7277) ; और भारतीय खा(cid:7378) सुर(cid:6979)ा और मानक (cid:7079)ािधकरण (cid:7367)ारा उ(cid:7334) (cid:7079)ा(cid:7272)प िविनयम(cid:7298) के संबंध म (cid:7286) जनता स े (cid:7079)ा(cid:7385) आ(cid:6979)ेप(cid:7298) और सुझाव(cid:7298) पर िवचार कर िलया गया ह ै; अतः, अब, भारतीय खा(cid:7378) सुर(cid:6979)ा और मानक (cid:7079)ािधकरण, उ(cid:7334) अिधिनयम क(cid:7409) धारा 16 के साथ प(cid:7407)ठत धारा 92 क(cid:7409) उपधारा (2) के खडं (ङ) (cid:7367)ारा (cid:7079)द(cid:7275) शि(cid:7334)य(cid:7298) का (cid:7079)योग करत े (cid:7263)ए, खा(cid:7378) सुर(cid:6979)ा और मानक (खा(cid:7378) उ(cid:7004)पाद मानक और खा(cid:7378) सहयो(cid:6996)य) िविनयम, 2011 का और संशोधन करने के िलए िन(cid:7388)िलिखत िव िनयम बनाती ह,ै अथा(cid:6981)त ्:- 5610 GI/2016 (1) .2 THE GAZETTE OF INDIA : EXTRAORDINARY [PART III—SEC. 4] िविनयम 1.(cid:32) संि(cid:6979)(cid:7385) नाम और (cid:7079)ारंभ - (1) इन िविनयम(cid:7298) का संि(cid:6979)(cid:7385) नाम खा(cid:7378) सुर(cid:6979)ा और मानक (खा(cid:7378) उ(cid:7004)पाद मानक और खा(cid:7378) सहयो(cid:6996)य) तेरहवाँ संशोधन िविनयम, 2016 ह ै। (2) य े राजप(cid:7074) म (cid:7286) इनके (cid:7079)काशन क(cid:7409) तारीख को (cid:7079)वृ(cid:7275) ह(cid:7298)गे तथा खा(cid:7378) कारोबार (cid:7079)चालक(cid:7298) को 1 जलु ाई, 2017 से इन िविनयम(cid:7298) के सभी (cid:7079)ावधान(cid:7298) का अनपु ालन करना होगा । 2 खा(cid:7378) सुर(cid:6979)ा और मानक (खा(cid:7378) उ(cid:7004)पाद मानक और खा(cid:7378) सहयो(cid:6996)य) िविनयम, 2011, के (क) िविनयम 2.10 के उप-िविनयम 2.10.6 “गरै ए(cid:7016)कोहालीई काब(cid:6981)नीकृत” से संबि(cid:7008)धत के खंड 1 के बाद िन(cid:7388)िलिखत खंड अतं : (cid:7021)थािपत (cid:7408)कया जाएगा, अथा(cid:6981)त्:- “2. कै(cid:7408)फनयु(cid:7334) पेय. – कै(cid:7408)फनयु(cid:7334) पेय के िलए िन(cid:7388)िलिखत मानक ह:(cid:7289) - (I)(cid:32) कै(cid:7408)फनयु(cid:7334) पेय को तैयार करने के िलए (cid:7079)योग होन े वाला जल खा(cid:7378) सुर(cid:6979)ा और मानक (खा(cid:7378) उ(cid:7004)पाद मानक और खा(cid:7378) सहयो(cid:6996)य) िविनयम 2011, के िविनयम 2.10.8 म(cid:7286) िनिहत पैकेज बंद पेय जल के मानक(cid:7298) के अनु(cid:7272)प होना चािहए। (II)(cid:32) आव(cid:7019)यक सि(cid:7013)म(cid:7088)ण:- उ(cid:7004)पाद क(cid:7409) िविनिमत(cid:7278) म(cid:7286) कुल कैफ(cid:7409)न (cid:7079)ित लीटर 145 िम(cid:7061)ा से कम और 300 िम(cid:7061)ा से अिधक नह(cid:7277) होगी चाह े (cid:7408)कसी भी (cid:7403)ोत से (cid:7390)ु(cid:7004)पप(cid:7382) क(cid:7409) जाए। (III)(cid:32) वकै ि(cid:7016)पक साम(cid:7061)ीः इसम(cid:7286) िन(cid:7388)िलिखत हो सकत ेह:(cid:7289) नीचे दी गई सारणी के (cid:7021)त(cid:7013)भ (1) म(cid:7286) सूचीब(cid:7373) उपादान म(cid:7286) स े कोई परंत ु सारणी के (cid:7021)त (cid:7013) भ (2) म (cid:7286) उस उपादान स े संबि(cid:7008)धत िविन(cid:7416)द(cid:7397) मा(cid:7074)ा से अिधक न हो। (क) उ(cid:7334) सारणी म (cid:7286) िनिहत उपादान स े अ(cid:7008)य कोई (cid:7079)(cid:7021)तािवत व(cid:7021)तु या सामा(cid:7061)ी, सुर(cid:6979)ा िनधा(cid:6981)रण और वै(cid:6980)ािनक सा(cid:7023)य (cid:7079)माणन के बाद, खा(cid:7378) (cid:7079)ािधकरण से अनुमोदन पर जोड़ी जा सकेगी। (i) लेबल पर एक घोषणा ‘‘(cid:7079)ित (cid:7408)दन 500 िमली स े अिधक उपभोग न कर(cid:7286)’’ जो (cid:7079)ित(cid:7408)दन क(cid:7409) मा(cid:7074)ा को दशा(cid:6981)ती ह।ै (ii) (cid:7079)ित(cid:7408)दन क(cid:7409) मा(cid:7074)ा कै(cid:7408)फनयु(cid:7334) (पैकेज या सव(cid:6981) के (cid:7272)प म)(cid:7286) पेय क(cid:7409) अिधकतम मा(cid:7074)ा ह ै जो एक (cid:7408)दन म(cid:7286) उपभोग क(cid:7409) जाए और उप-खंड (iii) के अनुसार िनि(cid:7391)त क(cid:7409) गई ह।ै (iii) जहां िन(cid:7388)िलिखत सारणी के (cid:7021)त(cid:7013)भ (1) म(cid:7286) (cid:7408)दया गया कोई भी उपादान, (cid:7021)त(cid:7013)भ (2) म(cid:7286) (cid:7408)दए गए उ(cid:7340)तम (cid:7021)तर तक उपभोग (cid:7263)आ, वह एक (cid:7408)दन क(cid:7409) मा(cid:7074)ा िन(cid:7272)िपत करेगा और सव(cid:6981) (cid:7408)कए जाने वाले पैक के आधार पर घोषणा क(cid:7409) जाएगी, जो(cid:7408)क संचयी (cid:7272)प से स(cid:7301)पा जाता ह ैजब एक (cid:7408)दन म(cid:7286) उपभोग (cid:7408)कया गया हो। (cid:7021)प(cid:7397)ीकरण:- “य(cid:7408)द 250 िमली पैक म(cid:7286) टॉ(cid:7407)रन 1000 िम(cid:7061)ा और D-(cid:6991)लूकोरोनो- Y-लै(cid:6989)टोन 300 िम(cid:7061)ा (cid:7079)यु(cid:7334) होती ह,ै तो 2×250 िम(cid:7061)ा पैक क(cid:7409) खपत करन े पर एक (cid:7408)दन क(cid:7409) मा(cid:7074)ा प(cid:7263)चं जाती ह।ै य(cid:7408)द पैक का आकार 125 िमली क(cid:7409) बोतल का ह ैतब (cid:7079)ित(cid:7408)दन क(cid:7409) मा(cid:7074)ा 4×125 िमली बोतल(cid:7298) क(cid:7409) खपत तक प(cid:7263)चं जाती ह।ै “ (ख) िवटािमन जैसे िथयामाइन, (cid:7407)रबो(cid:7080)लािवन, िनआिसन, िवटािमन बी6, िवटािमन बी12 एक अनुशंिसत दैिनक अनुमोदन (cid:7021)तर (100% अनुशंिसत दैिनक अनुमित) पर सि(cid:7013)मिलित (cid:7408)कए जा सकते ह।(cid:7289)¹Hkkx IIIµ[k.M 4º Hkkjr dk jkti=k % vlk/kj.k 3 सारणी (cid:7021)त(cid:7013)भ (1) (cid:7021)त(cid:7013)भ (2) उपादान (cid:7079)ित (cid:7408)दन उपभोग क(cid:7409) अिधकतम मा(cid:7074)ा टॉ(cid:7407)रन 2000िम(cid:7061)ा D-(cid:6991)लूकोरोना-Ү-लै(cid:6989)टोन 1200िम(cid:7061)ा आइनोिसटोल 100िम(cid:7061)ा प(cid:7289)टोथ(cid:7286)िनक एिसड 10िम(cid:7061)ा (IV) मधुरक(cid:7298), खा(cid:7378) सहयो(cid:6996)य(cid:7298), संदषू क(cid:7298) और सू(cid:7023)म जैिवक(cid:7298) क(cid:7409) अप(cid:6979)े ा(cid:7312) के िवषय म(cid:7286) उ(cid:7004)पाद काब(cid:6981)नीकृत जल के मानक(cid:7298) के अन(cid:7272)ु प होगा। (V) लबे (cid:7410)लग: उ(cid:7004)पाद िन(cid:7388)िलिखत अित(cid:7407)र(cid:7334) उपबंध(cid:7298) के साथ, पूव(cid:6981)-पैकेट बंद खा(cid:7378)(cid:7298) के िलए, खा(cid:7378) सुर(cid:6979)ा और मानक (पैके(cid:7410)जग और लेब(cid:7410)लग) िविनयम, 2011 क(cid:7409) साधारण लेब(cid:7410)लग अपे(cid:6979)ा(cid:7312) के सभी उपबंध(cid:7298) के अनु(cid:7272)प होगा- अ) उ(cid:7340) कै(cid:7408)फन: ‘‘X िम(cid:7061)ा/स(cid:7418)वग आकार’’ (जहां (cid:7079)ित पैक/सव(cid:6981) िमिल(cid:7061)ाम म (cid:7286)कै(cid:7408)फन क(cid:7409) मा(cid:7074)ा X ह;ै आ) चेतावनी का (cid:7079)मुखता (cid:7079)दश(cid:6981)न ‘‘ब(cid:7340)(cid:7298), गभव(cid:6981) ती या (cid:7021)तनपान करान े वाली मिहला(cid:7312) के िलए, कै(cid:7408)फन के (cid:7079)ित संवदे नशील (cid:7390)ि(cid:7334)य(cid:7298) के िलए अनशु िं सत नह(cid:7277)।” ख) उपिविनयम 2.10.7 म(cid:7286), खंड 4 के प(cid:7391)ात िन(cid:7388)िलिखत खडं अंत:(cid:7021)थािपत (cid:7408)कया जाएगा, अथा(cid:6981)त ् :- “5. पैके(cid:7410)जग िमनरल वाटर के िलए (cid:7079)यु(cid:7334) पॉली काब(cid:7299)नेट और पोली इिथलीन टेरे(cid:7009)थेलेट (पीईटी) से बन े पाँच लीटर या उससे अिधक के (cid:7009)लाि(cid:7021)टक आधान म (cid:7286) (cid:7011)ल ू (cid:7411)टट भारतीय मानक आईएस : 9833 के अनसु ार अनु(cid:6980)ात क(cid:7409) जा सकेगी: परंत ु आधान म (cid:7286) (cid:7079)यु(cid:7334) रंजक/रंग का कुल िवचलन आईएस 9845 के अनुसार 60 िम (cid:7061)ा॰(cid:7079)ित लीटर स े अिधक नह(cid:7277) होना चािहए।”; ग) उपिविनयम 2.10.8 म(cid:7286), खंड 5 के प(cid:7391)ात िन(cid:7388)िलिखत खडं अंत:(cid:7021)थािपत (cid:7408)कया जाएगा, अथा(cid:6981)त ् :- “6. पैके(cid:7410)जग िमनरल वाटर के िलए (cid:7079)यु(cid:7334) पॉली काब(cid:7299)नेट और पोली इिथलीन टेरे(cid:7009)थेलेट (पीईटी) से बन े पाँच लीटर या उससे अिधक के (cid:7009)लाि(cid:7021)टक आधान म (cid:7286) (cid:7011)ल ू (cid:7411)टट भारतीय मानक आईएस : 9833 के अनसु ार अनु(cid:6980)ात क(cid:7409) जा सकेगी: परंत ु आधान म (cid:7286) (cid:7079)यु(cid:7334) रंजक/रंग का कुल िवचलन आईएस 9845 के अनुसार 60 िम (cid:7061)ा॰ (cid:7079)ित लीटर स े अिधक नह(cid:7277) होना चािहए।”; [िव(cid:6980)पान- III/ 4/ असा.333(187-(cid:6989)य ू] पवन अ(cid:7061)वाल, मु(cid:6990)य काय(cid:6981)कारी अिधकारी (cid:7407)ट(cid:7009)पण : मूल िव िन यम भारत के राजप(cid:7074), असाधारण, भाग-III, खंड 4 म (cid:7286) अिध सूचना सं(cid:6990)यां3क फा.सं.2-15015/30/2010, तारीख 1 अग(cid:7021)त, 2011 (cid:7367)ारा (cid:7079)कािश त (cid:7408)क ए गए थ े उसके प(cid:7391)त् िन ि(cid:7388)लिखत अिध सूचना सं. (cid:7367)ारा संशोधन (cid:7408)क ए गए: (i) फा. सं. 4/15015/30/2011, तारीख 7 जून, 2013; (ii) फा. सं. पी./15014/1/2011-पीफए/एफ़एसएसएआई, तारीख 27 जून, 2013;4 THE GAZETTE OF INDIA : EXTRAORDINARY [PART III—SEC. 4] (iii) फा. सं. 5/15015/30/2012, तारीख 12 जलु ाई, 2013; (iv) फा. सं. पी.15025/262/2013-पीए/एफ़एसएसएआई, तारीख 5 (cid:7408)दसंबर, 2014; (v) फा. सं. 1-83एफ/एससीआई॰ पीएएन–अिध॰/एफ़एसएसएआई-2012, तारीख 17 फरवरी, 2015; (vi) फा. सं. 4/15015/30/2011, तारीख 4 अग(cid:7021)त, 2015; (vii) फा. सं. पी. 15025/263/13-पीए/एफ़एसएसएआई, तारीख 4 नव(cid:7013)बर, 2015; (viii) फा. सं. पी॰15025/264/13-पीए/एफएसएसएआई, तारीख 4 नव(cid:7013)बर, 2015; (ix) फा. सं. 7/15015/30/2012, तारीख 13 नव(cid:7013)बर, 2015; (x) फा. सं. पी.15025/208/2013-पीए/एफएसएसएआई, तारीख 13 नव(cid:7013)बर, 2015; (xi) फा. सं. पी.15025/261/2013-पीए/एफएसएसएआई, तारीख 13 नव(cid:7013)बर, 2015; (xii) फा.सं.1-10(1)/(cid:7021)टै(cid:7003)ड(cid:7001)स/(cid:6981) एसपी((cid:7408)फशएंड(cid:7408)फश(cid:7407)रज(cid:7079)ोड(cid:6989)(cid:6999)स)/एफएसएसएआई-2013, तारीख 11 जनवरी, 2016; (xiii) सं. 3-16/िविन(cid:7416)द(cid:7397)॰ खा(cid:7378)/अिधसूचना (खा(cid:7378) सहयो(cid:6996)य)/एफएसएसएआई-2014, तारीख 3 मई, 2016; (xiv) फा. सं. 15-03/ईएनएफ़/एफएसएसएआई-2014, तारीख 14 जून, 2016; (xv) फा. सं. 3-14एफ/अिधसूचना ((cid:7008)यू(cid:7069)ाि(cid:7021)ट(cid:6989)(cid:7016)स)/एफएसएसएआई-2013, तारीख 13 जुलाई, 2016; (xvi) फा. सं.1-12/मानक /एस. पी.(मधु, मधुकारक)/एफ.एस.एस.ए.आई.-2015, तारीख 15 जुलाई, 2016; (xvii) फा. सं. 1-120(1)/मानक/(cid:7408)करिणत/एफएसएसएआई-2015, तारीख 23 अग(cid:7021)त, 2016, (xviii) फा. सं. 11/09/रेग./हाम(cid:7299)नाइजेशन/2014, तारीख 5 िसतंबर, 2016; (xix) फा.सं. मानक/सीपीएल(cid:6989)यू.सीपी/ईएम/एफएसएसएआई-2015, तारीख 14 िसतंबर, 2016; (xx) फा.सं.11/12/िविन./(cid:7079)ोप./एफ.एस.एस.ए.आई.-2016, तारीख 10 अ(cid:6989)टूबर, 2016; (xxi) फा. सं. 1-110(2)/एसपी (जैिवक खतरे)/एफएसएसएआई/2010, तारीख 10 अ(cid:7334)ूबर, 2016; (xxii) फा. सं. मानक/एसपी(पानी एवं पेय)/िअध.(2)/एफएसएसएआई/2016, तारीख 25 अ(cid:7334)ूबर, 2016 और (xxiii) फा. सं. 1-11(1)/मानक/एसपी (जल और सुपेय) एफएसएसएआई-2015, तारीख 15 नव(cid:7013)बर, 2016 । MINISTRY OF HEALTH AND FAMILY WELFARE (Food Safety and Standards Authority of India) NOTIFICATION New Delhi, the 2nd December, 2016. F. No. P.15025/93/2011-PFA/FSSAI.—Whereas the draft of the Food Safety and Standards (Food Products Standards and Food Additives) Amendment Regulations, 2013 were published as required under sub- section (1) of section 92 of the Food Safety and Standards Act, 2006 (34 of 2006), vide notification of the Food Safety and Standards Authority of India number F.No. 5/15015/30/2011 dated the 18th April, 2013 in the Gazette of India, Extraordinary, Part III, Section 4, inviting objections and suggestions from the persons likely¹Hkkx IIIµ[k.M 4º Hkkjr dk jkti=k % vlk/kj.k 5 to be affected thereby, before the expiry of the period of thirty days from the date on which the copies of the Official Gazette containing the said notification were made available to the public; And whereas the copies of the said Gazette were made available to the public on the 18th April, 2013; And whereas the objections and suggestions received from the public in respect of the said draft regulations have been considered by the Central Government; Now, therefore, in exercise of the powers conferred by clause (e) of sub - section (2) of section 92 read with section 16 of the said Act, the Food Safety and Standards Authority of India hereby makes the following regulations further to amend the Food Safety and Standards (Food Products Standards and Food Additives) Regulations, 2011, namely. Regulations 2.(cid:32) Short title and commencement.—(1) These regulations may be called the Food Safety and Standards (Food Products Standards and Food Additives) Thirteenth Amendment Regulations, 2016. (2) They shall come into force on the date of their publication in the Official Gazette and Food Business Operator shall comply with all the provisions of these regulations by 1st July, 2017. 3.(cid:32) In the Food Safety and Standards (Food Products Standards and Food Additives) Regulations, 2011,- a)(cid:32) In regulation 2.10, in sub-regulation 2.10.6, relating to “BEVERAGES NON –ALCOHOLIC - CARBONATED”, after clause 1, the following clause shall be inserted, namely: - “2. Caffeinated Beverage. - The following are the standards for caffeinated beverages: (I)(cid:32) Water used in preparation of caffeinated beverages should conform to the standards of packaged drinking water as prescribed in regulation 2.10.8 of the Food Safety and Standards (Food Products Standards and Food Additives) Regulations, 2011. (II)(cid:32) Essential Composition: It shall contain not less than 145mg per liter and not more than 300 mg per liter total caffeine from whatever sources it may be derived in the formulation of the product. (III)(cid:32) Optional ingredients: It may contain the following: Any of the substances listed in column (1) of the table given below provided that the amount of that substance is not more than the amount specified in relation to that substance in column (2) of the table: (A) Any additional item or ingredient proposed to be added (other than the substances prescribed in the said table will be subject to approval by the Food Authority after safety assessment and substantiating scientific evidence. (i) A declaration “consume not more than 500 ml per day” shall be made on the label that represents the per day quantity. (ii) The per day quantity is the maximum amount of caffeinated beverage (as package or serves) that is consumed in one day and determined as in sub-clause (iii). (iii) Where any one of the substances given in column (1) of the following table is consumed at the maximum level given in column (2), it shall represent the per day quantity and the declaration shall be made on the basis of the number of packs of serves that cumulatively delivers this amount when consumed in a day. Explanation: if taurine is used at 1000mg and D-glucurono-Y-lactone at 300mg in a 250ml pack the per day quantity is reached by consuming 2×250ml packs and represents the one-day quantity. If the pack size is a 125ml bottle, then the per day quantity is reached by consuming 4×125ml bottles.”6 THE GAZETTE OF INDIA : EXTRAORDINARY [PART III—SEC. 4] (B) The vitamins namely, thiamine, riboflavin, niacin, vitamin B6, vitamin B12 may be added at one Recommended Daily Allowance level (100% Recommended daily allowance) TABLE Column (1) Column (2) Substance Maximum amount per day consumption Taurine 2000mg D-glucurono-Ү-lactone 1200mg Inositol 100mg Pantothenic Acid 10mg (IV)(cid:32) In respect of ingredients, flavors, sweeteners, food additives, contaminants and microbiological requirement the product shall conform to the standards for carbonated water. (V) Labelling: The product shall comply with all provisions of General Labelling requirements of Food Safety and Standards (Packaging and Labelling) Regulations, 2011 for pre-packaged foods, with the following additional provisions: - a) High Caffeine: “X mg/serving size” (where X is the amount of caffeine in milligrams per pack/serve; b) Prominent display of caution “Not recommended for children, pregnant or lactating women, persons sensitive to caffeine.”; b)(cid:32) in sub - regulation 2.10.7, after clause 4, the following clause shall be inserted, namely: - “5. Blue tint as provided in Indian Standard, IS: 9833 may be allowed in plastic container of five liter and above made of poly carbonate and Poly Ethylene Terephthalate (PET) used for Packaging mineral water: Provided the overall migration of pigment/colour used in container should not exceed 60 mg/liter as per IS: 9845.”; c)(cid:32) in sub-regulation 2.10.8, after clause 5, the following shall be inserted, namely: - “6. Blue tint as provided in Indian Standard, IS: 9833 may be allowed in plastic container of five liter and above made of poly carbonate and Poly Ethylene Terephthalate (PET) used for packaging packaged drinking water: Provided the overall migration of pigment or colour used in container should not exceed 60 mg/liter as per IS: 9845.”. [ADVT. III/4/Exty./333(187-Q] PAWAN AGARWAL, Chief Executive Officer 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 the 1st August, 2011 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; (iv) F.No. P.15025/262/13-PA/FSSAI dated the 5th December, 2014; (v) F. No.1-83F/Sci.Pan-Noti/FSSAI-2012 dated the 17th February, 2015; (vi) F.No. 4/15015/30/2011, dated the 4th August, 2015; (vii) F.No P. 15025/263/13-PA/FSSAI, dated the 4th November, 2015; (viii) F.No. P.15025/264/13-PA/FSSAI, dated the 4th November, 2015;¹Hkkx IIIµ[k.M 4º Hkkjr dk jkti=k % vlk/kj.k 7 (ix) F.No P.15025/261/2013-PA/FSSAI, dated the 13th November, 2015; (x) F.No. P.15025/208/2013-PA/FSSAI, dated the 13th November, 2015; (xi) F.No. 7/15015/30/2012, dated the 13th November, 2015; (xii) F.No.1-10(1)/Standards/SP(Fish and Fisheries Products)/FSSAI- 2013, dated 11th January, 2016; (xiii) No. 3-16/Specified Foods/Notification(Food Additive)/FSSAI-2014, dated 3rd May, 2016; (xiv) F.No. 15-03 Enf/FSSAI/2014, dated 14th June, 2016; (xv) No. 3-14F/Notification (Nutraceuticals) /FSSAI-2013, dated 13th July, 2016; (xvi) F.No. 1-12/Standards/SP (Sweets, Confectionery)/FSSAI-2015, dated 15th July, 2016; (xvii) F. No.1-120(1)/Standards/Irradiation/FSSAI-2015, 23rd August, 2016; (xviii) F.No. 11/09/Reg/Harmoniztn/2014, dated 5th September, 2016; (xix) F.No. Stds/CPLQ.CP/EM/FSSAI-2015, dated 14th September, 2016; (xx) F.No.11/12/Reg/Prop/FSSAI-2016, dated 10th October, 2016; (xxi) F. No.1-110(2)/SP (Biological Hazards)/FSSAI/2010, dated 10th October, 2016; (xxii) F.No. Stds/ SP (Water & Beverages) Notif(2)/FSSAI-2016, dated 25th October, 2016 and (xxiii) F. No.1-11(1)/Standards/SP(Water & Beverages)/FSSAI-2015, dated the 15th November, 2016. Uploaded by Dte. of Printing at Government of India Press, Ring Road, Mayapuri, New Delhi-110064 and Published by the Controller of Publications, Delhi-110054.(cid:32)

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