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Date: 2016-05-04 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 document contains two notifications from the Food Safety and Standards Authority of India (FSSAI) amending existing regulations. The first notification amends the Food Safety and Standards (Food Products Standards and Food Additives) Regulations, 2011, introducing regulations for "gluten-free food" and "food specially processed to reduce gluten content." The second notification amends the Food Safety and Standards (Packaging and Labelling) Regulations, 2011, to include specific labeling requirements for gluten-free and low-gluten products. Both amendments were published on May 3, 2016 and came into force on the date of their publication in the Official Gazette. Key Points / Main Content: Gluten-Free Food Regulations: * **Composition:** Gluten-free food must consist of or be made of ingredients such as rice, millets, ragi, pulses, or legumes. * **Labeling:** It must bear the label declaration referred to in subregulation 2.4.5 (50) of Food Safety and Standards Packaging and Labelling Regulations, 2011. * **Suitability:** Foods suitable as part of a gluten-free diet should not be named as special dietary or dietetic, but may state "this food is by its nature gluten-free". * **Gluten Levels:** Gluten levels must be below 20 mg/kg, as per OECD or AOAC methods. * **Compliance:** Must comply with essential composition provisions and not mislead consumers. Food Specially Processed to Reduce Gluten Content Regulations: * **Composition:** These foods consist of ingredients which may contain rice, millets, ragi, oats, rye, barley, maize, wheat, pulses, and legumes with gluten content in the range of 20-100 mg/kg. * **Labeling:** It must bear the label declaration referred to in subregulation 2.4.5 (51) and (52) of Food Safety and Standards Packaging and Labelling Regulations, 2011. Amendment to Packaging and Labelling Regulations: * **Gluten-Free Labeling:** Requires the term "Gluten Free" to be printed near the product name for foods meeting the gluten-free standard as per regulation 2.14 of the Food Safety and Standards (Food Products Standards and Food Additives) Regulations, 2011. * **Low Gluten Labeling:** Requires the term "Low Gluten" to be printed near the product name for foods meeting the low gluten standard as per regulation 2.15 of the Food Safety and Standards (Food Products Standards and Food Additives) Regulations, 2011. * **Low Gluten Warning:** Mandates a warning label stating that "Low Gluten" foods may pose a risk for those with celiac disease. Impact Analysis: Food Manufacturers: * Impact: Must adhere to the new compositional requirements for gluten-free and low-gluten foods, and ensure products meet the specified gluten level thresholds. * Action Required: Reformulate products as necessary, implement testing protocols to verify gluten content, and update labels to comply with the new labeling requirements. Consumers: * Impact: Will have clearer labeling information on gluten-free and low-gluten food products, allowing for more informed purchasing decisions. * Action Required: Review labels carefully to understand the gluten content and associated risks, especially for individuals with celiac disease. Food Safety and Standards Authority of India (FSSAI): * Impact: Responsible for enforcing the new regulations and ensuring compliance by food manufacturers. * Action Required: Develop and implement testing and monitoring programs, update guidance documents, and conduct inspections to ensure compliance with the new standards and labeling requirements.

Key Entities Referenced

Food Safety and Standards Act, 2006: A law enacted by the Parliament of India to consolidate the laws relating to food safety and standards. Food Safety and Standards Authority of India: An autonomous statutory body established under the Food Safety and Standards Act, 2006 responsible for setting standards and regulating food safety in India. Food Safety and Standards Food Products Standards and Food Additives Regulations, 2011: Regulations established by the Food Safety and Standards Authority of India pertaining to food product standards and food additives. Food Safety and Standards Packaging and Labelling Regulations, 2011: Regulations established by the Food Safety and Standards Authority of India pertaining to the packaging and labeling of food products. Gluten Free Food: Food that either by its nature is gluten-free or has been processed to remove gluten, according to standards set in the regulation. Organization for Economic Cooperation and Development: An intergovernmental organization that works to stimulate economic progress and world trade. Association of Official Agricultural Chemists: A globally recognized standards development organization that develops standards for analytical science. Pawan Agarwal: Chief Executive Officer of the Food Safety and Standards Authority of India.
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(cid:4)क gंखला म 3 UलDू टन अंतव>Tतु वाल े ऐसे एक या अिधक सघं टक, िजनम 3 चावल, िमलेट, रागी, जई, राई, जौ, मhा, गेi,ं दाल 3और समे अंतbव] ह9, होते ह Xया वह उनस ेबनाया जाता ह।ै (2) इस पर खा(cid:11) सुर(cid:15)ा और मानक (पकै 3िजग और लेबZलग) िविनयम, 2011 के उप िविनयम 2.4.5 (51) और (52) म 3 िन(द] घोषणा से यु8 लेबल लगा होगा।” पवन अeवाल, मुjय कायक> ारी अिध कारी [िवcापन-III/4/असा./60(187)] (cid:7)(cid:7)(cid:7)(cid:7)टटटट<<<<पपपपणणणण :::: मलू िवि न यम भारत के राजप2, असाधारण, भाग-III, खंड 4 म 3अिध सूचना सjं याकं फा. स.ं 2-15015/30/2010, तारीख 1 अगTत, 2011 0ारा (cid:26)कािश त (cid:4)क ए गए थे उसके पlात् िन िR‘ल िख त अिध सूचना सं. 0ारा सशं ोधन (cid:4)क ए गए: (i) फा.स.ं 4/15015/30/2011, तारीख 7 जून, 2013; (ii) फा.स.ं पी./15014/1/2011-पीफए/एफ़एसएसएआई, तारीख 27 जून, 2013; (iii) फा.स.ं 5/15015/30/2012, तारीख 12 जलु ाई, 2013; (iv) फा.स.ं पी.15025/262/2013-पीए/एफ़एसएसएआई, तारीख 5 (cid:4)दसंबर, 2014; (v) फा.स.ं 1-83एफ/एससीआई॰ पीएएन–अिध॰/एफ़एसएसएआई-2012, तारीख 17 फरवरी, 2015; (vi) फा.स.ं 4/15015/30/2011, तारीख 4 अगTत, 2015; (vii) फा.सं. पी. 15025/263/13-पीए/एफ़एसएसएआई, तारीख 4 नवRबर, 2015; (viii) फा.सं.पी.15025/264/13-पीए/एफएसएसएआई, तारीख 4 नवRबर, 2015; (ix) फा.सं.पी.15025/261/2013-पीए/एफएसएसएआई, तारीख 13 नवRबर, 2015; (x) फा.सं.पी.15025/208/2013-पीए/एफएसएसएआई, तारीख 13 नवRबर, 2015; (xi) फा.सं.7/15015/30/2012, तारीख 13 नवRबर, 2015 और (xii) फा.सं.1-10(1)/Tटैmडnस>/एसपी((cid:4)फश एंड (cid:4)फशDरज (cid:26)ोडopस)/एफएसएसएआई-2013, तारीख 11 जनवरी, 2016।¹Hkkx IIIµ[k.M 4º Hkkjr dk jkti=k % vlk/kj.k 3 MINISTRY OF HEALTH AND FAMILY WELFARE (FOOD SAFETY AND STANDARDS AUTHORITY OF INDIA) NOTIFICATION New Delhi, the 3rd May, 2016 No. 3-16/ Specified Foods/Notification(Food Additive)/FSSAI-2014.—Whereas the draft of the Food Safety and Standards (Food Products Standards and Food Additives) (Amendment) Regulations, 2015, was published as required by 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 3-16/ Specified Foods/Notification(Food Additive)/FSSAI- 2014, dated the 28th January, 2015, in the Gazette of India, Extraordinary, Part III, Section 4, inviting objections and suggestions from the persons likely to be affected thereby, before the expiry of the period of sixty 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 17th February, 2015; And whereas the objections and suggestions received from the public in respect of the said draft regulations have been considered by the Food Safety and Standards Authority of India; 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:- 1. Short title and commencement. - (1) These regulations may be called the Food Safety and Standards (Food Products Standards and Food Additives) Second Amendment Regulations, 2016. (2) They shall come into force on the date of their publication in the Official Gazette. 2. In the Food Safety and Standards (Food Products Standards and Food Additives) Regulations, 2011, after regulation 2.13, the following regulations shall be inserted, namely:- “2.14 Gluten Free Food.- (1) Gluten free food consist of or is made of one or more ingredients containing rice, millets, ragi, pulses or legumes. (2) It shall bear the label declaration referred to in sub-regulation 2.4.5 (50) of Food Safety and Standards (Packaging and Labelling) Regulations, 2011. (3) A food which, by its nature, is suitable for use as part of a gluten free diet shall not be named as ‘special dietary’, “special dietetic” or any other equivalent term, however, such food may bear a statement on the label that ‘this food is by its nature gluten-free’. (4) For the purpose of labelling of a product as gluten free, when such a product is analysed, the gluten levels shall be below 20 mg/kg as per the method declared by the Organization for Economic Co-operation and Development or the Association of Official Agricultural Chemists. Provided that it complies with the essential composition provisions for Gluten Free food and such a statement does not mislead the consumer. 2.15 Food specially processed to reduce gluten content to a level 20 -100mg/kg.- (1) This food consists of or are made of one or more ingredients which may contain rice, millets, ragi, oats, rye, barley, maize, wheat, pulses and legumes containing gluten content in range of 20 -100 mg/kg. (2) It shall bear the label declaration referred to in sub-regulation 2.4.5 (51) and (52) of Food Safety and Standards (Packaging and Labelling) Regulation, 2011.” PAWAN AGARWAL, Chief Executive Officer [ADVT.-III/4/Exty./60(187)] 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;4 THE GAZETTE OF INDIA : EXTRAORDINARY [PART III—SEC. 4] (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 and (xii) F.No.1-10(1)/Standards/SP(Fish and Fisheries Products)/FSSAI-2013, dated the 11th January, 2016. अअअअििििधधधधससससचचूूचचूू ननननाााा नई (cid:4)द(cid:6)ली, 3 मई, 2016 सससस00ंं00ंं 3333----11116666////ििििववववििििनननन(cid:19)(cid:19)(cid:19)(cid:19)दददद(cid:21)(cid:21)(cid:21)(cid:21)टट टट खखखखाााा(cid:25)(cid:25)(cid:25)(cid:25)////अअअअििििधधधधससससचचूूचचूू ननननाााा ((((खखखखाााा(cid:25)(cid:25)(cid:25)(cid:25) ललललबबबेेबेे ????ललललगगगग))))////एएएएफफफफएएएएससससएएएएससससएएएएआआआआईईईई----2222000011114444....---- खा(cid:11) सरु (cid:15)ा और मानक (पैकेZजग और लेबZलग) िविनयम, 2015 का (cid:26)ा(cid:27)प खा(cid:11) सुर(cid:15)ा और मानक अिधिनयम, 2006 (2006 का 34) क(cid:31) धारा 92 क(cid:31) उपधारा (1) क(cid:31) अपे(cid:15)ानसु ार भारतीय खा(cid:11) सरु (cid:15)ा और मानक (cid:26)ािधकरण क(cid:31) अिधसूचना स.ं 3-16/िविन(द) ट खा(cid:11)/अिधसूचना (खा(cid:11) लेबZलग)/एफएसएसएआई-2014, तारीख 28 जनवरी, 2015 0ारा भारत के राजप2, असाधारण, भाग III, खंड 4 म3 (cid:26)कािशत (cid:4)कया गया था िजसम 3उन 7ि8य9 स,े िजनके उससे (cid:26)भािवत होन े क(cid:31) सभं ावना थी, उस तारीख से िजसको उ8 अिधसूचना वाले राजप2 क(cid:31) (cid:26)ितयां जनता को उपल;ध करा दी गय< थ<, साठ (cid:4)दन9 क(cid:31) अविध क(cid:31) समाि= के पूव> आ(cid:15)ेप और सझु ाव आमिं 2त (cid:4)कए गए ; और उ8 राजप2 क(cid:31) (cid:26)ितया ंजनता को 17 फरवरी,,,, 2015 को उपल;ध करा दी गई थ<; और भारतीय खा(cid:11) सरु (cid:15)ा और मानक (cid:26)ािधकरण 0ारा उ8 (cid:26)ा(cid:27)प िविनयम9 के संबंध म 3 (cid:26)ा= आ(cid:15)ेप9 और सझु ाव9 पर िवचार कर िलया गया था; अतः, अब, भारतीय खा(cid:11) सुर(cid:15)ा और मानक (cid:26)ािधकरण, उ8 अिधिनयम क(cid:31) धारा 16 के साथ पDठत धारा 92 क(cid:31) उपधारा (2) के खंड (ट) 0ारा (cid:26)दJ शि8य9 का (cid:26)योग करते Kए, खा(cid:11) सुर(cid:15)ा और मानक (पैकेZजग और लेबZलग) िविनयम, 2011 का और संशोधन करन ेके िलए िनLिलिखत िनयम बनाता ह,ै अथा>त:्- 1. ससससंिंिंिंि####$$$$ ननननाााामममम औऔऔऔरररर &&&&ााााररररंंंंभभभभ.- (1) इन िविनमय9 का सिं (cid:15)= नाम खा(cid:11) सुर(cid:15)ा और मानक (पैकेZजग और लेबZलग) (cid:26)थम संशोधन िविनयम, 2016 ह ै। (2) य ेराजप2 म3 इनके अंितम (cid:26)काशन क(cid:31) तारीख को (cid:26)वृ(cid:20) त ह9गे । 2. खा(cid:11) सरु (cid:15)ा और मानक (पैकेZजग और लबे Zलग) िविनयम, 2011 के, िविनयम 2.4 के उप िविनयम 2.4.5 के खंड (49) के पQच ात् िनRन िलिखत खंड अंत:Tथ ािपत (cid:4)कए जाएगं ,े अथा>त् :-- ‘‘(50) “UलDू टन मुoत ”””” पद,,,, खा(cid:11) सुर(cid:15)ा और मानक (खा(cid:11) उ(cid:20) पाद मानक और खा(cid:11) सहयो(cid:25)य ) िविनयम, 2011 के िविनयम 2.14 म 3वbणत उ(cid:20)प ाद9 क(cid:31) दशा म 3उ(cid:20)प ाद के नाम के ठीक िनकट मु(cid:4)qत (cid:4)कया जाएगा, अथात> ्:-- “UलDू टन मुoत ”””” (51) “‘य ून UलूDटन” पद,,,, खा(cid:11) सुर(cid:15)ा और मानक (खा(cid:11) उ(cid:20)प ाद मानक और खा(cid:11) सहयो(cid:25)य ) िविनयम, 2011 के िविनयम 2.15 म 3वbणत उ(cid:20)प ाद9 क(cid:31) दशा म 3उ(cid:20)प ाद के नाम के ठीक िनकट मु(cid:4)qत (cid:4)कया जाएगा, अथात> ्:-- ‘‘‘ यून UलूDटन’’ (52) लेबल पीआर यह ‘चेतावनी’ होगी (cid:4)क ऐसा खा(cid:11), िजस पर ‘‘ यून UलूDटन’ का लेबल लगा हो, उदर रोग स े पीिड़त 7ि8य9 के िलए जोिखमपणू > हो सकता ह ै।” पवन अeवाल, मुjय कायक> ारी अिध कारी [िवcापन-III/4/असा./60(187)] (cid:7)(cid:7)(cid:7)(cid:7)टटटट<<<<पपपपणणणण :::: मलू िवि न यम भारत के राजप2, असाधारण, भाग-III, खंड 4 म3 अिध सचू ना सjं या ं क फा.सं.2-15015/30/2010, तारीख 1 अगTत, 2011 0ारा (cid:26)कािश त (cid:4)क ए गए थे उसके पlात् िन िR‘ल िख त अिध सूचना सं. 0ारा सशं ोधन (cid:4)क ए गए: (i) फा.स.ं 4/15015/30/2011, तारीख 7 जून, 2013; (ii) फा.स.ं पी./15014/1/2011-पीफए/एफ़एसएसएआई, तारीख 27 जून, 2013; और (iii) फा.स.ं 1-83एल/एससीआई॰ पीएएन–अिध॰/एफ़एसएसएआई-2012, तारीख 17 फरवरी, 2015.¹Hkkx IIIµ[k.M 4º Hkkjr dk jkti=k % vlk/kj.k 5 NOTIFICATION New Delhi, the 3rd May, 2016 No. 3-16/ Specified Foods/Notification(Food Labelling)/FSSAI-2014.—Whereas the draft of the Food Safety and Standards (Packaging and Labelling) (Amendment) Regulations, 2015, were published as required by 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 No. 3-16/ Specified Foods/Notification(Food Labelling)/FSSAI-2014, dated the 28th January, 2015, in the Gazette of India, Extraordinary, Part III, Section 4, inviting objections and suggestions from the persons likely to be affected thereby, before the expiry of the period of sixty 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 17th February, 2015; And whereas the objections and suggestions received from the public in respect of the said draft regulations have been considered by the Food Safety and Standards Authority of India; Now, therefore, in exercise of the powers conferred by clause (k) 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 (Packaging and Labelling) Regulations, 2011, namely:- 1. Short title and commencement. - (1) These regulations may be called the Food Safety and Standards (Packaging and Labelling) First Amendment Regulations, 2016. (2) They shall come into force on the date of their final publication in the Official Gazette. 2. In the Food Safety and Standards (Packaging and Labelling) Regulations, 2011, in regulation 2.4, in sub regulation 2.4.5, after sub-clause (49), the following sub-clauses shall be inserted, namely:- “(50) The term "Gluten Free" shall be printed in the immediate proximity of the name of the product in the case of products described in regulation 2.14 of the Food Safety and Standards (Food Products Standards and Food Additives) Regulations, 2011, namely:- “Gluten Free” (51) The term “Low Gluten” shall be printed in the immediate proximity of the name of the product in the case of products described in regulation 2.15 of the Food Safety and Standards (Food Products Standards and Food Additives) Regulations, 2011, namely:- “Low Gluten” (52) The label shall carry a ‘warning’ that ‘the food labelled as Low Gluten may pose a risk for those with celiac disease.” PAWAN AGARWAL, Chief Executive Officer [ADVT.-III/4/Exty./60(187)] 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 and iii) F. No. 1-83L/Sci. Pan- Noti/FSSAI-2012, dated the 17th February, 2015. 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.

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