## Policy Analysis Report: Amendment to Food Safety and Standards (Health Supplements, Nutraceuticals, Food for Special Dietary Use, Food for Special Medical Purpose, Functional Foods and Novel Foods) Regulations, 2016
**1. Executive Summary:**
This report analyzes the amendment to the Food Safety and Standards (Health Supplements, Nutraceuticals, Food for Special Dietary Use, Food for Special Medical Purpose, Functional Foods and Novel Foods) Regulations, 2016, as published in the Gazette of India on September 6, 2021. The core purpose of this amendment, based on the provided text, is to update and refine existing regulations pertaining to these specific food categories. Key findings include modifications to regulations regarding food for special medical purposes, updates to permissible ingredients and substances listed in Schedules I, II, V, VII and VIII. These changes affect food business operators (FBOs) involved in the production, distribution, and sale of these specialized food products.
**2. Introduction:**
This report aims to provide an informative analysis of the amendment to the Food Safety and Standards (Health Supplements, Nutraceuticals, Food for Special Dietary Use, Food for Special Medical Purpose, Functional Foods and Novel Foods) Regulations, 2016, based solely on the provided text from the Gazette of India notification dated September 6, 2021.
**3. Policy Overview:**
* This report focuses on an *amendment* to the original Food Safety and Standards (Health Supplements, Nutraceuticals, Food for Special Dietary Use, Food for Special Medical Purpose, Functional Foods and Novel Foods) Regulations, 2016.
* The core objective of this *amendment*, as inferred from the provided text, is to update, refine, and clarify the regulations governing health supplements, nutraceuticals, food for special dietary use, food for special medical purpose, functional foods, and novel foods. This includes updating ingredient lists, modifying definitions, and introducing new approved substances.
**4. Background and Rationale:**
The amendment is likely driven by the need to adapt regulations to reflect advancements in scientific knowledge, technological innovations in the food industry, and evolving consumer demands related to these specialized food products. The inclusion of new ingredients and modifications to existing definitions suggest an effort to ensure that the regulations remain current and relevant to the industry. Specifically, the inclusion of Magnesium alumina metasilicate, Bacillus indicus, and Guar gum derivative partially hydrolysed guar gum in Schedules V, VII and VIII may reflect the recognition of these substances as safe and beneficial for inclusion in food products covered by the regulations.
**5. Key Provisions / Changes:**
The amendment introduces the following key changes to the original regulations:
* **Regulation 9, sub-regulation 1, clause i (Food for Special Medical Purpose):** The definition of food for special medical purpose is amended to explicitly include "food specially prepared for weight reduction and intended as total replacement of normal diet." Furthermore, it includes "Foods intended for Special Diagnostic Purpose with the prior approval of the Authority" and specifies that FBOs seeking such approval must follow Food Safety and Standards Approval of nonspecified food and food ingredients Regulations, 2017. This *change* expands the scope of "food for special medical purpose" to explicitly include weight reduction products and diagnostic purpose foods, requiring FBOs to seek approval through existing regulatory pathways.
* **Schedule I (Related to Folic Acid and Calcium):**
* For Folic acid (A14), the entry "6S-5-methyltetrahydrofolic acid, glucosamine salt" is added.
* For Calcium (B1), the entry "Calcium from algae including red seaweed" replaces "Calcium from algal source Alguscalcarius".
* **Schedule II (List of amino acids and other nutrients):** The entire schedule is substituted with a new, comprehensive list of amino acids and nucleotides. This *change* updates the permissible list of amino acids and nucleotides that can be used in the specified food products. (See the document extract for specific amino acids and nucleotides added).
* **Schedule VF (Permitted Emulsifiers and Stabilizers):**
* For serial number 63, "Polysorbates Tweens" replaces "Sorbitanoleate esters Tweens".
* Serial number 87 is added for "Magnesium alumina metasilicate".
* **Schedule VII (List of Microorganisms):**
* Serial number 31 is added for "Bacillus indicus".
* **Schedule VIII (List of Prebiotics):**
* Serial number 14 is added for "Guar gum derivative partially hydrolysed guar gum".
**6. Target Audience and Stakeholders:**
Based on the provided text, the primary target audience and stakeholders affected by this amendment are:
* Food Business Operators (FBOs) involved in the manufacturing, processing, packaging, distribution, and sale of health supplements, nutraceuticals, food for special dietary use, food for special medical purpose, functional foods, and novel foods.
* The Food Safety and Standards Authority of India (FSSAI).
**7. Implementation Aspects (Inferred):**
* The responsible agency is the Food Safety and Standards Authority of India (FSSAI).
* FBOs are required to comply with the updated regulations immediately upon their final publication in the Official Gazette.
* FBOs using suitable hydrated and anhydrous forms of amino acids, and the hydrochloride, sodium, and potassium salts of amino acids must notify the Authority in writing. The FBOs shall be required to submit additional safety data/information when requested by the Authority.
* FBOs intending to produce foods for special diagnostic purposes must seek prior approval from the Authority according to the relevant regulations.
**8. Expected Outcomes / Impact of Changes:**
The expected outcomes of these amendments include:
* Enhanced regulatory clarity and alignment with current scientific knowledge and industry practices.
* Improved safety and quality of health supplements, nutraceuticals, food for special dietary use, food for special medical purpose, functional foods, and novel foods.
* Greater flexibility for FBOs to innovate and develop new products while adhering to safety standards.
* More effective enforcement by FSSAI due to clearer and more comprehensive regulations.
* The amendment pertaining to weight reduction foods is likely to facilitate the availability of safe and effective weight management options.
**9. Conclusion:**
The amendment to the Food Safety and Standards (Health Supplements, Nutraceuticals, Food for Special Dietary Use, Food for Special Medical Purpose, Functional Foods and Novel Foods) Regulations, 2016, represents a significant update to the regulatory framework governing these specialized food products. The changes address various aspects of the regulations, including definitions, permissible ingredients, and approval processes. This amendment is expected to have a positive impact on the industry, promoting innovation, ensuring food safety, and ultimately benefiting consumers. FBOs should carefully review the updated regulations and ensure compliance to avoid any penalties.
Key Entities Referenced
NEW DELHI: Location where the notification was issued.
Food Safety and Standards Authority of India: Statutory body responsible for setting standards for food in India.
Central Government: The government of India
Food Safety and Standards Act, 2006: The governing legislation for food safety and standards in India.
Chief Executive Officer, Food Safety and Standards Authority of India: The designated recipient for objections or suggestions regarding the draft regulations.
FDA Bhawan, Kotla Road, New Delhi 110002: Address of the Food Safety and Standards Authority of India where objections or suggestions can be addressed.
Food Safety and Standards Health Supplements, Nutraceuticals, Food for Special Dietary Use, Food for Special Medical Purpose, Functional Foods and Novel Foods Regulations, 2016: The principal regulations being amended by this notification.
Food Safety and Standards Approval of nonspecified food and food ingredients Regulations, 2017: Regulations related to the approval process for non-specified foods and food ingredients.
Folic acid: Nutrient listed in Schedule I
Alguscalcarius: Algal source mentioned in schedule I related to Calcium
Schedule II: Schedule related to List of amino acids and other nutrients
LHistidine: Amino Acid listed in Schedule II
Schedule VF: Schedule related to food
Bacillus indicus: Entry inserted to Schedule VII
Schedule VII: Schedule related to food
Guar gum: Entry inserted to Schedule VIII
Schedule VIII: Schedule related to food
ARUN SINGHAL: Chief Executive Officer
Government of India Press, Ring Road, Mayapuri, New Delhi 110064: Location of Dte. of Printing
Delhi: Location of Controller of Publications
रजजस्ट्री स.ं डी.एल.- 33004/99 REGD. No. D. L.-33004/99
xxxGIDHxxx
ससीी..जजीी..--डडीी..एएललxx..x--GअअID..--E00x77xx00 9922002211--222299445566
CCGG--DDLL--EE--0077009922002211--222299445566
असाधारण
EXTRAORDINARY
भाग III—खण्ड 4
PART III—Section 4
प्राजधकार स ेप्रकाजित
PUBLISHED BY AUTHORITY
स.ं 370] नई ददल्ली, सोमवार, जसतम्ब र 6, 2021पभाद्र 15, 1943
No. 370] NEW DELHI, MONDAY, SEPTEMBER 6, 2021/BHADRA 15, 1943
भारतीय खाद्य सरु क्षा और मानक प्राजधकरण
अजधसचू ना
नई ददल् ली, 6 जसतम्बर, 2021
फा. स.ं 1-स्ट्ट ैंड्सपसएस ी-05पटी (न्य रु ास्ट्य ुटिकटकल् स-02).—खाद्य सुरक्षा और मानक (स्ट्व ास्ट्् य अनु ूरक,
न्य ुरास्ट्य ुटिकटकल् स, जविेष आहाटिकरक उ योग हते ु खाद्य, जविेष जचदकत् सीय प्रयोजन हते ु खाद्य, कृत्य कारी खाद्य और नूतन
खाद्य) जवजनयम, 2016 में और आगे संिोधन, जो भारतीय खाद्य सुरक्षा और मानक प्राजधकरण, केंद्र सरकार के
ूवासनुमोदन से, खाद्य सुरक्षा और मानक अजधजनयम, 2006 (2006 का संखय ांक 34) का धारा 22 का उ -धारा (1) के
साथ टिकित धारा 92 का उ -धारा (2) के खंड (फ) द्वारा प्रदत्त िजतियय का प्रयोग करते ुएए करना चाहती ह , करने के जलए
इन जवजनयम का मसौदा इससे प्रभाजवत हो सकने वाले सभी व्य जतियय का सूचना के जलए उक् त अजधजनयम का धारा 92
का उ -धारा (1) का अ ेक्षा के अनुसार एतदद्व् ारा प्रकाजित करती ह और एतदद्व् ारा नोटिकटस ददया जाता ह दक उक् त मसौदा
जवजनयम र उस जतजथ से साि ददन का अवजध समाप् त होने के बाद जवचार दकया जाएगा, जजस जतजथ को इस अजधसूचना
को प्रकाजित करने वाले राज त्र का प्रजतया ाँ जनता को उ लब् ध कराई जाएाँगी।
यदद कोई आ जि या सुझाव हो तो उस े मुख य कायसकारी अजधकारी, भारतीय खाद्य सुरक्षा और मानक प्राजधकरण,
एफडीए भवन, कोटला रोड, नई ददल् ली-110002 को अथवा regulation@fssai.gov.in र ई-मेल से भेजा जा
सकता ह।
उक् त मसौदा जवजनयम के संबंध में दकसी व् यजतिय से इस प्रकार जनधासटिकरत जतजथ तक प्राप् त आ जिय और सुझाव
र भारतीय खाद्य सुरक्षा और मानक प्राजधकरण द्वारा जवचार दकया जाएगा।
4939 GI/2021 (1)2 THE GAZETTE OF INDIA : EXTRAORDINARY [PART III—SEC.4]
प्रारू जवजनयम
1. (1) इन जवजनयम को ‘खाद्य सुरक्षा और मानक (स्ट्व ास्ट्् य अनु ूरक, न्य ुरास्ट्य ुटिकटकल् स, जविेष आहाटिकरक उ योग हते ु
खाद्य, जविेष जचदकत् सीय प्रयोजन हते ु खाद्य, कृत्य कारी खाद्य और नतू न खाद्य) संिोधन जवजनयम, 2021’ कहा जा
सकता ह।
(2) ये राज त्र म ें इनके प्रकािन का तारीख से प्रवृत ह गे।
2. खाद्य सुरक्षा और मानक (स्ट् वास्ट् ्य अनु ूरक, न् युरास्ट्य ुटिकटकल् स, जविेष आहाटिकरक उ योग हते ु खाद्य, जविेष जचदकत् सीय
प्रयोजन हते ु खाद्य, कृत्य कारी खाद्य और नूतन खाद्य) जवजनयम, 2016 के,-
(क) जवजनयम 9 के उ -जवजनयम 1 के खंड (i) का जगह जनम्न जलजखत खंड जो़ा ा जाएगा, अथासत्,-
“जविेष जचदकत् सीय प्रयोजन हते ु खाद्य में भार कम करने के जलए और सामान् य आहार का जगह ूरी तरह लेन े के
जलए जविेषत: त यार खाद्य िाजमल होगा। जविेष जचदकत् सीय प्रयोजन हते ु खाद्य में प्राजधकरण का ूवासनुमजत से
जविेष न दाजनक प्रयोजन के जलए आिजयत खाद्य भी िाजमल हो सकता ह। ऐस े अनुमोदन के इच् छुक खाद्य
कारोबारी अनुमोदन खाद्य सुरक्षा और मानक (ग र-जनर्ददष् ट खाद्य और खाद्य संघटक का अनुमोदन) जवजनयम,
2017 के अनुसार लेंगे।”
(ख) अनुसूची-1 के,—
(i) “फोजलक एजसड” से संबंजधत क्रम संख् या क (14) के सामने कॉलम संख या (3) और (4) का मौजूदा प्रजवजिय
के नीच े जनम् नजलजखत सामग्री जो़ा ी जाएगी, अथासत्,-
“(ii) (6एस)-5-मेजथटेराहाइड्रोफोजलक एजसड, ग ल् ुकोस मीन लवण”
(ii) ‘क जल्ियम’ से संबंजधत क्रम संख य् ा ख (1) के सामने कॉलम (4) में ‘एल्गाल स्रोत से क जल्ियम (एल्गस
कल्केटिकरअस)’ का जगह जनम् नजलजखत सामग्री रखी जाएगी, अथासत्:-
“ि वाल, लाल सीवुड सजहत, से क जल्ियम”
(ग) अनुसूची II का जगह जनम्न जलजखत अनुसूची रखी जाएगी, अथासत्:-
अनसु चू ी-II
[दखे ें जवजनयम 3(13), 4(2), 6(2)(i), 7(2)(i), 8(2)(i) और 9(2)(i)]
एजमनो एजसड और अन्य ोषक तत् व का सचू ी
क. एजमनो एजसड
i L-जहस्ट्ट ीडाइन ii. L-एस्ट् ार्टिकटक एजसड
iii. L-जहस्ट्ट ीडाइन हाइड्रोक् लोराइड iv. L-आर्जजनाइन L-एस्ट् ाटेट
v. L-आइसोल् युजसन vi. L-जियोनाइन
vii. L-आइसोल् युजसन हाइड्रोक् लोराइड viii. L-एलानाइन
ix. L-ल् युजसन x. L-दफनाइलएलानाइन
xi. L-ल् युजसन हाइड्रोक् लोराइड xii. L-जसस्ट् टीन
xiii. L-लाइजसन xiv. L-जसस्ट् टीनडाइहाइड्रोक् लोराइड
xv. L-लाइजसन हाइड्रोक् लोराइड xvi. L-थायरोसाइन
xvii. L-जमजथयोनाइन xviii. L-आर्जजनाइन
xix. L-जसस्ट् टीन xx. L-टिकरप् टोफान[भाग III—खण् ड 4] भारत का राज त्र : असाधारण 3
xxi. L-जसस्ट् टीन हाइड्रोक् लोराइड xxii. L-व लाइन
xxiii. L-कार्जनटाइन xxiv. L-आर्जजनाइन हाइड्रोक् लोराइड
xxv. L-कार्जनटाइनहाइड्रोक् लोराइड xxvi. L-प्रोलीन
xxvii. L-ग् लटु जमक एजसड xxviii. L-लाइजसन L–ग् लटु ामेट डाइड्रेट
xxix. L –ग् लटु ाजमन xxx. L-म ग् नजे ियम L-एस्ट् ाटेट
xxxi. L-ग् लाइजसन xxxii. L-क जल्ियम L-ग् लटु ामेट
xxxiii. L-लाइजसन एजसटेट xxxiv. L- ोटाजियम L-ग् लटु ामेट
xxxv. N-एजसटिकटल L-जसस्ट् टीन xxxvi. L-कार्टिकटनाइन टाररेट
xxxvii. N-एजसटिकटल L-जमजथयोनाइन xxxviii. L-टौराइन
xxxix. L-ओर्जनथाइन xl. L-कोलीन
xli. L-ओर्जनथाइन मोनोहाइड्राक् लोराइड xlii. L-कालीन क् लोराइड
xliii. L-लाइजसन L–एस्ट् ाटेट xliv. L-कोलीन साइरेट
xlv L-जसट्रुलाइन xlvi. L-सेराइन
xlvii. L-कोलीन हाइड्रोजन टाररेट xlviii. मायो-आयनोजसटोल (=मेसो- आयनोजसटोल)
xlix. कोलीन बाइटाररेट
ख. न् यक्ु ल ीयोटाइड
i. एजडनोसाइन 5-मोनोफॉस्ट्फ ेट (एएम ी) ii. डाइसोजडयम यूरीडाइन 5-मोनोफॉस्ट् फेट साल् ट
iii. साइटिकटडाइन 5-मोनोफॉस्ट् फेट (सीएम ी) iv. डाइसोजडयम गुआनोसाइन 5-मोनोफॉस्ट् फेट साल् ट
v. गुआनोसाइन 5-मोनोफॉस्ट्फ ेट (जीएम ी) vi. डाइसोजडयम आयनोसाइन 5-मोनोफॉस्ट्फ ेट साल् ट
vii. आयनोसाइन 5-मोनोफॉस्ट्फ ेट (आईएम ी)
टिकटप् णी.- एजमनो एजसड के उ यक्ु त जलयोजजत और जनजसल रू , तथा एजमनो एजसड के हाइड्रोक् लोराइड, सोजडयम,
और ोटाजियम लवण का प्रयोग दकया जा सकता ह। ऐसे मामल में खाद्य कारोबारी प्राजधकरण को जलजखत में सूजचत
करेंगे। प्राजधकरण के अनुरोध र खाद्य कारोबाटिकरय को अजतटिकरक् त सुरक्षा ड टापसूचना प्रस्ट्त तु करनी होगी।
(घ) अनुसूची V F का,-
(i) क्रम संखय ा 63 के सामने कॉलम (2) में ‘सोर्जबटॉनोजलएटएस्ट्ट र (्वीन)’’ प्रजवजि का जगह जनम् नजलजखत
प्रजवजि रखी जाएगी, अथासत्,-
“ ॉजलसोबेट(्वीन)”
(ii) क्रम संखय ा 86 और उससे संबंजधत प्रजवजिय के बाद जनम्न जलजखत क्रम संखय ा और प्रजवजि जो़ा ी
जाएगी,अथासत्,-
“87 म ग् नजे ियम एल् युजमना मेटाजसजलकेट - 1%”
(ङ) अनुसूची VII का क्रम संखय ा 30 और उससे संबंजधत प्रजवजिय के बाद जनम्न जलजखत सामग्री जो़ा ी जाएगी, अथासत्,-
“31 ब जसलस इंजडकस”4 THE GAZETTE OF INDIA : EXTRAORDINARY [PART III—SEC.4]
(च) अनुसूची VIII का क्रम संख या 13 और उससे संबंजधत प्रजवजिय के बाद जनम् नजलजखत सामग्री जो़ा ी जाएगी, अथासत्:-
“14 गुआर ग द व्य ुत ् न्न (आंजिक रू से जल अ घटिकटत गुआर का ग द)”
अरुण ससघल, मुख य कायसकारी अजधकारी
[जवज्ञा न-III/4/असा./234/2021]
टिकटप् णी : मलू जवजनयम भारत के राज त्र, असाधारण, भाग III, खंड 4 में अजधसूचना संखय ा फा. सं. 1-4प
न्य ुरास्ट्य ुटिकटकल् सपएफएसएसएआई-2013, ददनांक 23 ददसंबर, 2016 द्वारा प्रकाजित दकए गए थे।
FOOD SAFETY AND STANDARDS AUTHORITY OF INDIA
NOTIFICATION
New Delhi, the 6th September, 2021
F. No. Stds/SP-05/T(Nutraceuticals-02).—The draft regulations further to amend the Food Safety
and Standards (Health Supplements, Nutraceuticals, Food for Special Dietary Use, Food for Special
Medical Purpose, Functional Foods and Novel Foods) Regulations, 2016, which the Food Safety and
Standards Authority of India proposes to make with previous approval of the Central Government, in
exercise of the powers conferred by clause (v) of sub-section (2) of section 92 read with sub-section (1) of
section 22 of the Food Safety and Standards Act, 2006 (34 of 2006) is hereby published as required under
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 sixty days from the date on which copies of the 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, FDA Bhawan, Kotla Road, New Delhi- 110002 or may be sent by e-mail
at regulation@fssai.gov.in;
Objections or suggestions which may be received with respect to the said draft regulations within
the period specified above shall be considered by the Food Safety and Standards Authority of India.
Draft Regulations
1. (1) These regulations may be called Food Safety and Standards (Health Supplements, Nutraceuticals,
Food for Special Dietary Use, Food for Special Medical Purpose, Functional Foods and Novel Foods)
Amendment Regulations, 2021.
(2) They shall come into force on the date of their final publication in the Official Gazette.
2. In the Food Safety and Standards (Health Supplements, Nutraceuticals, Food for Special Dietary Use,
Food for Special Medical Purpose, Functional Foods and Novel Foods) Regulations, 2016,
(a) in regulation 9, for clause (i) of the sub-regulation 1, following shall be substituted, namely,-
“Food for special medical purpose shall include food specially prepared for weight reduction and
intended as total replacement of normal diet. Food for special medical purpose may also include
Foods intended for Special Diagnostic Purpose with the prior approval of the Authority. Food
Business Operator seeking such approval shall take approval of the Authority in accordance with
Food Safety and Standards (Approval of non-specified food and food ingredients) Regulations,
2017.”
(b) in Schedule I,-[भाग III—खण् ड 4] भारत का राज त्र : असाधारण 5
(i) against serial number A(14) related to „Folic acid‟, below the existing entries at column (3) and
(4), following shall be inserted, namely;-
“(ii) (6S)-5-methyltetrahydrofolic acid, glucosamine salt”
(ii) against serial number B(1) related to „Calcium‟, for the entry „Calcium from algal source
(Alguscalcarius)‟ in column (4), following shall be substituted, namely;-
“Calcium from algae including red seaweed”
(c) for Schedule II, following schedule shall be substituted, namely,-
Schedule – II
[See regulations 3.(13), 4.(2), 6.(2)(i), 7.(2)(i), 8.(2)(i) and 9.(2)(i)]
List of amino acids and other nutrients
A. Amino Acids
i. L-Histidine ii. L-Aspartic acid
iii. L-Histidine hydrochloride iv. L-Arginine L-aspartate
v. L-Isoleucine vi. L-Threonine
vii. L-Isoleucine hydrochloride viii. L- Alanine
ix. L-Leucine x. L-Phenylalanine
xi. L-Leucine hydrochloride xii. L-Cystine
xiii. L-Lysine xiv. L-Cystinedihydrochloride
xv. L-Lysine hydrochloride xvi. L-Tyrosine
xvii. L-Methionine xviii. L-Arginine
xix. L-Cysteine xx. L-Tryptophan
xxi. L-Cysteine hydrochloride xxii. L-Valine
xxiii. L-Carnitine xxiv. L-Arginine hydrochloride
xxv. L-Carnitine hydrochloride xxvi. L- Proline
xxvii. L-Glutamic acid xxviii. L-LysineL-glutamate dihydrate
xxix. L-Glutamine xxx. Magnesium L- aspartate
xxxi. Glycine xxxii. Calcium L- glutamate
xxxiii. L-Lysine acetate xxxiv. Potassium L- glutamate
xxxv. N-Acetyl L-cysteine xxxvi. L-Carnitine tartrate
xxxvii. N-Acetyl L-methionine xxxviii. Taurine
xxxix. L- Ornithine xl. Choline
xli. L-Ornithine monohydrochloride xlii. Choline chloride
xliii. L-Lysine L-Aspartate xliv. Choline citrate
xlv. L-Citrulline xlvi. L-Serine
xlvii. Choline hydrogen tartrate xlviii. Myo-Inositol (=meso-Inositol)
xlix. Choline bitartrate6 THE GAZETTE OF INDIA : EXTRAORDINARY [PART III—SEC.4]
B. Nucleotides
i. Adenosine 5-monophosphate (AMP) i i . D i sodium Uridine 5-monophosphate salt
iii. Cytidine 5-monophosphate (CMP) i v . D isodium Guanosine 5-mono phosphate
salt
v. Guanosine 5-monophosphate (GMP) v i . D isodium Inosine 5-monophosphate salt
vii. Inosine 5-monophosphate (IMP)
Note.- Suitable hydrated and anhydrous forms of amino acids, and the hydrochloride, sodium, and potassium
salts of amino acids may be used. In such cases, Food Business Operators shall notify in writing to the
Authority. Food Business Operators shall be required to submit additional safety data/information when
requested by the Authority.
(d) in Schedule VF,
(i) against the serial number 63 for the entry “Sorbitanoleate esters (Tweens)”, in column (2),
following entry shall be substituted, namely,-
“Polysorbates (Tweens)”
(ii) after the serial number 86 and the entries relating thereto, the following serial number and entry
shall be inserted, namely,-
“87 Magnesium alumina metasilicate - 1 %
(e) in Schedule VII, after the serial number 30 and the entries relating thereto, the following shall be
inserted, namely,-
“31. Bacillus indicus”
(f) in Schedule VIII, after the serial number 13 and the entries relating thereto, the following shall be
inserted, namely,-
“14. Guar gum derivative (partially hydrolysed guar gum)”
ARUN SINGHAL, Chief Executive Officer
[ADVT.-III/4/Exty./234/2021]
Note : The principal regulations were published in the Gazette of India, Extraordinary, Part III, Section 4,
vide notification number F. No. 1-4/Nutraceutical/FSSAI-2013, dated the 23rd December, 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.