B SesikeranFormer Director

National Inst of Nutrition (ICMR)

Probiotics- regulatory status in india

‘Live micro-organisms which, when administered in adequate amounts,

confer a health benefit on the host’

Definition in 2001

Probiotic Guidelines - The Start

“Guidelines for the Evaluation of probiotics in Food. Report of a Joint FAO/WHO Working Group on Drafting Guidelines for the Evaluation of probiotics in Food.” London Ontario, Canada. April 30 and May 1, 2002.

Joint Food and Agriculture Organization/World Health Organization: Guidelines for the evaluation of probiotics in foods. London, Ontario, Canada; 2002, 1-11.

“live microorganisms that, when administered in

adequate amounts, confer a health benefit on the host”

Hill C et al (2014) Nat Rev Gastroenterol Hepatol 11:506–514.

Definition in 2014

Framework For Probiotic ProductsFramework For Probiotic Products

Live culturesProbiotic

Not probiotic

Probiotic drugs

Probiotic medical foods

Probiotic foods

Non-oral probiotics

Probiotic animal feed

Defined microbial consortia

Probiotic dietary supplement

Probiotic infant formula

Fermented foods with undefined microbial content

Undefined consortia, including

faecal microbiota transplant

Hill C et al (2014) Nat Rev Gastroenterol Hepatol 11:506–514.

Probiotic Classification - Intended Use

• Food - Component of human diet for millennia with no evidence of any harm•Dietary Supplement - contains a “dietary ingredient” intended to supplement the diet (DSHEA of 1994, amendment to the FD&C Act)•Drug - intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease (Food Drug & Cosmetic Act of 1938)•Medical Food

Sanders et al (2014) Ann N.Y. Acad Sci 1309:19-29.

Probiotic Regulations – The Global Landscape

Regulation on generic health claims: more and more countries concerned

UNITED STATES (US)

Level 1 (Basic Level – may not be a probiotic depending on definition)

Microorganisms used as starter cultures in preparations, such as Dahi /yogurt whose role is to ferment a food, and which then die in the stomach or upon exposure to bile.

• (Third Meeting SummaryFederal Regulation of Probiotics: An Analysis of the Existing Regulatory Framework and Recommendations for Alternative Frameworks – Meeting #3February 16 and 17, 2012 University of Maryland Baltimore)

Level 2 (Safe But Not Clinically Proven Probiotic)

• Products which themselves (or the microbial species they contain) have a long history of safe use, but have not specifically been clinically tested. Or, the evidence is only of increased numbers of those species in stool.

• These and all strains at Levels 2-5 must be genetically identified and meet safety standards of the regulatory agency in the country of use.

Level 3 (Clinically Documented Probiotic)

• Microorganisms whose utilization (by mouth, skin, vaginal or other target site), and delivery (dairy, powder, food, cream, medical device, other) confer a basic effect that benefits health, as shown in human studies,

• e.g., production of compounds that help create, restore or maintain

homeostatic pH or host cell barrier function, or benefit general immunity, and thereby may provide a benefit to all consumers.

Level 4 (Specific Probiotic Health Benefit)

• Microbial strain(s) that have an additional specific function not conveyed by all organisms that can be safely used by all consumers, but may or may not benefit everyone, and for which mechanisms of action are somewhat understood and proven.

Level 5 (Narrow Use)

• Microbial strain(s) with very targeted usage (e.g elevating certain neurochemical levels in the brain to relieve stress).

• Not for all consumers but not in the drug category.

INDIA

Guidelines for Probiotics in Food Joint initiative by Indian Council of Medical Research and Department of Biotechnology, Government of India.

•Developed for scientific purpose with the main aim to guide the regulatory authority for evaluating probiotic products in our country •Definition of probiotics – “live microorganisms which when administered in adequate amounts confer a health benefit on the host”•These guidelines are not meant for probiotics which by definition would come under drugs, beneficial microorganisms not used in foods or genetically modified microorganisms (GMO).

ICMR/DBT (2011). Guidelines for Regulation of Probiotics in Food. Indian Council of Medical Research/Department of Biotechnology, India.

ICMR – DBT Guidelines - Highlights

Ministry of Health and Family Welfare

Genus, Species, Strain

Strain Identification by Phenotypic and Genotypic Methods Genus, species and strain Deposit strain in an Internationally recognized collection center

Screening of potential probiotic strains In vitro tests

In vivo studies in validated animal models for Safety Efficacy

Labeling Requirements

Health claims

In vivo studies in humans for clinical evaluations Phase 1 - Safety Phase 2 -Efficacy Phase 3 -Effectiveness

ICMR-DBT Guidelines for Evaluation of Probiotic Foods, 2011

Probiotic Foods

Minimum viable numbers

Serving sizeStorage

conditions

The International Life Sciences Institute (ILSI) - India

ILSI-India has developed the ‘Guidelines and Criteria for Evaluation of Efficacy, Safety and Health Claim of Probiotic in Food Products in India.

ILSI. Guidelines and Criteria for Evaluation of Efficacy, Safety and Health Claim of Probiotic in Food Products in India. International Life Sciences Institute – India.

From Guidelines to Regulations

Status

• There is no regulation or standard in India on the use of probiotics in foods

• There is a regulation now from Nov 2016

FSSAI Regulations

These regulations may be called as theFood Safety and Standards (Food or Health Supplements, Nutraceuticals, Foods forSpecial Dietary Uses, Foods for Special Medical purpose, Functional Foods, and NovelFood) Regulations, 2016.

(a) Foods containing prebiotic ingredients means foods that containapproved prebiotics and are a non-viable food component which confers a health benefit to the consumer by modulation of gut micro biota.

(b) “Foods containing Probiotic Ingredients” means foods with live microorganisms beneficial to human health, which when ingested in adequate amounts (as a single strain or as a combination of cultures) confer one or more specified/or demonstrated health benefits in human beings;

and themicroorganism strain used in these foods shall be deemed to possess probiotic property when it is capable of surviving passage through the digestive tract, andhas the capability to adhere and proliferate in the gut and be able to confer a physiological benefit.

CHAPTER - VII9. Foods containing Probiotic Ingredients. -

(1) Essential Composition. -(i) Only probiotic cultures of specific strain of the microorganisms as specified inSchedule X of these regulations or those approved by the Food Authority from time to time may be used.

(ii) The Food Authority may enlist specific probiotic microorganisms after properscientific evaluation from time to time.

The presence of commonly used starter culture of lactic acid producing bacteria such as Lactococcus spp. (earlier known as Streptococcus spp.), Lactobacillus spp. and others used in the preparation in curd and related products shall not be considered as probiotics, if the probiotic properties have not been substantiated.

(iv) Any new strains of microorganisms, possessing probiotic properties, may be approved by the Food Authority after proper scientific evaluation, and the Food Authority may from time to time enlist specific microorganisms possessing probiotic properties (Schedule X).

Labelling.

(i) The labelling of probiotic foods shall follow Food Safety and Standards(Packaging and Labelling) Regulations, 2011.

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Food Not Drug

(iii) The labelling, presentation and advertising shall not attribute the property of preventing, treating or curing a human disease, or refer to such properties toProbiotics and the statements relating to structure or function or for the general well-being of the body are allowed as long as they are truthful and arealso supported by generally accepted scientific data and

in addition, the product shall bear a statement, “This product is not intended to diagnose, treat,cure or prevent any diseases.”

Every package of probiotic foods shall carry the following information on thelabel, namely:-

(a) the words “PROBIOTIC FOOD”;(b) genus, species, strain designation or International Culture Collection Number (International Culture Deposit Number in the bracket where probiotics are mentioned in the ingredient lists);(c) minimum viable numbers of probiotics strain at the level at which the efficacy is claimed and at the end of the shelf-life; ( ? ≥ 108 / CFU/g)

(d) the recommended serving size which must deliver the effective dose of probiotics related to the health claim and duration of use to have the optimal effect.

(e) proper storage temperature conditions and time limit for ‘Best Use’ after opening the container.

(f) a warning or any other precautions to be taken while consuming,Known side effects if any, contraindications and product-drug interactions, as applicable; and

g) expiry date.

Use of additives. - The additives specified in Schedule VIII (a) to VIII (e) ofthese regulations may be permitted to be used in probiotics also.

(4) Contaminants, Toxins and residues. - The product shall conform to the FoodSafety and Standards (Contaminants, Toxins and Residues) Regulations, 2011.

CHAPTER- VIII10. Foods containing prebiotic ingredients. –(1) Essential composition.-

(i) Only prebiotics specified in Schedule XI or those approved by the Food Authority from time to time may be used in the manufacture of foods containing prebiotics.

(ii) The Food Authority may enlist specific prebiotic components after proper scientific evaluation from time to time.

(iii) The prebiotic component (not an organism), to which the claim of being prebiotic is attributed, must be characterized for any given product by providing the source, origin, purity, chemical composition and structure, vehicle, concentration and amount in which it is to be delivered to the host.

Labelling requirements are as for probiotics

Schedule – X(See regulation 10)List of Strains as Probiotics (Live Micro-organisms)

1 Lactobacillus acidophilus2 Lactobacillus planatrum3 Lactobacillus reuteri4 Lactobacillus rhamnosus5 Lactobacillus salivarius6 Lactobacillus casei7 Lactobasillus brevis8 Lactobacillus infantis9 Lactobacillus johnsonii10 Lactobacillus bulgaricans11 Lactobacillus asporogenes12 Lactobacillus fermentis13 Lactobacillus caucasicus14 Lactobacillus helvetucs

15 Lactobacillus lactis16 Lactobacillus amylovorus17 Lactobacillus gallanarum18 Lactobacillus debrueckii19 Bifidobacterium bifidum20 Bifidobacterium lactis21 Bifidobacterium breve22 Bifidobacterium longum23 Bifidbacterium animalis24 Bifidbacterium infontis25 Streptococcus thermophilus26 Streptococcus bouraldi27 Saccharomyces species (as in codex)

PS: These organisms may be used either singly or in combination but must be declared on the label with full information and has to be non-GMO.

Schedule – XI(See regulation 11)List of Prebiotic Compounds

1 Polydextrose2 Soybean Oligosaccharides3 Isomalto-oligosaccharides4 Fructo-oligosaccharides5 Gluco-oligosaccharides6 Xylo-oligosaccharides7 Inulin8 Isomaltulose9 Gentio-ologsaccharides10 Lactulose11 Lactoferrin12 Sugar alcohols such as lactitol, sorbitol, maltitol, etc.

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