FSSAI Regulation on Nutrition and Health Claims

FSSAI Regulation On Nutrition and Health Claims 

Food Safety and Standards (Advertising and Claims) Regulations, 2018 was brought in to action since 1st Jul 2019 to prevent misuse of the Nutrition and other claims and  to protect consumer interests. Though these regulations contain several sections detailing definitions; general principles for claims and advertisements; criteria for nutrition claims, only criteria for claims are presented here to make it brief.

NUTRITION CLAIMS

A claim that a food containing the nutrient mentioned in column (2) is likely to have the benefits as mentioned in column (3) or has the same meaning for the consumer may be made subject to the conditions as mentioned in column (4) below:

1	2	3	4
Sl. No	Nutrient/ component	Claim	Conditions
1	Energy/Calorie	Low	Not more than 40 kcal# per 100 g for solids 20 kcal per 100 ml for liquids.
		Free	Not more than 4 kcal per 100 ml for liquids.
2	Fat	Low	Not more than 3 g of fat per 100 g for solids or 1.5 g of fat per 100ml for liquids.
		Free	Not more than 0.5 g of fat per 100 g for solids or 100 ml for liquids.
3	Cholesterol	Low	Not more than 20 mg cholesterol per 100 g for solids and 1.5 g saturated fat per 100 g for solids or 10 mg per 100 ml for liquids and 0.75 g of saturated fat per 100 ml for liquids and in either case must provide not more than 10% of energy from saturated fat.
		Free*	Not more than 5 mg cholesterol per 100g for solids or 100 ml for liquids. Additionally the food shall contain no more than 1.5 g saturated fat per 100 g for solids or 0.75 g of saturated fat per 100 ml for liquids and in either case must provide not more than 10% of energy from saturated fat.
4	Saturated fat	Low*	Not more than 1.5 g per 100 g for solids or 0.75 g per 100 ml for liquids and in either case must provide not more than 10% of energy from saturated fat.
		Free	Saturated fatty acids do not exceed 0.1 g per 100 g or 100 ml of food.
5	Unsaturated fat	High*	At least 70% of the fatty acids present in the product are derive from unsaturated fat under the condition that unsaturated fat provides more than 20% of energy of the product
6	Trans fat	Free	The food contains less than 0.2g trans fat per 100 g or 100ml of food
7	MUFA	High in MUFA*	Shall only be made where at least 45% of the total fatty acids present in the product are derived from mono unsaturated fat and under the condition that monounsaturated fat provides more than 20% of energy of the product
8	PUFA	High in PUFA*	Shall only be made where at least 45% of the total fatty acids present in the product are derived from
			poly unsaturated fat and under the condition that polyunsaturated fat provides more than 20% of energy of the product
9	Omega 3 fatty acids	Source	The product contains: at least 0.3g alpha-linolenic acid per 100 g and per 100kcal, or at least 40 mg of the sum of eicosapentaenoic acid and docosahexaenoic acid per 100g and per 100kcal
		High	The product contains: at least 0.6 g alpha-linolenic acid per 100g and per 100kcal, or at least 80mg of the sum of eicosapentaenoic acid and docosahexaenoic acid per 100g and per 100kcal
10	Sugars	Low	The product contains not more than 5 g of sugars per 100 g for solids or 2.5 g of sugars per 100 ml for liquids.
		Free	The product contains not more than 0.5 g of sugars per 100 g for solids or 100 ml for liquids.
11	Protein	Source*	10% of RDA per 100 g for solids 5% of RDA per 100 ml for liquids or 5% of RDA per 100 kcal
		Rich / High *	20% of RDA per 100 g for solids 10% of RDA per 100 ml for liquids or 10% of RDA per 100 kcal
12	Vitamin(s) and/or Mineral(s)	Source	The food provides at least 15% of RDA of the vitamin/mineral per 100g for solids or 7.5% of RDA of the vitamin/mineral per 100 ml for liquids
		High	The food provides at least 30% of RDA per 100 g for solids or 15% of RDA per 100 ml for liquids
13	Sodium	Low	Product contains not more than 0.12 g of sodium per 100 g for solids or 100 ml for liquids.
		Very low	Product contains not more than 0.04 g of sodium per 100 g for solids or 100 ml for liquids.
		Sodium free	Product contains not more than 0.005g of sodium per 100 g for solids or 100 ml for liquids.
14	Dietary fibre	Source	Product contains at least 3 g of fibre per 100 g or 1.5 g per 100kcal
		High Or Rich	The product contains at least 6 g per 100 g or 3 g per 100 kcal
15	Probiotics	Source	Product contains ≥108 CFU in the recommended serving size per day
16	Glycemic index (GI)	Low GI	GI value below 55 A food’s GI indicates the rate at which the carbohydrate in the food is broken down into glucose and absorbed from the gut into the blood and expressed as a per cent of the response to the same amount of carbohydrate from a standard food, white bread

Synonyms which may be used for claims defined in these regulations

Free				Low	Reduced/Less		High		Source
Zero, No, Without, ,				Little, few (for	Lower, fewer (for		Higher, Increased, More, Rich,		Provides,
Negligible Source				calories),	calories)		Enhanced		Contains
				contains a small
				amount of, low
				source of, Light

HEALTH CLAIMS
	Introductory note:		Health claims are structured on the following criteria: 1. Health claims are always to be stated as part of a balanced diet. 2. To obtain the claimed benefit two conditions are to be complied with a. A specified amount of the nutrient/ingredient per serving of the food for example 1 g ‘X’ nutrient) b. A statement that in order to obtain the claimed benefits, the daily intake of the nutrient/ingredient (for example 3g of ‘X’ nutrient) should be taken either from the same food or any other food that provides the beneficial nutrient/ingredient. 3. The health claims regarding vitamins and minerals – a statement regarding the RDA for the specific vitamin and mineral shall be given. Where no RDA is established by ICMR, the RDA provided in Codex/WHO guidelines shall be applicable. 4. The claim statements provided below may be used on labels and/or advertisements. Provided further that Food Businesss Operators may choose to use same or similar terms in the claim statements as provide in the schedule under this regulation while ensuring that the intent and meaning of the claim is not changed.

SI. No.	Nutrient/Food-Health Relationship			Conditions for claim	Claim Statement
1	Calcium or Calcium and Vitamin D and osteoporosis			o the food is a source or high in calcium or in calcium and vitamin D and o a statement that the beneficial effect is obtained with a daily recommended intake (RDA)	Adequate Calcium (or Calcium and Vitamin D) intake throughout life, through a balanced diet are essential for bone health and to reduce the risk of osteoporosis
2	Sodium and Hypertension			A food which o is low in sodium (0.12g sodium/100g or 100ml) o a statement that the beneficial effect is obtained with a low sodium diet.	Diets low in sodium may help in reducing the risk of high blood pressure.
3	Dietary saturated fat and blood cholesterol level			o low saturated fat o a statement that the beneficial effect is obtained with a diet low in fat, saturated fat and physical activity	Diets low in saturated fat contributes to the maintenance of normal blood cholesterol levels.
4	Potassium and risk of high blood pressure			the food is a good source of potassium and is o low in sodium o low in total fat and saturated fat.	Diets containing good sources of potassium and low in sodium, fat and saturated fat may help reduce the risk of high blood pressure.
5	Alpha – linolenic acid (ALA) and blood cholesterol level			o the food contains at least 1g of omega-3 fatty acids per 100g or 100ml or 100kcal. o statement that the beneficial effect is obtained with daily intake of 2g of ALA	Alpha – linolenic acid (ALA) contributes to the maintenance of normal blood cholesterol levels.
6	Soluble Dietary Fibre and lipid profile			o soluble dietary fibre from food sources including but not limited to oats, barley, millets or mixtures thereof o contains at least 1g per serving o statement that the beneficial effect is obtained with daily intake of 3g of soluble dietary fibre.	Soluble Dietary Fibre taken as part of a diet may help in the maintenance of normal lipid profile.
7	Phytosterol or stanol and lipid profile			food with phytosterol or stanol o contains at least 1g plant sterols or stanols per serving and o a statement that the beneficial effect is obtained with a daily intake of up to 3g per day.	Foods containing plant sterols or stanols (as applicable) containing at least 1g of plant sterols or stanols eaten twice a day with meals for a daily intake of up to 3g may help in improving the lipid profile.
8	Beta-glucans (oats, barley) and blood glucose			o the food is oats and/or barley, o contains at least 4g beta-glucans for each 30g of available carbohydrates in the quantified portion o statement that it is taken as part of the meal.	Beta- glucans from oats or barley when taken as part of a meal may help in reduction of rise in blood glucose after that meal.

Health Claims for Fortified Food Articles

SI. No.		Nutrients	Claims
1		Vitamin A	Vitamin A helps against night blindness.
2		Vitamin D	Vitamin D supports strong bones.
3		Vitamin B12	Vitamin B12 is important for maintaining normal functioning of Nervous system and blood formation.
4		Folate & Folic acid	Folate & Folic acid is important for foetal development and blood formation.
5		Iron	Iron fights Anemia.
6		Iodine	Iodine is required for normal growth, thyroid and brain function.
7		Zinc	Zinc supports a healthy immune system.
8		Thiamine	Thiamine is required for normal nerve and heart function.
9		Riboflavin	Riboflavin is necessary to release the energy from food.
10		Niacin	Niacin is necessary to release the energy from food.
11		Pyridoxine	Pyridoxine is necessary to release the energy from food.

Use of certain words or phrases The following words or phrases used as specified in column 1 shall be used according to the conditions listed in column 2:

Sl. No.	Column 1	Column 2
1	Natural	The word may be used to describe: (a) A single food, derived from a recognised source viz., plant, animal, microorganism or mineral and to which nothing has been added and which have been subjected only to such processing which would only render it suitable for human consumption like: (i)smoking without chemicals, cooking processes such as roasting, blanching and dehydration and physical refining; (ii)freezing, concentration, pasteurization, sterilisation and fermentation; and (Iii)packaging done without chemicals and preservatives. (b) Permitted food additives that are obtained from natural sources by appropriate physical processing. (c) Composite foods shall not themselves be described directly or by implication as “natural” but such foods may be described as “made from natural ingredients” if all the ingredients or food additives meet the criteria in (a) and (b) above: Provided that, the above principles shall also apply to use of other words or expressions such as “real”, “genuine”, when used in place of “natural “in such a way as to imply similar benefits. Provided further that the, claims such as “natural goodness”, “naturally better”, “nature’s way” shall not be used.
2	Fresh	(a) The term “fresh” shall only be used on products which have not been processed in any manner except, washed, peeled, chilled, trimmed or cut, irradiated by ionizing radiation not exceeding 1kGy or other processing necessary for making the product safe for consumption without altering its basic characteristics in any manner. If such processing also leads to extension in the shelf-life of the product the term “fresh” shall not be used. (b) The term “fresh” or “freshly” shall have no other connotation than the immediacy of the action being described. A food containing additives or subjected to packaging, storing or any other supply chain processes that control freshness shall not be termed as “freshly stored”, “freshly packed”, etc.: Provided that “Fresh” may be permitted to be used along with “frozen” if it is clear from the context. - “Frozen from fresh” “fresh frozen” “Freshly frozen”– which would indicate that the food was quickly frozen while still fresh.
3	Pure	(a) The term “pure” shall only be used to describe a single ingredient food to which nothing has been added and which is free from avoidable contamination and the levels of unavoidable contaminants shall need to be below the levels prescribed in the Food Safety and Standards (Contaminants, Toxins and Residues) Regulations, 2011 or in any other standard given under Food Safety and Standards Act, Rules and Regulations thereof. (b) Compound foods shall not generally be described, directly or by implication, as “pure” but such foods may be described as “made with pure ingredients” if all the ingredients meet the criteria in (a) above. (c) “Pure” shall not be included in any brand or fancy names, nor in coined or meaningless phrases, in such a way as to imply that a food that does not meet the criteria above is pure or made from pure ingredients.
4	Authentic, Genuine, Real	These terms may be used only if the label or advertisement also clarify in what way the overall quality is tangibly justified and why the particular term has been used.
5	Traditional	The term “traditional” shall demonstrably be used to describe a recipe, fundamental formulation or processing method for a product that has existed for a generation (thirty years), should have been available substantially unchanged, for that same period.
6	Original	(a)The term “original” shall only be used to describe a food that is made to a formulation, the origin of which can be traced, and that has remained essentially unchanged over time. It should not contain replacements for major ingredients. It may similarly be used to describe a process, provided it is the process first used in the making of the food, and which has remained essentially unchanged over time, although it may be mass-produced. (b) To be termed “original”, a product shall not have changed to any material degree and shall remain available as the ’standard’ product when new variants are introduced. A product re-introduced onto the market after a period of absence shall only be described as “original” if it can be shown to meet these criteria.