Through a notification dated 28 June, 2019 the FSSAI has issued directions regarding the operationalisation of the Food Safety and Standards (Advertising and Claims) Amendment Regulations 2019.
The FSSAI had notified the Food Safety and Standards (Advertising and Claims) Regulations, 2018 in November 2018. These regulations were to come into force on their publication in the Official Gazette and Food Business Operators were to comply with all the provisions of these regulations by 1st July 2019. However, representations were received from stakeholders who have mentioned certain difficulties in complying with these regulations. The FSSAI had placed these concerns before the Scientific Panel on Labelling and Claims/Advertisements. After due consideration the Scientific Panel has recommended some modifications in the regulations.
The recommendations of the Scientific Panel will be included in the Food Safety and Standards (Advertisement and Claims) Regulations, 2018 as an amendment. However, this is likely to take some time, as the due process of notification has to be followed. Pending the final notification of the amendment regulations it has been decided to operationalise these amendment regulations, with immediate effect, keeping in mind the consumer interest and the need for fair practices in food business operations.
The Food Safety and Standards (Advertisement and Claims) Regulations, 2018 together with the operationalised amendment regulations 2019 shall be followed by the Food Business Operators. However, the enforcement of these regulations shall commence six months after the date of issuance of this direction or after the final notification or the proposed amendment in the Gazette of India, whichever is later.
Further, in the event of any changes in the operationalised amendment regulations at the time of finalisation, further transition time would be given for only those changes, if required.
Notice for Operationalisation of the Food Safety and Standards (Advertising and Claims) Amendment Regulations, 2019
The following are the amendments in the the Food Safety and Standards (Advertising and Claims) Regulations, 2018
Under regulations 4, (General principles)
- The sub-regulation (5) has been amended from
Claims shall specify the number of servings of the food per day for the claimed benefit.
To the following amendment
“(5) Reduction of disease risk claims shall specify the number of servings of the food per day for the claimed benefit.”
- Sub-regulation (7) has been amended to the following
“(7) Where the meaning of a trade mark, brand name or fancy name containing adjectives such as“natural”, “fresh”, “pure”, “original”, “traditional”, “authentic”, “genuine”, “real”, appearing in thelabelling, presentation or advertising of a food is such that it is likely to mislead consumer as to thenature of the food, in such cases a disclaimer in not less than 1.5mm size in case of pack size under100sq. cm and not less than 3mm size in case of pack size above 100 sq. cm shall be given atappropriate place on the label stating that –
“*This is only a brand name or trade mark and does not represent its true nature”.
Under regulations 5- Nutrition Claims
- sub-regulation (3) has been amended to the following
“(3) When a nutrient content or any synonymous claim is made for the nutrients indicated in schedule-I, it shall be made in accordance with the conditions specified in Schedule I, providedflexibility in the wording of a nutrition claim is as per Schedule II, or the use of any other word ifthey are in accordance with conditions specified in Schedule I and the meaning of the claim is notaltered.”
- sub-regulation (4), clause (a) and (b), have been amended to the following
(a) at least thirty per cent. in the energy value or nutrient content except micronutrient
(b) at least ten per cent. of recommended dietary allowances per 100 g or 100ml, forclaims about micronutrients other than sodium.”
- sub-regulation (6) has been amended to the following
“(6) The equivalence claims in form of phrases such as “contains the same amount of [nutrient] as a [food]” and “as much [nutrient] as a [food]” may be used on the label or in the labellingoffoods, provided that the amount of the nutrient in the reference food is enough to qualify that foodas a “source” of that nutrient, and the labelled food, on per 100g or 100ml, is an equivalent, sourceof that nutrient or where the food nutrient is at the same level as the naturally occurring referencefood nutrient , the same shall be indicated on the label and through Nutritional information(e.g.,”as much fibre as an apple,” and “contains the same amount of vitamin C as ….. glass of orangejuice.”)”;
Under regulations 6 – Non-addition claims
- sub-regulation (2) has been amended to the following
“(2) Non-addition of Sodium salts- Claims regarding the non-addition of sodium saltsto a food,including “no added salt”, may be made if the following conditions are met, namely
(a) The food contains no added sodium salts, including but not limited to sodium chloride, sodium tripolyphosphate;
(b) The food contains no ingredients that contain added sodium salts including but not limitedto sauces, pickles, pepperoni, soya sauce, salted fish, fish sauce; and
(c) The food contains no ingredients that contain sodium salts that are used to substitute for added salt, including but not limited to seaweed.”;
- sub-regulation (3) has been amended to the following
“(3) Non-Addition of additives- Claims regarding the non-addition of additives including functional classes of additives as specified in Food Safety and Standards (Food Product Standards and Food Additives) Regulations, 2011 to a food, may be made -according to the following conditions, unless otherwise provided in any other Regulations:
(a) has not been added to the food or removed from food at the time of manufacture;
(b) is not contained in any ingredient of the food except where it is naturally present;
(c) is one which is allowed to be added in particular products as specified in Food Safety and Standards (Food Product Standards and Food Additives) Regulations, 2011; and (d) has not been substituted by another additive giving the food equivalent characteristics.”;
Under regulation 14, Procedure for redressal of non-compliance
- sub-regulation (3) has been amended from
- the food business operator or the marketer shall submit the information sought for within thirty days fromthe issue of the letter.
To the following amendment the food business operator or the marketer shall submit the information sought for within thirty days from date of receipt of letter seeking clarification.”
sub-regulation (5) has been amended from
The Food Authority may also suggest an improvement for the concerned claim and the improved claim shall be intimated to the Food Authority within forty- five days after issuance of letter
To the following amendment
The Food Authority may also suggest an improvement for the concerned claim and the improved claimshall be intimated to the Food Authority within forty- five days from the date of receipt of notice of the suggested improvement of the claim from the Food Authority.”
In SCHEDULE – I the following amendments have been made
SCHEDULE – I
[See regulation 5 (3) and (4) and regulation 7 (1)(b)]
Nutrient Content Claim
A claim that a food containing the nutrient mentioned in column (2) is likely to have the Content 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 gsaturated fat per 100 g for solids or 10 mg per 100 ml for liquids and 0.75 g of saturatedfat per 100 ml for liquids and in either case must provide not more than 10% ofenergy from saturated fat |
| Free | Not more than 5 mg cholesterol per 100g for solids or 100 ml forliquids. 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% ofenergy from saturated fat. | ||
| 4. | Saturated Fat | Low | Not more than 1.5g per 100 g for solids or 0.75 g per 100 ml for liquids and in either case must provide not more than 10% ofenergy 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 arederive from unsaturated fat under the condition thatunsaturated fat provides more than 20% of energy of the product |
| 6. | Trans fat | Free | The food contains less than 0.2gtrans-fat per 100 g or100ml of food Provided that for edible oils/fats: 1 g per 100 g/ml ofedible oils/fats |
| 7. | MUFA | High in MUFA | Shall only be made where at least 45% of the total fatty acids present in the product arederived from mono unsaturated fat and under thecondition that monounsaturated fat provides more than20% of energy of theproduct |
| 8. | PUFA | High in PUFA | Shall only be made where at least 45% of the total fatty acids present in the product arederived from poly unsaturated fat and under the condition that polyunsaturated fat provides more than 20% of energy of theproduct |
| 9. | Omega 3 fatty Acids | Source | The product contains: at least 0.3g alpha-linolenic acid per 100 g and/or per100kcal, or at least 40 mg of the sum ofeicosapentaenoic acid and docosahexaenoic acid per 100g and/or per 100kcal |
| High | The product contains: at least 0.6 g alpha-linolenic acid per 100g and/or per100kcal, or at least 80mg of the sum of eicosapentaenoic acid and docosahexaenoic acid per 100g and/or 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 forliquids |
| 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 forliquids. |
| Very low | Product contains not more than 0.04 g of sodium per 100 g for solids or 100 ml forliquids | ||
| Sodium Free | Product contains not more than 0.005g of sodium per 100 g for solids or 100 ml forliquids | ||
| 14. | Dietary Fibre | Source | Product contains at least 3 g of fibre per 100 g or 1.5 g per 100kcal or 100 ml |
| High or Rich | The product contains at least 6 g per 100 g or 3 g per 100 kcal or 100 ml | ||
| 15. | Probiotics | Source | Product contains ≥108CFU in the recommended servingsize per day |
| 16. | Glycemic index (GI)** | Low GI | GI value below 55 A food’s GI indicates the rate at which the carbohydrate inthe food is broken down into glucose and absorbed fromthe gut into the blood |
| 17. | Docosahexaenoic acid (DHA) | Source | Product contains at least 40 mg of DHA per 100 g and per 100 kcal. |
| 18. | Lactose | Free | Lactose content in the product shall not exceed 0.05 per cent. |
| 19. | Gluten | Free | Gluten content in the product shall not exceed 20 mg/kg. |
*A food which, by its nature, free from the nutrient/component shall not qualify for claiming free ofthat nutrient/component.
**GI is defined as the relation of the incremental area under the blood-glucose response curve(Incremental Area Under Curve, IAUC) of a tested meal containing 50 g of digestible carbohydratesand the average incremental area under blood-glucose response curve of a reference food. AcceptableReference foods are 1) anhydrous glucose powder (50 g), 2) Dextrose (glucose monohydrate, 55 g), 3)commercial solution used for oral glucose tolerance test containing glucose (50g) and 4) white breador other specific carbohydrate food of consistent composition and GI.
Note 1: Nutrient content claims for food products falling under health supplement categories shall begoverned by Food Safety and Standards (Health Supplements, Nutraceuticals, Food for SpecialDietary Use, Food for Special Medical Purpose, Functional Food and Novel Food) Regulations, 2016.
Note2: 1 kcal = 4.2 kJ
| % energy from nutrient = grams of nutrients per 100g of products x Conversion factor for nutrient1 x100 Total energy per 100g of products |
For “SCHEDULE –II” the amendments are as follows
SCHEDULE – II
[See regulation 5(3)]
Synonyms which may be used for claims defined in these regulations
| Free | Low | Reduced | High | Increased | Source |
| Zero, No, Without, Negligible Source | Little, few(for calories),contains asmallamount of,low sourceof, Lite, Light | Lower, Lesser, fewer (for calories), | More, Rich | Higher, Enhanced | Provides, Contains |
For “SCHEDULE –III” the amendments are as follows
SCHEDULE – III
[See regulation 7 (3)]
Reduction of disease risk claims
| S. N | Nutrient/Food-Health Relationship | Conditions for claim | Claim Statement |
| 1. | Calcium or Calcium and Vitamin D and osteoporosis | the food is a source or high in calcium or in calcium and vitamin D and a statement that the beneficialeffect is obtained with a dailyrecommended 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 is low in sodium (0.12gsodium/100g or 100ml) astatement 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 | low saturated fat 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 toreduction of blood cholesterol levels. |
| 4. | Potassium and risk of high blood pressure | the food is a good source of potassium and is low in sodium 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 | Thefood contains at least 1g of omega-3 fatty acids per 100g or 100ml or 100kcal. 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 blood cholesterol | soluble dietary fibre from food sources including but not limited to oats, barley, millets or mixtures thereof contains at least 1g per serving statementthat the beneficial effect is obtained with daily intake of 3g of soluble dietary fibre. | Soluble dietary fibre taken as part of a diet contributes to reduction of blood cholesterol levels. |
| 7. | Phytosterol or stanol and blood cholesterol | food with phytosterol or stanol contains at least 1g plant sterols or stanols per serving and astatement 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 contributes to reductionof blood cholesterollevel |
| 8. | Beta-glucans (oats, barley) and blood glucose | The food is oats and/or barley, contains at least 4g beta-glucansfor each 30g of availablecarbohydrates in the quantifiedportion statementthat it is taken as part ofthe 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 |
In SCHEDULE – V
- In the table, at serial number 2, against the entry “Fresh” in column 2, in clause (a), the words “If such processing also leads to extension in the shelf-life of the product the term “fresh” shall not be used.” shall be omitted.;
- in the table, at serial number 3, against the entry “Pure” in column 2, clause (c), shall be omitted.
Source: FSSAI
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