And plant explained: this guide covers what it means, who it applies to, the step-by-step process, documents required, fees, due dates and penalties in India — so you can stay compliant with confidence and avoid costly mistakes.
Regulation 3.3 is headed "other substances for use in food products". It brings six provisions that are not additives in the narrow sense: flavouring agents (3.3.1), lactulose syrup (3.3.2), oligofructose (3.3.3), trehalose (3.3.4), plant stanols (3.3.5) and plant sterols (3.3.6). The first sets types of flavouring and a list of banned flavouring agents, and the rest set where, and how much of, each substance may be used. Flavour houses, bakers and functional-food brands can start with food product approval.
This article reads the text as amended up to 21 October 2024 (FSSAI chapter compendium consolidated to amendment 83; the amendment of 10 July 2025 does not change this regulation). Later notifications should be checked on fssai.gov.in. A compendium is a reference consolidation; the Gazette text prevails.
Flavouring agents are natural, nature-identical or artificial and may be added as per Good Manufacturing Practices, but twelve listed flavouring agents are prohibited in any article of food, including coumarin and dihydrocoumarin, tonka bean and thujone. Oligofructose, as substituted on 21 October 2024, has maximum usage levels of 10, 15 and 1 per cent by food group. Plant stanols and sterols are limited to a maximum of 3 g per day.
Regulation 3.3.1: flavouring agents and related substances
Flavouring agents include flavour substances, extracts or preparations that impart taste, odour or both. Three types may be added as per Good Manufacturing Practices:
- Natural flavours and natural flavouring substances: flavour preparations and single substances acceptable for human consumption, obtained exclusively by physical processes from vegetables.
- Nature-identical flavouring substances: substances chemically isolated from aromatic raw materials or obtained synthetically, chemically identical to substances present in natural products.
- Artificial flavouring substances: substances not identified in natural products intended for human consumption.
Flavouring agents may contain permitted antioxidants, emulsifying and stabilising agents and food preservatives. Synthetic amorphous silicon dioxide (INS 551) may be used as an anticaking agent in powder flavouring substances to a maximum level of 2 percent.
Restriction on use. The use of the following flavouring agents is prohibited in any article of food:
- coumarin and dihydrocoumarin;
- tonkabean (Dipteryl odorata);
- beta-asarone and cinnamyl anthranilate;
- estragole;
- ethyl methyl ketone;
- ethyl-3-phenylglycidate;
- eugenyl methyl ether;
- methyl beta naphthyl ketone;
- p-propylanisole;
- safrole and isosafrole;
- thujone and isothujone (alpha and beta thujone); and
- 4,5 epoxydec-2(trans)-enal.
Diethylene glycol and monoethyl ether shall not be used as solvents in flavours. Two points to note for the spice and herb standards. The Regulations separately limit coumarin in cinnamon, as our article on whole and ground spices records, and the new dehydrated tarragon standard requires the volatile oil to be tested for constituents including methylchavicol (estragole); see our article on salt, seasonings and dried herbs. Flavoured tea also has its own conditions under the tea standard.
Regulation 3.3.2: lactulose syrup
Lactulose syrup may be used in special milk-based infant food formulations to be taken under medical advice, up to a maximum level of 0.5 per cent of the final food, subject to label declaration. It may also be used in bakery products up to 0.5 per cent maximum by weight.
Regulation 3.3.3: oligofructose
Oligofructose may be added as an ingredient in the foods in the table below, as substituted by the amendment of 21 October 2024. Usage levels may not exceed the printed maximums.
| Group | Examples printed | Maximum usage level |
|---|---|---|
| 1 | dairy products (yoghurt, mousse, cheese, ice-cream, frozen desserts), breakfast cereals, chocolate and sweets including milk-product based sweets, confectionery, cooked sausages and ham, cereal and soy products | 10 per cent |
| 2 | processed fruits, jams and chutneys, soups and broths, sauces, fruit and vegetable nectars, ready-to-eat savouries, bread and biscuit | 15 per cent |
| 3 | non-alcoholic ("soft") beverages, including sport and energy drinks | 1 per cent |
Regulation 3.3.4: trehalose
Trehalose is white or almost white crystals, soluble in water and slightly soluble in ethanol. It may be added at the level of good manufacturing practice in all food categories except infant food, provided that the standard specifications of the foods prescribed under these Regulations are not altered. The requirements are loss on drying not more than 1.5 per cent and total ash not more than 0.05 per cent. It may be added as an ingredient subject to label declaration under clause 1.8 of Schedule II of the Labelling and Display Regulations, 2020, without health claims, and analysis follows the JECFA method (2000). The bakery standard also caps trehalose at a maximum of 10% in bread and bread-type products, as our article on corn flakes, pasta, oats and bakery products notes.
Regulations 3.3.5 and 3.3.6: plant stanols and sterols
| Regulation | Substance | Foods and limit |
|---|---|---|
| 3.3.5 | Phyto or plant stanol esters | may be added to fat spread, milk products, milk based fruit drink, fermented milk products, soy and rice drink, cheese products, yoghurt products, spice sauces, salad dressings, and juices and nectars, so users can restrict intake to maximum 3 g stanol per day |
| 3.3.6 | Phyto or plant sterols from a non-genetically modified source | the same foods plus edible oils and bakery products; use not exceeding 3 g/day |
For both, products are sold in single portions containing either maximum 3 g or maximum 1 g of the plant stanols or sterols. If they do not, the label must clearly indicate what a standard portion is, in g or ml, and the amount of stanols or sterols in it, so users can restrict consumption to a maximum 3 g per day through one 3 g portion or three portions of 1 g. Plant sterol products must not exceed the Acceptable Daily Intake (ADI) for phytosterols and must carry the label declarations in clause 55 of sub-regulation 2.4.5 of the packaging and labelling regulations; plant stanol products carry the table declaration under sub-regulation 48 of regulation 2.4.5. Our overview of additives and processing aids places these substances in context.
A practical example
Vanilla Valley supplies a powdered flavour blend to a biscuit maker. The blend may contain permitted antioxidants and an anticaking agent, but silicon dioxide (INS 551) is capped at 2 percent of the powder, and none of the twelve prohibited flavouring agents may be present. A brand that adds oligofructose to a breakfast cereal checks the 10 per cent ceiling for that group, and one that adds it to a sports drink the 1 per cent ceiling.
Need help with flavours and functional ingredients?
Our team can check a flavour specification, a usage level and a label against these provisions. Start with food product approval. The next provision, on processing aids and enzymes, is in our article on regulation 3.4 and Appendix C.
Key takeaways
- Flavouring agents may be natural, nature-identical or artificial, subject to GMP.
- Twelve listed flavouring agents are prohibited in any article of food.
- Lactulose syrup is capped at 0.5 per cent in the foods named.
- Oligofructose has three usage levels, 10, 15 and 1 per cent, by food group.
- Plant stanols and sterols are capped at 3 g per day through printed portions.
Read next
- Regulation 3.4 and Appendix C: processing aids and enzymes
- Regulations 3.2.9 to 3.2.16: preservatives, antioxidants and thickeners
- Regulation 3.1: general conditions for food additives
- Food additives and processing aids: permitted list
Disclaimer: Based on the Food Safety and Standards (Food Products Standards and Food Additives) Regulations, 2011 as consolidated in FSSAI's chapter-wise compendium (to amendment 83 of 21 October 2024) and the First Amendment Regulations, 2025, as consulted on fssai.gov.in on 2-3 October 2026. Later notifications and the Food Safety and Standards Act, 2006 provisions referred to should be checked. This article is general information, not legal advice; check the official text before acting.