Regulation 3 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 3.2.1 sets the identity and purity specifications for the food colours that may be used in food. It has 18 clauses, from tartrazine and sunset yellow to caramel, annatto, riboflavin, a sunset yellow aluminium lake and titanium dioxide. The First Amendment Regulations, 2025, in force from 1 February 2026, omitted several table notes and substituted a new clause 12 on colour preparations and mixtures. Colour suppliers, food manufacturers and quality teams can start with food product approval when a recipe uses a colour.
This article reads the text as amended up to 10 July 2025 (FSSAI chapter compendium consolidated to amendment 83 of 21 October 2024, and the First Amendment Regulations, 2025 of 10 July 2025, in force 1 February 2026). Later notifications should be checked on fssai.gov.in. A compendium is a reference consolidation; the Gazette text prevails.
Each colour has a description (common name, synonyms, colour index number, class, chemical name, formula, solubility) and a table of purity requirements such as minimum total dye content and maximum lead, arsenic and heavy metals. These specifications say what a colour must be; the foods in which it may be used, and at what level, are set in Appendix A. From 1 February 2026 a new clause 12 governs colour preparations and mixtures, with 29 permitted diluents and a label declaration of total dye content.
The 18 clauses
| Clause | Colour | Defining feature |
|---|---|---|
| 1 | Tartrazine | monoazo dye; Colour Index No. 19140 |
| 2 | Sunset Yellow | monoazo dye; orange in solution |
| 3 | Erythrosine | xanthene dye; red |
| 4 | Indigo Carmine | indigoid dye; blue |
| 5 | Beta-carotene | carotenoid; minimum purity of 96.0 per cent |
| 6 | Chlorophyll | green plant pigment; magnesium complex |
| 7 | Caramel | four types by process |
| 8 | Annatto | from Bixa orellana L.; oil and water solutions |
| 9 | Riboflavin | vitamin colour |
| 10 | Ponceau 4R | synthetic red |
| 11 | Carmoisine | synthetic red |
| 12 | Food colour preparations and mixtures | as substituted from 1 February 2026 |
| 13 | Brilliant Blue FCF | triarylmethane dye |
| 14 | Fast Green FCF | triarylmethane dye |
| 15 | Aluminium lake of Sunset Yellow FCF | dye precipitated on alumina |
| 16 | Beta-apo-8'-carotenal | INS 160e |
| 17 | Ethyl ester of beta-apo-8'-carotenoic acid | INS 160f |
| 18 | Titanium dioxide | INS 171; white powder |
How the synthetic dye tables read
The tables for tartrazine, sunset yellow, indigo carmine and the other synthetic dyes share a pattern. A few lines exactly as printed for tartrazine:
| Characteristic | Requirement |
|---|---|
| Total dye content, corrected for sample dried at 105±1 °C for 2 hours, per cent by mass, minimum | 87 |
| Water insoluble matter, per cent by mass, maximum | 0.2 |
| Subsidiary dyes, per cent by mass, maximum | 1.0 |
| Lead, mg/kg, maximum | 10 |
| Arsenic, mg/kg, maximum | 3 |
| Heavy metals, mg/kg, maximum | 40 |
Indigo carmine and Brilliant Blue FCF print a minimum total dye content of 85. Erythrosine adds limits for inorganic iodide, fluorescein and zinc, and Fast Green FCF adds a list of organic impurities.
Table notes omitted from 1 February 2026. The First Amendment Regulations, 2025 omitted the note under the table for tartrazine (clause 1), sunset yellow (clause 2), erythrosine (clause 3), indigo carmine (clause 4) and Ponceau 4R (clause 10), the sentence in the general requirements of carmoisine (clause 11), and the notes under the tables for Brilliant Blue FCF (clause 13) and Fast Green FCF (clause 14). Those notes dealt with mercury, copper, selenium and chromium and with aromatic amines, aromatic nitro compounds, aromatic hydrocarbons and cyanides. The omissions were made by the First Amendment Regulations, 2025, in force 1 February 2026; the numerical rows of each table are unchanged.
Natural colours, caramel and lakes
- Beta-carotene (clause 5): minimum purity of 96.0 per cent, with arsenic 3 ppm, lead 10 ppm and heavy metal 40 ppm as maximum, plus spectrophotometric and colour-reaction identity tests.
- Chlorophyll (clause 6): a dark green solution of chlorophyll degradation products, with limits for arsenic, lead, copper and zinc, and residual solvents.
- Caramel (clause 7): four types: Type I plain caramel; Type II caustic sulphite caramel; Type III ammonia process caramel; Type IV ammonia sulphite caramel. Raw materials are listed carbohydrates, acids, alkalis and ammonium or sulphite compounds. Two tables, routine tests and type tests, give solid content, colour intensity, ammoniacal nitrogen, 4-methylimidazole (Types III and IV), lead, arsenic, sulphur, sulphur dioxide, nitrogen and other limits, all on a solids basis except metallic impurities. Caramel must be filled in amber coloured glass or high density polyethylene containers or other suitable well-closed containers.
- Annatto (clause 8): only from Bixa orellana L., in two solutions, one in edible vegetable oil for butter and other foods and one in water for cheese and other foods. Carotenoid, expressed as bixin or norbixin, is not less than 0.24 per cent by mass.
- Aluminium lake of sunset yellow FCF (clause 15): pure dye content not less than 17 percent weight by weight, substratum of aluminium oxide not more than 83 percent, and aluminium not more than 44 percent. The dye used must meet the sunset yellow specification.
- Beta-apo-8'-carotenal and its ethyl ester (clauses 16 and 17): purity of 96 minimum, sulphated ash 0.1 maximum, with melting ranges of 136 - 140 and 134 - 138 °C.
- Titanium dioxide (clause 18): purity as TiO2 of 99 per cent minimum by mass, with limits for mercury, antimony, zinc, arsenic, lead, barium compounds and aluminium.
Clause 12 as substituted: colour preparations and mixtures
Clause 12, "Food Colour - Preparation and Mixtures", was substituted by the First Amendment Regulations, 2025, in force 1 February 2026. The new text says:
- A colour preparation is one containing one or more of the permitted food colours conforming to the prescribed standard, along with diluents or filler materials or both, meant to impart colour to food. It may contain permitted additives as per Appendix A and C.
- Preparations are liquid or solid. Solid preparations must have no lumps and no visible extraneous or foreign matter, and liquid preparations no sediments.
- Only 29 listed diluents or fillers may be used, such as potable water, edible common salt, sugar, dextrose monohydrate, liquid glucose, sodium sulphate, glycerine, propylene glycol, sorbitol, citric acid, lactose, alginates, dextrins, starches, ethanol, edible oils and fats, beeswax, carrageenan and gum arabic, gelatin and pectin.
- The total dye content, per cent by mass (m/v), must be declared on the container label, on an "as in" basis for solid and liquid preparations. It must be within a tolerance on the declared value of ±15 per cent for liquid preparations and ±7.5 per cent for solid preparations.
- The preparation must meet the standards of the Contaminants, Toxins and Residues Regulations, 2011.
Our article on Appendix A, part IV explains where colour levels by food category are set, and our article on general conditions for additives covers GMP and the justification test. For the Act's side, see our post on section 19 of the FSS Act.
A practical example
Rangoli Colours blends tartrazine with sugar and sodium sulphate into a powder for confectioners. From 1 February 2026 the blend is a colour preparation under clause 12: its diluents must come from the 29 listed, the label must declare the total dye content, and the declared value must be met within ±7.5 per cent for a solid. Each dye used must still meet its own purity table.
Need help with colour compliance?
Our team can check a specification sheet and a recipe against the colour clauses, Appendix A and the label rules. Start with food product approval. For the next group of additive specifications, see our article on sweeteners, baker's yeast and food-grade acids.
Key takeaways
- Regulation 3.2.1 has 18 clauses of identity and purity specifications for food colours.
- Synthetic dye tables print minimum total dye content and maximum lead, arsenic and heavy metals.
- Table notes for eight clauses were omitted from 1 February 2026.
- Clause 12 now covers colour preparations and mixtures, with 29 diluents and a ±15 and ±7.5 per cent tolerance on total dye content.
- Use levels by food category sit in Appendix A, not in this regulation.
Read next
- Regulation 3.1: general conditions for food additives
- Regulations 3.2.2 to 3.2.8: sweeteners, baker's yeast and food-grade acids
- Appendix A, part IV: use of food additives tables
- 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.