Regulation 2 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 2.12 explains a category that most packaged-food brands meet sooner or later: the proprietary food, an article of food for which these Regulations set no standard. It has one sub-regulation, 2.12.1, with six clauses covering the definition, ingredients, additives, microbiology, claims and responsibility. Brands launching a new snack, sauce or ready meal can start with food product approval to see which route a recipe falls in.
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 chapter). Later notifications should be checked on fssai.gov.in. A compendium is a reference consolidation; the Gazette text prevails.
A proprietary food is an article of food that has not been standardised under these Regulations, and it excludes novel foods, foods for special dietary uses, foods for special medical purposes, functional foods, nutraceuticals and health supplements. It may use only standardised or permitted ingredients, plus foods listed in the Indian Food Composition Tables, 2017. The label must name the additive category and the generic name, nature and composition of the product, and no health claim may be made without adequate scientific evidence.
Clause 1: the definition
Clause 1 defines proprietary food as an article of food that has not been standardised under these Regulations, but not including:
- novel foods;
- foods for special dietary uses;
- foods for special medical purposes;
- functional foods;
- nutraceuticals;
- health supplements; and
- other food articles the Central Government may notify for this purpose.
A proviso blocks a shortcut. Any deviation in quality parameters of a standardised food, as specified in the regulations made under the Food Safety and Standards Act, 2006, does not qualify the resulting product as a proprietary food. A milk product that misses its fat limit, for example, does not become proprietary food by changing its name. It remains a standardised food that does not comply. Our article on the general standards for milk and milk products shows how names are tied to standards.
Clause 2: ingredients
Proprietary food may contain only those ingredients, other than additives, that are either standardised or permitted for use in the preparation of food products under the Food Safety and Standards Regulations, and those foods or ingredients mentioned in the Indian Food Composition Tables (IFCT), 2017, of the National Institute of Nutrition. Two exceptions are printed: ingredients that the Authority may specify from time to time, and those specified under the prohibition of hunting in the Indian Wildlife Protection Act, 1972. This clause was inserted by amendment. A proviso allows vitamins and minerals in quantities not exceeding one Recommended Dietary Allowance of the respective micronutrients.
Clause 3: additives and the label
Proprietary food may use only the additives, and at the levels, specified for the category or sub-category in Appendix A to which the food belongs. That category or sub-category must be clearly mentioned on the label, along with the generic name, nature and composition of the proprietary food. In practice a brand has to place its product in the food category system first. Our articles on Appendix A, parts I and II: the food category system and on the additive tables explain the system.
Clause 4: microbiology
Proprietary food must comply with the microbiological requirements of Appendix B. If Appendix B specifies no standard for a food or food category, proprietary foods in that category shall not contain any pathogenic microorganism at a level that may render the food product unsafe. Our article on Appendix B explains the table scheme.
Clause 5: other regulations and claims
Proprietary food must also comply with the provisions, as applicable, of all other regulations made under the Act, so labelling, packaging, contaminant and claims rules all apply. The clause adds that no health claims shall be made in respect of proprietary foods, on the label or otherwise, unless substantiated by adequate and scientific evidence. See our sister articles on health claims and on mandatory label declarations.
Clause 6: responsibility
The Food Business Operator shall be fully responsible for the safety of the proprietary food in respect of human consumption. The clause names no fee, form or approval step, and a proprietary food is not described as needing a prior approval under this regulation.
Proprietary food and non-specified food
A food that is not standardised and is not one of the excluded categories falls under 2.12, subject to its conditions. A food whose ingredients lie outside those clause 2 sources raises a different question, which our sister article on prior approval under the Non-Specified Food Regulations covers. The Act's side of proprietary and functional foods is in our post on section 22 of the FSS Act.
A three-step check for a new recipe
- Is there a standard? Search the product groups in Chapter 2. If the recipe fits one, that standard applies and deviations do not create a proprietary food.
- Is it an excluded category? Novel foods, special dietary foods, functional foods, nutraceuticals and health supplements are outside clause 1.
- Do the ingredients and additives pass clauses 2 and 3? Every non-additive ingredient must be standardised, permitted or listed in the IFCT, 2017, and additives must come from the Appendix A category that the label will name.
A practical example
Roti Rani Foods plans a millet and vegetable ready-to-eat bowl for which no Chapter 2 standard exists. The recipe uses ingredients that are standardised or listed in the IFCT, 2017, adds a preservative from the Appendix A category for the product, and fortifies with a vitamin at one Recommended Dietary Allowance. The label names the category, the generic name, nature and composition. A line such as "supports immunity" would be a health claim and needs adequate scientific evidence.
Need help with a proprietary food?
Our team can place a recipe in the right category, check ingredients and additives and review the label. Start with food product approval. For the preceding chapter see our article on baking powder, gelatin, silver leaf and pan masala.
Key takeaways
- Proprietary food is food not standardised under these Regulations, and it excludes six named categories.
- A deviation from a standard does not turn a food into proprietary food.
- Ingredients must be standardised, permitted or in the IFCT, 2017; vitamins and minerals are capped at one Recommended Dietary Allowance.
- Additives follow the Appendix A category, which the label must state.
- Health claims need adequate scientific evidence, and the operator is fully responsible for safety.
Read next
- Regulation 2.11: baking powder, gelatin, silver leaf and pan masala
- Regulation 2.13: radiation processing of food
- Section 22, FSS Act: genetically modified, organic, functional and proprietary foods
- Prior approval under the Non-Specified Food Regulations
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.