Regulations 2 1 8 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.
Regulations 2.1.8 to 2.1.12 cover the dairy products that are fat or dried: milk fat, butter oil and ghee, butter, milk powders and cream powder, dairy whitener and whey powder. Ghee is the product most often tested, and its standard is built on a set of laboratory parameters that dairies, packers and testing laboratories know well. Dairies that make these products can begin with FSSAI registration for food manufacturers.
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.
Ghee, milk fat and anhydrous milk fat each have a column of limits for moisture, milk fat, Butyro-refractometer reading, Reichert Meissl and Polenske values, the fatty-acid acidity parameter and more. Butter comes as table butter and white or cooking butter, powders in four types, and dairy whitener in four fat levels. Additives must be those permitted in Appendix A, and microbiological limits are in Appendix B.
Regulation 2.1.8: milk fat, butter oil and ghee
These are fatty products derived exclusively from milk, or products obtained from milk, by processes that remove almost all water and milk solids-not-fat. Ghee has a flavour and physical structure that come from its method of manufacture. The raw material must not contain added flavour, colour or preservative.
The standard prints one table with three columns: milk fat or butter oil, anhydrous milk fat or anhydrous butter oil, and ghee. The parameters are moisture, milk fat, Butyro-refractometer reading at 40 °C, Reichert Meissl value, Polenske value, the fatty-acid acidity parameter (printed as FFA, expressed as oleic acid), peroxide value, the Baudouin test, iodine value, saponification value and the presence of beta-sitosterol. Some of the figures printed for ghee:
| Parameter | Ghee |
|---|---|
| Moisture, maximum, % (m/m) | 0.5 |
| Milk fat, minimum, % (m/m) | 99.5 |
| Butyro-refractometer reading at 40 °C | 40.0 to 44.0 |
| Reichert Meissl value, minimum | 24.0 |
| Polenske value | 0.5 to 2.0 |
| Fatty-acid acidity (FFA as oleic acid), maximum, % | 2.0 |
| Baudouin test | Negative |
Beta-sitosterol must be absent, and a footnote names the RP-HPLC method for detecting vegetable oil in ghee, notified by an FSSAI office order of 25th March, 2019. Table 1 sets the fatty acid composition of ghee by GLC, as a percentage of total fatty acids, for saturated, mono-unsaturated and poly-unsaturated acids from butyric acid (C4:0) onward; the product must meet that table. The names are Milk Fat or Butter Oil, Anhydrous Milk Fat or Anhydrous Butter Oil, and Ghee. Our article on the fatty-acid and peroxide standards for oils and fats covers the parallel provisions for vegetable fats.
Regulation 2.1.9: butter
Butter is a fatty product, principally a water-in-oil emulsion, derived exclusively from milk or milk products. The standard recognises table butter, which must be made from pasteurised cream, and white or cooking butter. Permitted ingredients are sodium chloride and food grade salt (table butter only), starter cultures of harmless lactic acid and flavour-producing bacteria, and potable water.
The table prints, for table butter, moisture at a maximum of 16.0, milk fat at a minimum of 80.0, milk solids-not-fat at a maximum of 2.0 and common salt at a maximum of 3.0, all per cent (m/m). For white or cooking butter only milk fat is set, at a minimum of 76.0. Where butter is sold without saying which type, the table butter standard applies. Extracted fat must meet the Reichert Meissl value and Butyro-refractometer reading prescribed for ghee. The name is "Pasteurized Table butter" or "White butter/Cooking Butter", the latter preceded by "Pasteurised" if made from pasteurised cream.
Regulation 2.1.10: milk powders and cream powder
The standard covers whole milk powder, partly skimmed milk powder, skimmed milk powder and cream powder, made by partial removal of water from milk or cream. Fat or protein may be adjusted only to meet the table, without altering the whey protein to casein ratio, and milk retentate may be used for protein adjustment. The product shall not contain added whey or whey preparations.
The parameters are moisture, milk fat, milk protein in SNF, titratable acidity, insolubility index, total ash and scorched particles. The table prints moisture at a maximum of 5.0 for all four, milk fat at a minimum of 26.0 and less than 42.0 for whole milk powder, at a maximum of 1.5 for skimmed milk powder and at a minimum of 42.0 for cream powder, and milk protein in SNF at a minimum of 34.0. A note limits total sodium to not more than 650 mg/100 gm SNF, without counting sodium from additives. Partly skimmed milk powder may be called semi-skimmed if milk fat is not less than 14% and does not exceed 16% (m/m). Label rules say the word "skimmed" or "partly skimmed" must sit beside "milk" on skimmed powder packs, and restrict comment on the dilution statement, except for the printed dilution instruction.
Regulation 2.1.11: dairy whitener
Dairy whitener is a milk product with added carbohydrates such as sucrose, dextrose and maltodextrin. It must be white or light cream, uniform, with no lumps except those that break up under slight pressure, and with no extraneous matter or added colours. The flavour must be pleasant and sweet, with no off flavours. Four types follow: skimmed milk, low fat, medium fat and high fat dairy whitener. The table includes moisture at a maximum of 4.0, milk protein in SNF at a minimum of 34.0, and added sugar as sucrose at a maximum of 18.0 per cent (m/m). A note adds that added sugar up to 24% is permissible for two years from the date of final notification; the compendium text does not state that date.
Regulation 2.1.12: whey powder
Whey powder is made by drying whey or acid whey. Whey is the fluid left after cheese or casein is separated from the curd, coagulated mainly by enzymes of non-animal origin. Acid whey comes from paneer, channa and similar products and is coagulated principally by acidification and heating. The table sets moisture, milk fat, milk protein, lactose as anhydrous lactose, pH or titratable acidity, and total ash. The minimum milk protein printed is 10.0 for whey powder and 7.0 for acid whey powder. Whey powders may be modified, for instance by neutralisation or demineralisation, but not beyond the printed minimum or maximum for milk protein and water.
Summary table
| Product | Defining feature | Key parameters named | Clause |
|---|---|---|---|
| Milk fat, butter oil, ghee | almost all water and SNF removed | moisture, milk fat, BR reading, RM and Polenske values, iodine and saponification values | 2.1.8 |
| Butter | water-in-oil emulsion; two types | moisture, milk fat, SNF, salt | 2.1.9 |
| Milk and cream powders | partial removal of water; four types | moisture, fat, protein in SNF, acidity, ash | 2.1.10 |
| Dairy whitener | milk product with added carbohydrates | moisture, fat, added sugar | 2.1.11 |
| Whey powder, acid whey powder | dried whey | protein, lactose, ash, pH | 2.1.12 |
Common requirements
Every standard here points to Appendix A for additives, to the Contaminants Regulations, to Schedule 4 of the Licensing Regulations for hygiene, and, except 2.1.8, to Appendix B for microbiological limits. Our articles on Appendix A and Appendix B explain those tables. For label statements on milk, see our sister article on Schedule II, part 2, of the labelling regulations.
Need help with ghee and powder standards?
A ghee batch that fails on one parameter can be sub-standard even when it looks right. Our team can review your specification sheet and label against these standards through FSSAI registration for food manufacturers.
Key takeaways
- The ghee standard sets a column of laboratory parameters, from moisture to beta-sitosterol.
- Butter has two types, and table butter applies when the type is not stated.
- Milk powders come in four types and a sodium note applies.
- Dairy whitener has four fat types and a printed added sugar limit.
- Appendix A and Appendix B apply to all except where the text says otherwise.
Read next
- Regulations 2.1.2 to 2.1.7: milk, condensed milk, khoa and cream
- Regulations 2.1.13 to 2.1.16: dahi, ice cream, frozen dessert and paneer
- Dairy product standards: milk, curd and ghee
- FSSAI compliance for dairy businesses
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.