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The Food Safety and Standards Authority of India makes the Food Safety and Standards (Food Products Standards and Food Additives) First Amendment Regulations, 2025, to further amend the Food Safety and Standards (Food Products Standards and Food Additives) Regulations, 2011.

Detailed Summary

The Food Safety and Standards Authority of India (FSSAI), under F. No. STD/43-FA-Notifications/2024, dated 10th July, 2025, has issued the Food Safety and Standards (Food Products Standards and Food Additives) First Amendment Regulations, 2025, which will come into force on 1st February, 2026. These regulations are made in exercise of powers conferred by clause (e) of sub-section (2) of section 92 read with section 16 of the Food Safety and Standards Act, 2006 (34 of 2006), after considering objections and suggestions to the draft regulations published vide notification F.No. STD/39-FA/Notification/2022, dated 31st October, 2022. The amendments include revisions to regulation 2.2.1, substituting Refractive Index values for various parameters (e.g., 1.454-1.456 at 50°C, 1.458-1.460 at 40°C). A new clause 2A for 'Meat Sausages' is inserted under regulation 2.5.2, specifying standards for fresh or cooked sausages, including compositional requirements such as minimum meat content (50-65% w/w), maximum moisture (50-65% w/w), and maximum total ash (3% w/w), along with preparation, processing, and storage conditions (e.g., cooling to below 4°C, freezing at -18°C). Regulation 2.9 is amended to insert a new sub-regulation 2.9.45 for 'Dehydrated Tarragon' (whole and powder), detailing characteristics and requirements like maximum moisture content (10% m/m), total ash (12% m/m), acid-insoluble ash (1.5% m/m), and minimum volatile oil content (0.6 ml/100g for whole, 0.5 ml/100g for powder), along with chromatographic requirements. Regulation 2.10.8 concerning 'Packaged Drinking Water' is amended in Table 2 (serial 5) and Table 3 (serial 15, 16) to substitute specific entries with new values (e.g., "75 to 500", "10 to 75", "5 to 30"). In Chapter 3, regulation 3.2.1 relating to 'Food Colours' is significantly amended by omitting specific notes regarding freedom from contaminants for Tartrazine, Sunset Yellow, Erythrosine, Indigo Carmine, Ponceau 4R, Brilliant Blue FCF, and Fast Green FCF, and similar general requirements for Carmoisine. Clause 12 is substituted with new standards for 'Food Colour - Preparation and Mixtures', listing 29 permitted diluents or filler materials and specifying total dye content declaration with tolerance limits (±15% for liquid, ±7.5% for solid). Appendix A (Table 14) is amended by omitting the entry "160" for Steviol glycosides in Beverages. Appendix C is amended in Table 7 (Bleaching Agents) to substitute an entry with "5 (as hydrogen peroxide)", and in Table 11 (Enzymes) by inserting new production organisms for various enzymes. Furthermore, Table 11 A (Enzymes derived from Genetically Modified Microorganisms) is expanded to include new enzymes like Phospholipase A2, Lysophospholipase, Lipase triacylglycerol, Glucose Oxidase, Serine endopeptidase, and Chymosin, with details on their production organism, donor organism, functional purpose, food uses, and residual level (GMP), along with general criteria for all enzyme preparations (e.g., Lead: not more than 5 mg/kg, Salmonella spp.: absent in 25g). The original Regulations were published on 1st August, 2011, and last amended on 21st October, 2024.

Full Text

REGD. No. D. L.-33004/99 The Gazette of India CG-DL-E-17072025-264741 EXTRAORDINARY PART III—Section 4 PUBLISHED BY AUTHORITY NEW DELHI, MONDAY, JULY 14, 2025/ASHADHA 23, 1947 No. 506] FOOD SAFETY AND STANDARDS AUTHORITY OF INDIA NOTIFICATION New Delhi, the 10th July, 2025 F. No. STD/43-FA-Notifications/2024.—Whereas, the draft Food Safety and Standards (Food Products Standards and Food Additives) Amendment Regulations, 2022, were published as required by sub-section (1) of section 92 of the Food Safety and Standards Act, 2006 (34 of 2006) vide notification of the Food Safety and Standards Authority of India, number F.No. STD/39- FA/Notification/2022, dated the 31st October, 2022, in the Gazette of India, Extraordinary, Part III, Section 4, for inviting objections and suggestions from all persons likely to be affected thereby; And whereas the copies of the said Gazette were made available to the public on the 3rd November, 2022; And whereas the objections and suggestions received from the public in respect of the said draft regulations have been considered by the Food Safety and Standards Authority of India; Now, therefore, in exercise of the powers conferred by clause (e) of sub-section (2) of section 92 read with section 16 of the Food Safety and Standards Act, 2006 (34 of 2006), the Food Safety and Standards Authority of India hereby makes the following regulations further to amend the Food Safety and Standards (Food Products Standards and Food Additives) Regulations, 2011, namely: - 1. Short title and commencement. - (1) These regulations may be called the Food Safety and Standards (Food Products Standards and Food Additives) First Amendment Regulations, 2025. (2) They shall come into force on 1st February, 2026. 2. In the Food Safety and Standards (Food Products Standards and Food Additives) Regulations, 2011, (hereinafter referred to as said regulations), - (1) in regulation 2.2, in sub-regulation, 2.2.1, - (a) in clause 19, in the table, in serial number 1, for the entry in column (3) against the Parameter ‘Refractive Index at 50°C', the entry “1.454-1.456" shall be substituted; (b) in clause 20, in the table, for the entry in column (2) against ‘Refractive Index at 40°C', the entry "1.458-1.460” shall be substituted; (c) in clause 21, in the table, in serial number 1, for the entry in column (3) against the Parameter ‘Refractive Index at 40°C', the entry “1.448-1.452" shall be substituted; (d) in clause 29, in the table, in serial number 1, for the entry in column (3) against the Parameter ‘Refractive Index at 40°C', the entry “1.459-1.460” shall be substituted; (2) in regulation 2.5, in sub-regulation 2.5.2, after clause 2, the following clause shall be inserted, namely: - "2A. Meat Sausages. - (1) The standard specified under this clause shall apply to fresh or cooked meat sausages. (2) Sausage is a product obtained by stuffing minced meat (pork, poultry or meat from other food animals) and other ingredients (fat or oil, salt, water, extenders and spices) in casings (natural or artificial) which may be marketed as fresh (raw), fermented, cooked or smoked or a combination of the same. (3) Fresh meat sausages shall be palatable, and shall have pleasant flavour and attractive appearance. No foreign or any other objectionable odour shall be present. Fresh meat sausages shall be of a good uniform texture characteristic of the product. Pieces of hair and particles of bone shall not be present in the product. The product shall be free from dirt and from insect and rodent contamination. Any deleterious substance shall not be present. (4) Ingredients: Meat and other ingredients shall be as given under the standard of comminuted, restructured, cured, smoked and dry or fermented meat products specified under these regulations. (5) General requirements: 5.1 Fresh sausages shall be prepared from one or more kinds of fresh, chilled or frozen meat. 5.2 Smoked sausages shall be prepared from one or more kinds of fresh, chilled or frozen meat and smoked with only hard wood or other non-resinous materials. 5.3 Cooked sausages shall be prepared from one or more kinds of fresh, chilled or frozen meat and cooked to attain the internal temperature of 75°C. 5.4 Dry or fermented sausages shall be prepared from one or more kinds of fresh, chilled or frozen meat subjected to a controlled drying process. (6) Preparation and processing: (i) Mincing: Chilled or frozen meat or offals or trimmings shall be minced using a mechanical meat mincer. In case of pork fat, the same shall be minced after freezing. (ii) Emulsification: Minced meat and other ingredients in the sausage formulation shall be emulsified with the help of a meat chopper (bowl chopper) to form a fine paste (meat emulsion). (iii) Stuffing and linking: The minced meat or meat emulsion shall be stuffed into the casing with the help of a mechanical stuffer and linking of the sausages shall be performed either manually or with the help of mechanical linking machine. (iv) Cooking (applicable for cooked sausages): The stuffed and linked sausages shall be cooked by suitable means to attain the internal temperature of 75°C. (v) Cooling (applicable for cooked sausages): The cooked sausages shall be cooled to below 40°C prior to chilling or freezing. (7) Storage requirements: (i) Fresh meat sausages shall be brought to a temperature of 4°C within 12 hours. (ii) The fresh chilled sausages shall be stored at a temperature not exceeding 4°C. (iii) Fresh or cooked sausages shall be chilled before freezing and the freezing shall be completed at -18°C or lower. (iv) The cooked and chilled sausages shall be stored at a temperature not exceeding 4°C. (v) The frozen sausages shall be stored at -18°C or lower. (8) Composition of finished product: The product shall conform to the following compositional requirements: +-------+-------------------------------+-------+---------------+--------------+ | S. No. | Parameter | Fresh | Cooked/Smoked | Dry/fermented| +=======+===============================+=======+===============+==============+ | (1) | (2) | (3) | (4) | (5) | +-------+-------------------------------+-------+---------------+--------------+ | 1 | Meat, Minimum (w/w) | 50% | 60% | 65% | +-------+-------------------------------+-------+---------------+--------------+ | 2 | Moisture, Maximum (w/w) | 65% | 60% | 50% | +-------+-------------------------------+-------+---------------+--------------+ | 3 | Total ash, Maximum (w/w) | 3% | 3% | 3% | +-------+-------------------------------+-------+---------------+--------------+ (9) The product may contain Food Additives permitted in Appendix A. (10) The product shall conform to the microbiological requirement given in Appendix B. (11) In addition to the requirements specified under this standard, the standard of comminuted or restructured meat products specified under clause 2 of sub-regulation 2.5.2 above shall apply to these products.”; (3) in regulation 2.9, after sub-regulation 2.9.44, the following sub-regulation shall be inserted, namely: - "2.9.45 Dehydrated Tarragon (1) Dehydrated Tarragon, whole Dehydrated Tarragon (Vilayti Damnak), whole means the dried leaves obtained from perennial plant Artemisia dracunculus Linnaeus, belonging to the family Asteraceae. The colour of the dried leaves ranges from pale green to grey-green. It shall be free from visible foreign organic or inorganic matter including molds, living or dead insects and pests, tissues and excreta of rodents or of any other animal or human origin. It shall not contain any other plant species other than those specified. It shall conform to the following requirements, namely: - +-------+------------------------------------------------------------------+--------------+ | S. No. | Characteristics | Requirements | +=======+==================================================================+==============+ | (1) | (2) | (3) | +-------+------------------------------------------------------------------+--------------+ | 1. | Moisture content, per cent by mass (m/m) (Maximum) | 10 | +-------+------------------------------------------------------------------+--------------+ | 2. | Total Ash, per cent by mass (m/m) on dry basis, (Maximum) | 12 | +-------+------------------------------------------------------------------+--------------+ | 3. | Acid-insoluble ash, per cent by mass on dry basis, (Maximum) | 1.5 | +-------+------------------------------------------------------------------+--------------+ | 4. | Volatile oil content, ml/100g, on dry basis (Minimum) | 0.6 | +-------+------------------------------------------------------------------+--------------+ | 5. | Foreign matter, per cent m/m | Absent | +-------+------------------------------------------------------------------+--------------+ | 6. | Extraneous matter, per cent m/m, (Maximum) | 1 | +-------+------------------------------------------------------------------+--------------+ | 7. | Broken stems in form of whole or cut leaves, per cent m/m, | 3 | | | (Maximum) | | +-------+------------------------------------------------------------------+--------------+ | 8. | Yellow or brown leaves, per cent m/m, (Maximum) | 15 | +-------+------------------------------------------------------------------+--------------+ Explanation.- For the purpose of this clause, - (i) ‘extraneous matter' means other vegetative matter associated with the plant from which the product originates (except broken stems in form of whole or cut leaves and yellow or brown leaves). (ii) 'foreign matter' means any visible objectionable foreign detectable matter or material not usually associated with the natural components of the spice plant; such as sticks, stones, and any other material. (iii) 'chromatographic requirements': The volatile oil obtained by hydro or steam distillation of the dried leaves of tarragon, and analysed by using gas chromatography shall comprise the following main constituents: cis-ẞ-ocimene, trans-ẞ-ocimene, transanethole, methylchavicol (estragole) and methyleugenol. The volatile oil shall not contain significant amounts of either sabinene or elemicin. (2) Dehydrated Tarragon, powder Dehydrated Tarragon (Vilayti Damnak), powder means the powder obtained by grinding dried leaves of Artemisia dracunculus Linnaeus, belonging to the family Asteraceae. It shall be free from visible foreign organic or inorganic matter including molds, living or dead insects and pests, tissues and excreta of rodents or of any other animal or human origin. It shall not contain any other plant species other than those specified. It shall conform to the following requirements, namely: +-------+------------------------------------------------------------------+--------------+ | S. No. | Characteristics | Requirements | +=======+==================================================================+==============+ | (1) | (2) | (3) | +-------+------------------------------------------------------------------+--------------+ | 1. | Moisture content, per cent by mass (m/m) (Maximum) | 10 | +-------+------------------------------------------------------------------+--------------+ | 2. | Total Ash, per cent by mass (m/m) on dry basis, (Maximum) | 12 | +-------+------------------------------------------------------------------+--------------+ | 3. | Acid-insoluble ash, per cent by mass on dry basis, (Maximum) | 1.5 | +-------+------------------------------------------------------------------+--------------+ | 4. | Volatile oil content, ml/100g, on dry basis (Minimum) | 0.5 | +-------+------------------------------------------------------------------+--------------+ Explanation.- For the purpose of this clause, - (i) Chromatographic requirements: The volatile oil obtained by hydro or steam distillation of the dried leaves of tarragon, and analysed by using gas chromatography shall comprise the following main constituents: cis-ẞ-ocimene, trans-ẞ-ocimene, transanethole, methylchavicol (estragole) and methyleugenol. The volatile oil shall not contain significant amounts of either sabinene or elemicin."; (4) in regulation 2.10, under sub-regulation 2.10.8 relating to ‘Packaged Drinking Water (other than Mineral Water)', - (a) in Table 2, for the entry in column (3) against serial number 5, the entry “75 to 500” shall be substituted; (b) in Table 3, - (i) for the entry in column (3) against serial number 15, the entry “10 to 75” shall be substituted; (ii) for the entry in column (3) against serial number 16, the entry “5 to 30" shall be substituted; (5) in Chapter 3, in regulation 3.2, in sub-regulation 3.2.1 relating to ‘Food Colours', - (a) in clause 1 relating to ‘Tartrazine', the note under the Table, “It shall be free from mercury, copper and chromium in any form; aromatic amines, aromatic nitro compounds, aromatic hydrocarbons, and cyanides.” shall be omitted; (b) in clause 2 relating to ‘SUNSET YELLOW', the note under the Table, “It shall be free from mercury, copper and chromium in any form; aromatic amines, aromatic nitro compounds, aromatic hydrocarbons, and cyanides.” shall be omitted; (c) in clause 3 relating to ‘ERYTHROSINE', the note under the Table, “It shall be free from mercury, copper and chromium in any form; aromatic amines, aromatic nitro compounds, aromatic hydrocarbons, and cyanides.” shall be omitted; (d) in clause 4 relating to ‘INDIGO CARMINE', the note under the Table, “It shall be free from mercury, copper and chromium in any form; aromatic amines, aromatic nitro compounds, aromatic hydrocarbons, and cyanides.” shall be omitted; (e) in clause 10 relating to ‘PONCEAU 4R', the note under the Table, “It shall be free from mercury, selenium and chromium in any form; aromatic amines, aromatic nitro compounds, aromatic hydrocarbons, and cyanides.” shall be omitted; (f) in clause 11 relating to ‘CARMOISINE, in the ‘General Requirements', the words “The material shall be free from mercury, selenium and chromium in any form, aromatic amines, aromatic nitro compounds, aromatic hydrocarbons and cyanides.” shall be omitted; (g) for clause 12 relating to ‘SYNTHETIC FOOD COLOUR - PREPARATION AND MIXTURES' the following clause shall be substituted, namely: - "12- Food Colour - Preparation and Mixtures Colour Preparation and Mixtures (1) A preparation containing one or more of the permitted food colours conforming to the prescribed standard along with diluents or filler materials or both and meant to be used for imparting colour to food. It may contain permitted additives as per Appendix A and C. (2) The colour preparation and mixtures would be either in the form of a liquid or solid. Solid preparations shall be free from lumps and any visible extraneous or foreign matter. (3) Liquid preparations shall be free from sediments. (4) Only the following diluents or filler materials shall be permitted to be used in colour preparations and mixtures conforming to the prescribed standards; namely: - 1. Potable water 2. Edible common salt 3. Sugar 4. Dextrose Monohydrate 5. Liquid glucose 6. Sodium sulphate 7. Tartaric acid 8. Glycerine 9. Propylene glycol 10. Acetic acid, dilute 11. Sorbitol 12. Citric acid 13. Sodium carbonate and sodium hydrogen carbonate 14. Lactose 15. Ammonium, sodium and potassium alginates 16. Dextrins 17. Ethyl acetate 18. Starches 19. Diethyl ether 20. Ethanol 21. Glycerol mono, di and tri acetate 22. Edible oils and fats 23. Isopropyl alcohol 24. Bees wax 25. Sodium and ammonium hydroxide 26. Lactic acid 27. Carrageenan and gum arabic 28. Gelatin 29. Pectin (5) General Requirements.- The total dye content, per cent by mass (m/v) in the colour preparation or in the mixture shall be declared on the label of the container. In solid and liquid preparations, the declared value shall be on 'as in' basis. The total dye content shall be within the tolerance limits given below on the declared value: (a) Liquid preparation ±15 per cent (b) Solid preparations ±7.5 per cent It shall conform to the standards of contaminants as per the Food Safety and Standards (Contaminants, Toxins and Residues) Regulation, 2011."; (h) in clause 13 relating to ‘BRILLIANT BLUE FCF', the note under the Table shall be omitted; (i) in clause 14 relating to 'Fast Green FCF', the note under the Table shall be omitted; (6) in Appendix A, under the heading “IV. USE OF FOOD ADDITIVES IN FOOD PRODUCTS", in Table 14 relating to ‘Beverages, excluding dairy products', for ‘Food category system 14.1.5' relating to ‘Coffee, coffee/coffee substitutes, tea, herbal infusions, and other hot cereal and grain beverages, excluding cocoa' for food additive “Steviol glycosides" and entries related thereto, in column (6), the entry “160” shall be omitted; (7) in Appendix C, under the heading “II. USE OF PROCESSING AIDS IN FOOD PRODUCTS", - (a) in Table 7 relating to ‘BLEACHING, WASHING, DENUDING AND PEELING AGENTS', for the entries in column (4) against serial number 8, the entry "5 (as hydrogen peroxide)" shall be substituted; (b) in Table 11 relating to ‘ENZYMES (for treatment or processing of raw materials, foods, or ingredients)', - (i) against serial number 5, for the entries in column (3), after “Rice bran", the entry “Aspergillus oryzae” shall be inserted; (ii) against serial number 6, for the entries in column (3), after “Aspergillus niger”, the entry “Aspergillus oryzae” shall be inserted; (iii) against serial number 26, for the entries in column (3), after “Aspergillus oryzae”, the entry "Bacillus licheniformis” shall be inserted; (iv) against serial number 35, for the entries in column (3), after “Aspergillus oryzae”, the following entries shall be inserted, namely: - "Rhizomucor miehei Cryphonectria Parasitica”; (v) against serial number 42, for the entries in column (3), after “Kluyveromyces lactis”, the entry "Aspergillus niger (variety- Awamori)” shall be inserted; (c) in Table 11 A relating to ‘Enzymes derived from Genetically Modified Microorganisms (GMM)', after serial number 45, the following shall be inserted, namely: - +-----+-----------------------+-------------+---------------+-------------------+---------------+------------+ | S. | Enzyme Name | Production | Donor | Functional and | Indicative | Residual | | No | | Organism | Organism | technological | food uses | level | | | | | or Source | purpose | | (mg/kg) | | | | | | | | (Not more | | | | | | | | than) | +=====+=======================+=============+===============+===================+===============+============+ | (1) | (2) | (3) | (4) | (5) | (6) | (7) | +-----+-----------------------+-------------+---------------+-------------------+---------------+------------+ | "46.| Phospholipase | Trichoderma | Aspergillus | For use in | Oils and fats | GMP | | | A2# | reesei | nishimurae | degumming of | processing, | | | | (EC No. 3.1.1.4) | | (ex fumigatus)| oils and fats, | Egg products | | | | | | | Egg yolk | | | | | | | | processing | | | +-----+-----------------------+-------------+---------------+-------------------+---------------+------------+ | 47. | Lysophospholip | Trichoderma | Aspergillus | For use in starch | Oils and fats | GMP | | | ase# | reesei | nishimurae | processing, | processing, | | | | (EC No. 3.1.1.5) RF4847| | (ex fumigatus)| degumming of | Syrups for | | | | | | | oils and fats | use in soft | | | | | | | | drinks or | | | | | | | | bakery | | +-----+-----------------------+-------------+---------------+-------------------+---------------+------------+ | 48. | Lipase | Trichoderma | Fusarium | Facilitate the | Bakery | GMP | | | triacylglycerol# | reesei | oxysporum | handling of the | products, | | | | (EC No. | | | dough for | Oils and fats | | | | 3.1.1.3) | | | baking | processing | | | | | | | Improve dough | | | | | | | | stability and | | | | | | | | strength | | | | | | | | structure and | | | | | | | | behaviour | | | | | | | | during the | | | | | | | | baking steps | | | | | | | | and Regulate | | | | | | | | batter | | | | | | | | viscosity, | | | | | | | | degumming of | | | | | | | | oils and fats | | | +-----+-----------------------+-------------+---------------+-------------------+---------------+------------+ | 49. | Glucose | Trichoderma | Penicillium | Facilitate the | Egg Products | GMP | | | Oxidase# | reesei | amagasakiense | handling of | and Bakery | | | | (EC No. 1.1.3.4) | | | dough, (reduce | and Pasta | | | | | | | dough | Products | | | | | | | stickiness, | | | | | | | | strengthen | | | | | | | | dough structure, | | | | | | | | improve | | | | | | | | cooking | | | | | | | | tolerance) of | | | | | | | | pasta or noodle; | | | | | | | | egg processing | | | +-----+-----------------------+-------------+---------------+-------------------+---------------+------------+ | 50 | Serine | Trichoderma | Malbranchea | It is used as a | Fish and | GMP | | | endopeptidase | reesei | cinnamomea | processing aid | meat | | | | (protease) # | | | for partial or | processing | | | | (E.C No. 3.4.21. | | | extensive | | | | | 65) | | | hydrolysis of | | | | | | | | proteins from | | | | | | | | both animal and | | | | | | | | vegetable | | | | | | | | sources. | | | +-----+-----------------------+-------------+---------------+-------------------+---------------+------------+ | 51 | Chymosin# | Aspergillus | Bos taurus | Milk | Manufacture | GMP | | | (E.C No. | niger var. | | coagulating | of paneer and | | | | 3.4.23.4) | Awamori | | enzyme | cheese | | +-----+-----------------------+-------------+---------------+-------------------+---------------+------------+ #All enzyme preparations should meet the following criteria: (i) Lead: not more than 5 mg/kg. (ii) Salmonella spp.: absent in 25 g sample. (iii) Total coliforms: not more than 30 per g. (iv) Escherichia coli: absent in 25 g sample (v) DNA: absent in preparations from microbial sources (vi) Antibiotic activity: absent in preparations from microbial sources." G. KAMALA VARDHANA RAO, Chief Executive Officer [ADVT.-III/4/Exty./239/2025-26] Note: The Food Safety and Standards (Food Products Standards and Food Additives) Regulations, 2011 were published in the Gazette of India, Extraordinary, Part III, section 4 vide notification number F. No. 2-15015/30/2010, dated 1st August, 2011 and last amended vide notification number F.No. STD/FA/38/FSSAI(Part-1), dated 21st October, 2024.

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