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Core Purpose

The Food Safety and Standards Authority of India proposes draft regulations to further amend the Food Safety and Standards (Food Products Standards and Food Additives) Regulations, 2011.

Detailed Summary

The Ministry of Health and Family Welfare, through the Food Safety and Standards Authority of India (FSSAI), published draft regulations on June 4, 2025, proposing amendments to the Food Safety and Standards (Food Products Standards and Food Additives) Regulations, 2011. These draft regulations, to be called the Food Safety and Standards (Food Products Standards and Food Additives) Amendment Regulations, 2025, 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). The public is invited to submit objections or suggestions within sixty days from the date of gazette publication to the Chief Executive Officer, FSSAI, FDA Bhawan, Kotla Road, New Delhi-110002 or via email at regulation@fssai.gov.in. Key amendments include: in regulation 2.1.8, Table 1 for 'The fatty acid composition of ghee', C16:0 Hexadecanoic acid (Palmitic acid) is changed to 22.0-39.0 and C18:3 (cis 9,12,15) 9,12,15-Octadecatrienoic acid to 0.2-1.5. A new sub-regulation 2.1.17(a) is inserted, establishing a 'Standard for Cheese Powder' with specific descriptions, essential composition (minimum 40.0% milk fat dry matter, maximum 5.0% moisture, maximum 5.5% added sodium chloride), permitted ingredients, food additives, contaminants, hygiene, labelling, and sampling/analysis requirements. Regulation 2.5.1(a) defining 'animal' is amended by omitting 'and fish'. Regulation 2.10 sees multiple changes: sub-item (B) of item III is omitted in 2.10.6(2) 'Caffeinated Beverages'; serial number 28 is omitted from the table under clause 4 of 2.10.7; entries for 'Borates (as B)' in Table 3 under clause 4 of 2.10.8 are substituted to 2.4 mg/l, Max; and clause 2 of 2.10.9 is substituted with detailed requirements for 'Drinking water (purified)' across six tables covering organoleptic/physical, undesirable substances, toxic substances (e.g., Lead 0.01 mg/l Max, Mercury 0.001 mg/l Max), radio-active residues (e.g., Alpha emitters 0.1 Bq/l Max), microbiological (E. coli, Total coliform bacteria not detectable in 100 ml), and pesticide residues (e.g., DDT 1 µg/l Max). In Appendix A, Table 6 is amended to prohibit additives in Atta, Rice flour (including for Fortified Rice Kernel preparation), Millet flour, and Mixed millet flour. Table 12 for 'Mixes for sauces and gravies' (Food Category System 12.6.3) is updated to include Sucrose esters of fatty acids (INS 473) with a recommended maximum level of 10,000 mg/kg. The original Food Safety and Standards (Food Products Standards and Food Additives) Regulations, 2011, were published vide F. No. 2-15015/30/2010, dated August 1, 2011, and last amended vide F.No. STD/FA/38/FSSAI(Part-1), dated October 21, 2024. The notification is signed by G. Kamala Vardhana Rao, Chief Executive Officer.

Full Text

REGD. No. D. L.-33004/99 The Gazette of India CG-DL-E-10062025-263697 EXTRAORDINARY PART III—Section 4 PUBLISHED BY AUTHORITY No. 418] NEW DELHI, MONDAY, JUNE 9, 2025/JYAISTHA 19, 1947 MINISTRY OF HEALTH AND FAMILY WELFARE (Food Safety And Standards Authority Of India) NOTIFICATION New Delhi, the 4th June, 2025 F.No. SS-TOFA(NOTI)/2/2024-Standard-FSSAI(Part-I)-The following draft of certain regulations further to amend the Food Safety and Standards (Food Products Standards and Food Additives) Regulations, 2011, which the Food Safety and Standards Authority of India proposes to make with previous approval of the Central Government, 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) is hereby published as required under sub-section (1) of section 92 of the said Act for the information of all persons likely to be affected thereby and notice is hereby given that the said draft regulations shall be taken into consideration after the expiry of the period of sixty days from the date on which copies of the Gazette containing this notification are made available to the public. Objections or suggestions, if any, may be addressed to the Chief Executive Officer, Food Safety and Standards Authority of India, FDA Bhawan, Kotla Road, New Delhi- 110002 or sent on email at regulation@fssai.gov.in Objections or suggestions, which may be received from any person with respect to the said draft regulations before the expiry of period so specified, shall be considered by the Food Safety and Standards Authority of India. Draft Regulations 1. These regulations may be called the Food Safety and Standards (Food Products Standards and Food Additives) Amendment Regulations, 2025. 2. In the Food Safety and Standards (Food Products Standards and Food Additives) Regulations, 2011, (hereinafter referred to as the said regulations), - (1) in regulation 2.1, (a) in sub-regulation 2.1.8, in Table 1 relating to 'The fatty acid composition of ghee', for the entries at row number 9 and 16, the following shall be substituted, namely:- +------------------------------------------+-----------+ |"C16:0 Hexadecanoic acid (Palmitic acid) |22.0-39.0 | +------------------------------------------+-----------+ |C18:3 (cis 9,12,15) 9,12,15-Octadecatrienoic acid |0.2-1.5"; | +------------------------------------------+-----------+ (b) after sub-regulation 2.1.17, the following sub-regulation shall be inserted, namely:- "2.1.17(a) Standard for Cheese Powder 1. Description. - (a) Cheese powder is a powdered form of cheese made by drying cheese dispersed in potable water or cheese slurry. (b) Cheese powder shall be white or white with greenish tinge or light cream in colour. It shall be free from lumps except those that break-up readily under slight pressure and shall be reasonably free from scorched particles. It shall not contain any ingredient not found in milk except those permitted. (c) Cheese slurry means the product obtained by blending/grinding cheese curd, and optionally a liquid (e.g. water, milk, cream or butter oil) and /or milk solids. Cheese slurry is ripened for about 2 to 3 weeks at suitable temperature for flavour development. The flavour development in Cheese slurry is accelerated by using modified starters, adjunct cultures and exogenous enzymes. 2. Essential Composition and Quality Factors. - (a) Raw Material (i) Cheese (ii) Cheese slurry (b) Permitted ingredients (i) Sodium Chloride (ii) Potable water (c) Composition +-------+--------------------------------------------+-------------+ |S. No. |Parameters |Requirements | |(1) |(2) |(3) | +=======+============================================+=============+ |1. |Milk fat, Minimum, % (m/m), dry matter basis |40.0 | +-------+--------------------------------------------+-------------+ |2. |Moisture, Maximum, %(m/m) |5.0 | +-------+--------------------------------------------+-------------+ |3. |Salt (added sodium chloride), Maximum |5.5 | | |% (m/m) | | +-------+--------------------------------------------+-------------+ 3. Food Additives. - For products covered under this standard, specific food additives specified in Appendix 'A' of these regulations may be used and only within the limits specified. 4. Contaminants, Toxins and Residues. - The products shall comply with the limits stipulated under the Food Safety and Standards (Contaminants, toxins and Residues) Regulations, 2011. 5. Hygiene. - (a) The products shall be prepared and handled in accordance with the requirements specified in Schedule 4, as applicable, of the Food Safety and Standards (Licensing and Registration of Food Businesses) Regulations, 2011 and such other guidelines as specified from time to time under the provisions of the Food Safety and Standard Act, 2006. (b) The products shall conform to the microbiological requirements specified in Appendix 'B' of these regulations. 6. Labelling. - The provisions of the Food Safety and Standards (Labelling and Display) Regulations, 2020, shall apply to pre-packaged products. 7. Method of Sampling and Analysis. - The methods of sampling and analysis mentioned in the manuals as specified by the Food Safety and Standards Authority of India from time to time shall be applicable."; (2) in regulation 2.5, in sub-regulation 2.5.1, in clause (a) relating to definition of “animal”, the words “and fish” shall be omitted; (3) in regulation 2.10, (a) in sub-regulation 2.10.6, in clause (2) relating to "Caffeinated Beverages", in item III, sub-item (B) shall be omitted; (b) in sub-regulation 2.10.7, in the table under clause 4, serial number 28 and the entries relating thereto shall be omitted; (c) in sub-regulation 2.10.8, in the Table 3 under clause 4, the entries at serial number 24 shall be substituted with the following, namely:- +-------+---------------------------+---------+ |"24. |Borates (as B), mg/l, Max |2.4 ''; | +-------+---------------------------+---------+ (d) in sub-regulation 2.10.9, for clause 2, the following shall be substituted, namely:- "(2) Drinking water (purified) shall be clear without any sediments, suspended particles and extraneous matter. It shall also comply with the requirements given in Tables 1, 2, 3, 4, 5 and 6: Table 1: Organoleptic and Physical Parameters +-------+------------------------------+-------------------+ |Sl. No.|Characteristic |Permissible Limit | |(1) |(2) |(3) | +=======+==============================+===================+ |1. |Colour, Hazen units, Max |5 | +-------+------------------------------+-------------------+ |2. |Odour |Agreeable | +-------+------------------------------+-------------------+ |3. |pH value |6.5-8.5 | +-------+------------------------------+-------------------+ |4. |Taste |Agreeable | +-------+------------------------------+-------------------+ |5. |Turbidity, NTU, Max |1 | +-------+------------------------------+-------------------+ |6. |Total dissolved solids, mg/l, Max|500 | +-------+------------------------------+-------------------+ Table 2: General Parameters Concerning Substances Undesirable in Excessive Amounts +-------+-------------------------------------+-------------------+ |Sl. No.|Characteristic |Permissible Limit | |(1) |(2) |(3) | +=======+=====================================+===================+ |1. |Aluminium (as Al), mg/l, Max |0.03 | +-------+-------------------------------------+-------------------+ |2. |Ammonia (as total ammonia-N) mg/l, Max|0.5 | +-------+-------------------------------------+-------------------+ |3. |Anionic detergents (as MBAS) mg/l, Max|0.2 | +-------+-------------------------------------+-------------------+ |4. |Barium (as Ba), mg/l, Max |0.7 | +-------+-------------------------------------+-------------------+ |5. |Boron (as B), mg/l, Max |0.5 | +-------+-------------------------------------+-------------------+ |6. |Calcium (as Ca), mg/l, Max |75 | +-------+-------------------------------------+-------------------+ |7. |Chloramines (as Cl2), mg/l, Мах |4.0 | +-------+-------------------------------------+-------------------+ |8. |Chloride (as Cl), mg/l, Max |250 | +-------+-------------------------------------+-------------------+ |9. |Copper (as Cu), mg/l, Max |0.05 | +-------+-------------------------------------+-------------------+ |10. |Fluoride (as F) mg/l, Max |1.0 | +-------+-------------------------------------+-------------------+ |11. |Free residual chlorine, mg/l, Min |0.2 | +-------+-------------------------------------+-------------------+ |12. |Iron (as Fe), mg/l, Max |1.0 | +-------+-------------------------------------+-------------------+ |13. |Magnesium (as Mg), mg/l, Мах |30 | +-------+-------------------------------------+-------------------+ |14. |Manganese (as Mn), mg/l, Max |0.1 | +-------+-------------------------------------+-------------------+ |15. |Mineral oil, mg/l, Max |1.0 | +-------+-------------------------------------+-------------------+ |16. |Nitrate (as NO3), mg/l, Max |45 | +-------+-------------------------------------+-------------------+ |17. |Phenolic compounds (as C6 H5OH), mg/l, Мах|0.001 | +-------+-------------------------------------+-------------------+ |18. |Selenium (as Se), mg/l, Max |0.01 | +-------+-------------------------------------+-------------------+ |19. |Silver (as Ag), mg/l, Max |0.1 | +-------+-------------------------------------+-------------------+ |20. |Sulphate (as SO4) mg/l, Max |200 | +-------+-------------------------------------+-------------------+ |21. |Sulphide (as H2S), mg/l, Max |0.05 | +-------+-------------------------------------+-------------------+ |22. |Total alkalinity as calcium carbonate, mg/l, Max|200 | +-------+-------------------------------------+-------------------+ |23. |Total hardness (as CaCO3), mg/l, Max |200 | +-------+-------------------------------------+-------------------+ |24. |Zinc (as Zn), mg/l, Max |5 | +-------+-------------------------------------+-------------------+ Table 3: Parameters Concerning Toxic Substances +-------+---------------------------------------------+-------------------+ |Sl. No.|Characteristic |Permissible Limit | |(1) |(2) |(3) | +=======+=============================================+===================+ |1. |Cadmium (as Cd), mg/l, Max |0.003 | +-------+---------------------------------------------+-------------------+ |2. |Cyanide (as CN), mg/l, Max |0.05 | +-------+---------------------------------------------+-------------------+ |3. |Lead (as Pb), mg/l, Max |0.01 | +-------+---------------------------------------------+-------------------+ |4. |Mercury (as Hg), mg/l, Max |0.001 | +-------+---------------------------------------------+-------------------+ |5. |Molybdenum (as Mo), mg/l, Max |0.07 | +-------+---------------------------------------------+-------------------+ |6. |Nickel (as Ni), mg/l, Max |0.02 | +-------+---------------------------------------------+-------------------+ |7. |Polychlorinated biphenyls, mg/l, Max |0.0005 | +-------+---------------------------------------------+-------------------+ |8. |Polynuclear aromatic hydrocarbons (as PAH), mg/l, Max|0.0001 | +-------+---------------------------------------------+-------------------+ |9. |Total arsenic (as As), mg/l, Max |0.01 | +-------+---------------------------------------------+-------------------+ |10. |Total chromium (as Cr), mg/l, Max |0.05 | +-------+---------------------------------------------+-------------------+ |11. |Trihalomethanes: | | | |a) Bromoform, mg/l, Max |0.1 | | |b) Dibromochloromethane, mg/l, Max |0.1 | | |c) Bromodichloromethane mg/l, Max |0.06 | | |d) Chloroform, mg/l, Max |0.2 | +-------+---------------------------------------------+-------------------+ Table 4: Parameters concerning radio-active residues +-------+--------------------------------+-------------------+ |Sl. No.|Characteristic |Permissible Limit | |(1) |(2) |(3) | +=======+================================+===================+ |1. |Alpha emitters Bq/l, Max |0.1 | +-------+--------------------------------+-------------------+ |2. |Beta emitters Bq/l, Max |1.0 | +-------+--------------------------------+-------------------+ |3. |Uranium, mg/l, Max |0.03 | +-------+--------------------------------+-------------------+ Table 5: Microbiological Requirements +-------+--------------------------------------+--------------------------------------+ |Sl. No.|Characteristic |Permissible Limit | |(1) |(2) |(3) | +=======+======================================+======================================+ |1. |E. coli or thermotolerant coliform bacteria|Shall not be detectable in any 100 ml sample| +-------+--------------------------------------+--------------------------------------+ |2. |Total coliform bacteria |Shall not be detectable in any 100 ml sample| +-------+--------------------------------------+--------------------------------------+ Table 6: Parameters concerning pesticide residues +-------+----------------------------------------+-------------------+ |Sl. No.|Characteristic |Permissible Limit (µg/l)| |(1) |(2) |(3) | +=======+========================================+===================+ |1. |Alachlor |20 | +-------+----------------------------------------+-------------------+ |2. |Atrazine |2 | +-------+----------------------------------------+-------------------+ |3. |Aldrin/ Dieldrin |0.03 | +-------+----------------------------------------+-------------------+ |4. |Alpha HCH |0.01 | +-------+----------------------------------------+-------------------+ |5. |Beta HCH |0.04 | +-------+----------------------------------------+-------------------+ |6. |Butachlor |125 | +-------+----------------------------------------+-------------------+ |7. |Chlorpyriphos |30 | +-------+----------------------------------------+-------------------+ |8. |Delta HCH |0.04 | +-------+----------------------------------------+-------------------+ |9. |2,4- Dichlorophenoxyacetic acid |30 | +-------+----------------------------------------+-------------------+ |10. |DDT (o, p and p, p - Isomers of DDT DDE and DDD)|1 | +-------+----------------------------------------+-------------------+ |11. |Endosulfan (alpha, beta, and sulphate) |0.4 | +-------+----------------------------------------+-------------------+ |12. |Ethion |3 | +-------+----------------------------------------+-------------------+ |13. |Gamma HCH (Lindane) |2 | +-------+----------------------------------------+-------------------+ |14. |Isoproturon |9 | +-------+----------------------------------------+-------------------+ |15. |Malathion |190 | +-------+----------------------------------------+-------------------+ |16. |Methyl parathion |0.3 | +-------+----------------------------------------+-------------------+ |17. |Monocrotophos |1 | +-------+----------------------------------------+-------------------+ |18. |Phorate |2"; | +-------+----------------------------------------+-------------------+ (4) In Appendix A, under the heading “IV. Use of Food Additives in Food Products", - (a) in Table 6, against the entries relating to Food Category System 6.2.1 and 6.2.2 (Flours and starches*), in column (3), for the figure & words "*No additives permitted in Atta", the figure & words "*No additives permitted in Atta, Rice flour (including the flour for Fortified Rice Kernel preparation), Millet flour, and Mixed millet flour” shall be substituted; (b) in Table 12, against the entries relating to Food Category System 12.6.3 (Mixes for sauces and gravies), in column (3), after the food additive "Sodium aluminosilicate" and the entries relating thereto, the following shall be inserted, namely:- +------------------+---------------+---------------+-------+-----------------------+------+ |Food Category |Food Category |Food Additive |INS No |Recommended |Note | |System |Name | | |Maximum Level | | +==================+===============+===============+=======+=======================+======+ |"12.6.3 |Mixes for |Sucrose esters |473 |10,000 mg/kg |127" | | |sauces and |of fatty acids | | | | | |gravies | | | | | +------------------+---------------+---------------+-------+-----------------------+------+ G. KAMALA VARDHANA RAO), Chief Executive Officer [ADVT.-III/4/Exty./151/2025-26] 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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