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Core Purpose

Notification publishing draft Food Safety and Standards (Contaminants, Toxins and Residues) Amendment Regulations, 2024 to revise maximum limits and food categories for lead, arsenic, cadmium, aflatoxins, saffrole, trimethoprim, and oxolinic acid.

Detailed Summary

In notification F.No.01/SP-02/S&S/NotificationContaminants/2021-22 dated 18th September 2024, the Food Safety and Standards Authority of India (FSSAI), with prior approval of the Central Government and exercising powers under Section 92(2)(i) and (j) of the Food Safety and Standards Act, 2006 (34 of 2006), published draft Food Safety and Standards (Contaminants, Toxins and Residues) Amendment Regulations, 2024 for public comment within sixty days, addressed to the Chief Executive Officer, FSSAI, Food and Drug Administration Bhawan, Kotla Road, New Delhi-110002, or by email to [email protected]. The draft amends the Food Safety and Standards (Contaminants, Toxins and Residues) Regulations, 2011 (originally notified vide F. No. 2-15015/30/2010 dated 1 August 2011, last amended vide notification Stds/SP/(Contaminants)/Notification-1/FSSAI-2018 dated 7 August 2020) by: extending the maximum-limit entries for Lead to "Pulses and Pulse flours"; adding a footnote for Arsenic limits in edible fats and oils regarding inorganic arsenic testing methodology for fish oils; extending Cadmium limits to "Pulses and Pulse flours, excluding soybean dry"; revising food-article descriptions for Total Aflatoxins and Aflatoxin B1 to "Oils and Oilseeds for further processing" and "Ready to eat oilseeds"; inserting a new maximum limit of 10 ppm for Saffrole in beverages and foods containing mace and/or nutmeg kernel; omitting clause (1) of sub-regulation 2.3.2; inserting a tolerance limit of 0.05 mg/kg for Trimethoprim in seafoods including shrimps, prawns, and fish products; and adding a new tolerance limit of 0.3 mg/kg for Oxolinic acid in seafoods. The notification was issued under advertisement number ADVT.-III/4/Exty./504/2024-25 by G. Kamala Vardhana Rao, Chief Executive Officer.

Full Text

EXTRAORDINARY PART III—Section 4 PUBLISHED BY AUTHORITY No. 735] NEW DELHI, THURSDAY , SEPTEMBER 19, 2024/ Bhadra 28, 1946 CG-DL-E-25092024-257477 (3) “ (3) “ (1) (2) (3) (4) कॉलम (3) Column (4) FOOD SAFETY AND STANDARDS AUTHORITY OF INDIA Notification New Delhi, the 18th September, 2024 F.No.01/SP -02/S&S/NotificationContaminants/2021 -22.- The following draft of certain regulations, further to amend the Food Safety and Standards (Contaminants, Toxins and Residues) Regulations, 2011, which the Food Safety and Standards Authority of India, with previous approval of the Central Government, proposes to make in exercise of the powers conferred by clause (i) and (j) of sub -section (2) of section 92 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 is published 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, Food and Drug Administration Bhawan, Kotla Road, New Delhi - 110002 or sent on email at [email protected] . Objections and suggestions, which may be received with respect to the said draft regulations before the expiry of the 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 (Contaminants, Toxins and Residues) Amendment Regulations, 2024. 2. In the Food Safety and Standards (Contaminants, toxins and Residues) Regulations, 2011, - (1) in regulation 2.1 relating to “METAL CONTAMINANTS”, 1. in sub -regulation 2.1.1, in clause 2, in the Table, (i) against serial number 1 relating to Lead, in Column (2), for the words “Pulses”, the words “Pulses and Pulse flours” shall be substituted; (ii) against serial number 3 relating to Arsenic, in Column (2), for the words “Edible fats and oils (edible fats and oils not covered by individual standards)”, the words and figure “Edible fats and oils (edible fats and oils not covered by individual standards)* ” shall be substituted; (iii) at the end of the table, following shall be inserted, namely: - “*Note - For fish oils, the ML is for inorganic arsenic (As -in). Countries or importers may decide to use their own screening when applying the ML for As-in in fish oils by analyzing total arsenic (As -tot) in fish oils. If the As -tot concentration is below the ML for As -in, no further testing is required, and the sample is determined to be compliant with the ML. If the As -tot concentration is above the ML for As -in, follow -up testing shall be conducted to determine if the As -in concentration is above the ML.”; (iv) against serial number 5 relating to Cadmium, in Column (2), for the words “Pulses, excluding soybean dry ”, the words “Pulses and Pulse flours, excluding soybean dry ” shall be substituted. (2) in regulation 2.2 relating to “Crop contaminants and naturally occurring toxic substances”, - (a) in sub -regulation 2.2.1, in clause 1, in the Table, - (i) against serial number 1 relating to Total Aflatoxins, in Column (3), for the words “Oilseeds or oil: Oilseeds for further processing, Ready to eat” the following shall be substituted, namely: - Article of the food (3) “ • Oils and Oilseeds for further processing • Ready to eat oilseeds ”; (ii) against serial number 2 relating to Aflatoxin B1, in Column (3), for the words “Oilseeds or oil: Oilseeds for further processing, Ready to eat”, the following shall be substituted, namely: - Article of the food (3) “ • Oils and Oilseeds for further processing • Ready to eat oilseeds”; (b) in sub -regulation 2.2.1, in clause 2, in the Table, for serial number 4, the following shall be substituted, namely: - Sl. No. Name of naturally occurring toxic substances (NOTS) Article of food Maximum limits (ppm) (1) (2) (3) (4) “4 Saffrole Beverages and foods containing mace and/or nutmeg kernel as an ingredient 10” (3) in regulation 2.3, in sub -regulation 2.3.2, - (i) the clause (1) shall be omitted; (ii) in the clause (4), - (a) against the serial number 45 relating to Trimethoprim, in columns (3) and (4), after the existing entries, the following entries shall be inserted, namely: - Food Tolerance Limit (MRL) mg/kg Column (3) Column (4) “Sea foods including shrimps, prawns or any other variety of fish and fishery products 0.05” (b) after the serial number 49 (Zinc Bacitracin (minimum 60IU/mg dried substance)), the following shall be inserted , namely: - S. No. Antimicrobials and other drugs used in Food Tolerance limit (mg/Kg) veterinary practices Column (1) Column (2) Column (3) Column (4) “50 Oxolinic acid Sea foods including shrimps, prawns or any other variety of fish and fishery products 0.3” G. KAMALA VARDHANA RAO ,Chief Executive Officer [ADVT. -III/4/Exty./50 4/2024 -25] Note: The principal regulations were published in the Gazette of India, Extraordinary, Part III, Section 4 vide notification number F. No. 2 -15015/30/2010, dated the 1st August, 2011 and last amended vide notification Stds/SP/(Contaminants)/Notification -1/FSSAI -2018, dated 7th August, 2020. Uploaded by Dte. of Printing at Government of India Press, Ring Road, Mayapuri, New Delhi -110064 and Published by the Controller of Publications, Delhi -110054.

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