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On September 18, 2024, the Food Safety and Standards Authority of India (FSSAI) issued a notification regarding draft amendments to the Food Safety and Standards (Contaminants, Toxins and Residues) Regulations, 2011. These amendments, approved by the Central Government, propose changes to the regulation of metal contaminants, crop contaminants, and naturally occurring toxic substances. Key revisions include updating permissible limits for lead, arsenic, cadmium, and aflatoxins in various food products, including pulses, edible oils, and seafood. Stakeholders are invited to submit objections or suggestions regarding these draft regulations within sixty days of publication. The FSSAI will consider these inputs before finalizing the amendments, ensuring they reflect the latest scientific standards and practices in food safety.

FOOD SAFETY AND STANDARDS AUTHORITY OF INDIA

Notification

New Delhi, the 18th September, 2024

F.No.01/SP-02/S&S/Notification Contaminants/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), –

(iii) 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 veterinary practices Food Tolerance limit (mg/Kg)
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./504/2024-25]

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.

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