FSSAI Notifies Amendment Regulations on Contaminants, Toxins and Residues: Expanded Scope for Pulse Flours, Seafood Residue Limits, and Arsenic Testing Protocols

The Food Safety and Standards Authority of India has taken a significant step in fortifying the country’s food safety architecture by notifying the Food Safety and Standards (Contaminants, Toxins and Residues) Amendment Regulations, 2026. Issued on the 14th of May, 2026, and subsequently published in the Gazette of India on the 19th of May, 2026, these amendments introduce critical modifications to the existing Food Safety and Standards (Contaminants, Toxins and Residues) Regulations, 2011. The regulatory exercise traces its origins to a draft notification published by the Authority on the 18th of September, 2024, which was issued in exercise of the powers conferred under sub-section (1) of Section 92 of the Food Safety and Standards Act, 2006. The draft was made available to the public on the 25th of September, 2024, and stakeholders were afforded a period of sixty days therefrom to submit objections and suggestions. Upon the expiry of this consultation window, no objections or suggestions were received from the public. Consequently, the Authority, acting with the previous approval of the Central Government and in exercise of the powers vested in it under clauses (i) and (j) of sub-section (2) of Section 92 read with Sections 20 and 21 of the said Act, has now formalised the amendments. The regulations shall come into force on the 1st of December, 2026, thereby providing regulated entities with a structured transition period to ensure compliance.

The amendments are structured across three principal domains: metal contaminants, crop contaminants and naturally occurring toxic substances, and residues of veterinary drugs and antibiotics. Each domain reflects a deliberate effort to align Indian food safety standards with evolving scientific understanding and global best practices, while simultaneously addressing gaps that had persisted in the 2011 framework.

Insofar as metal contaminants are concerned, the amendments operate within Regulation 2.1, specifically sub-regulation 2.1.1 and clause 2 thereof. The first modification pertains to lead, where the existing entry covering “Pulses” in column (2) of the table has now been expanded to encompass “Pulses and Pulse flours.” This expansion is not merely semantic; it recognises that pulse flours, being derived directly from pulses, carry an equivalent risk of lead contamination and must therefore be subjected to the same maximum level scrutiny. A parallel expansion has been effected in respect of cadmium, where the entry “Pulses, excluding soybean dry” has been substituted with “Pulses and Pulse flours, excluding soybean dry.” This ensures regulatory consistency across the entire value chain of pulse-based food products, from the whole grain to its processed flour form.

Perhaps the most technically nuanced amendment within the metal contaminants segment relates to arsenic. The entry for “Edible fats and oils” has been updated with an asterisk, and a detailed note has been inserted immediately after the table. The note establishes that for fish oils, the maximum level of inorganic arsenic, expressed as As-in, shall be 0.1 milligrams per kilogram. The note further prescribes a two-tier testing protocol. If the total arsenic concentration in a sample is below the maximum level prescribed for inorganic arsenic, no further testing is required, and the sample is deemed compliant. Conversely, if the total arsenic concentration exceeds the maximum level for inorganic arsenic, follow-up testing must be conducted to ascertain whether the inorganic arsenic concentration itself exceeds the permissible limit. This tiered approach introduces both scientific rigour and regulatory pragmatism, ensuring that compliance determination is neither under-inclusive nor unnecessarily burdensome.

Turning to crop contaminants and naturally occurring toxic substances, the amendments under Regulation 2.2, sub-regulation 2.2.1, introduce both definitional clarity and expanded coverage. In respect of total aflatoxins and aflatoxin B1, the product descriptions in column (3) of the table have been revised. The earlier formulation, which read “Oilseeds or oil: Oilseeds for further processing Ready to eat,” has been substituted with “Oils, and Oilseeds for further processing Ready to eat oilseeds.” This rephrasing eliminates ambiguity by clearly distinguishing between oils as a finished product and oilseeds in their ready-to-eat form, thereby ensuring that the maximum level applies appropriately across distinct product categories. Additionally, in clause 2 of the same sub-regulation, serial number 4 and its accompanying entries relating to saffrole have been substituted. The amended entry now specifies that the maximum level of 10 applies to “Beverages and foods containing mace and/or nutmeg kernel as an ingredient.” This substitution provides much-needed specificity, linking the saffrole limit directly to products where mace or nutmeg kernel is present as a constituent, rather than leaving the scope open to interpretive uncertainty.

The third cluster of amendments addresses residues, operating within Regulation 2.3 and sub-regulation 2.3.2. A structural deletion has been carried out, whereby clause (1) has been omitted in its entirety. Beyond this editorial excision, the amendments introduce two new residue limits of considerable significance for the seafood sector. In respect of trimethoprim, which appears at serial number 45, new entries have been inserted in columns (3) and (4) of the table. These entries apply to “Sea foods including shrimps, prawns or any other variety of fish and fishery products,” with a tolerance limit of 0.05. Furthermore, a new serial number 50 has been introduced after serial number 49, bringing oxolinic acid within the regulatory fold. This new entry similarly applies to “Sea foods including shrimps, prawns or any other variety of fish and fishery products,” but with a higher tolerance limit of 0.3. The inclusion of these two antibiotics reflects a growing regulatory consciousness regarding veterinary drug residues in aquaculture and marine products, and it places an enforceable compliance obligation upon seafood processors, exporters, and importers.

It is worth noting that the entire regulatory exercise was preceded by a transparent and participatory consultation process. The draft amendments were published in September 2024, and the sixty-day window for stakeholder engagement remained open until late November 2024. The absence of objections or suggestions during this period facilitated a smooth transition from draft to final notification. The Authority has now provided a lead time of approximately six months, with the regulations set to take effect on the 1st of December, 2026. This timeline affords food business operators, testing laboratories, and enforcement agencies adequate opportunity to recalibrate their internal protocols, update standard operating procedures, and ensure that product specifications conform to the amended standards.

In conclusion, the Food Safety and Standards (Contaminants, Toxins and Residues) Amendment Regulations, 2026, represent a measured yet substantive advancement of India’s food safety regime. By extending metal contaminant limits to pulse flours, introducing a calibrated testing protocol for inorganic arsenic in fish oils, refining the scope of aflatoxin and saffrole regulations, and bringing trimethoprim and oxolinic acid under residue control for seafood, the amendments address both existing regulatory gaps and emerging public health concerns. The structured consultation timeline and the deferred effective date further demonstrate a commitment to participatory regulation and orderly implementation. For legal practitioners, food business operators, and compliance professionals, a careful study of these amendments is essential to navigate the evolving landscape of food safety governance in India.

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