Biotoxin and explained: this guide covers what it means, who it applies to, the step-by-step process, documents required, fees, due dates and penalties in India — so you can stay compliant with confidence and avoid costly mistakes.
Regulation 2.4 limits five marine biotoxins in bivalve molluscs, and regulation 2.5.1 sets maximum levels for melamine in powdered and liquid infant formula and in other foods. Both are short Tables with one line per entry, so they can be read in full. Exporters and infant formula makers can ask for report checks through FSSAI compliance support.
This article reads the text as amended up to 14 May 2026 (FSSAI Compendium Version IX dated 03.02.2026, consolidated to the notification of 17 October 2024; the Amendment Regulations, 2026 of 14 May 2026 do not touch these regulations). FSSAI compendia are reference consolidations and the Gazette text prevails. Later notifications should be checked on fssai.gov.in.
Regulation 2.4, "Limits of biotoxins in fish and fishery products", lists five poisons, each on Bivalve Molluscs: paralytic shellfish poison (PSP), amnesic shellfish poison (ASP), diarrhetic shellfish poison (DSP), azaspiracid poison (AZP) and brevetoxin (BTX). Regulation 2.5.1 says the contaminant in column 2 on the foods in column 3 shall not exceed the Maximum Level in column 4, and the one entry is melamine at 1.0 mg/kg in powdered infant formula, 0.15 mg/kg in liquid infant formula and 2.5 mg/kg in other foods. Shellfish exporters, infant formula makers and importers are affected.
Regulation 2.4: biotoxins in fish and fishery products
Regulation 2.4 was inserted by the notification of 4 January 2016 (footnote 5 in the compendium). Its Table has four columns: serial number, name of the contaminant, article of food, and limit with the heading "Limit (µg/kg)". Each entry prints its own unit with the figure, and each entry is on Bivalve Molluscs.
| Sl. No. | Name of the contaminant | Article of food | Limit as printed |
|---|---|---|---|
| 1 | Paralytic Shellfish Poison (PSP) | Bivalve Molluscs | 80 μg/100g (Saxitoxin Equivalent) |
| 2 | Amnesic Shellfish Poison (ASP) | Bivalve Molluscs | 20 μg/g (Domoic acid equivalent) |
| 3 | Diarrhetic shellfish poison (DSP) | Bivalve Molluscs | 160 μg of Okadaic acid equivalent/Kg |
| 4 | Azaspiracid poison (AZP) | Bivalve Molluscs | 160 μg of azaspiracid equivalent/Kg |
| 5 | Brevetoxin (BTX) | Bivalve Molluscs | 200 mouse units or equivalent/Kg |
The column heading says µg/kg, but the entries carry their own basis: per 100g for serial 1, per g for serial 2, per Kg for serials 3 and 4, and mouse units for serial 5. The printed entry is the one to follow, so a lab report is read in the unit written against the poison, with the equivalent named in brackets. The regulation does not convert the figures to a common unit, and neither does this article.
An invented example: Coastal Clam Exports ships clams to a buyer. Serial 3 (DSP) prints "160 μg of Okadaic acid equivalent/Kg", so the lab states its result as okadaic acid equivalent per Kg and the figure is read against that line.
Regulation 2.5.1: melamine
Regulation 2.5, "Other Contaminants", was inserted by the notification of 5 January 2016 (footnote 6). Regulation 2.5.1 reads: the contaminant mentioned in column 2 on the foods mentioned in column 3 shall not exceed the Maximum Level prescribed in column 4 of the Table.
| Sl. No. | Name of the contaminant | Food | Maximum level (mg/kg) |
|---|---|---|---|
| 1 | Melamine | Powdered infant formula | 1.0 |
| 1 | Melamine | Liquid infant formula | 0.15 |
| 1 | Melamine | Other foods | 2.5 |
Serial 1 carries three food lines. Infant formula is separated into powdered and liquid forms, and "Other foods" covers everything else. The product standards for infant formula are in the Foods for Infant Nutrition Regulations, 2020; see our article on definitions and the infant food categories.
Reading the two Tables side by side
The two Tables differ in shape. Regulation 2.4 lists five poisons against one food, Bivalve Molluscs, so the question for a shellfish exporter is which of the five entries its test report covers and in which unit. Regulation 2.5.1 lists one contaminant against three food lines, so the question for a manufacturer is which line its product falls under: powdered infant formula, liquid infant formula or "Other foods".
Some practical points follow from the printed words:
- Regulation 2.4 is headed "Limits of biotoxins in fish and fishery products", yet every entry names Bivalve Molluscs. The Table is read as printed.
- Regulation 2.5 is headed "Other Contaminants", so it is the place where further contaminants with a Maximum Level can sit. Today it holds one entry, melamine.
- The Table in 2.5.1 uses the words "Maximum level (mg/kg)" while regulation 2.4 uses "Limit". Both are ceilings: the figure is not to be exceeded.
- Neither regulation prints a sampling plan, a method of analysis or a count of units. Sampling and analysis follow the Laboratory and Sample Analysis Regulations, 2011, explained in our article on the procedure and quantity of sampling.
How these Tables relate to other limits
The product standards for fish and shellfish are in the sister article on fish and fish products. Fish contaminants continue in the histamine regulation, which has its own sampling plan; see our article on histamine in fish. The veterinary drug limits for animal foods are in regulation 2.3.2(4). For a general overview see maximum limits for contaminants and toxins.
Who needs to act
- Bivalve mollusc exporters and processors should keep lab reports that state each toxin in the unit printed in the Table.
- Infant formula manufacturers and importers should check melamine reports against the powdered or liquid line.
- Other food makers are within the "Other foods" line for melamine.
Food businesses that want help with these reports can approach FSSAI compliance support.
Need help with biotoxin and melamine limits?
Lab reports for shellfish and infant formula often arrive in units different from the Table. Our FSSAI compliance support service helps match each report to the line and unit the Regulations print.
Key takeaways
- Regulation 2.4 lists five biotoxins on Bivalve Molluscs, each with its own unit and equivalent.
- Regulation 2.5.1 limits melamine at 1.0 mg/kg (powdered infant formula), 0.15 mg/kg (liquid infant formula) and 2.5 mg/kg (other foods).
- The printed unit in each entry governs, not the column heading.
Read next
- Regulation 2.5.2: histamine in fish
- Regulation 2.3.2(4): veterinary drug residues
- Infant nutrition regulations 2020: definitions
- Maximum limits for contaminants and toxins under FSSAI
Disclaimer: Based on the FSSAI regulations named above as consolidated in FSSAI's compendium versions or as published in the Gazette, with the later notifications the article names (consulted on fssai.gov.in on 2-3 October 2026). Later notifications and the Food Safety and Standards Act, 2006 provisions referred to should be checked. This article is general information, not legal advice; check the official text before acting.