Regulation 2 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 2.5.2 sets histamine limits for fish and fishery products. It has two parts: a list of the fish species and families with potential to cause histamine poisoning, and a Table of limits by product category, with a sampling plan defined by the letters n, c, m and M and a rule for when a lot is satisfactory. Fish processors can map products to the categories 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 this regulation). FSSAI compendia are reference consolidations and the Gazette text prevails. Later notifications should be checked on fssai.gov.in.
Regulation 2.5.2 applies the limits to product categories made from the listed species. Eight categories, from raw, chilled or frozen finfish to other fish based products, carry n=9, c=2, m=100 mg/kg and M=200 mg/kg, and three categories, dried or salted and dried fishery products, fermented fishery products and fish pickle, carry n=9, c=2, m=200 mg/kg and M=400 mg/kg. A lot is satisfactory if the mean is not above m, no more than c/n values lie between m and M, and no value exceeds M. Fish processors, exporters, importers and laboratories are affected.
Part 1: fish species with potential to cause histamine poisoning
The regulation was inserted by the notification of 18 January 2017 (footnote 9). Its first part is a Table of species in three columns: serial number and family, scientific name, and common name. It lists ten families.
| Serial | Family | Examples of entries as printed (scientific name: common name) |
|---|---|---|
| 1 | Carangidae | Alepes spp.: Scad; Megalaspis cordyla: Horse Mackerel/Torpedo Scad |
| 2 | Chanidae | Chanos chanos: Milkfish |
| 3 | Clupeidae | Sardinella longiceps: Indian Oil Sardine; Tenualosa ilisha: Hilsa shad |
| 4 | Coryphaenidae | Coryphaena hippurus: Mahi-Mahi /Dolphin fish |
| 5 | Engraulidae | Stolephorus spp.: Anchovy |
| 6 | Istiophoridae | Makaira spp.: Marlin/Sailfish |
| 7 | Mugilidae | Mugil cephalus: Flathead Grey Mullet |
| 8 | Pristigasteridae | Pellona ditchella: Indian pellona |
| 9 | Scombridae | Rastrelliger kanagurta: Indian Mackerel; Thunnus albacares: Yellowfin Tuna |
| 10 | Xiphiidae | Xiphias gladius: Swordfish |
Only a few entries per family are shown. Some families, such as Carangidae, Clupeidae and Scombridae, have many entries, and each entry may be a single species or a "spp." group. A processor should check its species against the full list in the compendium, since a species' scientific name decides whether it is on the list.
Part 2: limits of histamine level
The second Table has three columns: serial number and product category, "Applicable to", and "Histamine Level". The "Applicable to" column reads "Finfish Species with high amount of histidine (Listed fish species with potential to cause histamine poisoning)".
| S. No. | Product category | Histamine level as printed |
|---|---|---|
| 1 | Raw/Chilled/Frozen Finfish | n=9, c=2; m=100 mg/kg, M=200 mg/kg |
| 2 | Thermally Processed Fishery Products | n=9, c=2; m=100 mg/kg, M=200 mg/kg |
| 3 | Smoked fishery products | n=9, c=2; m=100 mg/kg, M=200 mg/kg |
| 4 | Fish Mince/Surimi and analogues | n=9, c=2; m=100 mg/kg, M=200 mg/kg |
| 5 | Battered and breaded fishery products | n=9, c=2; m=100 mg/kg, M=200 mg/kg |
| 6 | Other Ready to Eat fishery products | n=9, c=2; m=100 mg/kg, M=200 mg/kg |
| 7 | Other value added fishery products | n=9, c=2; m=100 mg/kg, M=200 mg/kg |
| 8 | Other fish based products | n=9, c=2; m=100 mg/kg, M=200 mg/kg |
| 9 | Dried/ Salted and Dried fishery products | n=9, c=2; m=200 mg/kg, M=400 mg/kg |
| 10 | Fermented Fishery products | n=9, c=2; m=200 mg/kg, M=400 mg/kg |
| 11 | Fish Pickle | n=9, c=2; m=200 mg/kg, M=400 mg/kg |
The sampling plan letters
Where:
- n: number of units comprising the sample;
- c: maximum allowable number of defective sample units;
- m: acceptable level in a sample;
- M: specified level which, when exceeded in one or more samples, would cause the lot to be rejected.
The satisfactory and unsatisfactory rule
The lot is satisfactory if the following requirements are fulfilled: (1) the mean value observed is ≤ m; (2) a maximum of c/n values observed are between m and M; (3) no values observed exceed the limit of M.
It is unsatisfactory if the mean value observed exceeds m, or more than c/n values are between m and M, or one or more of the values observed are > M.
An invented example: Konkan Tuna Foods tests a lot of frozen yellowfin tuna under serial 1 with the printed plan. The lab reads the printed n, c, m and M for that line, and judges the lot against the three requirements above.
The amendment history
The compendium's Note lists sixteen amending notifications for the Regulations, from 3 December 2014 to 17 October 2024; the principal notification is dated 1 August 2011.
Where this sits in the Regulations
Regulation 2.5.2 is the last technical regulation before the Note. The metal limits for fish are in our article on metal contaminants, the biotoxin limits for bivalve molluscs are in biotoxins and melamine, and the product standard for fish is in the sister article on fish and fish products. For a general overview of limits see maximum limits for contaminants and toxins. Exporters who want a review of their sampling and lab reports can use FSSAI compliance support.
Need help with fish contaminant compliance?
A sampling plan and a species list can be confusing on a first read. Our FSSAI compliance support service helps fish processors map each product to a category, a species family and the printed limit.
Key takeaways
- The species list has ten families, from Carangidae to Xiphiidae.
- Eight categories carry m=100 mg/kg and M=200 mg/kg; dried, fermented and pickled fish carry m=200 mg/kg and M=400 mg/kg; n=9 and c=2 throughout.
- A lot is satisfactory only if all three printed requirements are met.
- The plan uses n, c, m and M exactly as defined in the regulation.
Read next
- Regulations 2.4 and 2.5.1: biotoxins and melamine
- Regulations 1.1, 1.2 and 2.1: metal contaminants
- Maximum limits for contaminants and toxins under FSSAI
- Fish and fish products: FSSAI food standards
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.