SGS Reports That the Government of India’s Food Safety and Standard Authority Has Amended the Food Safety and Standard Regulation 2011

The Government of India’s (GOI) Food Safety and Standard Authority of India (FSSAI) has amended the Food Safety and Standard Regulation 2011, by publishing limits for biotoxins in bivalve mollusks.

Yannawa, Thailand, January 06, 2016 --( Human Hazards Linked to Biotoxins

Biotoxins are secondary metabolites produced by several microalgal species ranging from dinoflagella to diatoms, and even cyanobacteria, when these organisms rapidly multiply and produce blooms. Shellfish accumulate these toxins when grazing. Shellfish, especially mussels, scallops, oysters and clams are major vectors for transferring biotoxins that result in human intoxication. Human consumption of contaminated shellfish can lead to different types of toxic syndrome which have attracted scientific attention in recent years. Based on these syndromes, biotoxins have been classified into six groups. The toxins in each group and the affected seafoods are shown in table 1 in the latest SGS Safeguards bulletin (1).

Measuring Negative Effects of Biotoxins

The mouse bioassay has been used as the official method to determine biotoxins in seafood in many countries, even though it has proven accuracy issues, low sample rates, and is time and labor intensive. With animal welfare in mind, new analytical methods have been developed, including Enzyme-linked immunosorbent assay and liquid chromatography coupled with tandem mass spectrometry (LC-MS/MS). Currently, food safety issues associated with biotoxins are placing greater responsibility on food producers, but regulations are limited to the European Union, United States of America and Japan. To comply with international regulations, the Indian government has proposed to set the limit of biotoxins in shellfish (2) by amending regulation F. No.2-15015/30/20, the details of which appear in table 2 (1) of the article in the latest SGS Safeguards bulletin.

The food supply chain needs to take no immediate action, however, since the draft amendment, and its biotoxins limits, have become law, seafood producers and processors need to implement an effective seafood testing program.


(1) SGS Safeguards - India: Draft Amendment on the Biotoxins Limit in Shellfish – September 7, 2015 (

(2) US FDA Foreign Agricultural Service – Draft Amendements on the Biotoxins in Fish and Fish Products - July 24, 2015 (

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