Question: Can we use synthetic colour in tablet, capsule, sachet and liquid formulation in food?

Answer : As per Food Safety and Standards (Health Supplements, Nutraceuticals, Food for Special Dietary Use, Food for Special Medical Purpose, Functional Food and Novel Food) Regulations, 2016, a food business operator may use the approved natural & synthetic colours as has been specified in schedule VF of the said regulations. The food authority may permit the food business operator to add food colours subject to the level restrictions as stated in Food Safety and Standards (Food Products Standards and Food Additives) regulations, 2011.

Question : What are the laboratory parameters (Physical, Chemical & Microbiological) that need to be tested for dry fruits such as Almonds, Pistachios, Raisins etc as per FSSAI and at what frequency?

Answer : As per the regulations;

  • The product shall be free from mould, living / dead insects, insect fragments and rodent contamination. The product shall be uniform in color with a pleasant taste and flavour characteristic of fruit /nut free from off flavour, mustiness, rancidity and evidence of fermentation. The product shall be free from added coloring.
  • The products shall be tested for Metal Contaminants, Crop Contaminants& Naturally Occuring Toxin Substances, Pesticide Residues, Microbiological parameters for Yeast & Mould Count, Salmonella, Shigella, E.coli etc.

As per one of the conditions of the license under the Food Safety and Standards Regulations; FBOs should go for the testing of the food products at-least once in every six months.

Question : Sir/Madam, please tell me something about Form B?

Answer : Form B is used while applying for the license/renewal of the license under the Food Safety & Standards Act, 2006. For more details, you can read Food Safety and Standards (Licensing and Registration of Food Businesses) Regulation, 2011. Apply online for the food license on FSSAI’s Food Safety Compliance System (FoSCoS): FoSCoS – FSSAI.

Question : What is the difference between FSSAI/State FDA Registration & License?

Answer : FSSAI is the apex food regulator in India for the manufacture, sale, distribution, import of the food articles. FSSAI is the central licensing authority for regulating & implementing the Food Safety & Standards Act, 2006. The state food authorities work under the FSSAI regulations. The criteria for state/central license & registration will depend upon various factors like production capacity, annual turnover etc.

Please more details, please follow : Compendium_Licensing_Regulations.pdf (

Question : Is it mandatory to mention the FSSAI License number on sales invoice document?

Answer: Food Safety Regulations state that a food business activity shall be carried out between a registered/licensed buyer & seller only. So, you have to make sure that you are buying from & selling to the registered FBOs only. Keeping this in mind, it will be good if FSSAI license number is mentioned, though it is not specifically mentioned that it is a mandatory requirement but Form of Guarantee (Form E) says that it is a requirement under the Food Safety & Standards Act, 2006. (see regulation 2.1.14 (2) of Food Safety and Standards (Licensing & Registration of Food Businesses) Regulation, 2011.

Question : What is Form D-2?

Ans. As per one of the requirements under the regulations, every manufacturer and importer who has been issued a license shall submit a return to the licensing authority in a prescribed formats called: ’Form D-1’ & Form D-2’ and this requirement has been clearly stated in clause 2.1.13 of the FSS (Licensing & Registration of Food Businesses) Regulation, 2011.

While Form D-1 is provided to file annual returns on or before 31st May of each year for all manufacturers & Importers other than Milk & Milk Products, the ’Form D-2’ has been specified for the licensed FBOs who are engaged in the manufacturing of Milk & Milk Products and it is stated that such licensee shall file half yearly returns for the periods 1st April to 30th September and 1st October to 31st March of every financial year.