The FSSAI has issued a notice proposing some amendments to the Draft Food Safety & Standards (Health Supplements, Nutraceuticals, Food for Special Dietary Use, Food for Special Medical Purpose, Functional food, and Novel food) Amendment Regulations, 2018. The FSSAI has also invited suggestions, views, comments etc. from stakeholders within a period of 60 days on the draft Regulations with a period of 60 days beginning from 27 July 2018.
The FSSAI had already drafted the Food Safety & Standards (Health Supplements, Nutraceuticals, Food for Special Dietary Use, Food for Special Medical Purpose, Functional food, and Novel food) Regulations 2018 in January 2018 but has now proposed some changes to the previous draft and which are as follows
- The entry Areca Catechu L which has been listed in Schedule IV is proposed to be deleted because of safety concerns. (Schedule IV lists the names of permitted plants or botanical ingredients)
- The entries Glutathione and Sterols/Stanols including their esters and cholesterol is proposed to be replaced with Glutathione/S-acetyl glutathione and Sterols/Stanols including their esters respectively
- Also Under Regulation 3 – General requirements a new addition has been proposed to be made in the regulation which will be numbered 29 and is as follows For combining ingredients there shall be rationale based on available scientific and technical evidence which shall be made available to the Food Authority as and when called for.
- In Schedule VF which is the List of food additives to be used in formats such as tablets, capsules, and syrups the following is to be substituted
Against the entry Cross carmellose sodium which is used as a disintegrant the maximum permitted level has is now proposed to be 0.5% to 5% and not 2%
Also, the FSSAI proposes to add the following additives to this list which are as follows
Additive Function Maximum permitted level
Isopropyl alcohol Solvent for coating GMP
Dichloromethane Solvent for coating GMP
Potassium chloride Gelling agent GMP
- Under Schedule VI List of Ingredients as Nutraceuticals in Part B the following will be replaced (number 168) Stanols and sterols including cholesterols will be replaced with Sterols/Stanols including esters.
- New ingredient Mucopolysaccharides is proposed to be added at number 196.