FSSAI has issued a draft notification dated 6 September, 2021 on amendments to the Food Safety and Standards (Health Supplements, Nutraceuticals, Food for Special Dietary Use, Food for Special Medical Purpose, Functional food and Novel Food) Regulations,2016
The FSSAI has also invited objections or suggestions, if any, which may be addressed as per the required format to the Chief Executive Officer, Food Safety and Standards Authority of India, Food and Drug Administration Bhawan, Kotla Road, New Delhi – 110002. Format is available from the following web link https://fssai.gov.in/upload/uploadfiles/files/Format_Draft_Notification_Nutra_08_09_2021.pdfYou may also submit comments online on the following web link https://fssai.gov.in/comments/Bestviewwl.aspx?NOTIFICATION_ID=4105 Objections and suggestions may also be emailed to [email protected] within 60 days from uploading of draft notification. FSSAI will take into consideration those objects and suggestions that reach the Food Authority within the specified time.
These regulations may be called Food Safety and Standards (Health Supplements, Nutraceuticals, Food for Special Dietary Use, Food for Special Medical Purpose, Functional Foods and Novel Foods) Amendment Regulations, 2021. They shall come into force on the date of their final publication in the Official Gazette.
Proposed amendments in the Food Safety and Standards (Health Supplements, Nutraceuticals, Food for Special Dietary Use, Food for Special Medical Purpose, Functional Foods and Novel Foods) Regulations, 2016 are as under.
Proposed Amendment in Regulation 9 – Food for special medical purpose
In the above-mentioned regulation sub-regulation 1 clause (i) is proposed to be changed from (1) (i) Food for special medical purpose shall include food specially
prepared for weight reduction and intended as total replacement of normal diet.
Proposed to be amended to the following
(1). (i) “Food for special medical purpose shall include food specially prepared for weight reduction and intended as total replacement of normal diet. Food for special medical purpose may also include Foods intended for Special Diagnostic Purpose with the prior approval of the Authority. Food Business Operator seeking such approval shall take approval of the Authority in accordance with Food Safety and Standards (Approval of non-specified food and food ingredients) Regulations, 2017.”
Proposed amendment in Schedule I List of vitamins and minerals and their components
- In list A for (14) Folic acid‟ component proposed to be included along with the already exiting is “(ii) (6S)-5-methyltetrahydrofolic acid, glucosamine salt”
- In the same Schedule I in list B for mineral related to (1) Calcium the entry (xiii) Calcium from algal source (Algus calcarius) is proposed to be substituted with the following “Calcium from algae including red seaweed”
Amendments in Schedule – II.
This Schedule II is proposed to be amended to the following
Schedule – II
[See regulations 3. (13), 4. (2), 6. (2)(i), 7. (2)(i), 8. (2)(i) and 9. (2)(i)]
Note – Suitable hydrated and anhydrous forms of amino acids, and the hydrochloride, sodium, and potassium salts of amino acids may be used. In such cases, Food Business Operators shall notify in writing to the Authority. Food Business Operators shall be required to submit additional safety data/information when requested by the Authority.
Proposed amendment in Schedule VF – List of food additives to be used in formats such as tablets, capsules and syrups
- Additive/pharmaceutical aid “Sorbitanoleate esters (Tweens)” at serial number 63 is proposed to be replaced with the following “Polysorbates (Tweens)”
- New additive/ pharmaceutical aid Magnesium alumina metasilicate with serial number 87 is being added with the maximum permitted level of 1%
Proposed amendment in Schedule VII to the List of strains as probiotics (live micro-organisms)
- Bacillus indicus is being included
Proposed Amendment is Schedule VIII to the List of prebiotic compounds
14 Guar gum derivative (partially hydrolysed guar gum)” is being included.