Through a notification uploaded on 11 April 2018 the FSSAI has asked for suggestions, views, comments etc from stakeholders on the Draft Food Sards (Health Supplements, Nutraceuticals, Food for Specfety & Standaial Dietary Use, Food for Special Medical Purpose, Functional food, and Novel food) amendment Regulations, 2018
Under Health supplements (Regulation 6)
The following sub-clause (i) from No.2)
The Health supplements shall contain any of the ingredients specified in Schedule I or Schedule II or Schedule IV or Schedule VII or Schedule VIII or enzymes only of Schedule VI.
to be substituted by the following
“Health supplement shall contain ingredients specified in Schedule I and/or Schedule II. It may also contain ingredients specified in Schedule IV, Schedule VI (enzymes only), Schedule VII and Schedule VIII”.
Under Nutraceuticals (Regulation 7)
The following sub-clause ((i) from 2.)
The Nutraceuticals shall contain any of the ingredients specified in Schedule I or Schedule II or Schedule IV or Schedule VI or Schedule VII or Schedule VIII.
To be substituted by the following
“Nutraceutical shall contain ingredients specified in Schedule VI. It may also contain ingredients specified in Schedule I, Schedule II, Schedule IV, Schedule VII and Schedule VIII.”
Under Food for special dietary use, other than infants, and those products intended to be taken under medical advice.(Regulation 8)
The following sub-clause (i) from 2.)
The articles of food for special dietary use shall contain any of the ingredients specified in Schedules I or Schedule II or Schedule III or Schedule IV or Schedule VI or Schedule VII or Schedule VIII.
To be substituted by the following
“Food for special dietary use shall contain any of the ingredients specified in Schedule I, Schedule II, Schedule IV, Schedule VI, Schedule VII, and Schedule VIII.”
In the same regulation
The following sub-clause (iv from 2.)
A food business operator may add the quantity of the nutrients at a level higher than the recommended daily allowance, but not exceeding the limits of vitamins and minerals specified in Schedule III.
To be substituted by the following
“A food business operator may add the quantity of the nutrients up to 50 percent of tolerable upper limit (TUL) or up to one Recommended Daily Allowance (RDA), whichever is higher”. In case, wherever TUL is not specified, FBOs shall not exceed more than one RDA.
If both RDA and TUL are not available, the addition may be rationalized and justified based on relevant national/international scientific documents for safety and efficacy.”
Under Food for the special medical purpose (Regulation 9)
The following sub-clause (i) from 2.)
Food for the special medical purpose shall contain any of the ingredients specified in Schedule I or Schedule II or Schedule III or Schedule IV or Schedule VII or Schedule VIII or enzymes only of Schedule VI
To be substituted by the following
“Food for the special medical purpose shall contain any of the ingredients specified in Schedule I, Schedule II, Schedule IV, Schedule VI (enzymes only), Schedule VII, and Schedule VIII”
FSSAI has also proposed a new regulation
Standards for ingredients (Regulation 14)
Psyllium (Isabgol) husk: (i)Psyllium(Isabgol) husk means a product manufactured from dry seed coats of Plantago ovate Forsk. (Fam. Plantaginaceae) obtained by crushing the clean seeds and separating the husks by winnowing.
- The product shall be white or translucent, odorless, thin boat shaped structures, 2 to 3 mm long and 0.5 to 1 mm wide. The taste shall be bland and mucilaginous. It should not give any gritty feeling during sensorial (organoleptic) evaluation.
- It shall be free from insect infestation, fungal contamination, and fermented, musty or other odors. It shall also be free of any added additives, colors, flavors and harmful foreign materials.
The product shall conform to the following requirements
| S. No | Characteristics | Requirements |
| i) | Moisture, percent by mass | Not more than11.5 |
| ii) | Total ash (on dry basis), percent by mass | Not more than 4.0 |
| Iii) | Acid Insoluble Ash (on dry basis), percent by mass | Not more than0.45 |
| iv) | Swell Volume, ml/gram | Not less than 40 |
| v) | Organic extraneous matter*, percent by mass | Not more than 2 |
*Organic extraneous matter includes broken or entire embryo, fragments of endosperm or capsular wall of fruits belonging to isabgol crop.”
Some amendments have also been proposed in Schedule III and Schedule VA
Schedule III
The heading
[See regulations 3.(13), 4.(2), 8.(2)(i), 8.(2)(iv), 9.(2)(i), 9.(2)(iv) and 9.(2)(v)]
Values for vitamins, minerals and trace elements allowed to be used in food for special dietary use and food for a special medical purpose (other than those intended for use in infant formula
To be substituted with the following
[See regulations 3(13), 4(2), 9(2)(i), 9(2)(iv) and 9(2)(v)]
Values for vitamins, minerals and trace elements allowed to be used in Food for Special Medical Purpose (other than those intended for use in Infant Formula)”
In Schedule VA – List of food additives for health supplements, nutraceuticals, and food with added probiotics and prebiotics
the following entry has been added after entry number 39 in the table.
| S. No | INS No. | Food Additive or Group | Maximum permitted level |
| 40 | 172(i), 172(ii), 172(iii) | Iron oxides | 7,500 mg/kg (For use in surface treatment only)” |
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