Fssai Standards On List Of Ban Ingredients/Enzymes Under Nutraceutical Regulations

As per FSSAI notification in continuation to the direction dated on June 29, 2018 and August 24, 2018 issued on December 31, 2018 with respect to the 14 ingredients listed in Appendix I from direction June 29, 2018.

As per notification Food Business Operators can continue the use of ingredient namely “Vitamin D3” from lichen (Cladonia rangiferina) as veg source in the existing nutraceutical products.

Below is the list of ingredients/enzymes which are not allowed to be used under nutraceutical Regulations: –

LIST OF INGREDIENTS/ENZYMES RESTRICTED TO USE
S.No.	PRODUCT NAME	REGULATIONS
1	Succinic Acid	Nutraceuticals
2	Inosine	Nutraceuticals
3	Para-amino benzoic acid	Nutraceuticals
4	Vanadium	Nutraceuticals
5	Prenolit	Nutraceuticals
6	Selenium Dioxide	Nutraceuticals
7	D-Ribose	Health Supplements/Nutraceuticals
8	Ipriflavone	Nutraceuticals
9	Polypodium leucotomos	Nutraceuticals
10	Artichoke	Health Supplements/Nutraceuticals
11	Kale Powder	Health Supplements/Nutraceuticals
12	Salvia hispanica	Health Supplements/Nutraceuticals
13	Cashew fruit	Health Supplements/Nutraceuticals
14	Kiwi fruit Extract	Health Supplements/Nutraceuticals
15	Passion fruit	Health Supplements/Nutraceuticals
16	Broccoli	Health Supplements/Nutraceuticals
17	Enzymes (Pectinase & Xylanase)	Health Supplements/Nutraceuticals
18	Raspberry Ketone	Nutraceuticals
19	Silica	Nutraceuticals
20	Angelica sinensis	Nutraceuticals
21	Paullinia cupana	Nutraceuticals
22	Saw palmetto	Nutraceuticals
23	Notoginseng	Nutraceuticals
24	Chlorella growth factor	Nutraceuticals
25	Pine bark extracted from Pinus radiata	Nutraceuticals
26	Pine bark extracted from Pinus pinaster	Nutraceuticals
27	Chaga Extract (Inonotus obliquus)	Nutraceuticals
28	Oxalobacter formigenes	Nutraceuticals
29	Tea Tree Oil	Nutraceuticals

As per FSSAI, if any FBO is manufacturing/importing any product with ingredients mentioned in the above table under aforesaid regulation before June 29, 2018 can sale those products for 30 days from the date of direction of this regulation.

Further, food business operators can continue the food business of existing formulations containing combination of vitamin and minerals only up to one RDA in dosage formats such as tablets, capsules, and syrups. This is for a period of three months from the date of this direction or till the further order.

References :-

• Implementation of Nutraceuticals Regulations, 2016. (Uploaded on: 31.12.2018) – https://fssai.gov.in/dam/jcr:d5182f2e-c095-4208-ab6e-c3d448198afd/Implementation_Health_Supplements_31_12_2018.pdf.Accessed on:07.02.2019