FSSAI has also made some amendments to the Food Safety and Standards (Health Supplements, Nutraceuticals, Food for Special Dietary Uses, Food for Special Medical Purposes, Functional Foods and Novel Food) Regulations, 2016 through a draft dated 9 January 2017. FSSAI has also invited comments, views and suggestions from stakeholders on these amendments and once approved will be called Food Safety and Standards (Health Supplements, Nutraceuticals, Food for Special Dietary Uses, Food for Special Medical Purposes, Functional Foods, and Novel Food) Amendment Regulations, 2018.
Regulation 3 – General requirements
- Number (1) clause has been changed and substituted by the following clause
“the articles of food sold in capsule format, hard or soft or vegetarian, shall comply with the General Monograph, wherever applicable and quality requirements specified for them in Indian Pharmacopoeia if applicable.”
- Number (21) clause will be changed to
“mere combinations of vitamins, including the use of single vitamins, in dosage formats such as tablets, capsules, syrups, at levels equal to RDA or below shall be covered in these regulations. “
The following three clauses have also been added to this section
(26) The products covered under these regulations for children under the age of 5 years shall be given only under medical advice by physician/ certified dietician/ nutritionist
(27) Cereals, grains, legumes, fruits, and vegetables mentioned in the Indian Food Composition Tables published by NIN or ICMR and spices included in the list published by Spices Board of India, may be used as processed ingredients including extracts, as a supplement or nutraceutical as applicable. However, for claiming specific health benefits, prior approval from the Food Authority shall be obtained.
(28) Flavors for products covered under these regulations may be used in accordance with provisions of regulations 3.3.1 of Food Safety Standards (Food Products Standards and Food Additives) Regulations 2011.
In Regulation 8 the heading of the regulation has been changed to the following
Food for Special Dietary Use (FSDU), other than infants, and those products intended to be taken under the medical advice of physician/ certified dietician/ nutritionist
- Under this regulation in clause (1) part (iii) the present clause will be substituted with the following:
“The food business operator may manufacture or sell an article of FSDU in single-use packaging or in dosage form, namely, granules, jelly, semi-solid and other similar forms, sachets of powder, or any other similar forms of liquids and powders designed to be taken in measured unit quantities with nutritional or physiological effect.”
Provided the FSDU products containing vitamins including single vitamin at levels equal to or below one RDA in formats/ dosage forms of capsules, tablets, pills, and syrups shall be permitted under these regulations.
- A new clause has been added to this regulation as clause (5) which is that
No food business operator shall advertise FSDU for the general public
In Regulation 9 – Food for special medical purpose
- In clause 1 part (ii) a second paragraph has been added which is as follows
FSMP products containing vitamins including single vitamins at levels equal to or below one RDA in formats/ dosage forms of capsules, tablets, pills, and syrups shall be permitted under these regulations.
- In clause 3 part (ii) (b) section the following will be substituted
Advisory warning: “recommended to be used only under the medical advice of physician/ certified dietician/ nutritionist” must appear in bold letters in an area separated from other written, printed or graphic information.”
In Regulation 10 – Food with added probiotic ingredients
- In clause 1 part (ii) the following will replace the existing clause
The viable number of microorganisms in the food with added probiotic ingredients shall be ≥108 CFU in the recommended serving size per day.
In Schedule I FSSAI has added the following
- “Tocotrienols” against Vitamin E
- Natural forms of calcium obtained from corals, shells, pearls, conch, oysters, and milk have been added to Calcium (B section)
- Copper oxide (copper II) oxide cupric and black copper oxide not exceeding 2mg/day has been added to Copper (B4)
- Selenious acid has been added to Selenium (B12)
- For Note under column Part B, the following note will replace the existing Note Suitable esters, derivatives and salts of vitamins and salts and chelates of minerals may be used
In Schedule II
The note has been replaced with – Suitable esters, derivatives, isomers, and salts of amino acids may be used
In Schedule IV the list of names of permitted plants or botanical ingredients has been increased from 400 to 439.
- Note 1 – Ingredients listed in Schedule IV shall be used after due processing or in their extract forms subject to permissible usage range given in the last column of the Table. Offering these ingredients, either alone or in combinations as such or minimally processed (cleaned, de-weeded, sorted, dried or powdered) is/are not permitted.
- Note 2 – The ingredients listed above shall comply with Food Safety and Standards (Contaminants, Toxins, and Residues) Regulations, 2011.
- Note 3 – Permitted range of usage for children between 5-16 years is ½ of the permitted range of usage for adults.
- Note 4 – Permitted range of usage for children between 1-5 years is ¼ of the permitted range of usage for adults.”
In Schedule VF – List of food additives to be used in formats such as tablets, capsules, and syrups- the following additives have added
- Glycerol palmito stearate
- Medium chain triglyceride
- Glyceryl behenate
- Triethyl citrate
- Methacrylate copolymers
- Propane 1, 2 diol alginate (INS 405)
In Schedule VI –List of Ingredients as nutraceuticals
In Part A the approved ingredients have been increased from 24 to 38
In Part B the approved ingredients have been increased from 187 to 195
Note: Enzymes – The enzymes listed in the schedule are primarily used as processing aids but they may be used in nutraceutical products also.
In Schedule VII- List of strains as probiotics (live micro-organisms)
The following have been added
- Bacillus clausii
- Established probiotics strains of Bacillus subtilis
In Schedule VIII – List of prebiotic compounds
- Soya polysaccharides and soya oligosaccharides have been added for entry number 2.
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