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 had been notified by the FSSAI on 23 December 2016. According to this notification, FBOs were required to ensure compliance with their existing and new products with all provisions of these regulations by 1 January 2018.
However, FSSAI has received several representations from stakeholders to include other ingredients and additives in these regulations since several ingredients/ products containing these ingredients are already in the market based on criteria that the formulation of articles of food shall be based on the principles of sound medicine or nutrition and supported by validated scientific data, wherever required. A mere combination of vitamins and minerals formulated into tablets, capsules or syrup is not food unless vitamins and minerals are added to an article of food based on a food format.
The foods are not permitted to contain hormones, steroids or psychotropic ingredients
The quantity of nutrients added to the articles of food shall not exceed the recommended daily allowance (RDA) as specified by the Indian Council of Medical Research. If such standards are not specified, then the standards in the Codex Alimentarius Commission will apply.
The FBOs may use approved colors and additives as permitted in Schedule VF of these regulations, natural, nature identical or synthetic flavors as permitted in the Food Safety and Standards (Food Product Standards and Food Additives) Regulations, 2011.
The Scientific Panel has met several times to discuss the issue and after careful consideration has recommended the inclusion of some new ingredients in the regulations. However, some of the ingredients have not been approved to be included in the regulations due to safety issues or because they are likely to exhibit properties of drugs or because of inadequate data.
Since some of these issues are still under consideration and since the finalization of the amendments to these regulations is likely to take some time, the FSSAI has laid down the following timelines with respect to compliance of these regulations to ensure a smoother transition for food businesses.
Ingredients and Additives
New ingredients and additives approved by the Scientific Panel and which are now included in the existing Schedules as per Annexure 1 are allowed to continue to be used in the existing formulations. Where new/revised permissible limits of ingredients/ additives have been specified, FBOs are given time till 30 June 2018 to formulate their products. In case the new or revised permissible limits of ingredients or additives are prescribed later, FBOs will be given a time of six months from the date of specifying new or revised limits to reformulate their products.
Ingredients not Approved by Scientific Panel because of inadequate data
Where ingredients that have not been approved by the Scientific Panel because of inadequate data
- FBOs will be given a time of four weeks from the date of issuance of direction to submit data required by the Scientific Panel.
- They are permitted to continue their food businesses of existing products containing ingredients as per Annexure-II till further orders.
- Any products for which data has not been submitted within four weeks from the date of the issuance of this direction must be withdrawn immediately from the market.
Ingredients not Approved by Scientific Panel because of Safety Concerns
FBOs are directed to discontinue the food business of products that carry the ingredients with immediate effect and withdraw such products from the market
- Potato Protein Isolate
Ingredients not approved by Scientific Panel because they exhibit properties of a drug
FBOs are directed to discontinue the food business of products carrying the following ingredients with immediate effect as they have been identified to exhibit properties of drugs
- Willow Bark Extract
- Pyrrol Quinoline Quinone
- Lemon Bam
However, products that have already been manufactured or imported are allowed to be sold until 30 June 2018
Restrictions on mere combination of vitamins and minerals
FBOs are allowed to continue the food business of existing products containing mere combinations of vitamins and minerals only up to one RDA in dosage formats such as tablets, capsules, and syrups for a period of six months or till further orders, whichever is earlier.
Schedule III with respect to FSDU category
FBOs are permitted to continue their existing formulations containing vitamins and minerals in Foods for Special Dietary Uses without referring to the energy value (Kcal/KJ) as specified under Schedule III for a period of six months or till further orders, whichever is earlier.
FSSAI has also made some changes 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
Under Regulation 3 – General requirements
- Number (1) clause has been changed and will now read as “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 below 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) Flavours 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 title has been changed to the following
Food for Special Dietary Use (FSDU), other than infants, and those products intended to be taken under medical advice of physician/ certified dietician/ nutritionist
In 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.
Another new clause has been added to this regulation as clause (5) which is that
No food business operator shall advertise FSDU for general public
In Regulation 9 – Food for special medical purpose
In clause 1 part (ii) a second para 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 has 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.
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.
Annexure II has been added which contains a list of 34 foods and substances that FBOs can continue to use in their food businesses. Examples – D-Ribose. Artichoke, Cashew fruit, Kale powder, Para-amino benzoic acid (PABA), Succinic Acid, Raspberry ketone, Inosine, Silica, Angelica sinensis, Paullinia cupana, Oxalobacter Formigenes, Ipriflavone, Salvia Hispanica, vanadium, Enzymes- pectinase, xylanase, Passion Fruit, Phytavail Iron, Saw Palmetto, Notoginseng, Chlorella growth factor, Pine bark extracted from Pinus radiata, Vitamin D3 veg (plant source), S-aceytyl glutathione, Pine bark extract from sp. Pinus pinaster, Alpha- cyclodextrin, prenolit, chaga extract, Kiwi fruit extract/ active ingredient, selenium dioxide, Tea tree oil/ Melaleuca alternifolia. Polypodium leucotomos, broccoli.