The FSSAI has issued directions dated 29 June 2018 regarding the implementation of 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. In this regard, the FSSAI has also superseded the previous directions dated 29 December 2017 wherein the FSSAI had laid down the timelines with respect to compliance of these regulations. The FSSAI has now issued new directions and timelines for compliance so FBOs do not have any problems during the transition and these directions are as follows:
New ingredients and additives recommended by the Scientific Panel for inclusion in the Nutraceutical Regulations and which are proposed to be included in the existing Schedules as per Annexure 1 of the previous directions may continue to be used in the existing formulations even after 30 June 2018. (According to previous directions, FBOs were given time till 30 June 2018 to formulate their new products.)They may use these ingredients till such time as the proposed amendment of the Nutraceutical regulations, in this regard, are finalized and notified. FBOs will however have to comply with the provisions with respect to permissible limits of ingredients/ additives as given in Annexure 1 of the previous directions.
In the previous directions, there were 33 ingredients that had not been recommended by the scientific panel for inclusions in the Nutraceutical Regulations due to lack of data. The Scientific Panel has reviewed these ingredients again based on the data made available by FBOs and the following decisions have been taken about products covered in the Nutraceutical Regulations till such time as the proposed amendments in this regard is finalized and notified.
- FBOs may continue to use the ingredient named ‘S-acetyl glutathione (50-600mg/day Max)’ and ‘alpha-cyclodextrin’ (already covered under ‘other fiber sources’ as mentioned in Schedule VI Part B of the Nutraceutical Regulations) in the already existing products.
- FBOs must not use the ingredients ‘Succinic acid’ and ‘Inosine’ with immediate effect as they have been withdrawn by the applicant and no further manufacturing of these products, using these ingredients is permitted. However, any such products already manufactured/imported are allowed to be sold till 30 September 2018
- FBOs to discontinue the use of ‘Paramono benzoic acid (PABA), ‘Vanadium’ ‘Prenolit’ and Selenium dioxide’ with immediate effect, due to safety concerns. No further manufacturing of products using these ingredients is allowed. Any products containing these ingredients which are already manufactured/ imported shall be withdrawn from the market immediately.
- FBOs need to discontinue the use of ‘D-ribose’ in health supplements/ nutraceuticals with immediate effect. Further manufacturing of health supplements/ nutraceuticals containing this ingredient for consumption by the general population in unsupervised usage is no longer allowed. If D-ribose is used in Food for Special Medical Purpose or in Food for Special Dietary Use, the prior approval shall be obtained from FSSAI. However, any such products containing this ingredient, which is already manufactured/ imported are permitted to be sold up to 30 September 2018
- FBOs may no longer use ingredients ‘Ipriflavone’ and ‘Polypodium leucotomos’ with immediate effect, since they exhibit properties of a drug and so no further manufacturing of products using this ingredient, is permitted. However, if any such products containing these ingredients are already manufactured/ imported may continue to be sold till 30 September 2018.
- FBOs must discontinue the use of ingredients/ enzymes namely ‘Artichoke’ kale powder, Salvia hispanica, Cashew fruit, Passionfruit, Kiwi fruit extract, Broccoli, Enzymes (Pectinase and Xylanase) as health supplements/ nutraceuticals. However, these ingredients/ enzymes may be used as general ingredients in products, if they are permitted under the Food Safety and Standards regulations but no claim can be made on their benefits as health supplements/ nutraceuticals for such ingredients. If any such products that contain these ingredients are already manufactured/imported making any such claims are permitted to be sold up to 30 September 2018.
- FBOs are directed to discontinue the use of ingredients listed under Appendix-1of this direction (given below) with immediate effect because of lack of data.No further manufacturing of products using these ingredients is permitted till such time as they have been assessed and approved by the Food Authority. The FBOs are also directed to the furnish information/data in respect of these ingredients within one month from the date of this direction for further assessment by the Food Authority.
- Raspberry ketone
- Angelica sinensis
- Paullinia cupana
- Saw palmetto
- Chlorella Growth factor
- Pine bark extracted from Pinus radiata
- Pine bark extract from Pinus pinaster
- Vitamin D3 (Veg)
- Chaga extract (Inonotus obliquus)
- Oxalobacter formigenes
- Phytavail iron
- Tee tree oil
FBOs are allowed to continue the food business of existing formulations containing mere combinations of vitamins and minerals
- Up to RDA in dosage formats such as tablets, capsules, and syrups for a period of six months from the date of this direction (29 June 2018) or till further orders whichever is earlier.
- In Food for Special Dietary Use without referring to the energy value (kcal/kl) as specified under Schedule III, till such time the proposed amendment of the said regulations are finalized and notified.