Nutraceuticals

New Year Update by FSSAI on banned 14 Ingredients from Appendix I

Through directions issued on 31 December 2018 the FSSAI has clarified its decision regarding 14 ingredients listed under Appendix 1 of the Food Safety and Standards (Health Supplements, Nutraceuticals, Food for Special Dietary Use, Food for Special Medical Purpose, Functional Food and Novel Food) Regulations 2016 (Nutraceutical Regulations).

In continuation of the directions issued previously in June and August 2018, the FSSAI has further decided on the following:

FBOs are allowed to continue to use the ingredient namely ‘Vitamin D3’ from lichen (Cladonia rangiferina) as a veg source in the existing products covered under the Nutraceutical Regulations, till such time the proposed amendment of the Nutraceutical Regulations are finalized and notified.

FBOs are directed to discontinue the use of ingredient namely Raspberry ketone, Silica, Angelica Sinensis, Chlorella growth factor, Chaga extract, Tea tree oil (Melaleuca alternifolia) in the products covered under Nutraceutical Regulations with immediate effect as no additional information has been provided by the applicant. No further manufacturing of products containing these ingredients is allowed. However, any such products containing these ingredients which are already manufactured/ imported under the aforesaid regulations before 29 June 2018 are allowed to be sold only up to a period of 30 days from the date of this direction.

FBOs are directed to discontinue the use of ingredients namely ‘Oxalobacter Formigenes’in the products covered under the Nutraceutical Regulations with immediate effect since they exhibit properties of a drug and no further manufacturing of products using these ingredients is allowed. However, any such products containing these ingredients which are already manufactured/ imported under the aforesaid regulations before 29 June 2018 are allowed to be sold only up to a period of 30 days from the date of this direction.

FBOs are directed to discontinue the use of ingredients namely Paullinia cupana(Gaurana), Saw Palmetto, Notoginseng, Pine bark extract from Pinus radiata, Pine bark extract from Pinus pinaster in the products covered under the Nutraceutical Regulations with immediate effect due to lack of adequate data such as history of safe usage in India for 15 years and also the specific advantage of these plants over the already listed India plants/ botanicals. No further manufacturing of products using these ingredients is allowed. However, any such products containing these ingredients which are already manufactured/ imported under the aforesaid regulations before 29 June 2018 are allowed to be sold up to a period of 30 days from the date of this direction.

Based on the clarification provided by FBO that phytavail iron is mustard powder from Brassica juncea, which is already covered under Schedule IV of the Nutraceutical Regulations, it has been decided that no specific inclusion is required and the ingredient mustard powder can be continued to be used in products covered under the Nutraceutical Regulations subject to compliance with the aforementioned regulations.

Further, FBOs are allowed to continue the food business of existing formulations 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 three months from the date of this direction or till further orders whichever is earlier.

Reference:

https://foodsafetyhelpline.com/2018/08/fssai-issues-new-directions/

FSSAI -Amendments

FSSAI has asked the FBO(Food Business Operator) to revalidate their existing and new products as per the notification dated on 23-12-2016.FBO are required to comply with the order by 1st Jan 2018.Scientific panel carefully considered the several representations received by stakeholders for their inclusion. Some ingredients have not been approved by FSSAI to be included in regulations due to-

  1. Safety
  2. Likely to exhibit properties of drugs
  3. Inadequate data
  4. Safety issue

Since some of the issues are yet to resolve , FSSSAI made following timelines for FBO:

  1. Ingredients and additives approved by FSSAI for inclusion:
    1. According to annexure I, the ingredients/additives which are approved by FSSAI for inclusion are given a time till 30th June 2018 for their reformulation
    2. In case of new permissible limit, FBO are given time for the period of six months from the date of revised/new formulation.
  2. Ingredients not approved by FSSAI for the inclusion due to inadequate data:
    1. The FBOs have given time to submit the data within 4 weeks from the date of issuance. For non- compliance, products containing such ingredients are to be withdrawn from the market immediately.
    2. Meanwhile, As per Annexure II, FBO are allowed to continue the food business of existing products.
  3. Ingredients not approved by FSSAI for safety reasons:
    1. FBO are directed to discontinue food business and withdraw the products containing ingredients namely ‘fluoride’ and ‘Potato protein isolate.
  4. Ingredients not approved by FSSAI since exhibiting drug like properties :
    1. FBOs are directed to discontinue the food business of products carrying drug-like ingredients namely ‘Willow Bark Extract’, ‘Pyrol Quinoline Quinone’ and ‘Lemon Bam’.
    2. For products already manufactured/imported are permitted to be sold till 30th June, 2018.
  5. FBOs are allowed to sell the formulation containing mere combinations of vitamins and minerals only up to one RDA in dosage formats such tablets, capsules and syrups for the period of 6 months or till the further order, whichever is earlier.
  6. As per Annexure lll, with respect to FSDU, FBOs be taken under medical advice are allowed to sell their existing formulations containing vitamins and minerals in food for special dietary uses without referring to the energy value(Kcal/K) for period of six months or till further orders, whichever is earlier.

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