Prohibition of selling of Health Supplement containing PABA (Para Amino Benzoic Acid) a banned ingredient
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....dia, Ministry of Health and Family Welfare, Regulatory Compliance Division enclosing FSSAI Order No. Stds/Nutr(DGCI)/FSSAl-2017 (Pt.I) dated 29-06-2018 (copy enclosed).The operative para 2 of the advisory is reiterated below for ease of reference: "2. FSSAI vide Order No. Stds/Nutr(DGCI)/FSSAI-2017(Pt.I) dated 29-06-2018 (copy enclosed) has banned the use of PABA (Para Amino Benzoic Acid) in the products covered under Nutraceuticals Regulations due to safety concerns with immediate effect. Para No. 2 (c) of the said order also directs the FBOs that no further manufacturing of products using this ingredient is allowed. Any product containing such ingredient which is already manufactured/ imported shall be withdrawn from the market immediately. However, it has come to the notice that several health supplements and nutraceutical products containing PABA are still being sold on e-commerce platform." 2. The advisory has been issued with a request to circulate Order dated 29-06-2018 to all Customs Officials working as Authorized Officers to comply and to ensure that imported products containing banned ingredient shall not be cleared through their respective point of ent....
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....No. 2 (c) of the said order also directs the FBOs that no further manufacturing of products using this ingredient is allowed. Any product containing such ingredient which is already manufactured / imported shall be withdrawn from the market immediately. However, it has come to notice that several health supplements and nutraceutical products containing PABA are still being sold on e-commerce platform. 3. All e-Commerce FBOs are advised to de-list /remove such products which contain PABA or any prohibited ingredients by FSSAI immediately from their website. 4: This issues with the approval of Competent Authority. 11-7-2-20 (Parveen Jargar) Joint Director (RCD) Tel: 01123231679 To, E-Commerce Food Business Operators as per list attached herewith. Copy to: 1. All Authorised Officers, FSSAI - To comply above order and to ensure that imported products containing banned ingredients shall not be cleared through their respective point of entries. 2. Director (Customs) & Commissioner (Single Window Project, CBEC) - with the request to circulate it to all Customs Officials working as Authorised Officer to comply above order and ....
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....ctional Food and Novel Food) Regulations, 2016 (referred to hereinafter as 'Nutraceutical regulations'), the following timelines are laid down with respect to compliance to these regulations to ensure smoother transition for food businesses: (i) (ii) New ingredients and additives recommended by the Scientific Panel for inclusion in Nutraceutical regulations and proposed to be included in the existing Schedules as per Annexure I of the earlier direction are allowed to continue to be used in the existing formulations* after 30th June, 2018 till such time the proposed amendment of the Nutraceutical regulations in this regard are finalized and notified. However, the Food Business Operators (FBOs) shall comply with the provision with respect to permissible limits of ingredients/additives as given at Annexure-I of the earlier direction. The earlier direction dated 29.12.2017 contained list of 33 ingredients, which were not recommended by the Scientific Panel for inclusion in the Nutraceutical regulations due to lack of data. The Scientific Panel has again reviewed the use of these ingredients based on the additional data made available by t....
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.... drug and no further manufacturing of products using these ingredients is allowed. However, any such products containing these ingredients which are already manufactured/ imported are allowed to be sold till 30th September, 2018. (1) FBOs are directed to discontinue the use of ingredients/enzymes namely 'Artichoke', 'Kale Powder', 'Salvia hispanica', 'Cashew fruit', 'Passion fruit', 'Kiwi fruit extract', 'Broccoli', 'Enzymes (Pectinase and Xylanase)' as health supplements/ nutraceuticals. However, FBOs may use these ingredients/enzymes in the products as general ingredients, if permitted under Food Safety and Standards Regulations, without claiming any benefits as health supplements/ nutraceuticals for such ingredients. Further, any such products containing these ingredients which are already manufactured/ imported making any such claims are allowed to be sold till 30th September, 2018. (g) FBOs are directed to discontinue the use of ingredients listed under Appendix 1 of this direction in the products covered under Nutraceutical 2 Regulations with immediate effect due to lack of adequate data and no further manufacturing of pro....
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