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The Food Safety and Standards Authority of India (FSSAI) is an agency of the Ministry of Health & Family Welfare, Govt. of India. The FSSAI is responsible for protecting and promoting public health through the regulation and supervision of food safety. The FSSAI has been established under the Food Safety and Standards Act, 2006 which is a consolidating statute related to food safety and regulation in India.
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What does FSSAI do?
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Laying down science based standards for articles of food |
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To regulate manufacture, storage, distribution, sale and import of food |
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To facilitate food safety |
Procedure of getting FSSAI Certifications:
The following procedure shall come into force with immediate effect;
1. (a) Food products where the safety of its ingredients present are known and are permitted under FSS Regulation, 2011/Codex and other regulatory bodies like EU/FSANZ/USFDA etc. and the food product does not contain plants or botanicals or substances from animal origin will be granted product approval. The application in form 1 (a) along with the affidavit to be submitted by the Food Business Operator (FBO) for the product approval shall be accompanied by following documents:
(b) Complete list of ingredients (specify the level of its use)
(c) Copy of the label for products in the market/to be placed in the market
(d) Category number of the product as applicable under the Indian Food Category Code After scrutiny of the application and documents and on the condition that the documents submitted by the FBO are satisfactory, Product Approval Division (PAD) shall grant the product approval.
2. (a) Food products where the safety of its ingredients present are known and are permitted under FSS Regulation, 2011/Codex and other regulatory bodies like EU/FSANZ/USFDA etc. and the food product contain ingredients including plants or botanicals or substances from animal origin shall be considered for Product approval/NOC. PA will be given to all products where safety assessment is completed. NOC will be granted to food products in market where license has been granted under previous Act/Orders. The application in form 1 (b) along with the affidavit to be submitted by the Food Business Operator (FBO) for the product approval will be accompanied by following documents:
(b) Complete list of ingredients (specify the level of its use)
(c) Copy of the label for products in the market/to be placed in the market
(d) Category number of the product under the Indian Food Category Code.
1(c) Food products falling under category 1 (b) above, prima facie where safety of the ingredients is insufficient to make a safety determination would be referred to respective Scientific Panels. Product approval shall be granted/ denied on the basis of risk assessment.
1(d) Products for which the safety of its ingredients and their conditions of use as stated therein and published by FSSAI or products whose ingredients are standardized or permitted under FSSR 2011 will not require further safety assessment except for authorization of the ingredients contained therein. The application in form 1 (d) along with the affidavit to be submitted by the Food Business Operator (FBO) for the product approval will be accompanied by following documents:
i. Complete list of ingredients (specify the level of its use)
ii. Copy of the label for products in the market/to be placed in the market
iii. Category number of the product under the Indian Food Category Code.
iv. Copy of PA/NOC issued by FSSAI
2. Safety data wherever required should be provided for all the ingredients.
3. The use of minerals/ vitamins/ proteins/ metals/amino acids/ their compounds should not exceed the Recommended Daily Allowance for Indians. In this regard, FBO shall follow the guidelines issued by Indian Council of Medical Research (ICMR) / National Institute of Nutrition (NIN) / World Health Organisation (WHO) / Food and Agriculture Organisation (FAO).
4. In case of rejection of application under the approval procedure, the product under reference shall be recalled as per the provisions laid down in FSS (Licensing and Registration of Food Businesses) Regulations 2011.
5. This procedure shall not be applicable if the food products or its ingredients are from the prohibited or banned source.
6. This procedure shall ipso facto be applicable to imported food products.
7. The terms used in the advisory will carry the meaning as defined in the FSS Act, 2006, Rules and Regulations made thereunder.
8. Application Fee: -
i. An application fee of Rs.25,000 (Non – Refundable) is payable in respect of each application. Since product approval is a safety assessment of ingredients, different permitted colours or flavours but having same composition shall be considered a single application.
ii. For cases wherein the application is forwarded to Scientific Panel additional fee of Rs.25,000 must be deposited for processing of the application.
iii. Application fee in the form of demand draft shall be in favour of “Senior Account Officer FSSAI” at New Delhi.
9. Product approval application forms and the format.
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