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The Food Safety and Standards Authority of India has announced new guidelines to streamline the product approval procedure with due consideration to the safety of food and public health, in supersession of earlier advisories, food products for which the standards are not specified under FSS Act 2006 Rules and Regulations made there under will be granted product approval. These procedural guidelines are made after receiving feedback from various stakeholders regarding the complexity and timelines for product approval. The FSSAI noted that following procedure has come into force with effect from May 11, 2013.
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.
1(b) 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 (PA)/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.
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.
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 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 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 there under.
8. 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.