FAQ’s on FSSAI Product Approval 2017-09-16T06:14:30+00:00

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FAQ FAQ’s on FSSAI Product Approval

 

Product approval is the process by which a product gets approved by FSSAI in which the ingredient(s) and / or additive (s) are not as per prescribed standards in the act and regulations.
A No Objection Certificate is an interim permission given to place a food product/ additives/ ingredients in the market.
Food Product(s) including food ingredient(s) or food additive(s) for which there are no standards notified by FSSAI will require product approval.
An FBO needs to apply for product approval before licensing when the ingredient(s) and / or additive (s) used by him are those for which standards are not specified under FSS Act 2006, Rules and Regulations and are different from those of the products which are detailed in the FSS Act and Regulations.
NOC is valid for one year and the same will be referred to the scientific panel for safety assessment/evaluation.

Pending the safety assessment/evaluation, NOC can be extended further after submission of application along with the requisite fee.

There about 20-30 documents required for Approval. The documentation is bit sensitive.
Yes, every product which has different ingredient(s) and / or additive (s) needs separate PA (except any number of flavours or colours can be accommodated in one application).

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Traditional /Ethnic foods are foods which have been and are traditionally being consumed in the country
The traditional/ ethnic foods mentioned in the regulation 3.1.1. (2) of Food Safety and Standards (Food Product Standards and Food Additives) Regulations, 2011 namely, – Snacks of Savouries (Fried Products), such as Chiwda, Bhujia, Dalmoth, Kadubale, Kharaboondi, Spiced and fried dals, banana chips and similar fried products sold by any name, Sweets,

Carbohydrates based and Milk product based, such as Halwa, Mysore Pak, Boondi Ladoo, Jalebi, Khoya Burfi, Peda, Gulab Jamun, Rasogolla and similar milk product based sweets sold by any name

Instant Mixes Powders only of Idli mix, dosa mix, puliyogare mix, pongal mix, Gulab jamoon mix, Jalebi mix, vada mix, Rice and Pulses based Papads, Ready-to-Serve Beverages (tea/coffee based only) are not required to get product approval, provided it contains food additives permitted in Table 2 of Appendix A of Food Safety and Standards (Food Product Standards and Food Additives) Regulations, 2011.

Organic Food Products, ingredients, and additives are treated in the same manner as non-organic products for the purpose of product approval.

However, no separate product approval is required for the organic nature of the standardized product or which has otherwise been granted product approval.

If the premix or intermediary products contain ingredients or additives which are not specified or do not have standards in the FSS regulation, these require product approval.
As per ICMR guidelines, amount of vitamins and minerals as per RDA are permissible and all applications with these above RDA will be rejected.
All available literature and studies with respect to that botanical or product need to be submitted for examination in relation to the safety of the product as food.

Data of use, internationally for 30 years and nationally for 10 years is required for all ingredients which are not traditionally used.

This means that ingredients of plant or botanical and/or animal origin, which are not normally consumed as conventional foods or are not represented for use as conventional foods in India.
If safety of the product containing such ingredient(s) and / or additive (s) has been established by the above mentioned bodies then such products may be given PA.
Yes. The application should be submitted in form 1(a) giving all relevant data on status of approval in Codex/USFDA/EU/ FSANZ etc.

If it is not approved by any of these regulatory bodies, then it will be forwarded to Scientific Panel on Additives for evaluation.

The PA Committee examines the ingredient safety and, if satisfied, grants an NOC or Approval, as the case may be.

In case of issues like label declarations, claim, nutritional information etc., the Committee shall review the application with respect to the listing of ingredient(s); nutrient value of any new ingredient(s); claims related to new ingredient(s) for which approval is sought; and impact on food safety.

However, FBO will be required to comply with the other relevant FSSAI Regulations for compliance.

If necessary, the PA Committee may refer to the relevant Scientific Panel(s).

The PA Committee has the mandate to review the application in terms of the safety of the product or ingredient(s) and / or additive (s) for which the NOC/PA is sought by the applicant as mentioned in the advisory
An attempt will be made to inform you by speed post within 10 working days from the date of receipt of your application.
No, any application seen in the screening committee meeting after 5th September 2013 will be exempt from any additional fee for reference to scientific panel.
No, only the applications of those products which are known to contain safe ingredient(s) and / or additive (s) as prescribed in the act and regulations will be granted PA.

Other applications may be referred to scientific panel for recommendations with relation to safety of the ingredients

If the panel has refused to grant product approval for the food product food ingredient (s) or food additive (s) before or after the validity of NOC, the FBO should stop the manufacture/import/ place on the market that food product immediately and the license for the manufacturing of that food product and the NOC obtained from the FSSAI stands cancelled.

In such case, the FBO should recall the product which is in the market, if any.

The product approval is required for the manufacturing of food products by 100% EOI units which sell and distribute a part of the food products domestically.

Further, the units covered under the Special Economic Zones (SEZs) as defined by the Ministry of Commerce are not required to apply for the product approval.

The FBO should get the license initially from the Central Licensing Authority for a period of one year after obtaining NOC.

Once the product approval is issued, the same license will be shifted to the concerned state for state licensing, if it qualifies as per the eligibility criteria, else it would continue to be under central licensing.

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