FSSAI BIS Certificate

The Food Safety and Standards Authority of India (FSSAI) is a regulatory body established under the Food Safety and Standards Act, 2006. The FSSAI frames regulations to lay down the standards and guidelines relating to food products. One of the regulations laid down by the FSSAI is the Food Safety and Standards (Prohibition and Restrictions on Sales) Regulations, 2011 (“Regulations”). 

The Food Safety and Standards (Prohibition and Restrictions on Sales) Regulations prohibit and restrict the manufacture, storage, or sale of certain food products. Under these Regulations, certain food products need to have the Bureau of Indian Standards (BIS) certification mark along with the FSSAI registration/license number for manufacturing or selling them.

What is the Bureau of Indian Standards (BIS)?

The Bureau of Indian Standards (BIS) was established under the Bureau of Indian Standards Act, 2016. The BIS operates product certification schemes through which it grants licenses to the manufacturers from almost every industrial discipline, from agriculture to electronics. 

The BIS is functioning under the Ministry of Consumer Affairs, Food and Public Distribution. The BIS certification permits the licensees to use the ISI (Indian Standards Institution) mark, indicating standard and quality products in Indian and overseas markets for over 55 years.

BIS Certificate for FSSAI Products

The product certification scheme operated by the BIS is voluntary. But the Indian Government, in the public interest, has enforced mandatory BIS certification on various products through different quality control orders issued from time to time, under several Acts and Regulations.

The BIS grants licenses on receipt of an application, but the enforcement of compulsory BIS Certificate is done by the authorities notified for quality control orders, FSSAI being one such authority for food products. Thus, FSSAI, through the Regulations, has made it compulsory for Food Business Operators (FBOs) involved in the manufacturing, selling, storing or exhibiting the following food products to have the BIS certificate mark:

• Milk cereal-based weaning food (IS 1656)
• Infant formula (IS 14433)
• Follow up formula (IS 15757)
• Processed cereal-based weaning food (IS 11536)
• Packaged mineral water (IS 13428)
• Packaged drinking water (IS 14543)
• Milk powder (IS 1165)
• Skimmed milk powder (IS 13334)
• Partly skimmed milk powder (IS 14542)
• Condensed milk sweetened (IS 12176)
• Condensed milk, partly skimmed and skimmed condensed milk (IS 1166)

The FSSAI issued an order stating that the FBOs involved in manufacturing the mineral water and packaged drinking water must obtain a BIS licence while applying for the FSSAI licence from 1 April 2021. The FSSAI laid down the procedure for considering the application for the issue of FSSAI licence for the FBOs manufacturing packaged mineral water and drinking water. 

The procedure provides for mandatory uploading of a copy of the BIS licence or copy of a letter indicating recording of application for the BIS licence while applying for FSSAI licence on the online FoSCoS system. The FBOs need to mandatorily submit the BIS licence document while applying for FSSAI license renewal. The FSSAI issued this order after receiving complaints that many FBOs manufacturing mineral water and packaged drinking water were operating without BIS certification marks. 

BIS Certificate Procedure for Food Products

The food products mentioned in the Regulations requiring BIS certification must apply for BIS license as per Scheme-I of Schedule-II of the BIS (Conformity Assessment) Regulations, 2018. The FBOs should file Form-V with the BIS along with the documents mentioned in that form. The BIS will follow either or all of the following procedures to grant a BIS licence:

• Procedure 1 –
  • The FBO should submit the test report of the food product issued from a third party laboratory along with the form
  • The BIS will arrange a factory visit for verification of the production process and collection of samples for third party laboratory testing
  • BIS will grant the license without waiting for the sample test report and review the license after receipt of the test report

• Procedure 2 –
  • The BIS will arrange a factory visit for testing of product and verification of production process in the factory when the complete testing facilities are available with the applicant
  • The BIS license will be issued based on the sample testing in the factory

• Procedure 3 – 
  • The BIS will arrange a visit to the factory for collection of the sample for testing in a third-party laboratory and the verification of the production process 
  • The BIS will grant license after the demonstration of conformity through the test report of this sample

On receipt of the application, i.e. Form-V, the BIS will examine whether the applicant has submitted all the required documents. The BIS will arrange for a factory visit after consulting with the applicant when the application is complete and proper. The BIS will review the report of the factory visit and the test results of the food products. 

When the BIS is satisfied that the FBO has the necessary infrastructure for manufacturing quality products and the test results indicate that the products conform with the relevant Indian Standards, the BIS will issue the license in Form-VIII to use the BIS certification mark. The license to use the Standard Mark (IS) is granted for a minimum of one year and a maximum of two years. The FBOs can renew the license for a further period of one year or a maximum of five years.

Required Documents for Obtaining a BIS Certificate

The documents mentioned in Form-V that an FBO needs to submit along with the form are as follows: 

• Name and address proof of office and factory
• MSME certificate, if applicable
• Manufacturing process flow
• Manufacturing machinery list
• Outsourcing of manufacturing operation, if applicable
• Testing equipment list
• In-house test report(s)
• Valid calibration certificate of testing equipment
• Third-party laboratory test report(s) as per Indian Standard, if applicable

Disclaimer: The materials provided herein are solely for information purposes. No attorney-client relationship is created when you access or use the site or the materials. The information presented on this site does not constitute legal or professional advice and should not be relied upon for such purposes or used as a substitute for legal advice from an attorney licensed in your state.

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