Introduction:

Manufacturers who wish to trade in India whilst having manufacturing units located outside India have to apply for the BIS FMCS scheme. FMCS is an abbreviation of Foreign Manufacturer’s Certification Scheme which assures the public of quality, safety, reliability, and many other factors that are relevant to Indian Standards.

Organizations selling food items for public consumption have to conform to the safety, hygiene, and reliability standards of the Bureau of Indian Standards. BIS FMCS authorities perform an audit of the food products and the factory to verify compliance.

Such organizations that conform to above mentioned standards are granted FMCS licenses. Professional Utilities experts will provide you with all the necessary information to obtain an FMCS license- ELIGIBILITY, STEPS, DOCUMENTS, BENEFITS, and many more.

Mandatory products under BIS certification:

Infant Formula ( IS 14433)
Milk Cereal-based Weaning Food (IS 1656)
Processed Cereal based cereal-weaning food ( IS 11536)
Follow Up Formula ( IS 15757)
Packaged Drinking Water (IS 14543)
Packaged Mineral Water (IS 13428)
Milk Powder (IS 1165)
Skimmed Milk Powder (IS 13334)
Partly Skimmed Milk Powder(IS 14542)
Condensed Milk, Partly Skimmed & Skimmed (IS 1166)
Condensed Milk sweetened (IS 12176)

Steps for FMCS for Food and Related Products :

Preparation: Food items firms’ priority is to collect all the documents that are required to submit to the BIS FMCS authorities. Documents include- a copy of factory information, a copy of the manufacturing process, a list of machinery and raw materials used, quality control methods, etc. Along with this, the firm has to agree to all the standards set by the BIS only then, they will be permitted to obtain the license.

Registration: The manufacturer is required to register their firm to obtain the license. The manufacturer has to pay the registration fee and submit the application form consisting of complete information about the product details, factory details, etc. to the authorities to begin the process. The manufacturer will have to submit the documents to the FMCD department in Delhi or they can apply online at the BIS portal.

Issue Raised (If any): Though it is the manufacturer's responsibility to fill in the entire information needed in the application form sometimes, the manufacturer fills incomplete or missing information. In such conditions, BIS authorities send an email to the concerned firm informing them about the encountered issue. Also, if the BIS authorities don’t find any issue in the application form i.e. if the manufacturer has filled in correct and complete information, the application request will be registered for further process.

Appointment of AIR: The Foreign Manufacturer will have to appoint an Authorized Indian Representative(AIR) to represent the manufacturing firm to the BIS authorities within India. An AIR handles the entire arrangements and communications needed with the BIS FMCS authorities. An AIR must know about the manufacturing firm, Government rules regarding the trading of food items, and FMCS standards.

Inspection: The manufacturer has to pay for the audit fee. The BIS FMCS authorities visit the manufacturing unit located outside India. It is performed to examine the location, manufacturing process, equipment, raw materials used, quality control methods, etc. on the mutually agreed upon date.

Product Assessment: The BIS FMCS authorities collect the samples of the food items to check their credibility to ensure no harm occurs to the people consuming them. The authorities verify the quality and safety standards of the item. In other words, it ensures that the product complies with the BIS standards. The product is assessed at the In-house laboratory as well as at the NABL-certified laboratories.

Laboratory Reports: After assessing the product at the laboratory, the laboratory provides the report of the assessment to the BIS authority who then decides whether to grant license or not. If the reports are positive i.e. if the reports suggest that the product complies with the BIS standards a license is granted. If the reports are negative i.e. the product is not in compliance with the BIS standards- the process does not progress further. In such cases, the manufacturer is informed about the non-compliance to make necessary changes.

Certification: The manufacturer has to pay for the license fee after which the firm will be granted an FMCS license that allows the manufacturer to trade within India freely. The manufacturer has to sign an indemnity bond and pay USD 10,000 forPerformance Bank Guarantee. It is refundable when the manufacturer surrenders the license.

Benefits of BIS FMCS for Food and Related Products:

BIS FMCS is beneficial for food manufacturers as it assists in enhancing the quality of the products.
It supervises that the food item manufacturing firm meets all the relevant Indian Standards.
BIS FMCS ensures that the food items are manufactured in a hygienic environment which is a result of healthy manufacturing methods.
It ensures verification of the safety standards of the food item to secure the health of the public. Therefore, provides non-contaminated food items to the public.
The BIS FMCS mark on the food item assists in reaching a larger and more diverse audience.
The BIS FMCS certification assists in distinguishing the firm from its competitors. It gives the firm an edge in the market by certifying the reliability of the product.
BIS FMCS helps in gaining the confidence of the public in the food item manufacturing firm.
It is beneficial for the firm as it assists in building a positive reputation of the organization within the public.
BIS FMCS helps in converting the public into the buyers which boosts the revenue of the organization.
It will also help in resolving any legal issues that a firm may face for not obtaining BIS FMCS certification.
BIS FMCS allows the manufacturers to use the ISI logo while selling their products within India. The ISI mark is a testament to compliance with all the relevant standards.
This certification helps the manufacturing firm to easily import or sell products within India. It provides easy market access to the firms.

Documents Required for BIS FMCS for Food and Related Products:

Business License is required to be submitted during the process.
A copy of the relevant Indian Standards is required to be submitted by the manufacturer.
Factory information i.e. address, layout, etc. is required to be submitted for further assessment of the factory.
A detailed list of the machinery used at the factory for the production of food items is required to be submitted.
Comprehensive details about the food items, their specifications, composition, etc. are required.
A flow chart of the manufacturing process explaining how the production occurs is essential.
A detailed list of the testing facilities available at the site such as In-House Laboratory is required to be submitted to the BIS FMCS authorities.
Details regarding the labeling and packaging of the food items and other related details are required.
Information regarding the nominated Authorized Indian Representative (AIR) is required to be submitted.
An Authorization Letter signed by the concerned authorities is required to be submitted to the BIS FMCS authorities.
A detailed list of the raw materials used for the production of food items is required.
Copies of valid calibration certificates of the equipment and the raw materials used are required to be submitted.

Validity of BIS FMCS for Food and Related Products:

Positive Laboratory reports of the food item samples result in the grant of the BIS FMCS license. The initial validity of the license is for 2 years which needs to be renewed to continue trading within India. The manufacturing firm also has to pay for the renewal of the license. The renewed license can be used for a minimum of 1 year to a maximum of 5 years. A late fee of Rs 5,000 is to be paid by the manufacturer for renewing the license after its expiry date.

Fee Structure of BIS FMCS for Food and Related Products:

Particulars	Fees
✅ Lab Test	₹25,000 + GST
✅Application Fee	₹53,000 + GST
✅Professional Fee	₹10,000 + GST
✅Validity of FMCS Registration	2 years
✅Renewal Fee	Same as application fee, additional our professional fee for renewal is ₹ 7,500/- Only

Note : It typically takes 2-3 months to obtain FMCS Certification from the BIS licensing authority.

Conclusion

FMCS is one of the schemes under BIS which helps Foreign Manufacturers to freely trade within India while having their manufacturing units outside India. FMCS ensures compliance with BIS standards.

In conclusion, BIS FMCS is accountable for ensuring the safety, reliability, hygiene, and quality service of the food and related products which helps in securing public health, gaining confidence in the product, building reputation, resolving legal issues, giving a competitive advantage, and many other advantages.

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