An FSSAI registration or licence is a legal requirement for running a food business in India. ISO 22000 certification is a voluntary, internationally recognised certificate of your food safety management system, usually sought because a buyer, an exporter’s customer or a tender asks for it. One cannot replace the other.
It becomes necessary for food safety standards such as FSSAI licensing and ISO 22000 certification to guarantee food safety standards and consumer confidence. Considering that FSSAI registration or licensing is concerned with legal aspects of food safety for businesses in the food industry in India, ISO 22000 is an international standard aimed at developing an efficient food safety management system (FSMS). Both FSSAI and ISO 22000 certification are associated with the food industry since food manufacturers, processors, distributors, restaurants, packers and other businesses dealing with the food industry come under these two categories. Understanding the difference between the two can be helpful for businesses to fulfill their legal obligations as well as consumers’ demands. While serving different purposes, these two can complement each other in ensuring regulatory compliance, systematic hazard control, efficiency and success of business operations.
Quick Summary
FSSAI License and ISO 22000 Certification serve different purposes in the food industry. FSSAI registration or licensing is a legal requirement for eligible food businesses operating in India, while ISO 22000 is an international food safety management system standard that helps businesses establish and maintain effective food safety practices. Understanding their differences helps food manufacturers, restaurants, distributors and exporters meet regulatory requirements and strengthen customer confidence.
- FSSAI License: Issued by the Food Safety and Standards Authority of India (FSSAI), it is a statutory registration or licensing requirement for food business operators, depending on their eligibility and business activities.
- ISO 22000 Certification: An internationally recognised certification based on a food safety management system that helps businesses identify, control and manage food safety risks throughout the supply chain.
- Legal requirement: FSSAI registration or licensing is mandatory for applicable food businesses, whereas ISO 22000 certification is generally voluntary unless required by a contract, buyer or specific business arrangement.
- Scope of application: FSSAI compliance applies to food businesses operating in India, while ISO 22000 can be implemented by organisations across the global food supply chain.
- Certification process: FSSAI registration or licensing involves submitting the required application and documents through the applicable regulatory process. ISO 22000 requires implementing a food safety management system and undergoing an audit by an accredited certification body.
- Business benefits: FSSAI licensing supports legal compliance, while ISO 22000 can strengthen food safety practices, customer confidence and business opportunities, including certain export and supply-chain requirements.
- Using both together: Food businesses can obtain the applicable FSSAI registration or licence and pursue ISO 22000 certification to combine statutory compliance with a structured food safety management system.
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What is an FSSAI License?
A licence issued by the FSSAI to the operators of food companies who are supposed to get the licence in accordance with food safety standards in India is an FSSAI licence. The Food Safety and Standards Authority of India (FSSAI) establishes the food safety standards and ensures compliance with them in order to ensure that the food products meet the safety standards and are safe for human consumption.
Food companies engaged in the manufacture, processing, packaging, storage, transportation, distribution, importing/exporting, and selling of food products need to register or get permission from the FSSAI. It depends on various factors such as the type of food company, its size, sales, etc. From 1 April 2026, the general turnover bands are: registration up to Rs. 1.5 crore, a State licence above that up to Rs. 50 crore, and a Central licence above Rs. 50 crore, with some special categories needing a Central licence at any turnover. Read the difference between FSSAI registration vs licence. Applications are made on FoSCoS.
There is a need to comply with the food safety standards, hygiene standards, and other labelling requirements. Disregarding the requirements due to lack of registration or license would lead to legal problems for the food company.
Registration/license from FSSAI will assist food companies in complying with the requirements, gaining the trust of consumers, and conducting business activities according to the law.
What Is ISO 22000 Certification?
ISO 22000 certification refers to an international certification process that guarantees adherence to the ISO 22000 standard in terms of a Food Safety Management System (FSMS). ISO developed the standard as a framework to identify, prevent, and control food safety hazards throughout the food chain. The current version is ISO 22000:2018, which combines the HACCP principles with prerequisite programmes and the plan-do-check-act approach of other ISO management standards.
The companies that operate in food manufacturing, food processing, food packaging, food storage, transportation, food distribution, catering, and related services can be certified for ISO 22000. To ensure the safety of the food products, the organizations need to develop policies, analyse risks, develop prevention procedures, document processes, and monitor processes. This kind of certification can be done voluntarily or, alternatively, it may be required as a result of customer requests, partner requirements, or contractual agreements. It is awarded by a reputable independent certification body after auditing food safety management systems of the organization.
ISO 22000 certification provides opportunities to improve food safety standards, increase trust among consumers, prove commitment to quality, and have more chances to cooperate with domestic and international customers. It certifies your system. It does not certify an individual product, so the ISO mark should not be printed on products or packaging.
FSSAI License vs ISO 22000 Certification
While both FSSAI and ISO 22000 are related to food safety topics, the distinction between these two standards is found in terms of the purpose, requirements, scope of activities, and certification procedures. In particular, the FSSAI is an Indian government organisation that regulates food businesses, whereas ISO 22000 is an international standard outlining the criteria of the Food Safety Management System (FSMS). Familiarity with these differences is necessary for food manufacturers, restaurants, distributors, exporters and other types of food businesses to know what requirements they have to follow.
| Point | FSSAI registration/licence | ISO 22000 certification |
| Nature | Legal requirement | Voluntary standard, unless a buyer requires it |
| Issued by | FSSAI and the licensing authority | An independent certification body |
| Law or standard | Food Safety and Standards Act, 2006 | ISO 22000:2018 |
| Applies to | Food businesses in India | Organisations anywhere in the food chain |
| Validity | Perpetual for those issued on or after 1 April 2026, with an annual fee and returns | 3 years, with annual surveillance audits |
| Checked by | Regulator, through inspection and returns | Audits by the certification body |
1. Complete description and complete name:
- FSSAI stands for Food Safety and Standards Authority of India.
- This organisation regulates food safety in India according to the Food Safety and Standards Act, 2006.
- ISO 22000 is an international standard adopted by the International Organisation for Standardisation (ISO).
2. Objective:
FSSAI was established to ensure the food safety of products produced, processed, stored, imported and sold in the territory of India.
The main objective of ISO 22000 is helping organisations to identify, prevent and control food safety risks using a management system.
3. Legal Requirement:
- It is mandatory that food businesses in India comply with the legal requirement of getting FSSAI registration/license, except where any exemption applies.
- On the other hand, ISO 22000 is a voluntary certification unless it is demanded by any client, contract, tender, or any other requirement.
4. Geographic Applicability:
- FSSAI is mainly concerned with food safety requirements in India.
- ISO 22000, being an international standard, can be used by organisations located in different countries, and hence is useful for companies catering to the international market.
5. Scope of Application:
- FSSAI regulations apply to all food business operators such as manufacturers, hotels, retailing, wholesaling, importation, transportation and storage businesses.
- ISO 22000 applies to those organizations which have direct or indirect involvement in the food chain such as food manufacturers, packaging, storage, transporters, caterers and others.
6. Authority issuing the compliance certificate:
- FSSAI registration and license are issued in the context of Indian food safety regulation, where FSSAI and competent licensing authorities have jurisdiction.
- Competent certification bodies issue ISO 22000 certificates based on the audit conducted on the food safety management system of the organization as per the standard. Look for a certification body accredited by NABCB or another recognised accreditation body.
7. Nature of compliance:
- FSSAI compliance consists of compliance with the food safety standards, hygienic standards, labeling regulations, licensing regulations and all other relevant regulations. Licence holders must also follow the hygiene and sanitary practices in Schedule 4, have a trained Food Safety Supervisor on each premises (FoSTaC), and use the 14-digit FSSAI number on bills and labels.
- ISO 22000 mandates organizations to document procedures, assess risks, implement controls, monitor performance and continually improve their food safety management systems.
8. Certification process or assessment process:
- FSSAI registration or license process includes submission of an application, submission of relevant documents, payment of fees and compliance with the regulatory requirements.
- ISO 22000 certification involves system audit, audit by the competent certification body, correction of deficiencies, if any and regular surveillance audits for certification. A stage 1 audit reviews your documents and readiness, and a stage 2 audit checks that the system works in practice.
9. Cost:
- The type, activity, and fee schedule of the company determine the cost of FSSAI registration or permits. The government fee for ordinary manufacturing is about Rs. 100 for registration, up to Rs. 5,000 for a State licence and Rs. 7,500 for a Central licence.
- The cost of ISO 22000 certification varies on the size, complexity, number of locations, audit requirements, and certification fees of the company. It is usually much higher than the FSSAI fee, and it includes the consultancy, training, and audit charges.
10. Benefits:
- The procurement of an FSSAI registration/license will not only help eligible food companies operate legally in India but will also indicate compliance with the applicable food laws.
- ISO 22000 certification will assist in ensuring the consistency of processes, enhancing hazard management, boosting the confidence of clients, and building business connections with organizations that require an approved food safety management system.
11. Validity & Renewal:
- FSSAI registrations and licences issued on or after 1 April 2026 have perpetual validity, subject to suspension, cancellation or surrender. The annual fee and the annual return still have to be paid and filed, and non-payment can lead to deemed suspension.
- The ISO 22000 certification is always up-to-date through the process of auditing and certification performed by the certification body, including surveillance and renewal criteria. The certificate is valid for three years, with annual surveillance audits and a recertification audit at the end of the cycle.
- The respective agency/certifying body should review the requirements for legitimacy and renewal in detail.
12. Consequences of negligence:
- Neglecting the acquisition of the required FSSAI registration/license, apart from disregarding the applicable food safety laws, may result in legal sanctions.
- In accordance with certain terms and policies of the certification body, failure to comply with the ISO 22000 requirements may cause suspension, cancellation of the certification, or requests for corrective actions.
How ISO 22000 Certification Works
- Gap analysis: compare your current practice with the standard.
- Build the FSMS: write the food safety policy, the HACCP plan, the prerequisite programmes, and records.
- Train and run it: train staff and operate the system for a period so that records exist.
- Internal audit and management review: check the system yourself before the external audit.
- Certification audit: stage 1 and stage 2 audits by an accredited certification body, and closure of any non-conformities.
- Certificate and surveillance: the certificate is issued for three years, and the body audits you once a year in between.
The time and cost depend mainly on the number of sites, employees and food categories. For a small unit, it often takes a few months, and the work is much easier if your FSSAI Schedule 4 compliance is already in place.
ISO 22000, HACCP, FSSC 22000 AND FSSAI Schedule 4
| Name | What it is | Typical use |
| FSSAI Schedule 4 | Mandatory hygiene and sanitary practices for licence holders | Every licensed food business |
| HACCP | A hazard analysis method, one part of an FSMS | Often asked for by buyers; see HACCP and FSMS |
| ISO 22000 | A full FSMS standard | Suppliers to organised buyers and exporters |
| FSSC 22000 | ISO 22000 plus sector programmes and extra requirements, recognised by GFSI | Big retailers and global brands that insist on GFSI-recognised schemes |
Can A Business Require Both FSSAI License And ISO 22000 Certification?
A food business has to hold the FSSAI registration or licence, and it may also choose ISO 22000 certification, as both serve different purposes in food safety management.
- Compliance with FSSAI rules: Food business organisations need to obtain appropriate FSSAI registration or licence based on the food safety laws and rules. It ensures compliance with food safety standards, sanitary laws, and other obligations.
- Food safety management: The ISO 22000 certification assists organizations in developing an effective Food Safety Management System. It helps organizations recognize potential risks, take precautionary measures, monitor systems, and improve food safety processes within the entire organization.
- Requirements of customers and markets: Big retail companies, institutions, food processing companies, and consumers from foreign countries may demand that their suppliers have ISO 22000 or some other food safety certification.
- Credibility and operational efficiency improvement: Adherence to both FSSAI requirements and ISO 22000 certification can help in increasing credibility and operational efficiency and can also help business organizations enter into new markets.
- No replacement for each other: It should be noted that the ISO 22000 certificate is not an alternative to FSSAI registration/license, just as an FSSAI license is not a guarantee of ISO 22000 compliance.
Do You Need ISO 22000?
- Start with FSSAI only if you are a small local food business and nobody has asked you for a certificate.
- Add ISO 22000 if you supply large retailers, hotels or institutions, or bid for tenders that ask for it.
- Consider FSSC 22000 if your customers require a GFSI-recognised scheme.
- Check the contract before you pay, because buyers sometimes name a specific scheme.
Common Mistakes To Avoid
- Treating ISO 22000 as a substitute for FSSAI registration or licence.
- Printing the ISO mark on product packaging, which suggests the product itself is certified.
- Forgetting the 14-digit FSSAI number on labels and bills.
- Assuming perpetual validity means no annual fee or returns.
- Choosing a certification body that is not accredited.
- Starting ISO 22000 before basic FSSAI hygiene requirements are in place.
Conclusion
However, FSSAI registration and ISO 22000 certification work hand in hand in terms of guaranteeing food safety and the legitimacy of the organization. While FSSAI registration or license needs to be obtained for compliance with the law in India, ISO 22000 certification plays an important role in improving the food safety management systems by analyzing and managing the possible risks related to food. Organizations should think about FSSAI registration and ISO 22000 certification as per their requirements.
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Frequently Asked Questions
1. Does an FSSAI license need to be obtained by all food business establishments in India?
Proper FSSAI registration or licensing should be obtained by all food businesses according to the relevant food safety regulations. This depends on the nature, size, and activities of the business, as well as the relevant requirements.
2. Is there a requirement for ISO 22000 certification for food business establishments?
This may not necessarily be mandatory. However, circumstances may demand that ISO 22000 certification be sought. These include customer demands, contracts, tender requirements, among others.
3. Can ISO 22000 certification substitute an FSSAI license?
No. ISO 22000 certification and FSSAI licensing have different purposes. FSSAI deals with statutory compliance on food safety in India, while ISO 22000 provides a systematic approach to food safety control and process optimization.
4. Which will suit best for the food production company?
Both have different objectives and are complementary. FSSAI requirements are essential where needed, but ISO 22000 certification helps in better hazard control, uniform processes, and assurance to customers. Choice of the right approach depends on the regulatory requirements, objectives of the firm, and the expectations of the customers.
5. Can a small food business get ISO 22000 certification?
Yes, small food businesses can get ISO 22000 certification provided they meet the criteria of the standard. Nevertheless, getting the certification involves implementation, documentation, audit, and maintenance. First, small firms need to fulfill their respective FSSAI requirements before making a decision regarding ISO 22000 certification.
6. How long is an ISO 22000 certificate valid?
Three years, with annual surveillance audits and recertification at the end of the cycle.
7. Does an FSSAI licence need renewal now?
Licences and registrations issued on or after 1 April 2026 have perpetual validity, but the annual fee and annual return, where applicable, are still due.
8. Is ISO 22000 the same as HACCP?
No. HACCP is a hazard analysis method. ISO 22000 is a complete management system standard that includes HACCP principles.
9. What is the difference between ISO 22000 and FSSC 22000?
FSSC 22000 is built on ISO 22000 with added sector programmes and requirements, and it is recognised by GFSI. Some buyers insist on it.
10. Can I use the ISO logo on my product?
No. ISO 22000 certifies your management system, not the product, so the mark should not appear on products or packaging.
11. Which comes first, FSSAI or ISO 22000?
FSSAI, because it is a legal requirement. ISO 22000 can follow once the basic hygiene and licensing are in place.
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