Every year, unsafe food causes approximately 600 million cases of illness and 420,000 deaths worldwide, according to World Health Organization estimates. For food businesses in India, implementing a robust food safety management system is no longer optional-it is essential for protecting consumers and maintaining market competitiveness. The Bureau of Indian Standards (BIS) Food Safety Management Systems (FSMS) Certification, based on IS/ISO 22000, provides a comprehensive framework that helps organizations systematically control food safety hazards throughout the supply chain.

Table of Contents

What is BIS FSMS certification?

BIS FSMS certification is a third-party certification that demonstrates an organization’s capability to meet the requirements of the IS/ISO 22000 food safety management standard. The Bureau of Indian Standards, as India’s national standards body, offers this certification as part of its management systems certification portfolio, which also includes quality management (IS/ISO 9001), environmental management (IS/ISO 14001), and occupational health and safety (IS/ISO 45001) certifications.

According to BIS, the FSMS certification scheme is accredited by the National Accreditation Board for Certification Bodies (NABCB), ensuring that the certification process meets international accreditation standards. This accreditation provides additional credibility and recognition for certified organizations, particularly those seeking to expand into international markets.

The scope of IS/ISO 22000

ISO 22000 is an international standard that specifies requirements for food safety management systems and can be applied to any organization in the food chain, regardless of size. This includes primary producers, food manufacturers, transport and storage operators, retailers, food service providers, and organizations that supply equipment, packaging materials, or cleaning agents to the food industry. The standard combines four key elements: interactive communication, system management, prerequisite programs, and HACCP principles.

Understanding HACCP integration

Central to the BIS FSMS certification is the integration of Hazard Analysis and Critical Control Points (HACCP) principles. HACCP is a systematic preventive approach to food safety that addresses physical, chemical, and biological hazards through analysis and control rather than relying solely on end-product testing.

The HACCP system is built on seven fundamental principles that guide food businesses in identifying potential hazards and implementing control measures:

Hazard analysis: Identifying potential hazards associated with food production at all stages. Critical Control Points (CCPs): Determining the points where control is essential to prevent or eliminate hazards. Critical limits: Establishing maximum or minimum values for each CCP. Monitoring procedures: Setting up systems to track CCPs. Corrective actions: Defining steps to take when monitoring indicates deviation from critical limits. Verification procedures: Confirming that the HACCP system works effectively. Documentation: Maintaining records and procedures for all principles.

While HACCP provides the operational foundation for hazard control, ISO 22000 extends further by incorporating management system elements that ensure the entire organization is aligned toward food safety objectives.

How ISO 22000 builds on HACCP

According to the Hong Kong Centre for Food Safety, ISO 22000 encompasses HACCP principles but takes a broader view on food safety management. The standard integrates additional elements including customer focus, process approach, and continual improvement-principles that enhance an organization’s ability to consistently deliver safe products while meeting regulatory requirements.

Key differences between HACCP alone and ISO 22000 include:

System management approach: ISO 22000 requires structured processes for implementing, operating, and updating the food safety management system. Prerequisite programs (PRPs): The standard has specific requirements for basic hygiene conditions, including facility maintenance, sanitation, pest control, and employee hygiene. Interactive communication: ISO 22000 emphasizes clear information exchange across the food chain, ensuring hazards are identified and controlled at every stage. Continual improvement: Organizations must demonstrate ongoing enhancement of their food safety performance through the Plan-Do-Check-Act (PDCA) cycle.

Benefits of BIS FSMS certification

According to BIS, FSMS certification helps organizations identify and control food safety hazards, generates a food safety culture, and reduces the risk of food safety incidents. The certification is compatible with both quality management systems and HACCP requirements, making integration straightforward for organizations with existing certifications.

Regulatory compliance

In India, food businesses must comply with the Food Safety and Standards Act, 2006, which established FSSAI as the apex regulatory body for food safety. FSMS certification demonstrates adherence to both national regulations and international standards, helping organizations meet their legal obligations while reducing the risk of non-compliance penalties.

The Food Safety and Standards Authority of India is responsible for framing regulations, laying down standards, and ensuring food safety across the country. Organizations with FSMS certification often find it easier to demonstrate compliance during regulatory inspections and audits.

Market access and competitiveness

FSMS certification opens doors to both domestic and international markets. Many large retailers and international buyers require suppliers to hold food safety certifications as a prerequisite for doing business. For export-oriented food businesses, certification to IS/ISO 22000 provides internationally recognized evidence of food safety competence.

TรœV SรœD notes that food safety certification helps businesses minimize risks and hazards through validated manufacturing processes, while also enhancing brand reputation by producing high-quality, safe products that reduce the likelihood of recalls.

Consumer confidence

With increasing consumer awareness about food safety issues, certification provides tangible assurance that an organization takes food safety seriously. This trust translates into customer loyalty and can differentiate a business in competitive markets.

The certification process

Obtaining BIS FSMS certification involves a structured process designed to thoroughly assess an organization’s food safety management system. The process typically includes several stages:

Application and preliminary assessment: Organizations submit an application, and BIS evaluates the scope and readiness for certification. Document review: BIS auditors examine the organization’s food safety documentation, including the HACCP plan, prerequisite programs, and system procedures. On-site audit: A team of qualified auditors conducts an on-site assessment to verify implementation of the food safety management system. Certification decision: Based on audit findings, BIS makes a certification decision. If successful, a license is granted. Surveillance audits: Regular surveillance audits ensure continued compliance with the standard.

BIS maintains a pool of qualified and trained auditors with relevant technical expertise who conduct these assessments, ensuring thorough and credible evaluations of food safety management systems.

Implementation considerations

Successfully implementing an FSMS requires commitment from top management and involvement of personnel at all levels. Key steps include establishing a food safety team with clearly assigned responsibilities, conducting thorough hazard analysis, developing and implementing prerequisite programs, and creating documentation that supports the system.

Organizations should also consider training requirements. The National Institute of Training for Standardization (NITS) at BIS offers various training programs including lead assessor courses, awareness programs, and internal audit training for food safety management systems.

The role of FSMS in reducing foodborne illness

The World Health Organization reports that children under five years of age are at particularly high risk from foodborne diseases, with 125,000 children dying annually from such illnesses. Implementing systematic food safety controls through FSMS certification directly contributes to reducing these preventable deaths and illnesses.

Foodborne diseases can cause both short-term symptoms like nausea, vomiting, and diarrhoea, as well as long-term consequences including cancer, kidney failure, and neurological disorders. By identifying and controlling hazards at critical points throughout the food supply chain, FSMS-certified organizations play a vital role in protecting public health.

Looking ahead

As food supply chains become increasingly complex and globalized, the importance of systematic food safety management will only grow. The IS/ISO 22000 standard provides a robust framework that helps organizations navigate these challenges while meeting both regulatory requirements and consumer expectations.

For Indian food businesses, BIS FSMS certification offers a credible, internationally recognized pathway to demonstrating food safety competence. Whether the goal is regulatory compliance, market expansion, or simply protecting consumers, investing in proper food safety management systems delivers benefits across the organization.

What do you think? How might wider adoption of food safety management systems across India’s food industry affect public health outcomes? What challenges do small and medium food businesses face in implementing these systems?

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References
  1. https://www.who.int/activities/estimating-the-burden-of-foodborne-diseases
  2. https://www.iso.org/standard/65464.html
  3. https://www.bis.gov.in/system-certification-overview/system-certification-faq/?lang=od/
  4. https://pecb.com/en/article/difference-between-haccp-and-iso-22000
  5. https://www.cfs.gov.hk/english/multimedia/multimedia_pub/multimedia_pub_fsf_218_02.html
  6. https://www.bis.gov.in/system-certification-overview/certification-process/systems-under-certification/benefits-of-food-safety-management-system-as-per-is-iso-22000/
  7. https://fssai.gov.in/cms/about-fssai.php
  8. https://en.wikipedia.org/wiki/Food_Safety_and_Standards_Authority_of_India
  9. https://www.tuvsud.com/en-in/services/auditing-and-system-certification/food-safety-management
  10. https://www.bis.gov.in/training-2/training-programmes/
  11. https://www.who.int/data/gho/data/themes/who-estimates-of-the-global-burden-of-foodborne-diseases

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Food Laws and Standards

1 Prevention of Foods Adulteration Act Rules

  1. Enforcement of the Prevention of Food Adulteration (PFA) Act 1954
  2. PFA Act Definitions
  3. Functions / Responsibilities of Various Authorities
  4. Central Food Laboratories
  5. Role of Food Inspectors
  6. Penalties
  7. Powers of State Governments
  8. Discussion on Amendments to the PFA Act and Rules
  9. Shortcomings
  10. Harmonization of PFA ACT with Codex

2 Foods Safety and Quality Requirements

  1. General Hygienic and Sanitary Practices to be Followed by Food Processing Units
  2. Quality Assurance
  3. Food Quality and Safety

3 Foods Safety and Standard Act, 2006

  1. Food Safety and Standards Authority of India
  2. General Structure of the Food Safety and Standards Act
  3. Compliance and Penalties
  4. Food Safety and Standards Act Regulations

4 Essential Commodities Act, 1955

  1. The Aim of the Act
  2. Various Sections of the Essential Commodities Act
  3. Various Control Orders in the Act
  4. Fruit Products Order, 1955
  5. Meat Food Products Order, 1973
  6. Milk and Milk Products Order, 1992
  7. Edible Oils Packing (Regulation) Order, 1998
  8. Vegetable Oils Products (Regulation) Order, 1998
  9. Sugar Control Order, 1966

5 Codex Alimentarious Commission (CAC)

  1. Historical Background
  2. Objectives of the Codex Alimentarius Commission
  3. Membership of the Codex Alimentarius Commission
  4. Structure of the Codex Alimentarius Commission
  5. The Codex Alimentarius Commission at Work
  6. The Codex Alimentarius and WTO

6 WTO Implications

  1. Trade-Related Aspects of Intellectual Property Rights (TRIPS) and the Agreement on Agriculture (AoA)
  2. Implications of the SPS and TBT Agreements on Food Standards
  3. Role of Codex Standards in International Food Trade
  4. Dispute Settlement Mechanism
  5. Impact on Developing Countries

7 Other International Standards Setting Bodies

  1. The International Organization for Standardization (ISO)
  2. The International Plant Protection Convention (IPPC)
  3. The World Organization for Animal Health (OIE)
  4. The World Health Organization (WHO)
  5. The Food and Agriculture Organization (FAO)
  6. International Non-Governmental Organizations

8 FTDR Act, 1992 and Foreign Trade Policy

  1. Salient Features of Foreign Trade Development and Regulation Act 1992
  2. Foreign Trade Policy
  3. General Provisions Regarding Export/Import
  4. Pre-requisite of Import/Export
  5. Export Promotion Schemes
  6. Regulations of Exports

9 Export (Quality Control and Inspection) Act, 1963

  1. Salient Features of the Export (Quality Control and Inspection) Act, 1963
  2. Prior to Liberalization
  3. Present Scenario
  4. Systems for Export Inspection and Certification
  5. In Process Quality Control (IPQC) System
  6. Self Certification (SC) System
  7. Food Safety Management Systems based Certification (FSMSC)
  8. Procedure for Approval and Renewal
  9. Procedure for Surveillance
  10. Residue Monitoring Plans (RMP)
  11. Provisions and Requirements for Items Covered Under Mandatory Export Certification
  12. Equivalence/Recognition Agreements

10 Export Regulations and Promotion Bodies

  1. Agricultural and Processed Food Products Export Development Authority (APEDA)
  2. Marine Product Export Development Authority (MPEDA)
  3. Coffee Board
  4. Spices Board
  5. Tobacco Board
  6. Tea Board of India
  7. The Cashew Export Promotion Council of India (CEPC)

11 Plant and Animal Quarantine

  1. History of Plant Quarantine
  2. Plant Quarantine Regulations in India
  3. The Destructive Insects and Pests Act 1914 (DIP Act)
  4. Plant Quarantine (Regulation of Import into India) Order, 2003 (PQ Order)
  5. Implementation of Plant Quarantine
  6. WTO-SPS Regulations
  7. Roles and Implementation of Plant Quarantine (PQ)
  8. Animal Quarantine

12 Customs Act and Import Control Regulations

  1. Items Allowed for Import/Export
  2. Compliance with Laws
  3. Procedure for Import of Goods into India
  4. Steps for Obtaining Importer/Exporter Code (IEC No.)
  5. Requirement of Import Authorization
  6. Special Import Provisions
  7. Procedure for Import Clearance in India
  8. Levy of Customs Duty
  9. Import of Goods by Post
  10. Warehousing of Imported Goods
  11. Green Channel for Import Cargo Clearance
  12. Imports by 100% EoUs/SEZ Units
  13. Duty Free Imports
  14. Special Economic Zone Scheme (SEZ)
  15. Import of Commercial Samples
  16. Exchange Control Regulations and Imports

13 Other Laws Related to Food Products

  1. Standards of Weights & Measures Act, 1976
  2. The Insecticides Act, 1968
  3. Consumer Protection Act, 1986
  4. Customs Act, 1962
  5. The Infant Milk Substitutes, Feeding Bottles & Infant Food (Regulation of Production, Supply & Distribution) Act, 1992 & Rules, 1993
  6. Environmental (Protection) Act, 1986
  7. The Water (Prevention & Control of Pollution) Act, 1974
  8. The Air (Prevention & Control of Pollution) Act, 1981

14 Voluntary National Standards- BIS and AGMARK

  1. Bureau of Indian Standards (Bureau of Indian Standards Act, 1986)
  2. License under BIS to use ISI Certification Mark
  3. Powers and Functions of BIS
  4. Establishment, Publication and Promotion of Indian Standards
  5. Establishment, Maintenance and Recognition of Laboratories
  6. Food Safety Management Systems Certification Scheme
  7. Applicability of BIS under PFA Act
  8. AGMARK {Agricultural Produce (Grading & Marking) Act, 1937]
  9. Standardization and Grading of Agricultural Commodities
  10. Formulation of Grade Standards
  11. Grading and Certification of Agricultural Commodities
  12. Grading and Certification for Internal Trade
  13. Grading and Certification for Exports
  14. Infrastructure for the Certification Programmes
  15. Role of Central Agmark Laboratory & Regional Agmark Laboratories
  16. Applicability of Agmark Standards under PFA Act

15 National Agencies for Implementation of International Food Laws and Standards

  1. Role of Ministry of Health & Family Welfare/ Directorate General of Health Services (Codex Contact Point)
  2. Codex Alimentarius Commission [CAC]
  3. National Codex Contact Point [NCCP]
  4. National Codex Committee of India
  5. Agencies involved in implementation of provisions of Agreement on Technical Barriers to Trade.
  6. WTO TBT Enquiry Point – Role of Bureau of Indian Standards
  7. Guidance for Stakeholders for Commenting on TBT Notifications
  8. Agencies involved in implementation of provisions of Agreement on SPS Measures.
  9. Role of States/Local Bodies
  10. National Food Control Acts/Rules
  11. Implementation of Food Related Acts
  12. Agencies involved in quality control and preshipment inspection for exports.
  13. Role of Export Inspection Council
  14. Role Directorate and Marketing of Inspection
  15. Role of Agricultural and Processed Food Products Export Development Authority of India
  16. Role of Ministry of Environment and Forest
  17. Regulatory Reforms in Bio-technology
  18. Genetic Engineering Approval Committee (GEAC)
  19. Role of Department of Agriculture & Cooperation, Ministry of Agriculture in implementing Insecticides Act, 1968.
  20. Good Agricultural Practices (GAP) in use of Pesticides
  21. Codex Maximum Limits for Pesticides Residues in Food & TBT Agreement

16 Food Labelling

  1. Food Labelling: Definition, Requirements and Scope
  2. Essential Commodities Act
  3. Prevention of Food Adulteration Act
  4. Food Safety and Standards Act, 2006
  5. The Fruit Products Order, 1955
  6. The Meat Food Products Order, 1973
  7. Packaging and Labelling Requirements under FSSAI
  8. Consumer Protection Act