Hazard analysis and critical control points, or HACCP is a systematic preventive approach to food safety and pharmaceutical safety that identifies physical, allergenic, chemical, and biological hazards in production processes that can cause the finished product to be unsafe, and designs measurements to reduce these risks to a safe level. In this manner, HACCP is referred as the prevention of hazards rather than finished product inspection. The HACCP system can be used at all stages of a food chain, from food production and preparation processes including packaging, distribution, etc. The Food and Drug Administration (FDA) and the United States Department of Agriculture (USDA) say that their mandatory HACCP programs for juice and meat are an effective approach to food safety and protecting public health. Meat HACCP systems are regulated by the USDA, while seafood and juice are regulated by the FDA. The use of HACCP is currently voluntary in other food industries.

HACCP is believed to stem from of a production process monitoring used during World War II because traditional "end of the pipe" testing on artillery shell's firing mechanisms could not be performed, and a large percent of the artillery shells made at the time were either duds or misfiring. HACCP itself was conceived in the 1960s when the US National Aeronautics and Space Administration (NASA) asked Pillsbury to design and manufacture the first foods for space flights. Since then, HACCP has been recognized internationally as a logical tool for adapting traditional inspection methods to a modern, science-based, food safety system. Based on risk-assessment, HACCP plans allow both industry and government to allocate their resources efficiently in establishing and auditing safe food production practices. In 1994, the organization of International HACCP Alliance was established initially for the US meat and poultry industries to assist them with implementing HACCP and now its membership has been spread over other professional/industrial areas.

Hence, HACCP has been increasingly applied to industries other than food, such as cosmetics and pharmaceuticals. This method, which in effect seeks to plan out unsafe practices based on science, differs from traditional "produce and sort" quality control methods that do nothing to prevent hazards from occurring and must identify them at the end of the process. HACCP is focused only on the health safety issues of a product and not the quality of the product, yet HACCP principles are the basis of most food quality and safety assurance systems,and the United States, HACCP compliance is regulated by 21 CFR part 120 and 123. Similarly, FAO/WHO published a guideline for all governments to handle the issue in small and less developed food businesses.




The ISO 22000 international standard specifies the requirements for a food safety management system that involves the following elements:

interactive communication
system management
prerequisite programs
HACCP principles
Critical reviews of the above elements have been conducted by many scientists Communication along the food chain is essential to ensure that all relevant food safety hazards are identified and adequately controlled at each step within the food chain. This implies communication between organizations both upstream and downstream in the food chain. Communication with customers and supplies about identified hazards and control measures will assist in clarifying customer and supplier requirements.

Recognition of the organization's role and position within the food chain is essential to ensure effective interactive communication throughout the chain in order to deliver safe food products to the final consumer.

The most effective food safety systems are established, operated and updated within the framework of a structured management system and incorporated into the overall management activities of the organization. This provides maximum benefit for the organization and interested parties. ISO 22000 has been aligned with ISO 9001 in order to enhance the compatibility of the two standards.

ISO 22000 can be applied independently of other management system standards or integrated with existing management system requirements.

ISO 22000 integrates the principles of the Hazard Analysis and Critical Control Point (HACCP) system and application steps developed by the Codex Alimentarius Commission. By means of auditable requirements, it combines the HACCP plan with prerequisite programmes. Hazard analysis is the key to an effective food safety management system, since conducting a hazard analysis assists in organizing the knowledge required to establish an effective combination of control measures. ISO 22000 requires that all hazards that may be reasonably expected to occur in the food chain, including hazards that may be associated with the type of process and facilities used, are identified and assessed. Thus it provides the means to determine and document why certain identified hazards need to be controlled by a particular organization and why others need not.




Certificate of Free Sale are certificates (not pertaining to a particular production lot or export consignment) that indicate that the particular product(s) is marketed in the United States or eligible for export, and that the particular manufacturer has no unresolved enforcement actions pending before or taken by FDA. These certificates may be issued by FDA-CFSAN or by a State governmental authority.