This regulation establishes requirements for food safety systems for human food. It details the necessary steps for conducting hazard analyses and implementing risk-based preventive controls to prevent the manufacture of adulterated food. The regulation applies to all food facilities that manufacture, process, pack, or hold food for consumption in the United States.

This regulation is a foundational document for food safety in the United States, providing a framework for manufacturers to proactively manage hazards. Its implementation is critical for ensuring the safety and integrity of the food supply. The detailed requirements aim to standardize preventive measures across the industry.