FDA released two new chapters to its draft guidance, Hazard Analysis and Risk-Based Preventive Controls for Human Food. The draft guidance is intended to help industry comply with certain requirements of the agency’s final rule for preventive controls for human food (PC Rule) under the Food Safety Modernization Act (FSMA).
The FDA had initially issued the first chapters in 2016 and has been adding more over time. The newly released chapters specifically focus on preventive controls for food allergens and acidified foods. This guidance is crucial for our work as it provides essential information for ensuring food safety and compliance with FSMA regulations.
Key Highlights –
- Chapter 11 focuses on Food Allergen Program, covering allergen advisory statements, supplier approval, allergen thresholds, and CGMP requirements.
- Chapter 16 provides guidance on how manufacturers can use policies, procedures, and records to comply with both the PC Rule and FDA’s acidified food regulations.
- Manufacturers should identify and comply with all applicable requirements under both frameworks.
- FDA is open to comments on the draft guidance chapters until March 25, 2024
To gain a deeper understanding of these crucial FDA guidance updates, connect with our in silico experts at InSilicoMinds today!
