21 CFR Part 108 - Emergency Permit Control

What it says

Part 108 provides authority for FDA to require emergency permits for classes of food where contamination with microorganisms during manufacture is reasonably likely to cause serious illness, and sets requirements for registration of food processing establishments and submission of process information for acidified and low-acid canned foods. Processors must file scheduled process information with FDA for each product and container size.

Paraphrased for plain-language clarity. Always verify against the current published regulation text.

What it means in practice

• It works alongside Parts 113 and 114, which set the process requirements for canned foods.
• A process filed with FDA must be the one actually used on the line.
• Changes to the product, container or process may require a new filing.

What FDA inspectors look for

• Whether the establishment is registered and processes are filed.
• Whether the process used matches the filed process.
• Whether changes were reviewed for filing.

Related regulations