21 CFR Part 109 - Unavoidable Contaminants in Food for Human Consumption and Food-Packaging Material

What it says

Part 109 sets out how FDA treats poisonous or deleterious substances that are unavoidable in food, even when good manufacturing practice is followed. FDA may set tolerances by regulation or issue action levels as guidance, and food that contains an added poisonous or deleterious substance above these levels may be considered adulterated.

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

What it means in practice

• A contaminant that can be avoided by good practice is not covered by an action level.
• Action levels are not permission to knowingly contaminate food up to the stated level.
• Raw material controls are the main defense, since many contaminants are in the ingredient.

What FDA inspectors look for

• Whether products contain contaminants above tolerances or action levels.
• Whether the source of contamination is avoidable.
• Whether raw material controls are in place.

Related regulations