US Food Safety

21 CFR Part 177 - Indirect Food Additives: Polymers

Plain-language explanation, inspection context and common violation patterns.

What it says

Part 177 lists polymers and other materials that may be used as components of food contact articles, such as plastics, coatings, films and rubber, together with specifications and limitations. These indirect food additives may migrate in small amounts to food, so each listing sets conditions such as temperature, food type and extractables limits.

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

What it means in practice

Packaging suppliers should be able to state that a material complies with the listing for the intended use.
A material may be allowed for dry food at room temperature but not for hot-fill or fatty food.
Changing packaging can change compliance, so changes should be reviewed.

What FDA inspectors look for

Whether food contact materials are suitable for the intended use.
Whether suppliers provide evidence of compliance.
Whether use conditions match what the material is cleared for.

Most common violation

Packaging used at a temperature or with a food type beyond what the material's clearance permits.

Related regulations

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