Food contact materials · United States

FDA 21 CFR Part 177 — Indirect Food Additives: Polymers Compliance

FDA 21 CFR Part 177 — Indirect Food Additives: Polymers is issued by US Food & Drug Administration and has applied since 1977-04-01. It applies to products sold in US. Below: what it covers, which products trigger it, the documents a supplier must provide, and how Complyra checks a product against it.

Authority: US Food & Drug Administration
Jurisdiction: United States
Regions: US
Effective: 1977-04-01
Evidence renewal: every 1825 days
Official source: https://www.ecfr.gov/current/title-21/chapter-I/subchapter-B/part-177

What FDA 21 CFR Part 177 — Indirect Food Additives: Polymers covers

FDA 21 CFR Part 177 — Indirect Food Additives: Polymers is a food contact materials requirement in United States. In Complyra's dataset it is triggered by products in the following categories and by product descriptions that mention the keywords listed below.

Product categories affected

food packaging
food ingredients

Keywords that trigger a check

food
beverage
packaging
container
bottle
food grade
food safe
food contact

Who it applies to

Buyers importing or placing the affected products on the market in US, and the suppliers who manufacture or distribute them. In a procurement workflow the buyer is responsible for obtaining the evidence listed below from the supplier before the order is placed.

Consequences of non-compliance recorded in the dataset: FDA Warning Letter, Import Alert, product seizure

Restricted substances and materials

Substance	Limit	Unit
Total extractables	—	per specific polymer limits
Colorants	—	must be on 21 CFR 178.3297

Materials and conditions that fail the check

non-FDA-approved polymers
unapproved additives

Supplier requirements and compliance evidence

Documents a supplier should be able to provide for products in scope. Ask for these in the RFQ rather than after the goods ship.

Document
FDA 21 CFR Part 177 Compliance Statement
Extractables and Leachables (E&L) Study
Composition Statement listing all additives
FDA FCN (Food Contact Notification) if applicable
GMP compliance documentation

Certification types recorded for this regulation

FDA food contact compliance

How Complyra checks FDA 21 CFR Part 177 — Indirect Food Additives: Polymers

When a product is searched or sourced in Complyra, its category and description are matched against the trigger categories and keywords above. If FDA 21 CFR Part 177 — Indirect Food Additives: Polymers applies, the product and its supplier are checked against the materials, substance limits and required documents recorded for the regulation, and the result is shown alongside the supplier match, before an RFQ is generated.

Suppliers on Complyra register and upload certifications that are reviewed by an administrator; see supplier compliance for how that review works and supplier sourcing for how compliant suppliers are found and matched.

Complyra checks product and supplier information against regulatory requirements to support procurement decisions. It does not issue certifications or guarantee legal compliance; final responsibility for compliance remains with the buyer and supplier.