Every regime ยท United States
FDA food contact substance rules
Materials that touch food must use substances that are approved, generally recognised as safe, or covered by an effective food contact notification, with documentation from the material supplier that says which.
named This regime is named, not quoted: what it covers and the documents it expects are described in our own words, and no requirement text is reproduced. On the sheet its chip is outlined; a product whose regimes are all named stands as reference.
What it expects in the file
- Declaration of conformity
The EU or UK declaration of conformity (or the food-contact declaration of compliance), signed by the manufacturer, naming the product, the legislation and the standards, and the notified or approved body where one was involved. - Test reports
Test reports from an accredited or accepted laboratory against the standards the technical file names, tied to the exact model and revision tested. - Technical file
The technical documentation: design, drawings, bill of materials, the standards applied, the conformity assessment route, and the evidence that the requirements are met. Kept for the retention period the regime sets, typically ten years from the last unit placed on the market.
Product categories that engage it
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