Plain-language explanation, inspection context and common violation patterns.
This Regulation sets specific rules for plastic materials and articles intended to come into contact with food. It contains the Union list of authorized substances, specific migration limits, an overall migration limit, and requirements for declarations of compliance and supporting documents throughout the supply chain.
Paraphrased for plain-language clarity. Always verify against the current published regulation text.
Plastic packaging used under conditions, such as high temperature, beyond those covered by the declaration of compliance.
GMPify's Regulation Explainer tool gives subscribers an AI-powered analysis of any 21 CFR, EU GMP, USP or ICH reference, with live inspection context.
Try the Regulation Explainer →