Are food packaging manufacturers required to register with the FDA and comply with the preventive control requirements for Human Food?

In general, subparts C (Requirements for Hazard Analysis and Risk-Based Preventive Controls) and G (Requirements for a Supply-Chain Program) of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food rule (21 CFR part 117; 80 FR 55908)(CGMP & PC rule) apply to an establishment that is required to register with FDA as a food facility. For purposes of registration, food-contact substances are not considered “food,” and therefore do not trigger the requirement to register (see 21 CFR § 1.227).