US FDA Regulation of Plastics used in food packaging

[Pages:42]US FDA Regulation of Plastic Used in Food Packaging

Tom Dunn

Society of Plastics Engineers Webinar

February 9, 2012

Agenda

Objective: provide participants with enough knowledge of US FDA regulations for plastic food packaging to make their own compliance determinations

I. Background II. Customary clearance determinations III. Special clearance determinations

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You also need to know

US FDA system: not Global Good Manufacturing Practice: added obligation Ultimate Enforcer: Consumer While this is a best effort to describe regulatory requirements for plastic food packaging, public concern about food safety raise expectations above minimal compliance.

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I. Background

US law controlling food packaging has a minimal statutory foundation but a comprehensive regulatory structure

Law-Federal Food Drug and Cosmetic Act (1938) as Amended (1958-2011) 21 U.S.C. ? 301 et seq.

Regulations-21 CFR 170-199

? Customary ? Special

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I. Background

US law controlling food packaging has a minimal statutory foundation but a comprehensive regulatory structure

Law-Federal Food Drug and Cosmetic Act (1938)

as Amended (1958-2011) 21 U.S.C. ? 301 et seq.

Regulations-21 CFR 170Tmh-ae1teU9rSia9rleognulylaitfetshfeoroedispaacrkeaagsionngable

? Customary

expectation that, when used as intended, a part of it would become

? Special

a component of the food [an

"additive"+ (with exceptions) .

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Compliance Fundamental

The law prohibits the introduction or delivery for introduction into interstate commerce of any food, drug, device, or cosmetic that is adulterated or misbranded

Food additives must have "premarket clearance" or food used with it is "unsafe and adulterated"

Customary premarket clearance Special premarket clearance

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Food Packaging Compliance: FFD&CA

? Can packaging component(s) enter the food?

Additive ?

? YES: Is/are component(s) cleared by US FDA?

Cleared?

? YES: Packaging material complies

Compliant !

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Food Packaging Compliance: no regs!

? Can packaging component(s) enter the food?

Additive ?

USE! ? No: No FDA clearance required!

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