US FDA Regulation of Plastics used in food packaging
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
2/8/2012
? Flexpacknology llc 2012
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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.
2/8/2012
? Flexpacknology llc 2012
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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
2/8/2012
? Flexpacknology llc 2012
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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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? Flexpacknology llc 2012
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