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. ¡ì 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. ¡ì 301 et seq.

The US regulates food packaging

?Regulations-21 CFR 170-199

material only if there is a reasonable

? Customary

? Special

2/8/2012

expectation that, when used as

intended, a part of it would become

a component of the food [an

¡°additive¡±+ (with exceptions) .

? Flexpacknology llc 2012

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