I need to know how 21 CFR 100, the Federal Regulations involving Food
regulations in particular those regulations regarding "good
manufacturing
practice" or GMP effect my plant that sells inert additives to the food
industry.   These are not biodegradeable or can support growth of
organisms so disinfection and pest control should not be as much an
issue.  I'm hoping for special regulations that cover these kind of
products that are a bit outside of the usual food regulations.

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Request for Question Clarification by pafalafa-ga on 07 May 2004 20:25 PDT

Hello Chris,

FDA regs are a complicated affair, and I'm not sure there is a simple,
straightforward answer to your question.  However, I can tell you that
the requirements for your operations are probably very much affected
by the answers to the following two questions:

1.  Does the additive in question belong to any special categories
recognized in federal food safety law:  "color additives", a drug or
pesticide, a nutrient, a dietary supplement, or a variety of other
special categories?

2.  Is the additve a GRAS (generally recognized as safe) substance?

In general, my understanding of federal food safety law is that food
additives are not treated any differently than foods themselves, and
would be subject to the same sort of GMP guidelines.  But as I said
above, there are somewhat different rules for different categories of
items.

Let me know as much as you can about your particular additive, and
I'll see if I can provide a formal answer to your question.

Thanks.

pafalafa-ga

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Clarification of Question by chris1742-ga on 10 May 2004 09:40 PDT

Hello pafalafa-ga,
Yes the material is GRAS.
Yes it is classified as a direct contact food additive under 21CFR 172.480.

Thanks for the help

We may have a solution relating directly to the management of the
21CFR regulations in document control.
http://www.proquis.com/information/document_control/