7 replies to this topic

[Simon]

I believe 21 CFR Part 110 are the food regulations applicable in the USA. Can anyone give me a bried overview of the requirements and where I can find other resources on them. Also what other regulations apply to food in the USA.

Thanks,
Simon

[Charles.C]

Dear Simon,

This is the USA version of "GMP" (or perhaps cGMP), one link -
http://www.fsis.usda...fda-gmpregs.htm

Also what other regulations apply to food in the USA.

Details depend on the food (eg processing some items is HACCP regulatory, others not). I believe one also gets involved with Federal and Local Regulations in some aspects (not an expert on USA )

My guess is that the Americans genericised the phrase "rejected for adulteration"

The US, encyclopaedic "Food Code" seems to be one of the popular general resources (maybe only RTE products .)

USA people should know more ???

Rgds / Charles.C

[BoomBoom]

Simon -
The Code of Federal Regulations (CFR) Part 21 Section 110 does cover the cGMPs for food processing in the U.S.
A more searchable link can be found here 21CFR110.
The sections 100-109 talk about labeling requirements, infant formula, dietary supplements and other areas of consumables manufacturing.

The FDA, USDA, CFSAN, FSIS, are all governmental food regulatory agencies that will point to 21CFR to back up their regulations.

Each of the states generally adopts the Federal Code, except California it seems where every law harsher and more detailed.

To Charles' comments, the food code applies to everything from "Farm to Fork" not just the RTE end product. Also, HACCP is only regulated in a small number of food sectors at the present time. Some of them being poultry, meat and seafood. This is expanding to include some agricultural products.

Hope some of this helps.

Good Luck!
Tom

[Simon]

Thanks very much Charles and Tom, I will do some reading abd revert if I have questions.

P.S. Sorry for the delay in replying I've been overseas and up to my neck in it.

[infoiqc]

This might help:

Food CGMP Modernization — A Focus on Food Safety

http://www.fda.gov/F...s/ucm207458.htm

Gail

[Simon]

Thanks Gail I will add it to my reading list.

[Cathy]

U.S. food regulations can be very interesting. 21CFR - is written for Food and Drugs - but 9CFR applies to Animal Products.

So - quite a bit of what you see in 21CFR part 110 is repeated un 9CFR part 416. Two different agencies - slightly different rules.

When looking at HACCP - there is also variation in the law when you look at meat/ poultry compared to the requirements for seafoood or juice.


As for the Food Code .....the FDA develops and recommends the Food Code but does not enforce it. It was written with retail operations in mind - not necessarily manufacturing. States enforce it - if they choose to do so. If a food is made and sold only within one State - it be made under state and not necessarily all federal laws. Each state decides what their food safety rules will be. Many - in fact most - but not all - have adopted some version of the Food Code. Check this site -

http://www.fda.gov/F...s/ucm108156.htm

[Simon]

Thanks Cathy - sorry for the late reply.