How Are Compliance End Tests and Conditions of Use Related?
What are the requirements concerning conditions of use for substances listed in Title 21 Code of Federal Regulations (C.F.R.) Part 177.1520? More specifically, if polyethylene resin complies with specification of (C) (2.1) or (2.2), what is the suitable FDA condition of use for plastic packaging by using this resin? Is it related to 21 CFR part 176.170, condition A-J or not?
The specifications in 21 C.F.R. Part 177.1520 are compliance end tests that set out the specifications which must be met for each resin type in order for it to be used for the specified conditions. Thus, a resin meeting the (C) (2.1) specifications may be used in articles in contact with food except for packing or holding food for cooking, whereas meeting the (2.2) specification permits the polyethylene to also be used in cooking applications. The conditions of use listed in 21 C.F.R. Part 176.170 are not applied to the resins cleared under this regulation. (For more information on compliance testing, see the packaginglaw.com article, Compliance Testing vs. Migration Testing: A Primer.)