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When We Change the Manufacturer of a Plastic Container, are New End Tests Required?

March 13, 2008
Question 

Regarding extractives compliance testing (end tests), when we change the manufacturer of a multilayer plastic container using the same materials and the same specifications, are extractives (end tests) required on the finished container made at the new manufacturer?

Answer 

The Food and Drug Administration has specified in its chemistry guidance for pre-market submissions for food contact notification that "end-test" or compliance test extractions are "quality control test methods for verifying whether a particular product is equivalent to the material that served as the basis for the regulation" (click here to view a copy of the guidance). If you change suppliers, you would need to conduct the end-tests on the new plastic containers to be assured that they are equivalent. Generally speaking, the regulations require compliance with the end-tests of any article that is placed into commerce for which regulatory compliance is claimed. Therefore, it is the responsibility of the manufacturer/distributor to assure that each product meets the end-test.