ASTM International

Standard Test Method for Two-Sided Liquid Extraction of Plastic Materials Using FDA Migration Cell
 N D4754

Annotation

This test method covers the use of the FDA migration cell in the extraction of components and permits quantitation of individual migrants from plastic materials by suitable extracting liquids, including liquid foods and food-stimulating solvents.

This test method provides a two-sided, liquid extraction test for plastic materials that can be formed into film, sheet, or disks.

This test method has been applied to a variety of migrant/polymer systems in contact with numerous foods and food simulants.2 Though most of the migrants examined were radiolabeled, the use of the FDA cell has been validated for migration studies of unlabeled sytrene from polystyrene.3

This test method has been shown to yield reproducible results under the conditions for migration tests requested by the FDA. However, if the data is to be submitted to the FDA, it is suggested that their guidelines be consulted.

Because it employs two-sided extraction, this test method may not be suitable for multi-layered plastics intended for single-sided food contact use.

The size of the FDA migration cell as described may preclude its use in determining total nonvolatile extractives in some cases.

NOTE 1—For more information, see Practice D1898, the AOAC Methods of Analysis on Flexible Barrier Materials Exposed for Extraction, and the Guidance for Industry: Preparation of Premarket Submissions for Food Contact Substances: Chemistry Recommendations, December 2007.

Analytical procedures must be available to quantitate the migrant(s) generated by this test method.