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ASTM D 4754 Document Information:
Title
Standard Test Method for Two-Sided Liquid Extraction of Plastic Materials Using FDA Migration Cell
ASTM International
Publication Date:
Jul 10, 1998
Scope:
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. 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.
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 D 1898, the AOAC Methods
of Analysis on Flexible
Barrier Materials Exposed for Extraction, and the 1995 Recommendations
for Chemistry Data for
Indirect Food Additive Petitions.
Analytical procedures must be available to quantitate the migrant(s)
generated by this test method.
The values stated in SI units are to be regarded as the standard.
This standard does not purport to address all of the safety concerns,
if any, associated with its
use. It is the responsibility of the user of this standard to
establish appropriate safety and
health practices and determine the applicability of regulatory
limitations prior to use. Specific
hazards statements are given in Section 8.
NOTE 2 - There is no similar or equivalent ISO standard.
Keywords:
- diffusion
- food packaging
- indirect additives
- migration cell
- migration testing
- polymer extraction
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