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Significance and Use
Knowledge of migrants from plastic materials may serve many useful purposes, such as testing for compliance with food additive regulations. The procedure described in this test method is recommended as suitable for obtaining such data on many migrant(s)/plastic(s) combinations.
1.1 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.
1.2 This test method provides a two-sided, liquid extraction test for plastic materials that can be formed into film, sheet, or disks.
1.3 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.
1.4 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.
1.5 Because it employs two-sided extraction, this test method may not be suitable for multi-layered plastics intended for single-sided food contact use.
1.6 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.
1.7 Analytical procedures must be available to quantitate the migrant(s) generated by this test method.
1.8 The values stated in SI units are to be regarded as the standard.
1.9 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.
2. Referenced Documents (purchase separately) The documents listed below are referenced within the subject standard but are not provided as part of the standard.
D883 Terminology Relating to Plastics
D1898 Practice for Sampling of Plastics
E691 Practice for Conducting an Interlaboratory Study to Determine the Precision of a Test Method
Association of Official Analytical Chemists (AOAC) Methods of AnalysisFlexible Barrier Materials Exposed for Extraction Available through the Association of Official Analytical Chemists, 481 North Frederick Avenue, Suite 500, Gaithersburg, Maryland 20877-2417 USA.
Federal DocumentGuidance for Industry: Preparation of Premarket Submissions for Food Contact Substances: Chemistry Recommendations, December 2007 Available from Division of Food Contact Notifications, Office of Food Additive Safety, Center for Food Safety and Applied Nutrition, Food and Drug Administration, College Park, MD 20740, USA.
ICS Number Code 83.080.01 (Plastics in general)
UNSPSC Code 13100000(Rubber and elastomers)
ASTM D4754-11, Standard Test Method for Two-Sided Liquid Extraction of Plastic Materials Using FDA Migration Cell, ASTM International, West Conshohocken, PA, 2011, www.astm.orgBack to Top