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Description of ASTM-D4754 2018ASTM D4754-18Active Standard: Standard Test Method for Two-Sided Liquid Extraction of Plastic Materials Using FDA Migration CellASTM D4754Scope 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.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 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 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. 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, health, and environmental practices and determine the applicability of regulatory limitations prior to use. Specific hazards statements are given in Section 8. Note 2: There is no known ISO equivalent to this test method. 1.10 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee. Keywords diffusion; food packaging; indirect additives; migration cell; migration testing; polymer extraction; ICS Code ICS Number Code 83.080.01 (Plastics in general) DOI: 10.1520/D4754-18 The following editions for this book are also available...This book also exists in the following packages...Subscription InformationMADCAD.com ASTM Standards subscriptions are annual and access is unlimited concurrency based (number of people that can access the subscription at any given time) from single office location. For pricing on multiple office location ASTM Standards Subscriptions, please contact us at info@madcad.com or +1 800.798.9296.
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About ASTMASTM International, formerly known as the American Society for Testing and Materials (ASTM), is a globally recognized leader in the development and delivery of international voluntary consensus standards. Today, some 12,000 ASTM standards are used around the world to improve product quality, enhance safety, facilitate market access and trade, and build consumer confidence. ASTM’s leadership in international standards development is driven by the contributions of its members: more than 30,000 of the world’s top technical experts and business professionals representing 150 countries. Working in an open and transparent process and using ASTM’s advanced electronic infrastructure, ASTM members deliver the test methods, specifications, guides, and practices that support industries and governments worldwide. |
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