ASTM_D_4754_-_18.pdf

Designation:D475418Standard Test Method forTwo-Sided Liquid Extraction of Plastic Materials Using FDAMigration Cell1This standard is issued under the fixed designation D4754;the number immediately following the designation indicates the year oforiginal adoption or,in the case of revision,the year of last revision.A number in parentheses indicates the year of last reapproval.Asuperscript epsilon()indicates an editorial change since the last revision or reapproval.1.Scope*1.1 This test method covers the use of the FDA migrationcell in the extraction of components and permits quantitation ofindividual migrants from plastic materials by suitable extract-ing liquids,including liquid foods and food-stimulating sol-vents.1.2 This test method provides a two-sided,liquid extractiontest for plastic materials that can be formed into film,sheet,ordisks.1.3 This test method has been applied to a variety ofmigrant/polymer systems in contact with numerous foods andfood simulants.2Though most of the migrants examined wereradiolabeled,the use of the FDA cell has been validated formigration studies of unlabeled sytrene from polystyrene.31.4 This test method has been shown to yield reproducibleresults under the conditions for migration tests requested by theFDA.However,if the data is to be submitted to the FDA,it issuggested that their guidelines be consulted.1.5 Because it employs two-sided extraction,this testmethod may not be suitable for multi-layered plastics intendedfor single-sided food contact use.1.6 The size of the FDA migration cell as described maypreclude its use in determining total nonvolatile extractives insome cases.NOTE1For more information,see Practice D1898,the AOACMethods of Analysis on Flexible Barrier Materials Exposed forExtraction,and the Guidance for Industry:Preparation of PremarketSubmissions for Food Contact Substances:Chemistry Recommendations,December 2007.1.7 Analytical procedures must be available to quantitatethe migrant(s)generated by this test method.1.8 The values stated in SI units are to be regarded as thestandard.1.9 This standard does not purport to address all of thesafety concerns,if any,associated with its use.It is theresponsibility of the user of this standard to establish appro-priate safety,health,and environmental practices and deter-mine the applicability of regulatory limitations prior to use.Specific hazards statements are given in Section 8.NOTE2There is no known ISO equivalent to this test method.1.10 This international standard was developed in accor-dance with internationally recognized principles on standard-ization established in the Decision on Principles for theDevelopment of International Standards,Guides and Recom-mendations issued by the World Trade Organization TechnicalBarriers to Trade(TBT)Committee.2.Referenced Documents2.1 ASTM Standards:4D883 Terminology Relating to PlasticsD1898 Practice for Sampling of Plastics(Withdrawn 1998)5E691 Practice for Conducting an Interlaboratory Study toDetermine the Precision of a Test MethodIEEE/ASTM SI 10 Standard for Use of the InternationalSystem of Units(SI):The Modernized Metric System2.2 Association of Offcial Analytical Chemists(AOAC)Methods of Analysis:Flexible Barrier Materials Exposed for Extraction61This test method is under the jurisdiction of ASTM Committee D20 on Plasticsand is the direct responsibility of Subcommittee D20.70 on Analytical Methods.Current edition approved May 1,2018.Published May 2018.Originallyapproved in 1987.Last previous edition approved in 2011 as D4754 11.DOI:10.1520/D4754-18.2“A Study of Indirect Food Additive Migration,”Arthur D.Little,Inc.,FDAContract No.223-77-2360.3Supporting data have been filed at ASTM International Headquarters and maybe obtained by requesting Research Report RR:D20-1141.4For referenced ASTM standards,visit the ASTM website,www.astm.org,orcontact ASTM Customer Service at serviceastm.org.For Annual Book of ASTMStandards volume information,refer to the standards Document Summary page onthe ASTM website.5The last approved version of this historical standard is referenced onwww.astm.org.6Available through the Association of Official Analytical Chemists,481 NorthFrederick Avenue,Suite 500,Gaithersburg,Maryland 20877-2417 USA.*A Summary of Changes section appears at the end of this standardCopyright ASTM International,100 Barr Harbor Drive,PO Box C700,West Conshohocken,PA 19428-2959.United StatesThis international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for theDevelopment of International Standards,Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade(TBT)Committee.1 2.3 Federal Document:Guidance for Industry:Preparation of Premarket Submis-sionsforFoodContactSubstances:ChemistryRecommendations,December 200773.Terminology3.1 GeneralThe units,symbols,and abbreviations used inthis test method are in accordance with Terminology D883 an