ASTM D4754-18
(Test Method)Standard Test Method for Two-Sided Liquid Extraction of Plastic Materials Using FDA Migration Cell
Standard Test Method for Two-Sided Liquid Extraction of Plastic Materials Using FDA Migration Cell
SIGNIFICANCE AND USE
5.1 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.
SCOPE
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.
General Information
Relations
Buy Standard
Standards Content (Sample)
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.
Designation: D4754 − 18
Standard Test Method for
Two-Sided Liquid Extraction of Plastic Materials Using FDA
1
Migration Cell
This standard is issued under the fixed designation D4754; the number immediately following the designation indicates the year of
original adoption or, in the case of revision, the year of last revision. A number in parentheses indicates the year of last reapproval. A
superscript epsilon (´) indicates an editorial change since the last revision or reapproval.
1. Scope* 1.7 Analytical procedures must be available to quantitate
the migrant(s) generated by this test method.
1.1 This test method covers the use of the FDA migration
cellintheextractionofcomponentsandpermitsquantitationof 1.8 The values stated in SI units are to be regarded as the
individual migrants from plastic materials by suitable extract- standard.
ing liquids, including liquid foods and food-stimulating sol-
1.9 This standard does not purport to address all of the
vents.
safety concerns, if any, associated with its use. It is the
responsibility of the user of this standard to establish appro-
1.2 This test method provides a two-sided, liquid extraction
priate safety, health, and environmental practices and deter-
test for plastic materials that can be formed into film, sheet, or
mine the applicability of regulatory limitations prior to use.
disks.
Specific hazards statements are given in Section 8.
1.3 This test method has been applied to a variety of
migrant/polymer systems in contact with numerous foods and NOTE 2—There is no known ISO equivalent to this test method.
2
food simulants. Though most of the migrants examined were
1.10 This international standard was developed in accor-
radiolabeled, the use of the FDA cell has been validated for
dance with internationally recognized principles on standard-
3
migration studies of unlabeled sytrene from polystyrene.
ization established in the Decision on Principles for the
Development of International Standards, Guides and Recom-
1.4 This test method has been shown to yield reproducible
mendations issued by the World Trade Organization Technical
resultsundertheconditionsformigrationtestsrequestedbythe
Barriers to Trade (TBT) Committee.
FDA. However, if the data is to be submitted to the FDA, it is
suggested that their guidelines be consulted.
2. Referenced Documents
1.5 Because it employs two-sided extraction, this test
4
2.1 ASTM Standards:
method may not be suitable for multi-layered plastics intended
D883 Terminology Relating to Plastics
for single-sided food contact use.
5
D1898 Practice for Sampling of Plastics (Withdrawn 1998)
1.6 The size of the FDA migration cell as described may
E691 Practice for Conducting an Interlaboratory Study to
preclude its use in determining total nonvolatile extractives in
Determine the Precision of a Test Method
some cases.
IEEE/ASTM SI 10 Standard for Use of the International
NOTE 1—For more information, see Practice D1898, the AOAC System of Units (SI): The Modernized Metric System
Methods of Analysis on Flexible Barrier Materials Exposed for
2.2 Association of Offıcial Analytical Chemists (AOAC)
Extraction, and the Guidance for Industry: Preparation of Premarket
Methods of Analysis:
Submissions for Food Contact Substances: Chemistry Recommendations,
6
December 2007. Flexible Barrier Materials Exposed for Extraction
1
This test method is under the jurisdiction ofASTM Committee D20 on Plastics
4
and is the direct responsibility of Subcommittee D20.70 on Analytical Methods. For referenced ASTM standards, visit the ASTM website, www.astm.org, or
Current edition approved May 1, 2018. Published May 2018. Originally contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM
approved in 1987. Last previous edition approved in 2011 as D4754 – 11. DOI: Standards volume information, refer to the standard’s Document Summary page on
10.1520/D4754-18. the ASTM website.
2 5
“A Study of Indirect Food Additive Migration,” Arthur D. Little, Inc., FDA The last approved version of this historical standard is referenced on
Contract No. 223-77-2360. www.astm.org.
3 6
Supporting data have been filed at ASTM International Headquarters and may Available through the Association of Official Analytical Chemists, 481 North
be obtained by requesting Research Report RR:D20-1141. Frederick Avenue, Suite 500, Gaithersburg, Maryland 20877-2417 USA.
*A Summary of Changes section appears at the end of this standard
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1
---------------------- Page: 1 ----------------------
D4754 − 18
6.1.1 Glass Vials, 23-mL,
6.1.2 Mininert® Slid
...
This document is not an ASTM standard and is intended only to provide the user of an ASTM standard an indication of what changes have been made to the previous version. Because
it may not be technically possible to adequately depict all changes accurately, ASTM recommends that users consult prior editions as appropriate. In all cases only the current version
of the standard as published by ASTM is to be considered the official document.
Designation: D4754 − 11 D4754 − 18
Standard Test Method for
Two-Sided Liquid Extraction of Plastic Materials Using FDA
1
Migration Cell
This standard is issued under the fixed designation D4754; the number immediately following the designation indicates the year of
original adoption or, in the case of revision, the year of last revision. A number in parentheses indicates the year of last reapproval. A
superscript epsilon (´) indicates an editorial change since the last revision or reapproval.
1. Scope*
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
2
simulants. Though most of the migrants examined were radiolabeled, the use of the FDA cell has been validated for migration
3
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 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 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 known ISO equivalent to this test method.
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.
2. Referenced Documents
4
2.1 ASTM Standards:
D883 Terminology Relating to Plastics
1
This test method is under the jurisdiction of ASTM Committee D20 on Plastics and is the direct responsibility of Subcommittee D20.70 on Analytical Methods.
Current edition approved Dec. 1, 2011May 1, 2018. Published December 2011May 2018. Originally approved in 1987. Last previous edition approved in 20032011 as
D4754 – 98D4754 – 11.(2003). DOI: 10.1520/D4754-11.10.1520/D4754-18.
2
“A Study of Indirect Food Additive Migration,” Arthur D. Little, Inc., FDA Contract No. 223-77-2360.
3
Supporting data have been filed at ASTM International Headquarters and may be obtained by requesting Research Report RR:D20-1141.
4
For referenced ASTM standards, visit the ASTM website, www.astm.org, or contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM Standards
volume information, refer to the standard’s Document Summary page on the ASTM website.
*A Summary of Changes section appears at the end of this standard
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1
---------------------- Page: 1 ----------------------
D4754 − 18
FIG. 1 FDA Migration Cell
5
D1898 Practice for Sampling of Plastics (Wi
...
Questions, Comments and Discussion
Ask us and Technical Secretary will try to provide an answer. You can facilitate discussion about the standard in here.