ASTM D4754-11
(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
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. 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.
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Designation: D4754 − 11
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* 1.8 The values stated in SI units are to be regarded as the
standard.
1.1 This test method covers the use of the FDA migration
cellintheextractionofcomponentsandpermitsquantitationof 1.9 This standard does not purport to address all of the
safety concerns, if any, associated with its use. It is the
individual migrants from plastic materials by suitable extract-
ing liquids, including liquid foods and food-stimulating sol- responsibility of the user of this standard to establish appro-
priate safety and health practices and determine the applica-
vents.
bility of regulatory limitations prior to use. Specific hazards
1.2 This test method provides a two-sided, liquid extraction
statements are given in Section 8.
test for plastic materials that can be formed into film, sheet, or
disks.
NOTE 2—There is no known ISO equivalent to this test method.
1.3 This test method has been applied to a variety of
2. Referenced Documents
migrant/polymer systems in contact with numerous foods and
4
2
2.1 ASTM Standards:
food simulants. Though most of the migrants examined were
D883 Terminology Relating to Plastics
radiolabeled, the use of the FDA cell has been validated for
5
3
D1898 Practice for Sampling of Plastics (Withdrawn 1998)
migration studies of unlabeled sytrene from polystyrene.
E691 Practice for Conducting an Interlaboratory Study to
1.4 This test method has been shown to yield reproducible
Determine the Precision of a Test Method
resultsundertheconditionsformigrationtestsrequestedbythe
IEEE/ASTM SI 10 Standard for Use of the International
FDA. However, if the data is to be submitted to the FDA, it is
System of Units (SI): The Modernized Metric System
suggested that their guidelines be consulted.
2.2 Association of Offıcial Analytical Chemists (AOAC)
1.5 Because it employs two-sided extraction, this test
Methods of Analysis:
method may not be suitable for multi-layered plastics intended
6
Flexible Barrier Materials Exposed for Extraction
for single-sided food contact use.
2.3 Federal Document:
1.6 The size of the FDA migration cell as described may
Guidance for Industry: Preparation of Premarket Submis-
preclude its use in determining total nonvolatile extractives in
sions for Food Contact Substances: Chemistry
7
some cases.
Recommendations, December 2007
NOTE 1—For more information, see Practice D1898, the AOAC
Methods of Analysis on Flexible Barrier Materials Exposed for 3. Terminology
Extraction, and the Guidance for Industry: Preparation of Premarket
3.1 General—The units, symbols, and abbreviations used in
Submissions for Food Contact Substances: Chemistry Recommendations,
this test method are in accordance withTerminology D883 and
December 2007.
Practice IEEE/ASTM SI 10.
1.7 Analytical procedures must be available to quantitate
the migrant(s) generated by this test method.
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
1
This test method is under the jurisdiction ofASTM Committee D20 on Plastics Standards volume information, refer to the standard’s Document Summary page on
and is the direct responsibility of Subcommittee D20.70 on Analytical Methods. the ASTM website.
5
Current edition approved Dec. 1, 2011. Published December 2011. Originally The last approved version of this historical standard is referenced on
approved in 1987. Last previous edition approved in 2003 as D4754 – 98(2003). www.astm.org.
6
DOI: 10.1520/D4754-11. Available through the Association of Official Analytical Chemists, 481 North
2
“A Study of Indirect Food Additive Migration,” Arthur D. Little, Inc., FDA Frederick Avenue, Suite 500, Gaithersburg, Maryland 20877-2417 USA.
7
Contract No. 223-77-2360. AvailablefromDivisionofFoodContactNotifications,OfficeofFoodAdditive
3
Supporting data have been filed at ASTM International Headquarters and may Safety, Center for Food Safety and Applied Nutrition, Food and Drug
be obtained by requesting Research Report RR:D20-1141. Administration, College Park, MD 20740, 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
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D4754 − 11
conducted using the 23-mL vials.
NOTE 5
...
This document is not anASTM standard and is intended only to provide the user of anASTM 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:D4754–98 (Reapproved 2003) Designation:D4754–11
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 Thistestmethodprovidesatwo-sided,liquidextractiontestforplasticmaterialsthatcanbeformedintofilm,sheet,ordisks.
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 ThistestmethodhasbeenshowntoyieldreproducibleresultsundertheconditionsformigrationtestsrequestedbytheFDA.
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
1995 Recommendations for Chemistry Data for Indirect FoodAdditive Petitions. , theAOAC Methods ofAnalysis 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.
NOTE2—There is no similar or equivalent ISO standard. 2—There is no known ISO equivalent to this test method.
2. Referenced Documents
4
2.1 ASTM Standards:
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
IEEE/ASTM SI 10 Standard for Use of the International System of Units (SI): The Modernized Metric System
2.2 Association of Offıcial Analytical Chemists (AOAC) Methods of Analysis:
5
Flexible Barrier Materials Exposed for Extraction
2.3 Federal Document:
1995Recommendations for Chemistry Data for Indirect Food Additive Petitions
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 March 10, 2003. Published May 2003. Originally approved in 1987. Last previous edition approved in 1998 as D4754–98. DOI:
10.1520/D4754-98R03.
Current edition approved Dec. 1, 2011. Published December 2011. Originally approved in 1987. Last previous edition approved in 2003 as D4754 – 98(2003). DOI:
10.1520/D4754-11.
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 referencedASTM standards, visit theASTM website, www.astm.org, or contactASTM 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.
5
Withdrawn.
5
Available through the Association of Official Analytical Chemists, 481 North 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 Dri
...
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