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Significance and Use
5.1 Knowledge of extractives from flexible barrier materials may serve many useful purposes. A test cell constructed as described in this practice may be used for obtaining such data. Another test cell has been found equivalent to the one described in this practice. See the appendix for the source of the alternate cell.
5.2 United States Federal Regulations 21CFR 176.170 (d)(3), 21CFR 177.1330 (e)(4), 21CFR 177.1360 (b), 21CFR 177.1670 (b), and 21CFR Appendix VI (b) cite this standard practice as the basis for determining the amount of extractables from the surface of a package or multilayer film or modified paper in contact with food. In some cases, it is the only practice defined for this purpose. No alternative detail is given in the regulations for conducting extractions.
5.3 Test Method is not an equivalent to this test method. It is for two-sided extraction of films having the same material on both of the exposed surfaces of the film.
1.1 This practice covers the construction of test cells which may be used for the extraction of components from flexible barrier materials by suitable extracting liquids, including foods and food simulating solvents.
1.2 The values stated in inch-pound units are to be regarded as standard. The values given in parentheses are mathematical conversions to SI units that are provided for information only and are not considered standard.
1.3 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.
1.4 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 (purchase separately) The documents listed below are referenced within the subject standard but are not provided as part of the standard.
D1193 Specification for Reagent Water
D4754 Test Method for Two-Sided Liquid Extraction of Plastic Materials Using FDA Migration Cell
AOAC International Methods of AnalysisOfficial Method 964.15 Extraction from Flexible Barrier Materials This method is available through the Association of Official Analytical Chemists, International, 481 North Frederick Ave., Suite 500, Gaithersburg, MD 20877 or from the AOAC website at www.aoac.org.
Code of Federal Regulations, Title 2121CFR 177.1330 (e)(4) 21CFR 177.1360 (b) Appendix VI (b) Cells for Migration Testing, Guidance for Industry: Preparation of Premarket Submissions for Food Contact Substances: Chemistry Recommendations (2007)
ICS Number Code 55.040 (Packaging materials and accessories)
|Link to Active (This link will always route to the current Active version of the standard.)|
ASTM F34-13(2018), Standard Practice for Construction of Test Cell for Liquid Extraction of Flexible Barrier Materials, ASTM International, West Conshohocken, PA, 2018, www.astm.orgBack to Top