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美国FDA拟制定一种新的方法测定食品中亚硫酸盐

2019.9.19

  据美国联邦公报消息,2019年9月17日,美国食品药品监督管理局(FDA)发布2019-19862号文件,拟制定一种新的方法测定食品中亚硫酸盐。

  据了解,相关意见需在2019年10月17日之前提交。

  部分原文报道如下:

  Our regulations at §§101.100(a)(4) and 130.9(a) specify the analytical method that FDA uses for determining sulfite concentrations in food. Both of these regulations establish the method of analysis in two steps. The first step incorporates by reference §§20.123-20.125, “Total Sulfurous Acid,” in “Official Methods of Analysis of the Association of Official Analytical Chemists,” 14th Ed. (1984); this method is known as the Monier-Williams method. The second step refines the Start Printed Page 48812Monier-Williams method to improve accuracy and reproducibility and make the method suitable for detecting sulfite concentrations as low as 10 ppm; the modifications are included in Appendix A to Part 101. Collectively, the Monier-Williams method with the Appendix A to Part 101 modifications is referred to as the “optimized Monier-Williams method.” After we incorporated by reference the Monier-Williams method and implemented the modifications to that method in Appendix A to Part 101, the AOAC amended the Official Methods of Analysis to include “Official Method 990.28, Optimized Monier-Williams Method,” which is the same as the two-step process in FDA's regulations; i.e, the Monier-Williams method and the refinements to the Monier-Williams method in Appendix A to Part 101. As such, this portion of the proposed rule would modernize our regulations to reflect the citation to the current AOAC method for determining sulfite concentrations in food, but would not result in a change in FDA methodology. We are, therefore, proposing to amend §§101.100(a)(4) and 130.9(a) to replac the existing incorporation by reference with “AOAC Official Method 990.28, Sulfites in Foods, Optimized Monier-Williams Method,” (Final Action 1994), Section 47.3.43, Official Methods of Analysis of AOAC INTERNATIONAL, 21st Edition (2019), and to remove Appendix A to Part 101.

译文如下:

  我们在§101.100(a)(4)和130.9(a)中的法规规定了FDA用于测定食品中亚硫酸盐浓度的分析方法。这两个规则都分两步建立了分析方法。第一步通过引用将§20.123-20.125“总亚硫酸”纳入“官方分析化学家协会官方分析方法”,第14版(1984年);该方法被称为Monier-Williams方法。第二步改进了起始印刷页48812Monier-Williams方法,以提高准确性和再现性,并使该方法适用于检测低至10ppm的亚硫酸盐浓度;修改内容见第101部分附录A。总的来说,Monier Williams方法以及第101部分附录A的修改被称为“优化Monier Williams方法”。在我们通过引用将Monier Williams方法合并并在第101部分附录A中实现对该方法的修改之后,AOAC修改了官方分析方法,包括“官方方法990.28,优化的Monier-Williams方法”,这与FDA法规中的两步过程相同;即Monier Williams方法和第101部分附录A中Monier-Williams方法的改进。因此,拟议规则的这一部分将使我们的规章制度现代化,以反映对目前测定食品中亚硫酸盐浓度的AOAC方法的引用,但不会导致FDA方法的改变。因此,我们建议修改§101.100(a)(4)和130.9(a),以参考“AOAC官方方法990.28,食品中的亚硫酸盐,优化Monier-Williams方法”(1994年最终行动),第47.3.43节,官方分析方法”,重新修订现有的合并。并删除第101部分附录A。

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