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Comments on China's Draft Amendment to GB 9685 Due by March 15

March 10, 2015

Comments of China's draft amendment to the Hygienic Standards for Uses of Additives in Food Containers and Packaging Materials (GB 9685-2008) are due by March 15, 2015. The draft amendment, published by the National Health and Family Planning Commission (NHFPC) on January 20, 2015, incorporates key revisions to the Standard, such as removing the following use scopes for listed additives: glass, metal, ceramics, and enamel. Published along with the amended Standard was a Drafting Explanation, which provides background details on the development of the Standard and other considerations relevant to the revision process.

The draft GB 9685 Standard defines "food contact materials and articles" to include various materials and articles, including food packaging materials, containers, utensils, coatings that may directly or indirectly come in contact with food, and coating layers, ink, adhesives, but does not include detergents, disinfectants, or public water facilities. Meanwhile, additives are defined to include substances added during the manufacturing process of food contact materials and articles that assist in improving the quality and properties, or aid to improve the quality and properties to achieve the desired effect. Notably, the term "additive" in this Standard includes monomers or other starting materials of polymerization for certain base polymers used during the manufacture of food contact materials and articles.

Those additives cleared under the "clean-up" procedures, or officially approved under the Management Rules for the Administrative Approval of New Varieties of Food Related Products (Management Rules) as of August 2014, have been added to the most recent draft GB 9685. This increases the total number of additives contained in Appendix A from 959 substances to 1316 substances. Additionally, the draft Standard sets forth the principles applicable to the use of additives in food contact materials, the types of permitted additives, scope of use, maximum use level, specific migration limit (SML) or maximum residual level (QM), total specific migration limit (SML(T)), as well as other restrictive requirements.

The draft amendment to GB 9685 also would permit the use of direct food additives listed in China's General Standard for Use of Food Additives (GB 2760) in food packaging, provided that the substance exhibits no technical function in the packaged food when used as intended. The draft Standard also clears the use of sodium, potassium and calcium salts of acids, alcohols and phenols listed within GB 9685 Appendix A, provided that they comply with the limitations imposed on the corresponding acid, alcohol, or phenol.

Further, the Standard is reformatted to facilitate the review of substances. Presently, the Standard mainly includes Table A.1, "Permissible Additives in Food Containers & Packaging Materials" in Appendix A. The draft separates these clearances into Tables A.1to A.7, with separate tables for the following food contact materials and articles: plastic, coatings and coating layers, inks, adhesives, paper, and silicon rubber and others. The amended Standard also includes additional Appendices that address: SML(T) requirements, restrictions on metal elements, resin abbreviations, and two indexes containing all of the approved substances sorted by CAS Number, and Chinese chemical nomenclature, respectively.

Four phthlates have been deleted from the GB 9685 Standard (i.e., dimethyl phthalate, diisobutyl phthalate, diisooctyl phthlate, and di-C9-11-branched alkyl esters, C10-rich), and other phthalate listings have been adjusted to restrict the permitted use scope and food types contacted. The use scope and maximum permitted use level of a number of other additives have also been revised.

For more detailed information on GB 9685, see the KHlaw.com article, China Publishes Draft Amendment to the GB 9685 Hygienic Standard on the Uses of Additives in Food Containers and Packaging Materials.