- China Publishes Draft Amendment to the GB 9685 Hygienic Standard on the Uses of Additives in Food Containers and Packaging Materials
- April 24, 2015 | Authors: David J. Ettinger; Mark Thompson
- Law Firms: Keller and Heckman LLP - Washington Office ; Keller and Heckman LLP - Shanghai Office
- On January 20, 2015, China’s National Health and Family Planning Commission (NHFPC) published an amendment to the current Hygienic Standards for Uses of Additives in Food Containers and Packaging Materials (GB 9685-2008) for comments from the general public. Comments on the amended Standard will be accepted until March 15, 2015. The key revisions to the Standard are detailed below.
I. Standard Application Scope, Definitions and Format
The title of the GB 9685 Standard has been revised to “Standard for Uses of Additives in Food Contact Materials and Articles.” The 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 contact with food, and coating layers, ink, adhesives, etc., as well as machines, pipes, conveyer belts, containers, utensils, tableware, etc., but does not include detergents, disinfectants or public water facilities. Meanwhile “Additives in food contact materials and articles” (“Additives”) 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, including also substances added during the manufacturing process of food contact materials and articles to promote smooth production rather than improve quality and property of final products. 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.
Published along with the amended Standard is a Drafting Explanation, which provides more background information on the development of the Standard and relevant considerations taken during the revision process. In addition, the Draft Explanation contains five annexes, which detail the major amendments and include the following:
Annex 1 Requirements for phthalates
Annex 2 Use scopes removed from the Standard including ceramics, metal, glass, and enamel.
Annex 3 Restrictions on certain substances in infant food packaging materials
Annex 4 Status of the “use scope” in the original Standard as it pertains to composite materials
Annex 5 Amended limitations on certain substances
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 into the draft GB 9685. This increases the total number of additives contained in Appendix A from 959 substances to 1316 substances. In other words, food-contact additives cleared in various former Ministry of Health (MOH) and NHFPC Announcements are now integrated into GB 9685. Per the Drafting Explanation, 365 additives have been added to the Standard since the 2008 iteration, 348 of which were issued in response to the “clean-up” procedures, while 17 resulted from filings under the Management Rules. In addition, the listings for 204 additives have been revised to permit an increased use level or expanded scope of use. Each listed substance has now been assigned a food contact additive (FCA) number, which is referenced along with the substance wherever it appears in the Standard. We believe this approach should facilitate substance searches.
The 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. Additionally, columns have been added to the table contained in Appendix B, which now list the substances for which the sum of migration must comply with the SML(T), as well as the corresponding SML(T) group number.
Thus, for each listed additive, the Standard now references the following parameters:
Max. Use Level
Further, the Standard is reformatted to facilitate the review of substances. Presently, the Standard mainly includes Appendix A, Table A.1 (“Permissible Additives in Food Containers & Packaging Materials”); however, the draft separates the list of additives and their use requirements into Table A.1-Table A.7 as follows:
Table A.1 - Plastic food contact materials and articles
Table A.2 - Food contact coatings and coating layers
Table A.3 - Rubber food contact materials and articles
Table A.4 - Inks of food contact materials and articles
Table A.5 - Adhesives of food contact materials and articles
Table A.6 - Paper food contact materials and articles
Table A.7 - Silicon rubber and other food contact materials and articles
As explained in Annex 2 to the Drafting Explanation, the amended Standard has removed the following use scopes for 6 listed additives: glass, metal, ceramics and enamel. The Drafting Explanation notes that additives used in these inorganic materials commonly exist as a part of the raw material or functions as a treatment used in the manufacturing process, which will ultimately be removed. Therefore, such substances should not be considered to fall within the definition of “additive” in this Standard. Moreover, additives used in these four materials are usually metal salts, and may thus be better regulated by setting relevant migration limits for these substances within the corresponding product safety Standard(s).
Lastly, the amended GB 9685 Standard has been modified to include additional Appendices that address the following content:
Appendix B - SML(T) requirements
Appendix C - Requirements on metal elements
Appendix D - Resin abbreviations
Appendix E - Indexes sorted by CAS Number, and pronunciation of Chinese name
II. Permissibility of Certain Salts
This amended Standard reflects the authorities’ earlier intent to permit the use of certain salts of cleared acids, phenols and alcohols. More specifically, the amended Standard permits the use of sodium, potassium and calcium salts of acids, alcohols and phenols listed within Appendix A for use in food contact materials, provided that they comply with the restrictive requirements for the corresponding acid, alcohol or phenol. In this regard, certain other sodium, potassium and calcium salts that are separately listed on the Standard must comply with the restrictions referenced therein. At the same time, the use of permitted substances that contain crystallization water (i.e., hydrous forms) must comply with corresponding restrictive requirements of the anhydrous form of the listed substance (e.g., use limit, scope, etc.). This differs from the draft GB 9685 Standard that was released to industry late last year, which noted that this allowance for hydrous forms only permitted its use for listed salts, rather than listed substances generally.
III. Clearance for Food Additives Listed in Table A.2 of GB 2760
The draft amendment to GB 9685 would permit the use of direct food additives listed in China’s General Standard for Use of Food Additives (GB 2760) in food packaging. Specifically, the draft would permit the use of substances listed in Table A.2 of GB 2760 in food packaging materials contacting all types of food at levels up to “dosage as necessary,” provided that the substance exhibits no technical function in the packaged food.
IV. Approved Polymers Having a Molecular Weight above 1,000 Daltons
Section A.1.5 of the draft amendment also permits the use of polymers approved in China which have a molecular weight greater than 1,000 Daltons for use in food contact materials and articles (except macromolecular substances made by microbial fermentation). Their use must comply with corresponding restrictive requirements in the Standard. We believe the language in this section refers to the approved “resins” in China. Revising this language to clarify its applicability to “resins” - consistent with Section A.3 and the List of 107 Resins published in response to the “clean-up” procedures - would be useful, and will hopefully be included in the final version of the amended Standard.
V. Changes to the Use Scope and Use Limit of Certain Additives
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. Other changes have also been made to specific listings. For example, the GB 9685-2008 listing for phenol permits the use of this substance at levels up to “dosage as necessary” in coatings with no specified SML. By contrast, the revised GB 9685 Standard would impose an SML of 3 mg/kg for phenol when used in coatings applications.
 See NHFPC Announcement No. 18 of 2015, available at http://www.nhfpc.gov.cn/sps/s3593/201501/6ec37970b020464db13bd634b86f70e2.shtml
 See MOH Announcement No. 5 of 2012 (http://wsb.moh.gov.cn/mohwsjdj/s7891/201205/54672.shtml), MOH Announcement No. 11 of 2012 (http://www.moh.gov.cn/sps/s7891/201207/7f504c03f06d42849edf3071d07106d0.shtml), NHFPC Announcement No. 1 of 2013 (http://www.nhfpc.gov.cn/sps/s7890/201403/64d65c405692488385c7d1da3d64207b.shtml),
NHFPC Announcement No. 14 of 2013 (http://www.nhfpc.gov.cn/sps/s7890/201401/98263bfea50048789b62f5dcd2867d13.shtml), NHFPC Announcement No. 14 of 2014 (http://www.nhfpc.gov.cn/sps/s7890/201407/d3aefea7488f4c4f92ffca1a0b7d59e0.shtml)
 The “total specific migration limit,” also known as the SML(T), pertains to the maximum permitted sum of particular substances released in food or food simulants expressed as total of moiety of the substances indicated.