About GB 9685

The Ministry of Health (MOH) and the Standardization Administration (SAC) jointly published the mandatory standard GB 9685 “Hygienic Standards for Uses of Additives in Food Containers and Packaging Materials”, which was subsequently updated in 2003, 2008 and 2016. GB 9685-2016 specifies principles for use of additives in food containers and packaging materials, the types of permitted additives, scope of use, maximum level, specific migration limit or maximum permitted quantity as well as other restrictive requirements. This standard also includes some monomers and initiators during the production of food contact materials and products. It has been effective October 19, 2017. Compared with the previous version, one of major changes of GB 9685 lies in that there is a more clear management model for raw and auxiliary materials. In GB 9685-2016, positive lists are used to manage the raw and auxiliary materials. For each category of food contact materials, including plastic, coating, rubber, silica gel, permitted additives list is provided to clearly indicate which kind of additive is permitted or not. Products with additives not included in those positive lists are illegal. In the latest GB 9685-2016, its positive list has included additives announced in NO.5 announcement and NO.11 announcement in 2012, NO.1 and NO.14 announcement in 2013 and NO.14 announcement in 2014. Besides, here are other changes of GB 9685-2016 compared with GB 9685-2008. • Some terms and definitions have been revised • The positive list for additives used in food contact materials has changed from 958 to 1294 • Special limitation of metallic element is added. • Abbreviations of plastic materials is added • Bibliography (according to CAS number or phonetic sequence) is added In addition, NHC also approved new additives and food contact materials to satisfy the demand of FCM industry. Detailed information of those new substances is included in released announcements. Compliance Declaration of Compliance (DoC) What is DoC？ Declaration of Compliance (hereinafter referred to “DoC” for short) is a document transferred from a supplier to downstream links in the supply chain, detailing that product meet regulatory compliance requirements. The DoC provides relevant production information for compliance verification, and is a mandatory requirement in China. DoC needs to list all the applicable provisions and limitations of relevant laws and standards to help downstream links in the supply chain to have a clear idea of product regulatory status. Chinese laws and regulations on the technical requirements for food contact materials and articles, is no longer just some basic indexes, but also stipulates limitations of ingredients and additives used for the product. Only with access to information of raw and auxiliary materials, especially to restricted substances and use conditions of food contact materials and articles, can we accurately assess the compliance and safety of food contact materials and articles. Therefore, in order to ensure the effective delivery of product information, GB4806.1-2016 General safety requirements for food contact material and articles stipulates the responsibilities of enterprises: “8.3 The identification information should contain product name, materials, declaration of compliance of related regulations and standards, the name, address and contact information of the producer and/or the entrusting party, production date and guarantee period(application date) etc. 8.4 Declaration of compliance should contain information of regulations and standards in compliance with, restricted substance and its limitation and the compliance of overall migration level (for products only) etc.” What kinds of substance/material need a DoC? • Substances listed in the national standard positive list, including • GB 9685-2016 Table A.1-A.7 • GB 4806.6-2016 Table A.1 • GB 4806.10-2016 Table A.1 • GB 4806.11-2016 Table A.1 and A.2 • Substances approved by NHFPC in official announcement New food contact materials and articles application What kinds of substances/materials require a new substance application？ • Food packaging materials, containers and their additives not listed in the national standard positive list nor approved by NHFPC in official announcement. For example：A plasticizer used in plastic is not listed in table A.1 of GB 9685-2016 nor approved by NHFPC in official announcement. Such plasticizer need to conduct a new substance application. • Food packaging materials, containers and additives intended to expand the use scope or the dosage. For example：Dosage of FCA0001 (CAS No.25013-16-5) used in plastic is 0.2% which is more than 0.1% as required in relevant standard, or FCA0001 (CAS No.25013-16-5) is to be used in paper and paperboard which is beyond the stipulated use scope, both of these situations need to conduct the new substance application.