On November 18th 2016, 53 new national standards for food contact materials and articles (hereinafter FCM GBs) were finally published in China. Among them, there are 2 horizontal standards, 9 commodity standards, 41 test standards and 1 food relevant standard.
With the release of these new FCM GBs, a brand new Chinese FCM standard system has been established. Compared with their draft version for comments issued last year (hereinafter the draft version in 2015), there are no major changes in the two horizontal standards. But in several commodity standards, revisions have been made to the definition, application scope, physicochemical properties, specialized migration test conditions and corresponding resin list. In certain standards the changes are quite significant. Under this new standard system, all GBs are divided into four parts, which are the horizontal standards, commodity standards, test methods and manufacturing practices.
1. Horizontal Standards
Horizontal standards are composed of 2 standards, which are GB 4806.1-2016 and GB 9685-2016 and will come into force on Oct. 19th, 2017.
1.1 GB 4806.1-2016 General Safety Requirements for Food Contact Materials and Articles
This newly established standard, resembling to the EU framework regulation (EC) No. 1935/2003, is the cornerstone of the whole new standard system. It stipulates fundamental requirements in general requirements, special limits, compliance principles, test methods, traceability, labeling, DoC, etc.
Compared with the draft version in 2015, changes include:
1.2 GB 9685-2016 Standards for Uses of Additives in Food Containers and Packaging Material
This new version replaces the GB 9685-2008. In comparison with GB 9685-2008, the name, application scope, as well as some terms and definitions of the standard are modified. The term "food containers, packaging materials" has become "food contact materials and articles" and its definition are changed. The term "total specific migration limit (SML (T))" and its definition are added.
With regards to the list of permitted additives, instructions for various appendices are added and the structure of Appendix A is adjusted. The number of additives increased from 958 to 1294, including the substances published in the 5 announcements issued by the former Ministry of Health and the current National Health and Family Planning Commission during 2012-2014, and some high-risk substances are ｄｅｌｅｔｅd.
In addition, this revision also adds special restrictions on the metal elements in Appendix C, the definition of the abbreviation of plastic materials in Appendix D, and an index sorted by CAS number and sequencing in Appendix E.
Compared with the draft version in 2015, changes include:
2. Commodity Standards
9 commodity standards including plastic, paper, metal, rubber, coating, glass, ceramics, enamels, etc. are released and will enter into force on April 19th, 2017, which is prior to the effective date of the horizontal standards.
Compared with the old version, the Commodity Standards generally revised the standard name, expanded the scope of application, changed from "food containers and packaging materials" to "food contact materials." Requirements on raw material are more refined, the number of inventories of raw materials increased, and the inventory management is strengthened. At the same time, sensory requirements, physicochemical properties and labeling requirements are also amended. Except those with special requirements, migration tests shall comply with the requirements of GB 31604.1-2015.
Compared with the draft version in 2015, metal and rubber standards have undergone more significant changes. Other adjusted standards are summarized as follows.
2.1 GB 4806.4-2016 Ceramics
This standard replaces 4 national standards (GB 13121-91, GB 14147-1993, GB 8058-2003 & GB 12651-2003). The application scope is reorganized. Terms and definitions on the different types of ceramics are added. (These definitions also apply to glass products.) Requirements on sensory and physicochemical properties are amended.
Compared with the draft version in 2015, changes include:
2.2 GB 4806.5-2016 Glass
This standard replaces GB 18778-2005. Aside from the revision of standard name and application scope, requirements on raw materials, sensory properties and labeling are added.
Compared with the draft version in 2015, changes include:
2.3 GB 4806.6-2016 Plastic Resin
This standard replaces 9 national standards and 1 MOH Announcement (GB 16331-1996, GB 9692-1988, GB 9693-1988, GB 9691-1988, GB 4803-1994, GB 15204-1994, GB 13115-1991, GB 13114-1991, GB 13116-1991 & MOH Announcement (2011) No. 23).
As there are separate standards for plastic resin and plastic articles, this separation is maintained in this standard revision and clean-up process. Plastic resin standard only applies to plastic resin. Plastic intermediates such as pre-polymers, plastic materials, etc., as well as plastic articles belong to the regulatory scope of Plastic Materials and Articles Standard.
Compared with the draft version in 2015, changes include:
2.4 GB 4806.7-2016 Plastic Materials and Articles
This standard replaces 11 national standards (GB 16332-1996, GB 9689-1988, GB 17326-1998, GB 9688-1988, GB 9681-1988, GB 14944-1994, GB 9687-1988, GB 17327-1998, GB 14942-1994, GB 9690-2009, GB 13113-1991).
Compared with the draft version in 2015, changes include:
2.5 GB 4806.8-2016 Paper & Paper Board
This standard replaces the GB11680-1989 and GB 19305-2003. The new standard extends the application scope, adds requirements on raw materials and additives, revises the physicochemical properties limits and microbial limits, etc.
Compared with the draft version in 2015, changes include:
2.6 GB 4806.9-2016 Metal
This standard replaces GB9684-2011 and GB 11333-1989. Previously, GB 9684 only suited to stainless steel while GB 11333 only applied to aluminum. With the new standard, metals other than stainless steel and aluminum could finally refer to a solid standard.
Compared with the draft version in 2015, there are some major changes including:
2.7 GB 4806.10-2016 Coating
This standard replaces 8 national standards (GB 4805-1994, GB 9680-1988, GB 9682-1988, GB 9686-2012, GB 11676-2012, GB 11677-2012, GB 11678-1989).
Compared with the draft version in 2015, changes include:
2.8 GB 4806.11-2016 Rubber
This standard replaces GB 4806.1-1994.
Compared with the draft version in 2015, there are some major changes including:
3. Test Methods
For test methods, one of the primary standards GB 31604.1-2015 General Rules for Migration Test of Food Contact Materials and Articles has already been published and come into force in September 2016. There are great similarities in the selection of food simulants, time and temperature with the corresponding rules in EU.
Among the 41 newly announced test methods, there is another essential standard, the GB 5009.156 General Rules of Pretreatment of the Migration Test of Food Contact Materials and Articles. Meanwhile, there are also many test methods for specific substance such as melamine, acrylonitrile, phthalates, heavy metals, etc.
With these new methods, the test methods system will be a more integrated system which provides the basis for the physicochemical properties and the SML or QM limit requirements listed in Horizontal Standards and Commodity Standards. These test methods will come into force on April 19th, 2017.
4. Manufacturing Practices
There is no new manufacturing practice in this newly published batch of standards.
However, the GB 31603-2015 General Hygienic Standard for Production of Food Contact Materials and Articles was issued in September 2015 and the one-year transition period was over in September 2016, meaning the GMP standard has now entered into force.
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