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:

• Revision of the definition of “food contact materials and articles” (requirements on lubricating grease added)
• Revision of the definition of “Non-Intentionally Added Substance”
• Addition of the definition of “functional barrier”
• Revision of requirements on DoC and labelling

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:

• Addition of one principle for additives listed in GB 2760 when used as FCM additives
• The total number of approved additives is 1294, 22 less than in the draft version in 2015
• Deletion of the definition of ‘food contact materials and articles’, which is already set for in GB 4806.1-2016
• Addition of the definition of FCA number
• Revision of the instructions for Appendix A

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:

• Special requirements on migration test of special types of ceramics are added
• Special labeling requirements on high temperature and microwaveable ceramic products are ｄｅｌｅｔｅd

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:

• Addition of the definition of “peristome” & ”flash”
• Deletion of the SML for Pb and Cd
• Addition of the SML for the condition of ‘peristome’
• Addition of special requirements on migration test conditions for special glass types

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:

• Addition of the elaboration of thermoplastic elastomer (TPE)
• Deletion of requirements on ”OML”, “KMnO4 consumption limit”, “SML of heavy metal” and ”discoloration test”
• Refining of the labeling requirements
• Varieties of resin in Appendix A was changed from 103 to 102

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:

• Addition of the definition of “masterbatch”
• Deletion of the definition of ‘food contact plastic materials and articles’ and ‘TPE’
• The limit of KMnO4 consumption is revised from 12 mg/kg into 10 mg/kg
• The SML of heavy metal is revised from 1.2 mg/kg into 1 mg/kg

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:

• Revision of the name of the standard
• Revision of the definition of “food contact paper and paper board materials and articles”
• Deletion of the definition of “paper”, ”paper board” and ”paper articles”
• Table 2 is split into 3 separate tables
• Revision of the application scope of products which require specific migration test
• Deletion of the discoloration test requirement

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:

• Main changes in the raw material requirements, especially the content and residue content limit for ‘impurity elements’
• The limits in physicochemical properties have been raised up to 5 -20 folds.
• Deletion of the different SML requirements for ‘impurity elements’ and ‘alloy elements’
• Deletion of the SML requirements for Al, Sn, Sb and Zn

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:

• Clear exclusion of paper coating
• Deletion of SML requirements on physicochemical properties for formaldehyde, free phenol, Cr6+ and fluorine.
• Addition of special requirements on migration test conditions for heavy metal
• Varieties of resin in Appendix A was changed from 110 to 105
• Special use limits on 9 resins approved by current coating standards are integrated into Appendix A

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:

• Application scope is extended into silicone rubber and vulcanized TPE
• Definitions for “natural rubber” and “silicone rubber” are added
• The limit of KMnO4 consumption is revised from 40 mg/kg into 10 mg/kg
• The SML requirements for Zn and N-nitrosamine are ｄｅｌｅｔｅd
• Varieties of resin for natural rubber in table A.1 was changed from 36 to 24
• A new table A.2 for silicone rubber with 19 resin varieties is added

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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