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China Releases Draft Amendment to GB Standard on Additives Used in Food-Contact Materials and Articles

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On February 13, 2023, China National Health Commission (NHC) released a draft amendment[1] of GB 9685-2016 Standard for Uses of Additives in Food Contact Materials and Articles for public comments. Main revisions of GB 9685-2016 are within three annexes, including Annex A, B, and D, which are summarized as follows.

  • In Annex A, the draft makes it clear that additives approved for use in rubber under GB 9685-2008 can also be used in the production of silicon rubber. In addition, given that China is currently working on the revision of GB 2760 Standards for Use of Food Additives, the amendment clarifies that the food additive standard that GB 9685 Standard refers to should be the GB 2760-2014 version. It further proposes to correct some errors of the current GB 9685 Standard, such as revising the specific migration limit (SML) of 5-Isobenzofurancarbonyl chloride, 1,3-dihydro-1,3-dioxo-, polymer with 4,4'-methylenebis[benzenamine]. 
  • In Annex B, the draft incorporates three new groups of SML (T) in accordance with Commission Regulation (EU) No.10/2011 (Plastics Regulation), as amended:
No. Cas No. Name SML(T)/(mg/kg) Restrictions
33 97-53-0 Phenol, 2-methoxy-4-(2-propenyl)- ND As Phenol, 2-methoxy-4-(2-propenyl)-
  156065-00-8 α-dimethyl-3-(4'-hydroxy-3'-methoxyphenyl)propylsilyloxy, ω-3-dimethyl-3-(4'-hydroxy-3'-methoxyphenyl)propylsilyl polydimethylsiloxane    
34 1477-55-0 1,3-Benzenedimethanamine 0.05 As 1,3-Benzenedimethanamine
  3634-83-1 1,3-bis(isocyanatomethyl)benzene    
35 3724-65-0 2-Butenoic acid 0.05 As 2-Butenoic acid
  80181-31-3 3-hydroxybutanoic acid-3-hydroxypentanoic acid, copolymer    
  147398-31-0 poly((R)-3-hydroxybutyrate-co-(R)-3-hydroxyhexanoate)    
  • In Annex D, the draft adds abbreviations of PVA/PVOH.

The authority issues such revisions to fix some minor issues and updates. Accordingly, the draft only proposes to revise the above-mentioned content of GB 9685-2016 Standard, which will not serve as a new version of GB 9685. It does not incorporate any new food-contact substances that were approved by NHC since the issuance of GB 9685 Standard in 2016. These new listings should comply with requirements under corresponding administrative approvals. All comments on the above draft must be submitted to NHC before March 20, 2023.

[1] See NHC Announcement No. 2/2023 (in Chinese), available at:;