China Releases Draft Amendment to GB Standard on Additives used in Food Contact Materials and Articles
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 | acid-3-hydroxypentanoic acid, copolymer |
- In Annex D, the draft adds abbreviations of PVA/PVOH.
We should note that 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.
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Should you have any questions or need any other assistance in China’s regulatory requirements for food-contact products, please do not hesitate to contact David Ettinger (ettinger@khlaw.com), Chen Hu (hu@khlaw.com), Eric Gu (gue@khlaw.com), or your existing contact at Keller and Heckman LLP.
[1] See NHC Announcement No. 2/2023, available at: http://www.nhc.gov.cn/sps/s7891/202302/a1d45c0ee4e64beaab96e039df2073cc.shtml; https://sppt.cfsa.net.cn:8086/cfsa_aiguo?task=a_do&standard_guid=AF786A76-DF3E-4611-9117-6013965E43A5&pici=B50C4865-E2F7-2F73-A734-E449C38DBF47&net_rand=c8c310d4-8378-1110-d314-fe7a8d48cdd5.