New update for Food Contact Materials additive (GB 9685) in China
On February 13, 2023, the National Health Commission of the People's Republic of China (NHC) published a draft amendment of the GB 9685 Standard for the use of additives in Food Contact Materials (FCM). The deadline for public comments on this draft was 20 March 2023.
GB 9685 specifies the use principle, positive list, and limitations on FCM additives, including Specific Migration Limits (SML), QM (Quantity Maximum), SML (T) (SML group total) and other usage restrictions. There are five Annexes:
• Annex A: Positive limit of FCM additives and any limitations;
• Annex B: SML(T) requirements;
• Annex C: Requirements for food contact substances containing metals;
• Annex D: Abbreviations for plastic materials.
Annex A, B and D were subject to the recent revision.
1. In addition to the additives listed in the existing Table A.7 in GB 9685, the available list of silicone rubber materials has been expanded. Additives allowed to be used with rubber listed in GB 9685-2008* can also be used in the production of silicone rubber.
*Note: The current version of the GB 9685 standard is GB 9685-2016, and the GB 9685-2008 version is otherwise invalid.
2. There is also a positive list of food additives in China, GB 2760, which is currently under revision. Additives listed in Table A.2 of GB 2760 can also be used as FCM additives. NHC plans to delete Table A.2 in GB 2760 in the future. A revision is anticipated to be published this year, and the use of additives listed in GB 2760-2014 are currently still allowed to be used in FCM.
3. Referencing Reg (EU) 10/2011, the following three groups of SML(T) are added in Annex B.
|
SML(T) Group No. |
CAS No. |
Substance name |
SML(T)/mg/kg |
Comment |
|
33 |
97-53-0 |
eugenol |
ND |
Expressed as eugenol |
|
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 |
Expressed as 1,3-benzenedimethanamine |
|
3634-83-1 |
1,3-bis(isocyanatomethyl)benzene |
|||
|
35 |
3724-65-0 |
crotonic acid |
0.05 |
Expressed as crotonic acid |
|
80181-31-3 |
3-hydroxybutanoic acid-3- hydroxypentanoic acid, copolymer |
|||
|
147398-31-0 |
Poly((R)-3-hydroxybutyrate-co-(R)-3-hydroxyhexanoate) |
4. The abbreviation of PVA or PVOH is added to Annex D.
| No. | Abbreviation | English name | Chinese name |
| 32 | PVA or PVOH | Poly (vinyl alcohol) | 聚乙烯醇 |
To ensure that your Food Contact Materials meet China’s regulatory requirements, please contact the knoell FFCM team via FFCM.NA@knoell.com or find more insight on Food Contact Material.
