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On July 3, 2025, the China National Center of Food Safety Risk Assessment (CFSA) opened a consultation on the draft amendments to the GB 9685-2016 Standard for the Use of Additives in Food Contact Materials and Articles. Comments from the industry are welcome before July 15, 2025.
Background
GB 9685 is one of the mandatory national standards under China's food contact materials (FCM) regulatory system, which ensures the standardized use of additives in the production of food contact materials and articles. The last amendments were made on March 16, 2025, by the No.1 Amendment Sheet, focusing on the updates to Annex A, B, and D of GB 9685-2016.
The draft revision GB 9685-XXXX under consultation this time amends the application scope of this standard, definitions of certain terms, principles for the use of additives in food contact materials and articles, and crucial requirements in Annexes A, B, C, D, E. The requirements cover permissible varieties and scope, maximum usage limits, migration limits, residue limits, and restrictions related to additives used in food contact materials and articles. Once officially adopted, the 2016 version is expected to be replaced.
Draft amendments
To add the following 8 substances in Annex A, which have been newly permitted to be used in regenerated cellulosic materials and products for food contact use:
Chemical name | CAS number |
Propylene glycol | 57-55-6 |
C.I. Pigment Black 7; carbon black | 1333-86-4 |
White mineral oil | 8042-47-5 |
Sodium hypochlorite | 7681-52-9 |
Polyoxyethylene sorbitan monooleate (Tween 80) | 9005-65-6 |
Sulfuric acid | 7664-93-9 |
Sodium hydroxide | 1310-73-2 |
Sodium dodecylbenzenesulfonate | 25155-30-0 |
To amend concentration limits for the following 6 FCM additives in Annex A:
Additive name | Limits for FCM additives | |
Current | Proposed | |
BPA (bisphenol A) | 0.6 mg/kg (SML) | 0.05 mg/kg (SML) |
1,2,4-Benzenetricarboxylic acid, tris(2-ethylhexyl) ester | 0.05 mg/kg (SML) | 1 mg/kg (SML) |
Phenol, 2-[4,6-bis(2,4-dimethylphenyl)-1,3,5 -triazin-2-yl]-5-(octyloxy)- | 0.05 mg/kg (SML) | 5 mg/kg (SML) |
Phosphorousacid,mixed2,4-bis(1,1-dimethylpropy1)pheny1 and 4-(1,1-dimethylpropy1) pheny1 triesters | 5 mg/kg (calculated as the sum of the phosphite ester and phosphate ester forms of this substance and 4-tert-pentylphenol, SML) | 10 mg/kg (calculated as the sum of the phosphite ester and phosphate ester forms of this substance and 4-tert-pentylphenol, SML) |
1,3-Benzenediamine | ND (DL=0.01 mg/kg) (SML) | ND (DL=0.002 mg/kg) (SML) |
Butenoic acid | 0.05 mg/kg (SML) | 0.05 mg/kg [calculated as butenoic acid, SML(T)] |
To remove 13 high-risk or phased-out FCM additives from Annex A, including FCA0271, FCA0283, FCA0558, FCA0705 (i.e., BPBG), FCA0780 (i.e., Sodium perchlorate), FCA0961 (i.e., DEHP), FCA0962 (i.e., DAP), FCA0964 (i.e., DINP), FCA0965 (i.e., DBP), FCA0967 (i.e., DINP), FCA1084, FCA1143, and one already eliminated high-risk FCM additive (CAS No. 863408-20-2).
To remove a total of 401 substances from Annex A, which have been either included in other standards or lack additive functions, covering plastics (3), coatings (105), rubber (12), inks (62), adhesives (219), etc.
To update the table of specific migration limit in total (SML (T)) in Annex B, adding three groups and their corresponding limit values which have been adopted by No.1 Amendment Sheet, as detailed below:
SML (T) Group No. | CAS No. | Substances | SML(T) (mg/kg) | Remark |
33 | 97-53-0 | 3-(4-Hydroxy-3-methoxyphenyl)-1-propene; Phenol, 2-methoxy-4-(2-propenyl)-; Eugenol | ND (DL=0.01 mg/kg) | 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 [SML(T) applies to the migration of its hydrolysis product, 1,3- benzenedimethanamine.] | |||
35 | 3724-65-0 | 2-Butenoic acid | 0.05 | Expressed as crotonic acid |
80181-31-3 | 3-Hydroxybutyric acid-3-hydroxyvaleric acid copolymer | |||
147398-31-0 | Poly(3-hydroxybutyrate-co-3-hydroxyhexanoate) |
To update the table of specific migration limits of metallic elements in Annex C, more specifically:
To adjust the specific migration limit of zinc from 25 mg/kg to 5 mg/kg.
To add aluminum in the table and set its specific migration limit as 1 mg/kg.
To update the abbreviations of various plastic materials in Annex D.
To delete the current Annex E - Catalogues of adhesives for food contact materials and their articles, and instead to add a new Annex E - Quality and specification requirements for coloring agents. In addition to the current purity requirements, for the coloring agent C.I. Pigment Black 7 (Carbon black; CAS No. 1333-86-4), the purity requirements “Benzo[a]pyrene ≤ 0.25 mg/kg; toluene extract < 0.1%” is proposed to be added.
