Request a Demo
On March 27, 2025, China National Health Commission (NHC) officially released the No.1 Amendment Sheet to GB 9685-2016 Standard for Uses of Additives in Food Contact Materials and Articles, a key standard governing the use of additives in food contact materials (FCM). As one of the foundational standards in China's FCM regulatory framework, GB 9685-2016 sets rules to ensure the safe and standardized use of additives in the production of food contact materials and articles. This latest amendment focuses on updates to Annex A, B, and D. It takes effect on March 16, 2025, the date of its official release.
Amendments to Annex A:
Annex A lists permitted additives for food contact materials, specifying usage conditions. It is divided into seven tables based on material types. Tables A.1 to A.7 cover plastics, coatings, rubber, inks, adhesives, paper and paperboard, and other materials such as silicone rubber.
The No.1 Amendment Sheet adopts the clarification from the previous draft, confirming that the permitted additives for food contact rubber listed in GB 9685-2008 can also be used for the production of silicone rubber.
In addition, several FCM additives listed in Annex A are revised. The affected additives are shown in the table below, with changes highlighted in red.
Chinese name | English name | CAS no. | Maximum level (%) | SML/QM (mg/kg) | SML(T) (mg/kg) | SML(T) group no. | Notes |
氧化淀粉，2-羟基-3-(三 甲基氨根)丙 基醚氯化物 | Starch 2-hydroxy-3-(trimethylammonio) propyl ether, chloride, oxidized | 221897-48-9 | As necessary | / | / | / | The usage of sodium hypochlorite must not exceed 55 g per kilogram of dry starch (calculated as chlorine). |
2,2-二羟甲基丁醇；三羟甲基丙烷；TMP | 2,2-Dihydroxymethyl butanol, Trimethylolpropane, TMP | 77-99-6 | 0.12 (inks); 0.45 (coatings); as necessary (adhesive); 0.12 (plastics) | / | / | / | / |
丙烯酸与次磷酸钠聚合物的钠盐 | 2-Propenoic acid, polymer with sodium hypophosphite, sodium salt | 129898-01-7 | As necessary (paper, adhesive) | 6 (by acrylic acid) (SML) (paper); /(adhesive) | / (paper); 6 (adhesive) | / (paper); 22 (adhesive) | / |
过氧化二叔戊醚 | Peroxide, bis(1,1-dimethylpropyl) | 10508-09-5 | As necessary (PS, coatings) | 0.05% (peroxide: QM) (PS, coatings) | / | / | / |
三氟氯乙烯和偏氟乙烯的共聚物 | Ethene, 1-chloro-1,2,2-trifluoro-, polymer with 1,1-difluoroethene | 9010-75-7 | As necessary | 5 (1,1-Difluoroethene: SML); ND (Chlorotrifluoroe-thene: SML, DL=0.01mg/kg) | / | / | If there is no corresponding detection method for migration limit of chlorotrifluoroethene, the limit value could be set as 0.5 mg/6dm2(QM). |
C.I.颜料蓝 15；酞菁蓝；酞菁铜 | C.I. pigment blue 15 | 147-14-8 | As necessary (PE,PP,PS,PC,PA,PET,AS,ABS,PVC,PVDC,UP,PEI,PPE,PBT); 1 (PMMA,POM,PU,PPS) | / | / | / | / |
1,3- 二 氢-1,3- 二氧 代-5-异苯并呋喃甲 酰氯与4,4'-亚甲基 双苯胺的聚合物 | 5-Isobenzofurancarbonyl chloride, 1,3-dihydro-1,3-dioxo-, polymer with 4,4'-methylenebis[benzenamine] | 25928-85-2 | As necessary | ND (4,4'-methylenebis[benzenamine], SML, DL=0.002 mg/kg) | 5 (by trimellitic acid) | 21 | / |
2-乙基己醇 | 2-Ethylhexanol | 104-76-7 | As necessary | 30 (SML) | / | / | / |
己二酸与 2,2’-乙醇醚、1,2-乙二醇、1,3- 苯二甲酸和 2-乙基 -2-（羟甲基）-1,3- 丙二醇的聚合物 | Hexanedioic acid, polymer with 2,2'-oxybis[ethanol], 1,2-ethanediol, 1,3-benzenedicarboxylic acid and 2-ethyl-2-(hydroxymethyl)-1,3-propanediol | / | As necessary | 6 (trimethylolpropane: SML) | 30 (by glycol); 5 (by isophthalic acid) | 2; 27 | / |
三苯六甲酸酐与 1,1'-亚甲基双(4-异 氰酸酯苯)的共聚物 | 1,3-Dioxo-1,3-dihydro-2-benzofuran-5-carboxylic acid -1,1'-methy lenebis(4-isocyanatobenzene) (1:1) | 25053-57-0 | As necessary | 1 (by Isocyanato group, QM) | ND (by Isocyanato group, DL=0.01mg/kg); 5 (by trimellitic acid) | 17; 21 | / |
Amendments to Annex B:
Annex B lists the SML(T) group numbers, CAS numbers, types and names of restricted substances, SML(T) values, and restriction notes. The 2016 version of the standard already includes 32 SML(T) groups. This amendment introduces three additional groups and their corresponding limit values, as detailed below.
SML(T) group no. | CAS no. | Substance name | SML(T) / (mg/kg) | Notes |
33 | 97-53-0 | 3-(4-hydroxy-3-methoxyphenyl)propylene, 2-Methoxy-4-(2-propenyl)phenol, Engenol Engenol | ND(DL= 0.01mg/kg) | Calculated by Engenol |
156065-00-8 | Siloxanes and silicones, dimethyl, 3-(4-hydroxy-3-methoxyphenyl)propyl group-terminated | |||
34 | 1477-55-0 | 1,3-Benzenedimethanamine | 0.05 | Calculated by 1,3-Benzenedimethanamine |
3634-83-1 | 1,3-bis(isocyanatomethyl)benzene | |||
35 | 3724-65-0 | 2-Butenoic acid | 0.05 | Calculated by Butenoic acid |
80181-31-3 | Pentanoic acid, 3-hydroxy-, polymer with 3-hydroxybutanoic acid | |||
147398-31-0 | Poly(3-Hydroxybutyrate-co-3-Hydroxyhexanoate) |
Amendments to Annex D:
Annex D provides explanations of abbreviations for various plastic materials. The original standard includes 31 polymer abbreviations and their meanings. This amendment adds the abbreviation for PVA or PVOH plastic materials.
S/N | Abbreviation | English name | Chinese name |
32 | PVA or PVOH | Poly (vinyl alcohol) | 聚乙烯醇 |
We provide full-scale global food market entry services (including product registration, ingredient review, regulatory consultation, customized training, market research, branding strategy). Please contact us to discuss how we can help you by 
