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On February 13, 2023, China National Health Commission (NHC) released the draft of No.1 Amendment Sheet to GB 9685-2016 Standard for the Use of Additives in Food Contact Materials and Articles, along with other 37 GB food standard drafts. GB 9685-2016 is one of the general 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. This draft amends three annexes of GB 9685-2016, including Annex A, B and D.
Amendments to Annex A:
Table A.7 of GB 9685-2016 lists the permitted additives for food contact silicone rubber. The draft clarifies that the permitted additives for food contact rubber in GB 9685-2008 can also be used for the production of silicone rubber.
In addition, several FCM additives listed in Annex A are subject to new changes brought by this draft. Involved additives are listed in the table below. The changes are marked 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 amount of sodium hypochlorite used in the production of this substance shall not exceed 55g per kg of dry starch (by chlorine) |
2,2-二羟甲基丁醇；三羟甲基丙烷；TMP | 1,3-Propanediol, 2-ethyl-2-(hydroxymethyl)- | 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:
Table B.1 of GB 9685-2016 lists the corresponding limit values of 32 SML(T) groups specified in Annex A. On the basis of using Commission Regulation (EU) No. 10/2011 as a reference, the draft adds three new groups and their corresponding limit values.
SML(T) group no. | CAS no. | Substance name | SML(T) / (mg/kg) | Notes |
33 | 97-53-0 | Engenol | ND | 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 of GB 9685-2016 lists the abbreviations of 31 plastic materials. The draft adds the abbreviations of one new plastic material.
S/N | Abbreviation | English name | Chinese name |
32 | PVA or PVOH | Poly (vinyl alcohol) | 聚乙烯醇 |
Please refer to Food Contact Materials Additives Database to check more permitted FCM additives in China.
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