GB 9685-2025National Food Safety Standard — Standard for Uses of Additives in Food Contact Materials and Their Products (English PDF)

Foreword

This standard replaces GB 9685-2008 "Hygienic Standards for Uses of Additives in Food Containers and Packaging Materials".

Compared with 9685-2008, the main changes in this standard are as follows:

Additives in Food Contact Materials and Their Products";

- Some terms and definitions are revised while some, such as "total specific migration limit", are added;

application instructions for each appendix of this standard are added while the contents of specific migration and inspection method judgment are deleted;

are respectively listed in Tables A.1~A.7 in Appendix A; three columns, namely FAC No., SML (T) and SML (T) Group No., are added;

requirements (Appendix A) are revised, and the contents in Tables A.1~A.7 are added;

- Varieties of additives listed in Appendix A are increased from 958 kinds to 1294 kinds;

- 4 kinds of phthalate esters, such as dimethyl phthalate, are deleted, the usage scope of other phthalate esters and the types of foods they are limited from contact are adjusted;

scope of glass, metal, ceramic and enamel are deleted.

- Substances simultaneously listed in Table A.2 of GB 2760-2014 are deleted;

- 3 kinds of perfluorochemicals used in paper, such as perfluoroalkyl acrylate copolymer, are deleted;

products (such as 1,6-hexanediamine and phenol) are revised;

- Requirements of total specific migration limit (Appendix B) are added;

- Special limitation of metallic elements (Appendix C) is added;

universal category of resin approved in the Announcement of the former Ministry of Health (No. 23 [2011]) is added in Appendix D;

- Search directory ordered according to CAS No. and Chinese name (Appendix E) are added.

1 Scope

This standard specifies the using principles of additives in food contact materials and their products, as well as the variety, use scope, maximum level, specific migration limit or maximum residue quantity, total specific migration limit and other limit requirements of their allowable additives.

This standard also includes monomers of some basic polymers or other initiators of polyreaction used during the processing of food contact materials and their products.

2 Terms and Definitions

The substances added in food contact materials and their products during the production, which improve or help to improve their quality and characteristics so as to meet the intended use; they also include the processing agents (hereinafter referred to as "additive") added in production process so as to ensure the smooth development of production process other than improving the quality and characteristics of the final products.

3 Using Principles of Additives in Food Contact Materials and Their Products

3.1 When the food contact materials and their products contact the foods under recommended use conditions, the level of additive migrating into foods and its impurity level shall not be harmful to human health.

3.2 When the food contact materials and their products contact the foods under recommended use conditions, the additive migrating into foods shall not change the composition, structure or color, aroma, taste, etc. of the foods (unless otherwise specified).

The quantity of additive used in food contact materials and their products shall be minimized under the premise of realizing the expected effect.

3.5 The substances listed in GB 2760, where permitted to be used as additives in food contact materials and their products, shall not generate technological function on the foods they contact.

4 Using Requirements of Additives in Food Contact Materials and Their Products

4.2 See Appendix A for food contact materials and their products allowable additives with their using requirements.

4.3 See Appendix B for the requirements of total specific migration limit.

4.4 See Appendix C for the special limitation of metallic elements.

4.5 See Appendix D for the meanings of plastic material acronyms. Appendix D describes the meanings of plastic materials and is only applicable to this standard.

4.6 See Appendix E for the retrieval catalogue ordered according to CAS No. and phonetic sequence.

Appendix A Food Contact Materials and Their Products - Allowable Additives

A.1 This appendix specifies allowable additives in various food contact materials and their products in table form. Additives in each table are ordered by the number of characters of Chinese names, numeric order and phonetic sequence of English alphabets and Chinese phonetic alphabets; meanwhile, they shall meet all those specified in each column of the table. A.2 The column of "maximum level" specifies the allowable maximum level of the additive. The column "maximum level" in the list of food contact plastic materials and their products allowable additives with their using requirements (Table A.1) also lists specific types of allowable plastic resins (expressed in acronyms). See Appendix D for the meanings of resin acronyms; specific resin types include those specified in GB 4806.6 and other approved ones. The column "SML/QM" specifies the specific migration limit or maximum residue quantity of additive. The column "SML (T)" lists the substances and corresponding limits which shall meet the requirements of total specific migration limit. The column "SML (T) Group No." list the SML (T) Group No. in Table B.1. The sum of corresponding additive migration quantities shall meet the corresponding total specific migration limit of the SML (T) Group No. in Appendix B. The unlimited "maximum level", "SML", "QM" and "SML (T)" express that there is no special limitation. Where both "SML" and "SML (T)" are unlimited, the migration of additive shall not exceed 60mg/kg. A.4 Where the additives listed in this appendix contain metallic elements listed in Table C.1, their use shall meet the special limitation for specific migration limit of metallic elements as listed in Table C.1. Some additives may have more than one CAS-No. due to the existence of isomer or uncoordinated proportion of ingredients. As for the additive with various English names, the CAS No. shall prevail; as for the additive without CAS No., the English name shall prevail. A.6 Table A.1 specifies the FCA No., English name, CAS No., use scope, maximum level, SML/QM, SML (T), SML (T) Group No. and relevant limit requirements of allowable additives in food contact plastic materials and their products. A.7 Table A.2 specifies the FCA No., English name, CAS No., maximum level, SML/QM, SML (T), SML (T) Group No. and relevant limit requirements of allowable additives in food contact paints and coatings. A.8 Table A.3 specifies the FCA No., English name, CAS No. […]

Appendix B Total Specific migration Limit [SML (T)]

Table B.1 shows the corresponding SML (T) group No., CAS No., names and SML (T) of limited substances, and limit description of total specific migration limit. Each group of substances is ordered according to CAS No. from small to large. Calculated in acetaldehyde 105-38-4 Vinyl propionate Calculated in glycol 107-21-1 1,2-ethanediol Calculated in maleic acid 110-16-7 Maleic acid (also known as maleic acid) Calculated in caprolactam 2123-24-2 Caprolactam sodium salt Calculated in the sum of substances 4066-02-8 2,2'-methylenebis(6-cyclohexyl-4-methylphenol) Calculated in iodine 7681-11-0 Potassium iodide Calculated in tertiary amine — N, N-bis(2-ethoxyl) alkyl (C8~C18) amine Calculated in the sum of substances Calculated in tin 68442-12-6 9-Octadecenoic acid (Z)-, 2-mercaptoethyl ester, reaction products with dichlorodimethylstannane, sodium sulfide and trichloromethylstannane Calculated in tin — 2-(ethyl maleic acid)-2-n-octyl tin SML (T) group No. Calculated in tin 26401-86-5 Monomethyltin tris(isooctyl mercaptoacetate) Calculated in the sum of substances 3864-99-1 2-(5-chloro-2H-benzotriazol-2-yl)-4,6-bis(1,1-dimethylethyl)-phenol Calculated in the sum of substances 119-47-1 2,2'-methylenebis(6-tert-butyl-4-methyl-phenol) Calculated in the sum of substances 693-36-7 3,3-thiodipropionic acid di-n-octadecyl ester Calculated in formaldehyde 100-97-0 Hexamethylene tetramine Calculated in boron 10043-11-5 Boron nitride (40% mass fraction) 2,2,4-trimethylhexane-1,6-diisocyanate and (60% mass fraction) 2,4,4-trimethylhexane-1,6-diisocyanate myristic acid Calculated in isocyanato SML (T) group No. Calculated in the sum of substances 68783-41-5 Dimer acid, hydrogenated Calculated in sulfur dioxide 7757-83-7 Sodium sulfite Calculated in the sum of substances 1034-01-1 Octyl gallate Calculated in trimellitic acid 552-30-7 Trimellitic anhydride Calculated in propenoic acid Calculated in propenoic acid Calculated in methylpropenoic acid SML (T) group No. Calculated in the sum of substances 110675-26-8 2,4-bis(dodecylthiomethyl)-6-methylphenol Sum of 2-(6-methylheptoxy)-2-oxo-ethanethiolate and diisooctyl 2,2'- [(didodecylstannylene)bis(thio)]di; […]

Appendix C Special Limitation of Metallic Elements

As for the allowable substances containing the metallic elements listed in Table C.1, the usage shall also meet the special limitation of specific migration limit for metallic elements in Table C.1; the specific migration limit of metallic elements listed in Table C.1 is only applicable to the substances containing these metallic elements approved by this standard; at the same time, when using two types of or above substances containing same metallic element, the sum of migration of the metallic element shall meet the requirements of Table C.1.

Appendix D Meanings of Acronyms for Plastic Materials in Table A.1

Meanings of acronyms for plastic materials in Table A.1 of Appendix A are detailed in Table D.1.

Appendix E Search Directory of Additives for Food Contact Materials and

Table E.1, in the order of CAS No. from small to large, lists the CAS-No., Chinese names, FCA-No. and pages of additives listed in Appendix A. The additives without CAS-No. are listed in the end of Table E.1 and ordered by the number of characters of Chinese names, numeric order and phonetic sequence of English alphabets and Chinese phonetic alphabets. Table E.2 lists the Chinese names, CAS-No., FCA-No. and pages of the additives listed in Table A by the number of characters of Chinese names, numeric order and phonetic sequence of English alphabets and Chinese phonetic alphabets.

2025XG1 Amendment No. 1

This amendment is approved by National Health Commission of the People’s Republic of China and State Administration for Market Regulation as No.2 Order on March 16, 2025. It shall be implemented since March 16, 2025.

1. Amend the content of clause A.12 to "Table A.7 specifies the range of use, FCA No., Chinese name, CAS No., max. level, SML/QM, SML(T), SML(T) group No. and related restrictive requirements of additives allowed in other food contact materials and products (such as silicone rubber). Additives allowed for rubber specified in GB 9685-2008 can also be used in the production of silicone rubber."

2. Amend the content of clause A.13 item b) to "Substances listed in Table A.2 of GB 2760- 2014, in the case of not producing technical functions for the food itself, their use meets the relevant requirements of this Standard;"

3. In Table A.6 Additives allowed for use and usage requirements in food contact paper and paperboard materials and products, it shall be amended from:

group No. CAS No. Chinese name FCA No.

5. In Table A.1 Range of use and maximum usage of additives allowed in food contact plastic materials and products, it shall be amended as follows:

CAS No. Range of use and max. level (before amendment) Range of use and max. level (after amendment) PPE, PBT: Use in appropriate amount according to production needs; PBT, PMMA, POM, PU, PPS, PEI:1 PBT: Use in appropriate amount according to production needs; PMMA, POM, PU, FCA No. Chinese name CAS No.

a Chinese name in “Appendix E Search Directory of Additives for Food Contact Materials and Products”.

Max. level/ FCA No. Chinese name CAS No. group No.

Chinese name CAS No. group No.

Max. level/ FCA No. Chinese name CAS No.

Max. level/ FCA No. Chinese name CAS No.

CAS No. Chinese name FCA No.

Addition of Table B.1 is as follows:

Max. level/ CAS No. group No.

Use in appropriate 1 (by isocyanate, QM); 5 amount according to production needs group No. Chinese name Name of limited substance Limit description group No.

Addition of Table D.1 is as follows:

1,3-Bis(isocyanatomethyl)benzene [SML(T) is applicable to its hydrolysis product 1,3-Bis(aminomethyl)benzene] By 1,3- Bis(aminomethyl) benzene Crotonic acid 3-hydroxybutyric acid-3-hydroxyvaleric acid copolymer By crotonic acid Poly (R)-3-hydroxybutyrate-co-(R)-3-hydroxyhexanoate Limit description No. Acronym or Chinese name English name