GB 9685-2016 National Food Safety Standard Standard for Uses of Additives in Food Contact Materials and Their Products
1 Scope
This standard specifies the using principles of additives in food contact materials and their products 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
2.1 Additives in food contact materials and their products
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.
2.2 Maximum usage quantity
The maximum allowable quantity of certain kind or type of additive added during the production of food contact materials and their products is expressed in mass fraction (%).
2.3 Maximum residue quantity (QM)
The maximum allowable quantity of certain kind or type of residue in food contact materials and their products, expressed by the amount of residue (in milligram) in each kilogram of food contact materials and their products (mg/kg) or by the amount of residue (in milligram) in each square decimeter of contact area between food contact materials/their products and foods (mg/dm2).
2.4 Specific migration limit (SML)
The maximum allowable quantity of certain kind or type of additive migrating from food contact materials and their products to foods or food simulants contacting them, expressed by the quantity of substance (in milligram) migrating from each kilogram of foods or food simulants (mg/kg) or by the quantity of substance (in milligram) migrating from each square decimeter of contact area between food contact materials/their products and foods or food simulants (mg/dm2).
2.5 Total specific migration limit [SML (T)]
The total maximum allowable quantity of two or more kinds of additives migrating from food contact materials and their products to foods or food simulants contacting them, expressed by the quantity of the specified kind or type of migrated substance (or group) (in milligram) in each kilogram of foods or food simulants (mg/kg) or by the quantity of the specified kind or type of migrated substance (or group) (in milligram) in each square decimeter of contact area between food contact materials/their products and foods or food simulants (mg/dm2).
2.6 CAS No. (chemical abstract service)
Chemical Abstract Service Registry Number.
2.7 Not detectable (ND)
The analyzed target substance shall not be detected out where the analysis method with specified detection limit (DL) is adopted.
2.8 FCA No.
Chinese number of additives in food contact materials and their 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).
3.3 The quantity of additive used in food contact materials and their products shall be minimized under the premise of realizing the expected effect.
3.4 The used additive shall meet corresponding quality specification requirements.
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
4.1 The use of additives in food contact materials and their products shall simultaneously meet the requirements of Appendixes A, B and C.
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 with Their Using Requirements
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.
A.3 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.
A.5 Some additives may have more than one CAS No.s 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., maximum level, SML/QM, SML (T), SML (T) Group No. and relevant limit requirements of allowable additives in food contact rubber materials and their products.
A.9 Table A.4 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 printing ink used for food contact materials and their products.
A.10 Table A.5 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 adhesives used for food contact materials and their products.
A.11 Table A.6 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 paper and board materials and their products.
A.12 Table A.7 specifies the use scope, FCA No., English name, CAS No., maximum level, SML/QM, SML (T), SML (T) Group No. and relevant limit requirements of allowable additives in other food contact materials and their products (such as silicon rubber).
A.13 In addition to the additives listed in this appendix, the substances complying with the following requirements may also be used as additives in food contact materials and their products:
a) Where there is no chemical reaction, the use of mixtures of substances listed in Tables A.1~A.7 shall meet relevant requirements of all additive thereof;
b) Where no technological function is generated on the foods, the use of substances listed in Table A.2 of GB 2760 shall meet relevant requirements of this standard;
c) As for the acids, alcohols or phenols listed in this appendix, their sodium salt, hoevellite and calcium salt (including acid salt and double salt) may also be used and shall meet the limit requirements of corresponding acid, alcohol or phenol additives; the use of sodium salt, hoevellite and calcium salt (including acid salt and double salt) listed in this standard shall meet the requirements of this standard;
d) The use of the substances containing crystal water listed in this appendix shall meet the limit requirements of corresponding substances;
e) As for the polymers (except the macromolecular substance generated through microbial fermentation) with molecular weight greater than 1000Da and permitted to be used in food contact materials and their products in China, their use shall meet the limit requirements of corresponding polymers.
