This standard supersedes "Hygienic Standard for Foodstuff Rubber Products" (GB 4806.1-1994) and "Announcement on Publishing the List of 107 Kinds of Resins Available for Food Package Materials such as polytetramethylene adipamide (Announcement No.23 [2011] of the former Ministry of Health) with regard to rubber polymer.
Compared with the above standard and announcement, the main changes in this standard are as follows:
- The standard name is revised as "National Food Safety Standard - Food Contact Rubber Materials and Articles";
- Scope is modified;
- Basic requirements are added;
- Raw material requirements are added;
- Physical and chemical indexes are modified;
- Requirements for migration test are added;
- Label identification requirements are added;
- Appendix A is added.
National Food Safety Standard
Food Contact Rubber Materials and Articles
食品安全国家标准
食品接触用橡胶材料及制品
1 Scope
This standard is applicable to food contact materials and articles with natural rubber, synthetic rubber (including vulcanized thermoplastic elastomer) and silicon rubber as major raw materials.
2 Terms and Definitions
2.1 Natural rubber
Cis-1,4-polyisoprene obtained from plant-origin Hevea rubber.
2.2 Silicon rubber
The silicone elastomer sulfurized by such substances as polysiloxane base polymer and hydrophobic silica under heating and pressuring.
3 Basic Requirements
Food contact rubber materials and articles shall be in accordance with those specified in GB 4806.1.
4 Technical Requirements
4.1 Raw material requirements
Application of natural rubber, synthetic rubber and silicon rubber raw materials in the food contact rubber materials and articles shall be in accordance with those specified in Appendix A and relevant announcement and the application of the vulcanized thermoplastic elastomer resin shall be in accordance with those specified in Appendix A of 4806.6-2016 and relevant announcement.
4.2 Sensory requirements
Sensory requirements shall be in accordance with those specified in Table 1.
Table 1 Sensory Requirements
Item Requirement
Sensory inspection Normal color and luster, and free from abnormal odor and dirt
Soak solution The soak solution obtained from migration test shall be free from sensory deterioration such as coloration, turbidity, precipitation and abnormal odor.
4.3 Physical and chemical indexes
4.3.1 Physical and chemical indexes shall be in accordance with those specified in Table 2.
Table 2 Physical and Chemical Indexes
Item Index Inspection method
Overall migration/(mg/dm2)a ≤ 10 GB 31604.8
Potassium permanganate consumption/(mg/kg)
Water (60℃, 0.5h) ≤ 10 GB 31604.2
Heavy metal (calculated in Pb)/(mg/kg)
4% acetic acid (volume fraction)(60℃, 0.5 h) ≤ 1 GB 31604.9
a As for rubber materials and articles in contact with foods for infants, the result shall be converted into mg/kg according to the area volume ratio in actual use, and the limit shall be less than or equal to 60mg/kg.
4.3.2 Specific migration limit, total specific migration limit and maximum residue limit of monomer and other starting materials of natural rubber, synthetic rubber and silicone rubber shall be in accordance with the requirements of Appendix A and relevant announcement, while specific migration limit, total specific migration limit and maximum residue limit of monomer and other starting materials of the vulcanized thermoplastic elastomer shall be in accordance with the requirements of Appendix A of GB 4806.6-2016 and relevant announcement.
4.4 Additive
Additive shall be in accordance with the requirements of GB 9685 and relevant announcement.
5 Other
5.1 Migration test
5.1.1 General requirements
Unless otherwise expressly stated in this standard, migration test shall be in accordance with the requirements of GB 31604.1 and GB 5009.156.
5.1.2 Food simulants
50% ethanol solution (volume fraction) shall be selected as the food simulants of the fatty foods and the selection of other food simulants shall be in accordance with the requirements of GB 31604.1.
5.1.3 Total migration test condition
Selection of total migration test condition of rubber materials and articles with the food contact temperature (T) and food contact time (t) of no less than 40℃ and 24h respectively shall be in accordance with those specified in Table 3 and the selection of the total migration test condition under other service conditions shall be in accordance with those specified in 5.2 of GB 31604.1-2015.
Table 3 Total Migration Test Condition
Expected service condition Migration test condition
T≤40℃, t≤10min 40℃, 10min
T≤40℃, 10min
Contents of GB 4806.11-2016
Foreword I
1 Scope
2 Terms and Definitions
3 Basic Requirements
4 Technical Requirements
5 Other
Appendix A Raw Material Requirements for Food Contact Rubber Materials and Products
