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China - Proposed to Update GB 4806.11 on Food Contact Rubber Materials and Articles

The National Health Commission of the People’s Republic of China (NHC) has proposed a new version of GB 4806.11 and shall replace 2016 version on food contact rubber materials and articles. Expiration date: Nov 20,2021.

The following are the highlight:

1. General requirements
Food contact rubber materials and articles shall meet the requirements of GB 4806.1.

2. Raw materials requirements

  1. For food contact rubber materials and articles with natural rubber and synthetic rubber as the main raw materials, the use of basic raw materials shall comply with the provisions of Appendix A and related announcements.
  2. For food contact rubber materials and articles with vulcanized thermoplastic elastomer as the main raw material, the use of basic raw materials shall comply with the requirements of Appendix A of the Plastic Standard and related announcements.
  3. The use of additives in food contact rubber materials and articles shall meet the requirements of GB 9685 and related announcements.

3. Sensory properties

Item Requirement
Sensory properties The colour shall be normal, and there is no odour, dirt.
Soaking solutions The soaking solutions obtained in the migration test shall be free from sensory performance deterioration such as coloring, turbidity, precipitation, peculiar smell and others.

4. Chemical requirements
a.

Item Limit Detection method
Total migration a 10 mg/dm2 GB 31604.8
Consumption of potassium permanganate
Distilled water (60℃, 0.5h)       
≤10 mg/kg GB 31604.2
Heavy metals (as Pb)
4% acetic acid (volume fraction) (60℃, 0.5h)
≤1 mg/kg GB 31604.9
Total migration of primary aromatic amine b Not detected
(Detection limit=0.01mg/kg)
GB 31604.52
Migration of N-nitrosamine and N-nitrosamine product c
N-nitrosamine
N-nitrosamine product
  ≤ 0.01 mg/kg
≤ 0.1 mg/kg
Determination of the migration of N-nitrosamine and N-nitrosamine products in food contact materials and articles
a. Rubber materials and articles that come into contact with infant food shall be converted into mg/kg according to the area-to-volume ratio in actual use, and the limit shall be ≤60 mg/kg.
b. Only applicable to food contact rubber materials and articles that use amine antioxidants and azo colorants. The migration limits of primary aromatic amine are specified in Appendix A of this standard, Appendix A of the Plastics Standard, GB 9685 and related. announcements, and their limits shall meet the relevant regulations.
c. Only applicable to food contact rubber materials and articles that use vulcanization accelerators.

b. Food contact rubber materials and articles made with natural rubber and synthetic rubber as main raw materials shall comply with the specific migration limit (SML), specific migration total limit [SML(T)], Maximum residue (QM) and other chemical indicators of the raw materials in Appendix A and related announcements. Food contact rubber materials and articles made with vulcanized thermoplastic elastomer as the main raw material shall comply with the Appendix A of Plastic Standard and related announcements on the physical and chemical indicators of the raw materials, such as SML, SML(T), QM, etc.

c. Additives in food contact rubber materials and articles shall meet the requirements of GB 9685 and related announcements on the physical and chemical indicators of such as SML, SML(T), QM, etc.

5. Other requirements

Food contact rubber materials and articles that use coatings, inks and (or) adhesives shall also comply with the relevant national food safety standards for coatings, inks and (or) adhesives.

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