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GB 4806.16-2025National Food Safety Standard — Food Contact Silicone Rubber Materials and Products (English PDF)

食品安全国家标准 食品接触用硅橡胶材料及制品

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Issued by

National Health Commission / SAMR

Level / Type

National · Mandatory

Issue date

September 2, 2025

Implementation date

September 2, 2026

Scope

GB 4806.16-2025 is the English-translated version of 食品安全国家标准 食品接触用硅橡胶材料及制品.

Specifies safety requirements for silicone rubber materials and products intended for food contact, covering raw material requirements, sensory standards, physical and chemical indicators, and migration testing.

Document preview — GB 4806.16-2025

National Standard of the People's Republic of China

Issued by: National Health Commission of the People’s Republic of China; State Administration for Market Regulation.

Contents

  • Foreword2
  • 1 Scope3
  • 2 Terms and Definitions3
  • 3 Basic Requirements3
  • 4 Technical Requirements3
  • 5 Others4
  • Appendix A Permitted Basic Raw Materials and Usage Requirements for Silicone Rubber
  • Appendix B Determination of Volatile Substances

Foreword

This Standard serves as a replacement for GB 4806.11-2016 National Food Safety Standard - Food Contact Rubber Materials and Articles regarding the relevant requirements for silicone rubber materials and products.

In comparison with the above-mentioned standard, the main technical changes are as follows:

---The terms and definitions are modified;

---The requirements for raw materials are modified;

---The physical and chemical indicators are modified, and volatile substances are added;

---The migration test requirements are modified;

---The requirements for label identification are modified;

---Appendix B - Determination of Volatile Substances is added.

1 Scope

This Standard is applicable to silicone rubber materials and products for food contact.

2 Terms and Definitions

Under the intended use conditions, materials and products primarily made from organosilicon elastomers formed by the cross-linking and curing reaction of polysiloxane polymers and hydrophobic silica, which have come into or may come into contact with food or food additives, or whose components may transfer into food.

3 Basic Requirements

Silicone rubber materials and products for food contact shall comply with the provisions of GB 4806.1.

4 Technical Requirements

4.1 Requirements for Raw Materials

4.2 Sensory Requirements

The sensory requirements for silicone rubber materials and products for food contact shall comply with the provisions of Table 1.

The immersion solution obtained from the migration test shall not exhibit any deterioration in sensory properties, such as discoloration, turbidity, precipitation and unusual odor

4.3 Physical and Chemical Indicators

4.3.1 General physical and chemical indicators

The general physical and chemical indicators of silicone rubber materials and products for food contact shall conform to the provisions of Table 2.

a For silicone rubber materials and products intended for infant and toddler food contact, the results shall be converted to mg/kg based on the area-to-volume ratio in practical use, and the limit is ≤ 60 mg/kg.

4.3.2 Other Physical and chemical indicators

4.3.2.1 Silicone rubber materials and products for food contact shall comply with the provisions of physical and chemical indicators in Appendix A and relevant announcements regarding the specific migration limits (SML), total specific migration limits [SML(T)] and maximum permitted quantity (QM) of the basic raw materials used.

4.3.2.2 Silicone rubber materials and products for food contact shall comply with the provisions of physical and chemical indicators in GB 9685 and relevant announcements regarding the SML, SML(T) and QM of the additives used.

5 Others

5.1 Migration Test

5.1.1 General requirements

The migration test shall be conducted in accordance with the provisions of GB 31604.1 and GB 5009.156. Where this Standard has special provisions, those provisions shall prevail.

5.1.2 Special requirements

The test conditions of total migration for silicone rubber materials and products with an expected contact temperature (T) not exceeding 40°C and a contact time (t) not exceeding 24 h shall conform to the provisions of Table 3.

5.2 Label Identification

Label identification shall comply with the provisions of GB 4806.1.

Appendix A Permitted Basic Raw Materials and Usage Requirements for Silicone Rubber

A.1 Table A.1 specifies the permitted basic raw materials and usage requirements for silicone rubber materials and products for food contact. The basic raw materials listed in Table A.1 are identified by their CAS numbers; for those without CAS numbers, their Chinese names shall prevail. A.2 Substances with a relative molecular mass greater than 1,000 Da, formed by polymerization or other modes from the basic raw materials listed in Table A.1, such as monomers, other starting materials and base polymers, are also permitted as the basic raw materials for silicone rubber materials and products for food contact, and shall comply with the restrictive requirements for the corresponding monomers, other starting materials and base polymers, etc. A.3 For polymers synthesized in Table A.1, where the monomers and other starting materials are acids, alcohols or phenols, their sodium, potassium, and calcium salts (including acid salts and double salts) may also be used in the synthesis of the corresponding polymers, provided they comply with the restrictive requirements for the corresponding acid, alcohol, or phenol monomers and other starting materials. The sodium, potassium, and calcium salts (including acid salts and double salts) of the monomers and other starting materials listed in Table A.1 shall be used in accordance with the provisions of this Standard. […]

Appendix B Determination of Volatile Substances

B.1 Scope

This Standard specifies the method for determining volatile substances in silicone rubber materials and products for food contact.

This Standard applies to the determination of volatile substances in silicone rubber materials and products for food contact.

B.2 Principle

After the pre-treatment of silicone rubber materials and products for food contact, determine the mass loss of the specimen under normal pressure and after heating and baking at a certain temperature and time, and obtain the amount of volatile substances in the silicone rubber materials and products for food contact under the corresponding conditions.

B.3 Reagents and Materials

B.3.1 Reagents

Water: Grade III water conforming to the provisions of GB/T 6682.

B.3.2 Materials

B.3.2.1 Containers: watch glass, evaporating dish, weighing dish, crucible, etc.

B.3.2.2 Weighing dish: made of aluminum, flat shape.
B.3.2.3 Desiccator: with desiccant.

B.4 Instruments and Equipment

B.4.1 Electronic balance: with a division value of 0.1 mg.

B.4.2 Electric blast drying oven: with a temperature control accuracy of (100 ± 2) °C and a temperature control accuracy of (200 ± 3) °C.

B.5 Analytical Procedures

B.5.1 Sample pre-treatment

Immerse the nipple-type sample in gently boiling water for 10 minutes and stir it at intervals to ensure that the sample does not contact the container wall. […]

B.5.2 Specimen preparation

Cut the sample into fragments with length, width and thickness not exceeding 2 cm. Place the fragments in a suitable container and ensure that they do not overlap. Place the container containing the sample fragments in the electric blast drying oven at (100 ± 2) °C and dry for (60 ± 5) minutes. […]

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This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 10 pages — is available in the English PDF.

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