GB 4806.11-2023 (English Version)

Standard No.: GB 4806.11-2023
Language: Chinese, English version preview
Release Date: 2023
Published By: General Administration of Quality Supervision, Inspection and Quarantine of the People‘s Republic of China
Latest: GB 4806.11-2023
Replace By: GB 4806.11-2016

Introduction

GB 4806.11-2023 Standard Interpretation

1. Background of Standard Revision

GB 4806.11-2023 is a comprehensive revision of the old version of "National Food Safety Standard Food Contact Rubber Materials and Products" (GB 4806.11-2016), and also replaces the former National Health and Family Planning Commission's Announcement No. 14 and related standards. This revision focuses on solving the following problems:

The scope of rubber materials and products has been adjusted
The migration test requirements and physical and chemical indicator system have been improved
Technical restrictions on specific substances (such as N-nitrosamines) have been added

II. Comparative Analysis of Standard Frameworks

Items	Requirements of the 2016 version	New/modified content of the 2023 version
Scope Definition	Food additive contact scenarios are not clearly involved	Clear provisions on food additive contact have been added
Migration test conditions	Using vegetable oil as a food simulant	Added ethanol solution as an alternative, and relaxed restrictions on use in specific scenarios
Physical and chemical index requirements	Not fully covering the detection of trace substances such as N-nitrosamines	Increased strict restrictions on the total migration of aromatic primary amines and N-nitrosamines

III. Detailed explanation of technical requirements

1. Raw material management and safety specifications

GB 4806.11-2023 clarifies the basic raw material usage specifications for rubber materials:

Natural rubber and synthetic rubber must comply with Appendix A and the provisions of the announcement
Vulcanized thermoplastic elastomers must comply with the requirements of GB 4806.7-2023
The use of additives must comply with GB 9685 and its announcement requirements

2. Sensory and physical and chemical indicators

Table 1 and Table 2 specify the sensory requirements and general physical and chemical indicators in detail:

Item	Indicator requirements	Test method
*Total migration amount/(mg/dm²)**	≤10	GB 31604.8
Potassium permanganate consumption/(mg/kg)	≤20	GB 31604.2

3. Migration test requirements

Migration tests are divided into general requirements and special requirements:

Food simulants containing fats and oils must be vegetable oils. When the technology is not feasible, 50% ethanol solution can be used
Specify the total migration test conditions under different use temperatures and times (see Table 3)
Potassium permanganate consumption test requires three independent migration tests

IV. Implementation Recommendations and Compliance Paths

1. Material Selection and Procurement

Enterprises should:

Give priority to basic raw materials that meet the requirements of Table A.1
Strictly review the list of additives used to ensure compliance with the requirements of GB 9685
Establish a qualification review mechanism for raw material suppliers

2. Quality Inspection and Verification

Recommendations:

Establish an internal physical and chemical index testing laboratory equipped with professional equipment (such as HPLC, GCMS)
Perform migration tests and sensory index monitoring regularly
For specific substances (such as aromatic primary amines, N-nitrosamines), select professional institutions to conduct trace analysis

3. Labeling and identification management

Notes:

Must indicate "the product contains natural latex" or similar warnings (if applicable)
Label information must comply with GB 4806.1, including production date, shelf life, etc.
It is recommended to provide a compliance statement and a summary of migration test results in a prominent position on the packaging

4. Training and system optimization