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GB 4806.11-2023National food safety standard - Rubber materials and products for food contact (English PDF)

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Issued by

NHC; SAMR

Level / Type

National · Mandatory

Issue date

September 6, 2023

Implementation date

September 6, 2024

Scope

GB 4806.11-2023 (National food safety standard - Rubber materials and products for food contact) is available as an English-translated PDF.

GB 4806.11-2023 — This standard is applicable to the food contact rubber materials and articles.

Document preview — GB 4806.11-2023

National Standard of the People's Republic of China

Issued by: NHC; SAMR

Contents

  • Foreword...3
  • 1 Scope...4
  • 2 Terms and definitions...4
  • 3 Basic requirements...4
  • 4 Technical requirements...4
  • 5 Others...6

Foreword

This standard replaces GB 4806.11-2016 National food safety standard - Food contact

rubber materials and articles with respect to the relevant requirements for rubber

materials and articles, as well as the Announcement No.14 [2013], Announcement No.14

[2014], Announcement No.5 [2016] and Announcement No.7 [2016] of the former National

Health and Family Planning Commission of the People's Republic of China and the

Announcement No.4 [2020] of the National Health Commission of the People's Republic

of China with respect to the basic raw materials for rubber.

The following main changes have been made with respect to the above standard and

announcements.

— The clause "Scope" has been modified;

— The clause "Terms and definitions" has been modified;

— The requirements for raw materials have been modified;

— The physical and chemical indexes have been modified;

— Other technical requirements have been added;

— The requirements for migration test have been modified;

— Annex A has been modified.

National food safety standard - Food contact rubber

materials and articles

1 Scope

This standard is applicable to the food contact rubber materials and articles.

2 Terms and definitions

2.1

food contact rubber materials and articles

materials and articles mainly made of natural rubber, synthetic rubber or vulcanized

thermoplastic elastomers, which have been or are intended to be in contact with food or

food additives or whose components may be transferred to food under normal conditions

of use

3 Basic requirements

The food contact rubber materials and articles shall meet the requirements of GB 4806.1.

4 Technical requirements

4.1 Requirements for raw materials

4.2 Sensory requirements

The sensory requirements for food contact rubber materials and articles shall meet those

specified in Table 1.

4.3 Physical and chemical indexes

4.3.1 General physical and chemical indexes

The general physical and chemical indexes of food contact rubber materials and articles

shall meet those specified in Table 2.

4.3.2 Other physical and chemical indexes

4.4 Other technical requirements

The food contact rubber materials and articles that use coatings, inks and/or adhesives

shall also comply with the corresponding national food safety standards for coatings, inks

and/or adhesives.

5 Others

5.1 Migration test

5.1.1 General requirements

The migration test shall be carried out in accordance with those specified in GB 31604.1

and GB 5009.156, unless there are special requirements in this standard.

5.1.2 Special requirements
5.1.2.1 Food simulants containing grease

Vegetable oils shall be selected as food simulants for foods containing grease according

to GB 31604.1.If it is technically infeasible to use vegetable oil for migration test of

materials or articles, or if changes in physical properties (deformation, melting and

swelling) that will not occur under normal conditions of use have occurred, 50% ethanol

solution (volume fraction) may be selected as food simulant. When 50% ethanol solution

(volume fraction) is used as food simulant, the correction factor for food simulants

containing grease and that for fat do not apply.

5.1.2.2 Overall migration test

The conditions of overall migration test for rubber materials and articles with food contact

temperature (T) not exceeding 40 degrees C and contact time (t) not exceeding 24h shall be

selected in accordance with those specified in Table 3.

5.1.2.3 Number of potassium permanganate consumption tests

When reused food contact rubber materials and articles are subjected to the potassium

permanganate consumption test, the same specimen shall be subjected to three migration

tests, using a new food simulant each time, and the result of the third migration test shall

be taken as the test result. If there is evidence that the migration in the first migration test

does not exceed the migration limit and that in the second and third migration tests will not

increase, the result of the first migration test shall be taken as the test result.

5.2 Labels

5.2.1 The labels shall meet the requirements of GB 4806.1.
5.2.2 If the product contains natural latex, it shall have a label indicating "the product

contains natural latex" or similar terms.

Annex A

Allowable basic raw materials in food contact rubber materials and

articles and their application requirements

A.1 Table A.1 specifies the allowable basic raw materials (such as natural rubber and

synthetic rubber) in food contact rubber materials and articles and their application

requirements. The basic raw materials listed in Table A.1 are based on their CAS No., and

for those without CAS No., their English names are used as references.

A.2 Substances with a relative molecular mass greater than 1,000 Da formed by

polymerization or other means from the basic raw materials such as monomers, other

starting materials and base polymers listed in Table A.1 are also allowed to be used as

basic raw materials for food contact rubber materials and articles, and shall meet the

restrictive requirements for the corresponding monomers, other starting materials and

base polymers and other basic raw materials.

A.3 The total specific migration limit [SML(T)] and SML(T) grouping number in GB 9685

apply to this standard.

A.4 If monomers and other starting materials used in the synthesis of polymers in Table

A.1 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 corresponding polymers,

and shall meet the restrictive requirements for corresponding acid, alcohol or phenolic

monomers and other starting materials. Sodium, potassium and calcium salts (including

acid salts and double salts) of monomers and other starting materials listed in Table A.1

shall be used according to the requirements of this standard.

Table A.1 -- Allowable basic raw materials in food contact rubber materials and articles and their application requirements

S.N. Name CAS No.

......

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

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