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This document is developed in accordance with the rules given in GB/T 1.1-2020 Directives for standardization — Part 1: Rules for the structure and drafting of standardizing documents.
This document replaces GB/T 22114-2008 Humectants for toothpastes — Glycerin and macrogol. The following technical changes have been made with respect to GB/T 22114-2008:
——The scope has been revised (see Clause 1 herein; Clause 1 of Edition 2008);
——The normative references have been revised (see Clause 2 herein; Clause 2 of Edition 2008);
——The glycerin product classification has been revised (see 4.2 herein; 3.1 of Edition 2008);
——The original Table 1 has been divided into “Table 1 Sensory, physical and chemical indexes” and “Table 2 Toxic substance limit indexes” (see Table 1 and Table 2 herein, Table 1 of Edition 2008);
——The reducing substances indexes in Table 1 have been deleted (see Table 1 of Edition 2008);
——The saponification equivalent index in Table 1 has been revised (see Table 1 herein; Table 1 of Edition 2008);
——The diethylene glycol indexes and related compounds have been revised (see Table 2 herein, Table 1 of Edition 2008);
——The ignition residue index has been revised (see Table 3 herein, Table 2 of Edition 2008);
——The original Table 2 has been divided into “Table 3 Sensory, physical and chemical indexes” and “Table 4 Toxic substance limit indexes” (see Table 3 and Table 4 herein, Table 2 of Edition 2008);
——The indexes of ethylene glycol, diethylene glycol and triethylene glycol have been divided (see Table 4 herein, Table 2 of Edition 2008);
——The arsenic index has been revised (see Table 4 herein, Table 2 of Edition 2008);
——The indexes and determination methods of dioxane, ethylene oxide and formaldehyde have been added (see Table 4, 5.3.6 and 5.3.7 herein);
——The determination method of glycerol content has been revised (see 5.2.4 herein, 4.1.4 of Edition 2008);
——The test method of average molecular weight has been revised (see 5.3.2 herein, 4.2.2 of Edition 2008);
——The test methods of ethylene glycol, diethylene glycol and triethylene glycol (see 5.3.4 herein, 4.2.4 of Edition 2008);
——The requirement of shelf life has been added (see 7.5 herein, 6.4 of Edition 2008).
Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. The issuing body of this document shall not be held responsible for identifying any or all such patent rights.
This document was proposed by the China National Light Industry Council.
This document is under the jurisdiction of the National Technical Committee on Oral Care Products of Standardization Administration of China (SAC/TC 492).
The previous editions of this document and documents replaced by this document are as follows:
——This standard was first issued in 2008 (GB 22114-2008);
——This edition is the first revision.
Humectants for toothpastes — Glycerin and polyethylene glycol
1 Scope
This document specifies the requirements, test methods, inspection rules, packaging, marking, transportation, storage and shelf life of glycerin and polyethylene glycol in humectants for toothpaste.
This document is applicable to glycerin and polyethylene glycol with relative molecular weight of 200 ~ 8000 in humectants for toothpaste.
2 Normative references
The following documents, in whole or in part, are normatively referenced in this document and are indispensable for its application. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.
GB/T 191 Packaging — Pictorial Marking for Handling of Goods
GB/T 601 Chemical reagent — Preparations of reference titration solutions
GB/T 602 Chemical reagent — Preparations of standard solutions for impurity
GB/T 603 Chemical reagent — Preparations of reagent solutions for use in test methods
GB/T 6678 General principles for sampling chemical products
GB/T 6679 General rules for sampling solid chemical products
GB/T 6680 General rules for sampling liquid chemical products
GB/T 6682 Water for analytical laboratory use — Specification and test methods
GB/T 13216 Test methods for glycerine
GB/T 35919 Oral cavity nursing materials classifications and terms
JJF 1070 Rules of metrological testing for net quantity of products in prepackages with fixed content
Measures for the metrological supervision and administration of quantitatively packed commodities ([2005] No.75 Decree of the General Administration of Quality Supervision, Inspection and Quarantine of the People's Republic of China)
Pharmacopoeia of the People's Republic of China (Edition 2015, Volume IV)
3 Terms and definitions
For the purposes of this document, the terms and definitions given in GB/T 35919 apply.
4 Requirements
4.1 Glycerin
Sensory, physical and chemical indexes and toxic substance limit indexes of glycerin shall meet the requirements of Table 1 and Table 2.
4.2 Polyethylene glycol
Sensory, physical and chemical indexes and toxic substance limit indexes of polyethylene glycol shall meet the requirements of Tables 3 and Table 4.
Table 1 Sensory, physical and chemical indexes of glycerin
Item Index
Saponification or hydrolysis Fermentation
Sensory index Appearance (transparency) Transparent, free of suspended substance or sediment
Odor No peculiar smell
Color (Hazen) ≤30 ≤20
Physical and chemical indexes Glycerin content (mass fraction)/% ≥98.0 ≥95.0
Density (20°C)/(g/mL) ≥1.2559 ≥1.2481
Chloride (mass fraction, calculated by Cl)/% ≤0.01 ≤0.001
Sulfated ash (mass fraction)/% ≤0.01
Acidity or alkalinity /(mmol/100g) ≤0.10
Saponification equivalent /(mmol/100g) ≤1.0 —
Ferric salt (calculated by Fe) /(mg/kg) — ≤2
Table 2 Toxic substance limit indexes of glycerin
Item Index
Toxic substance limit Diethylene glycol and related compounds (mass fraction)/% ≤1.0 (refers to the sum of diethylene glycol and related impurities, and the content of single impurity is ≤0.1 respectively)
Heavy metal content (calculated by Pb)/(mg/kg) ≤5
Arsenic content (calculated by As)/(mg/kg) ≤2
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Table 3 Sensory, physical and chemical indexes of polyethylene glycol
Item Index
Sensory index Appearance It is colorless or almost colorless, clear viscous liquid, or translucent waxy soft matter, or white waxy solid sheet or granular powder
Physical and chemical indexes Average molecular weight 200~8000
pH value 4.0~7.5
Ignition residue (mass fraction)/% ≤0.1
Table 4 Toxic substance limit indexes of polyethylene glycol
Item Index
Toxic substance limit Ethylene glycol, diethylene glycol and triethylene glycol (mass fraction)/% ≤0.25 (average molecular weight below 400, sum of ethylene glycol and diethylene glycol)
≤0.1 (average molecular weight 400 and above, each item)
Ethylene oxide /(mg/kg) ≤1
Dioxane /(mg/kg) ≤10
Formaldehyde /(mg/kg) ≤30
Heavy metal (calculated by Pb)/(mg/kg) ≤5
Arsenic content (calculated by As)/(mg/kg) ≤2
4.3 Net content
The net content of the packaged products of humectants for toothpaste shall meet the requirements of Measures for the metrological supervision and administration of quantitatively packed commodities.
Foreword i
1 Scope
2 Normative references
3 Terms and definitions
4 Requirements
5 Testing methods
6 Inspection rules
7 Packaging, marking, transportation, storage and shelf life
