Codeofchina.com is in charge of this English translation. In case of any doubt about the English translation, the Chinese original shall be considered authoritative.
This standard is developed in accordance with the rules given in GB/T 1.1-2009.
This standard replaces GB 8372-2008 Toothpaste and the following main technical changes have been made with respect to GB 8372-2008:
——Normative references were modified (see Chapter 2; Chapter 2 of 2008 edition);
——Definition of toothpaste was modified (see 3.1; 3.1 of 2008 edition);
——Contents of safety requirements were added (see 4.1);
——The requirements of pH value in physical and chemical indexes were modified (see Table 2; Table 2 of 2008 edition);
——The requirements of pH value lower than that of product in 5.5 in physical and chemical indexes were added (see note a of Table 2);
——The contents of soluble fluorine or free fluorine content selection method basis in physical and chemical indexes were added (see note b of Table 2);
——The requirements of absolute difference between parallel determined values in pH test method were modified (see 5.5.3; 5.5.3 of 2008 edition);
——Determination method of soluble fluorine or free fluorine content was modified (see 5.8; 5.8 of 2008 edition);
——The contents of marking were modified (see Chapter 7; Chapter 7 of 2008 edition);
——The contents of transportation and storage were added (see Chapter 8);
——The errors in A.1.1 were corrected (see A.1.1; A.1.1 of 2008 edition);
——Annex B was deleted (Annex B of 2008 edition).
This standard was proposed by China National Light Industry Council.
This standard is under the jurisdiction of National Technical Committee 492 on Oral Cavity Nursing Materials of Standardization Administration of China (SAC/TC 492).
The previous editions of the standard replaced by this standard are as follows:
——GB 8372-1987, GB 8372-1995, GB 8372-2001 and GB 8372-2008.
Toothpaste
1 Scope
This standard specifies the terms and definitions, requirements, test methods, inspection rules, marking, transportation and storage of toothpaste.
This standard is applicable to the toothpaste for oral cavity cleaning and nursing.
2 Normative References
The following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the normative 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 6682 Water for Analytical Laboratory Use - Specification and Test Methods
GB 7917.2 Standard Methods of Hygienic Test for Cosmetics; Arsenic
GB 22115 General Requirements on Raw Materials of Toothpastes
GB 29337 General Labeling for Oral Care and Cleaning Products
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 (AQSIQ Decree [2005] No.75)
Safety and Technical Standards for Cosmetics (China Food and Drug Administration)
3 Terms and Definitions
For the purposes of this document, the following terms and definitions apply.
3.1
toothpaste
pasty substance composed of such main materials as abrasive, humectant, thickener, foamer, aromatic, water and other additive (containing the composition which can improve the health condition of oral cavity)
Notes:
1 Basic functions of toothpaste: clean the oral cavity, reduce teeth stain and tartar, whiten teeth, reduce dental plaque, fresh breath, refresh taste, protect the health of teeth and periodontal tissue (including gingiva) and keep oral cavity health.
2 Standard specification of toothpaste: 100g/piece.
4 Requirements
4.1 Safety requirements
Under normal or reasonably foreseeable service conditions, toothpaste shall not damage human health.
4.2 Requirements for toothpaste materials
The materials for toothpaste production shall meet the requirements of GB 22115.
4.3 Hygienic index
Hygienic index of toothpaste products shall meet the requirements specified in Table 1.
Table 1
Hygienic index Requirements
Total bacterial count/(CFU/g) ≤ 500
Total number of mould and saccharomycetes /(CFU/g) ≤ 100
Thermotolerant coliform bacteria/g Not detectable
Pseudomonas aeruginosa/g Not detectable
Staphylococcus aureus/g Not detectable
Plumbum (Pb) content/(mg/kg) Shall meet the requirements of Safety and Technical Standards for Cosmetics
Arsenic (As) content/(mg/kg) Shall meet the requirements of Safety and Technical Standards for Cosmetics
4.4 Sensory, physical and chemical indexes
Sensory, physical and chemical indexes of toothpaste products shall meet the requirements specified in Table 2.
Table 2
Item Requirements
Sensory index Paste Uniform without foreign matters
Physical and chemical indexes pH 5.5a~10.5
Stability Paste not spilled out of mouth, liquid not separated, with normal fragrance, color and luster
Overhard particles No scratch on slide
Soluble or free fluorine contentb (lower limit is only applicable to fluorine-contained anticarious toothpaste)/% 0.05~0.15 (applicable to fluorine-contained toothpaste)
0.05~0.11 (applicable to children's fluoride-contained toothpaste)
Total fluorine content (lower limit is only applicable to fluorine-contained anticarious toothpaste)/% 0.05~0.15 (applicable to fluorine-contained toothpaste)
0.05~0.11 (applicable to children's fluoride-contained toothpaste)
a As for the toothpaste with pH value lower than 5.5, product responsibility party shall provide two test reports for safety assessment of oral cavity hard tissue (including enamel and dentine) according to standard method issued by qualified third-party organization; the test conclusions of both reports shall reach the safety requirements of standard method. Thereinto, at least one report shall be issued by stomatological research institution (School of Stomatology, provincial stomatological research institution) or stomatological medical institution (third rate stomatological hospital, stomatological department of general hospital).
b Soluble fluorine testing method is applicable to fluoride-contained toothpaste composed of sodium monofluorophosphate or sodium monofluorophosphate and sodium fluoride (stannous fluoride and ammonium fluoride); free fluorine testing method is applicable to fluoride-contained toothpaste made of sodium fluoride or (stannous fluoride and ammonium fluoride); if the used fluoride is not sodium monofluorophosphate, sodium fluoride, stannous fluoride or ammonium fluoride, the applicability of testing method shall be investigated.
4.5 Net content
Net content of toothpaste product shall meet the requirements of Measures for the Metrological Supervision and Administration of Quantitatively Packed Commodities.
4.6 Packaging appearance requirements
4.6.1 Hose or other packaging
Cap is tightly consistent with the hose mouth, the hose shall be free of damage or paste leakage.
4.6.2 Box (applicable to toothpaste packed in small box)
Box shall be free from damage.
5 Test Method
Unless otherwise specified, analytical reagents and water as specified in GB/T 6682 shall be used in this standard.
Unless otherwise specified, the standard solutions for titrimetric analysis, standard solutions for impurity determination, preparations and products required for test method are prepared according to the requirements of GB/T 601, GB/T 602 and GB/T 603.
As for the index with final testing result being calculated according to weighing method, the sampling procedures shall be as follows: squeeze out 20mm paste and discard, then squeeze sample for weighing.
5.1 Microbiological index
It is in accordance with the requirements of Chapter V Methods of Microbiological Examination in Safety and Technical Standards for Cosmetics.
5.2 Plumbum (Pb) content
5.2.1 General
It is an arbitration inspection, otherwise, follow Annex A.
5.2.2 Toothpaste with calcium carbonate or calcium hydrophosphate as abrasive
5.2.2.1.7 1% ammonium hydroxide solution: take 4mL ammonia water and dilute with water to 100mL.
Foreword i 1 Scope 2 Normative References 3 Terms and Definitions 4 Requirements 5 Test Method 6 Inspection Rules 7 Marking 8 Transportation and Storage Annex A (Normative) Plumbum Content Determination by Directly Injecting Sample in Graphite Furnace Annex B (Informative) Gas Chromatogram of Fluorine Ion Standard Solution
Codeofchina.com is in charge of this English translation. In case of any doubt about the English translation, the Chinese original shall be considered authoritative.
This standard is developed in accordance with the rules given in GB/T 1.1-2009.
This standard replaces GB 8372-2008 Toothpaste and the following main technical changes have been made with respect to GB 8372-2008:
——Normative references were modified (see Chapter 2; Chapter 2 of 2008 edition);
——Definition of toothpaste was modified (see 3.1; 3.1 of 2008 edition);
——Contents of safety requirements were added (see 4.1);
——The requirements of pH value in physical and chemical indexes were modified (see Table 2; Table 2 of 2008 edition);
——The requirements of pH value lower than that of product in 5.5 in physical and chemical indexes were added (see note a of Table 2);
——The contents of soluble fluorine or free fluorine content selection method basis in physical and chemical indexes were added (see note b of Table 2);
——The requirements of absolute difference between parallel determined values in pH test method were modified (see 5.5.3; 5.5.3 of 2008 edition);
——Determination method of soluble fluorine or free fluorine content was modified (see 5.8; 5.8 of 2008 edition);
——The contents of marking were modified (see Chapter 7; Chapter 7 of 2008 edition);
——The contents of transportation and storage were added (see Chapter 8);
——The errors in A.1.1 were corrected (see A.1.1; A.1.1 of 2008 edition);
——Annex B was deleted (Annex B of 2008 edition).
This standard was proposed by China National Light Industry Council.
This standard is under the jurisdiction of National Technical Committee 492 on Oral Cavity Nursing Materials of Standardization Administration of China (SAC/TC 492).
The previous editions of the standard replaced by this standard are as follows:
——GB 8372-1987, GB 8372-1995, GB 8372-2001 and GB 8372-2008.
Toothpaste
1 Scope
This standard specifies the terms and definitions, requirements, test methods, inspection rules, marking, transportation and storage of toothpaste.
This standard is applicable to the toothpaste for oral cavity cleaning and nursing.
2 Normative References
The following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the normative 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 6682 Water for Analytical Laboratory Use - Specification and Test Methods
GB 7917.2 Standard Methods of Hygienic Test for Cosmetics; Arsenic
GB 22115 General Requirements on Raw Materials of Toothpastes
GB 29337 General Labeling for Oral Care and Cleaning Products
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 (AQSIQ Decree [2005] No.75)
Safety and Technical Standards for Cosmetics (China Food and Drug Administration)
3 Terms and Definitions
For the purposes of this document, the following terms and definitions apply.
3.1
toothpaste
pasty substance composed of such main materials as abrasive, humectant, thickener, foamer, aromatic, water and other additive (containing the composition which can improve the health condition of oral cavity)
Notes:
1 Basic functions of toothpaste: clean the oral cavity, reduce teeth stain and tartar, whiten teeth, reduce dental plaque, fresh breath, refresh taste, protect the health of teeth and periodontal tissue (including gingiva) and keep oral cavity health.
2 Standard specification of toothpaste: 100g/piece.
4 Requirements
4.1 Safety requirements
Under normal or reasonably foreseeable service conditions, toothpaste shall not damage human health.
4.2 Requirements for toothpaste materials
The materials for toothpaste production shall meet the requirements of GB 22115.
4.3 Hygienic index
Hygienic index of toothpaste products shall meet the requirements specified in Table 1.
Table 1
Hygienic index Requirements
Total bacterial count/(CFU/g) ≤ 500
Total number of mould and saccharomycetes /(CFU/g) ≤ 100
Thermotolerant coliform bacteria/g Not detectable
Pseudomonas aeruginosa/g Not detectable
Staphylococcus aureus/g Not detectable
Plumbum (Pb) content/(mg/kg) Shall meet the requirements of Safety and Technical Standards for Cosmetics
Arsenic (As) content/(mg/kg) Shall meet the requirements of Safety and Technical Standards for Cosmetics
4.4 Sensory, physical and chemical indexes
Sensory, physical and chemical indexes of toothpaste products shall meet the requirements specified in Table 2.
Table 2
Item Requirements
Sensory index Paste Uniform without foreign matters
Physical and chemical indexes pH 5.5a~10.5
Stability Paste not spilled out of mouth, liquid not separated, with normal fragrance, color and luster
Overhard particles No scratch on slide
Soluble or free fluorine contentb (lower limit is only applicable to fluorine-contained anticarious toothpaste)/% 0.05~0.15 (applicable to fluorine-contained toothpaste)
0.05~0.11 (applicable to children's fluoride-contained toothpaste)
Total fluorine content (lower limit is only applicable to fluorine-contained anticarious toothpaste)/% 0.05~0.15 (applicable to fluorine-contained toothpaste)
0.05~0.11 (applicable to children's fluoride-contained toothpaste)
a As for the toothpaste with pH value lower than 5.5, product responsibility party shall provide two test reports for safety assessment of oral cavity hard tissue (including enamel and dentine) according to standard method issued by qualified third-party organization; the test conclusions of both reports shall reach the safety requirements of standard method. Thereinto, at least one report shall be issued by stomatological research institution (School of Stomatology, provincial stomatological research institution) or stomatological medical institution (third rate stomatological hospital, stomatological department of general hospital).
b Soluble fluorine testing method is applicable to fluoride-contained toothpaste composed of sodium monofluorophosphate or sodium monofluorophosphate and sodium fluoride (stannous fluoride and ammonium fluoride); free fluorine testing method is applicable to fluoride-contained toothpaste made of sodium fluoride or (stannous fluoride and ammonium fluoride); if the used fluoride is not sodium monofluorophosphate, sodium fluoride, stannous fluoride or ammonium fluoride, the applicability of testing method shall be investigated.
4.5 Net content
Net content of toothpaste product shall meet the requirements of Measures for the Metrological Supervision and Administration of Quantitatively Packed Commodities.
4.6 Packaging appearance requirements
4.6.1 Hose or other packaging
Cap is tightly consistent with the hose mouth, the hose shall be free of damage or paste leakage.
4.6.2 Box (applicable to toothpaste packed in small box)
Box shall be free from damage.
5 Test Method
Unless otherwise specified, analytical reagents and water as specified in GB/T 6682 shall be used in this standard.
Unless otherwise specified, the standard solutions for titrimetric analysis, standard solutions for impurity determination, preparations and products required for test method are prepared according to the requirements of GB/T 601, GB/T 602 and GB/T 603.
As for the index with final testing result being calculated according to weighing method, the sampling procedures shall be as follows: squeeze out 20mm paste and discard, then squeeze sample for weighing.
5.1 Microbiological index
It is in accordance with the requirements of Chapter V Methods of Microbiological Examination in Safety and Technical Standards for Cosmetics.
5.2 Plumbum (Pb) content
5.2.1 General
It is an arbitration inspection, otherwise, follow Annex A.
5.2.2 Toothpaste with calcium carbonate or calcium hydrophosphate as abrasive
5.2.2.1 Reagents
5.2.2.1.1 Nitric acid.
5.2.2.1.2 Nitric acid solution: 5mol/L.
5.2.2.1.3 Nitric acid solution: 0.2mol/L.
5.2.2.1.4 Nitric acid solution: 0.01mol/L.
5.2.2.1.5 Hydrogen peroxide solution: content 30%.
5.2.2.1.6 Ammonia water: ammonia content 25%~28%.
5.2.2.1.7 1% ammonium hydroxide solution: take 4mL ammonia water and dilute with water to 100mL.
Contents of GB/T 8372-2017
Foreword i
1 Scope
2 Normative References
3 Terms and Definitions
4 Requirements
5 Test Method
6 Inspection Rules
7 Marking
8 Transportation and Storage
Annex A (Normative) Plumbum Content Determination by Directly Injecting Sample in Graphite Furnace
Annex B (Informative) Gas Chromatogram of Fluorine Ion Standard Solution
