Dongfang Sun, Wei Zheng, Zhiqiang Gao

The Standardization Center of Toothpaste and Wax Products, China

Introduction

The key to staying the oral health is prevention and treatment. Generally speaking, oral cleansing products refer to the products which are intend to be applied to the human oral for cleansing and beautifying, and can help prevent the oral problems. These products include toothpaste, toothbrush, mouthwashes, teeth whitening products, chewing gum, dental floss, toothpick and denture cleanser. At present, the oral cleansing products in China are divided into three main categories: toothpaste,Chinese herbal toothpaste and toothbrush. In 2010, the National Oral Care Products Standardization Technical Committee was founded along with three subcommittees including the Toothpaste Committee, Chinese Herbal Toothpaste Committee and The Toothbrush Committee.As an important part of daily chemical industry in China,the development of oral care products needs to be more competitive in the growing demand of the consumer market, and it is also the demand of improving the production capacity and quality of the oral care products like toothpaste and toothbrush.

The period of “12th Five–Year Plan” is not only an important period for the development of oral cleansing products industry, but also the critical time to promote the strategy of fully implementation on the industry standardization. To stay oral healthy and rapid development of oral care products, it is great significance to scientifically work out the technical standard system for industries(light industry and daily chemical products/oral cleansing products) and to fully develop the strategic function of standardization in the field of social management,economic management and technical management.

The top framework of toothpaste technical standard system

Principle of construction

The principle of construction of the standard system in oral cleansing products as follows: the oral cleansing products belong to the industry of daily chemical products in“Classification of National Economy Industry” (GB/T4757-2011), therefore, the daily chemical products stay on the top level of the standard system in oral sanitary products. In“Classification of National Economy Industry” (GB/T 4757-2011), the daily chemical products include nine categories:printing ink (01), fireworks and firecracker (02), battery (03),materials of battery (04), flavor & fragrance and cosmetics(05), surfactant (06), cleaning and hygiene products (07),oral cleansing products (08), other household chemicals (09).The nine categories are considered as the second level of the standard system framework. The category of oral cleansing products is on the third level.

Nowadays, in the field of oral cleansing products, the standard includes three parallel kinds of products: oral care product, oral care implement and the raw material of oral care product.

The principle of adoption of national or industry technology standard system in oral cleansing product as follows: the toothpaste standard is national standard; the other oral care products, raw material of oral care product and oral care implement are industrial standard; the test method of toxic and harmful element in the method standard is national standard; the method of efficiency element testing is national standard; basis and general standards as well as the management standards are national standards.

The development of toothpaste industry can not be separated from the standardization work. With the development of toothpaste production, the standardization of China toothpaste industry founded and developed gradually. The earliest toothpaste standard in China can be traced back to the year of 1956, and it became the first national toothpaste draft standard until 1987 (GB 8372-1987) “Toothpaste”. The standard was officially approved to be implemented from March 1, 1988. Currently, the standard was revised for three times in 1995, 2001 and 2008, respectively. The technical index of GB 8372-2008 includes: net content, quality of toothpaste, pH vaule, stability, superhard particles, soluble fluoride, total fluoride content, contents of Pb and As, aerobic bacterial count, mildew and saccharomycetes count, fecal coliform,pseudomonas aeruginosa and staphylococcus aureus, etc.

Status of toothpaste standard in China

During these years, several toothpaste standards has been published, including ten oral care products standards, like “Toothpaste”, twelve raw material standards for toothpaste products, like “Oral care and cleansing products—crude calcium carbonate for toothpaste”, seventeen test method standards, like“Determination of diethylene glycol in toothpaste”, one basis and general standard (General requirements on raw materials of toothpaste) and one management standard(General labeling for oral care and cleansing products).The standards provide support for technological progress and scientific development of the industry. Meanwhile,with the development of the industry, some new raw materials appear constantly and are used to the products.Next, it will reinforce the establishment of the new raw material standard, and control the quality of products from the very beginning. With the improvement of safety awareness, the safety of products are receiving increasing concerns. In the following, it will focus on studying on the test method for the toxic and harmful substance of products. At the same time, it will establish the safety assessment standard system of the products to guide the management of produce safety and ensure the products quality and safety.

Status of abroad standard

At present, toothpaste industry implements the international standard: ISO 11609:2010 “Dentistry—dentifrices—requirements, test methods and marking”.The UK standard is BS EN ISO 11609:2010, and the required index is as same as the international standard ISO11609:2010. Taiwan, China implements CNS15492,T3075 “Toothpaste and toothpowder”, and ISO 16408:2004 “Dentistry—oral hygiene products—gargle”.implements European Cosmetic Directive, 76/768/EEC;Britain implements BS 5136:1981 “General requirements on toothpaste”. Most countries implement the ISO international standard.

The requirement of ISO 11609:2010 “Dentistrydentifrices-requirements, test methods and marking”mainly includes: total fluoride in toothpaste, heavy metal content, pH, microorganism content, abrasiveness,stability, fermentable sugars, and so on. The requirement of Taiwan, China standard CNS15492, T 3075“Toothpaste and dentifrices” and ISO11609:2010 is generally the same, by adding the content detection of triclosan and diethylene glycol. ISO16408:2004 “Dentistry—oral hygiene products—gargle” includes fllowing indexes:pH, total fluoride, fluorinion content, heavy metal,compatibility of oral tissue, microorganism, stability,fermentable carbohydrate, etc.

Work emphasis of Standardization Committee

The Standardization Committee will further strengthen the construction of institution and system according to the national standardization reform, accomplish the standard system of the “13th Five - Year Plan”. Establishing standard should focus on the safety of raw material, the connection between domestic and international standard, clean production,energy-saving and emission reduction, reinforcing the mandatory national standard, optimizing the recommendation industry standard, developing the organization standard, etc.For implementing the related policies issued by Chinese government, the committee focuses on the safety of the consumer goods, inspiring the confidence of consumption and promoting the growth of consumption. For the purpose of guaranteeing the healthy consumption, the committee will learn from international experience, formulate standards for the important goods, pay attention to the participation of the customer, establish the standardization system of safe consumer goods which is suitable to the industrial development and technological innovation.

Table 1. Oral cleansing products standards which have been approved

Table 2. Oral cleansing products standards which have not been approved

Figure 1. Block diagram of oral cleansing products standard system

Specifically, the standard system can be described as below.

The product standards (08010101) of oral care products(080101) contain the following categories: toothpaste,functional toothpaste, dentifrice, oral rinses and tooth whitening gel, denture cleanser and loose denture stabilizer.

The method standards (08010104) of oral care products(080101) contain the following categories:

001 Determination of diethylene glycol in toothpaste

002 Determination of triclosan in toothpastes

003 Determination of strontium chloride in toothpastes

004 Determination of chloroform in toothpaste

005 Determination of immunoglobulin egg yolk in toothpastes

006 Determinateion of friction value in toothpaste

007 Determination of tranexamic acid in toothpaste

008 Determination of nitro imidazoles antibiotics in toothpaste

009 Determinateion of Pedunculoside in toothpaste

010 Determinateion of syringin in toothpaste

011 Determination of mercury in toothpastes

012 Determination of arsenic in toothpastes

013 Determination of vitamin C in toothpastes of oral care products

014 Determination of vitamin E in toothpastes of oral care products

015 Determinateion of Xylitol in toothpaste

016 Determinateion of formaldehyde in toothpaste—liquid chromatography

017 Determinateion of aloe vera gel in toothpaste

018 Determination of ethylene glycol and diethylene glycol in oral care products

019 Determination of peroxide in oral care products

020 Determination of chlorate in oral care product—Ion chromatography

021 Determination of sodium phytate in oral care products

022 Determination of sodium azulene sulfonate in oral care products

023 Determination of piperine in oral care products—liquid chromatography

024 Determination of total flavonoids of propolis for toothpaste—spectrophotometry

025 Determination of L—Arginine in oral care products—liquid chromatography

026 Determinateion of dipotassium glycyrrhizinate in toothpaste

027 Determinateion of alantan in toothpaste

028 Safety evaluation outside test for low-pH toothpaste

029 Determination of inorganic sulfit for toothpastee

030 Determination of vitamin in toothpastes-liquid chromatography

031 Determination of orientin in toothpastes-liquid chromatography

032 Determination of ten kinds of metallic element in toothpaste

033 Test method of antibacterial effect in toothpaste

034 Determination of thymol crystals in toothpastes—liquid chromatography

035 Determination of cetyl pyridinium chloride in toothpastes—liquid chromatography

036 Determination of folic acid in toothpastes—liquid chromatography

037 Extracts of Periplaneta Americana in toothpaste

038 Test method of effection of toothpaste physical whitening

039 Determination of magnolo in toothpastes—liquid chromatographyl

040 Determination of erythritol in toothpastes—liquid chromatographyl

041 Test method of effection of oral care products on teeth mineralization

042 Determination of Acid soluble zinc in toothpaste and gargle

043 Determination of phillyrin in toothpastes

044 Determination of benzalkonium chloride in toothpastes—liquid chromatography

045 Determination of sorbic acid in toothpastes—liquid chromatography

046 Determination of chlorhexidine in toothpastes

047 Determination of boric acid and borate in toothpastes

048 Determination of chlorine phenol preservatives in toothpastes

049 Test method of effection of oral care products on flora

050 Determination of sodium copper chlorophyllin in toothpastes

051 Test method of suppression of oral care products for dental calculus

052 Determination of Tetrasodium pyrophosphate and five sodium tripolyphosphate in toothpastes

053 Determination of 3-Methyl-4-isopropylphenol in toothpastes

The product standards (08010201) of oral care appliance (080102) contain the following categories:dental floss, toothpaste strips, integrated dental floss and handles and tongue Scraper.

The product standards (08010301) of raw materials of toothpaste for oral care products (080103) contain the following categories:

001 Humectants for toothpastes—Glycerin and macrogol

002 Crude calcium carbonate for toothpaste

003 Carboxy methylcellulose sodium for toothpaste

004 Oral care and cleansing products—Sorbitol solution for toothpaste

005 Oral care and cleansing products—Sodium lauryl sulfate for toothpaste

006 Silicon dioxide for toothpaste

007 Dicalcium phosphate dihydrate for toothpaste

008 Calcium glycerophosphate for toothpaste

009 Xanthan gum for toothpaste

010 Hydroxypropyl guar gum for toothpaste

011 Aluminium and plastic laminated tubing for toothpaste

012 Plastic barrier laminate tube for toothpaste

013 Carrageenan for toothpaste

014 Sodium phytate for toothpaste

015 Extracts of Periplaneta Americana in toothpaste cproducts

016 Sodium lauroyl sarcosine for toothpaste

017 Tea extract for toothpaste

018 Hydroxyapatite for toothpaste

The management standards (08010103) of oral care products (080101) contain the following categories: General labeling for oral care and cleansing products; Standard of limitations for excessive packed toothpaste products; Safety evaluation standard for toothpaste.

The basic standards (08010102) of oral care products(080101) contain the following categories: General requirements on raw materials of toothpastes; General technical requirement of toothpaste of oral care products; General standard of toothpaste of oral care products; Classification and nomenclature of oral care and cleansing products.