Cosmetic Compliance
Intelligence & Solutions
China Mainland Toothpastes Regulation
Jun 23, 2021
Hedy He
Tags : ChinaCSAR
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CONTENTS

At present, China implements a simple management scheme for toothpastes. Toothpastes can enter the market as long as they comply with relevant national and industry standards. However, as per Cosmetic Supervision and Administration Regulation (CSAR), toothpastes are managed with reference to general cosmetics regulation and subject to a much more stringent management scheme. In other words, notification, testing, safety assessment, efficacy evaluation, and new ingredient application are required.

Part I Regulatory Framework and Competent Authority

1. Main Toothpastes Regulations and National Standards in China

Category

Name

Notes

Effective   Date

Status

Regulations

Cosmetic Supervision and Administration Regulation (CSAR)

Toothpastes should be managed with reference to the provisions on general cosmetics in CSAR.

Jan. 1, 2021

In force

Practice for Cosmetics Production Licensing

In January 2016, the former CFDA (now NMPA) promulgated the Practice for Cosmetics Production Licensing, regulating toothpastes as an independent unit of cosmetics in implementing the production license management. Toothpastes shall refer to the cosmetic production management requirements and can only be produced after obtaining a production license issued by the provincial FDA (now provincial MPA).

Jan. 1, 2016

In force

Technical Guidelines for Cosmetic Safety Assessment

Toothpastes notifier shall carry out product safety assessment in accordance with Technical Guidelines for Cosmetic Safety Assessment and submit a product safety assessment report during notification.

May 1, 2021

In force

Administrative Measures on Inspection and Quarantine of Import and Export Cosmetics

The regulation stipulates the inspection and quarantine requirements for importing and exporting cosmetics (including toothpastes).

Nov. 23, 2018

In force

Administrative Measures on Cosmetics Labeling

Toothpastes’Chinese name, warning labeling, and the use of permitted efficacy claims in conjunction with other terms shall comply with the provisions in Administrative Measures on Toothpastes and Administrative Measures on Cosmetics Labeling.

May 1, 2022

To be enforced

Administrative Measures on Toothpastes (Draft)

The regulation stipulates the definition of toothpastes and new toothpastes ingredients; the obligations of toothpastes manufacturers, importers, and operators; and the management scheme of new toothpastes ingredients.

/

Draft

Instructions for Toothpastes Notification Dossiers (Draft)

The regulation stipulates the documentation requirements for toothpastes notification.

/

Draft

Inventory of Existing Toothpastes Ingredients in China

NMPA will formulate and release an inventory of existing toothpastes ingredients for companies to determine the regulatory status of their ingredients used. Basically, a toothpastes ingredient is deemed as "new" if it is not included in the inventory. The company that intends to use a new toothpastes ingredient shall apply to formulating its safety and technical standards to the competent authority.

/

To be released

National Standards

For product: 5

e.g.:

GB/T 8372-2017 Toothpastes

GB 22114-2008 Humectants for Toothpastes – Glycerin and Macrogol

 

/

/

In force

Testing method: 22

e.g.:

GB/T 21842-2008 Determination of diethylene glycol in toothpastes

GB/T 32115-2015 Determination of ethylene glycol and diethylene glycol in oral care products

GB/T 32112-2015 Determination of peroxide in oral care products-High performance liquid chromatography method

GB/T 32118-2015 Determination of formaldehyde in toothpastes—High performance liquid chromatography

 

For basic management: 3

GB 22115-2008 General requirements on raw materials of toothpastes

GB 29337-2012 General labeling for oral care and cleansing products

GB/T 35919-2018 Oral cavity nursing materials classifications and terms

2. Competent Authority

Competent Authority

Main Responsibility

National Medical Products Administration (NMPA)

1.jpg

NMPA is established under the governance of SAMR to take all the work undertaken by the former CFDA. It is responsible for the national-level supervision and management of toothpastes in China.

 

Medical products administration (MPA) departments of provinces, autonomous regions, and municipalities directly under the Central Government, are responsible for the supervision and management of toothpastes in their administrative areas, including toothpastes notification and the issuance of production licenses for toothpastes manufacturers.

General Administration of Customs (GAC)

2-1.jpg

GAC is responsible for the customs import and export inspection and quarantine of cosmetics (including toothpastes).

Part II Current Regulatory Requirements

1. Definition

According to GB/T 8372-2017 Toothpastes, toothpastes refer to the paste materials formed by mixing main ingredients including abrasives, humectants, thickeners, foaming agents, fragrance compound, water, and other additives (may contain functional ingredients used for improving oral health).

2. Classification

Toothpastes are classified into two categories: general toothpastes and functional toothpastes.

Category

Scope

General Toothpastes

Toothpastes that only have the basic functions: cleaning the oral cavity, reducing teeth stains, reducing tartar, whitening teeth, reducing dental plaque, bringing fresh breath, refreshing taste, maintaining the health of teeth and periodontal tissue (including gingiva), and maintaining oral health.

Functional Toothpastes

  • Toothpastes with functional ingredients, which have additional efficacy of auxiliary precaution or alleviation to some oral issues, and can contribute to oral health except for the basic functions of toothpastes.

  • Efficacy: anti-caries, control of dental plaque, anti-dentin sensitivity, control of dental gingivitis, stain removal and whitening, anti-dental calculus, ozostomia alleviation, and other functions that complete the efficacy verification of improving oral problems.

3. Pre-market Requirements

In January 2016, the former CFDA (now NMPA) promulgated the Practice for Cosmetics Production Licensing, regulating toothpastes as an independent unit of cosmetics in implementing production license management. Toothpastes shall be subject to the cosmetic production management requirements and can only be produced after obtaining a production license issued by the provincial FDA (now provincial MPA).

2016101816511286.jpgToothpastes Production License (source: internet)

At present, the Chinese government does not implement registration or notification management for toothpastes. Products can enter the market as long as they comply with relevant national and industry standards.

Category

Current Pre-market requirements

General Toothpastes

  • Shall have a production license.

  • No need to register or notify the product. Products can enter the market as long as they comply with relevant national and industry standards.

Functional Toothpastes

  • Shall have a production license.

  • No need to register or notify the product.

  • Efficacy shall be supported by the efficacy evaluation report (clinical test or laboratory evaluation report) issued by the dental medical institution, stomatological hospital, etc. The relevant efficacy can be marked on the label if supported by evaluation reports.

  • Functional ingredients shall pass qualitative and quantitative tests.

 

Notes: 1. For toothpastes in which fluoride acts as the functional ingredient preventing caries, the clinical evaluation of caries prevention is not indispensable.

2. The efficacy evaluation is not required for toothpastes claiming the same efficacy, using the same functional ingredients, and the   concentration is no less than the verified products.

4. Labeling Requirements

Information Necessary for Oral Care and Cleansing Products Labeling

Product name

Manufacturer name and address (For imported products, country or region of origin, and agent, importer or distributor’s name and address)

Net content

Ingredient list

Manufacturing date and shelf life; or batch number and expiry date

Standard number

Warnings

Storage condition (if necessary)

Product user manual (if necessary)

Notes:

  • The product packaging whose maximum surface area is less than 10 cm2, or the net content is less than 15g/ml, may only label product name, manufacturer name and address, net content, manufacturing date, and shelf life or batch number, and expiry date. Other information can be indicated in the instructions attached to the products.

  • Net content, full ingredient list, and the standard number could be exempt for free trial products with corresponding marks (e.g., gifts, not for sale)

Oral care and cleansing products are prohibited from labeling or claiming the following content:

  • Medical terms

  • False, exaggerated, misleading, or confusing claims

  • Feudal superstition and violation of public order and good customs

  • Absolute terms

  • Claims prohibited by other laws, regulations, and national standards.

Toothpastes that have not been verified by efficacy evaluation shall not be marked with additional efficacy (except product basic function) on the product label.

5. Safety Management

Ingredients used in toothpastes shall meet the requirements in GB 22115-2008 General Requirements on Raw Materials of Toothpastes.

Prohibited Ingredients

1466

Including benzene, benzidine sulphate, carbon monoxide, chlorine, etc.

Restricted Ingredients

39

Including aluminum fluoride, ammonia, calcium fluoride, sodium nitrite, stannous fluoride, etc.

Permitted Preservatives

48

Including chlorobutanol, 2-chloroacetamide, formaldehyde and paraformaldehyde, sodium iodate, etc.

Permitted Colorants

102

Including CI 11920, CI 12490, CI 13015, CI 14270, CI 14700, etc.

Each ingredient used should be subject to a safety assessment. To assess toothpastes ingredients' safety, stakeholders should first consider its hygiene, sensory and physicochemical indicators, and then follow the four steps of hazard identification, dose-response assessment, exposure assessment, and risk characterization.

The overall safety assessment of the toothpastes should also combine with the part of the safety data of the finished product, including but not limited to

  • Past formulation experience, adverse reaction statistics of marketed products, epidemiological survey data;

  • Clinical data of the product;

  • Tests on the safety of oral soft tissues;

  • Tests on the safety of teeth/hard tissues, such as the relative dental abrasivity, RDA/Profilometry.

Specific requirements can refer to Administrative Measures for Safety Assessment of Oral Care and Cleansing Products and Guideline for Safety Assessment of Oral Care and Cleansing Products.

Part III Future Regulatory Requirements

According to CSAR, toothpastes shall be regulated with reference to the provisions on general cosmetics, and NMPA will be responsible for the pre-market approval and post-market surveillance of toothpastes. To implement this new requirement, NMPA has released the draft Administrative Measures on Toothpastes and Instructions for Toothpastes Notification Dossiers, standardizing the manufacture, operation, and pre-market requirements for toothpastes.

Notes: The following content is written based on the two draft regulations. The future regulatory requirements for toothpastes are subject to the finalized regulations.

1. Definition

Toothpastes refer to the solid and semi-solid preparation applied to the teeth surface of human and surrounding tissues by friction for cleansing, beautifying, and protecting.

2. Classification Code

Toothpastes are classified according to efficacy and target users and adopt a coding system. The classification code is composed of 2 layers of numbers, and each layer is separated by "-" and represented by a 2-digit number. When applying for toothpastes notification, the notifier needs to fill in the classification code of the toothpastes.

The details of the coding rules are as follows.

Layer

Code

Category

Efficacies

01

Basic cleansing

02

Caries prevention

03

Inhibition of dental plaque

04

Anti-dentin hypersensitivity

05

Reduce gum problems

06

Whitening

07

Anti-dental calculus

08

Reduce bad breath

09

Other efficacies


Target Users

01

Adult

02

Children (6 months to 12 years old)

For example:

  • The classification code of adult whitening toothpastes is 06-01;

  • The classification code of cleansing and caries prevention toothpastes for children is 0102-02.

3. Manufacturing Requirements

The manufacture of toothpastes shall meet the requirements for plants specified in Good Manufacturing Practices for Cosmetics. Prior to manufacture, companies shall submit documents to the local MPAs for a license. After document review and on-site inspection, local MPA will issue a license to compliant companies. With the license, companies are permitted to start manufacturing.

4. Notification

China will implement a notification scheme for toothpastes. Only toothpastes completing the notification are permitted for sale and import.

a071312b-5501-4e73-90e2-5ee640be755c-1.pngTo apply for the notification, the notifier shall submit the following documents:

NMPA Notification Platform Account Application

1. Notifier information form and the resume of the person in charge of quality and safety;

2. Overview of the quality management system of the notifier;

3. Overview of the adverse reaction monitoring and evaluation system of the notifier;

4. Domestic responsible person information form (for overseas notifier);

5. The original copy of the authorization letter for the domestic responsible person and the original notarization (for overseas notifier);

6. Manufacturer information form and a resume of the person in charge of quality and safety;

7. The original copy of the GMP certification documents (for overseas manufacturer).

Toothpastes Notification

1. Toothpastes notification information form and related documents

  • Product name

  • Product classification

  • Entrusted manufacture confirmation (for imported toothpastes, requiring documents to prove the entrusted manufacture relationship)

  • Certificate of Free Sales (for imported toothpastes whose product sales packaging is specially designed for the Chinese market, the explanatory documents stating that the product formula and production process should be consistent with the product in the country of origin)

  • Explanatory documents for formula design according to the consumption needs of Chinese consumers (for imported toothpastes whose product formula is specially designed for the Chinese market)

  • Letter of commitment to undertake product quality and safety responsibility (if other enterprises or institutions are indicated as "joint research and development," "produced by," or "supervised by" on the product label);

2. The naming reason of the product name;

3. Product formula;

4. Product executive standards;

5. Product label sample;

6. Product testing report;

7. Product safety assessment documents.

Notes:

  • Toothpastes ingredient manufacturers shall submit ingredient quality and safety related information through the ingredient safety information service platform under NMPA. The ingredient submission code will be automatically generated after the submission of quality and safety information. The toothpastes notifier can fill the ingredient submission code in the column of ingredient information during the notification.

  • Toothpastes notifier shall carry out product safety assessment in accordance with Technical Guidelines for Cosmetic Safety Assessment.

5. Efficacy Claims Evaluation

1) Permitted and Prohibited Efficacy Claims

Toothpastes shall not claim efficacy beyond the scope specified in the following table. These permitted efficacy claims of each category are fixed combinations and shall not be added, deleted, or adjusted at will. If they are used in conjunction with other words, it shall comply with Administrative Measures on Toothpastes and Administrative Measures on Cosmetics Labeling.

Category

Scope of Permitted Efficacy Claims

Basic cleansing

Clean teeth/clean mouth, maintain oral hygiene, maintain oral health, reduce soft dirt, freshen breath, refreshing taste

Caries prevention

Prevent dental caries, strengthen teeth, prevent cavities, inhibit teeth demineralization, and promote teeth remineralization

Inhibition of dental plaque

Inhibit dental plaque and reduce the formation of dental plaque

Anti-dentin hypersensitivity

Anti-dentin sensitivity, reduce the irritation of hot and sour on the teeth, reduce the irritation caused by hot and sour, alleviate sensitivity, anti-sensitivity, soothing, repair sensitive teeth, seal dentin tubules

Alleviating gum problems

Clear fire, dispel fire, improve gum health, and protect gums

Whitening

Whiten teeth, whiten teeth through oxidation reaction, reduce exogenous staining, mechanically reduce exogenous staining, chemically reduce exogenous staining, achieve whitening effects through optical effects

Anti-dental calculus

Reduce dental calculus, decompose dental calculus, reduce dental calculus formation, prevent dental calculus, inhibit dental calculus formation

Alleviating bad breath

Reduce bad breath, reduce bad odor, remove volatile sulfur compounds, inhibit bad breath-causing bacteria

Other efficacies

Moisturize the mouth, improve dry mouth

Notes:

  • Children toothpastes can only claim cleansing and caries prevention efficacy.

  • NMPA will timely update the catalog of permitted efficacy claims based on the possible advice from companies and associations and the actual development of the toothpastes industry.

The following claims are also not allowed for toothpastes:

  • Contents indicating medical effects implicitly or explicitly;

  • False or misleading contents;

  • Contents violating public social order and good customs;

  • Other contents prohibited by laws, administrative regulations, and mandatory national standards.

2) Efficacy Evaluation

Efficacy evaluation is mandatory for all toothpastes except for cleansing toothpastes. The toothpastes notifier shall submit efficacy evaluation abstracts for the notification and keep the efficacy evaluation report for future reference. The evaluation abstracts should include the efficacy evaluation items, evaluation methods, evaluation institutions, conclusion, etc.

Efficacy evaluation should be carried out based on qualitative or quantitative testing of functional ingredients in the toothpastes. A toothpaste is subject to one of the two evaluations as per the type of its efficacy, 1) clinical evaluation and 2) laboratory evaluation.

Before clinical evaluation, the product's microbiological, physical and chemical, and special safety tests should be completed, and a written report should be issued. Microbiological, physical and chemical tests shall be conducted by testing institutions that have obtained China Inspection Body and Laboratory Mandatory Approval (CMA) and have corresponding testing capabilities.

Toothpastes Categories

Efficacy Evaluation Methods

Efficacy Evaluation Institution Qualification

Claims the efficacies of caries   prevention, inhibition of dental plaque, anti-dentin hypersensitivity, and alleviating gum problems

Adopt clinical evaluation methods in accordance with the requirements of Administrative Measures on Toothpaste, national standards, industry standards, and technical specifications

1. Class A tertiary oral medical institution with qualifications for clinical trial bases for drugs or devices recognized by the national regulatory agency; or

2. Stomatological hospital awarded the National Key Clinical Specialty (Stomatology) by the health supervision and administration department of the State Council; or

3. Provincial dental specialist hospital with qualifications for clinical trial bases for drugs or devices.

 

*Laboratory evaluation reports can be issued by testing institutions that have been filed with NMPA.

Claims the efficacies of whitening, anti-dental calculus, alleviating bad breath, and improving oral problems

  • Methods stipulated by domestic and foreign laws, regulations, technical standards, and technical specifications; or

  • Methods published on guidelines from authoritative organizations or technical institutions and industry associations, professional academic journals, etc.

 

If a method developed by the laboratory is used, the method should be confirmed in accordance with the CMA/CNAS method, and the complete text of the self-developed method should be included in the evaluation report.

Quantitative efficacy claims (such as efficacy retention time, statistical data, degree, etc.)

Carry out efficacy evaluation according to regulations.

Efficacy Evaluation Exemption

  • Toothpaste that uses fluoride as a caries prevention ingredient, and meets the fluoride content required by national standards and technical specifications, can be exempt from clinical evaluation of caries prevention efficacy.

  • The efficacy evaluation is not required for the product of the same notifier, claiming the same efficacy, using the same functional ingredients, and the addition amount is not less than the toothpaste that has been evaluated. But the efficacy of the functional ingredient still needs to be stated in the efficacy evaluation abstracts.

6. Labeling

Toothpastes labeling requirements must comply with Administrative Measures on Toothpastes and Administrative Measures on Cosmetics Labeling. The following information shall be indicated on labels of imported toothpastes:

1. Product name

2. Name and address of the notifier and domestic responsible person

3. Name and address of the manufacturer

4. Product executive standard number

5. List of full ingredients

6. Net content

7. Durability

8. Application method

9. Safety warnings

10. Other content prescribed by laws, administrative regulations, and mandatory national standards

Notes:

  • For small-size packaged cosmetic products with a net content of no more than 15g or 15mL, only the Chinese name, the notifier name, the net content, and the durability shall be labeled on the visible panel of the sales packaging. Other information can be indicated in the instructions attached to the products.

  • For small-sized packaged products with a packaging box, the Chinese name and the durability of the products shall also be labeled on the inner packing in direct contact with the contents.

7. Requirements for New Toothpastes Ingredients

New toothpastes ingredients refer to the natural or artificial ingredients used in toothpaste for the first time in China. Food additives or food ingredients complying with existing national standards are not managed as new toothpastes ingredients when they are used in toothpastes for the first time in China.

NMPA will formulate and release the Inventory of Existing Toothpastes Ingredients in China for companies to determine the regulatory status of their ingredients used. Basically, a toothpaste ingredient is deemed as "new" if it is not included in the inventory.

Obligations for Different Kinds of Ingredients

Type

Obligations

Ingredients included in the Inventory of Existing Toothpastes Ingredients in China

Manufacturers and operators shall use them reasonably in accordance with the national standards, technical norms, and requirements in the inventory.

New toothpastes ingredients

The company that intends to use a new toothpastes ingredient shall apply to formulating its safety and technical standards to the competent authority. The ingredient can only be used after it is added to national standards or technical norms.

Food additives or food ingredients used in toothpastes for the first time

The ingredient’s use frequency and exposure in toothpaste should be compared with the corresponding indicators when used in food, and a safety assessment report should be submitted.

Part IV Timeline of Major Regulatory Events for Toothpastes

  • Before 2006: A production license is not required for toothpastes.

  • August 2006: The former General Administration of Quality Supervision promulgated the “Implementation Rules for Toothpastes Product Production License." According to this document, toothpastes shall be produced after obtaining a production license and shall label the QS (Quality Safety) mark. Only toothpastes producers with an annual output of more than 2,000 tons are eligible for the production license.

  • 2010: China Oral Care Industry Association (COCIA) was established, and a complete standardization system was set up, covering all the steps in the product cycle from ingredient procurement to the marketed product labeling.

  • June 2011: The toothpastes production was included in the list of the restricted industries. No new production license would be issued.

  • 2015: CSAR’s draft for approval classified toothpastes and other oral care products as cosmetics, but the specific management methods are not clear.

  • January 2016: The former CFDA implemented the Practice for Cosmetics Production Licensing, regulating toothpastes as an independent unit of cosmetics to implement production license management. Toothpastes shall refer to the cosmetic management requirements and obtain a production license issued by the provincial FDA (now provincial MPA).

  • October 2019: Toothpastes was removed from the restricted industries' list, and the restriction on the production license was canceled.

  • June 2020: The final CSAR stipulated that toothpastes do not belong to cosmetics but shall be managed with reference to the general cosmetics provisions.

  • July 2020: COCIA released an announcement to collect all the ingredients used in toothpastes that have been on the market in China before July 31, 2020. The Inventory Existing Toothpastes Ingredients in China will be formulated later.

  • November 2020: Administrative Measures on Toothpastes was issued, which clarified the management scheme for toothpastes, requiring a series of procedures including notification, testing, safety assessment, efficacy evaluation, new ingredient application, etc.

  • January 2021: Instructions for Toothpastes Notification Dossiers was issued, which clarified the dossiers requirements for toothpastes notification, toothpastes classification and coding system, permitted efficacy claims, requirements for efficacy evaluation and safety assessment.

Tags : ChinaCSAR