China Toothpaste Filing Requirements were issued on November 22, 2023, by the National Medical Product Administration (NMPA) and come into effect on December 1, 2023.
The NMPA’s Announcement No. 148/2023 is entitled “Provisions on the Management of Toothpaste Filing Materials” and outlines the guidelines and requirements for notifying (filing) of toothpaste in the People’s Republic of China. Here is a summary of the key provisions:
Information items and requirements
Initial filings require submission of user information-related materials, including the filer’s information, quality and safety personnel resumes, quality management system overview, adverse reaction monitoring and evaluation system overview, and overseas filers’ domestic responsible person’s information.
Overseas production enterprises must submit supporting materials complying with quality management standards. These materials must be issued or approved by relevant authorities.
Product name requirements
The guidelines emphasize the need for transparency and accuracy in product naming. For imported products, both Chinese and foreign language names must be provided, and the Chinese name must align with relevant legal requirements. Additionally, trademarks in the Chinese product name require a trademark registration certificate for verification. These details are vital for proper product identification and branding in the market.
They also address the categorization of toothpaste products based on their intended use and user population. This categorization ensures that toothpaste products are properly classified and regulated according to their specific attributes and functions.
Proof of being listed for sale
Importers are required to provide a certificate of marketed sales issued by the competent government department in their country of origin or producing region. This certificate verifies that the toothpaste product has been legally sold in its home market, adding an additional layer of quality control and safety assurance.
Specially designed products for the Chinese market
Importers must provide detailed explanations and data supporting the formulation of toothpaste specifically tailored for the Chinese market, including safety tests conducted on Chinese consumers.
Adherence to relevant technical specifications and standards issued by the State Food and Drug Administration is obligatory. A formula table should provide comprehensive details, including raw material serial numbers, names, percentage content, purposes of use, and remarks. This ensures that regulatory authorities have a complete understanding of the toothpaste’s composition and can assess its safety and efficacy accurately.
Raw material quality specifications, safety risk assessments, and relevant safety control measures must also be provided.
If a new ingredient for toothpaste is used that is still under safety monitoring, the filing person or the domestic responsible person must provide the registration certificate number or filing number for the use of the new raw material, submit the authorization document of the new raw material registrant and the filing person to allow the use of the new raw material, and confirm the authorized use information of the raw material.
Toothpaste products must adhere to various standards covering product name, ingredient composition, production process description, sensory indicators, microbial and physical-chemical indicators, quality control measures, usage instructions, safety warnings, storage conditions, and shelf life. These standards are essential to guarantee product safety, efficacy, and quality. The China toothpaste filing requirements appendices contain preparation instructions and examples.
- Product Name: One of the fundamental elements of toothpaste regulation is the product name. It must be clearly stated, both in Chinese and, for imported products, in a foreign language. This is essential to avoid confusion among consumers and ensure transparency in product identification. The name should accurately reflect the nature of the toothpaste and its intended use.
- Full Composition: Toothpaste manufacturers and importers are required to provide a detailed list of all ingredients used in the product. This includes not only the names of the raw materials but also their respective percentages in the formula. By arranging the ingredients in descending order of content, regulatory authorities can evaluate the safety and efficacy of the toothpaste accurately.
- Brief Description of the Production Process: Understanding the production process of toothpaste is critical for assessing its quality and safety. Manufacturers must provide a concise overview of the steps involved in the production process, including activities such as feeding, mixing, and filling. Additionally, any cooperation with multiple production entities should be transparently disclosed.
- Sensory Indicators: Toothpaste, like any consumer product, must meet certain sensory criteria. This includes descriptions of color, character, and odor. These indicators are not only important for quality control but also for ensuring consistency in consumer experience.
- Microbiological and Physicochemical Indicators: Maintaining high standards of microbiological and physicochemical quality is essential in toothpaste production. The regulation specifies that toothpaste products must conform to the “Requirements for Microbial and Physical and Chemical Inspection Items for the Filing of Toothpaste.” This ensures that toothpaste meets the necessary safety and quality benchmarks.
- Quality Control Measures: Regulatory authorities expect toothpaste manufacturers to implement effective quality control measures. This may involve the use of inspection methods, which should be clearly defined and aligned with official standards. Manufacturers should also establish reasonable inspection frequencies to guarantee product quality and safety.
- How to Use: Proper usage instructions are essential to ensure consumers use toothpaste correctly. These instructions should be clear and comprehensive. Special requirements for specific user populations, such as children or individuals with specific dental conditions, should be provided when necessary.
- Safety Warning Language: Safety warnings are crucial to protect consumers from potential risks associated with toothpaste use. These warnings should align with relevant laws, regulations, and standards. For example, toothpaste with fluoride should include warnings and precautions related to its use, especially for children.
- Storage Conditions: Proper storage conditions are necessary to maintain toothpaste quality over time. The regulation requires manufacturers to specify the appropriate storage conditions, taking into account factors such as packaging and product stability.
- Period of Use: Determining the shelf life of toothpaste is critical to ensure product efficacy and safety. This shelf life should be based on packaging specifications, product stability, or the results of relevant experiments.
Standardized Chinese characters must be used in Chinese labels, with exceptions for specific information like website addresses and overseas enterprise details. There is a need for consistency between the Chinese label and the original label, particularly regarding safety and efficacy claims.
Except for registered trademarks, the font size of other character fonts on the same visual surface of Chinese labels shall be less than or equal to the font size of the corresponding standard Chinese character fonts.
Filing companies are also required to submit sample product labels and sales packaging for review by the NMPA.
- Sample Product Labels: Toothpaste manufacturers and importers must provide detailed sample product labels. These should contain information such as the name and address of the filing person, manufacturer details, ingredient identification, net content, expiration date, safety warnings, and explanations of the product name. By providing complete and accurate sample product labels, manufacturers ensure transparency and compliance with regulations.
- Information of the Filing Person and the Manufacturer: Labels must prominently display the name and address of the filing person, domestic responsible person, and manufacturer(s). This information helps consumers and regulatory authorities identify the responsible parties for the toothpaste product. If multiple production entities are involved, these should be indicated using codes or other means.
- Full Ingredient Identification: To inform consumers accurately, toothpaste labels must list all ingredients in standard Chinese characters, in descending order of content. This transparency allows consumers to make informed choices based on their preferences and potential allergies or sensitivities.
- Net Content: The net content of the product, presented according to the packaging specifications, is a vital piece of information for consumers to understand what they are purchasing.
- Explanation of the Product Name: If the product name might cause consumer ambiguity regarding its efficacy, an explanation must be provided. Additionally, if the Chinese product name contains letters, Hanyu pinyin, numbers, symbols, etc., their meanings should be clarified.
- Other Content: Labels should include other content as required by relevant laws and regulations. This may encompass explanations of innovative terms used by the filing person or the disclosure of specific functional ingredients for certain claims, such as caries prevention, plaque inhibition, dentin sensitivity resistance, or gum problem alleviation.
- Other Content: Manufacturers have the flexibility to include other copywriting content of their choosing on toothpaste labels. This can be used for branding, marketing, or conveying additional product information to consumers.
- Product Sales Packaging: Manufacturers and importers must also provide pictures of the product sales packaging. These images should accurately represent the product and its labeling, ensuring that the packaging aligns with regulatory requirements. For imported toothpaste, it is essential to include both the original packaging from the country of production and the Chinese translation of the foreign language label.
China’s toothpaste filing requirements establish stringent standards for toothpaste products to ensure their safety, quality, and proper representation to consumers. Meeting these standards is paramount for manufacturers and importers to navigate the regulatory landscape successfully and provide consumers with safe and effective oral care products.
Read the original article on China toothpaste filing requirements released by NMPA.
Read our previous blog posts on China toothpaste simplified notification information released and China’s New Toothpaste Supervision & Administration Regulation: A brief guide.
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