1. What is the scope of the application and regulatory department of the Measures for the Supervision and Management of Toothpastes (hereinafter referred to as Measures)?
According to Article 2 of the Measures, those who engage in toothpaste production and operation activities and their supervision and management within the territory of China shall be governed by these measures. Article 4 stipulates that NMPA is responsible for the national supervision and management of toothpastes. The departments responsible for drug supervision and management of local people's governments at or above the county level are responsible for the supervision and management of toothpaste in their respective administrative regions.
2. What are the basic requirements for toothpaste management?
According to Article 5 of the Measures, toothpastes shall be subject to filing management, and toothpaste filers shall be responsible for the quality, safety, and efficacy claims. Article 6 stipulates that toothpaste manufacturers and operators shall engage in production and operation activities in accordance with laws, regulations, mandatory national standards, and technical specifications, and ensure the quality and safety of toothpaste products with strengthening management, keeping integrity and self-discipline. Article 7 stipulates that the toothpaste industry association shall strengthen industry self-discipline, supervise and guide production and business operators to engage in production and business activities in accordance with the law, and promote the construction of industry integrity.
3. What are the management requirements for toothpaste raw materials?
According to Article 8 of the Measures, the natural or artificial raw materials used in toothpaste for the first time within the territory of China are new raw materials for toothpaste.
New raw materials for toothpaste shall be registered or filed in accordance with the relevant regulations on the management of new cosmetic raw materials. Article 9 stipulates that the toothpaste registrant shall select raw materials that meet the requirements of laws, regulations, mandatory national standards, and technical specifications for toothpaste production, and shall be responsible for the safety of the used toothpaste raw materials. Under application for toothpaste filing, the filer shall clarify the source of raw materials and information related to raw material safety through the filing information service platform.
4. What is the product labeling requirement for children's toothpaste?
Article 20 of the Measures, toothpaste products that claim to be suitable for children shall comply with laws, administrative regulations, mandatory national standards, technical specifications, and other provisions on children's toothpaste, and shall be labeled in accordance with the NMPA regulations.
According to Article 6 of the Provisions for the Supervision and Administration of Children's Cosmetics, children's cosmetics shall mark the exclusive logo stipulated by NMPA on the display surface of the sales package. Non-children's cosmetics shall not be marked with the children's cosmetics logo. Children's cosmetics shall use "(注意) attention" or "(警告) warning" as guide words, and mark warning words such as "(应当在成人监护下使用) should be used under adult supervision" on the visible surface of the sales package. Article 13 stipulates that Children's cosmetics labels shall not be marked with words such as "(食品级) food grade", "(可食用) edible" or food-related patterns.
5. What is the requirement for the filing of overseas toothpaste products?
According to Article 6 of the Measures, the filer of overseas toothpaste shall designate domestic enterprise legal persons as the responsible persons for filing, assisting in monitoring adverse reactions of toothpaste, implementing product recalls, and cooperating with the supervision and inspection work of the drug regulatory department.
6. How to handle illegal activities of toothpaste filers, entrusted production enterprises, operators, and domestic responsible persons according to the Measures?
According to Article 22 of the Measures, if a toothpaste filer, entrusted production enterprise, operator, or domestic responsible person commits the following illegal acts, they shall be dealt with in accordance with the relevant provisions of the Cosmetics Supervision and Administration Regulations:
Provide false documents for applying for toothpaste administrative license or filing, or forge, alter, rent, lend, or transfer toothpaste license documents;
Engage in toothpaste production activities without permission, or fail to organize production in accordance with the requirements of the quality management standards for cosmetics production;
Illegally add substances that may endanger human health in toothpaste;
Change the expiration date of toothpaste;
Fail to publish a summary of efficacy claims basis in accordance with the provisions of Measures;
Fail to monitor and report adverse reactions to toothpaste in accordance with the provisions of Measures;
Refuse to implement decisions made by the drug regulatory department in accordance with the law to order recall, suspension, or suspension of production and operation;
The domestic responsible person fails to fulfill the obligations stipulated in Measures, or the overseas toothpaste filing person refuses to fulfill the administrative penalty decision made in accordance with the law.
7. What is the basis for the management of the content not clearly specified in the Measures?
According to Article 23 of the Measures, the supervision and management of toothpaste products, which is not covered within the Measures, shall refer to the Provisions for Registration and Filing of Cosmetics, Provisions for Supervision and Administration of Manufacturing and Marketing of Cosmetics and other provisions.
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