On December 1, 2023, the Measures for Toothpaste Supervision and Administration(hereinafter referred to as the Measures) officially came into effect in China, stipulating that toothpaste shall be subject to filing in accordance with provisions regarding general cosmetics in the Cosmetic Supervision and Administration Regulation(CSAR).
ZMUni Compliance Centre has made this Export Compliance Guideline to provide manufacturers and stakeholders a glimpse into the regulatory framework and critical requirements.
Main Content
| Part I Related Regulations |
| Part II Regulatory Requirements |
| 1. Definition |
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2. Requirements of Filing |
| 3. Requirements of Namin |
| 4. Requirements of Labeling |
| 5. Requirements of New Ingredient Use |
| 6. Requirements for Children's Toothpaste |
| 7. FAQs Collection |
Part I Related Regulations
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Related Regulation |
Remark |
Effective Date |
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Cosmetic Supervision and Administration Regulation (CSAR) |
Toothpastes should be managed with reference to the provisions on general cosmetics in CSAR. |
Jan. 1, 2021 |
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Technical Guidelines for Cosmetic Safety Assessment |
Toothpastes filers shall carry out product safety assessment in accordance with Technical Guidelines for Cosmetic Safety Assessment and submit a product safety assessment report during filing. |
May 1, 2021 |
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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 |
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Measures for Toothpaste Supervision and Administration |
The regulation stipulates the responsibilities of all stakeholders, toothpaste’s definition, the management requirements for toothpaste products and new ingredients, the ongoing use of the existing toothpaste production licensing system, and the requirements for toothpaste safety assessment, efficacy claims and labeling. |
Dec. 1, 2023 |
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Provisions on the Management of Toothpaste Filing Materials |
The regulation stipulates the documentation requirements for toothpastes notification. |
Dec. 1, 2023 |
Part II Regulatory Requirements
1. Definition
Under the Measures, toothpaste is defined as a paste applied to the surface of human teeth by friction for cleaning.
Due to the same usage, Tooth Gel can be regarded as toothpaste. The following tooth products are explicitly not classified as toothpaste: mouthwash, tooth powder, tooth stickers, children's foam dental cleansers, etc.
2. Requirements of Filing
According to the Measures, domestically produced toothpaste in China must be filed with the local Medical Products Administration (MPA) before it goes on sale. Imported toothpaste from overseas must be filed with the National Medical Products Administration (NMPA) before importation. The NMPA may, by law, delegate the import toothpaste filing management work to the local MPA with the corresponding capabilities.
(1) Filling Process
(1) Filling Documents
| Filling Documents |
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