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Under Cosmetics Supervision and Administration Regulations (CSAR) issued in 2020, cosmetics are divided into special cosmetics and ordinary cosmetics. Companies who plan to place cosmetics on the Chinese market must apply for registration or filing with the NMPA or provincial MPA to get approval license or filing certificate. Toothpaste will be regulated as ordinary cosmetics. The toothpaste filer can claim the function of preventing cavities, inhibiting dental plaque, resisting dentine sensitivity, and reducing gingival problems after the efficacy evaluation in terms of the national and industrial standards.

News Updates

On March 23, 2023, China’s State Administration for Market Regulation (SAMR) officially published theMeasures for Toothpaste Supervision and Administration.

The Measures cover:

• Efficacy management requirements and labeling requirements;
• Contents that must be indicated as well as contents that are not allowed; and
• Scope of the efficacy claim and standardized words for the efficacy claims.

The Measures will take effect from December 1, 2023.

On September 25, 2023 China announced to simplify the filing documents requirements for marketed toothpaste. A certain number of toothpaste products had already been on the market for a long time and their safety had been widely verified during use. These products should be distinguished from new products, thus the requirements for filing documents could be simplified.

Who Shall Register?

• Toothpastes who intend to sell cosmetics products via offline stores in China

• Toothpastes who intend to sell cosmetics products via online platforms except cross-border e-commerce such as TMALL, JD, etc.,

Application Types

Filing of toothpastes	Generally, the electronic filing certificate will be issued if passing the official review of submitted dossiers by NMPA or provincial MPA.

Our Services

Filing of Toothpaste

Acting as domestic responsible person for the application of user rights of online filing system; Preliminary review of formula and label so as to check if complying with the regulatory requirements for the toothpastes ingredients and efficacy claim; Regulatory compliance testing in product safety and efficacy according to the related national standard, industrial standard and technical specifications; Full dossiers preparation and submission.

Further Information

Interpretation of the Measures for Toothpaste Supervision and Administration

CIRS is to host a free webinar on the new filing requirements for toothpaste in China on December 11-12, 2023. This webinar is available in English, Chinese, Japanese and Korean, click here to know more details.