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China Cosmetic Registration and Filing

EnterCo specializes in cosmetic registration and filing, helping your cosmetics enter the Chinese market easily! Feel free to hit me up by booking a meeting.

 

  • Free registration and filing consultation

  • Free formula/package/claims pre-check

  • Free access to analysis of cosmetic regulations

  • Free access to compliance document templates

Cosmetic Registration and Filing

Cosmetic Registration and Filing in  China

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Since the official implementation of the Provisions for Registration and Filing of Cosmetics on May 1, 2021, cosmetics imported and sold legally in Chinese Mainland must have completed registration or filing with the National Medical Products Administration (NMPA) or provincial Medical Products Administration (MPA).

 

China implements registration management for special cosmetics and filing management for general cosmetics. Except for selling through cross-border e-commerce channels, any enterprise or individual who sells cosmetics without registration or filing will face severe punishment once identified.

What is the Definition of Cosmetics 

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Cosmetic Products Definition: Daily chemical industrial products that are applied to the surface of the human body such as skin, hair, nails, lips, etc. by rubbing, spraying, or other similar methods for the purpose of cleaning, protecting, beautifying and modifying.

Note:

1. Soaps are cosmetics, but only soaps claiming to have special cosmetic efficacy (such as whitening) shall be registered with reference to the Cosmetics Supervision and Administration Regulation (CSAR) before selling on the market.

2. Toothpaste is not defined as cosmetic. It is subject to filing management in accordance with the Measures for the Supervision and Management of Toothpastes, which shall be effective as of December 1, 2023. Prior to this time, filing management shall be conducted with reference to general cosmetics.

 

3. Oral hygiene products, women’s intimate care and wash products, anti-bacterial products are not defined as cosmetics in China.

Cosmetic Products Classification

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Cosmetic Classification

Special Cosmetics: refer to anti-spot and whitening, sunscreen, hair dye, hair perm, anti-hair loss cosmetics, and cosmetics claiming new efficacy.

General Cosmetics: refer to cosmetics other than special cosmetics (such as skin care, hair care, body care, perfume, and other products).

Domestic Cosmetics: the last process of contacting cosmetics contents is completed in the Chinese Mainland.

Imported Cosmetics: the last process of contacting cosmetics contents is completed out of the Chinese Mainland.

Note:

If the last process of contacting cosmetics contents is completed in Hong Kong S.A.R, Macao S.A.R, or Chinese Taipei, it shall be regulated with reference to the requirements of imported cosmetics.

China Cosmetic Registration and Filing Process

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Period: General cosmetic notification (within 3-5 months, excluding efficacy evaluation);

Special cosmetic registration (within 8-15 months)

Cosmetic Registration and Filing Process

China Cosmetic Registration and Filing Requirements

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According to the Rules for Registration and Notification Dossiers of Cosmetics, implemented on May 1, 2021, the application for cosmetic registration and filing shall submit the following materials:

1. Cosmetics registration and filling information form and related documents

2. Product name information

3. Product formula

4. Product implementation standard

5. Product label template

6. Product testing report

7. Product safety assessment documents

Our Services Related to China Cosmetic Registration and Filing 

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Before the project start-up

1. Free product classification, primary screening of new ingredients, China IECIC check, etc. 

2. The formulation of application solutions or project feasibility analysis.

Mid-term of project

1. Product inspection: carry out necessary tests in China, such as microbiological and physicochemical tests, toxicology tests, human safety tests, and human efficacy evaluation.

2. Documents preparation and review: guide the company to sort out or draft other documents, such as production implementation standards, free sale certificates, entrusted processing agreements, and review if all the files meet the requirements.

3. Cosmetic safety assessment report writing and product dossier compilation: strictly checked by certified toxicologists and compliance technical experts in China.

Project start-up

1. Account application: guide the company to fill in relevant information, complete the authorization of the responsible person, and sort out or establish a quality management system with our assistance.

2. Product review: review whether the ingredient, formula, label, efficacy claims, etc. of the product comply with relevant regulations, and define the feasibility of registration or filing.

Later stage of project

1. Registration and filing documents review: build a good relationship with relevant government departments, directly discuss and solve key problems with NMPA experts.

2. Dossier submission: a special person is responsible for sorting out the paper data and completing the submission through the offline window.

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