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Imported Cosmetics Filing Process

China's imported cosmetics compliance business.
01
Definition and classification of cosmetics

Cosmetics: refers to the daily chemical products which can spread on any part of the human body surface (skin, hair, nails, lips, etc.) by means of rubbing, spraying or other similar methods, so as to achieve the purpose of cleaning, eliminating bad smell, skin care, beauty and modification.(cosmetic hygiene supervision ordinance (Cosmetics MOH order no. 3) .

Special Use Cosmetics: specifically refers to the anti-freckle category (whitening), sunscreen category, hair-growing category, breast beauty category, bodybuilding category, hair-dying category, hair-perming category, hair removal category, deodorization category, and these nine products.

General Cosmetics: except for special purpose cosmetics.

Imported Cosmetics: refers to the products which the final product process which can contact content are finished outside China (including Hong Kong, Macao and Taiwan) .

Domestic cosmetics: refers to the products which the final product process which can contact content are finished in Chin.

02
China's cosmetics regulatory model

Approved by the State Council in 1989, the Ministry of Health issued Order No. 3 of the “Regulations on Hygiene Supervision of Cosmetics” (hereinafter referred to as the “Regulations”), which came into effect on January 1, 1990. The “Regulations” is divided into six chapters, which stipulate the definition of cosmetics, and the production and operation hygiene supervision and licensing system. In 2008, the State Council’s institutional reform, the responsibility of cosmetic hygiene supervision and management was transferred from the Ministry of Health to the National Food and Drug Administration (CFDA), and from August 29, 2018, the CFDA was officially changed to the National Drug Administration (NMPA).

According to the requirements of the “Announcement Concerning the Implementation of the Administration of Imported Non-special Use Cosmetics on a Nationwide Scale” (No. 88 of 2018) issued by the National Medical Products Administration, starting from November 10, 2018, the first import of non-special use cosmetics The current examination and approval management and the trial implementation of filing management in the pilot free trade zone will be adjusted to unified nationwide filing management. The State Drug Administration will no longer accept applications for administrative licenses for importing non-special use cosmetics. Overseas cosmetics manufacturers should entrust the domestic responsible person ( RP ) to complete the relevant procedures before importing non-special cosmetics. The registered place of the domestic responsible person is in, Liaoning, Shanghai, Zhejiang, Fujian, Henan, Hubei, Guangdong, Chongqing, Sichuan, Shaanxi, and other provinces (municipalities) that have carried out pilot free trade zone pilot zones in the early stage to implement the record management of imported non-special use cosmetics If it is within the administrative area, it shall file with the provincial Food and Drug Administration of the place where it is located. If the registration place of the domestic responsible person is within the administrative area of ​​other provinces (autonomous regions, municipalities), the registration shall be filed with the State Drug Administration. Products that have been filed and are intended to be imported at ports outside the administrative region of the province (city, district) where the responsible person in the country is located must be added to the port of import and consignee through the filing system before importing.

Special cosmetics will continue to implement the examination and approval system, and they can entrust the reporting unit ( RA ) in China (for overseas companies) to submit to the National Medical Products Administration for administrative license review. After expert review, they can obtain administrative license approval for imported special-purpose cosmetics. Domestic non-special use cosmetics can be put on the market after being put on record by the Provincial Drug Administration Department.

Administrative license approval or filing certificate is an important review basis for product import and marketing, and cosmetics registration/ filing is an indispensable step before its successful sale.

03
Application Materials for Registration

1) Application form for hygiene approval of import generally used cosmetics

2)Basis for Chinese name

3)Quantitative formula

4)The requirements or standards for quality control

5)Pictures of the product original package (including product label and specification); If the product is going to design a new package for the China market, the product design package (including product label and specification) shall be submitted at the same time.

6)Brief manufacturing process

7)Product technical requirements;

8)Test reports issued by test authority

9)Safety assessment of some risky ingredients

10)BSE guarantee letter

11)Free Sales Certificate

12)Overseas manufacturing country relevant certification materials for production quality management;

13)Other documents possibly beneficial to product evaluation

Additionally, one piece of sample product which sealed by licensed test authority

04
Declaration process

Imported special purpose cosmetics

Imported non-special purpose cosmetics

Responsible unit for reporting in China (RA)

Domestic Responsible Person (RP)

Qualification requirements: a unit that is legally registered in mainland China and has independent legal personality.

Qualification requirements: corporate legal persons registered in mainland China and responsible for product quality and safety in accordance with the law.

[ Note: The business scope of the domestic responsible person company must cover cosmetics sales and import and export business ]

Responsibility: Responsible only for the cosmetic product registration process.

Responsibilities: Responsible for the registration application, import and operation of related products, and bear the corresponding product quality and safety responsibilities in accordance with the law.

Authorization: An overseas company should only appoint one responsible entity for reporting in China.

Authorization: An overseas company can entrust multiple domestic responsible persons to be responsible for different products, but there is only one domestic responsible person for the same product.

05
Relevant regulatory authorities:

National Medical Products Administration (NMPA): Responsible for supervising the production, declaration, and post-marketing supervision of cosmetics

Provincial Food and Drug Administration: Responsible for non-special cosmetics filing approval and post-marketing supervision

Administration for Industry and Commerce: business license application, trademark application, advertising supervision

Customs and Entry-Exit Inspection and Quarantine Bureau: import and export customs clearance inspection and quarantine

General Administration of Quality Supervision, Inspection, and Quarantine: Cosmetics label review

06
Our service

Acting for the responsible unit for reporting in China

Compliance audit of finished cosmetics formulations

Compliance audit of finished cosmetics labels

Schedule required tests

Preparation of filing dossiers

Submit application and respond to review comments

For more questions, please refer to ” FAQ ” or send an email to info@zmuni.com

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ZMUNI Cosmetics Compliance Team

Provide efficient compliance services with solid knowledge and regulatory experience.

ZMUNI is a consulting company specialized in providing registration consulting services for imported products. With high standards process service, integrity management, and simplified compliance process to make foreign cosmetics all-round efficiently import into China by general trade.

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With high standards process service, integrity management, and simplified compliance process to make foreign cosmetics all-round efficiently import into China by general trade.
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