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Recommended collection! China's cosmetic raw material management requirements are the most complete

How to distinguish used cosmetic raw materials from new cosmetic raw materials

Used cosmetic raw materials: the raw materials included in the "Catalogue of Used Cosmetic Raw Materials (2021 Edition)"
New cosmetic raw materials: raw materials not included in the "Catalogue of Used Cosmetic Raw Materials (2021 Edition)"

National Medical Products Administration (NMPA) regulatory requirements for cosmetic raw materials

Cosmetic raw materials have been used

"Regulations on the Supervision and Administration of Cosmetics"

According to Article 30, cosmetic raw materials shall comply with mandatory national standards and technical specifications. Cosmetics shall not be produced from cosmetic raw materials that have exceeded the expiry date, are discarded or recycled.

"Cosmetics Safety Technical Specifications"

Lists the list of prohibited cosmetic ingredients, prohibited plant (animal) raw materials, restricted ingredients, permitted preservatives, permitted sunscreens, permitted colorants, and permitted hair dyes.

Announcement of the State Food and Drug Administration on matters related to the implementation of the "Regulations on the Administration of Cosmetics Registration and Filing Materials" (2021 No. 35)

■ From 2021.5.1, when applying for cosmetic registration and filing, it is necessary to fill in the source and trade name information of the raw materials of the product formula, which involve the raw materials with quality specifications in the "Cosmetic Safety Technical Specifications", and the quality specification certificate or safety specification of the raw materials should also be submitted. Related Information.

■ From January 1, 2022, when applying for cosmetic registration and filing, the safety-related information on raw materials with anti-corrosion, sunscreen, coloring, hair dyeing, freckle-removing and whitening functions should be provided in accordance with the requirements of the "Regulations on the Management of Cosmetics Registration and Filing Materials".

■ From 2023.1.1, when applying for cosmetic registration and filing, the safety-related information of all raw materials should be provided in accordance with the requirements of the "Regulations on the Management of Cosmetics Registration and Filing Materials".

■ Before 2023.5.1, for cosmetics that have been registered or completed the filing, the registrant and filing person need to provide additional safety-related information on all raw materials in the product formula.

How to fill in the safety information of cosmetic raw materials

How to Apply for Cosmetic Raw Material Safety Information Reporting Code

Application subject

Application by raw material manufacturers or authorized enterprises.

Remarks: Cosmetic raw material manufacturers refer to the enterprises that are responsible for the safety of raw materials, which can be the actual production enterprises of raw materials, affiliated enterprises that belong to the same group as the actual production enterprises of raw materials, or the entrusted enterprises in the commissioned production of raw materials. Only one company can authorize the raw material safety information of the same quality specification.

Application path

Domestic users: log in directly through the "Cosmetic Raw Material Safety Information Registration Platform" module in the online office of the State Food and Drug Administration (click here to view).
Overseas users: need to log in after opening an account on the "Cosmetic Raw Material Safety Information Registration Platform" (click here to view).

application process

Raw material reporting code public information

After the raw material safety-related information is submitted through the information platform, the raw material reporting code is automatically generated. The raw material reporting code consists of five-digit manufacturer's digital code, six-digit raw material digital code and three-digit raw material quality specification digital code. The State Drug Administration discloses some of the raw material composition and raw material reporting code information in the submitted raw material safety information in the official publicity system (click here to view).

data request

User permission activation

Scanned copy of the company information form with the seal;
Raw material manufacturer's main certification document;
Authorization letter issued by the raw material manufacturer (in the case of authorized submission)

Remark:

■ The "name of the raw material manufacturer" in the enterprise information table is an important basis for identifying the enterprise and assigning the raw material manufacturer code. It should be consistent with the content contained in the enterprise main body certification documents.

■ If it is authorized and reported, the raw material manufacturer shall inform all authorized enterprises of the unique and correct name of the raw material manufacturer to ensure that the same raw material manufacturer code is used in the raw material reporting code.

■ If the overseas raw material supplier submits by itself or authorizes the overseas enterprise to submit, the main certification document of the raw material manufacturer should be notarized by the Chinese notary office or certified by the Chinese embassy (consulate).

Material Safety Information

Basic information and process brief
Raw material identification and characterization indicators
Risk Information and Control Indicators
Evaluation conclusions of international authoritative institutions
A brief description of the requirements for use in other industries
Other issues that need to be explained

National Medical Products Administration (NMPA) regulatory requirements for cosmetic raw materials

New cosmetic raw materials

Definition of new cosmetic raw materials: natural or artificial raw materials used in cosmetics for the first time in China
Classification of new cosmetic raw materials

New cosmetic ingredients with higher risk: preservatives, colorants, freckle/whitening agents, sunscreens and hair dyes
New raw materials for non-high-risk cosmetics

Pre-market regulatory requirements

According to Article 4 of the "Regulations on the Supervision and Administration of Cosmetics", the state implements registration management for new cosmetic raw materials with high risk, and records management for other new cosmetic raw materials.

Registration and filing process

Post-market regulatory requirements

The Ministry of Ecology and Environment (MEE) Order No. 12 Supervision Requirements for Cosmetics Raw Materials

Scope of applicable substances:

Cosmetic raw materials are new chemical substances (except those that are not applicable or exempted): substances that are not included in the Inventory of Existing Chemical Substances in China (IECSC Inventory for short) need to be registered as new chemical substances;
Cosmetic raw materials belong to existing substances: substances that have been included in the list and are intended to be used for other industrial uses other than permitted uses or are high-hazard chemical substances, which need to be registered for new use management

Note: Cosmetic raw materials in finished cosmetic products are exempted from China's new chemical substance notification requirements.

New chemical substance applicant

* When registration is required for inapplicable products or existing substances

New chemical substance registration type

■ One of the following conditions is met for filing:

■ The registered amount is less than 1 ton;

■ 2% or low concern polymers and are not excluded from polymer filing;

■ Simple registration is required for registrations of more than 1 ton but less than 10 tons.

■ Regular registration shall be carried out for the registered volume of more than 10 tons.

Post-market regulatory requirements

The regulatory authorities conduct post-market supervision of the declared new chemical substances according to the requirements recorded on the notification type or registration certificate.

■ First event report

■ Annual activity report

■ New Hazard Characteristic Information Report