Cosmetic Compliance
Intelligence & Solutions
Guidelines for the Approval of Registration of Cosmetics and New Cosmetic Ingredients
Local Title:
化妆品和新原料注册审批办事指南
Country/Region:
Chinese Mainland
Competent Authority:
National Institutes for Food and Drug Control
Type:
Notice
Status:
In force
Release Date:
2023-06-05
Implementation Date:
2023-06-05
Document
Language Source Title Access
ZH
Official Attachment 1 Guidelines for the Approval of Registration of New Cosmetic Ingredients with High Risks
ZH
Official Attachment 2 Guidelines for the Approval of Registration Change of Chinese Domestic Special Cosmetics
ZH
Official Attachment 3 Guidelines for the Approval of Initial Registration of Chinese Domestic Special Cosmetics
ZH
Official Attachment 4 Guidelines for the Approval of Registration Renewal of Chinese Domestic Special Cosmetics
ZH
Official Attachment 5 Guidelines for the Approval of Registration Cancellation of Chinese Domestic Special Cosmetics (Cancellation upon Application)
ZH
Official Attachment 6 Guidelines for the Approval of Registration Change of Imported Special Cosmetics
ZH
Official Attachment 7 Guidelines for the Approval of Initial Registration of Imported Special Cosmetics
ZH
Official Attachment 8 Guidelines for the Approval of Registration Renewal of Imported Special Cosmetics
ZH
Official Attachment 9 Guidelines for the Approval of Registration Cancellation of Imported Special Cosmetics (Cancellation upon Application)
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Guidelines for the Approval of Registration of Cosmetics and New Cosmetic Ingredients
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Summary

On June 5, 2023, China National Institutes for Food and Drug Control (NIFDC) released nine guidelines pertaining to the registration of Chinese domestic and imported special cosmetics, as well as high-risk new cosmetic ingredients (NCIs). These guidelines provide clear details and time limits for the first registration, registration change, registration renewal and registration cancellation applications, which are highly informative for enterprises seeking guidance.

Guidelines’ Main Content

No.

Guidelines

Main Contents

Attachments

1

Guidelines for the Approval of Registration of New Cosmetic Ingredients with High Risks

  • Administrative licensing item name and code

  • Sub-item name and code of administrative licensing

  • Business items that need to be handled

  • Competent authority

  • The Guidelines’ establishment and implementation basis

  • Executive agency

  • Approval levels

  • Types of administrative licensing items

  • Licensing conditions

  • Application documents

  • Intermediary services

  • Approval procedures

  • Acceptance and approval time limit

  • Fees

  • Administrative license

  • Administrative license’s quantity limit

  • Annual inspection requirements after administrative license’s issuance

  • Annual report requirements after administrative license’s issuance

  • Regulatory body

  • Service object type

  • Information of the business items that need to be handled

  • FAQ

NCI registration and notification information form and its example, basic information of NCI’s R&D report and its example, NCI’s usage information and its example, technical requirements for NCI and its example, flowchart for NCI registration, NCI’s registration certificate, the template of decision letter on not approving administrative licensing for NCI

2

Guidelines for the Approval of Registration Change of Chinese Domestic Special Cosmetics

Application form for registration change of special cosmetics and its example, handling process, example of the registration certificate of Chinese domestic special cosmetics, the template of decision letter on not approving registration change

3

Guidelines for the Approval of Initial Registration of Chinese Domestic Special Cosmetics

Cosmetics registration and notification information form and its example (applicable for Chinese domestic cosmetics and Chinese domestic registrant/notifier), cosmetic product naming basis and its example, formula table and its example, cosmetic executive standard and its example, cosmetic labeling manuscript and its example, cosmetic product’s safety assessment report and its examples (full version and simplified version), handling process, example of Chinese domestic special cosmetics’ registration certificate, the template of decision letter on not approving administrative licensing for special cosmetics

4

Guidelines for the Approval of Registration Renewal of Chinese Domestic Special Cosmetics

Cosmetic product registration renewal application form and its example, the self-inspection report on cosmetic registration renewal and its example, handling process, example of Chinese domestic special cosmetics registration certificate, the template of decision letter on revoking cosmetic administrative license

5

Guidelines for the Approval of Registration Cancellation of Chinese Domestic Special Cosmetics (Cancellation upon Application)

Cosmetic registration cancellation application form and its example, handling process, the template of decision letter on cancellation approval

6

Guidelines for the Approval of Registration Change of Imported Special Cosmetics

Application form for registration change of special cosmetics and its example, handling process, example of registration certificate of imported special cosmetics, the template of decision letter on not approving registration change

7

Guidelines for the Approval of Initial Registration of Imported Special Cosmetics

Cosmetics registration and notification information form and its example (applicable for imported cosmetics and Chinese domestic registrant/notifier), cosmetic product naming basis and its example, formula table and its example, cosmetic executive standard and its example, cosmetic labeling manuscript and its example, cosmetic product’s safety assessment report and its examples (full version and simplified version), handling process, example of imported special cosmetics registration certificate, the template of decision letter on not approving administrative licensing for special cosmetics

8

Guidelines for the Approval of Registration Renewal of Imported Special Cosmetics

Cosmetic product registration renewal application form and its example, the self-inspection report on cosmetic registration renewal and its example, handling process, example of imported special cosmetics registration certificate, the template of decision letter on revoking cosmetic administrative license

9

Guidelines for the Approval of Registration Cancellation of Imported Special Cosmetics (Cancellation upon Application)

Cosmetic registration cancellation application form and its example, handling process, the template of decision letter on cancellation approval


Noteworthy Information