China Unveils the Finalized Guidelines for Cosmetics Safety Assessment Dossiers Submission

On April 30, 2024, the China National Institutes for Food and Drug Control (NIFDC) announced the release of the finalized version of the Guidelines for Submission of Cosmetics Safety Assessment Dossiers (the Guidelines). These guidelines mark significant progress in cosmetic safety assessment and come after public consultation on March 29, 2024. To help address common queries, the NIFDC also provided several FAQs along with the guidelines.

Key highlights of the Guidelines include:

1. Streamlined Product Classification

Unlike the previous three-tier classification in the draft version, the finalized Guidelines simplifies the categorization of cosmetics into two main groups.

Category I Cosmetics includes special cosmetics, infant and children’s cosmetics, and those with new cosmetic ingredients under safety monitoring period.
Category II Cosmetics encompasses all other cosmetics, and is further subdivided based on ingredient risk and usage with instruments or tools. Please see Table 1 below for specific product types.

2. Revised Management of Safety Assessment Dossiers

Corresponding to the updated product classification system, the requirements for submitting cosmetic safety assessment dossiers have also been revised.

Enterprises handling Category I Cosmetics are mandated to provide comprehensive safety assessment reports, while those dealing with Category II Cosmetics enjoy greater flexibility. They can either submitting safety assessment reports, or providing safety assessment conclusions with relevant supporting materials and archiving the safety assessment reports for future reference.

It's essential to note that archiving the safety assessment reports neither exempts companies from preparing such reports, nor lowers safety assessment standards.

Table 1: Safety Assessment Dossiers’ Submission Requirements

Classification		Product Type	Submission of Safety Assessment Dossiers
			Basic Requirements	Additional Requirements
Category I Cosmetics		Special cosmetics Infant and children's cosmetics Cosmetics using new cosmetic ingredients that are in the safety monitoring period	The safety assessment report should be submitted.
Category II Cosmetics	Situation 1	(1) Cosmetics added with nano ingredients	Enterprise can choose any of the following methods: 1. To submit safety assessment conclusions (including the summary of the self-inspection report) and specific assessment materials (if any), and archive the safety assessment report for future reference. 2. To submit the safety assessment report.	Safety assessment dossiers for nano ingredients
		(2) Non-sunscreen cosmetics added with sunscreen agents that are not listed in Table 5 of the Safety and Technical Standards for Cosmetics (STSC) as light stabilizers		Safety assessment dossiers for light stabilizers
		(3) Cosmetics with claims of anti-acne, anti-wrinkle (except physical anti-wrinkle), deodorant, anti-dandruff, depilating, and exfoliation (except physical exfoliation) efficacies		Safety assessment dossiers for the functional ingredients in efficacy claims
		(4) Cosmetics in the form of patches, films, cosmetics contaning base materials (those contain functional raw materials or pigments), or aerosols		Safety assessment dossiers for functional ingredients /colorants contained or propellants
		(5) Cosmetics that must be used with instruments or tools (except brushes, air cushions, perming tools, etc. that only assist in the application of the cosmetics).		Safety assessment dossiers on the mechanism of action of the instrument or tool on the cosmetic product and its impact on product safety.
	Situation 2	General cosmetics other than Situation 1 in Category 2 Cosmetics		/

3. Implementation of Self-Inspection Framework

The Guidelines introduces the Self-Inspection Points for Cosmetics Safety Assessment Reports (the "Self-Inspection Points") as an annex, which covers the technical points required in the safety assessment report, which specifically includes ingredient safety assessment, cosmetic final product safety testing, safety assessment of special situation products, assessment of possible risk substances, product stability and microbiological assessment, safety assessment conclusions, etc.

The Self-Inspection Points assists companies in conducting self-inspections on their product safety assessment reports and forming safety assessment conclusions.

4. The Distinguish of Safety Assessment Conclusions and Safety Assessment Reports

The "Cosmetic Safety Assessment Conclusions" mainly involves self-inspection on all ingredients and possible risk substances in cosmetics, cosmetic stability, cosmetic packaging compatibility, microorganisms, and other aspects according to the Self-Inspection Points, as well as the forming of a summary of cosmetic safety assessment report.

The "Cosmetic Safety Assessment Report" requires a complete and detailed safety assessment of specific types of cosmetic ingredients, product stability and microbiology, possible risk substances, etc., as well as clear risk control measures and safety assessment conclusions, and provide references and appendices.

Table 2: Comparison Between Safety Assessment Conclusions and Reports

Cosmetic Safety Assessment Conclusion	Cosmetic Safety Assessment Report
Explanation of Dossiers Submission
Cosmetic Safety Assessment Abstract
Cosmetic Safety Assessment Conclusion
/	The Product’s Brief Introduction
	Safety Assessment of Ingredients
	Safety Assessment of Specific Types of Ingredients
	Cosmetic Final Product Safety Testing
	Safety Assessment of Products in Special Circumstances
	Product Stability and Microbiological Assessment
	Risk Control Measures or Recommendations
	Safety Assessment Conclusions
Signature of the Person in Charge of Quality and Safety	Resume and Signature of Safety Assessor