China NMPA Consults on the Key Points for Reviewing of Cosmetic Safety Assessment Report

Starting from Jan. 1, 2022, cosmetic registrants and notifiers shall conduct cosmetic safety assessments in accordance with Technical Guidelines for Cosmetic Safety Assessment. Before May 1, 2024, a simplified version of the safety assessment report can be submitted when applying for special cosmetics registration or general cosmetics notification.

Starting from Feb. 21, 2022, a draft of Key Points for Reviewing of General Cosmetics Safety Assessment Report (Simplified Version) (hereinafter referred to as “Key Points”) proposed by National Medical Products Administration (NMPA) is being discussed among cosmetic industry insiders. ¹ National Institutes for Food and Drug Control, provincial MPAs, and inspection centers are required to provide feedback before Mar. 31.

The Key Points sets a unified standard for the review of the safety assessment report, and has great reference significance for companies to prepare safety assessment report in a standardized manner.

Main Content

The Key Points is applicable to the review of the safety assessment report of general cosmetics. It clarifies the requirements for data collation and technical review of the safety assessment report, stipulates the judgment principles for reviewing the safety assessment report, etc.

Chapter I General Principles

Chapter II Data Collation Requirements (including the paper's size, font color, page numbering, the standardization of Chinese characters, unit of measurement, punctuation, charts, normative terms, sealing, signature, etc.)

Chapter III Technical Review Requirements

Chapter IV Judgment Principles

Attachment Guidelines for Review of General Cosmetics Safety Assessment Report (Simplified Version)

Data Collation Requirements
Technical Review Requirements
Annex I Cosmetic Exposure Information Sheet
Annex II IFRA Product Classification
Annex III List of Common Risk Substances
Annex IV Description of Adverse Reaction Monitoring

Judgment Principle

The Key Points stipulates three review conclusions of the safety assessment report. If the safety assessment data is true and complete, and the assessment conclusion can fully prove that the product is safe and meets the requirements of the Key Points, the report will be judged as "Pass."

Situation		Conclusion
The safety assessment data is true and complete, and the assessment conclusion can fully prove that the product is safe and meets the requirements of the Key Points.		Pass
The safety assessment conclusion is basically accepted, with defects that do not involve product safety	The report format is not standardized	Charging correction
	The safety assessment data is incomplete (under the premise that the data incompletion will not affect the assessment conclusion)
	The notifier is required to make further explanations (under the premise of not affecting the assessment conclusion)
	The notifier is required to submit relevant supporting documents (under the premise of not affecting the assessment conclusion)
	Other situations that require data modification or supplementation
Incomplete safety assessment data or doubtful assessment conclusion concerning product safety	Failure to provide a safety assessment report as required by regulations	Charging correction and suspending sales
	The safety assessment data does not meet the requirements of the Key Points and affects the product safety judgement
	Failure to provide ingredient quality specification certificates in accordance with the requirements of Safety and Technical Standards for Cosmetics
	Children and infant cosmetics lack the safety basis for the ingredient use
	Other situations that do not comply with relevant regulations and affect the product safety judgement

Companies need to be cautious when preparing safety assessment reports. If the report cannot prove the product's safety, the regulatory authority will suspend the product's sale.

Examples of Review Items, Points, and Methods (extract)

Review Items	Review Points	Review Methods
Average daily usage	The product usage/exposure amount should be reasonable and with a reference basis; For the basis of product usage/exposure, please refer to the EU Guidelines for the Safety Assessment of Cosmetics and Ingredients or other published literature. If there is no published literature or data, the product usage/exposure should be fully and scientifically assessed based on the actual situation.	Annex I: Cosmetic Exposure Information Sheet (exposure and retention factor) in the EU Guidelines for the Safety Assessment of Cosmetics and Ingredients
Ingredient assessment principles	All ingredients in the formula should be assessed; The assessment should follow the principle of the weight of evidence. At least one type of evidence should be selected for assessment to determine the ingredient's safety; For ingredients that either type of evidence is applicable to, they should be assessed according to the procedures stipulated in Technical Guidelines for Cosmetic Safety Assessment.	The types of evidence that can be used in the safety assessment are: 1) Safety and Technical Standards for Cosmetics; 2) Assessment conclusions issued by authoritative Chinese or foreign organizations; 3) Ingredient's highest use concentration among this enterprise’s products on the market; 4) Ingredient's highest historical use concentration announced by the regulatory authority.
Ingredients that for which any of the above types of evidence is not capable to be used	Toxicological assessment data, assessment process, results, and conclusions of the ingredient, or product's toxicological testing report should be provided to prove product safety; If the corresponding evidence cannot be obtained based on the current scientific and technological level, the simplified safety assessment report and product toxicological testing report can be submitted together to prove product safety. The toxicological tests should include items that can fully prove product safety.	/
Fragrance	The added amount of fragrance in the formula shall not be higher than the maximum allowable amount listed in the IFRA certificate (or other certification documents provided by the ingredient supplier, or GB/T 22731-2017 Fragrance compound).	Annex II IFRA Product Classification

Industry's Comment

At present, one of the difficulties faced by the industry for safety assessment is obtaining the safety data of each ingredient. The Key Points states that “If the corresponding evidence cannot be obtained, the simplified safety assessment report and product toxicological testing report can be submitted together to prove product safety.” In other words, if some ingredients cannot obtain the assessment conclusions from authoritative institutions, or exceeds the usage amount specified in the ingredient catalog, the notifier can supplement the product's toxicological testing report to prove product safety. ²