ZMUni Compliance Centre

Previously, the Beijing Municipal MPA launched an entry-level guide on conducting full-version safety assessment reports for cosmetics, providing fundamental insights into the process.

On October 16, 2024, the Beijing Municipal MPA released the "FAQs on Notification of General Cosmetics (Vol. 37)," which offers a more advanced guide for completing full-version safety assessment reports. This practical resource addresses common issues related to the using of nano materials, plant extracts, and new cosmetic ingredients still under safety monitoring in general cosmetics.

Q1: Is the Ingredient Usage Information of Marketed Products equivalent to the Inventory of Existing Cosmetic Ingredients in China 2021?

A: No, the two are not equivalent.

The Ingredient Usage Information of Marketed Products (hereinafter referred to as "Ingredient Information") is a record of ingredients that have been used in special cosmetics with valid licenses in China. These ingredients are not included in the Safety and Technical Standards for Cosmetics and do not have evaluation reports from international authoritative cosmetic safety assessment organizations.The usage data of these ingredients is updated dynamically. The data from Ingredient Information can serve as evidence for the full-version safety assessment report of cosmetics and provide a reference for the evaluation process. However, no systematic evaluation of the listed ingredients has been conducted. When cosmetic registrants and notifier use this information for certain cosmetics, they must comply with the relevant national laws, regulations, standards, and guidelines to conduct their safety assessments.

The Inventory of Existing Cosmetic Ingredients in China 2021 provides an objective record of ingredients that have been used in cosmetics produced and sold within China. The highest historical usage of these ingredients, as listed in the Inventory, can be used as evidence for simplified cosmetic safety assessment reports and provide a reference for the safety evaluation process.

Q2: What points should be noted when conducting safety assessments for new cosmetic ingredients (NCI) that are still within the three-year safety monitoring period during the notification of general cosmetics?

A: According to the Guidelines for Submission of Cosmetic Safety Assessment Dossiers, cosmetics that incorporate NCI still under the three-year safety monitoring period must include a cosmetic safety assessment report.

During the safety assessment of the NCI, it is essential to evaluate whether the ingredient's intended purpose, scope of use, concentration, and any usage restrictions or requirements comply with the technical requirements for NCI.

Q3: What points should be noted when conducting safety assessments for nano materials during the notification of general cosmetics?

A: According to the Provisions for Management of New Cosmetic Ingredient Registration and Notification Dossiers and the Guidelines for Submission of Cosmetic Safety Assessment Dossiers, if a product formulation contains nano materials, it is necessary to provide quality specifications that include information on purity, crystal form, initial particle size distribution, and surface coating substances, and to conduct a safety assessment based on these specifications for the nano materials used in the formulation. Additionally, it is important to indicate whether the toxicological testing methods employed are suitable for assessing nano materials.

Due to the small particle size of nano materials, there is a heightened risk of inhalation exposure; therefore, their use in products that may pose inhalation risks is discouraged.

• Children's Cosmetics: According to the Supervision and Administration Provisions on Children's Cosmetics, the use of nano materials and other ingredients produced using new technologies is prohibited in children's cosmetics.If the use of such ingredients is deemed necessary and no alternatives are available, the reasons must be clearly outlined in the safety assessment documentation. This should include a necessity analysis, an explanation of the exclusivity of the nano technology, and a comprehensive safety evaluation for children’s use. Additionally, safety evaluation test results should be provided as supporting evidence, if applicable.

Q4: What types of evidence and assessment methods can be used when conducting safety assessments for plant extracts?

A: The types of evidence and assessment methods that can be used include:

1. Assessment conclusions published by international authoritative cosmetic safety assessment organizations.

2. Safety limits or conclusions published by reputable organizations such as the World Health Organization (WHO) and the Food and Agriculture Organization (FAO).

3. Ingredient usage information for marketed products published by regulatory authorities.

4. A three-year usage history of the ingredient.

5. Historical data on safe consumption.

6. Toxicological Concern Threshold (TTC) values.

Q5: What common issues do companies face when using historical data on safe consumption for safety assessments?

A:

1. Relying on safety limits or conclusions from authoritative organizations like the WHO and FAO (e.g., ADI, TDI, RfD, GRAS) without properly analyzing the data or confirming whether these conclusions comply with China's cosmetic regulations.

2. Directly using oral safety data from the Chinese Pharmacopoeia without further analysis or consideration.

3. Using historical safety data for plant ingredients that do not correspond to the parts used in the cosmetic formulation.

4. Discrepancies between the plant ingredient in the formulation and the historical safety data regarding extraction methods and impurity levels.