Prohibited cosmetic ingredient testing methods update

Prohibited cosmetic ingredient testing methods update announcement has been released by the National Medical Products Administration (NMPA). Each of the ten (10) named ingredients are strictly prohibited in cosmetics in China.

These prohibited cosmetic ingredients will be tested by the NMPA during sampling inspections.

1. Scope:

The Announcement (no. 3/2024) specifies testing methods for the determination of the presence of ten pharmaceutical drugs in cosmetics:

1. Hydroxyflutamide,
2. Finasteride,
3. Nilutamide,
4. Bicalutamide,
5. Flutamide,
6. Flutamine,
7. Cyproterone acetate,
8. Cyproterone acetate acetate,
9. Dutasteride, and
10. Epristeride.

The testing methods are applicable to various cosmetic forms, including creams, liquids (water and oil-based), gels, wax-based products, and powders, for both qualitative and quantitative analysis of these ten components.

2. Principles:

Samples are subjected to ultrasound extraction using 50% acetonitrile, followed by separation using high-performance liquid chromatography (HPLC) and detection using mass spectrometry (MS). Qualitative analysis is based on the relative abundance of characteristic ion pairs and retention times, while quantitative analysis is performed by measuring peak areas using the standard curve method.

3. Sample Preparation and Storage:

The Announcement states that samples should be stored according to labeled storage conditions. Before sampling, inspectors are required to check the integrity of the packaging and observe the characteristics of the sample. After opening the packaging, the required portion shall be analyzed as quickly as possible, and the remaining sample stored in a sealed container.

4. Analytical steps:

• Screening Mixed Standard Solution
• Blank Matrix Extraction Solution
• Matrix Mixed Standard Intermediate Solution
• Matrix Mixed Standard Series Solutions
• Sample processing
• Instrument Reference Strip
• qualitative determination
• quantitative measurement
• Parallel test
• Blank test

Further information

Read the original announcement on the updated list of prohibited cosmetic ingredient testing methods.

Read our previous articles:

• China prohibited cosmetic ingredient list update has been proposed
• Testing methods for azelaic acid and other cosmetics raw materials in China – Draft for public consultation

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