Cosmetic Compliance
Intelligence & Solutions
BJH 202301 Determination of Tacrolimus and Pimecrolimus in Cosmetics
Local Title:
化妆品中他克莫司和吡美莫司的测定
Country/Region:
Chinese Mainland
Competent Authority:
National Medical Products Administration
Type:
Regulation
Status:
In force
Release Date:
2023-07-07
Implementation Date:
2023-07-07
Document
Language Source Title Access
ZH
Official BJH 202301 Determination of Tacrolimus and Pimecrolimus in Cosmetics
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BJH 202301 Determination of Tacrolimus and Pimecrolimus in Cosmetics
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Summary

On July 7, 2023, NMPA released a new cosmetics supplementary testing method, BJH 202301 Determination of Tacrolimus and Pimecrolimus in Cosmetics, for the determination of the following two prohibited ingredients.

No.

Ingredient Name (CAS No.)

Detection Limit (ng)

Lower Quantitative Limit (ng)

Detection Concentration (mg/kg)

Minimum Quantitative Concentration (mg/kg)

1

Tacrolimus (104987-11-3)

0.0004

0.001

0.01

0.025

2

Pimecrolimus (137071-32-0)

0.0004

0.001

0.01

0.025

These two ingredients are mainly used in the medical field but not allowed to be used in cosmetics. The new method is applicable for the determination of these two ingredients in cream, emulsion, and liquid (water, oil) cosmetics.

Noteworthy Information