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China NMPA Issues a New Cosmetics Supplementary Testing Method for 16alpha-hydroxyprednisolone

On November 23, 2022, China NMPA released a new cosmetics supplementary testing method, BJH 202203 Determination of 16alpha-hydroxyprednisolone in Cosmetics, which specifies the qualitative and quantitative determination method of the prohibited ingredient 16alpha-hydroxyprednisolone. 1

Chinese Name

English Name

CAS No.

Detection Limit (ng)

Quantitative Lower Limit (ng)

Detection Concentration (mg/kg)

Minimum Quantitative Concentration (mg/kg)

16α-羟基泼尼松龙

16alpha-hydroxyprednisolone

13951-70-7

0.001

0.0025

0.01

0.025

16alpha-Hydroxyprednisolone is an advanced intermediate in the synthesis of various corticosteroids such as budesonide and ciclesonide. Its use in cosmetics is prohibited. The above-mentioned supplementary method is applicable for the determination of 16alpha-hydroxyprednisolone in cream, lotion, and liquid (water) cosmetics.

Cosmetic Supplementary Testing Methods

Cosmetic supplementary testing methods supplement conventional testing methods specified in the national cosmetic standards and technical specifications such as Safety and Technical Standards for Cosmetics. They are established for prohibited ingredients that lack testing methods and are used in adulterated products. The application scope covers the testing of cosmetics produced after and even before the release date of the methods.

Supplementary testing methods is an important means for regulators in cosmetics’ post-market surveillance and law enforcement, especially in combating with illegal additions. Since the Working Rules for Management of Cosmetic Supplementary Testing Methods came into effect in July 2021, China NMPA has issued five supplementary testing methods, involving the determination of 20 prohibited ingredients, as shown below.

No.

Method Name

Prohibited Ingredients

Release Date

1

BJH 202101 Determination of Benvitimod in Cosmetics

Benvitimod

September 2, 2021 2

2

BJH 202102 Determination of Five Components Including Bimatoprost in Cosmetics

Bimatoprost, Tafluprost Ethyl Amide, Latanoprost, Travoprost, Tafluprost

September 13, 2021 3

3

BJH 202201 Determination of Five Components Including Mupirocin in Cosmetics

Mupirocin, Fusidic Acid, Timolol, Terbinafine, Erythromycin

July 28, 2022 4

4

BJH 202202 Determination of Eight Components Including Elubiol in Cosmetics

Elubiol, 5-Nitrobenzimidazole, 5-Chloro-1-methyl-4-nitroimidazole, Ornidazole, Tinidazole, Ipronidazole, Ronidazole, 1-(2-Hydroxyethyl)-2-Hydroxymethyl-5-Nitroimidazole

September 13, 2022 5

5

BJH 202203 Determination of 16alpha-hydroxyprednisolone in Cosmetics

16alpha-hydroxyprednisolone

November 23, 2022

ChemLinked expects to assist companies in applying for ingredient submission codes and registering/notifying cosmetics in China. If you have any further cosmetic compliance consultation needs, please contact us at cosmetic@chemlinked.com.

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