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 | 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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