China NMPA Issues a New Cosmetics Supplementary Testing Method: Five Imidazoline Drugs Involved

The new cosmetic supplementary testing method applies to five imidazoline drugs such as Tetrahydrozoline and Naphazoline in cream, lotion, liquid (water), gel, and wax-based cosmetics. Up to now, China has approved six cosmetics supplementary testing methods.

On December 23, 2022, China NMPA released a new cosmetics supplementary testing method, BJH 202204 Determination of Five Components Including Tetrahydrozoline in Cosmetics, which specifies the qualitative and quantitative determination method of the following five prohibited ingredients. ¹

No.	Ingredient Name (CAS No.)	Detection Limit (μg/L)	Lower Quantitative Limit (μg/L)	Detection Concentration (mg/kg)	Minimum Quantitative Concentration (mg/kg)
1	Tetrahydrozoline (84-22-0)	0.0016	0.005	0.08	0.25
2	Naphazoline (835-31-4)	0.0016	0.005	0.08	0.25
3	Oxymetazoline (1491-59-4)	0.0016	0.005	0.08	0.25
4	Antazoline (91-75-8)	0.0016	0.005	0.08	0.25
5	Xylometazoline (526-36-3)	0.0016	0.005	0.08	0.25

(Table 1 Five Imidazoline Drugs)

The five imidazoline drugs 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 ingredients in cream, lotion, liquid (water), gel, and wax-based cosmetics.

Cosmetic Supplementary Testing Methods

Cosmetic supplementary testing methods are supplements to the conventional testing methods in the national cosmetic standards and technical specifications such as Safety and Technical Standards for Cosmetics 2015. They are established for products that may be adulterated or produced with prohibited cosmetic ingredients but lack corresponding testing methods. The application scope covers not only the testing of cosmetics produced after the release date of the methods but also those 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 six supplementary testing methods, involving the determination of 24 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 ⁶
6	BJH 202204 Determination of Five Components Including Tetrahydrozoline in Cosmetics	Tetrahydrozoline, Naphazoline, Oxymetazoline, Antazoline, Xylometazoline	December 23, 2022

(Table 2 Six Approved Cosmetic Supplementary Testing Methods)

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