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China NMPA Issues a New Cosmetics Supplementary Testing Method: Eight Prohibited Antifungal Agents Involved

The new cosmetic supplementary testing method applies to eight prohibited antifungal agents such as Elubiol and Ornidazole in cream, lotion, and liquid (water) skin cosmetics. Up to now, China has approved four cosmetics supplementary testing methods.

On September 13, 2022, China NMPA released a new cosmetics supplementary testing method, BJH 202202 Determination of Eight Components Including Elubiol in Cosmetics, which specifies the determination method of the following eight 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

Elubiol (67914-69-6)

2.0

10.0

0.10

0.50

2

5-Nitrobenzimidazole (94-52-0)

2.0

20.0

0.10

1.0

3

5-Chloro-1-methyl-4-nitroimidazole (4897-25-0)

2.0

20.0

0.10

1.0

4

Ornidazole (16773-42-5)

2.0

10.0

0.10

0.50

5

Tinidazole (19387-91-8)

2.0

4.0

0.10

0.20

6

Ipronidazole (14885-29-1)

2.0

10.0

0.10

0.50

7

Ronidazole (7681-76-7)

10.0

50.0

0.50

2.5

8

1-(2-Hydroxyethyl)-2-Hydroxymethyl-5-Nitroimidazole (4812-40-2)

2.0

10.0

0.10

0.50

 (Table 1 Eight Prohibited Antifungal Agents)

The eight antifungal agents 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, and liquid (water) skin 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 are an important weapon for regulators in cosmetics’ post-market supervision and administrative law enforcement, especially in the fight against illegal additions. Since the Working Rules for Management of Cosmetic Supplementary Testing Methods came into effect in July 2021, China NMPA has issued four supplementary testing methods, involving the determination of 19 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

Please refer to the eight ingredients listed in Table 1

September 13, 2022

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