China Opens Public Consultation on Draft National Standards for Determination of Prohibited/Permitted Ingredients in Cosmetics

On Sep. 17, China released 3 draft national test standards including 2 for the determination of 11 kinds of azoles (antifungal agents) and 15 quinolones (antibiotics) all of which are prohibited in cosmetics. 1 standard for the determination of tranexamic acid was also released which is a permitted ingredient. The three drafts are now open for public consultation...

Takehome:

2 GBs for the determination of prohibited Ingredients

As specified in the Safety and Technical Standard for Cosmetics, azole antifungal agents such as fluconazole, bifonazole and clotrimazole and quinolone antibiotics such as enoxacin, marbofloxacin, norfloxacin, ofloxacin are prohibited ingredients in cosmetics. If these ingredients are present in cosmetics as impurities (which during the production process cannot be avoided due to technical reasons), the content shall not exceed the limitation specified in relevant national standards.

Considering there is no limit value of these substances at present, China drafted “Determination of 11 kinds of azoles antifungal agents in cosmetics—Liquid chromatography tandem mass spectrometry” and “Determination of 15 quinolones in cosmetics—Liquid chromatography tandem mass spectrometry” to provide standard test requirements and methods for the determination of them in aqueous, emulsion and non-wax based cream cosmetics. In addition, the two standards also stipulate the limit of detection (LOD) and limit of quantitation (LOQ) of these ingredients. Specifics are as follows:

Determination of 11 kinds of azoles antifungal agents in cosmetics—Liquid chromatography tandem mass spectrometry
No.	English name	CAS No.	Detection limit (mg/kg)	Quantitation Limit (mg/kg)
1	Fluconazole	86386-73-4	0.10	0.30
2	Bifonazole	60628-96-8	0.10	0.30
3	Clotrimazole	23593-75-1	0.10	0.30
4	Econazole	27220-47-9	0.10	0.30
5	Miconazole	22916-47-8	0.10	0.30
6	Voriconazole	137234-62-9	0.10	0.30
7	Fenticonazole	72479-26-6	0.10	0.30
8	Terconazole	67915-31-5	0.20	0.60
9	Ketoconazole	65277-42-1	0.20	0.60
10	Oxiconazole	64211-45-6	0.20	0.60
11	Itraconazole	84625-61-6	0.20	0.60

Determination of 15 quinolones in cosmetics—Liquid chromatography tandem mass spectrometry
No.	English name	CAS No.	Detection limit (mg/kg)	Quantitation Limit (mg/kg)
1	Enoxacin	84294-96-2	0.15	0.50
2	Marbofloxacin	115550-35-1	0.15	0.50
3	Norfloxacin	70458-96-7	0.15	0.50
4	Ofloxacin	82419-36-1	0.15	0.50
5	Fleroxacin	79660-72-3	0.15	0.50
6	Pefloxacin	149676-40-4	0.15	0.50
7	Ciprofloxacin	97867-33-9	0.15	0.50
8	Lomefloxacin	98079-52-8	0.15	0.50
9	Danofloxacin	112398-08-0	0.15	0.50
10	Enrofloxacin	93106-60-6	0.15	0.50
11	Orbifloxacin	113617-63-3	0.15	0.50
12	Sarafloxacin	98105-99-8	0.15	0.50
13	Sparfloxacin	110871-86-8	0.15	0.50
14	Difloxacin	98106-17-3	0.15	0.50
15	Moxifloxacin	192927-63-2	0.15	0.50

1 GB for the determination of permitted ingredients

Tranexamic acid is considered a permitted cosmetic ingredient in China (included in the IECIC and generally functions as a skin conditioning and skin whitening agent in cosmetic products). The standard “Determination of tranexamic acid in cosmetics - High performance liquid chromatography” applies to the determination of tranexamic acid in aqueous, emulsion and non-wax based cream cosmetics. The limit of detection (LOD) of tranexamic acid is 3.0 mg/kg and the limit of quantitation (LOQ) is 10.0 mg/kg.

Deadline for public comments is Nov. 14, 2018. Any advice or suggestions can be submitted to Shanghai Research Institute of Fragrance and Flavor Industry by email at [email protected], or by fax at (021)54483433. Meanwhile, some relevant patents and supporting documents can be attached to support your feedback.