China Blocks Market Entry of Imported Toothpaste Containing Benzethonium Chloride

Recently 32 batches of imported cosmetics were disqualified during entry inspection and quarantine. Although not regulated as a cosmetic in China a consignment of toothpaste also failed to pass customs inspection due to the presence of Benzethonium Chloride. Although Benzethonium Chloride is allowed to be used in cosmetics as a preservative, toothpaste has not yet been designated as a cosmetic in China. Currently toothpaste is regulated by a specific standard...

Takehome:

Although Benzethonium Chloride is allowed to be used in cosmetics as a preservative, toothpaste has not yet been designated as a cosmetic in China. Currently toothpaste is regulated by a specific standard: GB 22115-2008 General requirements on raw materials of toothpastes. This is the standard which stipulates requirements of raw materials used in toothpastes including prohibited ingredients, restricted ingredients, permitted preservatives and permitted colorants. In this document, Benzethonium Chloride is prohibited in toothpaste.

Foreign Enterprises looking to export toothpaste to China should keep an eye on the GB 22115 in case their product contains ingredients which are banned in China.

Annex: Example of positive/negative ingredient lists in GB 22115

Table 1: List of Prohibited Ingredients in Toothpaste

No.	Chinese Name	English Name
1.	ɑ,ɑ,ɑ-三氯甲苯	ɑ,ɑ,ɑ-trichlorotoluene (CAS No 98-07-7)
2.	ɑ,ɑ-二氯甲苯	ɑ,ɑ-dichlorotoluene (CAS No 98-87-3)
3.	ɑ-氯甲苯	ɑ-chlorotoluene (CAS NO 100-44-7)

Table 2: List of Prohibited Ingredients in Toothpaste (sources from plant/animal)

No.	Chinese Name	Original Plant/Animal Latin Name
1.	毛莨科乌头属植物	Aconitum L, (Ranunculaceae)
2.	铁棒槌	Aconitum szechenyianum Gay
3.	毛莨科侧金盏花属植物	Adonis L, (Ranunculaceae)

Table 3: List of Prohibited Ingredients in Toothpaste (III)

No.	Chinese Name	English Name
1.	二甘醇	Diethylene glycol
2.	乙二醇	Ethylene glycol
3.	碱金属的硫化物类	Alkali sulphides

Table 4: List of Restricted Ingredients in Toothpaste

No.	Name			Restriction			Use conditions and precautions that should marked on the label
No.	Chinese Name	English Name	INCI Name	Application Scope	Maximum Concentration	Other Restriction
1.	6-甲基香豆素	6-methyl coumarin	6-methyl coumarin		0.003%
2.	氟化铝	Aluminium fluoride	Aluminium fluoride		0.15% (count as F), when blended with other permitted fluoride in this list, the total concentration of F not exceed 0.15%		Contain "Aluminium fluoride"
3.	氨	ammonia	ammonia		6% (count as NH3 )		When containing more than 2% of ammonia, claim "contain ammonia" on the label
4.	氟化铵	Ammonium fluoride	Ammonium fluoride		0.15% (count as F), when blended with other permitted fluoride in this list, the total concentration of F not exceed 0.15%		Contain "Ammonium fluoride"China Blocks Market Entry of Imported Toothpaste Containing Benzethonium Chloride

Table 5: List of Permitted Preservatives in Toothpastes

No.	Name			Maximum Concentration	Use Conditions and Precautions	Use conditions and precautions that should marked on the label
No.	Chinese Name	English Name	INCI Name	Maximum Concentration	Use Conditions and Precautions
1.	2-溴-2-硝基丙烷-1，3 二醇	Bronopol (INN)	2-bromo-2-nitropropane-1, 3-diol	0.1%	Avoid being transformed as nitrosamine
2.	5-溴-5-硝基-1，3-二噁烷	5-bromo-5-nitro-1, 3-dioxane	5-bromo-5-nitro-1, 3-dioxane	0.1%	Avoid being transformed as nitrosamine
3.	烷基（C12-C22）三甲基铵溴化物或氟化物	Alkyl (C12-C22) trimethyl ammonium, bromide and chloride	Alkyl (C12-C22) trimethyl ammonium, bromide and chloride	0.1%	Avoid being transformed as nitrosamine

Table 6: List of Permitted Colorants in Toothpaste

No.	Color Index	C.I. Generic Name	Color	General Chinese Name of Color Index	Other Restrictions and Requirements
1.	CI 10316	Acid yellow 1	黄	酸性黄1
2.	CI 11920	Food orange 3	橙	食品橙3
3.	CI12085	Pigment red 4	红	颜料红4	Concentration =<3%.