New Chinese standard for cosmetics published

On 23 December 2015, China Food and Drug Administration released Notification No. 268 of Year 2015 that Safety and Technical Standards for Cosmetics (Version 2015) was published upon review of experts from Cosmetics Standard Committee and would take into force on 1 December 2016.

Safety and Technical Standards for Cosmetics (hereinafter referred to as “Standard”) provides for safety technical requirements for cosmetics, including general requirements, requirements on prohibited/restricted components, requirements on allowed subtances and methods for test and assessment, applicable to cosmetics that are produced or intended for sale in domestic China. (Except to products intended for sale in foreign countries).

The Standard is an update for Hygienic Standard for Cosmetics (Version 2007). The major amendments to the Standard include the following:

I) Clarify the definitions of terms. It provides definitions for terms involved thereof, clarifying the concepts and connotation.

II) Specify general safety and technical requirements for cosmetics. According to the risk assessment concerning heavy metals and other substances of high concern in cosmetics, the lead limit is adjusted from 40mg/kg to 10mg/kg and arsenic limit from 10mg/kg to 2mg/kg. Besides, it also adds a limit of 5 mg/kg for cadmium. In the meanwhile, it also requires that dioxane should not exceed 30mg/kg and asbestos should be ND in accordance with requirements in normative technical documents in China Food and Drug Administration.
Hazardous Substances in Cosmetics

Hazardous Substance	Limit (mg/kg)	Remarks
Mercury	1	Excluding cosmetics containing organic mercury preservatives
Lead	10
Arsenic	2
Cadmium	5
Methanol	2,000
Dioxane	30
Asbestos	ND

Microbiological Limits for Cosmetics

Microbiological	Limit	Remarks
Total bacteria colonies (CFU/g or CFU/ml)	≤500	Cosmetics for eyes, mouth/lips and children
Total bacteria colonies (CFU/g or CFU/ml)	≤1,000	Other cosmetics
Sum of mycete and saccharomycetes (CFU/g or CFU/ml)	≤100
Thermotoletant coliform bacteria /g (or ml)	ND	ND
Staphylococcus aureus /g (or ml)	ND
P.Aeruginosa /g (or ml)	ND

III) Amend the lists for prohibited/restricted and allowable components in cosmetics. The new standard includes: 1,388 prohibited components in total (with 133 additions and 137 amendments), 47 restricted components in total (with 1 addition, 31 amendments and 27 deletions). Besides, it also includes 51 allowable preservatives in total (with 14 amendments and 5 deletions); 27 allowable sun-screening agents in total (with 6 amendments and 1 deletion); 157 allowable colourants in total (with1 addition and 69 amendments); 75 allowable hair dyes in total (with 63 amendments and 21 deletions).

IV) Amend physical and chemical inspection methods for cosmetics testing and assessment. Based on original test in Hygienic Standard for Cosmetics, it adds 60 test methods on prohibited/restricted components for cosmetics and deletes other contents beyond the scope of the Standard, for instance, test methods for strontium and fluorine. Minor errors in the previous version are also corrected. Furthermore, it standardises microbiological and toxicological test methods and adjusts the format. For body safety and performance assessment, the test methods are categorised as body safety inspection and body performance assessment inspection. SPF also adds preparation method for P2 and P3.

The Standard will apply in this December. C&K Testing advises companies should adjust production techniques and choose allowable components thereof and meet the requirements for prohibition and restriction. It is important to choose authoritative testing bodies to ensure products comply with regulations.

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Safety and Technical Standards for Cosmetics (in Chinese)

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