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Safety and Technical Standards for Cosmetics 2015

Safety and Technical Standards for Cosmetics 2015 is the overarching technical standards used for regulation of cosmetics in China. It specifies the general safety standards, defining prohibited/restricted/permitted ingredients and setting testing methods for manufactured and operated in the China (except those only for sale abroad).

History of the standards

Version

Release date

Implementation date

Competent Authority

First Version

 

1999-12-1

China Ministry of Health

Second Version

2002-9-19

2003-1-1

China Ministry of Health

Third Version

2007-1-4

2007-7-1

China Ministry of Health

Fourth Version

2015-12-23

2016-12-1

China Food and Drug Administration

The first version of the standard was named as Hygienic Standard for Cosmetics. It was implemented by China Ministry of Health (MOH), the competent authority for supervising cosmetics at that time. To make the standards consistent with the industry situation, China MOH amended the standards about every four years.

From 1 Sep 2008, CFDA took over the full responsibility of cosmetic supervision from the MOH. CFDA realized that compared with international standards part of China's cosmetic testing methods were lagging behind and the requirements for cosmetic products and ingredients were too simple or not specific enough. Therefore, in 2009 CFDA authorized National Institutes for Food and Drug Control (NIFDC) to be responsible for the revision work.

Safety and Technical Standards for Cosmetics 2015

After three rounds of public consultation, the standards were finalized in December 2015 and will enter into force in 2016. Compared to the previous version, the new standards give greater consideration to the safety of both products and ingredients and improves evaluation methods, aiming to be a more comprehensive and scientific technical reference which not only sets standards for all cosmetics placed on the Chinese market but also promotes the research and development of cosmetics.

Comparison between STSC 2015 and Hygienic Standard for Cosmetics 2007

Contents

Standard 2007

STSC 2015

Applicable scope

This standard applies to cosmetics that are sold in the People's Republic of China.

This standard applies to all the cosmetics that are manufactured and operated in the People's Republic of China, except those only for sale abroad.

Reference documents

Europe cosmetic standard 76/768/EEC

Deleted

Terms and definitions

/

Define 18 terms, such as cosmetic ingredient, new cosmetic ingredient, prohibited ingredient

Requirements

Cosmetic hygiene requirements:

1.General requirements

2.Ingredient requirements

3.Finished products requirements

Cosmetic general safety requirements

1.General requirements

2.Requirements on product formula

3.Requirements on the microbiological indicators

4.Restriction on hazardous substances

5.Packaging requirements.

6.Labeling requirements

7.Requirements on children’s cosmetics

8.Requirements on the ingredients

Limits of Heavy Metals

Mercury

1

1

Lead

40

10

Arsenic

10

2

Methanol

2000

2000

Cadmium

/

5

Dioxane

/

30

Asbestos

/

Not be tested out

Prohibited ingredients

1208

1290

Prohibited Plant Animal Ingredients

78

98

Restricted ingredients

73

47

•Delete: 6-Methyl coumarin, Aluminium fluoride, Ammonium fluoride, Ammonium, Ammonium monofluorophosphate, Benzoyl peroxide, Calcium fluoride, Calcium monofluorophosphate, Cantharides tincture, Hexadecyl ammonium fluoride, Hydroquinone, Hydroquinone methylether, Magnesium fluoride, Magnesium fluorosilicate, Nicomethanol hydrofluoride, Octadecenyl ammonium fluoride, Olaflur, Palmityl trihydroxyethyl propylenediamine dihydrofluoride, Potassium fluoride, Potassium fluorosilicate, Potassium monofluorophosphate, Sodium fluoride, Sodium fluorosilicate, Sodium monofluorophosphate, Stannous fluoride, Strontium acetate hemihydrate, Triclocarban

•Add: Laureth-9

Permitted Preservatives

56

51

•Delete: Chloroacetamide, Methenamine, Methyldibromo glutaronitrile, Quaternium-15, Sodium iodate

Permitted Sunscreens

28

27

•Delete: PABA

Permitted Colorants

156

157

•Add: GALLA RHOIS GALLNUT EXTRACT

Permitted Hair Dyes

93

75

  • Delete: 2,4-Diaminophenol, 2,4-Diaminophenol HCl, 2-Nitro-p-phenylenediamine, 2-Nitro-p-phenylenediamine, Dihydrochloride, 2-Nitro-p-phenylenediamine sulfate, 4,4’-Diaminodiphenylamine, 4,4’-Diaminodiphenylamine sulfate, 6-Amino-o-cresol, Acid Orange 3, Basic Blue 26, Basic Violet 14, Disperse violet 4, HC Yellow No.6, Hydroquinone, N,N-diethyl-p-phenylenediamine sulfate, N,N-diethyltoluene-2,5-diamine HCl, N,N-dimethyl-p-phenylene diamine, N,N-dimethyl-p-phenylenediamine sulfate, o-Aminophenol, o-Aminophenol sulfate, Toluene-3,4-diamine

  • Add:  5-Amino-4-Chloro-o-Cresol HCl, p-Aminophenol HCl and other colorants can be used in hair dyes products

Physical and Chemical Testing Methods

27 methods

77

  • Delete testing methods of strontium and total fluorine

  • Add other 60 testing methods

  • Delete the testing method of anti-dangdruff agents

  • Revise the testing method of PH

Microbiological Testing Methods

5 methods

5

Toxicological Testing Methods

16 methods

16

Human Body Safety Testing Methods

5 methods

2

Human Body Efficacy Evaluation Testing Methods

3

Add preparation methods of high SPF value standard sample (P2 and P3)

The most significant change is the revision of ingredient lists, which requires companies to apply for corresponding modifications or make adjustments regarding their products before Dec 1 this year. The limits of hazardous substances differ greatly: limits of lead and arsenic are subject to stricter restrictions and three substances are newly restricted. However there is some good news for industry in that the requirements for restriction of the three new substances will not become mandatory until the release of "Measures for Cosmetic Administrative Licensing Testing". It has been revealed that the measures will be released next year. Nevertheless, companies are recommended to conduct testing of the three substances in order to avoid any inconvenience caused by requirements to supplement testing reports in the future.

There has also been revision to the negative lists and positive lists. More ingredients are prohibited and fewer ingredients are permitted to be used in cosmetics. China revised the standards by referring to European standards, so for cosmetics imported from Europe this should not be a major issue.

As for the testing methods, only the chapter on Physical and Chemical Testing Methods are subject to big changes. The testing methods of strontium, total fluorine and anti-dandruff have been deleted and the testing methods of PH have been revised in addition to adding 60 other testing methods. Other chapters are almost the same. The standards still don't mention alternatives to animal testing.

The standards deleted all the contents relating to oral care products as the Regulations concerning Supervision and Administration over Cosmetics hasn't been released yet, which regulates oral care products as cosmetics. After its release, the standards will add the contents. At that time the standard is likely to be overhauled to align with the regulations. According to our information, another version of the standards has been completed by NIFDC and includes a large number of significant changes.

Explanations to some issues in STSC

  • The maximum concentrations of the 75 hair dyes refer to the concentrations after mixing with oxidizing agents.

  • The difference between skin care products and body care products is that skin care products include products used on head and neck.

  • For bromide, refer to the requirements for chloride.

  • For prohibited plant animal ingredients, if the specific source of a part of a plant used as an ingredient is specified, only that specific part is prohibited (root is prohibited but leaves and stems etc. can be use). If it isn't specified the whole plant is prohibited. 

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