Technical Safety Standard for Cosmetics (draft) Issued for Public Comments for the Third Time

12 Aug 2015, CFDA invite public comments on the draft of Technical Safety Standard for Cosmetics (TSSC) for the third time since 2012. Any opinions can be sent to the email address: hzpbwh@nifdc.org.cn before 1st Sep 2015.

Background

On 4th Dec 2012, CFDA has published a notice to invite public comments on revised Hygienic Standards for Cosmetics, now renamed as Technical Safety Standard for Cosmetics (TSSC). The First Draft only contains the body part of TSSC.National Institutes for Food and Drug Control (NIFDC) issued a second draft of Technical Safety Standard for Cosmetics on 3rd Feb 2015. Given that the Hygienic Standard for Cosmetics (HSC 2007) was compiled based on The Cosmetics Directive of the Council European Communities, 76／768／EEC, and amendments until 21st Nov2005, so the contents of safety risk substances are adjusted. Additionally, the technical requirements and evaluation methods of oral care cosmetics are immature so the new regulation will not include related contents.

Main changes

1) Content

HSC 2007

3rd TSSC

Part 1: General rules

Part 2: Toxicological test methods

Part 3: Hygiene safety test methods

Part 4: Microbiological test methods

Part 5: Human safety and efficacy evaluation methods

Body part

Appendix 1: Banned ingredients

Appendix 2: Restricted ingredients

Appendix 3:Test and evaluation methods:

1. Physiochemical tests

2. Microbiological tests

3. Toxicological tests

4. Human safety tests

5. Efficacy evaluation tests

2) Definition of cosmetics

HSC 2007: Products which can be spread on the outer surface of human body((e.g. skin, hairs, nails. lips etc),for the purpose of cleaning, perfuming, changing appearance, deodorizing, protecting, and keeping in good condition by way of smearing, spraying or other similar means;

3rd TSSC: Same as HSC 2007

3) Requirements for microbiological control in cosmetics

HSC 2007

3rd TSSC

aerobic bacterial count: ≤500(CFU/mL or CFU/g) for cosmetics used around eyes, lips and intended for children/babies

aerobic bacterial count: ≤1000(CFU/mL or CFU/g) for other common cosmetics not mentioned above

moulds and yeasts count: ≤100(CFU/mL or CFU/g)

thermotolerant coliform bacteria: Not detected

Staphylococcus aureus: Not detected

Pseudomonas aeruginosa: Not detected

Same as HSC

4) Limit level of hazardous substances in cosmetics

HSC 2007

3rd TSSC

Hg: ≤1mg/kg except organomercury used as preservative in cosmetics around eyes

Pb: ≤40mg/kg

As: ≤10mg/kg

Methanol: ≤2000mg/kg

Hg: ≤1mg/kg except organomercury used as preservative in cosmetics around eyes

Pb: ≤10mg/kg

As: ≤2mg/kg

Cd: ≤5mg/kg

Methanol: ≤2000mg/kg

1,4-Dioxane: ≤30mg/kg

Asbestos: Not detected

5) Banned and restricted ingredients*

HSC 2007

3rd TSSC

Banned ingredients:

Ø chemical substance: 1208

Ø Plant or animal-derived:78

Restricted ingredients:

Ø Preservatives: 56

Ø Sunscreen agents: 28

Ø Colorants: 156

Ø Hair dyes: 93

Ø Others: 73

Banned ingredients:

Ø chemical substance: 1288

Ø Plant or animal-derived:98

Restricted ingredients:

Ø Preservatives: 51

Ø Sunscreen agents: 27

Ø Colorants: 157

Ø Hair dyes: 75

Ø Others:47

* If you would like to get the detailed list of banned and restricted ingredients or to know which ingredient is added to or deleted on the 3rd TSSC. Please send your request to april.guo@cirs-reach.com.

6) Test and evaluation methods

Compared with the old regulation HSC 2007, the following test methods are added to the Technical Safety Standard for Cosmetics:

Banned ingredients:4-Aminoazobenzene and Benzidine, Biphenyl-4-ylamine and its salts, 8-methoxypsoralen and other 3 materials, α-Chlorotoluene, Aminocaproic Acid, Benzo [а] pyrene, Acrylamide, Psoralen and other 3 materials, Dioxane, Ethylene oxide and Methyloxirane, Diethyl maleate, Minoxidil, Asbestos, Tretinoin and Isotretinoin.

Restricted ingredients:6-Methyl coumarin, Hydrogen peroxide, Resorcinol, Quinine, Oxyquinoline, Salicylic acid andMusk ketone.

Preservatives:Sodium benzoate, Benzoic acid Sodium benzoate, Phenoxyisopropanol, Benzalkonium chloride, Benzethonium chloride, Ammonium chloride, Cetalkonium Chloride, Chlorphenesin, Triclocarban, Sorbic acid and Dehydroacetic.

Sunscreen agents:Denzophenone, Titanium dioxide, Diethylaminohydroxybenzoyl hexyl benzoate, Diethylhexylbutamidotriazone, Benzylidene camphor sulfonic acid and Zinc oxide.

Colorants:Acid Yellow 36 and other 4 materials, Acid Violet 43 and other 6 materials, CI 16185 and other 9 materials.

Hair dyes:p-Phenylenediamine and Other 31 kinds of Material

Anti-infective drug:Fluconazole and other 8 materials, Enoxacin and other 9 materials

Hormones:Hydrocortisone and other 6 kinds of material.

Organic solvent:Dichloromethane and 14 kinds of material.

Others:Diethylene glycol, Dimethylphthalate and 9 kinds of material, Dibutylphthalate and 7 kinds of material, Nd and 14 kinds of elements, Ethanolamine and other 4 materials.

CIRS comments:

Ø Oral care products are not included in the definition of cosmetics in the 3rd version of new standard. But this kind of products will be managed as cosmetics when the technical requirements and evaluation methods are mature;

Ø There are new requirements for the control of Pb, As, Cd, 1,4-Dioxane and Asbestos. It will be a challenge for domestic manufacturers in the process of controlling harmful substances in cosmetics ;

Ø More safety risk substances added to the list of banned ingredients and less restricted ingredients contained in the new standard.

Ø More physiochemical testing methods added to the Technical Safety Standard for Cosmetics so as to be referred for the supervision of cosmetics.

Source: http://www.sda.gov.cn/WS01/CL0781/126540.html

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