A Complete Technical Safety Standard for Cosmetics Launched after 2 Years to Replace Hygienic Standard for Cosmetics 2007

original article from CIRS

National Institutes for Food and Drug Control (NIFDC) was appointed by SFRC-CFDA to revise the Hygienic Standard for Cosmetics (HSC 2007) in Aug 2009. 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. NIFDC issued a second draft of Technical Safety Standard for Cosmetics on 3rd Feb 2015. The public could send any comments to hzpbwh@nifdc.org.cn before 28th Feb 2015

Background

The Hygienic Standards for Cosmetics issued by the Ministry of Health in 2007 is the most important cosmetic standard in China that sets detailed safety requirements on finished cosmetic products manufactured or sold in China. The Hygienic Standard for Cosmetics have banned over 1286 substances in cosmetics and restricted the use of 73 substances, 56 preservatives, 156 colorants, 28 sun block agents and 93 dyes in cosmetics.

With the development of production and consumption of cosmetics in China, Hygienic Standards for Cosmetics (2007) will go against the development of industry. Moreover, Hygienic Standard for Cosmetics (2007) mainly applies to the approval and supervision of cosmetics. However, it is not available to the supervision of safety in the process of research & development, production and use.

Therefore, Technical Safety Standard for Cosmetics includes new requirements of product safety, safety requirements of cosmetic ingredients, revised list of banned and restricted ingredients, amended testing and evaluation methods.

Comparison

i.Definition of cosmetics

HSC

1ST TSSC

2nd TSSC

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.

Same as HSC

Products which can be spread on the outer surface of human body((e.g. skin, hairs, nails. Lips etc), teeth and oral mucosa for the purpose of cleaning, protecting, beautifying, decorating, changing appearance, deodorizing and keeping in good condition by way of smearing, spraying or other similar means.


ii. Requirements for microbiological control in cosmetics

HSC

1ST TSSC

2nd 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

Same as HSC


iii. Limit level of hazardous substances in cosmetics

HSC

1ST TSSC

2nd 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: ≤4mg/kg
Methanol: ≤2000mg/kg
1,4-Dioxane: ≤30mg/kg
Asbestos: Not detected

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


iv. Banned ingredients

HSC

1ST TSSC

2nd TSSC

Chemical substances: 1208
Plant or animal-derived:78

n/a

Chemical substances: 1288
Plant or animal-derived:98


v. Restricted ingredients

Item

HSC

1ST TSSC

2nd TSSC

Preservatives

56

n/a

51

Sunscreen agents

28

n/a

27

Colorants

156

n/a

156

Hair dyes

93

n/a

73

Others

73

n/a

47


vi. Testing/evaluation methods

Item

HSC

1ST TSSC

2nd TSSC

Physiochemistry

27

n/a

75*

Microbiology

5

n/a

5

Toxicology

16

n/a

16

Human safety and efficacy evaluation

5

n/a

5**

*The testing methods of Sr and total fluorin are deleted. Additional 50 methods for banned and restricted substances are added
**Method for the preparation of standard substance with high SPF value is added in terms of ISO 24444 and ISO 24442

CIRS’ Comments

  • Oral care products will be managed as cosmetics. Pre-market approval will be available to this kind of products as other cosmetics;
  • There will be a challenge for domestic manufacturers as result of stricter requirements for the control of harmful substances in cosmetics ;
  • More banned ingredients and less restricted ingredients included in the Technical Safety Standard for Cosmetics.
  • More physiochemical testing methods are added to the Technical Safety Standard for Cosmetics so as to be a reference for domestic manufacturers in the process of R &D and production.

 

Source: http://www.nicpbp.org.cn/CL0014/6564.html

Contact Us

  • CIRS China
    Hangzhou CIRS Co. Ltd (CIRS China)
    11F Building 1, Dongguan Hi-Tech Park, 288 Qiuyi Road, Binjiang District, Hangzhou 310052, China
    Tel: +86-571 8720 6574 | Fax: +86-571 8720 6533
    Email: service@cirs-reach.com
-