China SFDA Updates the Hygienic Standard for Cosmetics

Revised from Hygienic Standard for Cosmetics 2007, the Technical Safety Standard for Cosmetics is under public consultation until 15 Dec 2012.

At present, the SFDA only releases the body text while the Annexes are still under amendment and will be put on the website for public comments later.

China sees rapid development of cosmetic production and consumption. However, the Hygienic Standard 2007 is not comprehensive and scientific enough to oversee the whole process of the research and development, production and use of cosmetics. First, the 2007 Standard puts more emphasis on the safety of cosmetic finished products other than ingredients; Second, some outdated test and evaluation methods are not specific and instructive enough for effective safety assessment of cosmetics.

Compared with the Hygienic Standard 2007, the Technical Standard gives consideration to the safety of both cosmetic finished products and ingredients. A new part “general requirement for safe use of cosmetic ingredients” has been added, with the key points listed as follows,

•  Some risk substances (such as banned or restricted substances) which may be introduced inevitably from cosmetic ingredients, are required to be kept under the limits prescribed. For those which do not have restrictions specified, risk assessment needs to be carried out.
•  The manufacturers must provide the information on quantitative and qualitative test methods of ingredients, the test method of impurities as well as control measurements for possible safety risk substances.  
•  In case that the ingredient is a hazardous chemical, its label must conform to the relevant regulations for hazardous chemicals.

Furthermore, the Technical Standard also revises the prohibited and restricted lists and improves the toxicological, hygienic chemical, microbiological, and human safety test methods, all of which will be compiled in the Annexes.

Besides, the revised standard makes some changes in the limits of hazardous or banned substances in cosmetics.

• It greatly reduces the limits for the lead and the arsenic in cosmetic products, from 40 mg/kg and 10 mg/kg to 10 mg/kg and 4 mg/kg, respectively.
• It stipulates the limit for dioxane to be 30 mg/kg. Although dioxane is a prohibited ingredient, the safety evaluation shows that the dioxane would cause no harm to human if controlled within the limit, according to the SFDA.
• The asbestos is prohibited in cosmetic products according to the revised Standard.

Overall, the Technical Standard will act as an indispensable criteria for all commercially available cosmetics in China and serve as a key reference for supervisory departments, manufacturers and testing institutions to conduct safety evaluation on cosmetic products and ingredients in a more scientific manner.

Note: for any comment on this opinion-soliciting draft, you need to fill out the feedback form and send it to the SFDA before 15 Dec. 

Reference Links

• SFDA news alert
• Technical Safety Standard for Cosmeticsl (download in Chinese)

 Hygienic Standard for Cosmetics

 Technical Safety Standard for cosmetics