China SFDA approves 2 new cosmetic ingredients: Nivitol and PM-Lysine

23 March 2012, China SFDA has finally approved 2 new cosmetic ingredients: Nivitol and PM-Lysine after nearly 9 months' public consultation. This is the first time China SFDA has approved new cosmetic ingredients since taking over responsibilities of approving licenses for new cosmetic ingredients from the Ministry of Health in 2008.

Both substances can now be used in cosmetics placed on Chinese market provided that they meet the following technical requirements:

  PM-Lysine Nivitol
INCI Name POLYMETHACRYLOYL LYSINE Dimethoxytolyl Propylresorcinol
CAS 543700-70-5 869743-37-3
Main Use Skin-Conditioning Agents

Adjustment of Skin Tones

Scope All cosmetics Cream, lotion, gel, facial mask and other cosmetics.
Limit 3% 2%
Impurities As <2mg/kg; Heavy metals<20mg/kg; and other restrictions. Pb≤ 5 mg/kg; Methanol<0.3% and other other restrictions.
Shelf Life 3 years 2 Years


The orginal notice from China SFDA can be found here.

CIRS's Comments

Only 8 new cosmetic ingredients have been approved so far since 2004 based on CIRS’s statistics. Companies may also have trouble with the determination criteria for a new ingredient, mandatory animal testing and risk assessment for the registration of new cosmetic ingredient in China. In this article, we have written article about the latest requirements for the registration of new cosmetic ingredient in China.

This article can be found here.

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