China SFDA to approve a new cosmetic ingredient: Phenylethyl Resorcinol

7 August 2012, China SFDA consults on the approval of a new cosmetic ingredient Phenylethyl Resorcinol. The deadline for comments is 31 August 2012. The technical requirement of Phenylethyl Resorcinol can be found below.

Items Phenylethyl Resorcinol
INCI Name Phenylethyl Resorcinol
CAS 85-27-8
Main Use Whitening
Scope Skin care products
Limit 0.5%
Impurities Pb≤ 0.1mg/kg;Hg≤ 0.01mg/kg; As≤ 0.1mg/kg; resorcinol≤ 10ppm; and other restrictions related to the count of microbial.
Shelf Life 2 years

 

The original notice from China SFDA can be found here.

http://www.sfda.gov.cn/WS01/CL0781/74100.html

CIRS's Comments

China SFDA has expedited the approval of new cosmetic ingredient recently. Phenylethyl Resorcinol is going to be the third new cosmetic ingredient approved by SFDA since it took responsibilities of cosmetics management from the Ministry of Health since 2008. Phenylethyl Resorcinol itself can be found in INCI(2010) and the registrant should be Symrise. The other two ingredients Nivitol and PM-Lysine were approved in March this year.

China SFDA is also working hard on compling a new Inventory of Existing Cosmetic Ingredient in China (IECIC) to replace the old version issued in 2003. On 1 July 2012, China SFDA published the second batch of the Inventory of Existing Cosmetic Ingredient in China (IECIC) for public consultations[Link]. The deadline for comments is 15 July 2012. There are 673 ingredients in the second batch of IECIC (2012). The first batch of IECSC (2012) was revised on 1 May 2012 and includes 1674 cosmetic ingredients.

According to the hygiene supervision over cosmetics (1990), the use of new ingredient for cosmetics production must be approved first. The rules for the application of administrative licenses for cosmetics (2009) have also clearly indicated that the use of new ingredient in cosmetics in China must be licensed.

An ingredient will be regarded as “used” if it meets any one of the three following criteria:

  • The ingredient is included in the Inventory of Existing Cosmetic Ingredients in China (IECIC 2003 or 2012) and is not a banned substance; or
  • The ingredient has been used in a licensed special use cosmetic product; or
  • The ingredient is part of a plant that has been approved as cosmetic ingredient.

More info about registration of a new cosmetic ingredient with China SFDA can be found here.

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