On 7 August, 2012, SFDA started to seek comments on approval of Phenylethyl Resorcinol as a cosmetic ingredient. The deadline for this consultation is 31 August, 2012.
According to Regulations on the Hygiene Supervision over Cosmetics, SFDA organized cosmetics experts to carry out review on Phenylethyl Resorcinol, which turns out to be in conformity with the technical requirements of cosmetic ingredients.
Table: Basic Information of Phenylethyl Resorcinol
|
INCI name |
Phenylethyl Resorcinol |
|
CAS |
85-27-8 |
|
Intended Use |
Whitening |
|
Scope |
Skin care products |
|
limit |
0.5 % |
|
impurities |
Lead ≤ 0.1 mg/kg; mercury ≤ 0.01mg/kg; arsenic ≤ 0.1mg/kg; resorcinol ≤ 10 ppm |
|
Microbiological index |
Aerobic bacterial count ＜100 CFU/g; Molds and Yeast Count ＜10 CFU/g |
|
precaution |
Avoid substantial inhalation and contact with eyes |
|
Storage condition |
Stored in a sealed container, to avoid exposure to light, heat and humid environment |
|
Shelf life |
2 years |
SFDA has released Technical Requirements for Phenylethyl Resorcinol, the contents are as follows:
- basic information, physicochemical properties, identification methods, assay methods of content (purity), examination of impurities, microbiological index, purpose, scope and limits of its application, precautions, storage conditions and shelf life;
- assay methods of Phenylethyl Resorcinol;
- testing methods of resorcinol in cosmetics.
Phenylethyl Resorcinol is going to be the third new cosmetic ingredient following the PM-Lysine and Nivitol approved on March 19 this year, since SFDA took over the responsibility of cosmetics supervision from Ministry of Health as of September 1, 2008.
As far as cosmetic ingredients are concerned, in 2012, SFDA has published the first batch of Inventory of Existing Cosmetic ingredient in China (IECIC) and issued the second batch for public commentary. There are 1674 cosmetic ingredients in total in first batch and 637 ingredients in the second.
IECIC is a very important list for judging whether a cosmetic ingredint is new or not. Manufactures or importers are allowed to use ingredients in IECIC directly to make cosmetics without registering it with SFDA for approval, while a new cosmetic ingredient must be licensed prior to use according to Regulations concerning the Hygiene Supervision over Cosmetics (1989). Overseas producers need to appoint a responsible agent in China to help you register the ingredient.
Besides, if an ingredient has been used in licensed special use cosmetics and from part of a plant which has been approved as cosmetic ingredients, it does not belong to new cosmetic ingredient, either.
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