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On November 30, 2021, China NMPA officially issued a notice, announcing that the addition of whitening ingredient SymWhite 377 in general cosmetics is suspected of violating the relevant provisions of the Cosmetic Supervision and Administration Regulation and Administrative Measures on Cosmetics Registration and Notification, and will be investigated and dealt with by the provincial medical products administrations. All provincial medical products administration shall report the investigation and handling progress of the general cosmetics added with SymWhite 377 to NMPA by December 20 this year. 1
Following NMPA’s notice, the medical products administration (MPA) of Guangxi Zhuang Autonomous Region and the Market Regulation Administration of Guangzhou successively issued notices on the handling of already notified cosmetics with whitening ingredient SymWhite 377. Details are as follows:
Release Date | Authority | Main Content |
Dec. 10, 2021 | MPA of Guangxi Zhuang Autonomous Region 2 | Some notified general cosmetics use phenylethyl resorcinol (the ingredient only for skin whitening), which is beyond the scope of general cosmetics. Relevant cosmetics notifiers are required to take the initiative to withdraw notifications and recall the product before December 16, 2021. Otherwise, the medical products administrations will investigate and deal with the enterprises that refuse to carry out the order in accordance with the laws. |
Dec. 10, 2021 | Guangzhou Market Regulation Administration 3 | Phenylethyl resorcinol is not allowed to be used in general cosmetics. Enterprises should stop producing such products and take the initiative to withdraw product notifications as soon as possible. |
(Last Updated on Dec. 14, 2021)
Recently, cosmetic industry insiders revealed that China National Medical Products Administration (NMPA) is organizing spot check of the notification information on the new notification platform, with the focus placed on general cosmetics that contain whitening ingredients such as phenethyl resorcinol (commonly known as SymWhite 377 in the industry). These products often claim “skin brightening and skin whitening." Such products are suspected of special cosmetics with whitening efficacy, which exceeds the scope of general cosmetics. All notifiers are required to strictly check the notification dossiers, prohibit the use of restricted or permitted ingredients beyond their scope or limits, and prohibit illegal claims and exaggerated publicity.
Although NMPA has not yet issued an official notice, some companies have confirmed this with the technical review experts of Guangzhou Medical Products Administration’s Review Center. Besides, some products have been issued with a negative review opinion, stating that they are non-compliant due to suspicion of using the ingredient phenethyl resorcinol beyond its scope, which does not conform to the "Announcement of the Food and Drug Administration (CFDA, now NMPA) on Approving 4-(1-Phenylethyl)1,3-Benzenediol for the Use as Cosmetic Ingredients" (CFDA Announcement No. 71 of 2012).
Introduction of Phenylethyl Resorcinol (SymWhite 377)
Phenylethyl resorcinol, also known as SymWhite 377, is a new and highly efficient whitening active ingredient, which not only can effectively restrain the formation of melanin by inhibiting tyrosinase activity but also has strong antioxidant capacity, good stability, and high safety. It is often used as a lightening agent in skincare, hair styling, and makeup products.
In 2012, Symrise’s SymWhite 377 was approved by CFDA as a cosmetic ingredient for skin whitening in China. In 2021, SymWhite 377 is included in the Inventory of Existing Cosmetic Ingredients in China 2021.
Basic information of the whitening agent phenylethyl resorcinol
Chinese Name | 苯乙基间苯二酚 |
INCI Name | Phenylethyl Resorcinol |
Trade Name | SymWhite® 377 |
Chemical Name | 4-(1-phenylethyl)-1,3-benzenediol |
CAS Number | 85-27-8 |
Use Purpose | Skin whitening agent, restraining the formation of melanin by inhibiting the activity of tyrosinase |
Applicable Scope | Skin care products |
Usage limits | ≤0.5% |
Notifier | Symrise |
ChemLinked Comments
1. This move by NMPA is a sure sign that China will reinforce the management of functional ingredients (ingredients with certain efficacies, such as whitening and freckle-removing) and will compile and announce a list of permitted whitening ingredients.
2. Cosmetic companies shall conduct self-inspection and take measures as early as possible to meet compliance requirements.
For notified general cosmetics containing phenylethyl resorcinol, ChemLinked suggests stakeholders cancel the notification and apply for registration instead; or remove the ingredient from the product formula and re-apply for notification of the new product. Otherwise, the products will be deemed to involve the manufacturing or import of unregistered special cosmetics. Stakeholders will face severe penalties per Cosmetic Supervision and Administration Regulation.
Meanwhile, to avoid punishments during the post-notification review, stakeholders shall also note that the products’ claim can’t contain words implying whitening and freckle-removing effects.
For new general cosmetics, the whitening ingredient phenylethyl resorcinol is not recommended to be added. ChemLinked suggests stakeholders carefully select ingredients in their formulas, pay attention to product claims and make sure that they belong to the scope of general cosmetics’ claims.
For any queries or further cosmetic compliance consultation, please email [email protected].
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