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美國食品藥品監督管理局已停止接受自愿化妝品注冊計劃（VCRP）的申請

2023年3月27日

美國食品藥品監督管理局（FDA）已停止接受自愿化妝品注冊計劃（VCRP）的申請（可簡單理解為舊的化妝品FDA申報系統），自2023年3月27日起生效，因為美國食品藥品管理局計劃制定一項計劃（可簡單理解為新的化妝品FDA申報系統），提交《2022年化妝品現代化監管法》（MoCRA）規定的設施企業注冊和產品登記。

VCRP成立于1972年，是美國食品藥品監督管理局自愿從商業分銷化妝品的制造商、包裝商和分銷商那里獲得有關化妝品和成分、使用頻率以及從事其制造和分銷的企業的最佳信息估計的一種方式。VCRP還向產品出口到美國銷售的外國化妝品公司開放。

FDA利用VCRP提供的信息來協助其履行監管在美國銷售的化妝品的職責。這不是一個批準系統。由于該系統是自愿的，通過VCRP提供的信息并沒有提供美國市場上化妝品的完整情況(有關該計劃的完整細節，請參閱21 CFR, 710和720部分)。

由于《2022年化妝品現代化監管法》（MoCRA）要求特定公司在FDA注冊其企業并登記其產品，FDA正在創建新的系統以便處理由此產生的大批量申請。因此FDA不會在采用自愿注冊系統，也不再接受和處理提交至VCRP的申請。

我們要求化妝品公司耐心等待在FDA的注冊，直至我們宣布新系統可用。VCRP中的信息不會傳輸到為MoCRA監管的企業注冊和產品列名所研發的新系統。

總結：

· FDA已經停止接受和處理提交至VCRP的申請。

· FDA正在研發受MoCRA監管的企業注冊和產品列名申請的新系統，并會提供該系統未來可用性的更新信息。

· VCRP中的信息不會轉移到這個為受MoCRA監管的企業注冊和產品列名所研發的新系統中。

FDA官方通知鏈接以及英文原文如下：

官方鏈接：

https://www.fda.gov/food/cfsan-constituent-updates/fda-has-stopped-accepting-submissions-voluntary-cosmetic-registration-program-vcrp

FDA Has Stopped Accepting Submissions to the Voluntary Cosmetic Registration Program (VCRP)

March 27, 2023 

The U.S. Food and Drug Administration (FDA) has stopped accepting submissions to the Voluntary Cosmetic Registration Program (VCRP) effective March 27, 2023 as a result of FDA’s plans to develop a program for submission of the facility registrations and product listings mandated by the “Modernization of Cosmetics Regulation Act of 2022” (MoCRA). 

The VCRP was established in 1972 as a way for FDA to obtain the best estimate of information available about cosmetic products and ingredients, their frequency of use, and businesses engaged in their manufacture and distribution, voluntarily, from manufacturers, packers, and distributors of cosmetic products in commercial distribution. The VCRP was also open to foreign cosmetics companies whose products are exported for sale in the U.S.  

FDA used the information from the VCRP to assist it in carrying out its responsibility to regulate cosmetics marketed in the U.S. It was not an approval system. Because the system was voluntary, the information provided through the VCRP did not present a complete picture of cosmetics in the U.S. marketplace (Refer to 21 CFR, parts 710 and 720, for full details regarding the program).

Because MoCRA requires certain companies to register their facilities and list their products with FDA, FDA is creating a new system to handle the large number of submissions that will result. FDA therefore will no longer use the voluntary registration system, and is no longer accepting and processing submissions to the VCRP.  

We request that cosmetics companies wait to register with FDA until we announce the availability of the new system. Information in the VCRP will not be transferred to the program being developed for facility registrations and product listings mandated by MoCRA.

Summary:

· FDA has stopped accepting and processing submissions to the VCRP.  

· FDA is developing a system for submission of the facility registrations and product listings mandated by MoCRA and will provide further updates on its forthcoming availability. 

· Information in the VCRP will not be transferred to the program being developed for facility registrations and product listings mandated by MoCRA.