美国食品药品管理局(FDA)发布化妆品企业设施注册和产品登记指南草案（后附英文原文）
2023年8月7日
根据《2022年化妆品监管现代化法》（MoCRA）的授权，FDA今天发布了化妆品企业设施注册和产品登记指南草案。
最终版发布后，该指南草案将阐明谁负责提交注册和产品登记，需要包括哪些信息，如何提交，何时提交，以及注册和产品登记要求的某些豁免，从而帮助利益相关者向FDA提交化妆品企业设施注册和产品登记。
通过MoCRA，FDA获得了以下新的授权：
· 企业设施注册：化妆品生产商和加工商必须在FDA注册其企业设施，在发生任何变更后的60天内更新注册信息，并每两年延续一次注册。
· 产品登记：负责人必须登记每种上市化妆品的名称，包括产品成分，并每年进行更新。
负责人是指化妆品的生产商、包装商或经销商，根据《食品、药品和化妆品法》第609（a）条或《公平包装和标签法》第4（a）条的规定，化妆品的标签上需印上其名称。
豁免
MoCRA免除了某些小企业的设施注册和产品登记要求。
然而，此类豁免不适用于生产或加工以下化妆品的企业设施或负责人：
· 在通常或常规使用条件下经常接触眼睛粘膜的产品。
· 注射的产品。
· 内服的产品。
· 在通常或常规使用条件下，预期改变外观超过24小时的产品，消费者将其移除不属于此类使用条件的一部分。
某些需要遵守药品和医疗器械要求的产品和企业设施也可以豁免本项要求。
2023年3月，FDA发布了一项法规更新：鉴于MoCRA授权了FDA对企业设施注册和产品登记的要求，FDA已停止接受“化妆品自愿注册计划（VCRP）”项下的申请。
指南草案还包含关于新的线上注册和登记提交系统的信息。FDA计划在2023年10月推出该新的线上提交系统。FDA强烈建议企业通过线上提交，以促进数据提交和FDA管理的效率和及时性。FDA还在开发一种纸质表格，作为线上提交系统的替代提交方式。
如指南草案所述，FDA计划使用FDA企业设施识别码（FEI）作为所需的企业设施注册号码。为了方便注册过程，企业设施的所有者或经营者在提交设施注册之前需要获得FEI号。更多信息，包括如何申请FEI号或确定企业是否已经有FEI号，请参见FEI查询系统。
负责人需要为生产或加工其化妆品的每个设施申请企业设施识别码（FEI），因为进行产品登记时需要企业设施注册号。如果企业是一家可以免于注册的小企业，也没有企业设施注册号，在进行产品登记时可以只提供企业设施名称和地址。
利益相关者应在2023年12月29日法定截止日期之前完成企业设施注册和产品登记。
此外，FDA正在征集有兴趣参与一个自愿试点项目的化妆品企业的申请，该项目将进行“用户可接受测试（UAT）”，以帮助评估化妆品企业设施注册和产品登记的新的线上提交系统。该线上提交系统是根据MoCRA实施的。FDA计划接受最多九家企业参与该试点。该试点旨在为评估这一新的线上提交系统提供信息。更多信息请参阅：《联邦公报》公告：化妆品企业设施注册和产品登记线上提交用户可接受测试试点项目。
提交对指南草案的意见和建议：
对指南草案的意见和建议需要在2023年9月7日之前提交。您可以通过Regulations.gov线上提交意见和建议。所有书面意见和建议都应标明文件编号FDA-2023-D-1716和指南文件的标题。
附加信息：
· 《联邦公报》公告：化妆品企业设施注册和产品登记；行业指南草案
· 《联邦公报》公告：化妆品企业设施注册和产品登记线上提交用户可接受测试试点项目
FDA Issues Draft Guidance on Registration and Listing of Cosmetic Product Facilities and Products
August 7, 2023
The U.S. Food and Drug Administration, today, issued draft guidance on cosmetic product facility registrations and product listings, as mandated by the Modernization of Cosmetics Regulation Act of 2022 (MoCRA).
When finalized, the draft guidance will assist stakeholders with cosmetic product facility registration and product listing submissions to FDA, by describing who is responsible for making the registration and listing submissions, what information to include, how to submit, and when to submit, as well as certain exemptions to the registration and listing requirements.
MoCRA provided new authorities to FDA including:
· Facility Registration: Cosmetic product manufacturers and processors must register their facilities with FDA, update content within 60 days of any changes, and renew their registration every two years.
· Product Listing: A responsible person must list each marketed cosmetic product with FDA, including product ingredients, and provide any updates annually.
Responsible person means the manufacturer, packer, or distributor of a cosmetic product whose name appears on the label of such cosmetic product in accordance with section 609(a) of the FD&C Act or section 4(a) of the Fair Packaging and Labeling Act.
Exemptions
MoCRA exempts certain small businesses from facility registration and product listing requirements.
However, such exemptions do not apply to facilities that manufacture or process, or responsible persons for, the following cosmetic products:
· Products that regularly come into contact with mucus membrane of the eye under customary or usual conditions of use.
· Products that are injected.
· Products that are intended for internal use.
· Products that are intended to alter appearance for more than 24 hours under customary or usual conditions of use and removal by the consumer is not part of such conditions of use.
Exemptions also exist for certain products and facilities that are subject to requirements for drugs and devices.
In March 2023, FDA issued a Constituent Update FDA Has Stopped Accepting Submissions to the Voluntary Cosmetic Registration Program (VCRP) as a result of the facility registration and product listing authorities mandated by MoCRA.
The draft guidance also contains information about a new electronic registration and listing submission portal. FDA intends to make the new electronic submission portal available in October 2023. FDA strongly encourages electronic submissions to facilitate efficiency and timeliness of data submission and management for the agency. FDA is also developing a paper form as an alternative submission tool to the electronic submission portal.
As described in the draft guidance, FDA intends to use the FDA Establishment Identifier (FEI) as the required facility registration number. To facilitate the registration process, the owner or operator of a facility will need to obtain an FEI number before submitting the facility registration. For more information, including how to request an FEI number or determine if an entity already has an FEI number, please refer to the FEI Search Portal.
The responsible person will need to obtain the relevant facility registration (FEI) number(s) for each facility where their cosmetic products are manufactured or processed, because the facility registration number(s) is required for the product listing submission. If the facility is a small business that is exempt from registration and has no facility registration number, then facility name/address can be provided instead for the product listing.
Stakeholders should plan to register and list well in advance of the December 29, 2023, statutory deadline.
In addition, FDA is soliciting applications from members of the cosmetic product industry interested in participating in a voluntary pilot program to conduct User Acceptance Testing (UAT) to help evaluate a potential new electronic submissions portal for cosmetic product facility registration and listing. This electronic submission portal is being implemented pursuant to MoCRA. FDA plans to accept up to nine participants for the pilot program. The pilot program is intended to provide input to inform evaluation of this new electronic submission portal. For more information, please refer to: Federal Register Notice: Pilot Program for Cosmetic Product Facility Registration and Listing Electronic Submissions User Acceptance Testing.
To Submit Comments on the Draft Guidance:
Comments on the draft guidance should be submitted by 9/7/2023. You may submit electronic comments to Regulations.gov. All written comments should be identified with the docket number FDA-2023-D-1716 and title of the guidance document.
Additional Information:
· Draft Guidance for Industry: Registration and Listing of Cosmetic Product Facilities and Products
