MoCRA Updates: US Consults on Electronic Portal and Paper Forms for Cosmetic Facility Registration and Product Listing

On September 18, 2023, the U.S. Food and Drug Administration (FDA) unveiled its newly developed draft electronic submission portal (Cosmetics Direct), Paper Form FDA 5066-Registration of Cosmetic Product Facility and Paper Form FDA 5067-Cosmetic Product Listing for public consultation. The period for public consultation will last until October 18, 2023.

Companies have the option to choose either electronic submission via Cosmetics Direct or paper submission methods. However, the FDA encourages electronic submission to enhance the efficiency and timeliness of data submission. Moreover, by utilizing the electronic submission method, companies can conveniently access their previous registrations and listing submissions as well as view the Submission ID for accepted submissions.

Cosmetics Direct

Cosmetics Direct incorporates the necessary information for registration and listing submissions from the Paper Forms FDA 5066 and 5067 into a standardized electronic format.

New users who wish to access the Cosmetics Direct Home Page are required to create a new account by submitting the organization’s basic information such as name, DUNS, address, contact information. DUNS is only a required field for companies seeking to log in to both CDER Direct and Cosmetics Direct.

On the Home Page, companies are able to see the two types of selections: Registration of Cometic Product Facility and Cosmetic Product Listing.

1) Registration of Cometic Product Facility

Companies can choose to create a new registration using a blank form or import an FDA-accepted SPL in a valid XML zip file.

The mandatory information required for the registration includes (the same as what is stated on Form 5066):

• Facility's name, address and contact information

• Brand names of cosmetic products manufactured or processed in the facility

• Name of the responsible person listed on the products' labels

• Product category code

• Contact information for the U.S. agent (applicable to international companies only)

Upon making a submission, companies can check the status of their submission. In the case of an accepted submission, a submission ID will be issued.

2) Cosmetic Product Listing

There are also two options: create a new registration using a blank form or import an FDA-accepted SPL in a valid XML zip file. The mandatory information required for the product listing includes (the same as what is mentioned on Form 5067):

• Responsible person: the name listed on the products' labels, the type of business, phone number

• Product: category code, name, the presence of fragrance or flavor

• The facility where the cosmetic is manufactured or processed: FDA Establishment Identifier (FEI) of each facility. (If the facility is a small business and is not required to register, enter the name and address)

• List of ingredients in the cosmetic product: common, usual or chemical name, and ingredient UNII-Name

After submitting their information, companies can verify the progress of their submission and find the submission ID for accepted submissions.