
Name of the business owner and/or operator;
Business name, address, mailbox, and phone number;
For foreign companies, contact information for their U.S. agent is required;
FDA Business Registration Number (FEI Code);
The brand name of the product produced or processed by the enterprise;
Product categories and information about the person in charge;
Parent company information (if the business is a subsidiary or branch);
Corporate DUNS coding (Data Universal Numbering System).
Note: Since the new law adds the U.S. agent information, FEI code and DUNS code to the registration information requirements, foreign companies need to be prepared to obtain these codes in advance before the FDA's new electronic filing system goes online.
The following information should be provided during the product listing registration process:
The FEI code of the cosmetic manufacturer or processor;
Name of the person in charge, contact number, and name of the cosmetic product;
The category of cosmetic declarations;
A complete list of ingredients, including information such as the ratio of ingredients;
Product Listing Number;
Type of submission (same as initial submission, update, etc.);
Name of the parent company, if applicable;
Business type (e.g. retail, wholesale, etc.);
Pictures of the draft label design;
Links to product web sites with additional product information;
Whether the product is for professional use;
The DUNS code of the relevant responsible enterprise;
Unique Ingredient Identifier (UFI), or Unique Ingredient Identifier (UNII) is used to uniquely identify cosmetic ingredients.
The addition of the above details represents an increase in the FDA's regulatory efforts in the cosmetics sector, and requires more accurate and transparent disclosure of corporate and product information by the relevant companies. This requirement will help the FDA conduct more efficient risk assessment and oversight to further ensure the safety of cosmetics products when they enter the U.S. market. If you need help preparing MoCRA-compliant registration materials, you can contact Green Circle for further assistance and guidance.
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