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‘De System’ helps you in U.S. FDA Cosmetic Establishment Registration and Cosmetic Product Ingredient Filings.

Cosmetic Establishment Registration: 21 C.F.R. Part 701 et seq. The owner or operator of a cosmetic product establishment which is not exempt under 710.9 and engages in the manufacture or packaging of a cosmetic product is requested to register for each such establishment, whether or not the product enters interstate commerce.


Medical Devices are classified by Regulation, that is detail descriptions are contained within the Code of Federal Regulations (21 CFR 862 - 892), and various classifications and requirements listed for each device. There are three classes: class 1 are the lowest risk devices and class 3 are the highest risk devices.

Cosmetic Product Ingredient Statements: 21 C.F.R. § 720.2

Cosmetic Product Ingredient Statements "should be filed for each cosmetic product within 60 days after the beginning of commercial distribution" De assists businesses with FDA compliance. Certificates of Registration issued by Registrar Corp provide confirmation to industry that you are fulfilling FDA registration requirements. FDA does not issue or recognize Certificates of Registration. Registrar Corp is not affiliated with the US Food and Drug Administration.

When importing or manufacturing cosmetics, there are essentially five distinct issues:
  • the labeling must conform to certain regulatory standards;
  • the ingredients must be safe and appropriate for cosmetic use;
  • the colorants must be approved, declared properly, and may require particular warnings
  • the products must not make drug claims unless they contain an approved active Over-The- Counter (OTC) ingredient (such as sun block)
  • for any cosmetics that are also OTC drugs, the drug regulations will apply

We routinely assist clients with labeling compliance, as well as ingredient safety, color approval, and cosmetic-drug combination (e.g., cosmeceutical) . Since most label designers are not prepared to conform to the regulatory requirements, we can also work with label designers to achieve complete FDA regulatory compliance

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