U.S. FDA Food Contact Substance (FCS) Requirements
U.S. FDA FCS Regulations Can Be Complicated
Registrar Corp's team of Regulatory Advisors can provide an assessment of how U.S. FDA FCS regulations apply to your particular product. Simply click below to receive information about your FCS products.
Learn how U.S. FDA FCS regulations apply to you >>
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Anything that touches food (or touches something that touches food) may be an Indirect Food Additive. The U.S. FDA requirements regarding the use of Indirect Food Additives are known as "Food Contact Substance" (FCS) regulations. Examples of FCS products may include:
- Food Packaging, Cookware, Tableware, etc.
- Food Processing Equipment, Production Aids, Sanitizers, etc.
- Chemicals used as Adhesives, Lubricants, Coatings, etc.
The U.S. FDA requires that all FCS products are determined safe for their intended use before they are permitted for sale in the United States. Safety is dictated by the regulatory status of each component that comprises the FCS. New components and uses of FCS products require premarket notification to the U.S. FDA prior to marketing in the United States.
The determination of how an FCS is regulated depends on its chemical composition. It is the responsibility of the FCS manufacturer to ensure that food contact materials comply with the specifications and limitations in all applicable authorizations. The identity, specifications, and limitations of the individual FCS components are regulated by provisions in the Code of Federal Regulations, the Federal Register, Effective Food Contact Notifications, Prior Sanctioned Letters, GRAS Notices, Threshold of Regulations Exemptions, as well as U.S. FDA enforcement actions such as import refusals, import alerts, warning letters, etc.
Many companies want a written evaluation determining the regulatory status of their FCS product. Registrar Corp offers an FCS review that includes:
- A detailed report (typically 10-15 pages) prepared by our team of Regulatory Specialists who determine the regulatory status of each element of your FCS, including intended uses, composition, and the need for premarket notification.
- A detailed outline of U.S. FDA testing procedures required of specific FCS products, if applicable.
- A generous revision policy allowing you to submit revisions for further reformulations of your FCS within 90 days at no extra cost.
Having your FCS product reviewed by Registrar Corp can prevent costly errors. To learn how this service would be helpful for your particular FCS product, simply click on the link below:
Learn how U.S. FDA FCS regulations apply to you >>
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U.S. FDA Regulations:
U.S. FDA Food Contact Substances: 21 C.F.R. sections 170, 174-178
Fees:
Food Contact Substance Review: US$ 1495/product
Discounts are available for multiple products. |
Registrar Corp assists businesses with U.S. FDA compliance. Certificates of Registration issued by Registrar Corp provide confirmation to industry that you are fulfilling U.S. FDA registration requirements. U.S. FDA does not issue or recognize Certificates of Registration. Registrar Corp is not affiliated with the U.S. Food and Drug Administration.
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