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FDA Cosmetic Color Additives Batch Certification
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All cosmetic color ingredients and additives must be FDA-approved for their specific intended use and cosmetic formulation. Cosmetic color additives must be either FDA-approved colors for particular uses, FDA-certified colors (on a batch basis), or exempted from FDA color certification. The FDA categorizes cosmetic color additives into two main groups:
1.Certifiable Color Additives: Synthetic colors must undergo FDA batch certification to ensure safety and purity. Examples include FD&C and D&C colors like FD&C Red No. 40 and FD&C Yellow No. 5.
2. Exempt Color Additives: These are primarily natural colors, such as iron oxides and titanium dioxide, that do not require batch certification but must meet FDA safety standards.
The FDA also classifies color additives by their permitted uses (e.g., external use, eye area restrictions) and prohibits specific unsafe colors. The complete list of certifiable, exempt, and prohibited color additives can be found on the FDA website.
Color Additive Batch Certification
Batch Certification is the procedure by which the FDA analyzes the composition of all the colors used in cosmetic formulation. To obtain the color additive batch certification, cosmetic manufacturers must submit a sample of the color additive for each batch used in the product formulation along with the batch-specific documents. After proper examinations, the U.S. FDA will certify the color additive if the batch sample analysis meets the FDA requirements. The FDA’s cosmetic color additive batch certification involves the following steps:
1.Application Submission: Manufacturers apply with batch details testing results and pay the required fee.
2.Sample Submission: A representative sample of the batch is sent to the FDA for testing.
3.FDA Testing: The FDA tests the sample to verify purity and compliance with safety standards.
4.Certification Decision: If the batch passes, it is certified and given a certification number. If it fails, it is rejected.
5.Labeling: Certified batches are labeled with the FDA certification number.
6.Recordkeeping and Auditing: Manufacturers and the FDA maintain records for compliance and audits.
7.Ongoing Monitoring: The FDA monitors certified color additives for continued safety.
Color additive violations are some of the most common causes of FDA import detentions and refusals while importing cosmetic products into the United States. FDA Listing Inc. assists cosmetic manufacturers in demonstrating to the FDA that color additives contained in imported products are certified and adequately declared on the product label.
Our experts will help you determine whether a batch certification is needed for your used color additive and walk you through filling out the form for batch certifications and approval. Please email or call us for assistance regarding cosmetic color additive review and certification.
Service Details & Fees
Cosmetic Batch Certification
Time Required (Filing)
Batch Documents Review
Discount on Multiple Batches
395 USD
2-3 Days
_______ Related Services _______
Frequently Asked Questions (FAQ)
U.S. FDA requires filling of Prior Notice before food shipments enter the United States. This will include Prior Notice for food samples for trade shows or consumption. After filling the Prior Notice, you will be assigned with a confirmation number that will be used by your U.S. customs broker for the shipment release. A Prior Notice can also be filed by your own compnay or international transit firms as well as shipment companies (DHL, FedEx, TNT, etc).
U.S. FDA requires filling of Prior Notice before food shipments enter the United States. This will include Prior Notice for food samples for trade shows or consumption. After filling the Prior Notice, you will be assigned with a confirmation number that will be used by your U.S. customs broker for the shipment release. A Prior Notice can also be filed by your own compnay or international transit firms as well as shipment companies (DHL, FedEx, TNT, etc).
U.S. FDA requires filling of Prior Notice before food shipments enter the United States. This will include Prior Notice for food samples for trade shows or consumption. After filling the Prior Notice, you will be assigned with a confirmation number that will be used by your U.S. customs broker for the shipment release. A Prior Notice can also be filed by your own compnay or international transit firms as well as shipment companies (DHL, FedEx, TNT, etc).
U.S. FDA requires filling of Prior Notice before food shipments enter the United States. This will include Prior Notice for food samples for trade shows or consumption. After filling the Prior Notice, you will be assigned with a confirmation number that will be used by your U.S. customs broker for the shipment release. A Prior Notice can also be filed by your own compnay or international transit firms as well as shipment companies (DHL, FedEx, TNT, etc).
U.S. FDA requires filling of Prior Notice before food shipments enter the United States. This will include Prior Notice for food samples for trade shows or consumption. After filling the Prior Notice, you will be assigned with a confirmation number that will be used by your U.S. customs broker for the shipment release. A Prior Notice can also be filed by your own compnay or international transit firms as well as shipment companies (DHL, FedEx, TNT, etc).
Frequently Asked Questions (FAQ)
U.S. FDA requires filling of Prior Notice before food shipments enter the United States. This will include Prior Notice for food samples for trade shows or consumption. After filling the Prior Notice, you will be assigned with a confirmation number that will be used by your U.S. customs broker for the shipment release. A Prior Notice can also be filed by your own compnay or international transit firms as well as shipment companies (DHL, FedEx, TNT, etc).
U.S. FDA requires filling of Prior Notice before food shipments enter the United States. This will include Prior Notice for food samples for trade shows or consumption. After filling the Prior Notice, you will be assigned with a confirmation number that will be used by your U.S. customs broker for the shipment release. A Prior Notice can also be filed by your own compnay or international transit firms as well as shipment companies (DHL, FedEx, TNT, etc).
U.S. FDA requires filling of Prior Notice before food shipments enter the United States. This will include Prior Notice for food samples for trade shows or consumption. After filling the Prior Notice, you will be assigned with a confirmation number that will be used by your U.S. customs broker for the shipment release. A Prior Notice can also be filed by your own compnay or international transit firms as well as shipment companies (DHL, FedEx, TNT, etc).
Service Details & Fees
Cosmetic Batch Certification
395 USD
Time Required (Filing)
2-3 Days
Batch Documents Review
Discount on Multiple Batches
_______ Related Services _______