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Introduction and Process of FDA Color Additive Batch Certification
2026-03-13
I. What is FDA batch certification for color additives?
In the United States, someSynthetic color additives must undergo FDA batch certification before they can be used in food, drugs, cosmetics, or medical devices.。
This system is administered by the U.S. Food and Drug Administration (FDA).CFSAN – Color Certification Branch (CCB)Responsible for management.
The core purpose of batch certification is:
Ensure that each batch of synthetic pigments meets the requirements.FDAPurity and composition standards
Preventing the presence of harmful impurities or unauthorized ingredients
Ensure the safety of products for different uses (food, medicine, cosmetics, etc.)
Only certified batches of pigments can be legally used in the U.S. market.
Please note:
Not all pigments require batch certification.
The FDA classifies pigments into two categories:
Certifiable Color Additives (requiring batch certification)
Pigments that do not require batch certification (Exempt from Certification)
generallySynthetic pigments require certification,andNatural pigments are generally exempt from certification.。
II. Common Pigments Requiring Batch Certification
Food coloring:
FD&C Blue No. 1.
FD&C Blue No. 2.
FD&C Green No. 3.
Orange B.
Citrus Red No. 2.
FD&C Red No. 3.
FD&C Red No. 40.
FD&C Yellow No. 5.
FD&C Yellow No. 6.
Pharmaceutical pigments
FD&C Blue No. 1
FD&C Blue No. 2.
D&C Blue No. 4.
D&C Blue No. 9.
FD&C Green No. 3.
D&C Green No. 5.
D&C Green No. 6.
D&C Green No. 8.
D&C Orange No. 4.
D&C Orange No. 5.
D&C Orange No. 10.
D&C Orange No. 11.
FD&C Red No. 3.
FD&C Red No. 4.
D&C Red No. 6.
D&C Red No. 7.
D&C Red No. 17.
D&C Red No. 21.
D&C Red No. 22.
D&C Red No. 27.
D&C Red No. 28.
D&C Red No. 30.
D&C Red No. 31.
D&C Red No. 33.
D&C Red No. 34.
D&C Red No. 36.
D&C Red No. 39.
FD&C Red No. 40.
D&C Violet No. 2.
FD&C Yellow No. 5.
FD&C Yellow No. 6.
D&C Yellow No. 7.
Ext. D&C Yellow No. 7.
D&C Yellow No. 8.
D&C Yellow No. 10.
D&C Yellow No. 11.
Pigments for cosmetics
D&C Black No. 2.
D&C Black No. 3.
FD&C Blue No. 1.
D&C Blue No. 4.
D&C Brown No. 1.
FD&C Green No. 3.
D&C Green No. 5.
D&C Green No. 6.
D&C Green No. 8.
D&C Orange No. 4.
D&C Orange No. 5.
D&C Orange No. 10.
D&C Orange No. 11.
FD&C Red No. 4.
D&C Red No. 6.
D&C Red No. 7
D&C Red No. 17.
D&C Red No. 21.
D&C Red No. 22.
D&C Red No. 27.
D&C Red No. 28.
D&C Red No. 30.
D&C Red No. 31.
D&C Red No. 33.
D&C Red No. 34.
D&C Red No. 36.
FD&C Red No. 40.
D&C Violet No. 2.
Ext. D&C Violet No. 2.
FD&C Yellow No. 5.
FD&C Yellow No. 6.
D&C Yellow No. 7.
Ext. D&C Yellow No. 7.
D&C Yellow No. 8.
D&C Yellow No. 10.
D&C Yellow No. 11.
medical devices
[Phthalocyaninato(2-)] copper.
D&C Black No. 4.
FD&C Blue No. 2.
D&C Blue No. 6.
D&C Green No. 6.
D&C Red No. 17.
D&C Violet No. 2.
D&C Yellow No. 8.
D&C Yellow No. 10.
These pigments after productionEach production batch must be submitted for FDA certification.。
III. Which products are subject to this certification?
Pigment batch certification is typically applicable to the following industries:
1 food industry
For example:
drinks
candy
Baked goods
ice cream
condiment
2 pharmaceutical industry
For example:
Tablet Coating
Capsule shell
Liquid medicines
3 Cosmetics industry
For example:
lipstick
eyeshadow
nail polish
Skin care product coloring
4 medical devices
For example:
Certain dyed medical materials
Medical diagnostic reagents
Please note:
Batch certification is for pigment manufacturers, not end-product companies.
IV. FDA Pigment Batch Certification Application Process
Step 1: Confirm whether the pigment falls within the scope of certification.
The company needs to confirm:
Does pigment belong toCertifiable Color Additives
Should it be included?21 CFR 74Or 82
If it falls within this scope, batch certification must be applied for.
Step 2: Prepare batch samples
Companies need to take samples from production batches.
Common requirements include:
Sample weight is typically approximately10–50gram
The sample must represent the production batch.
Use sealed containers for packaging.
Clear labelingLot Number
Step 3: Submit the certification application
Companies need to submit the following to the FDA:
U.S AgentLetter of Authorization
Application letter for pigment additives
The application includes:
Company Information
Pigment name
Batch number
Batch weight
Uses (food/pharmaceutical/cosmetics)
Production date
Certification fees also need to be paid.
Step 4: Send samples to the FDA laboratory
Samples should be sent to:
FDA Color Certification Branch
Step 5: FDA laboratory testing
FDAThe laboratory will conduct tests according to regulations and standards, for example:
Purity requirements
Hazardous impurity limits
Ingredient ratio
If it meets the standards, the FDA will approve the batch.
Step 6: Obtain batch certification
After passing the test, the FDA will:
For this batchCertification Lot Number
Include itFDA Certified Color Additives List
The company is legal to sell this batch of pigment.
If the test fails:
FDAAuthentication will be rejected.
This batch is not permitted for use in the US market.
V. Certification Fees
FDAPigment certification fees are typically calculated per batch weight (pounds).
The cost structure generally includes:
Basic testing fees
Charged by weight
The fee schedule may be adjusted annually, usually within...Prices range from several hundred dollars to over a thousand dollars.。
VI. Validity of Certification
Batch certification has the following characteristics:
For a single production batch only
Each production batch requires recertification.
Not a long-term license
Therefore, pigment manufacturers typically submit certification applications regularly.
VII. Common Compliance Considerations
Companies should pay attention to the following during the application process:
Ensure production process stability
Strictly control impurity content
Batch numbers must be clear
The sample must be representative
Maintain production and quality records
VIII. Summary
FDABatch certification of pigment additives is a process for...Important systems for the safety management of synthetic pigments。
Its core features include:
Only applicable to some synthetic pigments
Each production batch requires certification.
Tested by FDA laboratories
Only after passing certification can it enter the US market.
This system is widely usedFood, pharmaceutical, cosmetics and some medical device industriesThis is an important compliance requirement for entering the US market.