FDA Proposes Fee Increase to Color Additive Certification Services

The Food and Drug Administration (FDA) recently issued a guidance to amend color additive regulations to increase fees for certification services. FDA states that the fee increase would allow the agency “to continue to maintain an adequate color certification program as required by the Federal Food, Drug, and Cosmetic Act (FD&C Act).” If the rule is finalized, FDA proposes that the changes be effective 30 days after the final rule’s date of publication in the Federal Register.

Get Assistance with FDA Compliance for Color Additives

Registrar Corp’s Regulatory Specialists help companies comply with FDA’s regulations for color additives.

For more assistance with FDA regulatory requirements, call: +1-757-224-0177, email: info@registrarcorp.com, or chat with a Regulatory Advisor 24-hours a day: www.registrarcorp.com/livechat.

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FDA Color Additive Regulations­­­

A food color additive is any dye, pigment, or other substance that can impart color to a food product, including both synthetic substances and substances derived from natural sources. The FD&C Act created the requirement that FDA must certify certain color additives when they are being used in food, drugs, cosmetics, and medical devices.

For those color additives that require certification, manufacturers must submit samples of their batches to FDA for testing.  FDA analyzes samples from each batch to determine whether they meet the purity and compositional specifications described in regulation. Manufacturers pay fees for certification of their color additive, based on the batch’s weight. The fees support expenses incurred by FDA in the certification process.

Why is FDA Proposing Increased Fees?

The current color additive certification fees became effective in 2005. The certification program has become more costly since 2005 due to increases in general operation expenses. The fees are designed to cover all costs necessary to certify batches of color additives, including expenses associated with required testing, inspections, research, equipment maintenance, data review, issuing certificates, and accounting.

FDA states that “the current fee schedule is insufficient to provide, equip, and maintain an adequate certification program.” FDA intends to use the fee increase to recover the full costs of operating the certification program.

What Would the New Fees be?

The rule, if finalized, would increase certification fees as follows:

  • Certification services
    • Straight colors including lakes: from $0.35 to $0.45 per pound
    • Minimum fee: from $224 to $288
  • Repacks of certified color additives and color additive mixtures
    • 100 pounds or less: from $35 to $45
    • Over 100 pounds, but not over 1,000 pounds: from $35 plus $0.06 for each pound over 100 pounds to $45 plus $0.08 for each pound over 100 pounds
    • Over 1,000 pounds: from $89 plus $0.02 for each pound over 1,000 pounds to $114 plus $0.03 for each pound over 1,000 pounds

Guidance with Color Additive Regulations

Because products that contain unapproved color additives are considered to be adulterated under the FD&C Act (21 U.S.C. 342(c)), manufacturers must factor in the costs of certification when producing color additives that require it.

Registrar Corp can help you understand updates in color additive regulations, submit your color additives to FDA for color batch certification, or cross reference your color against FDA regulatory requirements.

Get Assistance with FDA Compliance for Color Additives

Registrar Corp’s Regulatory Specialists help companies comply with FDA’s regulations for color additives.

For more assistance with FDA regulatory requirements, call: +1-757-224-0177, email: info@registrarcorp.com, or chat with a Regulatory Advisor 24-hours a day: www.registrarcorp.com/livechat.

Get Assistance Today

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FDA registration today.

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For more assistance with FDA regulatory requirements, call: +1-757-224-0177, email: info@registrarcorp.com, or chat with a Regulatory Advisor 24-hours a day: www.registrarcorp.com/livechat.

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