FDA to increase certification fee for color additives amid rising operating costs

14 Nov 2022 --- The US Food and Drug Administration (FDA) is proposing an amendment to the Regulation of color additives which would increase the certification services fees by ten cents per pound. If passed, personal care and cosmetic companies should note that color additives must be certified for product use under the Federal Food, Drug and Cosmetic Act.

“The fees for straight colors, including lakes, would be US$0.45 per pound with a minimum fee of US$288. There would be similar increases in fees for repacks of certified color additives and color additive mixtures,” sums up the proposed rule.

Straight colors are those that have not been mixed chemically nor have been chemically reactive. Lakes are formed by chemically reacting to straight colors, shares the FDA.

Moreover, the FDA justifies that an increase in fees is “necessary” due to increased operating costs and to ensure the certification program continues to operate at the highest level of quality and efficiency expected.

“As the increase in fees is not associated with any change in our certification program, no economic benefits are expected to result from the proposed rule,” clarifies the proposal.FDA justifies that an increase in fees is “necessary” due to increased operating costs.

“Accordingly, we do not estimate economic benefits associated with this proposed rule, and the impact of the increase in color certification fees is estimated as an ongoing transfer from manufacturers of color additives to the federal government. If finalized, the economic burdens of this proposed rule would accrue to color additive manufacturers.”

How colors are certified
The association explains that it analyzes samples from each batch of color additives from manufacturers to verify whether it meets FDA composition and purity standards.

Moreover, certifications are provided before the color additives are allowed to be used in products marketed to US-based consumers.

In this process, manufacturers pay a fee based on the weight of each batch. These fees are noted to “support FDA’s color certification program.”

The proposal for an increase is the first to be suggested since 2005, shares the FDA.

Since 2005
The current fee became effective in 2005 and was amended in 2006. Since then, the FDA highlights that the costs of “ the certification program have significantly increased” due to operating expenses, the purchase and maintenance of equipment, rent and facility charges and escalating staff payroll.Fees for straight colors, including lakes, would be US$0.45 per pound, proposes the rule.

In 2005, the interim final rule increased the fees per pound. 

“The fee for straight colors, including lakes, increased from US$0.30 to US$0.35 per pound (a US$0.05 per pound increase) with a minimum fee increase from US$192 to US$224. The fee for repacks of certified color additives and color additive mixtures increased from US$30 to US$35 for 100 pounds or less, from US$30 to US$35 plus US$0.06,” elaborates the proposal.

The new proposed fee, if finalized, will go from US$0.35 to US$0.45 per pound for straight colors, including lakes, and change the minimum price from $224 to $288. Fees for color additive mixtures would go from US$35 for 100 pounds or less to US$45.

Final changes
Any final rule resulting from the proposal will be effective 30 days after the final rule’s date of publication in the Federal Register, shares the FDA. 

It believes that the time frame is appropriate as it will give the industry “sufficient time” to adjust to the changes in the fee.

Comments on the proposed rule can be submitted to the FDA.

Regulation takes over
Governments across the globe are tightening up rules around cosmetic chemicals to reduce health and environmental risks.

Recently, the Canadian government released a Notice of Intent, proposing amendments to the Canadian Environmental Protection Act, 1999, which would legally require cosmetic companies to label certain substances in cosmetic products to minimize adverse environmental- and human-health impacts.

Across the ocean, the European Commission proposed stricter rules on ambient air, surface and groundwater pollutants and urban wastewater treatment to protect human health and ecosystems. These rules would require cosmetic companies to pay to remove “toxic micro-pollutants” from EU wastewater.

Additionally, the Scientific Committee on Consumer Safety presented its final opinion on the safe use of triclocarban and triclosan as cosmetic substances with potential endocrine-disrupting properties.

By Venya Patel