The U.S. FDA has just transmitted to the WTO a draft regulation aiming at increasing the fees for colo additives certification services. This certification is required for the use of certain colorants in food, drugs and cosmetics.
Backgroung
The current fee schedule became effective in 2005 and was amended in 2006.
Since 2005, the costs of the certification program have significantly increased because of general operating expenses, including the purchase and maintenance of critical equipment, rent and facility charges, and escalating staff payroll.
Therefore, the FDA propose to increase the fees for certifying color additives to reflect increasing operating costs for the certification program.
The change in fees would allow FDA to continue to maintain an adequate color certification program.
Proposed rule
The proposed rule, if finalized, would:
• Increase the fee for certification services from $0.35 to $0.45 per pound for straight colors including lakes, and change the minimum fee from $224 to $288
• Increase the fees for repacks of certified color additives and color additive mixtures from $35 for 100 pounds or less to $45
• Increase the fees for repacks of certified color additives and color additive mixtures 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
• Increase the fees for repacks of certified color additives and color additive mixtures over 1,000 pounds …
