CFSAN Colour Index Nomenclature Acceptance Tops CTFA Priority Request

FDA should permit the use of the European-developed Colour Index nomenclature for color additive labeling in place of existing agency requirements, according to the Cosmetic, Toiletry and Fragrance Association.

The nomenclature change should rank among the Office of Cosmetics & Colors' top priorities for fiscal 2003, the trade association says in Aug. 20 comments to the Center for Food Safety & Applied Nutrition. The comments were submitted in response to CFSAN's recent request for input on its program priorities (¹ 'The Rose Sheet' June 24, 2002, In Brief).

"The CI nomenclature has now become the international standard and is recognized throughout the world as the appropriate way to designate color additives on the label," CTFA asserts. The FDA nomenclature required in the U.S. has "posed a significant barrier to international harmonization of cosmetic labels for some time," the association adds.

CTFA made a similar request to CFSAN last year, but maintains the issue should be given higher priority in 2003 due to the current potential for labeling changes in Canada, where the government is considering a proposal to require color additive labeling.

While the proposal would allow the use of both FDA and CI nomenclature, the FDA version would have to be accompanied by a French translation, CTFA says. "Thus, instead of being able to list the color as CI 45380 on a U.S./Canadian harmonized cosmetic product, Red 22 would be required to be labeled as Red/Rouge 22 in Canada, nomenclature that would not be allowed in the U.S. or anywhere else," CTFA says.

A shift to color additive nomenclature in the U.S. would not prompt a change to marketing or trade names, to additive names in the regulation or to what colorants are allowed stateside, CTFA points out.

"The only possible concern FDA could have would be to ensure that the consumer and professionals needing such information would be able to adjust to recognizing the CI numbers as colorants, and being able to determine which FDA colorant these CI numbers reflect," the association says.

To address the issue, a transition period could be implemented to educate consumers, industry and the medical community, CTFA suggests. A cross-reference comparison could be distributed and posted on FDA's Web site, the association adds, offering to work with the agency to design other education programs.

Approval of color additive carbon black also is included in CTFA's priority request. The trade group petitioned for the approval in 1987, but since then FDA has issued numerous requests to industry for additional information without proceeding to a decision.

"It appears that we have entered a cycle from which there is no exit," the association says. "CTFA believes it is time for the agency to complete its review of the information in the petition" and to explain "exactly what, if anything, is still needed and why it is needed." Any additional requests, CTFA states, should be "consistent with what has been requested for other color additive petitions."

Several pending items on CFSAN's existing agenda reappear in CTFA's request for 2003. For example, the trade group urges the center to develop a "sun alert" warning for products containing alpha hydroxy acid, an activity that has been on the center's "A" list of priorities since 2000 (² (Also see "AHA Labeling Proposal Tops CFSAN's Cosmetics Priorities "A" List" - HBW Insight, 14 Feb, 2000.), p. 8).

CTFA also recommends CFSAN complete its Web-based, interactive Voluntary Cosmetic Registration Program, which the agency has been testing for some time. The trade group additionally reiterates its request that the agency accept new cosmetic ingredient nomenclature based on the CTFA International Ingredient Dictionary and Handbook.

The only priority action for cosmetics completed by CFSAN so far this year was an internal agreement allowing the cosmetics office to manage enforcement actions against cosmetics making disease claims (³ 'The Rose Sheet' Aug. 5, 2002, In Brief).

While CTFA acknowledges FDA's responsibility to protect the public from terrorism complicated its agenda in 2002, the association asserts "it remains as important as in the past that FDA continue to maintain a strong cosmetic regulatory program within CFSAN."

FDA recently appointed Linda Katz, MD, as permanent director of the Office of Cosmetics & Colors, which may provide the office an opportunity to be more proactive following two years of rotating acting directors (⁴ (Also see "FDA Cosmetics, Colors Office Director Katz Joins From OTC Division" - HBW Insight, 19 Aug, 2002.), p. 6).