COLIPA UV Simulator Standards Sought For FDA Sunscreen Reg - Petition

The OTC sunscreen monograph should be amended to include the adoption of the European Cosmetic, Toiletry & Perfumery Association's standard for solar simulators used in sunscreen testing, Rapid Precision Labs states in a June 29 citizen petition. Solar simulators mimic the spectral risk of natural sunlight and are used to ascertain the efficacy of sunscreen products.

In reference to solar simulators, Sec. 352.71 of the sunscreen regulation states, in part, "a solar simulator used for determining the SPF of a sunscreen drug product should be filtered so that it provides a continuous emission spectrum from 290 to 400 nanometers similar to sunlight at sea level from sun at a zenith angle of 10degrees."

The reg also dictates that less than 1% of the total energy should come from wavelengths shorter than 290 nm, and not more than 5% from wavelengths longer than 400 nm.

FDA does not, however, provide a requisite solar zenith angle of 10degrees, or statistically define the phrase "similar to," the Memphis, Tenn.-based testing lab's petition points out. In addition, the monograph does not discuss light source specifications, UV spectrum details or requirements regarding the ozone layer, all of which are key aspects of solar spectrum testing. The sunscreen final rule was issued May 21 (¹ (Also see ""SPF 30 Plus" Term Required For High-Protection Sunscreens - FDA Final Reg" - Pink Sheet, 24 May, 1999.).

Rapid Precision asks FDA to amend the monograph with the following language: "Solar simulators which comply with the COLIPA standard for Solar Simulators are deemed to meet the requirements for solar simulator spectral emission."

To determine if a testing protocol complies with the COLIPA standard, "a simulator is measured with a spectroradiometer with a 1 nm band pass, at either 1 nm or 2 nm increments from at least 250 nm to 400 nm. The measured spectra-irradiance is then multiplied by the McKinlay-Diffey Erythemal Action spectrum. Spectral regions of resulting effectiveness spectrum are then compared to the total risk."

One factor that may adversely affect Rapid Precision's petition is that as many as 40% of all existing solar simulators meet the COLIPA standards but do not meet the monograph's requirement that 5% of the total energy come from wavelengths longer than 400 nm, the company acknowledges. Precision also has been "critical in the past of the acceptance limits adopted" in the COLIPA standard but acknowledges that changing the limits would negate all testing conducted since FDA issued the tentative final monograph in 1993.

Rapid Precision Labs specializes in the measurement of solar sources used in cosmetic and drug clinical trials. Since the adoption of the COLIPA standard in 1994, the company "has been making the requisite measurements and providing certification that solar simulators meet this standard," the petition states.

Over the past 15 months, Precision Labs "has measured solar simulators in more than 30 testing labs, including the U.S., Canada, France, Germany and the U.K."

Precision estimates 80% to 90% of existing sunscreen products will need to be retested under the new requirements, and therefore requests FDA expedite the petition in light of the two-year compliance deadline. Since a "massive amount of testing" is required, it is "critical for the sunscreen industry to have a standard defined as quickly as possible," Precision states.

FDA must allow sufficient time for testing as well as product reformulation, the firm continues. Only 12 labs in the U.S., including Precision, are equipped to perform the solar simulations, and each test requires the expertise of 25 personnel.

Thus, the large number of companies requiring sunscreen testing, coupled with the small amount of labs able to perform such tests, will create a backlog, Rapid Precision predicts. The firm acknowledges, however, some companies are capable of conducting the tests in-house.

If COLIPA's standards are not adopted, labs would be required to maintain two different solar simulators for sunscreen requirements in the U.S. and the European Union, which would increase the cost to sun care manufacturers, Precision notes.

Precision Labs also submitted its petition to the U.S. Cosmetic, Toiletry & Fragrance Association and COLIPA for review. In the next few months, the company plans to submit a separate citizen petition addressing additional concerns about the reg.