FDA gives approval to its first C. I. Pigment Blue 36
Color pigment supplier The Shepherd Color Company can claim a first with the recent announcement that the U.S. Food & Drug Administration has approved for indirect food contact the company's new Blue 10F545 pigment. Blue 10F545 is insoluble in virtually all solvents and resins and will not bleed or migrate, according to Shepherd.
December 1, 2010
The supplier (Cincinnati, OH) says the approval covers the intended use of the pigment in all polymers, at a maximum loading of 5% by weight. It also meets other regulatory requirements such as AP 89.1, AS 2070, BfR, China GB9685-2008, CONEG, EN 71.3, French Positive List, RoHS, TCLP, WEEE and ELV.
So far, Blue 10F545 is the only C. I. Pigment Blue 36 approved by the U.S. FDA. A spokesperson for Shepherd said she was not sure if any other supplier had ever tried for approval with such a colorant. Shepherd, though, has had some customers request that it pursue the FDA approval, she added.
The new complex inorganic color pigment (CICP) has the lightfastness needed for use in extreme applications—those high in UV exposure, in high-heat systems, and those in contact with harsh chemical environments. Deep blue-green in color, sky blue in a white let-down, Blue 10F545 has good hiding power, opacity, and tinting strength, reports the supplier. It is a strong absorber of UV radiation but not degraded by UV and therefore resistance to weather and light are good. Heat stability is to > 800°C (1800°F).
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