Ext.

Ext. D&C Yellow Nos. 9 and 10. These colors cannot be produced with any assurance that they do not contain -naphthylamine as an impurity. While it has been asserted that the two colors can be produced without the impurity named, no method of analysis has been suggested to establish the fact. -Naphthylamine is a known carcinogen; therefore, there is no scientific evidence that will support a safe tolerance for these colors in products to be used in contact with the skin. The Commissioner of Food and Drugs, having concluded that such action is necessary to protect the public health, hereby terminated the provisional listing of Ext. D&C Yellow No. 9 and Ext. D&C Yellow No. 10.

Source

21 CFR § 81.10


Scoping language

None
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