FDA facts sheet #4
Text copied directly from the FDA web site http://vm.cfsan.fda.gov/~dms/cos-lab3.html#clga
| COSMETIC WARNING
STATEMENTS
GENERAL REQUIREMENT
PROMINENCE CONSPICUOUSNESS 21 CFR 740 (1) and (2) |
A cosmetic is considered misbranded if its safety has not adequately been substantiated, and it does not bear the following conspicuous statement on the PDP:
Warning - The safety of this product has not been determined.
The safety of a cosmetic may be considered adequately substantiated if experts qualified by scientific training and experience can reasonably conclude from the available toxicological and other test data, chemical composition, and other pertinent information that the product is not injurious to consumers under conditions of customary use and reasonably foreseeable conditions of misuse.
The safety of a cosmetic can adequately be substantiated by:
a. Reliance on available toxicological test data on its ingredients and on similar products, and
b. Performance of additional toxicological and other testing appropriate in the light of the existing data.
Even if the safety of each ingredient has been substantiated, there usually still is at least some toxicological testing needed with the formulated product to assure adequate safety substantiation.
| COLOR ADDITIVES
ADDED SOMETIMES FOR COLOR MATCHING
LISTED AFTER THE DECLARATION OF OTHER COLOR ADDITIVES AND AFTER THE PHRASE "MAY CONTAIN." 21 CFR 701.3(g) (1) |
This hypothetical toilet water formulation in which D&C Yellow No. 10 is added to some batches for the purpose of color adjustment shows on the right side the correct label declaration of the color additive D&C Yellow No. 10.
| COLOR ADDITIVES
SOMETIMES ADDED FOR COLOR MATCHING
D&C Yellow No. 10 used for Color Adjustment |
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Incidental ingredients need not be declared on the label.
An incidental ingredient is defined in § 701.3(1) as:
1. A substance added during manufacture and removed from the cosmetic in accordance with good manufacturing practices before the cosmetic is packaged in finished form. Example: Filter aid.
2. A substance that is added during manufacture of a cosmetic, is converted to an ingredient declared on the label, and does not significantly increase the concentration of the declared ingredient. Example: Sodium hydroxide added to a sodium stearate and stearic acid-containing cosmetic.
3. A substance added to a cosmetic during manufacture for its technical effect in processing but present in the finished cosmetic at an insignificant level and not having any technical or functional effect in that cosmetic. Example: Defoaming agent.
4. A substance added to a cosmetic as a component of a cosmetic ingredient and having no technical or functional effect in the finished cosmetic. Example: Preservative of a raw material added to a cosmetic as an ingredient at a concentration which reduces the preservative to a level at which it is no longer effective.
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