Substantiating safety

The requirement

Each ingredient used in a cosmetic product and each finished cosmetic product shall be adequately substantiated for safety prior to marketing. Both halves: the ingredients and the finished product, and before marketing rather than in response to a problem.

And the consequence of not doing it

Any such ingredient or product whose safety is not adequately substantiated prior to marketing is misbranded unless it contains the conspicuous statement "Warning - The safety of this product has not been determined" on the principal display panel.

Which is the cleverest rule in this library

It does not ban the product. It makes the warning the price of skipping the work, on the front of the package, conspicuously. Nobody chooses the warning, so the rule gets the substantiation.

What adequate means is not specified here

Which is both the difficulty and the flexibility. The expectation is a reasoned safety assessment appropriate to the ingredients and the exposure, and for a bath product the exposure is whole-body and often includes children.

There is a narrow allowance for new information

Where safety had been adequately substantiated before new, inconclusive information arose, the warning is not required if the new information does not demonstrate a hazard to human health and adequate studies are being conducted expeditiously.

And that allowance is not an exemption

The regulation says so directly: it does not constitute an exemption to the adulteration provisions or to any other requirement. It covers a specific situation and not a general reluctance.

Build the file as you formulate

Ingredient safety data, supplier documentation, the exposure reasoning and the finished product assessment, kept together and dated. Assembled alongside the formula it is a morning; reconstructed later it is a project.

References