Safety substantiation, which has no exemption

Of everything in this property, this is the obligation most small brands do not know they have, and it is the one with no way around it.

The obligation

A cosmetic must be substantiated as safe for its intended use. Not tested by somebody else, not assumed safe because the ingredients are common, and not covered by a disclaimer.

Safety substantiation applies to businesses of every size and has no small-business exemption. That single sentence is the most consequential thing on this page.

What the exemptions actually cover

Under MoCRA there are small-business exemptions, and they are real. They cover facility registration and product listing: the administrative obligations.

They do not cover safety. And they fall away entirely for certain products regardless of size: anything classified as both a cosmetic and a drug, which includes sunscreen, SPF makeup and medicated products, sits under OTC drug requirements and is not eligible.

So the common assumption, that a small brand is lightly regulated, is half right in a way that is dangerous. The paperwork is lighter. The substance is not.

What substantiation involves

A documented assessment that the formula, at its use level, by its route of application, on its intended users, is safe. In practice that means ingredient safety data at the concentrations used, the preservation evidence, the stability evidence, packaging compatibility, and an assessment drawing those together.

Many small brands commission that assessment rather than write it, which is a reasonable answer. Having no assessment at all is not.

Why this is the page to act on

Because the challenge test and the stability study are the inputs to it. A brand that has run both is most of the way there; a brand that has run neither has nothing to substantiate with.

And because the cost of doing it is known and modest, while the cost of not doing it is a question you cannot answer in advance about a customer you have not met yet.

References