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What goes wrong

No substantiation file

By Dwight Davis, Founder

Updated

On this page9
The alternative to doing the work is a sentence no business would print.

The requirement

Each ingredient used in a cosmetic product and each finished cosmetic product shall be adequately substantiated for safety prior to marketing. Both levels, and before marketing rather than in response to a complaint.

And the consequence

An unsubstantiated ingredient or product is misbranded unless it bears the conspicuous statement "Warning - The safety of this product has not been determined" on the principal display panel.

Body care has a high exposure profile

Large surface area, daily use, often on broken or sensitive skin, and in the case of a stretch mark balm often in pregnancy. The reasoning has to be built around that rather than around a small leave-on product.

Essential oils are the usual pressure point

Loading, sensitization and phototoxicity for some citrus oils are real, and a body product distributes them over far more skin than a facial one. The percentage that is fine in a serum is not automatically fine here.

A range multiplies the work

Nine leaves and several scents each is a lot of finished products, and every one of them is a finished product for this purpose. Building the file as the range grows is the only proportionate way.

Supplier data is the input, not the file

An ingredient safety data sheet addresses handling. The finished product assessment at your use level is yours, and it is the half that does not arrive with the raw material.

Keep it with the formula and the label version

So that a reformulation or a new scent visibly reopens it. A file describing a product you have since changed is a historical document rather than a current one.

A scent is a finished product

Which is what makes this heavier for a body range than for a single product. Nine leaves at four scents each is thirty-six finished products, and sharing a base does not reduce that to nine.

References

21 CFR 740.10, which requires each ingredient and each finished cosmetic product to be adequately substantiated for safety before marketing, and makes an unsubstantiated one misbranded unless it bears "Warning - The safety of this product has not been determined" on the principal display panel. law.cornell.edu
21 CFR 740.1, which requires the label of a cosmetic product to bear a warning statement whenever necessary or appropriate to prevent a health hazard that may be associated with the product. law.cornell.edu
Written from federal statute and from measured catalog data, not from a formulation bench. Whether a particular particle is a plastic microbead within 21 U.S.C. 331(ddd) is a question about that particle and its purpose. Nothing here is a determination about a specific exfoliant or a specific formula.