How to change a filed formula, label or product name

After a cosmetic has been filed, you should not simply reprint the pack. Under the Measures for the Administration of Cosmetics Registration and Filing and the dossier provisions, changes to filed items should be submitted before the changed product is placed on the market or imported. Products already made or imported before the change may be sold until the end of their shelf life. A name should not be changed without a proper reason, and a formula should not be changed at will except for permitted minor changes, such as certain raw-material source changes. If the change in substance creates a new product, file again rather than only submitting a change.

Published 11 November 2026 · Updated 11 November 2026

How to judge change versus re-filing

Ask whether the change affects safety, efficacy claims or the identity of the product. A corrected typographical error on a label is different from a new brand name. A permitted minor formula adjustment caused by a raw-material source change is different from adding an active that supports a new claim. If the filer’s or Domestic Responsible Person’s address change causes the administering authority to change, the product should be filed again. Where a product was cancelled for a non-safety reason and is filed again, the rules may allow copies of the original materials to be reused if the conditions are met.

What to prepare

Identify exactly what changed—name, label, formula, manufacturer or responsible person—and submit the corresponding change file. After the change is completed, update online listings so they match the new public information.

Cautions

What counts as a “minor” formula change should be read against the rules and current review practice, not expanded by the brand. When in doubt, describe the old and new formulas rather than deciding alone that no submission is needed.

Questions we are often asked

Can we keep selling stock printed with the old label?

Products already manufactured or imported before the change may be sold until the end of their shelf life. New production or new imports should follow the changed file.

Is a new fragrance always a new filing?

Not automatically, but it is not automatically a minor change either. Assess whether the adjustment stays within permitted minor changes and whether claims or safety conclusions still hold.