Safety records are required, animal testing is not
Cosmetic manufacturers must hold records supporting adequate safety substantiation for their products, and animal testing is not required to market a cosmetic product in the United States.
The US asks for a defensible safety file, not a specific test method, so existing Korean or EU safety data can carry the load.
Exceptions and limits
95 of a possible 97Tier A, primary document or measured outcome. Nothing at this tier is allowed past 97, however good it looks.
Verified August 4, 2026Rechecked every 180 days, next by January 31, 2027.
Held since August 4, 2026A rule, law or policy that limits what you may do or say. The earliest date we are willing to say this held. It may well have been true before that; we do not backdate a record past the evidence we have read. Supported, version 1.
This entry is wrong if
FDA states that animal testing is required for cosmetic marketing, or drops the safety substantiation records requirement.
Written before the record was published, not after. If you can show this, send it to hello@tryorbt.com and the correction goes on the record with the entry.
Evidence
- Tier Aregulation
U.S. Food and Drug Administration: Modernization of Cosmetics Regulation Act of 2022 (MoCRA)
A responsible person is required to ensure and maintain records supporting adequate safety substantiation of their cosmetic products. Manufacturers can use relevant safety data that is already available to support the safety of their products. Animal testing is not a requirement for marketing a cosmetic product.
Read 2026-08-04 · Public domain · page hash
8cc8da80f378
History
- v1created
Initial entry from primary regulator text, read 2026-08-04.
Append-only. Nothing in this list is edited or removed once written, including the entries that record our own mistakes. Every change to every record is on the corrections page, and the same log is in entries.json under revisions.
Cite this entry
“Safety records are required, animal testing is not”, The Orbt Market Index 0.1.0, entry omr:us:mocra-safety-substantiation-without-animal-testing, retrieved September 9, 2026, https://tryorbt.com/markets/entry/us--mocra-safety-substantiation-without-animal-testing. Dataset: https://doi.org/10.5281/zenodo.22679129
Orbt, "Safety records are required, animal testing is not," Orbt Market Index, entry omr:us:mocra-safety-substantiation-without-animal-testing, verified August 4, 2026, https://tryorbt.com/markets/entry/us--mocra-safety-substantiation-without-animal-testing.
@misc{orbt-us-mocra-safety-substantiation-without-animal-testing,
title = {Safety records are required, animal testing is not},
author = {{Orbt}},
year = {2026},
doi = {10.5281/zenodo.22679129},
note = {The Orbt Market Index 0.1.0 (dataset DOI 10.5281/zenodo.22679129), entry omr:us:mocra-safety-substantiation-without-animal-testing. Verified 2026-08-04},
howpublished = {\url{https://tryorbt.com/markets/entry/us--mocra-safety-substantiation-without-animal-testing}},
license = {Orbt Index Public Licence. Free to quote and cite; not to redistribute}
}For a deck, a brief or a chat.
Free to quote, cite and act on. Not to resell or redistribute — the sources ask that of us, and each one’s terms are named. Machine-readable: entries.json carries this record under the id omr:us:mocra-safety-substantiation-without-animal-testing, with the same evidence and falsifier.
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- United StatesEvery product listed with FDA, ingredients included
- United StatesFDA can recall a cosmetic and suspend the facility
- United StatesA Korean plant is a US facility under MoCRA
- United StatesSerious adverse events report in 15 business days
- United StatesFDA registration is not FDA approval
Everything we hold on United StatesEvery record for this corridor