Cosmetics under MoCRA
Cosmetics went from one of the least regulated import categories to one requiring registration, listing and evidence. Many importers have not caught up.
Licensed U.S. customs brokerage. Customs broker of record; movement coordinated through vetted partners.
The Modernization of Cosmetics Regulation Act introduced facility registration, product listing, adverse event reporting and safety substantiation requirements for cosmetics. Importers who previously brought cosmetics in with very little regulatory overhead now carry real obligations.
Key takeaways
- Facilities manufacturing or processing cosmetics require registration.
- Products require listing, with their ingredients.
- Safety substantiation must exist and be available.
- Adverse event reporting and recordkeeping obligations apply.
- Implementation detail has moved since enactment and continues to.
What changed, in practical terms
Cosmetics were for a long time among the lightest-touch import categories. An importer could bring in product with little more than accurate labelling and a correct classification.
MoCRA replaced that with a structure resembling other regulated categories: facilities registered, products listed, safety substantiated, adverse events reported and records kept. The obligations are not onerous individually. What catches importers is not knowing they exist.
Substantiation is the part people underestimate
A requirement that safety be substantiated means evidence has to exist, and it has to be adequate for the product as sold. An assurance from a supplier that the formulation is safe is not, by itself, substantiation.
For importers of private-label or contract-manufactured cosmetics, this is the practical gap: the manufacturer holds the technical file, the importer holds the obligation, and nobody arranged for the two to meet. That is a conversation to have while negotiating, not afterwards.
This is still moving
Requirements, timelines and enforcement approach have been adjusted since enactment, and guidance has continued to develop.
Treat any position on MoCRA as current rather than settled. If your compliance assessment was made a year ago, it is worth reconfirming before relying on it for a new product or a new supplier.
How it works
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01
Establish who manufactures
Registration attaches to facilities.
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02
Confirm registration is in place
For the facilities involved in your products.
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03
List the products
With ingredients, kept current as formulations change.
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04
Secure the safety substantiation
Held or accessible, adequate for the product as sold.
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05
Reconfirm periodically
Requirements here have moved and continue to.
Common mistakes
- Assuming cosmetics are still lightly regulated. That changed.
- Relying on a supplier's safety assurance. Substantiation means evidence.
- Not arranging access to the technical file. The obligation is yours; the file is theirs.
- Listing a product then changing the formula. Listings have to keep up.
- Relying on an assessment made a while ago. Implementation has continued to develop.
Questions
Does MoCRA apply to imported cosmetics?
Yes. Facility registration, product listing and safety substantiation requirements reach cosmetics brought into the United States, not only those made here.
What counts as safety substantiation?
Adequate evidence supporting the safety of the product as it is sold. A general assurance from a supplier is not the same thing.
My supplier holds the technical file. Is that enough?
Only if you can actually access it when it is needed. The obligation sits with you, so access should be arranged commercially rather than assumed.
Has the position changed since MoCRA was enacted?
Yes. Requirements, timelines and guidance have continued to develop, so a position confirmed a year ago is worth reconfirming.
Related
Tell us what you're importing.
Commodity, origin, port and arrival date is enough to start.