Cosmetic compliance: who files what
Most buyers assume the factory handles compliance. In practice the law splits the obligations, and a meaningful share lands on the brand — even when the brand never touches the product.
The responsibility matrix
Read each row as: what the obligation is, and who carries it in the US versus the EU. Where a rule's effective status matters, it is called out below the table.
| Obligation | United States | European Union |
|---|---|---|
| Facility registration | The manufacturing facility files. A foreign facility also needs a US agent | Not the EU mechanism — the EU works through the responsible person instead |
| Product listing / notification | The responsible person named on the label files the product listing | The responsible person notifies the product through the CPNP portal |
| Safety assessment | Not a standalone filing, but safety is the brand's responsibility | A safety assessment by a qualified assessor is required before placing on the market |
| Product information file | No direct equivalent | The responsible person must keep the file and make it available to authorities |
| Label identity | The responsible person's name and address identify who stands behind the product | The responsible person must be established in the EU, and named on the label |
The US framework for cosmetics is often referred to by the name of the 2022 reform act, "MoCRA". What matters for a buyer is not the acronym but the split above: facility registration is filed by the factory, while product listing is filed by the responsible person. For background on how the FDA regulates cosmetics without "approving" them, see the FDA's own explainer.
A closing point on "certificates"
Dates: what is in force, and what is not
Effective dates for cosmetics rules have moved more than once, and secondary sources disagree with each other. This page therefore states status rather than dates wherever the position is still settling.
- US fragrance allergen labelling — not yet in force. The rule has been proposed, not finalised, so do not design a label around it yet. Confirm the current position at the FDA cosmetics section.
- EU fragrance allergen labelling — in force through an amendment to the EU regulation; the allergen list and thresholds are set out in the regulation's annexes. See the EU regulation text.
Why "the factory will handle it" fails
In a private label or contract manufacturing project the responsible person on the label is usually the brand, not the filler. That means product listing, the safety assessment and — in the EU — the product information file are yours to hold, even though the factory does the physical work. Set this out in writing before you brief a factory: the checklist is in how to vet a cosmetic contract manufacturer, and the identity terms are covered in how to start a cosmetics brand. The EU side has its own page: EU cosmetic regulation.
Related reading
- EU Cosmetic Regulation — Who Is Responsible and What Gets FiledThe EU cosmetic regulation explained as a chain of responsibility: the responsible person in the EU, the safety assessment, the product information file and CPNP notification — none of which is a marketing authorisation.
- How to Vet a Cosmetic Contract ManufacturerThe eight documents worth asking a cosmetic contract manufacturer for, what each one proves and what it does not — plus three checks you can run yourself before you place an order.
- How to Start a Cosmetics Brand — The Order That Wastes the Least MoneyThe five stages from idea to first order: define one SKU, decide who owns the formula, sample, sort compliance, then scale. Starting with a factory quote instead is the expensive way round.
Frequently asked questions
Who files the product listing under US cosmetics law?
The responsible person named on the label, which is usually the brand rather than the factory. Facility registration, by contrast, is filed by the manufacturing facility.
Does the FDA issue a certificate proving a cosmetic complies?
No. The FDA has stated it does not provide any certificate, letter or other document to verify that a cosmetic facility or product complies with the law, even though marketplaces often ask sellers for one.
What is the EU equivalent of product listing?
A notification through the CPNP portal by the responsible person. It is a notification, not a marketing authorisation.
Who has to keep the safety assessment?
In the EU a safety assessment by a qualified assessor is required and the responsible person must keep the product information file. In the US there is no standalone safety filing, but safety remains the brand's responsibility.
Is fragrance allergen labelling in force in the US?
Not yet. The US rule has been proposed rather than finalised, so this site treats it as not in force. The EU position is different and is set out in the regulation's annexes.
Why does compliance cost more than brands expect?
Because the obligations are split between the factory and the brand. Many brands price a project assuming the factory covers everything, then discover product listing, safety assessment and, in the EU, the product information file are theirs.