Selling the same serum into the United States and the European Union means satisfying two regulatory systems that share a goal — product safety — and share almost nothing in procedure. Getting this wrong delays launches at customs, not at the factory.
Key takeaways
- EU: product-level notification (CPNP) plus a safety assessment (CPSR) plus a local Responsible Person — all required before the product is placed on the market.
- US (MoCRA): facility registration plus product listing plus serious adverse event reporting; no pre-market approval for most cosmetics.
- The responsible party differs: EU needs a legal entity inside the EU; US needs a "responsible person" who can be the manufacturer, packer, distributor or brand owner.
- Both require you to keep documentation on hand and to be able to produce it quickly.
- Plan two to four extra weeks for documentation when entering either market for the first time.
Side-by-side requirements
| European Union (Regulation 1223/2009) | United States (MoCRA) | |
|---|---|---|
| Pre-market approval | No, but notification required before placing on market | No |
| Who must register | Responsible Person registers the product via CPNP | Facility (manufacturer/processor) registers with FDA; responsible person lists products |
| Safety evidence | CPSR safety assessment by a qualified assessor — mandatory | Manufacturer must ensure adequate substantiation of safety; specific testing not prescribed |
| Product file | PIF (Product Information File), retained 10 years | Records must be maintained and made available to FDA |
| Labelling | Responsible Person name and address, nominal content, PAO symbol, batch code, full INCI, function | Identity, net quantity, ingredient declaration, responsible person name and address, warnings |
| Adverse events | Undesirable effects reported by Responsible Person | Serious adverse events reported to FDA within 15 business days |
| Restricted substances | Annexes II–VI of the regulation; frequently updated | Prohibited and restricted ingredients; colour additive approval; state-level rules (e.g. California) |
| Animal testing | Ban on animal-tested cosmetics and ingredients | Not banned federally; several states restrict |
EU route: what you must assemble before sale
- Appoint a Responsible Person (RP) — a legal entity established in the EU. If you are outside the EU, you must contract one; your manufacturer may be able to introduce you to one, but the RP's legal duty is to the market, not to you.
- Compile the PIF — product description, CPSR, GMP statement, method of manufacture, proof of claimed effects, and existing animal testing data.
- Obtain the CPSR — a Cosmetic Product Safety Report in two parts (safety information and safety assessment), signed by a qualified safety assessor. This requires full formula disclosure including percentages and impurity profiles of raw materials.
- Notify via CPNP — submit product category, RP details, formula frame, and (for certain products) nanomaterial information. Notification is per product, and must happen before placing on market.
- Finalise labelling — including the PAO (period-after-opening) symbol where shelf life exceeds 30 months, and full INCI in descending order above 1%.
Practical note: the CPSR depends on information only your manufacturer holds (impurity profiles, raw material specifications). Ask at the quotation stage whether they can supply a complete safety data package — some cannot, and discovering this at week 14 costs you the launch window.
US route: what MoCRA requires
- Facility registration — facilities that manufacture or process cosmetic products distributed in the US must register with the FDA and renew periodically. If your contract manufacturer in China has not registered, your products cannot legally be distributed.
- Product listing — a responsible person must list each marketed cosmetic product, including ingredients, and update annually.
- Safety substantiation — you must have adequate evidence that the product is safe; unlike the EU there is no prescribed assessment format, but the expectation is real and increasing.
- Serious adverse event reporting — report to FDA within 15 business days, and keep records for six years.
- Labelling — including a domestic address or contact, and fragrance allergen labelling requirements that FDA has been developing.
- State-level rules — California and others restrict additional substances independently of federal rules; check per state if you sell nationally.
Timeline and cost planning
| Task | EU | US |
|---|---|---|
| Administrative lead time | 2 – 4 weeks (CPSR is the bottleneck) | 1 – 3 weeks (registration dependent on facility) |
| Typical documentation cost per formula | US$400 – US$1,200 | US$150 – US$600 |
| Ongoing obligation | PIF kept 10 years; update on reformulation | Annual listing renewal; facility renewal |
| Blocked if manufacturer cannot supply | Full formula + impurity data | Facility registration number |
Common failures we see
- Launching in the EU without an RP — the product is non-compliant from the first sale, and marketplaces will delist it.
- Reformulating without updating the CPSR — a new preservative or fragrance invalidates the existing safety report.
- Assuming a US-compliant formula is EU-compliant — the EU prohibits and restricts more substances, and retinol restrictions are a live example.
- Missing batch codes on packaging — required in the EU and expected everywhere for traceability.
- Claiming SPF without testing — SPF is a regulated claim with prescribed test methods in both markets.
Frequently asked questions
Do I need both if I sell in the US and EU?
Yes. They are independent regimes; compliance in one does not transfer to the other. The good news is that most of the underlying technical work — stability, microbiology, full formula documentation — serves both, so the marginal cost of the second market is mostly administrative.
Can my Chinese manufacturer be my EU Responsible Person?
No. The RP must be established within the EU. Your manufacturer can supply the technical documentation the RP needs, and many factories work with partner RP services, but the appointment itself is your decision as brand owner.
Who is the "responsible person" under MoCRA?
The manufacturer, packer or distributor whose name appears on the label. In practice, if your brand name is on the product, that is usually your company — which means the listing and adverse event obligations fall on you, not on your contract manufacturer.
How often do these rules change?
Continuously. The EU amends its annexes several times a year, and MoCRA implementation is still producing new requirements. Build a six-month compliance review into your calendar and ask your manufacturer to flag any raw material affected by a new restriction.
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