Selling a cosmetic product in the European Union without a CPSR, PIF and CPNP notification is illegal — and the fastest way to get your brand pulled from the market. At Laboratori Italiani, compliance isn’t an afterthought: every product we develop can be delivered with its Cosmetic Product Safety Report, Product Information File and CPNP notification completed, so your brand launches in all 27 EU countries fully compliant from day one.
Every product we formulate is developed to EU standards by default — compliance is built into the formula from the first lab sample. Our regulatory team handles the entire EU process (CPSR, PIF, CPNP) directly in-house under EU Regulation 1223/2009, and we support your compliance needs for markets worldwide.
What EU law requires before you can sell a single unit
Under EU Regulation 1223/2009, every cosmetic product placed on the EU market must have three things in place before launch:
- A Cosmetic Product Safety Report (CPSR) — a toxicological safety assessment signed by a qualified safety assessor
- A Product Information File (PIF) — the complete technical dossier, kept available for authorities for 10 years
- A CPNP notification — registration of the product in the EU’s Cosmetic Products Notification Portal
You also need a Responsible Person (RP) established inside the EU — a legal requirement that many non-EU brands discover only when their shipment is already blocked at customs. Miss any of these and the consequences range from forced product withdrawal to fines and border seizures.
CPSR: the Cosmetic Product Safety Report
The CPSR is the heart of EU cosmetics compliance. It is a two-part scientific document:
- Part A — Safety Information: quantitative composition, physico-chemical characteristics, microbiological quality, stability and challenge test results, packaging compatibility, normal and foreseeable use, and exposure data for every ingredient.
- Part B — Safety Assessment: the toxicological evaluation and signed conclusion of an EU-qualified safety assessor, stating the product is safe for human health.
Our laboratory prepares the full CPSR in-house. Because we formulate and test the products ourselves, Part A is built directly from primary data — stability studies, challenge tests, and raw-material documentation from our own supplier network — not reconstructed from second-hand paperwork. That means faster assessments and fewer surprises.
Typical timeline: 2–4 weeks once formulation data and packaging specifications are final.
PIF: the Product Information File
The PIF is the master dossier that EU authorities can request at any moment. It contains the product description, the CPSR, the GMP manufacturing statement (ISO 22716), proof of claimed effects, and animal-testing declarations.
We compile and maintain the complete PIF for every product we produce, ready for inspection, for the 10 years the law requires. If you work with your own Responsible Person, we hand over a complete, audit-ready file.
CPNP notification: registering your product with the EU
Before launch, each product must be notified in the Cosmetic Products Notification Portal (CPNP) — including the frame formulation, label artwork, and the Responsible Person’s details. Once notified, your product can circulate in all 27 EU member states.
Our team manages the entire CPNP submission: portal registration, frame formulation classification, label upload and nanomaterial declarations where applicable.
Typical timeline: 3–5 working days once the PIF is complete.
How our compliance service works
| Step | What happens | Typical timing |
|---|---|---|
| 1. Product review | We audit your formula, claims and artwork against EU requirements | 1 week |
| 2. Testing | Stability, compatibility and challenge tests (if not already available) | 8–12 weeks* |
| 3. CPSR | Part A compiled, Part B signed by our safety assessor | 2–4 weeks |
| 4. PIF | Full dossier assembled and archived | 1 week |
| 5. CPNP | Product notified, ready for sale in the EU | 3–5 days |
*Testing runs in parallel with production for products we manufacture, so compliance rarely adds time to a private label project.
Compliance services are included as part of our private label development projects and available at additional cost for products manufactured elsewhere. Label and claims review (INCI listing, mandatory warnings, drained-weight declarations, environmental claims) is part of every package.
Why brands handle EU compliance through a manufacturer
- EU-compliant by design. Every formula that leaves our lab is developed to EU Regulation 1223/2009 standards from day one — restricted ingredients, allergen labelling and claims substantiation are checked during development, not after.
- One accountable partner. Formula, testing, documentation and notification under one roof — no chasing three consultancies for one dossier.
- Primary data, not paperwork reconstruction. As the manufacturer, we hold the stability studies, GMP records and raw material specs the CPSR is built on.
- 50 years of regulatory practice. Our lab has brought thousands of SKUs to the EU market under Regulation 1223/2009 and its predecessors.
- Speed. Compliance runs in parallel with production — your launch date doesn’t wait for a consultant’s queue.
Frequently asked questions
Do I need a CPSR for every product I sell in the EU?
Yes. Every individual cosmetic product — including each variant with a different formula — must have its own Cosmetic Product Safety Report signed by a qualified safety assessor before it is placed on the EU market.
How much does a CPSR cost?
Costs depend on the complexity of the formula and how much test data already exists. When we manufacture your product, compliance documentation is quoted within your development project; for external products we quote after a formula review. Contact us for a precise quote.
How long does CPNP notification take?
The notification itself takes 3–5 working days once the PIF is complete. There is no waiting period after notification — you can sell immediately. The longer timeline is the testing and CPSR stage, which we run in parallel with production.
Can you act as our Responsible Person in the EU?
Non-EU brands need a Responsible Person established in the EU. We can support RP arrangements as part of a manufacturing partnership — ask us about the setup that fits your situation.
Do you support compliance for markets outside the EU?
Yes. We handle EU compliance directly in-house, and we support your regulatory needs for other markets — such as the UK (SCPN), the US, the Gulf region and Asia. Because every product is formulated to EU standards, the strictest baseline, adapting documentation for other markets is significantly easier.
Launch in the EU with compliance handled
Your formula, your brand, our regulatory team. Tell us about your product and we’ll map exactly which tests and documents you need — and quote the fastest route to a compliant EU launch.
