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Cosmetics · European Union
Under Regulation (EC) No 1223/2009, every cosmetic needs an EU Responsible Person, a safety report (CPSR), a product file (PIF), a compliant label and a CPNP notification before it is sold. We set up the whole route, whether you export to Europe or are already there.
One CPNP notification covers 30 European countries
Europe in numbers
The market
Market surveillance
Official sources, checked on 7 November 2026.
Is this for you?
The obligations are the same. What changes is who acts as Responsible Person.
Your company is outside the EU
Your company is in the EU
The route
Step 1 of 5
One company in the EU answers for your product.
Required for every product · Article 4What it includes
Step 2 of 5
Every ingredient checked against the EU lists before any report is written.
Every formula · Annexes II to VIWhat it includes
Step 3 of 5
A qualified safety assessor confirms the product is safe as used.
Every product · Annex IWhat it includes
Step 4 of 5
The full product file, ready whenever an authority asks.
Kept for 10 years · Article 11What it includes
Step 5 of 5
A compliant label, then the notification before the first sale.
Before the first sale · Article 13What it includes
What changes and when
Dates checked on 7 November 2026. We confirm each one for your products.
Coming from Brazil or the US?
You already have
You need for the EU
Why Sobel
Four disciplines work on every project, in the same team, from the first decision to post-market.
Classification and market sequence decided first. The right class from day one avoids rework.
Biological, clinical and toxicological evaluation by our own Clinical Evidence & Product Safety team.
ANVISA, FDA, EU MDR, MHRA and Health Canada, coordinated together.
A dedicated technology team builds the workflows that keep every project traceable and on time.
“We know how auditors think, because we’ve been one of them.”
Maik Endler
Founder & CEO
Questions, answered
Rules cited on this page: Regulation (EC) No 1223/2009 · Regulation (EU) No 655/2013 · Regulation (EU) 2023/1545 · Regulation (EU) 2026/909 · Regulation (EU) 2023/2055 · Directive (EU) 2024/825
Yes. Every cosmetic placed on the EU market needs one Responsible Person established in the EU (Article 4 of Regulation (EC) No 1223/2009). For products made outside the EU, this is usually the importer or an appointed service provider. Sobel acts as Responsible Person for brands outside the EU.
The CPSR is the safety report, signed by a qualified safety assessor. The PIF is the full product file: it includes the CPSR, the product description, the manufacturing method with the GMP statement, and the evidence for your claims. The PIF stays at the Responsible Person’s address for 10 years after the last batch is placed on the market.
No. The CPNP is a free electronic notification made by the Responsible Person before the first sale. Authorities do not approve the product, but they can ask for the PIF at any time. One notification covers every EU and EEA country.
Partly. Formula specifications, supplier data, and stability and efficacy studies can often be reused. The CPSR, the check against the EU annexes, the label and the CPNP notification must be done for the EU.
The expanded fragrance allergen labelling applies to products placed on the market from 31 July 2026, and every product on sale must comply by 31 July 2028. Regulation (EU) 2026/909 bans or restricts 12 ingredients from 1 January 2027. Rules on environmental claims apply from 27 September 2026.
Yes. Since Brexit, Great Britain requires a Responsible Person based in the UK and a notification in the UK portal (SCPN). Sobel provides this through a qualified partner.
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