Regulatory roles · Cosmetic products · EU
Your EU Responsible Person for cosmetic products
Cosmetic Products
Under Article 4 of Regulation (EC) No 1223/2009, cosmetic products placed on the EU market have an EU Responsible Person. We can be yours. We take the role with our address in Portugal, notify your products and stay in the role after launch.
What the role covers and who contracts it
What the law asks for. A named EU Responsible Person who answers for the product’s compliance. It is a legal responsibility, not an address on a label.
What we do in the role
- Appointment as your EU Responsible Person, with our address in Portugal.
- Notification of each product on the Cosmetic Products Notification Portal (CPNP), and updates when the product changes.
- Review of the product’s documents.
- The Product Information File (PIF) kept available.
- Cosmetovigilance: undesirable effects reported for the product, including serious undesirable effects, handled under the role.
Where it applies. The 30 countries of the European Economic Area: the 27 EU Member States plus Iceland, Liechtenstein and Norway. Product types we work with include hair care, make-up, skin care, fragrances, nail care, and artisanal or small-scale ranges.
Who contracts it. CRITICAL CATALYST - Health Consulting, Lda., Matosinhos, Portugal. If you also sell in Great Britain, the UK Responsible Person is contracted by CRITICAL CATALYST LTD, and the two roles can be taken together.
Before the notification. The product needs a Cosmetic Product Safety Report (CPSR) signed by a safety assessor and a label that holds up to review. We can prepare both, or review what you already have.
Portugal and the EU
CRITICAL CATALYST - Health Consulting, Lda., Matosinhos
Questions people ask
We have two versions of the formula on the market at the same time. Is one notification enough?
No. In our reading, two formulations on the market at the same time need two CPNP notifications. If the new formula replaces the old one, the existing notification can be updated.
Our product name includes a word like "prebiotic". Does that matter?
Yes. A functional word in a trade name is a claim, and it needs substantiation under Regulation (EU) No 655/2013.
We are a small, artisanal producer. Do the same rules apply to us?
Yes. Artisanal and small-scale producers fall under the same legal requirements as industrial ones.
Our product sits close to the line between cosmetic and medicine.
Then we say so. Where the borderline status is unresolved, we document the risk and ask you to accept it in writing before the safety report is signed.
Is the EU Responsible Person the same as the Portuguese Responsible Technician?
No. The Responsible Technician is a separate Portuguese role under Decreto-Lei n.º 189/2008.
Where this role sits
- Formula and testing
- Safety report and product file
- Label, ingredients and claims
- Responsible Person and notificationThis role: EU Responsible Person
- After launch
- Step: Responsible Person and notification
- Before it: Safety report and product file · Label, ingredients and claims
- After it: After launch (cosmetovigilance and regulatory monitoring)
- Related roles: UK Responsible Person · US Agent · all Regulatory roles
- Beside the role: Ongoing support for monthly regulatory support
What happens next
Our team replies to every enquiry and asks for the products, the markets and the date you are working to.