Bringing a cosmetic product to market in the European Union isn’t just about innovation and branding — it’s a regulatory journey that demands precision, accountability, and in-depth knowledge of the law. With the EU Cosmetic Regulation (EC) No 1223/2009 in place, no product can be legally sold without first passing through a strict compliance process. At CE.way, we simplify this process and make sure brands of all sizes can enter the market with confidence.
Over the past decade, we’ve worked with hundreds of companies across the globe — from artisan skincare creators to multinational corporations. Our team handles the complex regulatory tasks so you can focus on what you do best: creating safe, effective, and inspiring cosmetic products.
Understanding EU Cosmetic Regulation
The EU Cosmetic Regulation sets clear and binding requirements for any cosmetic product placed on the market. These rules ensure product safety and protect consumers by demanding a high standard of manufacturing, documentation, and labeling.
But for many brands, especially those unfamiliar with the European market, this regulation can seem overwhelming. That’s where we come in — turning complexity into clarity, step by step.
Our cosmetic regulatory services cover everything you need:
✅ Product Information File (PIF)
Every product must have a PIF — a comprehensive document that includes:
- A full qualitative and quantitative formula
- Description of manufacturing methods
- Safety assessment
- Proof of claimed effects (e.g., clinical studies or testing)
- Label artwork and compliance checks
We build the PIF for you, collect the necessary documentation, and make sure it’s ready for inspection by local authorities at any time.
✅ Cosmetic Product Safety Report (CPSR)
A central component of the PIF is the CPSR — a toxicological assessment performed by a qualified safety assessor. The CPSR evaluates whether the product is safe for human health under normal or reasonably foreseeable use.
At CE.way, we provide this assessment through experienced professionals with a deep understanding of toxicology, EU ingredient restrictions, and specific concentration limits.
✅ Cosmetic Notification via CPNP
Before your product hits the shelf, it must be submitted through the Cosmetic Product Notification Portal (CPNP). This digital platform allows EU authorities to access all relevant product data, including formulation, packaging, and Responsible Person information.
We manage the entire CPNP notification process for you — accurately, quickly, and without delays.
✅ Label & Claim Review
What you say on your packaging is just as important as what’s inside. We review your product labels to ensure compliance with:
- Mandatory EU language requirements
- Ingredient lists (INCI naming)
- Product function and precautions
- Validity of marketing claims
Whether you’re promoting “natural,” “hypoallergenic,” or “anti-aging,” we help you avoid misleading statements that could result in legal issues.
✅ Appointing a Responsible Person in the EU
If your brand is located outside the EU, it’s mandatory to appoint a Responsible Person for cosmetics established in the Union. This individual or company assumes full legal responsibility for compliance.
We can act as your Responsible Person — taking care of notifications, documentation, regulatory updates, and product safety monitoring on your behalf.
Going Beyond EU: UK & U.S. Compliance
Brexit has introduced new requirements for cosmetic products sold in the UK. We assist our clients in navigating the UK notification system (SCPN), preparing product files according to UK regulations, and appointing a UK-based Responsible Person where necessary.
Similarly, for companies targeting the United States, we provide regulatory support under the new MoCRA (Modernization of Cosmetics Regulation Act), including product listings, adverse event reporting, and facility registration with the FDA.
Additional Support Services
We understand that regulatory work doesn’t stop once your product is approved. We offer a complete suite of services to support your business as it grows:
- Stability testing and challenge testing coordination
- Claims substantiation guidance for efficacy and performance marketing
- Ingredient reviews and regulatory checks for formulation changes
- Ongoing updates about new allergens, restricted substances, and regulation changes
Why Choose CE.way?
We’re more than just a regulatory consultancy — we’re a long-term partner in your cosmetic product’s success. Our clients rely on us for our responsiveness, scientific expertise, and practical solutions tailored to their needs.
With CE.way, you gain:
- A clear step-by-step roadmap for EU (and UK/US) compliance
- Access to qualified safety assessors and regulatory experts
- Fast turnaround times and transparent communication
- Peace of mind knowing your brand is fully compliant
We believe regulatory compliance shouldn’t slow your momentum — it should support it.
Compliance Without Compromise
In today’s market, consumers expect transparency, and authorities demand traceability. That means cosmetic brands must meet high standards — not just in terms of product quality, but also regulatory integrity. Cutting corners can lead to delays, penalties, or worse — product bans.
At CE.way, we ensure you launch legally, responsibly, and successfully. Whether you’re preparing your first PIF or expanding into multiple countries, we’re here to guide you with accuracy and care.
Let us handle the regulations, so you can focus on innovation.
