Quick Overview
- Client Type: Efficacy-Focused Skincare Brand
- Market: Belgium / European Union
- Product: Custom Efficacy-Focused Skincare Series
- Project Type: Formula Development and EU Market Preparation
- Main Need: Custom formulation, sample refinement, CPSR coordination, PIF documentation, CPNP notification support, labeling review, and EU Responsible Person coordination
- Project Outcome: Approved formulas, completed market-entry preparation, product launch, and repeat production
This case study follows a Belgian skincare brand developing an efficacy-focused product series for professional skincare clinics and organic retail channels. The client understood its market and brand positioning but needed a structured pathway connecting formulation, production, safety documentation, labeling, and EU market-entry requirements.
We coordinated formula development, sample refinement, labeling review, safety-assessment documentation, EU Responsible Person arrangements, CPNP notification support, and production planning.
Client Privacy Note: This case study is based on a real client project. For privacy reasons, the client’s name, brand name, and confidential business details are not disclosed.
Client Background and EU Market-Entry Challenge
The client was a Belgian skincare brand with established local market knowledge, customer access, and brand operating experience. Its products were intended for professional skincare and organic-focused retail channels, with an emphasis on targeted performance, mildness, and a refined product experience.
However, the brand had not previously managed the full EU cosmetic product market-entry process. It was unfamiliar with the different roles of the Cosmetic Product Safety Report (CPSR), Product Information File (PIF), Cosmetic Products Notification Portal (CPNP), and EU Responsible Person.
The project had to align:
- Efficacy-focused formula development
- Mildness, tolerability, texture, and after-feel
- Ingredient and technical documentation
- Safety-assessment requirements
- Product claims and mandatory label information
- EU Responsible Person and CPNP requirements
- Production and launch preparation
Formula development and compliance could not be managed separately. Changes to ingredients, concentrations, product claims, or intended use could affect the safety assessment, PIF, labels, and information required for CPNP notification.
Under the EU Cosmetics Regulation, a cosmetic product placed on the EU market must have a designated Responsible Person established within the EU. A safety assessment and CPSR must also be completed before market placement, and the PIF must contain the required product, manufacturing, safety, and supporting information. [1]
Our Solution
Step 1: Developing the Efficacy-Focused Formula Direction
We began by reviewing the client’s intended positioning, professional channel requirements, preferred product experience, and efficacy goals.
Our R&D team developed formula options that balanced targeted performance with mildness, tolerability, texture, and daily-use comfort. Ingredient purity and suitability were reviewed alongside the intended claims and safety-assessment requirements.
During sampling, the client evaluated:
- Texture and absorption
- Skin feel and finish
- Perceived product performance
- Mildness during use
- Compatibility with the intended routine
- Fit with the brand’s professional positioning
Feedback from each testing round was used to refine the formula structure, ingredient balance, texture, and after-feel.
Step 2: Refining Samples and Aligning Product Claims
As the formulas developed, we reviewed how the intended product benefits would be presented.
Cosmetic claims used in the EU should meet common criteria covering legal compliance, truthfulness, evidential support, honesty, fairness, and informed decision-making. [3] The formula, product experience, intended claims, and available supporting information therefore needed to remain consistent.
Multiple sample rounds focused on:
- Absorption and spreadability
- Texture and finish
- Mildness and tolerability
- Ingredient concentration balance
- Consistency across the product series
- Alignment between formulas and intended claims
This reduced the risk of creating labels or marketing statements that did not match the finalized formulas or available evidence.
Step 3: Coordinating EU Market-Entry Requirements
The client’s largest knowledge gap was understanding how the different EU requirements connected. We coordinated the process with qualified external parties, including a cosmetic safety assessor and an EU-based Responsible Person.
| Project Area | Client Gap | Support Provided |
|---|---|---|
| Safety Assessment and CPSR | No experience coordinating the required cosmetic safety assessment | Prepared the necessary formula and product information and coordinated CPSR completion with a qualified safety assessor |
| Product Information File | No structured technical file for the product series | Compiled the product information and supporting manufacturing, safety, testing, and claims documentation required for the PIF |
| EU Responsible Person | No established legal arrangement within the EU | Coordinated with an EU-based Responsible Person for the intended products |
| CPNP Notification | Unfamiliar with the pre-market notification process | Prepared and coordinated the product information required for CPNP notification |
| Labeling and Ingredient Information | Labels needed to meet the requirements of the intended EU markets | Reviewed ingredient naming, mandatory label information, language requirements, and consistency with the final formulas |
| Product Claims | Benefit statements needed to match the formulas and supporting evidence | Reviewed intended claims against formula details and available documentation |
The CPNP is the EU’s online cosmetic product notification system. Required product information must be submitted before the cosmetic is placed on the EU market, but notification is not product approval or certification. [1][2]
Coordinating formulation and documentation together reduced the risk of late-stage conflicts between the final formulas, CPSRs, PIFs, labels, claims, and CPNP information.
The Result
The final formulas met the client’s expectations for product direction, texture, mildness, and efficacy-focused experience. The associated documentation and market-entry coordination were then completed for the intended Belgian and EU launch.
The project delivered:
- Confirmed efficacy-focused formula directions
- Refined and approved product samples
- Coordinated cosmetic safety assessments and CPSR preparation
- Compiled product information and supporting documentation for the PIFs
- An established EU Responsible Person arrangement
- CPNP notifications completed through the EU Responsible Person
- Reviewed ingredient information, labels, and intended claims
- Coordinated transition from development to production
After completing the required development and market-entry preparation, the client proceeded with the product launch and continued the cooperation through repeat production orders.
The project connected formulation, safety assessment, technical documentation, labeling, notification, and manufacturing within one coordinated process.
What Similar Clients Can Learn
- Takeaway 1: EU Compliance Should Begin During Formula Development
Ingredient restrictions, safety requirements, claims, and labeling can affect the final formula. Reviewing them only after samples are approved may create avoidable reformulation or documentation work. - Takeaway 2: CPSR, PIF, and CPNP Serve Different Purposes
The CPSR documents the cosmetic safety assessment and forms part of the PIF. The PIF contains the required product and supporting information, while the CPNP is the pre-market notification system—not an EU product approval or certification process. [1][2] - Takeaway 3: The EU Responsible Person Should Be Identified Early
A cosmetic product placed on the EU market must have a designated Responsible Person established within the EU. [1] Confirming this arrangement early clarifies responsibility for documentation, notification, labeling, and ongoing compliance. - Takeaway 4: Formula, Claims, Labels, and Documentation Must Remain Consistent
A formula change may require updates to the CPSR, PIF, ingredient list, claims support, label content, or CPNP information. These elements should be managed as one connected system rather than separate final-stage tasks. [1][3]
Planning to Launch Skincare Products in the EU?
Zoe supported this project by connecting formula development, sample refinement, safety-assessment coordination, PIF documentation, labeling review, EU Responsible Person arrangements, CPNP notification support, and production planning.
If you are developing skincare products for Belgium or another EU market, contact Zoe to organize the formulation, documentation, and manufacturing steps required before launch.
Sources
[1] European Union. Regulation (EC) No 1223/2009 on Cosmetic Products.
[2] European Commission. Cosmetic Product Notification Portal.
[3] European Union. Commission Regulation (EU) No 655/2013 Laying Down Common Criteria for the Justification of Claims Used in Relation to Cosmetic Products