Developing a cosmetic product involves far more than creating an attractive formula. When consumers apply a cream or a shampoo, they rarely think about what lies behind it: toxicological assessments, legal ingredient limits, technical documentation, official notifications and regulatory controls. A cosmetic is not just a beauty product – it is a legally regulated product from the moment it is conceived.
In the European Union, developing a cosmetic means complying with one of the most demanding regulatory frameworks in the world: Regulation (EC) No 1223/2009 and the legislation that supports it. Regulation does not start at the end of the process – it starts at the product design stage.
1. The product concept is already a legal decision
Before a formula exists, the cosmetic must exist as a regulatory concept. At this stage, key elements are defined that directly determine the product’s legal viability:
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Product type (leave-on, rinse-off, sunscreen, haircare, etc.)
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Cosmetic function
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Intended claims
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Market of sale
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Target consumer
Each of these factors determines which ingredients can be used, which tests are required and what type of documentation will be needed. A mistake at this stage can make a product illegal before it is even formulated.
2. Cosmetic formulation under the EU legal framework
Every ingredient in a cosmetic formula is regulated under European cosmetic law. During formulation, the following must be verified:
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Prohibited substances (Annex II)
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Restricted substances (Annex III)
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Permitted colourants, preservatives and UV filters (Annexes IV, V and VI)
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SCCS restrictions and opinions
Formulation is not just a chemical exercise, it is a regulatory process. A formula can be technically excellent and still be impossible to place on the market.
3. Testing, stability and safety justification
Before a cosmetic can be sold, it must demonstrate that it is stable and safe. This is documented through:
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Stability studies
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Microbiological testing
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Challenge tests
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Packaging–formula compatibility
These data feed into the Product Information File (PIF), which is the central document required by Regulation 1223/2009.
4. Safety assessment and the PIF
Every cosmetic must have a Safety Assessment carried out by a qualified professional.
This assessment evaluates:
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The toxicological profile of each ingredient
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The real exposure of the consumer
All of this is recorded in the PIF, together with:
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Qualitative and quantitative formula
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Description of the manufacturing process (GMP)
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Claim substantiation
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Labelling
This file must be available to authorities at any time.
5. GMP, ISO 22716 and compliance control
The manufacturer must operate under Good Manufacturing Practices (GMP) in accordance with ISO 22716, ensuring:
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Raw material traceability
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Process control
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Production records
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Deviation management
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Quality control
Without GMP, a cosmetic product cannot legally be sold in the EU.
6. CPNP notification and market placement
Before a cosmetic is placed on the European market, it must be notified in the CPNP (Cosmetic Products Notification Portal).
The notification includes:
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Responsible person
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Formula
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Labelling
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Countries of sale
Without CPNP, the product is illegal, even if it has already been manufactured.
Regulation is not a formality – it is part of development
Cosmetic regulation is not a final administrative step. It is a layer that runs through the entire product lifecycle, from the first idea to the last unit sold.
That is why more and more brands, manufacturers and legal teams rely on regulatory.cosmeticsinMind as their central regulatory platform to:
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Access up-to-date legislation
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Check ingredient restrictions
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Monitor SCCS, European Commission and ECHA updates
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Anticipate regulatory risks
Access the legal platform with a 1-month free trial: Keep your products, formulas and claims fully aligned with European cosmetic law without relying on multiple sources or external consultants.