The placing of cosmetic product on the European Union market is subject to one of the most stringent regulatory frameworks worldwide. Regulation (EC) No 1223/2009 establishes the obligations that manufacturers, importers, and responsible persons must comply with to ensure that cosmetic products placed on the market are safe, compliant, and properly documented.
Despite the clarity of the legal framework, many products still reach the market with regulatory deficiencies, documentation errors, or compliance gaps that may lead to withdrawals, sanctions, or border rejections. In most cases, these issues do not stem from bad faith, but from an incomplete or incorrect interpretation of regulatory requirements.
This article provides a structured and up-to-date overview of the steps required to correctly place a cosmetic product on the EU market, from safety assessment to CPNP notification, identifying the most common mistakes and best practices to avoid them.
Regulation Of Cosmetic Product Marketing In The EU
Any cosmetic product marketed in the European Union must comply with Regulation (EC) No 1223/2009, regardless of its country of manufacture or sales channel (physical stores, e-commerce, marketplaces).
This Regulation establishes that:
- The product must be safe for human health.
- A Responsible Person must be established in the EU.
- Safety must be assessed prior to placing the product on the market.
- The product must be notified in the CPNP.
- Information must be available to the competent authorities.
This is neither an optional nor an adaptable system: compliance is mandatory for all cosmetic products, including artisanal, niche, or emerging brands.
First Step In Cosmetic Product Marketing
Before starting any regulatory process, it is essential to confirm that the product falls within the legal definition of a cosmetic product.
According to Regulation 1223/2009, a cosmetic product is any substance or mixture intended to be placed in contact with the external parts of the human body (skin, hair, nails, lips, etc.) or with the teeth and oral mucosa, with the exclusive or main purpose of:
- Cleaning
- Perfuming
- Changing appearance
- Protecting
- Keeping in good condition
- Correcting body odours
Common mistakes include products with therapeutic claims, unauthorised biocidal actions, or functions that bring them closer to the category of medicinal products or medical devices.
Key Role In Cosmetic Product Marketing
Each cosmetic product must have a Responsible Person (RP) established in the EU. This role may be fulfilled by:
- The manufacturer (if established in the EU)
- The importer
- A third party designated through a written mandate
The Responsible Person assumes full legal responsibility for the product and must ensure that all regulatory requirements are met before and after placing the product on the market.
Their responsibilities include:
- Ensuring the safety assessment is performed
- Keeping the PIF up to date
- Notifying the product in the CPNP
- Managing post-marketing surveillance
- Cooperating with competent authorities
Safety Assessment In Cosmetic Product Marketing
No cosmetic product may be placed on the market without a prior Safety Assessment, documented in the Cosmetic Product Safety Report (CPSR).
The CPSR consists of two parts:
Part A – Safety Information
This includes, among other aspects:
- Qualitative and quantitative composition
- Physicochemical properties
- Stability
- Microbiological quality
- Ingredient purity and impurities
- Exposure assessment
Part B – Safety Assessment
This contains:
- Safety conclusion
- Scientific justification
- Warnings and conditions of use
- Signature of a qualified safety assessor
The safety assessment must be updated whenever regulatory limits change, the formula is modified, or new SCCS opinions are published.
Product Information File (PIF): The Documentary Core
The PIF is the technical dossier that must be made available to the authorities for 10 years after the last placing of the product on the market.
It must include:
- CPSR
- Product description
- Manufacturing method and GMP compliance (ISO 22716)
- Evidence supporting claims
- Test data (microbiology, stability, etc.)
- Ingredient information
An incomplete or outdated PIF is one of the most frequent causes of non-compliance.
CPNP Notification
Before placing the product on the market, the Responsible Person must notify it via the Cosmetic Products Notification Portal (CPNP).
The notification includes:
- Product category
- Name and contact details of the Responsible Person
- Qualitative and quantitative formula
- Labelling
- Countries of marketing
Notification is not an authorisation, but it is mandatory and allows authorities and poison centres to access information in case of emergency.
Correct Labelling: More Than A Formal Requirement
Labelling must strictly comply with Article 19 of Regulation 1223/2009. It must include, among other elements:
- Name and address of the Responsible Person
- Country of origin (if applicable)
- Nominal content
- Date of minimum durability or PAO
- Precautions for use
- Batch number
- List of ingredients (INCI)
Common errors include incorrect translations, unsupported claims, or missing mandatory warnings.
Cosmetic Claims: What Can And Cannot Be Said
Claims must comply with Regulation (EU) No 655/2013, which sets criteria such as:
- Legal compliance
- Truthfulness
- Evidence
- Honesty
- Fairness
- Informed decision-making
Medical, therapeutic, or misleading claims are not permitted. Every claim must be supported by evidence included in the PIF.
Post-Marketing Surveillance
Once the product is on the market, responsibility does not end. The Responsible Person must:
- Collect and assess undesirable effects
- Notify serious undesirable effects to authorities
- Update the CPSR when necessary
- Withdraw the product if a risk is identified
Safety is a continuous process, not a one-off pre-launch step.
Common Mistakes In Cosmetic Product Marketing
The most frequent issues include:
- Placing products on the market without a valid CPSR
- Copying safety assessments
- Failing to update the PIF
- Claims without scientific support
- Use of restricted ingredients without impurity control
- Confusion between cosmetics, biocides, and medicinal products
Avoiding these mistakes reduces regulatory risks and protects brand integrity.
How SHAPYPRO Can Help
In a constantly evolving and increasingly demanding regulatory environment, specialised technical support is essential.
SHAPYPRO provides assistance in:
- Interpretation of Regulation 1223/2009
- Cosmetic safety assessment
- Ingredient and formula review
- Preparation and maintenance of the PIF
- Support with CPNP notifications
- Assistance with post-marketing surveillance
This approach allows companies to focus on product development and commercialisation with the confidence that they comply with current European regulations.