Wat Are the Obligations Under Cosmetics Regulation (EC) No 1223/2009? 

Cosmetics Regulation (EC) No 1223/2009 is the European reference framework for product safety and regulatory compliance. 
It governs every stage of a cosmetic product’s life cycle: formulation, manufacturing, regulation, quality, labelling, and market placement. 
His objective is clear: to ensure safety for human health and the traceability of every cosmetic product made available in the European Union. For any company in the sector – manufacturers, brands, importers, or distributors – it is essential to understand and apply this regulation in order to avoid non-compliance. 

1. Designating a Responsible Person: A Key Requirement in article 4 of Regulation (EC) No 1223/2009 

The regulation requires a Responsible Person to be appointed for every cosmetic product. 
This person acts as the regulatory compliance guarantor and serves as the main contact point for authorities. 

Their role includes: 
• verifying product compliance with Regulation (EC) No 1223/2009, 
• keeping the technical documentation available for authorities, 
• ensuring traceability and communication in case of issues, 
• and managing cosmetovigilance after market placement. 

The Responsible Person can be the manufacturer, the importer, or a mandated representative appointed in writing. 

2. The Product Information File (PIF): A Pillar of Regulatory Compliance 

The PIF is a central requirement of Regulation (EC) No 1223/2009, located in article 11. 
It compiles all the information necessary to demonstrate product compliance. 

It must include: 
• the description of the cosmetic product, 
• the Cosmetic Product Safety Report (CPSR), 
• A description of the manufacturing method in accordance with ISO 22716 (GMP), 
• evidence supporting claimed effects by the product, 
• And the data related to tests on animals. 

The PIF must be kept up to date and retained for at least 10 years after the last product has been placed on the market of the product, by the responsible person.  

Without a complete PIF, a cosmetic product is considered non-compliant, under the European regulation. 

3. Safety Assessment: A Mandatory Step Before Market Placement of article 10 of the European regulation 

Each cosmetic product must undergo a safety assessment carried out by a qualified expert (toxicologist, pharmacist, or chemist). 
This assessment determines whether the product is safe for human health under normal or reasonably foreseeable conditions of use. 

It considers: 
• the full formulation, 
• the potential toxicity of ingredients, 
• the route of exposure (cutaneous, ocular, oral), 
• and the target population (adults, children, professionals). 

The Cosmetic Product Safety Report (CPSR) is a key component of the PIF. 

4. CPNP Notification: A Mandatory Administrative Step located in article 13 of regulation (CE) n°1223/2009 

Before being placed on the market, every cosmetic product must be notified through the European CPNP portal(Cosmetic Products Notification Portal). 
This notification enables authorities and poison control centres to access essential information about the product. 

A product not notified on the CPNP cannot be legally marketed within the European Union. 

5. Cosmetic Labelling: Transparency and Traceability 

Labelling is strictly regulated by Regulation (EC) No 1223/2009, article 19.  It must include: 

• the name and address of the Responsible Person
• the nominal content
• the date of minimum durability or period after opening (PAO)
• precautions for use
• the batch number
• the product function
• and the complete INCI list of ingredients
• The country of origin for products imported from outside the EU

Labeling must be in indelible characters, easily readable and visible on the container and/or packaging. The information must be written in the official language of the country where the product is marketed. This helps ensure safety and strengthens consumer confidence. 

6. Cosmetic Claims: Scientific Evidence Required 

All product claims (e.g., anti-aging, moisturizing, soothing) must be scientifically substantiated. 
Regulation (CE) n°1223/2009 article 20 and (EU) No 655/2013 establishes six compliance criteria: truthfulness, honesty, evidential support, fairness, sincerity, and consumer awareness. 

A claim that lacks sufficient justification may lead to sanctions or product withdrawal. 

7. Cosmetovigilance: Ensuring Safety After Market Placement (article 23) 

Once a product is on the market, the Responsible Person must monitor any adverse effects reported by consumers or professionals. 
In the event of a serious adverse effect, the responsible person must promptly notify the competent authority of the Member State where the effect was observed, providing all relevant data. 
This ongoing monitoring ensures the continuous safety of cosmetic products over time. 

Scientific and Regulatory Expertise for Your Cosmetic Products  

Pharmanager Development leverages its scientific and regulatory expertise to help cosmetic industry professionals meet European requirements throughout the entire product life cycle. 

Our teams assist you from product design to market launch, ensuring compliance with key European regulations: 

• Regulation (EC) No 1223/2009 on cosmetic product safety, 
• Regulation (EU) No 655/2013 on cosmetic claims justification, 
• and Regulation (EU) No 1545/2023  strengthening the obligation to indicate more allergenic fragrance substances on the labeling. 

Our areas of expertise include: 

• regulatory compliance verification for cosmetic products
•  formulation safety assessment and drafting of the CPSR
• creation and maintenance of the Product Information File (PIF)
• CPNP notification prior to market launch
•  claim and labelling validation
• and regulatory monitoring and export support for European and international markets

Through continuous regulatory and scientific monitoring, Pharmanager Development helps you anticipate legislative changes, maintain compliance, and secure successful product launches worldwide.