The Product Information File (P.I.F.) is a mandatory technical document required under Regulation (CE) No. 1223/2009 on cosmetic products. It certifies the safety and regulatory compliance of cosmetic products placed on the EU market. The P.I.F. contains essential information regarding the quality, safety, and manufacturing of cosmetics and is fundamental for ensuring safe use, consumer protection, and legal compliance.

When a cosmetic product is placed on the market, the Responsible Person is required to maintain an informational dossier containing all minimum required details, signed by a qualified safety assessor.

To protect your business, it is crucial that the P.I.F. is complete, thorough, and that the safety assessment is conducted with due diligence and expertise.

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Our P.I.F.s Are Peer-Reviewed

Our P.I.F.s are evaluated by top industry experts and recognized as top quality.

 

Structure and Contents of the P.I.F.

The P.I.F. consists of several sections, the most important being the Cosmetic Product Safety Report (CPSR), which is divided into two parts:

Part A:

• Includes physico-chemical characteristics, qualitative and quantitative composition, stability tests (aging tests), and microbiological safety tests (Challenge Test).

• Evaluates the interaction between the product and its packaging and the microbiological quality.

• Contains a full toxicological profile of each ingredient, assessing purity, impurities, and traces of prohibited substances.

• Considers exposure scenarios for different types of users, including application area and frequency of use.

• The safety assessor must also review and weigh any adverse or serious adverse reactions reported by consumers.

Part B:

• Contains the expert safety assessor’s conclusions, based on scientific evidence.

• Provides the rationale behind the conclusions and specifies warnings and precautions for consumer safety.

• Includes proof of the safety assessor’s qualifications, demonstrating their legal compliance and professional experience.

• Offers recommendations for the Responsible Person to address any documentation gaps and ensure the P.I.F. is fully protective.
  
   

Other Key Elements of the P.I.F.:

• Detailed product description and manufacturing data, including the production method and compliance with Good Manufacturing Practices (GMPs).

• Validation of the INCI ingredient list, to be included on the label, along with the assessment of other mandatory labeling elements, including claims verification.

• Proof of product notification to the EU centralized portal (CPNP).

• Skin safety testing on volunteers (Patch Test).

• Documentation of efficacy tests, if claimed on the label.

• Evidence confirming the absence of animal testing, both for the finished product and its raw materials.

 

Regulatory Obligations & P.I.F. Storage

The P.I.F. must be readily available to the Competent Authorities of the Member State where the cosmetic product is manufactured (Italy: Ministry of Health and the Higher Institute of Health). It must be stored electronically or in another format at the Responsible Person’s registered address, which serves as the official access point for information.

Since the P.I.F. must be “immediately available”, authorities expect it to be provided within a reasonable timeframe. However, it does not have to be physically stored at the access point. Supporting documentation can be stored offsite (e.g., at a consultant’s office or even outside the EU). If not stored at the company’s premises, a Declaration of Availability must be provided.

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The P.I.F. must be retained for at least 10 years from the date of the last batch placed on the market. The Responsible Person is responsible for keeping it updated in case of product modifications, regulatory changes, or newly identified adverse effects.

 

Our Support Services

To simplify P.I.F. management, we offer a comprehensive range of services to assist Responsible Persons with compliance.

• CPSR and P.I.F. drafting, delivered for storage at the Responsible Person’s premises, with free regulatory advice on necessary updates or revisions.

• CPSR and P.I.F. drafting, storage, and updating at our premises, with a Declaration of Availability for the official access point.

• Dedicated P.I.F. services for bulk and semi-finished products, useful for third-party manufacturers seeking partial evaluations while preserving confidentiality.

• Supplementary P.I.F. drafting, for those who already have a bulk/semi-finished product safety assessment.

• Confidential P.I.F. abstracts, containing sensitive formulation data expressed as ranges, ensuring data protection while meeting compliance requirements.

• Cosmo-Ware Software:

  • For advanced manufacturers with independent structures, we offer a proprietary software solution to streamline P.I.F. drafting and cosmetic manufacturing operations.

  • Developed by cosmetic formulators and regulatory experts, Cosmo-Ware is designed to meet real industry needs.
     

All our P.I.F.s are natively produced in both Italian and English, ensuring compliance with EU, UK, and US regulations.

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Our approach enables companies to quickly align with legal requirements and ensure the safety and quality of their cosmetic products.