PIF and CPSR
From: €200.00
A signed Cosmetic Product Safety Report for your concealer, prepared by a qualified Safety Assessor. We assess your formula against real-world use — daily, on the face, close to the eyes — so you can place it on the EU market with confidence.
- Description
- Additional information
The Cosmetic Product Information File (PIF) is a comprehensive document that serves as a central repository of information related to a cosmetic product. It is a mandatory requirement under the European Union (EU) Cosmetic Regulation (Regulation (EC) No 1223/2009). The PIF is intended to provide competent authorities with access to key details about a cosmetic product and its safety assessment.
This bundle will provide :
- Product Information File (PIF)
- Safety Assessment (CPSR)
- Cosmetic label review
- CPNP
All required laboratory testing results should be available for this bundle. If no lab test have been done, please use our bundle with lab testing included:
How the Process Works
- Order your assessment
Buy this package and complete your purchase on our website. - Receive secure access
After purchase, you’ll receive login details to our secure portal. - Complete the intake form
Provide your product details and upload available documentation. - Receive your PIF
Our safety assessor will prepare your Product Information File (PIF), including Parts I, II, and III. - CPNP Notification
We handle the EU registration for you and deliver the complete documentation.
Label revieuw options
1. Standard Label Review
This option is perfect for brands seeking a rapid regulatory review to ensure their labels meet basic compliance standards for the desired region(s).
What’s included:
- Evaluation of mandatory consumer information on the primary label, secondary label, and leaflet.
- Review of marketing communication to ensure claims align with regulatory requirements.
2. Extended Label Review
Our Global Label Review is a comprehensive option designed for brands aiming to perfect their labels for international markets.
What’s included:
- Everything in the Standard Review, plus:
- Validation of tests used to substantiate claims.
- Advanced recommendations for updating problematic claims while maintaining their original intent.
- Creation of the list of ingredients in the required format for each country.
- Verification of warnings and directions for use to align with regulations.
What is a Cosmetic Product Information File (PIF)
- Product Information: This section includes details such as the product name, category, and intended use. It also specifies the name and address of the Responsible Person—the entity or person responsible for placing the cosmetic product on the market.
- Cosmetic Product Safety Report (CPSR): The PIF contains the full Cosmetic Product Safety Report, which is a comprehensive assessment of the safety of the cosmetic product. The CPSR includes information on the product’s composition, exposure assessment, toxicological profile, safety assessment, and other relevant details.
- Method of Manufacturing: Information about the manufacturing process, including details about the facilities, equipment, and quality control measures, is provided in this section.
- Good Manufacturing Practices (GMP) Compliance: The PIF includes documentation to demonstrate that the cosmetic product is manufactured in accordance with Good Manufacturing Practices to ensure its safety and quality.
- Data on Animal Testing: Details regarding any animal testing conducted on the cosmetic product or its ingredients, including justifications for such testing, are included in the PIF. However, it’s essential to note that animal testing for cosmetics is prohibited in the EU, and alternative testing methods are encouraged.
- Stability Data: Information on the stability of the cosmetic product under various conditions (e.g., temperature, light) is included to ensure that the product remains safe and effective throughout its shelf life.
- Labeling Information: The PIF includes details on the labeling of the cosmetic product, ensuring that it complies with the relevant labeling requirements outlined in the EU Cosmetic Regulation.
The PIF is a confidential document, and its availability is essential for regulatory compliance and market surveillance. The Responsible Person must keep the PIF updated and accessible to the competent authorities for a period of 10 years after the last batch of the cosmetic product has been placed on the market. The PIF provides a comprehensive overview of the cosmetic product’s safety and compliance with regulatory requirements.
Additional information
Cosmetic Product Safety Report - CPSR
| Your Product Recipe Ingredients | 1- 9 Ingredients, 10- 14 Ingredients, 15- 19 Ingredients, 20- 29 Ingredients, 30+ ingredients |
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Cosmetic Label Review
| Label Review | Extended, Standard |
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What we assess & prepare for your cosmetic product
From formulation safety to regulatory documentation, we handle the essential steps required for EU cosmetic compliance. Our qualified Safety Assessors evaluate your product and prepare the CPSR, PIF, CPNP notification, and label review to help you enter the European market with confidence.
Ingredient Safety & Toxicology
We evaluate each ingredient's toxicological profile, concentration, regulatory restrictions, and potential risks to ensure the formulation is safe for its intended use.
Exposure & Safety Calculations
We assess consumer exposure based on the application area, frequency of use, product quantity, and target population, including calculations of the Margin of Safety (MoS) where applicable.
Stability & Microbiological Safety
We review stability, microbiological quality, and preservative effectiveness, including relevant laboratory test results, to support product safety and shelf life.
Cosmetic Product Safety Report (CPSR)
A qualified Safety Assessor prepares and signs the CPSR, including Part A and Part B, documenting the scientific evaluation and safety conclusion in accordance with EU requirements.
Product Information File (PIF)
We compile the required technical documentation, including the CPSR, product description, manufacturing information, GMP compliance statement, and supporting evidence.
CPNP Notification
We prepare and submit the required product information through the EU Cosmetic Products Notification Portal (CPNP), coordinating with the designated Responsible Person.
Cosmetic Label & Claims Review
We check your label for mandatory information, INCI declarations, allergens, warnings, durability information, Responsible Person details, and compliance of cosmetic claims.
Final Compliance Verification
We review the documentation for consistency and completeness, identify outstanding requirements, and help ensure your product is prepared for compliant EU/EEA market access.
Which tests are required for a cosmetic product?
Tests generate the data; the CPSR is the assessor's evaluation of that data. Your assessor needs the right test reports to sign off.
Stability Testing
Confirms that the product remains stable and suitable throughout its intended shelf life.
Microbiological Quality
Required where microbiological risk needs to be demonstrated.
Challenge Testing
Evaluates whether the preservative system adequately protects the product against microbial contamination.
For water-based cosmetic product, stability, microbiological and challenge testing are all required.
For oil-based or anhydrous cosmetic product, stability testing is usually enough. Microbiological and challenge testing can often be replaced by a low-risk justification.
Start your assessment3 easy steps to get your cosmetic product Product Safety Assessment
Buy your assessment
See which assessment fits with your product and needs
Add your product recipe
In our secure online platform you can easily create your product for assessment.
Receive your assessment
We create the full assessment. Your sales can start!
You receive a complete Cosmetic Product Safety Report
Delivered as a signed PDF in your Secure Portal, ready to file in your Product Information File (PIF).
- CPSR Part A
- CPSR Part B
- Ingredient safety assessment
- Exposure calculations
- Margin of Safety calculations
- Safety conclusion
- Warnings & conditions of use
- Qualified assessor signature
Make sure your cosmetic product label is EU compliant
A safe formula still can’t be sold with a non-compliant label. We check your artwork against Article 19 of Regulation (EC) No 1223/2009 — and, with the extended review, every claim you make.
Label Review
The legal basics every cosmetic label needs.
- Mandatory information Responsible Person, nominal content, durability date or PAO, precautions, batch number and country of origin.
- INCI ingredient list Correct INCI names, descending order, colorants, nano-materials and labelled fragrance allergens.
- Icons & symbols PAO jar, open-book symbol, hourglass and ℮-mark — correct use and placement.
Extended Label Review
Standard checks, plus a review of every claim on your packaging.
- All claims reviewed Every claim on pack is checked against the common criteria of Regulation (EU) No 655/2013.
- Claim validity & evidence Claims such as “dermatologically tested”, “long-lasting” or “free from” are matched against your supporting data.
- Rewording advice Where a claim can’t be supported, we suggest compliant alternatives.
Your cosmetic product is assessed by qualified professionals — not generated
Article 10 of Regulation (EC) No 1223/2009 requires the safety assessment to be carried out by a person holding a diploma in pharmacy, toxicology, medicine or a similar discipline. Every CPSR we issue is reviewed, concluded and signed by such an assessor, who takes professional responsibility for the conclusion.
- 01 Degree in pharmacy, toxicology, medicine or equivalent
- 02 Assessment follows the SCCS Notes of Guidance
- 03 Direct contact with your assessor via the Secure Portal
What if my cosmetic product formula doesn't pass?
You don't just receive a rejection. If your assessor identifies an ingredient concentration, restriction or other safety concern, we explain the issue and what needs to be resolved before the assessment can be completed.
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Issue identified
E.g. a restricted substance above its Annex III limit, or missing impurity data.
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Clear explanation
Your assessor tells you what the concern is and which options resolve it.
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You adjust or supply data
Reformulate, add documentation or run an additional test.
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Assessment completed
Your CPSR is finalised and signed.
Frequently asked questions
What is included in the complete EU cosmetic compliance service?
Our complete EU cosmetic compliance service includes four essential components: a Cosmetic Product Safety Report (CPSR), a Product Information File (PIF), notification through the Cosmetic Products Notification Portal (CPNP), and a cosmetic label review. Together, these services help you meet the requirements of Regulation (EC) No 1223/2009 and prepare your cosmetic product for the EU market.
What is a Cosmetic Product Safety Report (CPSR)?
A Cosmetic Product Safety Report (CPSR) is a mandatory safety assessment for cosmetic products sold in the European Union. It evaluates the safety of the formulation, including ingredient concentrations, toxicological information, exposure, microbiological quality and relevant testing results. The report consists of Part A (Cosmetic Product Safety Information) and Part B (Cosmetic Product Safety Assessment), which includes the conclusion and signature of a qualified Safety Assessor.
What is a Product Information File (PIF)?
A Product Information File (PIF) is the technical and regulatory documentation required for every cosmetic product placed on the EU market. It includes the product description, CPSR, manufacturing method and statement of compliance with Good Manufacturing Practice (GMP), proof of claimed effects where justified, and information concerning animal testing where applicable. The PIF must be maintained by the Responsible Person and made readily accessible to competent authorities for 10 years after the last batch is placed on the market.
What is a CPNP notification and why is it required?
The Cosmetic Products Notification Portal (CPNP) is the European Commission's online notification system for cosmetic products. Before a cosmetic product is placed on the EU market, the Responsible Person must submit the required product information through the CPNP. This includes details about the product, its Responsible Person, relevant formulation information and labelling. CPNP notification is mandatory but does not constitute product approval or certification by the European Commission.
What does the cosmetic label review include?
Our cosmetic label review checks your product label against the applicable requirements of EU Cosmetic Regulation (EC) No 1223/2009. We review elements such as the INCI ingredient list, fragrance allergens, Responsible Person details, nominal content, batch identification, durability information, product function and mandatory warnings. We also assess relevant regulatory requirements for cosmetic claims and identify missing or potentially non-compliant information.
Do I need all four services to sell cosmetics in the EU?
Every cosmetic product placed on the EU market must have a safety assessment documented in a CPSR, a complete PIF, compliant labelling and a CPNP notification. A separate commercial label review is not legally mandatory, but it helps identify compliance issues before the product is launched. Our combined service brings these requirements together to simplify the regulatory process.
What documents do I need to provide?
We generally require the complete quantitative formulation with INCI names and ingredient percentages, together with relevant raw-material documentation such as Safety Data Sheets (SDS), Certificates of Analysis (CoA), specifications, fragrance allergen declarations and IFRA certificates where applicable. We may also request manufacturing information, packaging details, product label artwork and laboratory test results. The exact documentation depends on the product type and formulation.
Is laboratory testing included in the service?
Laboratory testing is a separate service unless explicitly included in your quotation or package. Depending on your formulation, additional testing may be necessary, including stability testing, microbiological quality testing and preservative efficacy testing (challenge testing). Water-based cosmetics generally require more extensive microbiological evaluation than anhydrous products. We can advise which tests are appropriate and arrange the required testing through Certified Cosmetics.
Can I sell my cosmetic product immediately after receiving these documents?
Once the CPSR has a positive safety conclusion, the PIF is complete, the product is correctly labelled and the required CPNP notification has been submitted, your product may be placed on the EU market provided all other applicable obligations are fulfilled. These include having an EU-established Responsible Person, manufacturing in accordance with Good Manufacturing Practice (GMP) and meeting any relevant national language requirements.
Do I need an EU Responsible Person for my cosmetic product?
Yes. Every cosmetic product placed on the EU market must have a Responsible Person established within the European Union. The Responsible Person is responsible for ensuring regulatory compliance, maintaining the PIF, submitting the CPNP notification and cooperating with competent authorities. Certified Cosmetics also offers an EU Responsible Person service if you require an external company to fulfil this role.
Can you prepare the documentation for cosmetics manufactured outside the EU?
Yes. We can prepare CPSRs, PIFs, CPNP notifications and label reviews for cosmetic products manufactured outside the European Union. This includes products manufactured in the United Kingdom, United States, China, Turkey and other countries. The manufacturer must provide sufficient formulation, ingredient, manufacturing and testing documentation to demonstrate compliance with EU cosmetic requirements.
Can multiple fragrances, colours or product variations be included?
In some cases, multiple product variations can be assessed together when they share the same base formulation and differ only in fragrance or colour. Each variation must be evaluated for ingredient safety, regulatory restrictions and relevant allergens. Whether variations can share a CPSR depends on their composition and safety profile. Separate CPNP notifications may still be required depending on how the products are presented and marketed.
How long does it take to complete the CPSR, PIF, CPNP and label review?
The processing time depends on the complexity of your cosmetic product, the completeness of the documentation and whether additional laboratory testing is required. Products with complete ingredient documentation and available test results can generally be processed more quickly. If stability, microbiological or challenge testing is required, the overall timeline will be longer. We can provide an estimated completion time after reviewing your product information.
Can you review and correct my cosmetic label before printing?
Yes. We recommend having your cosmetic label reviewed before printing packaging or launching your product. Our label review identifies missing mandatory information, incorrect INCI declarations, relevant allergen labelling requirements and other potential compliance issues. We provide feedback so you can make the necessary corrections before finalising your packaging design.
Do I need to update my CPSR and PIF if I change my formulation?
Yes, changes that may affect product safety or regulatory compliance must be evaluated. This includes modifications to ingredient concentrations, fragrances, preservatives, colourants, packaging or intended use. Depending on the changes, the CPSR and PIF may need to be updated, and the CPNP notification or product label may also require revision. We can review your changes and advise which updates are necessary.
Does the CPNP notification need to be renewed every year?
No. A CPNP notification does not require annual renewal. However, the submitted information must be kept up to date. Changes to the product name, Responsible Person, formulation information or other relevant details may require the existing notification to be updated. The CPSR and PIF must also remain current throughout the product's market life.
Is the documentation valid throughout the European Union?
Yes. A CPSR and PIF prepared in accordance with Regulation (EC) No 1223/2009 support cosmetic compliance throughout the European Union. A CPNP notification is valid for the EU market and does not need to be repeated separately for each EU Member State. However, product labels must comply with applicable national language requirements, and certain countries may have additional obligations. For EEA countries outside the EU, applicable local requirements must also be considered.
Can Certified Cosmetics manage the entire EU cosmetic compliance process?
Yes. Certified Cosmetics provides an integrated approach to EU cosmetic compliance. We can assist with the Cosmetic Product Safety Report (CPSR), Product Information File (PIF), CPNP notification, cosmetic label review, laboratory testing and EU Responsible Person services. By combining these services, we help cosmetic brands, manufacturers and importers simplify the regulatory process and prepare their products for the European market.
Ready to make your cosmetic product EU compliant?
Start your Cosmetic Product Safety Assessment today. Our Safety Assessors review your formulation and documentation and guide you through every requirement for completing your CPSR.
Order Safety Assessment- EU compliant
- Qualified Safety Assessor
- Complete CPSR
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