Cosmetic Product Safety Report (CPSR)
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Cosmetic Product Safety Report (CPSR)
This service provides a comprehensive Cosmetic Product Safety Report (CPSR), which is a mandatory regulatory document required for placing a cosmetic product on the market, particularly within the European Union (EU) under Regulation (EC) No 1223/2009.
Cosmetic Product Safety Report (CPSR) Service
The CPSR is essential for demonstrating that a cosmetic product is safe for human health when used under normal or reasonably foreseeable conditions. It is prepared by a qualified Safety Assessor and consists of two main parts:
1. Part A- Information on Cosmetic Product Safety (Data Collection)
This section includes:
- Detailed data on the product’s formulation, physical/chemical properties, stability, microbial quality, and packaging materials.
- Toxicological profiles of all raw materials (ingredients).
- Existing safety data on the finished product.
2. Part B- Cosmetic Product Safety Assessment (Risk Assessment)
This section provides:
- A formal conclusion on product safety.
- Assessment of toxicological risks using Margin of Safety (MoS) calculations for ingredients of concern.
- Evaluation of systemic effects and local tolerance, including skin and eye irritation or sensitization.
- Guidance on necessary warning labels and instructions for use.
Our CPSR Service Includes:
- Raw Material Review (Tox Data): Examination of Safety Data Sheets (SDS), Technical Data Sheets (TDS), and toxicological information for all ingredients.
- Exposure Calculation: Estimating the amount of each substance a consumer may be exposed to, based on product type and intended use.
- Risk Characterization: Professional safety assessment, including MoS calculations where required.
- Final Report Preparation: Generation of a legally compliant CPSR, signed and dated by an accredited Safety Assessor.
- Regulatory Compliance: Ensuring the formulation meets restrictions in Annexes II–VI of the EU Cosmetic Regulation.
Who Needs This Service?
- Cosmetic manufacturers.
- Responsible Persons (RPs) importing or distributing cosmetics in the EU.
- Brand owners and private label companies.
Note: The CPSR is a key part of the Product Information File (PIF), which must be kept accessible for competent authorities.
FAQs About The Service
There are many questions about the service, we have selected frequently asked questions about this service. If you do not see your answer, please contact us.
What is a CPSR and why is it mandatory?
The Cosmetic Product Safety Report (CPSR) is a mandatory document under EU Regulation (EC) No 1223/2009. It confirms that a cosmetic product is safe for human use under normal and foreseeable conditions. Without a valid CPSR, you cannot legally place a cosmetic product on the EU market.
Who is responsible for commissioning the CPSR?
The Responsible Person (RP), who is named on the product label and notified via the CPNP portal, is ultimately responsible for ensuring the CPSR is available and accurate. This is usually the manufacturer, importer, or brand owner established within the EU.
Who is qualified to sign and prepare the CPSR?
The CPSR must be signed by a qualified Safety Assessor. This person must possess a diploma or other evidence of formal qualifications awarded on completion of a university course in pharmacy, toxicology, medicine, or a similar relevant discipline.
What information is needed to start the CPSR process?
To begin preparing a Cosmetic Product Safety Report (CPSR), you need to provide detailed product information. Specifically, we require:
1. Product Identification – Name, category, and intended use.
2. Full Ingredient List – INCI names and concentrations for all ingredients.
3. Physical & Chemical Properties – Appearance, pH, viscosity, and stability data.
4. Manufacturing Information – Process details and production site.
5. Microbiological Data – Test results if available, or indication that testing is required.
6. Packaging Details – Materials that come into contact with the product.
7. Intended Use Instructions – How consumers will use the product.
8. Toxicological Data – Any existing safety data for the ingredients or product.
9. Previous Safety or Efficacy Studies – Human, in vitro, or literature data if available.
10. Labeling Draft – Proposed claims, warnings, and mandatory symbols.
Once this information is provided, our qualified safety assessors can prepare a fully compliant CPSR for EU market entry.
1. Product Identification – Name, category, and intended use.
2. Full Ingredient List – INCI names and concentrations for all ingredients.
3. Physical & Chemical Properties – Appearance, pH, viscosity, and stability data.
4. Manufacturing Information – Process details and production site.
5. Microbiological Data – Test results if available, or indication that testing is required.
6. Packaging Details – Materials that come into contact with the product.
7. Intended Use Instructions – How consumers will use the product.
8. Toxicological Data – Any existing safety data for the ingredients or product.
9. Previous Safety or Efficacy Studies – Human, in vitro, or literature data if available.
10. Labeling Draft – Proposed claims, warnings, and mandatory symbols.
Once this information is provided, our qualified safety assessors can prepare a fully compliant CPSR for EU market entry.
How long does it take to complete a CPSR?
The typical turnaround time varies depending on the complexity of the formulation and the completeness of the documentation you provide. Generally, it takes between 2 to 4 weeks after all necessary documentation has been submitted and verified.