What is Cosmetic Product Safety Assessment?
A Cosmetic Product Safety Assessment is a scientific and systematic evaluation conducted to ensure that a cosmetic product does not cause harm to human health. The resulting Cosmetic Product Safety Assessment Report must comply with both the Turkish Cosmetic Regulation and the EU Regulation (EC) No 1223/2009.
This report protects consumer health by assessing the safety of cosmetic products and their ingredients. Chemleg is ready to assist you in preparing your Cosmetic Product Safety Assessments.
What Does a Cosmetic Product Safety Assessment Report Contain?
In Türkiye, this report is also known as the Cosmetic Product Safety Assessment Report (ÜGDR). It can be divided into two main sections:
Part A: Safety Information | Part B: Safety Assessment |
1. Qualitative and quantitative composition of the cosmetic product | 1. Assessment conclusion |
2. Physical/chemical characteristics and stability of the product | 2. Warnings and instructions for use on the label |
3. Microbiological quality | 3. Justification |
4. Impurities, traces, and information on packaging material | 4. Information on the responsible safety assessor and approval of Part B |
5. Normal and reasonably foreseeable use |
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6. Exposure to the cosmetic product |
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7. Exposure to substances |
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8. Toxicological profile of the substances |
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9. Undesirable and serious undesirable effects |
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10. Other relevant information on the cosmetic product |
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Minimum Documents Required for Preparing the Safety Assessment Report:
- Product formulation
- Technical documentation for raw materials used in the formulation
- Product specifications
- Product testing reports
- Packaging documentation
- Product label
Common Mistakes & How Chemleg Helps
Errors such as incorrect documentation, insufficient toxicological assessment, or missing test and analysis data are frequently made during safety assessments and may result in non-compliance or delays.
As a consultancy specialized in chemical legislation, Chemleg provides end-to-end support to companies throughout this complex process.
Chemleg CPSR Preparation Service includes:
- Toxicological & Safety Evaluation: Assessment of each ingredient’s toxicological profile to ensure compliance with safety standards.
- Physicochemical & Microbiological Testing Support: Verification of product stability, purity, and microbiological safety.
- Exposure & Risk Assessment: Evaluation of potential risks based on product use and consumer exposure levels.
- Regulatory Compliance Check: Ensuring compliance with Turkish and EU cosmetic regulations, including ingredient restrictions.
- Dermatological & Compatibility Review: Evaluation of skin compatibility and potential irritation risks.
- Final CPSR Report Issuance: Delivery of a legally compliant Cosmetic Product Safety Report signed by a qualified safety assessor.
With Chemleg’s CPSR preparation service, you can ensure that your cosmetic products meet the highest safety standards, preventing regulatory issues and market delays.
Fill out the form to schedule a meeting with our experts.
Frequently Asked Questions
For which products is a CPSR required?
A CPSR is mandatory for all cosmetic products applied to the external parts of the human body or to the teeth and mucous membranes of the oral cavity — such as creams, lotions, perfumes, shampoos, soaps, makeup products, toothpaste, deodorants, and nail polish.
Who can prepare this report? Can any chemist do it?
No, not everyone can prepare it. The person preparing the CPSR must possess the qualifications specified in the Turkish Cosmetic Products Regulation.
This person — referred to as the Safety Assessor — must hold a degree in pharmacy, medicine, dentistry, biology, chemistry, biochemistry, or microbiology, and possess theoretical and practical knowledge in toxicology or an equivalent field.
What happens if I market my product without a CPSR?
This constitutes a serious violation of the Cosmetic Products Regulation. If detected during market surveillance by the Turkish Ministry of Health, your products may be withdrawn from the market, administrative fines may be imposed, and in severe cases, your company’s activities may be suspended.
I have obtained my CPSR. What is the next step?
The CPSR is one of the most important parts of the Product Information File (PIF). Once completed, it must be kept together with all other technical documents within the PIF, maintained at your company’s address, ready for inspection.
