Safety Assessment for Cosmetics – CPSR and PIF and 3 Laboratory Tests.

A cosmetic safety assessment is a detailed safety assessment of a cosmetic product. This assessment is conducted to ensure the safety of a cosmetic product before it is placed on the market. A qualified safety assessor performs this assessment based on the product dossier containing all required information and documentation about the cosmetic product provided by the manufacturer. This file is called a Cosmetic Product Information File (PIF).

What is a Cosmetic Product Information File (PIF)?

The Cosmetic Product Information File (PIF) is a comprehensive collection of documentation required for any cosmetic product. The PIF can be divided into three parts:

Part I: Identification of manufacturer, responsible person, production site

Contains information about the manufacturer and production site, including GMP certification.

Part II: Information about the cosmetic product

Contains cosmetic product information including composition, raw material documentation, finished product specifications, test results, labeling and packaging.

• The composition of the product
• Production method
• Product identification (lot or batch no./barcode no./production code etc.).
• Documentation of the raw materials used in the product (TDS, MSDS, CoA, etc.)
• Specifications of the finished product (TDS, CoA, MSDS)
• Laboratory test results (shelf life and compatibility test, microbiological and preservative efficiency (challenge) test reports)
• Packaging Specifications
• Labeling
• Claims
• If there is an undesirable effect / serious undesirable effect, the relevant documents

Part III: Cosmetic product safety report (CPSR).

The CPSR consists of two main parts: Part A and Part B.

Part A – Cosmetic Product Safety Information: Summarizes all PIF elements listed above and provides product information.

Part B – Cosmetic Product Safety Assessment: Contains the safety assessor’s conclusions, warnings and justifications that ensure the product is safe under normal use.

1. In-depth formula analysis
   • Analysis of the composition of your product, including active ingredients, fragrances and preservatives.
   • Assessment of the concentration of each ingredient to ensure it is within safe limits.
2. Checking ingredients
   • Check that all ingredients are permitted according to the Cosmetics Regulation (EC) No. 1223/2009.
   • Control of source and purity of raw materials.
   • Odor Analysis (IFRA) Evaluation of odors according to IFRA standards and the latest allergen regulations.
3. Analysis of laboratory test results
   • All necessary analysis and documentation to demonstrate the safety of the product.
4. Toxicological evaluation
   • Assessment of toxicological profiles of the substances used in the cosmetic product.
5. Risk assessment and hazard identification
   • Assessment of potential risks based on the proposed application and target group (e.g., baby products or products for sensitive skin).

What laboratory tests are required?

For a cosmetic safety assessment, the following three laboratory tests are essential to comply with European regulations and ensure the safety of the product:

1. Microbiological Test

• Purpose: Checks the microbiological quality of the product. It identifies possible contamination by bacteria, yeasts or fungi that may be harmful to the user.
• Important for: Water-based products or products prone to bacterial growth.
• How is this tested: Aerobic bacterial counts, fungal and yeast analyses.

2. Challenge Test (Preservative Efficacy Test).

• Purpose: Test the effectiveness of preservatives in the product. This is to prevent microorganisms from multiplying during the period of use.
• Important for: Products that have an extended shelf life or are in repeatedly opened containers.
• How is this tested: Simulation of different use scenarios to evaluate the effect of preservatives.

3. Stability test

• Purpose: Determines whether the product remains stable under normal and extreme conditions, such as heat, cold and exposure to light. This involves checking changes in texture, color, odor and function.
• Important for: Ensuring the shelf life and safety of the product during its lifetime.
• How is this tested: Storage of the product at different temperatures for a specified time.

How does the process work?

1. Choosing Assessment
   • You purchase the assessment through our website.
2. Access to secure Portal
   • After purchase, you will gain access to our secure portal where you can complete the intake.
3. Complete Intake
   • Complete all requested information about your product and upload relevant documentation.
4. Send Samples
   • Send physical samples of your product to our laboratory. We will tell you exactly what we need for this. The samples can be sent to us free of charge.
5. Laboratory tests
   • We perform stability, microbiological and other required tests.
6. Safety Assessment
   • Our safety reviewer prepares the PIF, including Part A and Part B.
7. EU CPNP notification and documentation delivery
   • We will take care of the registration of your product in the Cosmetic Products Notification Portal (CPNP) and you will receive the complete PIF documentation from us.

What do you need to apply for a CPSR?

To make the process go smoothly, we need the following information from you:

1. Product Formulation: A complete list of ingredients, including concentrations and INCI names.
2. Product packaging: Information on packaging and labels.
3. Instructions for use: How the product is used by consumers.
4. Sample: A physical sample of your product for laboratory analysis.
5. Documentation: Certificates of raw materials (e.g., MSDS and COA).

Cost of the CPSR service.

Our prices depend on the type of product and the complexity of the formulation.

For whom is this service intended?

Our cosmetic safety assessment is designed specifically for:

• Producers of cosmetics who want to sell their products in the EU.
• Small entrepreneurs offering handmade cosmetics.
• Large companies looking to launch a wide range of cosmetics.
• DIY makers who want to professionalize their creations.

Why choose our safety assessment for cosmetics service?

• Experienced Safety Assessors: Our safety assessments are conducted by certified professionals with years of experience in the cosmetics industry.
• Quick Turnaround Time: We deliver the CPSR within 10 to 15 business days of receiving all required data.
• Clear Communication: No jargon, but clear explanations throughout the process.
• Customized Recommendations: We provide practical recommendations if your product needs customization.
• Fully Compliance-Focused: Our reports are 100% compliant with European regulatory requirements.

Frequently Asked Questions

• How long is a CPSR valid? A CPSR remains valid as long as the product formulation and other relevant aspects remain unchanged.
• Can I make changes to my product after the CPSR? Yes, but then the CPSR must be revised to ensure that the changes do not affect safety.
• Are there any products that do not require CPSR? No, all cosmetic products sold within the EU must have a CPSR.
• How do I know if my ingredients are allowed? We help you do this by checking all ingredients based on the latest regulations.
• Can I use ingredients from suppliers other than YouWish? Yes, that’s no problem at all. As long as you have documentation, we can make a safety assessment for you.

What do I need for a safety assessment of my product?

Here is an overview of product groups and what is required for a product safety assessment. If you make a product that is not listed in the table and don’t know what you need, please send us an email or give us a call. We will be happy to help you!

Product group	PIF	CPSR	Microbiological Test	Challenge Test	Stability test
Skin care (creams, lotions)	✅	✅	✅	✅	✅
Hair care (shampoo, conditioner)	✅	✅	✅	✅	✅
Facial care (day creams, serums)	✅	✅	✅	✅	✅
Hand and body care (body lotions, hand creams)	✅	✅	✅	✅	✅
Liquid soap / shower gel	✅	✅	✅	✅	✅
Makeup with water phase (mascara, foundation)	✅	✅	✅	✅	✅
Children’s cosmetics (baby shampoo, baby cream)	✅	✅	✅	✅	✅
Perfume and body sprays (with water phase)	✅	✅	✅	✅	✅
Oil-based products (such as facial oils)	✅	✅	❌	❌ (no water phase)	✅
Powders (bath powder, face powder)	✅	✅	❌	❌ (no water phase)	✅
Casting soap (Melt & Pour)	✅	✅	❌	❌ (no water phase after curing)	✅
Cold Process Zeep	✅	✅	❌	❌ (pH > 9 inhibits microbial growth)	✅
Lip balms	✅	✅	❌	❌ (mostly anhydrous)	✅
Body butters and balms	✅	✅	❌	❌ (mostly anhydrous)	✅
Fixed perfumes	✅	✅	❌	❌ (no water phase)	✅
Oil-based cleansers or serums	✅	✅	❌	❌ (no water phase)	✅
Scrubs (oil-based)	✅	✅	❌	❌ (no water phase)	✅
High pH products	✅	✅	❌	❌ (minimal microbial risk)	✅
Cleaning powders	✅	✅	❌	❌ (stable without preservation)	✅
Lye-based products	✅	✅	❌	❌ (very high pH)	✅
Perfume sprays (alcohol base)	✅	✅	❌	❌ (alcohol preserves)	✅
Hand sanitizers (alcohol base)	✅	✅	❌	❌ (high alcohol content)	✅
Face masks (powdered)	✅	✅	❌	❌ (no water to use)	✅