A hand care safety assessment detailed safety assessment of a hand care product. This assessment is conducted to ensure the safety of a hand care product before it is marketed. A qualified safety assessor performs this assessment based on the product dossier containing all required information and documentation on the hand care product provided by the manufacturer. This file is called a Cosmetic Product Information File (PIF) .
What is a Cosmetic Product Information File (PIF) for a cosmetic product?
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.
- Cosmetic product composition
- Production method
- Product identification (lot or batch no./barcode no./production code etc.).
- Documentation of the raw materials used in the cosmetic product (TDS, MSDS, CoA, etc.)
- Specifications of the finished product (TDS, CoA, MSDS)
- Laboratory test results (shelf life and compatibility test)
- Packaging Specifications
- Labeling
- Claims
- If there is an undesirable effect / serious undesirable effect, the relevant documents
Part III: Cosmetic Product Safety Report (CPSR) for the cosmetic
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.
- In-depth formula analysis
- Analysis of the composition of your cosmetic product, including active ingredients, fragrances and preservatives.
- Assessment of the concentration of each ingredient to ensure it is within safe limits.
- 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.
- Analysis of laboratory test results
- All necessary analysis and documentation to demonstrate the safety of the product.
- Toxicological evaluation
- Assessment of toxicological profiles of the substances used in the cosmetic product.
- Risk assessment and hazard identification
- Assessment of potential risks based on the proposed application and target population (e.g., baby shampoo or shampoo for sensitive skin).
What products can be evaluated with this safety assessment for a hand care product?
This assessment is for a hand care product. Here you see an overview where 1 or 3 laboratory tests are required. You can select which laboratory tests you want to order. For a hand care product it is also necessary to provide an MSDS of the finished product in the packaging. We can make these or you can provide them. You can choose whether to order these.
Product group | PIF | CPSR | Microbiological Test | Challenge Test | Stability test |
---|---|---|---|---|---|
Hand Cream | ✅ | ✅ | ✅ | ✅ | ✅ |
Hand lotion | ✅ | ✅ | ✅ | ✅ | ✅ |
Hand soap (liquid) | ✅ | ✅ | ✅ | ✅ | ✅ |
Hand soap (solid) | ✅ | ✅ | ❌ | ❌ | ✅ |
Hand Mask | ✅ | ✅ | ✅ | ✅ | ✅ |
Cuticle oil | ✅ | ✅ | ❌ | ❌ | ✅ |
Peeling for hands | ✅ | ✅ | ✅ | ✅ | ✅ |
Hand Balm | ✅ | ✅ | ✅ | ✅ | ✅ |
Hand care product with water phase | ✅ | ✅ | ✅ | ✅ | ✅ |
Hand care product without water phase | ✅ | ✅ | ❌ | ❌ | ✅ |
Hand care product with high alcohol content | ✅ | ✅ | ❌ | ❌ | ✅ |
This table is indicative. If your product is not listed or if you are not sure, you can always ask us. An additional laboratory test can also be ordered during the safety review. Additional testing or documentation may be required at the direction of the safety assessor.
- Hand care product with water phase require microbiological testing and challenge testing because of the risk of microbial growth.
- Hand care product without a water phase (such as cuticle oils and solid hand soaps) usually only need a stability test.
- Products with a high alcohol content (such as hand sanitizer) have fewer microbial risks and often do not require microbiological or challenge testing.
Some hand care products contain water and are prone to microbial growth, necessitating both a microbiological test and a challenge test. Low pH results in microbial risk. You can measure this with a digital pH meter or pH test strips.
The stability test is essential to verify that the hand care maintains its properties during shelf life.
What laboratory tests are required?
For a cosmetic safety assessment for a hand care product, the following laboratory tests are essential to comply with European regulations and ensure the safety of the product:
1. Stability test
- Purpose: Determines whether the hand care product remains stable under normal and extreme conditions, such as heat, cold and exposure to light. This involves monitoring changes in texture, color, odor and action.
- Important for: Ensuring the shelf life and safety of the hand care product over its lifetime.
- How is this tested: Storage of the hand care product at different temperatures for a specified time.
2. 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.
3. 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.
How does the process work?
- Choosing Assessment
- You purchase the assessment through our website.
- Access to secure Portal
- After purchase, you will gain access to our secure portal where you can complete the intake.
- Complete Intake
- Complete all requested information about your product and upload relevant documentation.
- 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.
- Laboratory tests
- We perform stability test and compatibility test.
- Safety Assessment
- Our safety reviewer prepares the PIF, Part I, II and III.
- 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:
- Product Formulation: A complete list of ingredients, including concentrations and INCI names.
- Product packaging: Information on packaging and labels.
- Instructions for use: How the product is used by consumers.
- Sample: A physical sample of your product for laboratory analysis.
- Documentation: Certificates of raw materials (e.g., MSDS and COA).
For whom is this service intended?
Our hand care product safety review is specially designed for:
- Manufacturers of hand care products or products wishing to sell their products in the EU.
- Small business owners offering handmade hand care products.
- Large companies looking to launch a wide range of hand care products.
- DIY makers who want to professionalize their creations.
Why for our safety assessment for a hand care product choose?
- 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 hand care 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,
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