Safety Assessment for Children’s Cosmetics

Safety Assessment for Children's Cosmetics

The pediatric cosmetics safety assessment is a detailed safety assessment for cosmetic products developed for babies aged 0 to 3 years and for children under 18 years of age. This assessment is conducted to ensure the safety of a children’s cosmetics 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 children’s cosmetic products provided by the manufacturer. This file is called a Cosmetic Product Information File (PIF).

What is a Cosmetic Product Information File (PIF) for a children’s 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 on children’s cosmetics

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.

1. 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.
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 population (e.g., baby shampoo or shampoo for sensitive skin).

What products can be evaluated with this safety assessment for a pediatric cosmetic?

This assessment is meant for a children’s cosmetic. Here you see an overview where 1 to 4 laboratory tests are required. You can select which laboratory tests you want to order. For children’s cosmetics 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	Dematological test (patch test)
Children’s shampoo	✅	✅	✅	✅	✅	✅
Children’s hot tub	✅	✅	✅	✅	✅	✅
Children’s toothpaste	✅	✅	✅	✅	✅	✅
Children’s lotion	✅	✅	✅	✅	✅	✅
Children’s sunscreen	✅	✅	✅	✅	✅	✅
Baby wipes	✅	✅	✅	✅	✅	✅
Baby Oil	✅	✅	✅	❌	✅	✅
Baby soap (water-based)	✅	✅	✅	✅	✅	✅
Baby soap (oil-based)	✅	✅	✅	❌	✅	✅
Cream for diaper rash	✅	✅	✅	✅	✅	✅
Lip balm for children	✅	✅	✅	✅	✅	✅
Children’s perfume (alcohol-based)	✅	✅	✅	❌	✅	✅
Children’s perfume (water-based)	✅	✅	✅	✅	✅	✅
Make-up for children (powder)	✅	✅	✅	❌	✅	✅
Make-up for children (liquid)	✅	✅	✅	✅	✅	✅

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.

For cosmetic products intended for use on infants aged 0 to 3 years, dermatological testing in volunteers with sensitive skin is important to assess product safety. It is also strongly recommended that dermatological testing be conducted for products intended for use by children under 18 years of age.

Alcohol-based perfume for children has fewer microbial risks, but water-based products must be tested.

Children’s cosmetics require extra attention due to the sensitivity of young skin. Therefore, microbiological tests and challenge tests are often required even for products where this is not normally required.

• Pediatric water-phase cosmetics require microbiological testing and challenge testing due to the risk of microbial growth.
• Children’s cosmetics without a water phase (such as hair sprays and body sprays) usually only need a stability test.
• Alcohol-based products such as perfume sprays are naturally preserved by the alcohol content.
• Powdered products usually have fewer microbial risks, but liquid products require extensive testing.

Some children’s cosmetics contain water and are prone to microbial growth, necessitating both a microbiological test and a challenge test. Low pH levels indicate microbial risk. You can measure this with a digital pH meter or pH test strips.

The stability test is essential to verify that the children’s cosmetic retains its properties during its shelf life.

What laboratory tests are required?

For a cosmetic safety assessment for a child cosmetics 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 children’s cosmetic remains stable under normal and extreme conditions, such as heat, cold and exposure to light. This involves checking changes in texture, color, fragrance and action.
• Important for: Ensuring the shelf life and safety of the children’s cosmetic during its lifetime.
• How is this tested: Storage of the children’s cosmetics 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.

4. Dermatology test

• Purpose: To determine the safety of cosmetics used on sensitive skin. During the test, skin reactions are examined to ensure that the products are safe for use by children.
• Important: Ensure the safety of children’s skin when using cosmetics and avoid irritation or allergic reactions.
• How this is tested: Selected subjects with sensitive skin are selected for the test. The product is applied to a small area of skin in a controlled manner. After application, skin reactions such as redness, itching and swelling are monitored for a specified time (e.g., 48 hours). All observations are documented and reviewed by dermatologists to verify the safety of the product for the relevant age groups.

5. Product Specification Report

A Product Specification Report is used to create a Certificate of Analyses (CoA) of your finished product. If you have a CoA of your finished product, this test is not required. If you do not have a CoA of your finished product, then this test is mandatory.

Several physicochemical laboratory tests are required to obtain a detailed product specification report. These tests provide information on the properties of the product and are used to assess the stability, safety and suitability of the product. These values are tested there:

• Color
• Fragrance
• pH values
• Viscosity
• Density

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 test and compatibility test.
6. Safety Assessment
   • Our safety reviewer prepares the PIF, Part I, II and III.
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).

For whom is this service intended?

Our cosmetics safety assessment has been specially developed for:

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

Why choose our safety assessment for a child cosmetics 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 children’s cosmetics 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,