What Is a CPSR (Cosmetic Product Safety Report)?

CPSR, or Cosmetic Product Safety Report, is a mandatory safety assessment document for cosmetic products.

Materials Required Before Applying for CPSR

1. Heavy Metal Test Report of the Product

2. Microbiological Test Report of the Product

3. Preservative Challenge Test Report of the Product

4. Stability Test Report of the Product

5. Other Risk Substance Test Reports (depending on formulation)

6. Heavy Metal Test Report of Packaging Materials

7. COA (Certificate of Analysis) and msds for Each Ingredient

 - Can be requested from raw material suppliers

 - Must be in English

 - If not available, our company can assist in obtaining them

8. If Fragrance Is Included:

 - IFRA Certificate, MSDS, and 26 Allergen Reports

 - Can be requested from the fragrance supplier

 - Must be in English

 - If not available, our company can assist in obtaining them

9. Factory GMPC Certificate

Additional Documents Required:

- One complete formulation

- MSDS for all raw materials

- Fragrance documentation (if applicable)

- Microbial Test Report

- Challenge Test Report

- Stability Test Report

- Packaging Material Report

- Product label artwork

- Information on any nano-materials used

- Specification and Certificate of Analysis for raw materials and packaging materials

- Specification of the finished product

- Records of undesirable effects and serious adverse events

Background

As of July 12, 2013, according to the EU Cosmetics Regulation (EC) No. 1223/2009, all cosmetic products must have a completed CPSR (Cosmetic Product Safety Report)before being placed on the EU market.

Is CPSR a certification or a test?

CPSR is neither a certification nor a single test.

It is a comprehensive safety assessment reportbased on:

- The complete formulation of the cosmetic product (including percentage composition)

- Related product testing reports

- Factory quality management certification

The outcome is a single, consolidated Cosmetic Product Safety Report (CPSR).

CPSR Contents

Part A — Cosmetic Product Safety Information

This section contains the product description, ingredient percentages, and relevant testing data.

1. Description of the Cosmetic Product, Ingredients, and Percentage Composition

 - If fragrance is included: MSDS, IFRA certificate, and 26 allergen reports must be provided.

2. Physical/Chemical Characteristics and Stability

 - Includes the Stability Test Report.

3. Microbiological Quality

 - Microbial Contamination Test Report

 - Efficacy of Antimicrobial Preservation (Preservative Challenge Test Report)

4. Impurities, Traces, and Information About Packaging Materials

 - Purity of raw materials

 - Evidence of technically unavoidable traces of prohibited substances

 - Specifications of packaging materials (including purity, stability, and heavy metal test results)

 - Other relevant risk substance testing data

5. Normal and Reasonably Foreseeable Use

6. Exposure to the Cosmetic Product

7. Exposure to Individual Ingredients

8. Toxicological Profile of Each Ingredient

9. Undesirable Effects and Serious Adverse Effects

10. Additional Product Information

 - Factory Quality Management Certification (GMP certificate or equivalent GMP audit report is required)

 - If no GMP certificate is provided, the product must still be manufactured in a facility compliant with GMP requirements.