Cosmetovigilance – Cosmetic Product Safety Report (CPSR)

Cosmetics are regulated in the European Union by Regulation (EC) No 1223/2009. The main objectives of this regulation are to create a set of rules that all cosmetics comply with and to ensure a high level of protection for human health. One of the requirements of the regulation is that prior to placing the product on the market a safety assessment is carried out. The regulation specifies that this safety assessment should be in the form of a cosmetic product safety report (CPSR).

This CPSR is the key to ensuring a product is safe when used in the expected way by a consumer and is the most important document held in the Product Information File.

The CPSR is a critical scientific review of the safety of the cosmetic product conducted by a suitably qualified person (safety assessor). The safety assessor works closely together with the Responsible Person to ensure that the safety of the product is properly assessed, documented and kept up-to-date.

Safety assessor is “a person in possession of a diploma or other evidence of formal qualifications awarded on completion of a university course of theoretical and practical study in pharmacy, toxicology, medicine or a similar discipline, or a course recognised as equivalent by a Member State” When the qualification degree diploma is not obtained from a European University, the Safety Assessor must have it recognized by the appointed national bodies within one of the EU Member States.

What must be include in the Cosmetic Product Safety Report?

The Cosmetic Product Report must be established in accordance with Annex I of the Cosmetics Regulation and shall, as a minimum, contain the following:

The Cosmetic Product Safety Report consists of two parts:
PART A – Cosmetic product safety information: holds the product information and test data

1. Quantitative and qualitative composition of the cosmetic product
2. Physical / chemical characteristics and stability of the cosmetic product
3. Microbiological quality
4. Impurities, traces, information about the packaging material
5. Normal and reasonably foreseeable use
6. Exposure to the cosmetic product
7. Exposure to the substances
8. Toxicological profile of the substances
9. Undesirable effects and serious undesirable effects
10. Information on the cosmetic product

PART B – Cosmetic product safety assessment: It includes the safety assessor’s expert opinion as to why the product is safe to be placed on the market.

1. Assessment conclusion
2. Labelled warnings and instructions of use
3. Reasoning
4. Assessor’s credentials and approval of part B

Part B of the CPSR includes an overall assessment of product safety. For this, critical points of departure (PoDs) such as no-observed-adverse-effect levels (NOAELs) or lowest-observed-adverse-effect levels (LOAELs) are identified from the toxicity hazard data for each ingredient and compared with consumer exposures. The resulting margin-of-safety (MoS) values are used to conclude on the health risks posed to people using the cosmetic.

A special safety assessment needs to be issued in case the products are:
Intended for use on children under 3 years old. Intended exclusively for use in external intimate hygiene.

CPSRs are written in accordance with the Cosmetics Regulation, using the guidance from the European Commission and from the Scientific Committee on Consumer Safety’s Notes of Guidance (NoG) for the testing of cosmetics ingredients and their safety evaluation.

In order to complete the CPSR a large amount of documentation is required about the cosmetic product:

1. Method of Manufacture
2. GMP Certification
3. Qualitative and Quantitative Formulation
4. Raw Material Safety Data Sheets
5. Details of any Serious or Undesirable effects
6. IFRA Certificate and Allergen Declarations for artificial fragrances
7. Stability Test Data
8. Challenge Test Data (If applicable)
9. Microbial Limits Test Data (If applicable)
10. SPF Test Data (If applicable)