Table of contents
- Why is the safety assessment required?
- Cosmetic Product Safety Report – structure and content
- Scope of analysis during safety assessment
- Safety as a foundation for compliance and competitiveness
- When must the CPSR be updated?
- 5 most common mistakes made by cosmetic manufacturers
- GCB - Services in Compliance Verification
Why is the safety assessment required?
The purpose of the safety assessment is to confirm that the cosmetic product is safe for human health under normal or reasonably foreseeable conditions of use. It forms the basis of the product’s technical documentation and is an essential part of the Product Information File (PIF).
Is CPSR mandatory?
Yes, without exception. In accordance with Regulation (EC) No 1223/2009:
- every cosmetic product must have a CPSR prior to being placed on the market,
- absence of a CPSR constitutes non-compliance and illegal market placement,
- the document is subject to inspection by competent authorities.
Failure to provide a CPSR may result in:
- product withdrawal from the market,
- financial penalties,
- legal liability of the Responsible Person or manufacturer.
Cosmetic Product Safety Report – structure and content
The CPSR, as defined in Annex I to Regulation (EC) No 1223/2009, consists of two key parts:
- Part A – Cosmetic Product Safety Information: includes data on INCI composition, physicochemical properties, product stability, microbiological quality, toxicological profiles of ingredients, and conditions of use.
- Part B – Cosmetic Product Safety Assessment: contains the assessment conclusions, reasoning, warnings and precautions, and qualifications of the responsible Safety Assessor.
Scope of analysis during safety assessment
The safety assessment is based on a comprehensive review of multiple elements, including:
- complete raw material documentation, including Material Safety Data Sheets (MSDS),
- toxicological evaluation of each ingredient with respect to dosage, function, and potential interactions,
- stability testing and compatibility with packaging materials,
- microbiological profile of the finished product,
- target consumer group (e.g., infants, sensitive skin users).
Safety as a foundation for compliance and competitiveness
An up-to-date and complete CPSR is a prerequisite for placing a cosmetic product on the market. It serves as evidence of compliance with current legal requirements and may be subject to inspection by competent authorities.
The report should be regularly updated, especially in cases of changes in formulation, raw material suppliers, or product characteristics. Maintaining compliance supports consumer trust and strengthens market position.
When must the CPSR be updated?
The CPSR must be revised in case of:
- changes in product composition,
- changes in raw material suppliers,
- availability of new toxicological data,
- modifications in intended use or exposure scenarios,
- updates in regulatory requirements.
Failure to update the CPSR introduces a risk of non-compliance.
5 most common mistakes made by cosmetic manufacturers
- Incomplete raw material documentation – missing SDS or toxicological data.
- Incorrect ingredient concentrations – exceeding regulatory limits.
- Lack of microbiological testing – particularly in natural cosmetics.
- Outdated CPSR – formulation changes without reassessment.
- Self-prepared CPSR without qualifications – lack of a qualified Safety Assessor leading to legal risk.
GCB – Services in Compliance Verification
GCB, as a notified body, provides services in verification of compliance with applicable regulatory documentation requirements for cosmetic products, including verification of Cosmetic Product Safety Reports (CPSRs). These services relate to regulatory conformity assessments within the scope of market access in Poland and the broader European Economic Area.
