Table of contents
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).
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.
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.
