CPRS (CPSR) - Cosmetic Product Safety Report Reporting Service

KDG (Cosmetic Safety Assessment) and CPSR are terms used in the medical device and cosmetic industry, related to product tracking and registration processes. These terms are generally involved in the Turkish Medicines and Medical Devices Agency's (TİTCK) Product Tracking System (ÜTS) and cosmetic product registration processes.

The Cosmetic Product Safety Assessment Report (KDG Report) is a safety assessment report prepared to document that cosmetic products do not harm human health, in accordance with the European Union Cosmetics Regulation (1223/2009/EC) and the Turkish Cosmetics Regulation. This report is prepared to demonstrate that the safety of cosmetic products has been ensured and that they comply with regulatory requirements before being placed on the market.

Content of the KDG Report

The Cosmetic Product Safety Assessment Report consists of two main parts:

1. Safety Information File (Part A):

* Detailed analysis of product components (INCI names, concentrations, etc.).

* Raw material safety information and toxicological profiles.

* Physical, chemical, and microbiological properties of the product.

* Stability test results regarding the product formulation.

* Instructions for use and warnings.

* Exposure assessment (daily amount of product used and routes of exposure).

2. Safety Assessment (Part B):

* Overall safety assessment of the product.

* Assessment of potential risks and toxicological effects.

* Expert opinion on whether the product is safe as a conclusion.

CPSR (Cosmetic Product Safety Report)

What is it? CPSR is a report prepared to evaluate the safety and suitability of a cosmetic product for human health. This report is prepared in accordance with the European Union Cosmetics Regulation (EC 1223/2009) and Turkey's relevant cosmetic legislation.

Content: The CPSR consists of two main parts:

* Part A (Product Safety Information): Contains technical information such as the product's formulation, toxicological profile, chemical and physical properties.

* Part B (Product Safety Assessment): Contains a detailed analysis and risk assessment conducted by a safety assessor.

Who prepares it? This report must be prepared by individuals who are experts in toxicology, dermatology, or chemistry.

Requirement: The CPSR is mandatory for legally placing cosmetic products on the market.