COSMETIC PRODUCT VIGILANCE
TOLLEON has developed a dedicated Cosmetic Vigilance System, ensuring user safety while also offering monitoring services for other European and international cosmetic product companies.
At TOLLEON, comprehensive monitoring of our products’ market presence is crucial to protect consumer health, minimize adverse event recurrence, and ensure top-tier product quality and services. Our Vigilance System establishes a Complete Product Information Record, enables public access to certain information, assesses Serious Undesirable Effects (SUEs), submits Reports to Authorities, and disseminates information to prevent recurrence and mitigate adverse effects.
According to European Guidelines, all companies producing or marketing cosmetic products in the EU must maintain a Procedure System to effectively respond to reports of undesirable effects from normal or foreseeable product use. This includes documentation, evaluation, and future risk assessment.
CLARIFICATIONS
Adverse Event
The identification of an Adverse Event is conducted under Regulations set by European Authorities. It is considered valid based on the completeness of the source data, the precise description of the situation, and the readability of the product information.
Undesirable Effect (UE)
An Undesirable Effect (UE) refers to an unwanted reaction to a cosmetic product that occurs during its normal and foreseeable use (e.g., irritation or allergic skin reaction).
Serious Undesirable Effect (SUE)
A Serious Undesirable Effect (SUE) is considered serious when confirmed by a healthcare professional to result in temporary or permanent functional impairment for a significant period, disability, hospitalization, or immediate life-threatening risk and must be reported to National Authorities.