Cosmetic Product Safety Report (KÜGR/CPSR) and Product Information File (ÜBD/PIF) are mandatory for placing cosmetic products on the market. Some points are critical in the evaluation.
Considerations for: toxicological profile of each ingredient in the formulation; prohibited and restricted substances list compliance; exposure calculations and margin of safety; stability and microbiological safety; labeling and claim compliance; notification (ÜTS/CPNP).
Incomplete or incorrect evaluation creates the risk of market pullback. ONAY Mühendislik provides safety assessment and UBD preparation service.
Assessor Qualifications
Cosmetic product safety assessment is carried out and signed by an evaluator who has the training and competence defined by the legislation. The assessor must be competent to interpret the toxicological profile of the ingredients and calculate exposure. Reports prepared with the template filling approach and without justification and signature are not considered valid in the audit.
Accuracy of Exposure Calculation
The essence of the assessment is to calculate the daily exposure for each component and establish the safety margin. The amount of application of the product, frequency of use, application area and whether it is rinsed or not are decisive in the calculation. Using non-rinsed product assumptions for a rinsed product may make the margin appear lower or higher than it actually is.
Source of Component Data
Toxicological data are compiled from supplier documentation, scientific literature and official evaluation reports. The source from which the data was taken and its date should be stated in the report. Values whose source is not shown make it impossible to determine which part of the report is affected in a subsequent legislative update.
Microbiological and Stability Data
Safety assessment is not limited to chemical components alone. Stability results, including preservative effectiveness testing, microbiological quality data and compatibility with packaging, are also input into the evaluation. The impact of packaging change on stability and migration risk is an often overlooked topic.
Situations Requiring Updates
Changing the formulation, switching to a new raw material supplier, changing the instructions for use or imposing a legislative restriction on one of the components requires renewal of the evaluation. Undesirable effect notifications should also be evaluated separately and whether they affect the safety margin should be discussed in the report.
Citation in Safety Assessment Report
The source and date of each toxicological value used in the Safety Assessment report must be stated. Values whose source is not written make it impossible to determine which part of the report is affected when the legislation is updated. The ability to update the Safety Assessment report later depends on a correctly prepared source list.
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Official full text of the regulation: KKDIK Regulation - Official Gazette.