Safety Assessment in Cosmetic Products
Product Safety Assessment Report (UGR); For a cosmetic product, it is an evaluation report made on the finished product in accordance with Article 12 of the Cosmetics Regulation, taking into account the toxicological character, chemical structure and exposure levels of the product components, the target group where the product is offered for use, or the obvious exposure characteristics of the region where the product will be applied.
A Product Safety Assessment Report (PGR);
a) It should be prepared accurately and clearly; It should be well discussed and easily understandable.
b) Its structure and content should reflect the requirements of the headings in the relevant guide.
c) If the information is not directly included in the document, a reference or an accessible source should be provided.
Product Information File (ÜBD-PIF), for all cosmetic products to be put on the market, documents related to raw materials and packaging materials (MSDS, analysis certificates, etc.), reports on the safety of the finished product, product labels, information on the production process, etc. It is a mandatory file to be kept at an address located in Turkey in accordance with the second paragraph of Article 12 of the Cosmetics Regulation.
The manufacturer has to keep the cosmetic product information file for ten years from the date the last batch of the relevant cosmetic product is placed on the market.
The information must be up-to-date and correct in keeping the product information file. Every change should be transferred to the product information file. In case of any change regarding the cosmetic product, the reason should be included in the file in addition to the change.
Product information file; change in cosmetic product formulation, serious undesirable effect, etc. cases, it should be updated accordingly.
Cosmet Group; Turkish Pharmaceuticals and Medical Devices Agency prepares your assessment reports, which is a legal requirement within the framework of the Guidelines on Safety Assessment in Cosmetic Products, in the fastest and most accurate way, and sends them to you by mail as certified and signed. All your formulations and processes related to your products are guaranteed by our Confidentiality Agreement.