Turkiye: Turkish Medicine and Medical Devices Agency Published Cosmetic Product Regulation

ARQon
Jun 26, 2023
2 min read

Updated: Sep 5, 2023

The Cosmetic Product Regulation was published on 8 May 2023 by the Turkish Medicines and Medical Devices Agency (TITCK) with the purpose of regulating procedures and principles related to cosmetic products on the market. This initiative may help to upgrade the protection level of human health.

The Regulation has been amended according to the European Parliament and Council Cosmetic Regulation (EC)1223/2009 and will take effect 6 months after the official publication. Any cosmetic products on the market that comply with the regulation, may continue to be marketed up until 2 years after the enforcement.

Among the principle prioritized in the regulation are:

The Responsible Person is the manufacturer of any cosmetic products manufactured based in Turkiye. The manufacturer outside Turkiye and the importer should hire a local Responsible Person to handle the compliance procedures. The Responsible Person may hire technical staff, for instance, chemists, microbiologists, or chemical engineers, to assist in supervising product compliance with the regulations and take corrective actions if there is any compliance issue related to the cosmetic products.
If there is any request for a Free Sale certificate, it should be applied by the Responsible Person via an electronic database.
The product information file should keep a record of the product description, manufacturing method, safety report, statement of conformity, possible effect, and animal test report. The file must be written in Turkish or English and kept for 10 years after the last marketing of a cosmetic product.
The manufacturer or Responsible Person must notify the agency of the presence of substances in the form of the nanomaterial or classified as carcinogenic, mutagenic, or toxic for reproduction.
Information about the manufacturer, packaging contents, the minimum shelf life of cosmetic products, precautions or warnings, cosmetic product identification, and product ingredients must be labeled inside or outside the packaging. The leaflets or informational brochures can be attached together with the packaging.
The authorities will periodically monitor the monitoring process to ensure that all cosmetic products circulating in the market comply with regulations.

With the new regulation enforcement, the agency expects all cosmetic products circulating on the market to be legally registered and comply with regulations. In addition, accepting cosmetic products that comply with EU regulations helps facilitate market movement and export procedures for manufacturers exporting cosmetic products to the EU market.