The Regulation on Cosmetic Products ("Regulation") has been published in the Official Gazette dated May 8, 2023 and numbered 31676 (1st bis.) to enter into force after 6 months and the Cosmetic Regulation published in the Official Gazette dated May 23, 2005 and numbered 25823 ("Abrogated Regulation") has been abrogated
Purpose of the Regulation
The Regulation aims to harmonize with European Union ("EU") legislation on cosmetic products, in particular Regulation (EC) No. 1223/2009 of the European Parliament and of the Council of November 30, 2009.
The Main Factors Covered By the Regulation
By the Regulation drafted in order to harmonize with the EU Legislation, the following provisions have been introduced;
I. Responsible Person and Distributor
Within the scope of the Regulation, the concepts of Responsible Person and Distributor are defined and the actors responsible for the market supply of cosmetic products are determined. Thus, the definitions of Responsible Person, importer, manufacturer and distributor, which are also included in the EU Cosmetics Regulation, have been added to our legislation with the Regulation.
Pursuant to the Regulation, Responsible Persons can only be designated as natural persons and legal entities residing in Turkey and will ensure the placing of cosmetic products on the market. However, many obligations are also imposed on the natural persons or legal entities designated as responsible persons. Accordingly, responsible persons are obliged to employ technical staff, to immediately take the necessary corrective measures to withdraw or recall cosmetic products from the market if they do not comply with the Regulation, to cooperate with the Turkish Medicines and Medical Devices Agency ("Agency"), to ensure the preparation of the safety assessment report, to report relevant information to the Agency through the national electronic database and to monitor the labeling of cosmetic products.
A distributor within the scope of the Regulation is a natural person or legal entity, other than the manufacturer or importer, that has a cosmetic product on the market by taking part in the supply chain. In addition to responsible persons, the Regulation also imposes many obligations on distributors. Accordingly, distributors are also obliged to take corrective measures and cooperate with the Agency in terms of labeling, assessing whether cosmetic products comply with the requirements set out in the Regulation or, if they have grounds to do so, not placing the product on the market until it complies with the relevant requirements, bringing the product into compliance, withdrawing it from the market or recalling it.
II. Product Content Restriction
It has been regulated that cosmetic products cannot contain prohibited substances specified in the relevant annexes of the Regulation, substances that are not suitable for use, substances classified as (i) dyestuffs, (ii) preservatives, (iii) UV-filters and (iv) nanomaterials, carcinogens, mutagens and toxic substances for reproduction, which are excluded from the Regulation.
III. Product Safety Assessment Report
In order to demonstrate that a cosmetic product complies with the Regulation, the Responsible Person is required to conduct a safety assessment before placing the product on the market and to prepare a product information file and a product safety assessment report in the light of this information. Furthermore, the education level of the persons who will prepare the Product Safety Assessment Report has been changed in line with the EU Cosmetics Regulation.
With the provisions introduced, the acceptability of valid and appropriate Product Safety Assessment Reports for cosmetic products from the EU will be ensured without the need for repetition in Turkey.
IV. Support for Export
Within the scope of the Regulation, cosmetic products are included within the scope of the free sale certificate, providing incentives and support to local cosmetics producers to export.
V. Harmonization with EU Legislation
In order to ensure that the Regulation and all its annexes are in line with the Cosmetics Regulation (EC) 1223/2009, all updates to be made by the EU Commission will be reflected directly and simultaneously in the Regulation.
The Regulation and its annexes are available
here.
Aslı Pamukkale, Partner
İrem Tanık, Associate
Mehmet Oğuz Koç , Trainee Lawyer