Introduction
Turkey's position as a bridge between the leading European cosmetic companies, and Asian and Middle East countries where there is a high demand for cosmetic products is significant. Additionally, because of a considerable increase in domestic consumer interest, the cosmetic product market in Turkey grows 10% each year.1 Although cosmetics are not generally prescribed or used for medical treatments, they are used on the human body, which requires the cosmetic industry to be regulated in a manner that not only protects human health but also considers commercial marketing and advertising potential.
Organization
The Ministry of Health ("MoH") and its competent authority the Turkish Medicine and Medical Devices Authority ("TMMDA") set forth the principles and procedures for the production, distribution, clinical trials, promotion, market release, surveillance, and safety standards of cosmetic products. Both the MoH and the TMMDA track, control and audit cosmetics released to the market to ensure product safety and to protect public health. The products produced and placed on the Turkish market must comply with the Cosmetic Law and the Cosmetic Regulation.2
Regulation
Cosmetic Law No. 5324 published in the Official Gazette dated 30 March 2005, numbered 25771 ("Cosmetic Law") regulates the principles regarding the declarations that must be made to competent authorities before cosmetic products can be released onto the market to ensure that they reach the public in a safe, effective, and high-quality manner. It also regulates market surveillance, auditing, and the inspection of production sites. In relation to this Law, the Cosmetic Regulation published in the Official Gazette dated 23 May 2005, No. 25823 ("Cosmetic Regulation") regulates technical characteristics and requirements; packaging information; declarations; market releases; market surveillance and auditing; product site inspections; and the measures that should be taken during inspections. The main aims are to ensure that cosmetic products reach the public with accurate and understandable information and in a manner that prevents misunderstanding and does not give rise to adverse health effects.
The Regulation on Efficacy and Safety Studies and Clinical Trials of Cosmetic Products or Raw Materials published in the Official Gazette dated 20 September 2015 and numbered 29481 regulates the procedures and principles regarding efficacy and safety studies or clinical trials for cosmetic products or raw materials carried out on volunteers, ensuring scientific and ethical standards, and protecting volunteers' rights.
The TMMDA publishes a number of guidelines to regulate most matters related to cosmetics, ranging from safety assessment, analysis, clinical trials, and product claims to reporting cosmetics' mal effects, ethics boards, voluntary experiments, and so on.
Declarations, Responsibilities and Inspections
Turkish cosmetics regulations do not require a license or permission for the production or sale of cosmetic products, they do, however, adopt a declaration system that is based on a manufacturer's own statements. According to the Cosmetic Law, a declaration must be made to the MoH before a cosmetic product's first market release. Any changes that occur to the cosmetic product post-release or to the manufacturer must also be notified to the MoH. The regulation of Turkey's cosmetic industry is generally based on the system of a manufacturer's obligation to make declarations to the MoH and to comply with the regulations and required standards, and the MoH's inspection and market control. The Regulation requires manufacturers to ensure their products comply with the Good Manufacturing Practices and with the Regulation and its annexes which regulate the technical and chemical requirements and standards before they are released to the market.
The definition of "manufacturer" under the Cosmetic Law and the Cosmetic Regulation does not only refer to real or legal persons who manufacture products. A natural or legal person who produces, manufactures, or develops a cosmetic product or who introduces himself/herself as a manufacturer by placing his/him name, trade mark or diacritical mark on a product; or a representative or importer authorized by a manufacturer if the manufacturer is outside of Turkey; or any natural or legal person involved in the supply chain of a product or whose activities affect the safety characteristics of the product is considered to be a "manufacturer" under Turkish cosmetic regulations.
The general framework of manufacturers' responsibilities is determined in the Cosmetic Law:
- to notify the MoH before producing, packaging, opening, or operating an import establishment or expanding the field of activities of an organization or of any changes made after the first declaration,
- to employ responsible technical staff and qualified personnel adequate for the scope of services,
- to notify product safety information to the MoH Poison Research Center before market release and to update this information through making regular safety assessments,
- to take necessary measures to ensure that a cosmetic product will not harm human health when applied under normal and recommended conditions or foreseen conditions of use when considering the presentation, packaging, use of the product or the information provided,
- to comply with the principles specified in the Cosmetic Regulation related to packaging and label information for cosmetic products,
- to keep a cosmetic product file including all the up-to-date information required by the Cosmetic Regulation,
- to send the information requested by the MoH duly and on time,
- to comply with the principles related to cosmetics production sites determined by the MoH.
The MoH takes necessary decisions and carries out processes related to production site inspections, market surveillance and inspection, sampling, warnings, product withdrawal, product destruction, product remediation and the closure of production sites. By defining general procedures and benchmarks for product standards, the MoH refrains from prohibiting, restricting, or limiting the market release of any cosmetic product that complies with the standards.
Declarations are made through the TMMDA's Product Tracking System ("UTS"). Manufacturers must register their firms, as well as their responsible technical staff to the UTS. Following registration, an electronic application is made for the declaration of the relevant cosmetic product through the UTS. The MoH does not make confirmation of the accuracy of the information upon declaration, all the manufacturers are held responsible for the information in their notifications (or for their omissions), as well as all the responsibilities that may arise in cases of noncompliance with the regulations.
Conclusion
As an industry with a worldwide market that is growing even under pandemic conditions, the cosmetic industry remains one of Turkey's most in-demand and valuable consumer business segments. This article aims to highlight the key points of regulation without including all aspects of the cosmetic industry or the general responsibilities of cosmetic companies. You can find more detailed information by following our article series.
With thanks to Elif Sıla Taşlıçay for her help on this article.
Footnotes
1. Turkish Ministry of Trade's report on Cosmetic Industry, 2021. https://ticaret.gov.tr/data/5b87000813b8761450e18d7b/Kozmetik%20Sekt%C3%B6r%20Bro%C5%9F%C3%BCr%C3%BC-Mart%202021.pdf
2. https://ceway.eu/international-services/turkey/
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