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 protect public health. The products produced and placed on the Turkish market must comply with the Cosmetic Law and the Cosmetic Regulation.
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. It is also worth mentioning that TMMDA works on the amendment of Cosmetic Regulation in order to uniform it with the EU regulations.
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 cosmetic manufacturers’ 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 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/her 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 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 by 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.
Advertising
Different from pharmaceuticals, cosmetic advertisements are open to the general public, and cosmetics can be promoted and marketed through mass media directly to the end-user of these products.
The standards, procedures, and principles of promotion of cosmetics are specified in TMMDA’s Guideline on the Promotion Activities of Cosmetic Products (“Cosmetic Promotion Guideline”). The Cosmetic Promotion Guideline binds all producers as defined in the Cosmetic Regulation and addresses all cosmetic manufacturers, distributors, promoters, and intermediaries.
The requirements arising from the principle of protecting consumers and preventing unfair competition constitute the general limits in the advertisement of all products, such as informing the consumer right about the quality, quantity, potency, purity, standard, price, intended use, and usage instructions and not intentionally misleading or causing consumers to misunderstand through deceptive marketing strategies and prohibition of implicit advertisement. Any advertisement that can mislead the consumer regarding any feature of the product is prohibited according to the Law on the Protection of the Consumer Numbered 6502 and the Regulation on Commercial Advertisement and Unfair Commercial Practices published in the Official Gazette dated 10 January 2015 numbered 29232.
However, there are two important points to especially consider when promoting cosmetics:
(i) In product promotions, any phrases, claims, advertisements such as “to treat and/or prevent, diagnose or treat any disease”; phrases related to “correcting, regulating and/or altering physiological function”, statements claiming “to renew, correct and/or change functions as a result of pharmacological, immunological and/or metabolic effects, or statements referring to the effect of a medicinal product for human use must not be used.
(ii) The name or logo of the MoH and the TMMDA must not be used.
Cosmetic product advertisements cannot imply that the product has a healing qualification. Any implication of treatment or prevention of diseases and diagnoses, the effect of renewal or correction, or any reference to a medicinal product cannot be involved in the advertisements.
The Advertisement Board and court decisions should also be remarked on since they impose strict sanctions to ensure the protection of the related market and the advertisement mentioned. For instance, the decision made by the Advertisement Board (2014/1173, T. Numbered 247, Date: 12.04.2016) can be regarded. In the decision, it has been stated by the Advertisement Board that "All cosmetic products subject to the Cosmetic Legislation must be products that are applied to the external parts of the human body and whose effects are temporary; in this context, the expression "permanent solution to hairs" is considered to be misleading and exceeding the definition of the cosmetic product since it implies that it treats the related subject… also the information and documents proving the allegations made in relevance were not presented". It is understood that the Advertisement Board strictly examines the advertisement about whether they exceed the definition of 'temporary' and also the proof of the allegations presented.
As a commonly used marketing strategy, distributing free samples is also a part of cosmetic promotions. The Cosmetic Promotion Guideline also touches upon this issue and requires all free samples of cosmetic products to be produced at the same cosmetic production sites, to comply with the provisions of the Cosmetics Regulation related to inside and outside packaging and labeling, and to contain the all information required in the normal cosmetic products.
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.
Disclaimer
This article is originally published by CETINKAYA Attorneys-at-Law
CETINKAYA is a full-service law firm based in Istanbul servicing local and international clients. Our lawyers have extensive expertise in advising on dispute resolution, business crime, technology, data protection, and intellectual property.
CETINKAYA prides itself on helping clients navigate their way through a constantly changing and challenging legal landscape. With a seamless multi-disciplinary approach positioned at the intersection of industry knowledge and legal expertise, we provide our clients with legal solutions that are tailored to their needs in Turkey.
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