Request a DemoPositioned at the crossroads of Europe, Asia, and the Middle East, Türkiye represents a strategically important cosmetics market with strong growth prospects. Its role as a regional trade hub, combined with well-developed commercial links with neighboring markets and a domestic population exceeding 85 million, has made Türkiye an increasingly attractive destination for international cosmetic brands and manufacturers.
Despite these market opportunities, access to the Turkish cosmetics market is subject to a comprehensive and clearly defined regulatory framework. Cosmetic products are overseen by the Turkish Medicines and Medical Devices Agency (TİTCK) and are governed primarily by Cosmetic Law No. 5324 and the Cosmetic Products Regulation No. 32184, together with supporting regulatory guidelines. These legal instruments set out detailed compliance obligations for businesses, including requirements related to ingredient use, product notification, labeling and claims.
Part 1 Regulatory Framework and Competent Authority
1.1 Main Cosmetic Regulations in Türkiye
Regulations | Introduction | Effective Date/Effective Date of Last Revision |
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The Law establishes the fundamental legal principles governing the placement of cosmetic products on the Turkish market, with the objective of ensuring that products made available to consumers are safe, effective, and of appropriate quality. It provides the overarching framework for regulatory oversight, covering key areas such as product notification, market surveillance and control, inspections of production sites, and enforcement measures. | March 30, 2005 | |
Published in the Official Gazette on May 8, 2023, the Regulation replaces the former Cosmetics Regulation No. 25823 of May 23, 2005 and aims to further align Türkiye's cosmetics regulatory system with European Union legislation, particularly Regulation (EC) No. 1223/2009. The Regulation sets out detailed requirements, including definitions, responsibilities of relevant market entities, safety assessment and product information files, notification procedures, ingredient restrictions, animal testing provisions, labeling and claims requirements, as well as rules on market surveillance, inspections, non-compliance, protective measures, and administrative sanctions. To facilitate implementation, the TİTCK has issued a series of supporting guidelines, some of which are listed below. | November 8, 2023 | |
Guideline for Using and Applying for the Product Tracking System (ÜTS) for Cosmetic Products | This Guideline provides detailed instructions for manufacturers and responsible persons on electronic applications handled by the Cosmetic Products Department of the TİTCK. It covers procedures for company registration and updates, cosmetic product notifications, notifications for cosmetic products containing nanomaterials, applications for Cosmetic Product Export Certificates (for domestically manufactured products intended solely for export), applications for studies or research conducted on volunteers using cosmetic products or raw materials, and other related processes within the ÜTS system. | July 12, 2024 (Effective Date of Last Revision) |
This Guideline aims to assist manufacturers, importers, distributors, promoters, responsible persons, media organizations, and intermediaries in understanding and complying with regulatory requirements applicable to cosmetic product claims. | October 8, 2024 (Effective Date of Last Revision) | |
Information Guide for Cosmetic Product Responsible Persons and End-Users | This Guide has been prepared to prevent potential risks arising from the improper use of cosmetic products and to promote the safe marketing and use of cosmetics in accordance with applicable legislation, providing guidance for both responsible persons and end-users. | December 7, 2023 (Effective Date of Last Revision) |
Guideline on Cosmetic Product Information File (PIF) and Responsible Technical Personnel | This Guideline provides detailed guidance on the regulatory requirements for Responsible Persons and Responsible Technical Personnel, as well as comprehensive instructions on the content, preparation, and maintenance of the PIF. | March 21, 2024 (Effective Date of Last Revision) |
Guideline on Safety Assessment of Cosmetic Products (Version 3.0) | This Guideline has been developed to guide cosmetic manufacturers in carrying out a safety assessment of a cosmetic product in accordance with Article 12 of the Cosmetics Regulation. | November 15, 2022 (Effective Date of Last Revision) |
Guidelines on the Reporting of Undesirable/Serious Undesirable Effects of Cosmetic Products | This Guideline provides detailed guidance on the monitoring, reporting, and managing of undesirable and serious undesirable effects associated with cosmetic products, with the aim of ensuring consumer safety and minimizing potential health risks. | February 1, 2024 (Effective Date of Last Revision) |
This Guideline assists cosmetic manufacturers, distributors, promoters, and media organizations or intermediaries in evaluating products that may fall within the borderline between cosmetics and other regulated product categories, such as medicinal products, medical devices, biocidal products, toys, textiles, accessories, or food products. | October 11, 2024 (Effective Date of Last Revision) | |
This Regulation lays down the procedures and principles regarding the conduct, record-keeping, reporting, validity, and other matters related to efficacy studies, safety studies, or clinical trials of cosmetic products or raw materials to be carried out on volunteers, to ensure scientific and ethical standards and the protection of the rights of volunteers, as well as to regulate the establishment, duties, and working procedures and principles of Cosmetic Clinical Research Ethics Committees. The TİTCK has also issued supplementary guidelines to support the implementation of this Regulation. | September 20, 2015 |
1.2 Competent Authority
The Turkish Medicines and Medical Devices Agency (TİTCK), operating under the Ministry of Health (MoH), is the competent authority responsible for the regulation and supervision of cosmetic products in Türkiye. In addition to cosmetics, TİTCK also oversees pharmaceuticals, medical devices, and biocidal products.
Within the cosmetics sector, TİTCK is responsible for establishing regulatory rules and technical standards governing the entire product lifecycle, including manufacturing, storage, sale, import and export, notification, marketing, and distribution. The Agency also conducts market surveillance and inspections, manages product recalls, sets safety requirements, and is empowered to authorize, license, supervise, and, where necessary, impose administrative sanctions on public and private entities and individuals engaged in cosmetic-related activities.
Part 2 Cosmetic Products
2.1 Definition
A cosmetic product is defined as any substance or preparation intended to be placed in contact with various external parts of the human body (such as the epidermis, nails, hair, lips, and external genital organs) or with the teeth and the mucous membranes of the oral cavity. The sole or primary purpose of such products is to cleanse, perfume, change appearance, protect, maintain the body in good condition, or correct body odors.
Products that claim health-related benefits; are used for the diagnosis, prevention, monitoring, treatment, or alleviation of disease; or that exert a controlling effect on harmful organisms from a chemical or biological perspective—including restricting their movement, repelling, neutralizing, or destroying them—are not considered cosmetic products.
2.2 Responsible Person and Responsible Technical Personnel
2.2.1 Responsible Person
Under Turkish cosmetics legislation, cosmetic products may be placed on the Turkish market only if a natural or legal person residing within the country is appointed as the "Responsible Person (RP)". The RP is tasked with ensuring that products made available on the market are safe and comply with all applicable regulatory requirements.
The RP must maintain continuous compliance of cosmetic products throughout their market lifecycle, take immediate corrective actions—such as withdrawal or recall—where non-compliance is identified, and promptly inform the TİTCK of any non-compliance and the corrective actions taken if a product poses a risk to human health.
Generally, the manufacturer acts as the RP for domestic products, while the importer assumes this role for imported products. However, both parties may designate another natural or legal person established in Türkiye as the RP through a written agreement. In such cases, the designated RP bears the same legal responsibilities as the manufacturer or importer, and its name and address must be clearly indicated on the product packaging.
2.2.2 Responsible Technical Personnel
The RP must employ a Responsible Technical Personnel (RTPs) with appropriate qualifications and relevant professional experience. The RTP is responsible for verifying that cosmetic products intended to be placed on the market comply with cosmetic legislation, Good Manufacturing Practices (GMP), and other relevant legislation.
Eligible RTPs are limited to specific professional categories, including chemists, biochemists, chemical engineers, biomedical engineers, biologists, microbiologists, and pharmacists. Other professional backgrounds are not accepted. Where the RP meets the relevant qualification criteria, they may also serve as the RTP. A qualified RTP can work for more than one company.
2.3 Cosmetic Product Notification
Cosmetic products are not subject to a pre-market licensing or authorization system. Instead, Türkiye operates a notification-based regime relying on declarations made by RPs. Pursuant to the Cosmetic Products Regulation No. 32184, each cosmetic product must be notified to the TİTCK via the electronic Product Tracking System (ÜTS) prior to its first placement on the market.
The notification process generally involves the following steps:
Appointment of a RP: Foreign cosmetic companies must first designate a RP established in Türkiye. The RP is responsible for product safety, regulatory compliance, and completion of all notification obligations.
Company Registration in the ÜTS System: Before submitting product notifications, the company must complete its registration separately and simultaneously via the ÜTS and the Electronic Application System (EBS). During registration, the appropriate "field of activity" (manufacturer, importer, or responsible person) must be selected. After completion, the RP may appoint RTP in the system, which becomes effective once the appointed RTP logs in and confirms the assignment.
Submission of Product Notification: Product notification is submitted electronically via the ÜTS and generally involves three stages: formulation entry, product and product set addition, and product application. During this process, detailed product information must be provided, including barcode, brand name, product name, net content, function code, formulation details, country of origin, RP and contact information, as well as labeling, packaging, and product visuals. A clear and legible copy of the original product label must be uploaded. Where the original label does not include Turkish information, an additional Turkish label and a visual representation of the product packaging must also be provided.
Updating Notification Information: The RP is required to promptly update the notification in the ÜTS system whenever any of the submitted information changes.
The TİTCK will not issue any letter or document to confirm that a cosmetic product notification has been recorded. In addition, cosmetic products containing nanomaterials are subject to a specific notification requirement: such products must be notified at least six months prior to market placement, together with detailed information on the nanomaterials used, including specifications, toxicological profiles, safety data, and reasonably foreseeable conditions of exposure.
2.4 Product Information File (PIF)
The RP is required to maintain a PIF in electronic or other appropriate format at the address indicated on the product label. The PIF must be readily accessible to the TİTCK upon request and retained for ten years after the last batch of the cosmetic product has been placed on the market.
The RP may designate a single address at which the PIF is kept, which does not need to be the manufacturing site. Where multiple addresses appear on the product label, the address at which the PIF is accessible must be clearly identified (for example, by underlining).
The PIF shall be prepared in Turkish or English and must be kept up to date. It shall contain, at a minimum, the following information:
A description of the cosmetic product;
The Cosmetic Product Safety Report;
A description of the manufacturing method and a statement of compliance with the GMP;
Evidence supporting the claimed efficacies of the cosmetic product, where justified by the nature or effect of the cosmetic product;
Data on any animal testing performed by the manufacturer, its agents, or suppliers in relation to the development or safety assessment of the cosmetic product or its ingredients, including animal testing conducted to meet legal or regulatory requirements of countries outside Türkiye and EU member states.
2.5 Safety Assessment
Before placing a cosmetic product on the Turkish market, the RP must ensure that a safety assessment has been conducted demonstrating that the product is safe for human health under normal or reasonably foreseeable conditions of use and that it complies with applicable cosmetics legislation.
The safety assessment must be performed by a qualified assessor holding a diploma or other official proof of qualification demonstrating completion of university-level education in pharmacy, toxicology, medicine, or a comparable discipline, or another training program whose equivalence is recognized by the TİTCK.
Following completion of the assessment, a corresponding product safety assessment report shall be compiled. The report consists of two parts, each containing at least the information listed below, and must be kept up to date to reflect any relevant new information generated after the product has been placed on the market.
Part A Cosmetic Product Safety Information | Part B Cosmetic Product Safety Assessment |
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2.6 Ingredients
The regulation of cosmetic ingredients in Türkiye is largely harmonized with the EU Cosmetic Products Regulation (EC) No. 1223/2009. Türkiye applies a c similar ingredient management system based on five key annexes:
Annex II: List of Substances Prohibited in Cosmetic Products
Annex III: List of substances Which Cosmetic Products Must Not Contain Except Subject to Restrictions Laid down
Annex IV: List of Colorants Allowed in Cosmetic Products
Annex V: List of Preservatives Allowed in Cosmetic Products
Annex VI: List of List of UV Filters Allowed in Cosmetic Products
Furthermore, there are additional requirements for CMR substances (those identified as carcinogenic, mutagenic, or toxic for reproduction) and Nanomaterials. Category 1A and 1B CMR substances are banned in cosmetics, while Category 2 CMR substances cannot be used unless explicitly evaluated as safe by the TİTCK.
As noted above, cosmetic products containing nanomaterials are subject to prior notification. It is recommended that specifications, toxicological profiles, safety data, and conditions of exposure be submitted during ÜTS notification and clearly documented in the PIF.
2.7 Labeling
Cosmetic products placed on the Turkish market must bear mandatory labeling information on both the inner and outer packaging in a permanent, easily legible, and clearly visible manner. Required labeling elements include:
Name/registered trade name and address of the Responsible Person
Net content (ml/g)
Minimum durability date, or the period of opening (for cosmetics with a shelf life exceeding 30 months)
Special precautions or warnings for use
Batch number or serial number
Function of the cosmetic product (if not clear from the product presentation)
List of ingredients
Country of origin for imported products
The ingredient list must be preceded by the term "Ingredients" or an equivalent expression in Turkish or English and must use common ingredient names, such as INCI names. Ingredients shall be listed in descending order of weight at the time of formulation, with ingredients present at less than 1% permitted to appear in any order after those exceeding 1%. Fragrances must be indicated as "parfum" or "aroma," nanomaterials must be identified with the term "nano" in brackets following the ingredient name, and colorants are subject to specific listing rules, including the optional use of CI numbers.
Where space constraints make on-pack labeling of precautions and ingredient lists impractical, such information may be provided via leaflets, labels, tapes, tags, or cards enclosed with or attached to the product, with appropriate symbols or references on the packaging. Certain key elements—such as net content, durability information, precautions, and product function—must be presented in Turkish.
2.8 Claims
As a general principle, cosmetic claims must not imply characteristics or functions that the product does not possess, regardless of the form in which the claim is presented, including text, names, trademarks, pictures, and other signs. To support consistent enforcement, the TİTCK has issued a guideline incorporating the EU common criteria for cosmetic claims, as well as specific provisions addressing "free from" claims and "hypoallergenic" claims.
The common criteria for cosmetic claims include.
Legal compliance
Truthfulness
Evidential support
Honesty
Fair competition
Informed decision making
"Free from" claims should not be made for ingredients prohibited by the cosmetic regulations. Where such claims are used on cosmetic product packaging, an analytical test report confirming the absence of the specified substances must be obtained from a laboratory accredited in accordance with TSE ISO/IEC 17025 and uploaded to the ÜTS during the notification process.
For products claiming to be "hypoallergenic," the presence of known allergens, allergen precursors, or mixtures thereof should be totally avoided. As the term does not guarantee the absence of allergic reactions in all circumstances, claims suggesting that a product is completely non-allergenic are prohibited. The Responsible Person must provide appropriate evidence supporting the product's low allergenic potential.
In addition, claims implying medical, therapeutic, health-related, antibacterial, or pharmacological effects—such as diagnosing, treating, or preventing disease, or modifying physiological functions—are strictly prohibited, as they would reclassify the product outside the cosmetic category. All cosmetic claims must be truthful, verifiable, supported by evidence, must not suggest authorization or endorsement by a competent authority, and must not attribute characteristics to the product that it does not possess.
2.9 Animal Testing
Türkiye enforces a strict ban on animal testing for cosmetics, largely aligned with the EU regulatory approach. It is prohibited to place products on the market if either the final formulation or its ingredients have been tested on animals using methods other than OECD-validated and TİTCK-accepted alternative methods. Furthermore, the performance of animal testing on finished cosmetic products within Türkiye is not allowed, nor is the performance of animal testing of ingredients or ingredient combinations using non-validated methods.
Limited exemptions may be granted only in exceptional cases where a widely used ingredient raises serious safety concerns, no suitable alternative testing methods are available, and the need for animal testing is scientifically justified and supported by a detailed research protocol, with notification to the relevant authorities.
2.10 Post-market Surveillance
Post-market surveillance of cosmetic products in Türkiye is carried out by the TİTCK to ensure that products placed on the market comply with the Cosmetics Regulation and do not pose risks to human or public health. Surveillance activities include market inspections, review of PIF, physical checks, sampling, and laboratory testing where necessary, as well as monitoring compliance with GMP.
Responsible persons and distributors must promptly report any serious undesirable effects, providing product identification and details of corrective actions taken. Where safety concerns arise regarding specific ingredients, the authority may request product lists and concentration data to support risk assessment, enforcement actions, and consumer protection measures.
