Obligations of the Responsible Person under the Guideline on the Notification of Adverse Effects/Serious Adverse Effects of Cosmetic Products to the Agency

Introduction

Turkish cosmetic regulations establish a comprehensive framework that safeguards product safety both before placement on the market and throughout a product’s market life. Central to this framework is the “responsible person,” who must ensure compliance with safety standards and full adherence to applicable legislation. A primary duty of the responsible person is the systematic monitoring of adverse effects and the effective management of related notification processes to protect consumer safety after market entry. This article assesses these obligations under the “Guideline on the Notification of Adverse Effects/Serious Adverse Effects of Cosmetic Products to the Agency”[1] (“Guideline”) issued by the Turkish Medicines and Medical Devices Agency (“TMMDA” or the “Agency”).

The Sector, Relevant Legislation, and the Concept of the Responsible Person

The Turkish cosmetics sector is notable domestically and internationally for its dynamism and rapid growth. According to the 2023 Ministry of Trade Cosmetics Sector Report, the cosmetics and personal care market has grown at an average annual rate of 10%, and Turkey ranks 29th among the world’s largest cosmetics importers.[2] This growth compels all sector stakeholders to comply fully with applicable legislation and to implement regulatory health and safety standards with rigor. These requirements are critical for market sustainability and the preservation of competitive advantage. The report “Mirror, Mirror on the Wall: What is the Beauty Compass in Our Country?” prepared by L’Oréal Türkiye and Ipsos indicates that Turkey is expected to make the largest contribution to European beauty market growth in 2025, at 16%.[3]

The legal framework for cosmetic products in Turkey is set out in the Cosmetics Law No. 5324[4] (“Law”) and the Cosmetic Products Regulation[5] (“Regulation”) issued under the Law. Article 6 of the Regulation defines the “responsible person” as the natural or legal person who ensures that products placed on the market comply with obligations under the relevant legislation. A responsible person established in Turkey must be designated for every cosmetic product placed on the market.

For products manufactured in Turkey, the manufacturer may serve as the responsible person, or another person may assume this role by written agreement. If the manufacturer is established abroad, a Turkey-based person must be appointed as the responsible person. For imported products, the responsible person is, as a rule, the importer, unless changed by written agreement.

The responsible person’s obligations continue for as long as the product remains on the market. In this context, the obligation to report serious adverse effects, set out in Article 26 of the Regulation, and related details are addressed in the Guideline issued by the TMMDA.

The Concepts of Adverse Effect and Serious Adverse Effect

The Regulation and the Guideline clearly define “adverse effect” and “serious adverse effect.” An adverse effect is any adverse change in human health resulting from the normal or reasonably foreseeable use of a cosmetic product. A serious adverse effect refers to outcomes such as “temporary or permanent functional impairment, disability, hospitalization, congenital anomalies, or a sudden life-threatening risk or death” following use of a cosmetic product. This distinction clarifies the scope and urgency of notification for regulators and responsible persons.

Obligations of the Responsible Person:

Establishment and Management of the Cosmetovigilance System

Under Article 6 of the Guideline, the responsible person must establish and effectively operate a cosmetovigilance system to collect, analyze, and monitor adverse effects. Cosmetovigilance is a post-marketing safety mechanism that enables evaluation of user reports and timely implementation of necessary measures. By ensuring continuous and effective monitoring of the product’s safety profile after market placement, the system aims to minimize potential harm.

Maintaining Records and Keeping the Product Information File Up to Date

The responsible person must record all product-safety information comprehensively, update it regularly, and maintain it within the Product Information File (“PIF”). Upon the TMMDA’s request, the relevant product’s PIF and sales data must be provided without delay.

Reporting Serious Adverse Effects to the TMMDA

The responsible person must report serious adverse effects to the TMMDA within at least 15 business days. This period begins on the date the causality assessment is completed.[6] The assessment analyzes the possible cause-and-effect relationship between the product and the adverse effect.[7] Under Article 7 of the Guideline, only effects considered to have occurred as a result of correct use—based solely on the cosmetic product’s packaging information—and attributable to the product fall within this reporting obligation. Adverse effects arising from misuse are outside the scope of cosmetovigilance because they break the causal link. Article 7 also allows end users and healthcare professionals to report directly to the TMMDA via the Product Tracking System (Ürün Takip Sistemi, “ÜTS”); reporting is not limited to the responsible person.

Evaluation and Conclusion

Ensuring the safety of cosmetic products extends beyond pre-market processes and requires careful monitoring of adverse effects during product use. Accordingly, the responsible person must establish a cosmetovigilance system, keep product-related data in the PIF updated, and report serious adverse effects to the TMMDA within 15 business days following a causality assessment. Full compliance is critical for regulatory adherence, protection of public health, maintenance of consumer trust, and sector sustainability. Pursuant to Article 31 of the Regulation, if the responsible person fails to fulfill certain duties and obligations, the Agency may prohibit or restrict the product’s availability on the market, or withdraw or recall the product.

 References

2023 Yılı Ticaret Bakanlığı Kozmetik Sektör Raporu. (2023). Retrieved from T.C. Ticaret Bakanlığı: https://ticaret.gov.tr/data/5b87000813b8761450e18d7b/Kozmetik%202023.pdf

5324 Sayılı Kozmetik Kanunu. (2005, 03 30). Retrieved from T.C Cumhurbaşkanlığı Mevzuat Bilgi Sistemi: https://www.mevzuat.gov.tr/mevzuat?MevzuatNo=5324&MevzuatTur=1&MevzuatTertip=5

Kozmetik Ürünler Yönetmeliği. (2023, 05 08). Retrieved from T.C Cumhurbaşkanlığı Mevzuat Bilgi Sistemi: https://www.mevzuat.gov.tr/mevzuat?MevzuatNo=40405&MevzuatTur=7&MevzuatTertip=5

Kozmetik Ürünlerin İstenmeyen Etkilerinin/Ciddi İstenmeyen Etkilerinin Kuruma Bildirimine İlişkin Kılavuz. (n.d.). Retrieved from Turkey Tıbbi Cihaz ve İlaç Kurumu: https://www.TMMDA.gov.tr/mevzuat/kozmetik-urunlerin-istenmeyen-etkilerinin-ciddi-istenmeyen-etkilerinin-kuruma-bildirimine-iliskin-kilavuz-surum-1-0-27122018172902

Kozmetovijilans. (n.d.). Retrieved from T.C. Sağlık Bakanlığı Turkey Tıbbi Cihaz ve İlaç Kurumu: https://www.TMMDA.gov.tr/faaliyetalanlari/denetim/kozmetovijilans

Köse, Ö., Sabuncuoğlu, S., Erkekoğlu, P., & Koçer Gümüşel, B. (2018). Kozmetovijilans: Avrupa ve Turkey’deki Güncel. Retrieved from FABAD Journal of Pharmaceutical Sciences: https://dergi.fabad.org.tr/index/pdf/volum43/Issue1/79-90.pdf

L’Oréal, Turkey’nin Güzellik Pusulasını Açıkladı. (2025, 02 14). Retrieved from Fortune Turkey: https://www.fortuneturkey.com/loreal-turkiyenin-guzellik-pusulasini-acikladi