The 'Guideline on the Cosmetic Product Information File, the Responsible Technical Staff, and the Product Safety Assessor and Their Training' has been repealed and replaced with the 'Guideline on the Cosmetic Product Information File and the Responsible Technical Staff.' To guide responsible persons, responsible technical staff, and product safety assessors on the training and certification required for preparing the cosmetic product safety assessment report, the 'Guideline on the Product Safety Assessor, Their Training, and Certification' has been published.

The Regulation Amending the Cosmetic Products Regulation has been published in the Official Gazette, numbered 32480, dated 05.03.2024. [Link to the Official Gazette] This notification is provided to all relevant parties.

The 'Guideline on the Reporting of Undesirable Effects/Serious Undesirable Effects of Cosmetic Products' has been updated. You can access the current guideline via the following link: https://www.titck.gov.tr/duyuru/kozmetik-firmalarinin-dikkatine-02022024191945

With the official approval dated 12.07.2024 and numbered 19303, the “Guide on Electronic Transaction Processes for Cosmetic Activities” was updated and entered into force as the “Guide on the Use and Applications of the Product Tracking System for Cosmetic Products”.

In the fourth quarter of 2023 (October-November-December), the Cosmetic Inspection Department of the Deputy Chairmanship of the Inspection Services of the Turkish Medicines and Medical Devices Agency conducted market surveillance and inspection activities for cosmetic products. As a result, non-compliant products (products that violate technical regulations and pose risks) were identified, and administrative sanctions (administrative fines, corrective actions, recalls, and destruction procedures) were imposed on these products. The 2023 cosmetic inspections were planned to detect non-compliant (technical regulation-violating, unsafe/risky) products in the market through risk analysis. As a result of effective inspections, 98% of the inspected products (871) were found non-compliant (857), achieving the intended outcome. Number of inspected cosmetic products: 871 Number of compliant products: 14 Total number of non-compliant products: 857 Number of risky products: 4 Number of products violating technical regulations: 853 Total fine imposed due to non-compliance: 190,000 TL Other fines imposed within the framework of the legislation: 30,000 TL Total fine: 220,000 TL 585 counterfeit/illegal perfumes and deodorants reported by courts/prosecutors, law enforcement agencies, and other public institutions, and identified by our Agency, have been classified as unsafe/risky products under the Turkish Cosmetic Law No. 5324. For these products, which have unknown manufacturers, only destruction decisions have been made. You can access the list at the following link: https://www.titck.gov.tr/duyuru/kozmetik-urunlere-iliskin-2023-yili-dorduncu-ceyrek-denetim-verileri-15012024115656

With the official approval dated 12.07.2024 and numbered 19303, the “Guide on Electronic Transaction Processes for Cosmetic Activities” was updated and entered into force as the “Guide on the Use and Applications of the Product Tracking System for Cosmetic Products”.

With the approval dated 12.07.2024 and numbered 19303, the "Guideline on Electronic Process Procedures for Cosmetic Activities" has been updated and put into effect as the "Guideline on the Use of the Product Tracking System and Applications for Cosmetic Products."

Attention Cosmetic Companies: The updated versions of the guidelines titled “Guidelines for Cosmetic Product Safety Evaluators, Training, and Certification” and “Guidelines for Products Bordering on Cosmetics” have come into effect as of June 14, 2024, with official decree number 18986. For your information.

As is known, in Annex V of the Biocidal Products Regulation, Product Type-1 human hygiene products are defined as “Biocidal products in this group are used for human hygiene; their primary purpose is the disinfection of the skin and scalp, and they are applied to or come into contact with human skin and scalp.” The relevant definitions in Regulation 528/2012 on Biocidal Products are also stated in this manner. Additionally, in the guide "Biocidal Products Regulation Guide: Part 2 Efficacy – Section B+C: Measurement and Evaluation," the following statements are explicitly mentioned for Product Type-1 (PT-1) biocidal products: “Products intended for the disinfection of damaged skin (e.g., wound disinfection) or for the disinfection of undamaged skin prior to a patient's medical treatment (e.g., pre-operative skin disinfection and pre-injection disinfection) and products with medical use claims are always classified as human medicinal products (fall under Directive 2001/83/EC on human medicinal products). PT-1 biocidal products mainly consist of hand sanitizers, which may also include wrist and forearm disinfection. When applying for a license for a PT-1 biocidal product, a detailed explanation of the intended use must be provided to prevent the licensing of human medicinal products or cosmetic or medical uses as biocidal products (e.g., the statement "skin disinfection" is insufficient).” Within this scope, with the approval of our Institution's Presidential Authority dated 07.06.2024 and numbered E-24931227-512.99-18893; For products intended to include statements such as "around the wound" and/or "preparing the surgical site before surgery, disinfecting/antisepsis of the area to be treated before injection/lumbar puncture" on their labels, an application for licensing as a human medicinal product must be made. For products already licensed under Product Type-1 but containing medical use statements on their labels, if it is desired that these products continue to be marketed as biocidal products, these statements must be removed from the labels, and a label registration application must be submitted. In this context, biocidal products for which an application for a human medicinal product license is submitted by 01.01.2027 and reported to the Cosmetic Products Department, or those wishing to remain on the market as biocidal products and for which the relevant medical claims have been removed from the label and a label registration application submitted, will be allowed to remain on the market in their current form until the expiration date. It is emphasized that the licenses of biocidal products that do not remove the relevant statements from their labels and submit a label registration application or apply for a human medicinal product license by 01.01.2027 will be canceled. This information is hereby communicated to all relevant parties.

The Guide for Cosmetic Product Safety Assessors, Training and Documentation has been updated. The guide is attached and all training to be provided after the effective date of the guide, 21.03.2024, must be provided within the scope of this guide. Documents for training outside the scope of this guide after 21.03.2024 will not be accepted. For your information.

During the period of January-February-March 2024, the Department of Cosmetic Inspection under our Vice Presidency conducted market surveillance and inspection activities on Type-1 (hand sanitizers, antibacterial liquid soaps, etc.) and Type-19 (insect repellents, etc.) biocidal products, which directly contact the human body. As a result, non-compliant products (those violating technical regulations and posing risks) were identified, and administrative sanctions (administrative fines, recalls, and disposal processes) were applied to these products. The 2024 biocidal product inspections were planned to identify non-compliant (violating technical regulations and risky) products through risk analysis. As a result of effective inspections, 11 products were found to violate technical regulations, and 5 products were identified as posing risks. Information about the 5 risky products has been announced on our institution's website. Additionally, information about risky products has been added to the list of risky products available at the following URL: https://www.titck.gov.tr/faaliyetalanlari/denetim/tip-1-ve-tip-19-biyosidal-guvensiz-urunler Number of Type-1 and Type-19 Biocidal Products Inspected: 32 Total Number of Non-Compliant Products (Risky and Violating Technical Regulations): 16 Number of Risky Products: 5 Number of Products Violating Technical Regulations: 11 Total Administrative Fines Imposed Due to Non-Compliance (Risk and Technical Regulation Violations): 609,516 TL

As a result of the market surveillance and inspection activities of cosmetic products conducted by our Vice Presidency's Department of Cosmetic Inspection for the first quarter of 2024 (January-February-March), non-compliant products (those violating technical regulations and posing risks) were identified, and administrative sanctions (administrative fines, corrective actions, recalls, and disposal processes) were imposed on these products. The 2024 cosmetic inspections were planned with a focus on identifying non-compliant (violating technical regulations, risky) products in the market through risk analysis. As a result of effective inspections, 92% of the inspected products (263 out of 287) were found to be non-compliant, achieving the intended outcome. Number of cosmetic products inspected: 287 Number of compliant products: 24 Total number of non-compliant products: 263 Number of risky products: 147 Number of products violating technical regulations: 116 Total fines imposed due to non-compliance: 160,000 TL Other fines imposed within the framework of legislation: 10,000 TL Total fines: 170,000 TL

An update process has been initiated for the Cosmetic Products Regulation, which has been prepared in alignment with the 1223/2009 (EC) Cosmetics Regulation, in accordance with the EU Commission Regulations 2024/858 and 2024/996.

The "Guide on Cosmetic Product Information File, Responsible Technical Personnel, Product Safety Assessors and Training" has been repealed and replaced by the "Guide on Cosmetic Product Information File and Responsible Technical Personnel", - The "Guide on Cosmetic Product Safety Assessors, Training and Certification" has been published to guide the responsible person, responsible technical personnel and product safety assessors regarding the training and documentation that the product safety assessor who will prepare the cosmetic product safety assessment report must receive.

The Regulation on Amendments to the Cosmetic Products Regulation was published in the Official Gazette dated 05.03.2024, numbered 32480. https://www.resmigazete.gov.tr/eskiler/2024/03/20240305-4.htm Announced to the relevant parties.

The Guide for Notification of Adverse Effects/Serious Adverse Effects of Cosmetic Products has been updated. You can access the updated guide from the link below. https://www.titck.gov.tr/duyuru/kozmetik-firmalarinin-dikkatine-02022024191945

During the period of October-November-December 2023, the Department of Cosmetic Inspection under the Vice Presidency of the Turkish Medicines and Medical Devices Agency conducted market surveillance and inspection activities on Type-1 (hand sanitizers, antibacterial liquid soaps, etc.) and Type-19 (insect repellents, etc.) biocidal products, which come into direct contact with the human body. As a result, non-compliant products (those violating technical regulations and posing risks) were identified, and administrative sanctions (administrative fines, recalls, and disposal processes) were applied to these products. The 2023 biocidal product inspections were planned to identify non-compliant (violating technical regulations and risky) products through risk analysis. As a result of effective inspections, 20 products were found to violate technical regulations, and 2 products were identified as posing risks. Information about the 2 risky products has been announced on our institution's website. Additionally, information about the risky products has been added to the list available at the following URL: https://www.titck.gov.tr/faaliyetalanlari/denetim/tip-1-ve-tip-19-biyosidal-guvensiz-urunler Number of Type-1 and Type-19 Biocidal Products Inspected: 39 Total Number of Non-Compliant Products (Risky and Violating Technical Regulations): 22 Number of Risky Products: 2 Number of Products Violating Technical Regulations: 20 Total Administrative Fines Imposed Due to Non-Compliance (Risk and Technical Regulation Violations): 217,920 TL

The Department of Cosmetic Inspection under the Vice Presidency of Inspection Services at the Turkish Medicines and Medical Devices Agency identified non-compliant products (those violating technical regulations and posing risks) during market surveillance and inspection activities of cosmetic products in the fourth quarter of 2023 (October-November-December). Administrative sanctions (administrative fines, corrective actions, recalls, and disposal processes) were imposed on these products. The 2023 cosmetic inspections were planned with a focus on identifying non-compliant (violating technical regulations, unsafe/risky) products in the market through risk analysis. As a result of effective inspections, 98% of the inspected products (857 out of 871) were found to be non-compliant, achieving the intended outcome. Number of cosmetic products inspected: 871 Number of compliant products: 14 Total number of non-compliant products: 857 Number of risky products: 4 Number of products violating technical regulations: 853 Total fines imposed due to non-compliance: 190,000 TL Other fines imposed within the framework of legislation: 30,000 TL Total fines: 220,000 TL A total of 585 counterfeit/illegal perfumes and deodorants reported by courts/prosecutors, law enforcement agencies, and other public institutions and identified by our Institution have been classified as unsafe/risky products under the Cosmetics Law No. 5324. Since the manufacturers of these products are unknown, only a disposal decision has been made. The list can be accessed via the following link: https://www.titck.gov.tr/duyuru/kozmetik-urunlere-iliskin-2023-yili-dorduncu-ceyrek-denetim-verileri-15012024115656

The Institution's 2024 Price Tariff has been published on the official website, and the related fees can be accessed via the following link: https://www.titck.gov.tr/dinamikmodul/70