Cosmetic products are products prepared for application to various external parts of the human body such as the epidermis, nails, hair, lips, and external genital organs, as well as teeth and oral mucosa. Their purposes of use should be to cleanse these parts, provide fragrance, alter appearance, or maintain or improve body odors.
Products containing health benefits, used for the diagnosis, prevention, monitoring, treatment, and alleviation of disease, or for the diagnosis of harmful organisms controlled, restricted, removed, rendered harmless, or destroyed chemically or biologically, are not considered "cosmetic products".
Cosmetic product consultancy service aims to support companies in completing the necessary procedures in the process of placing cosmetic products on the market. Thus, companies can ensure compliance with Cosmetic Products Regulation and prevent their risk of administrative fines by meeting legal requirements. So, what services does cosmetic product consultancy provide, and how should the process of placing these products on the market be?
According to Article 6 of the Cosmetic Regulation, a cosmetic product placed on the market must be safe for human health when applied under normal and reasonably foreseeable conditions or according to recommended conditions of use taking into account the presentation, labeling, and instructions for use of the product provided by the manufacturer. To ensure this, the Cosmetic Regulation imposes certain obligations on relevant parties, including cosmetic product registration.
Every cosmetic product must be registered in the Ministry of Health's Product Tracking System (ÜTS) before being placed on the market. This registration does not imply approval; it is merely a notification to the Ministry. Product notifications are the responsibility of manufacturers or importers.
Additionally, a product information file (PIF) must be available for every cosmetic product to be placed on the market. This file will be presented to inspectors during possible Ministry inspections. All technical information, documents, reports, and tests related to the safety of the product must be kept at the address on the product packaging for 10 years following the last batch's placement on the market.
In case the requirements of the Cosmetic Products Regulation are not met, companies may face administrative fines or penal sanctions. The application of an administrative fine does not mean that other penal sanctions will not be applied. The table below shows the penal sanctions that may be encountered:
| Sanction Reason | Amount of Sanction |
|---|---|
| Failure to employ responsible technical personnel | 10.000 ₺ |
| Supplying products containing substances outside certain limits and conditions to the market | 15.000 ₺ |
| Supplying products containing substances that should not be in their formula to the market | 20.000 ₺ |
| Non-compliance of the production site with specified criteria | 20.000 ₺ |
| Failure to fulfill Notification Obligation | 20.000 ₺ (per product) |
| Deficiencies in the Product Information File | 96.226 ₺ (per product) and product withdrawal |
| Complete absence of the Product Information File | 120.282 ₺ (per product) and product withdrawal |
| Determination of the product being harmful to health | Penal sanctions starting from 50.000 ₺ (may vary depending on the risk) and product recall and destruction practices |
By benefiting from our Cosmetic Product Consultancy service, you can prevent such negativities and complete the process of introducing your cosmetic products to the market.
For information and support, please contact us.
