Cosmetic products are mainly regulated under the Cosmetics Law No. 5324, the Cosmetics Regulation, and the relevant guidelines issued by the Turkish Medicines and Medical Devices Agency of the Ministry of Health (the "TMMDA"), which bring a number of obligations on manufacturers.

According to the cosmetics legislation, manufacturer can be any individual or legal entity that manufactures or improves a cosmetic product, or introduces themselves as a manufacturer by placing their name, trademark or distinctive sign on a cosmetic product. If the manufacturer is based outside Turkey, the local representative and/or importer authorized by such manufacturer will be treated as the manufacturer under the legislation. Further, any individual or legal entity involved in the supply chain of a cosmetic product and whose activities have an impact on the safety of the product is also considered as a manufacturer.

Manufacturers are under the obligation to take the necessary measures to ensure release of only those cosmetic products that are in compliance with the cosmetics legislation, and to carry out the manufacturing activities in accordance with the TMMDA's Cosmetics Good Manufacturing Practices Guide announced on 31 December 2015. Main obligations of cosmetics manufacturers set forth in the legislation are as follows:

  • Notification Requirements. Any cosmetic product must be notified to the TMMDA before its release to the market, and any new business must be notified to the TMMDA in advance. Thereafter, any change in the cosmetic product or the manufacturer would also be notifiable.
  • Further, manufacturers should notify the TMMDA of the formula and other required information concerning the product. Any serious adverse effects that are known by the manufacturer or that the manufacturer would be reasonably expected to be aware of, the name of the product, which makes a specific definition possible, and corrective measures taken by the manufacturer must also be notified.
  • Product Information File. A product information file should be maintained for a period of ten years from the date on which the last batch of the cosmetic product was placed on the market. The file should include, amongst others (i) a description of the qualitative and quantitative details of the product (if it is a perfume or perfume combination, the code of combination and the identity of the supplier), (ii) physicochemical and microbiological specification of the raw material and the final product as well as the control criteria for compliance with these specifications, (iii) the manufacturing method used by the manufacturer that complies with the Good Manufacturing Practices Guide, a statement of compliance with the good manufacturing practices, training and study documentation confirming the professional competence and necessary experience of the manufacturer at appropriate level. Upon request of the TMMDA, manufacturers should make the file available within three days at the address specified on the label of the product.
  • Responsible Technical Personnel. The manufacturer should employ personnel with appropriate level of professional competence and experience to ensure compliance of the product with the legislation and the good manufacturing practices. Such personnel can be a chemist, biochemist, chemical engineer, biologist or microbiologist (provided he/she has at least two years' experience in cosmetics sector) or a pharmacist. As per the guideline issued by the TMMDA regarding the responsible technical personnel, the obligations and working hours of the responsible technical personnel should be determined under his/her employment contract, and his/her training certificate should be included in the product information file.
  • Packaging and Labelling. The following information should take place on the packaging of the cosmetic product in non-erasable, easily visible and legible form:
    1. List of ingredients,
    2. Precautions to be taken and instructions to be followed for use of the product,
    3. Minimum durability period of the product,
    4. Function of the product, if not clear from the presentation,
    5. Nominal quantity by weight or volume of the product at the time of packaging,
    6. Corporate name and address of the manufacturer located in Turkey,
    7. Country of origin of the product if being imported to Turkey, and
    8. Manufacturing code or manufacturing charge code of the product.

Sanctions in case of non-compliance. In the event of non-compliance with the aforementioned obligations, the manufacturer may be imposed on administrative fines ranging from approximately TRY 60,000 to TRY 300,000 in 2022, and other sanctions such as warning, restriction of sale of the product, recalls, partial or complete destruction of the product, announcement of the measures taken through national newspapers and television channels and on the internet, reclamation, destruction and/or closure of the production site, depending on the severity of the case in hand. To the extent the relevant actions constitute breach under other applicable legislation, such as breach of safety rules and/or a criminal law, further administrative or criminal penalties may be imposed.

There is a new regulation in the pipeline which is expected to entirely replace the Cosmetics Regulation. The draft regulation was announced on 30 December 2020, and offers major changes to the cosmetics legislation. One of the most significant changes in the draft regulation is the concept of "authorised representative", who must be a Turkish resident and who will be fully responsible for compliance with the obligations under the draft regulation. Authorised representative can be the manufacturer, the importer or the distributor of the product, depending on the scope of activity or whether the product is being imported. Distributors can be deemed as authorised representative in exceptional cases, and unless this is the case, their liability arising from the draft regulation will be limited as compared to those of manufacturers and importers. Nevertheless, any individual or entity resident in Turkey can be designated as the authorised representative under agreement. The draft regulation, the enactment date of which remains unclear aims to ensure further compliance with the EU Regulation No. EC 1223/2009. Once the new regulation is enacted, the TMDDA is anticipated to issue a new guideline to clarify practices under this new piece of legislation.

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.