Cosmetic Products Regulation

The Cosmetic Products Regulation, published in the repeated issue of Official Gazette No. 32184 of 8 May 2023, regulates the procedures for cosmetic products made available on the market in order to ensure a high level of protection of human health (Article 1). It is based on Law No. 7223, Article 7 of the Cosmetics Law No. 5324 and the relevant Presidential Decree (Article 3), and was prepared taking into account the EU Cosmetics Regulation (EC) No. 1223/2009 (Article 37). It repealed the Cosmetics Regulation published in Official Gazette No. 25823 of 23 May 2005 (Article 38) and entered into force six months after publication (Article 39). It is administered by the Turkish Medicines and Medical Devices Agency and was amended in the Official Gazette No. 32480 of 5 March 2024.

What makes a cosmetic product safe and who is responsible?

A cosmetic product on the market must be safe for human health under normal or reasonably foreseeable conditions of use; the assessment takes into account the presentation of the product, labelling, instructions for use and disposal, and other information supplied by the responsible person (Article 5). Cosmetic products may be placed on the market only if a natural or legal person established in Türkiye is designated as the responsible person (Article 6). For domestic production the responsible person is the manufacturer, for imports the importer; another person may also be designated by written mandate. The responsible person employs a responsible technical staff member (Article 7).

Which documents and notifications are needed before placing on the market?

Before placing a product on the market, the responsible person has a safety assessment carried out and a safety report prepared (Article 13), keeps the product information file for ten years after the last batch is placed on the market (Article 14) and notifies the product to the Agency through the national electronic database (Article 16). Products containing nanomaterials are additionally notified six months before placing on the market (Article 19). Prohibited and restricted substances are set by the annexes of the Regulation (Article 17), and animal testing is prohibited under certain conditions (Article 21). Label information such as batch or serial number, ingredient list, minimum durability date and warnings is mandatory, and some of it must be in Turkish (Article 22).

Which corrective measures are taken for a non-compliant product?

If the responsible person considers, or has reason to believe, that a cosmetic product it placed on the market does not comply with the Regulation, it must immediately take the corrective measures needed to bring it into conformity, withdraw it or recall it, and immediately inform the Agency if the product poses a risk to human health (Article 8(2)). A distributor that considers a product non-compliant does not make it available until it is brought into conformity and ensures that measures are taken (Article 9(3)). Serious undesirable effects are reported immediately to the Agency and the manufacturer (Article 26).

Under the definitions, “recall” means any measure aimed at achieving the return of a product that has already been made available to the end user to the economic operator, and “withdrawal” means any measure aimed at preventing a product in the supply chain from being made available on the market (Article 4).

What can the Agency do in market surveillance?

The Agency monitors products on the market through the product information file, physical checks and, where necessary, laboratory tests, and also monitors compliance with good manufacturing practice (Article 25). In case of a specific non-conformity it asks the responsible person, within a reasonable period proportionate to the risk, to bring the product into conformity, withdraw it or recall it (Article 28). Even where a product complies with the requirements, if it presents a serious risk to human health the Agency takes all necessary measures to have it withdrawn, recalled or restricted in access (Article 30). Except in urgent cases, the responsible person is given a reasonable period to state its view before any decision (Article 31(2)).

What does it mean for destruction and costs?

The Regulation addresses destruction directly. Where urgent action is needed because of a serious risk, or where the responsible person fails to take the necessary measures in time, the Agency, at the economic operator’s expense, takes all measures to prohibit or restrict making the product available, to withdraw or recall it and, if making it safe is impossible, to have it destroyed in part or in full according to the risks it carries (Article 31(4)). Distributors may also be required to carry out corrective actions up to and including destruction of the product (Article 29).

For products that carry risk, the economic operator makes an announcement under Article 18 of Law No. 7223, on its own initiative or at the Agency’s request (Article 31(5)). Details on inspection of production sites, sampling, warnings, withdrawal, destruction, rectification and closure of production sites are determined by the Agency (Article 25(3)). The Regulation does not separately regulate the management of the destroyed product as waste; that is subject to waste legislation.

What sanctions apply in case of non-compliance?

For breaches of the Regulation, the relevant provisions of Law No. 5324, Law No. 7223 and the Turkish Penal Code apply, depending on the nature of the act (Article 35(1)). A responsible person that breaches its obligations is held liable as a manufacturer or importer under Law No. 7223, including where the person was designated by written mandate (Article 35(2)-(3)). Products placed on the market in compliance with the former Regulation may remain on the market for two years from the entry into force of this Regulation (Transitional Article 1).