The Cosmetic Products Regulation ("Regulation") published in the Official Gazette dated 08.05.2023 and numbered 32184 (Repeated) regulates the procedures and principles regarding the cosmetic products available in the market in order to ensure a high level of protection of human health. The Cosmetics Regulation dated 23.05.2005 ("Repealed Regulation") has been repealed by this Regulation which has been prepared by the Turkish Medicines and Medical Devices Agency ("Agency").
According to Regulation, cosmetic product means all substances or mixtures prepared for application to the external parts of the human body, epidermis, nails, bristles, hair, lips and external genital organs or teeth and oral mucosa, and whose sole or main purpose is to clean, fragrance, change the appearance of these parts, protect them, keep them in good condition or correct body odors.
Regulation stipulates various amendments on the safety of cosmetic products, responsibilities, limitations on certain substances, animal testing, labeling, etc. With this Regulation, which is more comprehensive compared to Repealed Regulation, many new regulations have been envisaged as well as improving the provisions in Repealed Regulation. Some important amendments are as follows;
1- Product Safety and Liability
With Regulation, a "Responsible Person" with expanded powers, responsibilities and obligations will be introduced. Cosmetic products shall only be placed on the market provided that a natural or legal person resident in Turkey is appointed as the Responsible Person. Responsible Persons are obliged to immediately take the necessary corrective measures to bring a cosmetic product into conformity, withdraw it from the market or recall it if they assess or have reason to believe that a cosmetic product placed on the market does not comply with Regulation. Where the cosmetic product poses a risk to human health, Responsible Persons shall inform the Agency, in particular about the non-conformity and any corrective action taken.
According to Regulation, the Responsible Person may determine chemists, biochemists, chemical engineers, biomedical engineers, biologists, microbiologists, and pharmacists as responsible technical staff.
Cosmetic products on the market shall be safe for human health when used under normal or reasonably foreseeable conditions of use, in particular taking into account the presentation, labeling, instructions for use and disposal of the product, and other data and information provided by the Responsible Person. The Responsible Person shall ensure that for all notified cosmetic products; the intended use of the cosmetic product and the expected systemic exposure for each component in the final formulation are taken into account in the safety assessment, and that an appropriate weight of evidence method is used to examine data from all available sources in the safety assessment, and that the cosmetic product safety assessment report is kept up to date in the light of relevant additional information obtained after the product is placed on the market. For each product, the Responsible Person shall also keep a product information file containing (i) a description of the cosmetic product, ensuring that the product information dossier is clearly attributed to the cosmetic product, (ii) the cosmetic product safety report, (iii) a description of the manufacturing method and a declaration of compliance with good manufacturing practices, (iv) evidence of the claimed effect of the cosmetic product where justified on the basis of the nature or effect of the cosmetic product; and (v) data on any animal testing carried out by the manufacturer, its agents or suppliers in relation to the development or safety assessment of the cosmetic product or its components, including that carried out to meet the legal or regulatory requirements of countries other than Turkey and EU Member States.
The Responsible Person shall ensure, without prejudice to the protection of trade secrets and intellectual property rights in particular, that the quantitative and qualitative composition of the cosmetic product, the name and code number of the compositions in the case of perfumes and aromatic compositions as well as the name of the supplier, available data on undesirable effects and serious undesirable effects resulting from the use of
the cosmetic product are made available to the public by appropriate means.
With Regulation, detailed regulations have been introduced the use of substances classified as carcinogenic, mutagenic, and toxic substances for reproduction, prohibited substances, nanomaterials, etc. in order to ensure product safety.
Regulation also stipulates animal tests. Accordingly without prejudice to the general obligations regarding the safety of a cosmetic product (i) after alternative methods validated by taking into account the developments in validation within the OECD are accepted by the Agency in order to meet the requirements of Regulation, (ii) the placing on the market of cosmetic products containing a final formulation that has been subjected to animal testing using a method other than these methods (iii) domestic animal testing of finished cosmetic products (iv) conducting animal tests for components or component combinations, excluding the permitted, validated alternative tests specified in Regulation on Test Methods to be Applied in Determining the Physico-Chemical, Toxicological and Ecotoxicological Properties of substances and mixtures are prohibited.
2- Information for Consumers
Regulation stipulates regulations on the labeling of cosmetic products. Accordingly, in order for a cosmetic product to be placed on the market, information such as (i) the name or registered title and address of the Responsible Person, (ii) the nominal content at the time of packaging in terms of weight or volume, except for packages under five grams or five milliliters, free samples and single-dose products (iii) the minimum expiry date at which a cosmetic product, if stored under normal conditions, continues to fulfill its initial functions (iv) special warnings to be considered in the use of the product must be indelibly, easily readable and visible on the inner and outer packaging of the product.
If the number of products is easily visible from the outside or if the product is normally sold alone, the number of products need not be indicated on the packaging. The list of product ingredients shall be indicated on the outer packaging of the product in descending order of weight based on their weight at the time they are added to the cosmetic product.
At the same time, in the labeling, placing on the market, promotion, and advertising of cosmetic products, texts, names, trademarks, registered trademarks, images and figurative or other signs that imply that these products have properties or functions that these products do not have shall not be used. The Agency shall establish a national list of common criteria with reference to the common criteria published by the European Commission regarding the claims that may be used in cosmetic products and shall take the necessary measures to ensure the conformity of products that are contrary to this list.
Regulation also provides for the actions to be taken, sanctions to be imposed, and administrative fines in case of non-compliance with the rules and the occurrence of undesirable situations.
Consisting of 40 articles and 9 annexes totaling 346 pages, this Regulation shall enter into force six months after the date of its publication. Pursuant to Provisional Article 1 of Regulation, products that have been placed on the market in accordance with Repealed Regulation when Regulation entered into force shall be available on the market for a period of 2 years from the entry into force of Regulation.
The product safety assessment to be made by the Responsible Persons and the product information file to be prepared shall be made within six months from the date of entry into force of Regulation for the products notified under the Repealed Regulation.
With this Regulation, which regulates the articles in Repealed Regulation more comprehensively and makes detailed regulations and new additions on cosmetic products, it is aimed to eliminate all problems in practice.