Ministry of Health, Turkey
Turkish Cosmetic Regulation
Regulatory Authorities Website :
T.C. Sağlık Bakanlığı (saglik.gov.tr)
Who Can Register:
- Responsible person
- The product information file shall contain the following information and data, which shall be updated as necessary:
- A cosmetic product description that allows the product information file to be easily linked to the cosmetic product
- The cosmetic product safety report referred to in Article 13 (1)
- A description of the production technique referred to in Article 11, and a statement on conformity with good manufacturing practise.
- Proof of the stated claim for the cosmetic product, where justified by the type of effect of the cosmetic product
- Any animal testing carried out by the manufacturer, his agents, or suppliers in connection with the development or safety assessment of the cosmetic product or its ingredients, including any animal testing to meet the legislative or regulatory requirements of countries other than Turkey and the EU Member States.
Before placing the cosmetic product on the market, the responsible person shall submit the following information to the Agency via the national electronic database, including cosmetic products notified under the repealed Cosmetics Regulation:
- The barcode and the cosmetic product’s category, as defined in Annex 1 of the Communique, and its name or names, allow for its precise identification.
- The name and location of the person in charge of making the product information file accessible
- In the case of import, the nation of origin, as well as the countries in which the product is sold;
- The contact information for a physical person to contact in the event of an emergency;
- The existence of substances in the form of nanomaterials and:
- their identification, including the chemical name (IUPAC) and other descriptors as specified in Article 4 of the Communique
- The reasonably foreseeable exposure conditions
- The name and the Chemicals Abstracts Service (CAS) or EC number of substances have to be classified as carcinogenic, mutagenic or toxic for reproduction (CMR) as shown under Part 3 of Annex VI to the Regulation on Classification, Labeling, and Packaging of Chemical Substances and Mixtures published on the repeated Official Gazette No. 28848,
- The formulation in which volume or quantity ratios, including frame formulation, are specified in intervals to provide rapid and appropriate medical treatment in emergencies.
According to the Turkish Cosmetic Regulation, a manufacturer is any natural or legal person that manufactures a cosmetic product or has one designed or manufactured for him and markets it under his name or trademark. The cosmetics maker must register his company with the Turkish Cosmetic Notification Portal (UTS) and choose a Responsible Person with the necessary professional competence and experience. “Pharmacist or, if they have worked in cosmetics for two years, chemist, biochemist, chemical engineer, biologist, or microbiologist may be chosen as the responsible person,” according to Cosmetic Regulations.
Before the products are placed on the market, they must be informed to the Turkish Cosmetic Notification Portal (UTS), and Product Information Files (PIF) must be ready.
Timeframe and fees:
The labelling must adhere to all of the legislation’s requirements. The manufacturer’s name and address and the notification system should be written on the label. It is critical not to include any assertions prohibited by cosmetic legislation.
Good Manufacturing Practices (GMPs) must be followed when making cosmetics (GMP).