FOOD SUPPLEMENT AUTHORIZATION in TURKEY

This is an authorization that certifies that products to be marketed in Turkey for the purpose of supplementing nutrition are safe and compliant with regulations. Without this authorization, the manufacturing, importation, and sale of food supplements are prohibited in Turkey.

What is a Food Supplement? Food supplements are products intended to supplement the normal diet and contain concentrated forms of one or more nutrients such as vitamins, minerals, proteins, carbohydrates, fiber, fatty acids, amino acids, or other substances of botanical, herbal, and animal origin, bioactive substances, and similar substances with nutritional or physiological effects, presented alone or in combination, in forms such as capsules, tablets, pastilles, single-use powder packets, liquid ampoules, dropper bottles, and other similar liquid or powder forms, with a determined daily dosage.

Why is Authorization Necessary? Food supplement authorization is necessary for the following purposes:

• Protecting Consumer Health: To ensure that food supplements are safe and healthy.

• Ensuring Quality and Standardization: To ensure that food supplements placed on the market comply with specific quality standards.

• Preventing Unfair Competition: To prevent unfair competition by ensuring that all manufacturers and importers adhere to the same rules.

• Preventing False and Misleading Information: To ensure that consumers are provided with accurate and complete information about food supplements.

• Ensuring Registration and Traceability: To ensure that food supplements placed on the market are registered and traceable.

What are the Required Documents?

The application dossier should generally include the following documents:

• Application Petition: A formal application petition written by the company.

• Product Ingredient List: A list of all ingredients in the product, along with their quantities.

• Manufacturing Method: A detailed production flow chart explaining how the product is manufactured.

• Certificates of Analysis: Analysis reports related to the product's composition and safety.

• Label Sample: A sample of the product label, including all information that will appear on the label (in Turkish).

• Stability Studies: Studies demonstrating the product's stability throughout its shelf life.

• Scientific Data: Scientific data supporting the claimed effects of the product.

• Company Information: Documents such as the company's trade registry record, tax registration certificate, signature circular, etc.

• Responsible Technical Personnel Information: Information and professional credentials of the technical personnel responsible for food supplements within the company.

• Product Safety Information: Documents such as GMP (Good Manufacturing Practices), HACCP (Hazard Analysis and Critical Control Points) certifications, etc., demonstrating the product's safety.

• Other Documents: Other documents that may be requested by the Ministry.