PIF/ÜBD PREPATION SERVICE

ÜBD/PIF registration is the type of file that must be prepared and maintained in the cosmetics industry before a cosmetic product is placed on the market. This term is used to ensure that cosmetic products are legally and safely placed on the market in compliance with Turkish regulations.

What is ÜBD?

ÜBD stands for Ürün Bilgi Dosyası (Product Information File). It is a mandatory file that must be prepared for each cosmetic product under the Turkish Cosmetics Regulation and the European Union Cosmetics Regulation (EC 1223/2009). The ÜBD is a document that proves the product's safety, quality, and legal compliance.

What is PIF?

PIF is the abbreviation for Product Information File and is the international equivalent of ÜBD. This file covers the processes of the product from production to the end user and can be requested by regulatory authorities for inspection.

What is Included in the ÜBD/PIF Record?

• Product Description and Characteristics:

  • The product's name, category, intended use, target audience, and other essential information.

• Formulation Details:

  • A list of all ingredients used in the product and the usage rate of each ingredient.

  • A declaration that prohibited or restricted substances are not present.

• Cosmetic Product Safety Report (CPSR):

  • Toxicological analyses and risk assessment proving the product's suitability for human health.

• Manufacturing Information:

  • Information demonstrating that the product is manufactured in accordance with Good Manufacturing Practices (GMP).

• Labeling and Packaging Information:

  • Documents demonstrating the compliance of the statements and warnings on the product with the law.

• Microbiological and Stability Tests:

  • Analysis results proving that the product will remain safe and effective throughout its shelf life.

• Product Efficacy and Claims:

  • Supporting the claimed effects of the product (e.g., moisturizing, blemish removal) with scientific data.

• Data Required for Consumer Safety:

  • A procedure for handling complaints related to the product.

Importance of ÜBD/PIF Registration

• Legal Obligation: It is prohibited to market cosmetic products without ÜBD/PIF registration.

• Consumer Safety: This registration proves that the products will not harm human health.

• Ease of Inspection: TİTCK or European regulatory bodies refer to this file when they want to inspect your products.

• Market Credibility: You can enhance your brand's reputation by offering a product that complies with legal processes.
  
  

Who Should Register ÜBD/PIF?

• Cosmetic product manufacturers,

• Importers,

• Companies selling private label products.