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Czech Republic Cosmetic Product Registration

COSMETIC REGISTRATION IN CZECH REPUBLIC

Regulatory Authority

Ministry of Health, Czech Republic 

Link for Regulatory Authority

https://www.mzcr.cz/

Local Regulation

Regulation (EC) N° 1223/2009 

Who can Register? 

  • Responsible person
  • Manufacturer
  • Importer
  • Distributer

Data to be Communicated

Product Information File

  1.   A description of the cosmetic product which enables the product information file to be attributed to the cosmetic product
  2. The cosmetic product safety report referred to in Article 10(1)
  3. A description of the method of manufacturing and a statement on compliance with good manufacturing practices are referred to in Article 8
  4. Proof of the stated claim for the cosmetic product, where justified by the type of effect of the cosmetic product
  5. Data on any animal research conducted by the manufacturer, his agents, or suppliers connected with the development or safety evaluation of the cosmetic product or its constituents.

Notification

  1.  The category of cosmetic product and its name or names, enabling its specific identification
  2. The name and address of the responsible person where the product information file is made readily accessible
  3. The country of origin in the case of import
  4. The Member State where the cosmetic product is to be placed on the market
  5. The contact details of a physical person who have to be contacted in the case of necessity
  6. The presence of substances in the form of nanomaterials and:
  7. Their identification includes the IUPAC name and other descriptors that are specified in point 2 of the Preamble to Annexes II to VI
  8. The reasonably foreseeable exposure conditions
  9. The name and the CAS or EC number of substances classified as carcinogenic, mutagenic or toxic for reproduction (CMR), of category 1A or 1B, under Part 3 of Annex VI
  10. The frame formulation allows for prompt and appropriate medical treatment in the event of difficulties.

Process to Register Cosmetic Product

  • A compliance check of the cosmetic formula
  • A redaction of a Product Information File (PIF) and a Cosmetic Product Safety Report (CPSR)
  • A CPNP number (Cosmetic Product Notification Portal)
  • A Responsible Person based in the European Union territory
  • Completing all the necessary Safety Tests

Timeframe and Fees

While 4-8 months is the typical period, the registration process’ schedule is highly dependent on the Manufacturer. 

Additional Information

The PIF is a compilation of technical documents that must accompany each cosmetic product before it may be sold in Europe. The responsible person must keep the file for at least 10 years after the last batch of a specified product was put on the market inside the European Union. It must be always available to European Competent Authorities. 

Appointing a Responsible Person early in the process, completing all the necessary testing and having PIF ready will speed up the process. The manufacturer or importer must guarantee that the cosmetic products they produce or import are safe when introduced into the market, ensuring they do not endanger people’s health and comply with hygiene standards outlined in the Decree. 

Prior to market placement, they are responsible for ensuring the product’s safety for individual health through assessment conducted by an authorized expert. Prior to marketing a cosmetic product, the manufacturer or importer is required to perform a notification process. 

This involves informing the relevant public health protection authority (regional public health authority) about various details, including the commencement date of manufacturing or importing, a comprehensive list of the intended cosmetic products for manufacturing or importing, and the location where essential product documentation is maintained.