Poland Cosmetic Product Registration

COSMETIC REGISTRATION IN POLAND Regulatory Authority

Ministry of Health, Poland 

Link for Regulatory Authority

https://www.gov.pl/

Regulation (EC) N° 1223/2009

Who can Register?

• Responsible person
• Manufacturer
• Importer
• Distributer

Product Information File

• A description of the cosmetic product which enables the product information file to be attributed to the cosmetic product.   
• The cosmetic product safety report referred to in Article 10(1)   
• A description of the method of manufacturing and a statement on compliance with good manufacturing practices are referred to in Article 8.
• Proof of the stated claim for the cosmetic product, where justified by the type of effect of the cosmetic product.   

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

• The category of cosmetic product and its name or names, enabling its specific identification.
• The name and address of the responsible person where the product information file is made readily accessible. 
• The country of origin in the case of import 
• The Member State where the cosmetic product is to be placed on the market. 
• The contact details of a physical person who have to be contacted in the case of necessity. 
• The presence of substances in the form of nanomaterials and:
  1. Their identification includes the IUPAC name and other descriptors that are specified in point 2 of the Preamble to Annexes II to VI   
  2. The reasonably foreseeable exposure conditions  
• 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   

The frame formulation allows for prompt and appropriate medical treatment in the event of difficulties.    

• 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 

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

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.   

Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30 November 2009 serves as the primary legislation governing cosmetic products. Since 11 July 2013, the registration of cosmetics in Poland has been facilitated through the CPNP portal, which replaced the National Cosmetics Information System. 

The notification of cosmetic products via the online CPNP portal aims to provide competent authorities with comprehensive information about cosmetics placed on the market. This information is utilized for surveillance and market analysis, product assessment, and to swiftly address any potential health concerns, ensuring effective communication with consumers and poison centers in case of irregularities.