OMC Medical
OMC Medical

 Cosmetics Registration in Ireland

Regulatory Authority:

Health Products Regulatory Authority

Link for RA:

https://www.hpra.ie/

Local regulation:

Regulation (EC) No. 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: 

Before placing a cosmetic product on the market, a responsible person (RP) must notify the product to the cosmetic product notification portal (CPNP). One notification is sufficient to place that cosmetic product on the market in any Member State of the EEA.

Timeframe and fees:

It has to be stressed that while 4-8 months is the usual timeframe, the timeline of the registration process depends greatly on the Manufacturer.

There is a one off fee of £25 per piercing treatment that must be paid on completion of the registration form. Once registered, there is no requirement to register annually, though routine inspections will be carried out. If you move premises or the business operator changes, you will be required to apply for a new registration and pay the £25 fee. 

Additional information: 

The cosmetic product safety report (CPSR) must be completed according to Annex 1 of Regulation (EC) No 1223/2009 and the Annex I guidelines. An RP may outsource the completion of the CPSR; however, it remains their obligation to provide the complete and correct information to the safety assessor and review/approve the document and ensure it is kept up to date. Unfortunately, as the competent authority, we are not in the position to recommend a safety assessor. The RP should ensure all ingredients are safe for use in the product. 

A manufacturer or designated responsible person can apply for a free sale cosmetic product certificate provided they are located in Ireland. A completed application form and an excel spreadsheet listing the products concerned should be submitted to [email protected]. The spreadsheet must list the product codes and product names.