Making, importing or selling cosmetic products in Ireland

What do I need to do to sell a cosmetic product on the Irish market?

All individuals intending to sell cosmetic products must comply with EU and national regulations. This includes manufacturers, distributors, retailers, small business start-ups, large enterprises, and those seeking to import products from outside the European Economic Area to sell here.

The Regulatory requirements must be met regardless of the size of operation.

Before placing a cosmetic product on the market

• A Responsible Person (RP) must be in place for each cosmetic product placed on any market in the European Union to ensure compliance with quality and safety requirements.
• Each product must be labelled with the European address of the Responsible Person and all other appropriate labelling and claims substantiation requirements.
• A Product Information File (PIF) must be compiled and maintained at the Responsible Person address.
• A Cosmetic Product Safety Report (CPSR) must be maintained consisting of a safety assessment carried out by a toxicologist or suitably qualified expert.
• Each product must be notified to the Cosmetic Product Notification Portal (CPNP)
• Data on animal testing (if applicable) must be provided.
• A system for documenting and reporting serious undesirable effects experienced following product use must be in place.
• Documentation to verify product manufacture in accordance with Good Manufacturing Practice guidelines (ISO 22716). This guideline can be purchased online. The HPRA has also published supplementary guidance on Guide to good manufacturing practice of cosmetic products. A copy of this Guide can be found below on this page.

Making Cosmetic Products in Ireland

All cosmetics manufactured in Ireland or anywhere in the EEA intended for sale in the EEA must be manufactured in accordance with Good Manufacturing Practice guidelines. The 'standard' EN ISO 22716:2007 sets out the specific criteria that should be met.

Other GMP standards are acceptable provided they are equal or superior to ISO 22716:2007

We have published a Guide to good manufacturing practice of cosmetic products, however, this is for guidance purposes only and should be read alongside the ISO standard. A copy of this Guide can be found below on this page.

After placing a cosmetic product on the market:

• The Responsible person must update the Product Information File (PIF) with new information that comes to light (e.g. undesirable effects, ingredient information).
• Update the PIF and the European portal (CPNP) when there is a change in formulation.
• Amend the PIF according to any changes to the Regulation.

Please note, the above does not purport to be an interpretation of law and/or regulations and is for guidance purposes only. The relevant legislative requirements should be referred to for full details.