Making, Importing or Selling Cosmetic Products in Ireland
What do I need to do to sell a cosmetic product on the Irish market?
The HPRA regularly receives queries in relation to what steps are needed to sell cosmetic products on the Irish market. These may be received from varied sources, for example from manufacturers, small business start-ups or those wishing to import products from outside the European Economic Area (EEA) for placing on the Irish market.
Therefore, the following general guidance is provided to assist with such questions and to provide direction as to where further information is available.
The primary piece of legislation governing cosmetic products in Europe is the Cosmetics Regulation (EC) No. 1223/2009. Each cosmetic product placed on the European market must have a designated responsible person (RP) established in the EEA or in Northern Ireland. The RP of the cosmetic product must ensure that it is in compliance with the legislation.
For example, if an individual or company is manufacturing cosmetic products and/or placing cosmetic products on the market under their own brand/trademark and/or importing cosmetic products from outside of the EEA, then, in general, they would be taking on the role of RP and they must ensure the obligations of an RP are met. It is also possible to mandate another EU entity to act as RP for the products, which must be accepted in writing between both parties. The requirements must be met regardless of size of operation.
Obligations of the RP
Our Guide to Cosmetics for Responsible Persons details some of the key obligations of the RP which are stated below:
Notification of the product on the European database, the Cosmetic Products Notification Portal or CPNP.
Documentation that the product is manufactured in accordance with Good Manufacturing Practice guidelines (ISO 22716). This guideline can be purchased online. The HPRA has also published supplementary guidance on GMP.
Preparation and maintenance of a product information file (PIF) at the address of the Responsible Person.
Preparation of a cosmetic product safety report (CPSR) consisting of a safety assessment carried out by a toxicologist or suitably qualified expert.
Data on animal testing (if applicable).
A system for documenting and reporting serious undesirable effects experienced as a result of product use.
Appropriate labelling as per Article 19 of the Regulation.
The cosmetic product safety report (CPSR) must be completed in line with 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 to 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. The following guide The SCCS Notes of Guidance for the Testing of Cosmetic Ingredients and their Safety Evaluation can be used for additional information regarding the testing of cosmetic products. The Annexes of the EU Cosmetics Regulation should be verified to assure no ingredients that are prohibited from use in cosmetic products are present in the product, and any restricted ingredients are in line with the requirements.
Furthermore, there are specific requirements in relation to claims made for cosmetic products in Commission Regulation (EU) No 655/2013, and guidance is provided in the associated Technical document on cosmetic claims. Please also be aware it is not permitted to make any claims of a medicinal nature in relation to a cosmetic product; more information is available in the HPRA Guide to the Definition of a Human Medicine.
There is no HPRA authorisation or certification in order to place a cosmetic product on the market. Certain RP obligations, in particular the generation of a PIF containing a CPSR, and notification of a cosmetic product to CPNP must be met prior to placing the products on the market. RPs are required to have all documentation in place prior to placing the product on the market.
Please also download our Cosmetic Products Information Pack for further guidance on placing products on the Irish market.
Distribution or retail of cosmetic products
If a company intends to sell cosmetic products solely as a distributor or retailer, and it is not the case that they are taking on the role of RP, please refer to Distribution or Retail of Cosmetic Products in Ireland.
Any specific queries may be sent to firstname.lastname@example.org.
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.