Regulatory Information
Cosmetic products placed on the market in Ireland must meet the requirements outlined in Regulation (EC) No. 1223/2009 on cosmetic products, as amended (the ‘Cosmetics Regulation’) and S.I. 440 of 2013 European Union (cosmetic products) Regulations 2013.
Guidance on cosmetic product legislation is available in our Guide to Cosmetics.
The Responsible Person
A responsible person (RP) should be designated for each cosmetic product placed on the European market. The RP may be the manufacturer, importer or person to whose order a cosmetic product is manufactured. The responsible person shall be based within the EU and their address should appear on the cosmetic product packaging.
As there is no premarket approval of cosmetic products, the RP is obliged to comply with the Cosmetics Regulation and must keep and maintain a product information file, demonstrating the conformity of the products with the legislation. This product information file must be readily accessible to the competent authority.
The key requirements of the responsible person include but are not limited to:
- The product information file (PIF)
- Good Manufacturing Practices (GMP)
- Consumer Information
- Communication of serious undesirable effects
- Traceability within the supply chain
- Labelling
- Sampling and analysis
- Corrective actions in the event of product non-compliance
- Notification
Guidance for the responsible person is available in our Guide to Cosmetics for Responsible Persons.
The Distributor and Retailer
The key requirements of the distributor, including the retailer, include but are not limited to:
- Labelling verification
- Traceability within the supply chain
- Storage and transport conditions
- Corrective actions in the event of product non-compliance
- Communication of serious undesirable effects
The Manufacturer
All cosmetic products must be manufactured in accordance in Good Manufacturing Practice guidelines, as required by the EU Regulation No. 1223/2009.
The standard applicable is I.S. EN ISO 22716:2007 (“the standard”).
The HPRA has also published a guide to Good Manufacturing Practice of Cosmetic Products; however, it should be noted this guide is to be read in conjunction with I.S. EN ISO 22716:2007.
Safety Assessor of Cosmetic Product Safety Reports
Article 10 of the Cosmetics Regulation requires the completion of a safety assessment for each cosmetic product placed on the market in the EU, named the Cosmetic Product Safety Report (CPSR). This assessment must be carried out by an appropriately qualified Safety Assessor. More information in relation to requirements of qualifications of Safety Assessors of Cosmetic Products can be found here.
Guides
Guidance for manufacture, distribution and retail of cosmetic products is available as follows:
Appeals
Following issuance of a compliance notice (or measures taken pursuant to Regulations 12(9), 14 and 15 of the S.I.) by the HPRA, the person on whom it is served can appeal the notice or measures by contacting secretary@hpra.ie.
The Guide to appeals under cosmetic product legislation provides information on the procedure for appealing the issue of notices or measures and on the procedure for written or oral representations the appellant may wish to make.
For compliance notices issued by the HSE, please contact the HSE about the relevant appeals procedure.