COVID-19 Update - Hand Sanitisers

The European Commission has published guidance (30 March 2020) on the applicable legislation for leave-on cleaners and hand disinfectants (gel, solution, etc.) for operators including small and medium-sized enterprises. Further guidance was published 12 November 2020 in the Borderline working document on leave on hand gels. Both of these documents can be found on the European Commission website.

Please note that products with a primary function of hand sanitisation, or which by virtue of their presentation imply an action of sanitisation, are not considered to meet the definition of a cosmetic product. Such products, or those that make general claims in relation to an antibacterial action or killing of germs (and do not make medicinal claims or contain substances exerting a medicinal effect), are likely to be classified as biocides. Biocidal products are regulated by the Pesticides Registration and Control Division in the Department of Agriculture, Food and the Marine.

Please contact if you have any queries on registration of biocidal products for hand sanitisation.

Please see our news item for more information.

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



Guidance for manufacture, distribution and retail of cosmetic products is available as follows:



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. The Guide to Appeals Under Cosmetic 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, the relevant appeals procedure can be found on the HSE website