Written answers

Tuesday, 21 October 2025

Department of Health

Departmental Policies

Photo of Pádraig RicePádraig Rice (Cork South-Central, Social Democrats)
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857. To ask the Minister for Health her plans in relation to the regulation of aesthetic and cosmetic medicine; and if she will make a statement on the matter. [57366/25]

Photo of Jennifer Carroll MacNeillJennifer Carroll MacNeill (Dún Laoghaire, Fine Gael)
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The area of aesthetics and cosmetics is diverse in terms of the types of products and procedures that fall under its scope, with a wide range of levels of invasiveness and associated risks. Cosmetics, which range from non-invasive topical applications to non-surgical aesthetic procedures to surgical interventions, are currently regulated through a combination of:

1) professional regulation, including the regulation of doctors and dentists who engage in cosmetic procedures. Where there are concerns regarding the practice of a regulated health professional, a complaint can be made to the relevant regulator.

and;

2) product regulation, which include:

  • products placed on the market as cosmetic products, which are subject to the requirements in EU Regulation 1223/2009 (Cosmetic Products Regulation, CPR).
  • products which are, or would be, classified as authorised medicinal products and thereby potentially restricted to prescription control. A common example is botulinum toxin-containing products.
  • products which are, or would be, regulated as medical devices and thereby are subject the requirements in EU Reg 2017/745 (Medical Device Regulation, MDR). This includes certain specified implanted and surgically invasive products that are used for non-medical purposes, such as for aesthetic purposes. A common example is injectable dermal fillers.
In the context of the CPR, a cosmetic product is defined as any substance or mixture intended to be placed in contact with the external parts of the human body or with the teeth and the mucous membranes of the oral cavity with a view exclusively or mainly to cleaning them, perfuming them, changing their appearance, protecting them, keeping them in good condition or correcting body odours. Of note, products?intended to be ingested, inhaled, injected or implanted are not regulated as cosmetic products; typically, these would be subject to regulations governing medicinal products (e.g., botulinum toxin-containing products) or medical devices (e.g., dermal fillers).

Each cosmetic product placed on the EU market must have a Responsible Person in place. Among their responsibilities, the Responsible Person must ensure that each cosmetic product has a Cosmetic Product Safety Report completed by a suitably qualified safety assessor, that confirms the safety of the cosmetic product and all its ingredients are safe for use.

The Health Products Regulatory Authority (HPRA) is responsible for monitoring the safety and compliance of cosmetic products placed on the Irish market, through market surveillance activities and in collaboration with the Health Service Executive (HSE) and Revenue Commissioners.

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