Catherine Murphy (Kildare North, Social Democrats)
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623. To ask the Minister for Health the number of Health Products Regulatory Authority audits conducted on cosmetic and skin care production companies in each of the years 2017 to 2020 and to date in 2021. [23125/21]

Catherine Murphy (Kildare North, Social Democrats)
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624. To ask the Minister for Health the number of cosmetic and skin care products of concern that have been notified to the Health Products Regulatory Authority; the number of these notifications that have been investigated; and the number of these investigations that ultimately lead to a ban and or recall of product. [23126/21]

Catherine Murphy (Kildare North, Social Democrats)
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625. To ask the Minister for Health the number of instances in which the Health Products Regulatory Authority has directed companies to amend or change its cosmetic and skin care product packaging to truly reflect the content of the product and the effectiveness of the product. [23127/21]

Stephen Donnelly (Wicklow, Fianna Fail)
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I propose to take Questions Nos. 623, 624 and 625 together.

Cosmetic products placed on the market in Ireland must meet the requirements outlined in Regulation (EC) No. 1223/2009 on cosmetic products (the ‘Cosmetics Regulation’) and S.I. 440 of 2013 European Union (cosmetic products) Regulations 2013. In line with the Cosmetics Regulation, a cosmetic product on the market must be notified to the European Commission Cosmetic Products Notification Portal (CPNP) in advance of being placed on the market; products are not notified directly to the HPRA.

The HPRA conducts reactive and proactive market surveillance of cosmetic products available on the Irish market, in collaboration with the Health Service Executive (HSE). Reactive market surveillance includes investigation of quality-related complaints (compliance cases), reports of adverse events relating to the use of cosmetics (vigilance cases) and Safety Gate RAPEX alerts. From 2017 to 2020, the HPRA initiated 1276 such market surveillance cases.

Of the 1276 cases, 753 were regarding investigations of potential or confirmed non-compliances of cosmetic products with the requirements of the Cosmetics Regulation. Such compliance cases may be initiated as a result of non-compliances found as part of the proactive HPRA and HSE annual sampling plan or on a reactive basis. As part of compliance case work, non-compliances with the Cosmetics Regulation are notified to the cosmetic product operators. Non-compliances that are found vary; however, these can often involve a non-compliance with the labelling requirements of Article 19 of that Regulation. The market action, if any, that is carried out is dependent on the perceived risk to consumers in Ireland of the non-compliance(s). This may involve discontinuation of further sales of non-compliant product, or recall from the market place. In other instances, corrective actions proposed by the company may be considered acceptable, for example, labelling changes for future batches to be placed on the Irish market.The HPRA initiated 70 vigilance cases in the years 2017 to 2020, following receipt of reports of suspected undesirable or serious undesirable effects following the use of a cosmetic product. Of these vigilance cases, two products were discontinued from sale and one product was recalled from end-users.

Between 2017 and 2020, the HPRA notified 33 cosmetic products to the European Commission for notification to other member states and publication online on the Safety Gate website (the EU rapid alert system for dangerous non-food products), previously called RAPEX. Cosmetic products considered to present a serious risk are notified in this manner when it is known the product of concern is available on the market of another member state. This is in line with the European Cosmetic Regulation and Directive 2001/95/EC (the General Product Safety Directive).

Article 8 of the Cosmetic Regulation establishes ISO 22716, or equivalent, as the requirements for Good Manufacturing Practice in the manufacture of cosmetic products, and it is the obligation of the RP to ensure this is met. Article 7 lists the obligations of cosmetic product distributors. Inspection of manufacturers and distributors is not mandatory for products to be placed on the market; rather, it is carried out using a risk-based approach.

The number of inspections of cosmetic product distributors and manufacturers located in Ireland from 2017 to 2020 is outlined below. The inspection programme for cosmetic product manufacturers and distributors in 2020 and 2021 has been impacted by the Covid-19 pandemic, and onsite inspection is suspended at present. A remote inspection/assessment process can be used as an alternative.

Catherine Murphy (Kildare North, Social Democrats)
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626. To ask the Minister for Health the number of Health Products Regulatory Authority audits conducted on veterinary products in each of the years 2017 to 2020 and to date in 2021. [23128/21]

Stephen Donnelly (Wicklow, Fianna Fail)
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The Health Products Regulatory Authority (HPRA) is the competent authority in Ireland for veterinary medicinal products (VMPs). Under the European Communities (Animal Remedies) (No. 2) Regulations, 2007 (S.I. 786 of 2007, as amended), this role includes inspection and licensing of manufacturers of veterinary medicinal products based in Ireland. A number of inspections of manufacturers, based outside the European Economic Area (EEA), that are supplying VMPs into the EEA are also carried out. During an inspection, the state of compliance of the manufacturer with European Union guidelines on good manufacturing practice is examined.

In Ireland, an inspection is carried out on foot of an application for a manufacturer’s licence, while routine inspections of licensed manufacturers are carried out on a risk basis with the interval being, generally, from 18 – 30 months.

The numbers of inspections of manufacturers of VMPs carried out over the period 2017 – end April 2021 are as follows:

2017 – 20

2018 – 23

2019 – 24

2020 – 23

2021 (to end April) – 6

The current number of licensed manufacturers of VMPs is 30. A list of licensed manufacturers in available on the HPRA website at