Maureen O'Sullivan (Dublin Central, Independent)
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To ask the Minister for Health further to Parliamentary Question No. 636 of 12 March 2013, which does not include a reference to any specific enforcement activities undertaken by the Irish Medicines Board or his Department to ensure compliance with the EU marketing ban on animal tested cosmetics, the number of cosmetic products that have been surveyed by the IMB in conjunction with Environmental Health Services to ensure their compliance with cosmetics regulations, in particular the prohibitions on the marketing of animal tested cosmetics in regulation 9 of S.I. No. 870 of 2004, since 11 March 2009; the number of reports of EU cosmetics surveillance programmes that have been brought to the Government or IMBs attention since 11 March 2009; the number of cosmetics products to which they refer; if he will describe the detailed protocol for any active surveillance programmes to be performed by the IMB or in conjunction with other agencies to ensure compliance with the full marketing ban on animal tested cosmetics that came into force on 11 March 2013; and if he will make a statement on the matter. [15084/13]

Alex White (Dublin South, Labour)
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The European Communities (Cosmetic Products) (Amendment) (No. 3) Regulations 2010 (S.I. 440 of 2010) nominated the Irish Medicines Board (IMB) as competent authority for cosmetics on 1 October 2010. Since then 292 separate cosmetic products have been surveyed by the IMB in conjunction with the HSE, Environmental Health Services. There have been no incidences of breaches of the animal testing ban detected.

Since the IMB assumed the role as competent authority for cosmetics on 1 October 2010, 354 cosmetic products have been brought to the attention of the IMB from EU surveillance reports and there have been no reported instances of breaches of the animal testing ban. The IMB, in conjunction with the EU Commission and other European Member States, takes a risk-based approach with respect to enforcement of cosmetics legislation, including surveillance programmes, to ensure a high level of public safety. As a notification system operates and there is no pre-approval of cosmetic products in Europe, the regulation of these products primarily involves post-marketing surveillance programmes which are both pro-active and reactive in nature. There is a requirement for a Responsible Person to be designated for each cosmetic product placed on the European market and the Responsible Person must maintain a Product Information File (PIF) relating to each product. This PIF contains all information relating to testing and can be requested for review by the IMB both proactively, as part of a pre-planned surveillance programme, and reactively if there are grounds to suspect a non-compliance.

The PIF must also contain the cosmetic product safety report as specified in Annex I of Regulation (EC) 1223/2009 on cosmetic products, this includes information on the toxicological profile of the substance for all relevant toxicological endpoints and a clear identification of the source of the information. The IMB will be pro-actively reviewing PIFs over the next 12 months for compliance with the implementation of the full animal testing ban as part of a pre-planned surveillance programme.

Prior to October 2010 the HSE, Environmental Health Services was responsible for enforcement activities in relation to cosmetics and my Department has requested the Parliamentary Affairs Division of the Executive to arrange to have the statistic compiled for the period March 2009 to October 2010 and to have a reply issued directly to the Deputy.