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.
