Update on the Draft Guidance on Cosmetic-Biocide Borderline Products

18 May 2012

The recent public consultation on the draft guide to cosmetic-biocide borderline products resulted in a significant level of feedback and comment from industry and other stakeholders. The Irish Medicines Board (IMB) and the Pesticide Registration and Control Division (PRCD) of the Department of Agriculture, Food and the Marine would like to thank all participants for their contribution to this process.

Feedback from the consultation has now been extensively reviewed. This has resulted in the draft guidance being updated to restrict its scope to the regulatory framework of both the cosmetic and biocide sectors and to remove examples of the medicinal and medical device product categories from the guide. In addition, assistance is currently being sought from the European Commission in respect of secondary claims and the acceptability of secondary biocidal claims on a cosmetic product.

In the interim, for products placed on the market as either cosmetic products or biocidal products, industry operators should continue to maintain their responsibility in ensuring that the correct and appropriate legislative framework is applied. In addition, prior to placing the product on the market, the relevant legislative requirements must be adhered to including those related to: safety assessment, labelling, notification and claim substantiation. Further guidance can be obtained by contacting the IMB in relation to cosmetic products (cosmetics@imb.ie) and the PRCD of the Department of Agriculture, Food and the Marine (biocides@agriculture.gov.ie) in relation to biocidal products.