Fabian Demicoli

Proposal for a European Regulation concerning the placing on the market and use of biocidal products

 Objectives & Scope

The European Commission has proposed a European Regulation for the placing on the market and use of biocidal products,  replacing the Directive that was transposed into the Biocides Regulation. Once in force (scheduled for January 2013), the Regulation would equally act in all 27 Member States . The proposal is a reaction that the current regulatory regime for biocidal products is not working. The proposal keeps the concept of assessing active substances at EU level for inclusion in a positive list and then authorising biocidal products for the market. It also aims to improve and update certain elements of the system.

Among the key changes proposed are:

Extending the regulatory regime to cover treated materials containing biocides.

Adopting a centralised Community product authorisation scheme for some products.

Requiring mandatory data-sharing of vertebrate animal test data.

Reducing the burden of data requirements.

Harmonising the fee structure across Member States.

The proposed Regulation is scheduled to enter into force subject to making reasonable progress through the co-decision process involving the European Council and the European Parliament over the next 12 to 18 months.

In making its proposal, the European Commission has recognized there are significant problems with the existing BPD that have resulted in very slow progress in reviewing active substances. Furthermore, the high cost of supporting active substances through the review process has resulted in many existing biocidal products being withdrawn from the market for economic reasons. The proposed Regulation includes some welcome initiatives to address the problems with the BPD, such as the option of product authorisation at Community level instead of in each Member State.

Any comments are to reach the GRTU by writing or via e-mail on by not later than 8th September 2009

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