Revision of the BPD
This year has seen some major changes to the BPD proposed. Firstly the ‘mini-revision’ to the BPD was announced, agreed and published. This allows the Commission an additional 4 years to complete the review programme. This extends the deadline for the evaluation of active substances used in biocidal products from 14 May 2010 to May 2014. This was published as Directive 2009/107/EC OF 16 September 2009.
The second and more significant change is the ‘major revision’ this proposes a number of significant changes to the BPD. On 12 June 2009, the European Commission adopted a proposal for a Regulation concerning the placing on the market and use of biocidal products (COM (2009)267). The proposed Regulation will repeal and replace the current Directive 98/8/EC concerning the placing of biocidal products on the market. The proposed new Regulation if agreed will introduce a number of significant changes to the BPD.
These changes include extending the scope to include ‘in-situ’ biocides and treated articles, including furniture and textiles while restricting the scope in other areas to exclude foodstuffs. The proposal also put in place a new system of centralized authorization (via ECHA) for biocidal products based on new active substances and for low-risk biocidal products.
The proposed regulation sets out 'exclusion criteria' to prevent authorisation of active substances with very poor hazard profiles, including substances that can cause cancer, mutations, reproductive problems and hormonal imbalances. In future, such substances will only be allowed if specific criteria can be met. Under the proposed regulation, data requirements will be more aligned with the actual needs of the evaluating authorities and it will be easier to waive requirements. It will no longer be possible to repeat tests that have already been carried out on vertebrate animals, and information gained from such tests must be shared, but will be eligible for data compensation.
The changes introduced by the new regulation, including the data requirements, data waiving, obligatory sharing of vertebrate animal data will only apply to active substances whose evaluation starts after 1 January 2013 which is when the new Regulation is planned to enter into force.
