Regulation (EU) No 528/2012 of the European Parliament and of the Council of 22 May 2012 concerning the making available on the market and use of biocidal products (the EU Biocides Regulation) was published in the Official Journal of the European Union on 27 June 2012 and comes into force 20 days later (17 July 2012). However, it does not apply in Member States until 1 September 2013.
The EU Biocides Regulation repeals and updates the Biocidal Products Directive 98/8/EC (the BPD). Although it ensures high standards of health and environmental protection, the BPD has proven extremely costly for industry. Shortly after it first entered into force in 1998, a review was set in motion of all the active substances then on the market. However, to date fewer than 60 substance reviews have been completed, and only a handful of products authorised, with many active substances withdrawn from the market because the cost of ‘supporting’ them through the review process is so high.
The EU Biocides Regulation aims to simplify and streamline existing EU requirements without reducing the level of protection it offers to health and the environment.
The BPD is implemented in the UK by the Biocidal Products Regulations 2001 (and the Northern Ireland equivalent). The BPD will effectively be replaced by the new EU Regulation, and so HSE intends to revoke the redundant UK legislation that implements the BPD. However, new legislation will be required at the same time to support the new EU Regulation, specifically:
Transitional arrangements are also required to enable parts of legacy systems (BPD and the Control of Pesticides Regulations 1986) to remain in place until affected products are brought under the new EU Regulation. We propose that these new provisions will be introduced through new legislation, and will be consulting on our proposals in late summer 2012. The current UK regime in the Biocidal Products Regulations will remain in place until then.
If you are a company marketing a biocidal product or producing an active substance, you will not need to do anything differently in the short term, especially if your active substance and/or biocidal product application is already being considered under the BPD and current UK Regulations. The new EU Biocides Regulation retains the basic structure of the BPD – a two-step procedure for approving active substances at EU level and authorising biocidal products in Member States. The current review programme of active substances will also continue under the new Regulation.
However, the Regulation will introduce some changes that will affect some businesses marketing biocidal products and producing active substances. These include:
In addition, new provisions on treated articles mean that if you are importing an article into the EU that is treated with a biocide, you will have to ensure that the active substance that was used is approved under the Regulation. If you make biocidal claims for the article, it may have to carry a label with information about the biocide that was used.
In most cases there are transitional arrangements before these provisions apply fully.
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