A biocide is a substance that can destroy, render harmless, deter or prevent the action of any harmful organism. They are highly regulated because of their possible implications on human health and the environment. They need to be compliant with directives and regulations. All aspects of biocidal products are regulated by the EC directive i.e Biocides Regulation (EU) 98/8/EC. There was a change in the regulation on 22 May 2012 called (EU) 528/2012. This will repeal and replace Directive 98/8/EC and will be applicable as of 1 September 2013. This new regulation was published on 27 June 2012, and the following are the main changes to this EU Directive that will come into affect later this year. The new EU Biocides Regulation repeals and updates the Biocidal Products Directive 98/8/EC (BPD). Its aim is to simplify and streamline existing EU requirements, without reducing the level of protection to human health and the environment.
Even though new changes will be brought in, the basic mechanisms already in place will remain as they are. The new regulation will establish a two step process of approval. The first step is the evaluation of the active substance at the Union level. The second step is the authorization of the product at the member state level. The new regulation will maintain this two step process, with the view that some biocidal products are authorized at the union level giving them direct access to the entire union market. Another objective of the regulation is to improve the functioning of the internal market. The new directive will also remedy a number of weaknesses that were identified with the current Directive 98/8/EC. Areas of the regulation to be updated include reducing animal testing by making the sharing of data compulsory and encouraging a more flexible and intelligent approach to testing. Another new addition will be a dedicated IT platform to submit applications. This will also be used for providing the public with information. This platform will also be used to record decisions. Another aspect will be on strengthening rules on data waiving ie if data doesn’t need to be submitted it will be made clear that that is do. There will be information on articles and materials tested with biocidal products, so it will be a kind of information highway and research resource. There will be an equilibrated fee structure between all member states. Before manufacturers place biocidal products on the market they will need to hold data on active substances in their product they wish to sell. There will be binding deadlines and mutual recognition dispute settlement. The European Chemicals Agency (ECA) will have an active involvement in scientific work on biocides. They will also provide technical and scientific backup to the Commission and the Member States under this new Regulation.
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