Customers for Halamid® are affected by two major European Regulations. One is the EU Biocidal Product Directive which rules the authorization of Biocides on the European Market. For most disinfectant applications where a biocidal activity is claimed this is the most relevant regulation. Extensive dossiers for all supported active ingredients are currently being reviewed by the EU Rapporteur Member States and by 2010 more and more active substances will be listed on Annex 1 and by that officially approved for use in commercial disinfectant products. Other active substances for which no dossier has been prepared or the dossier is not accepted, will be banned for use in biocide products in the EU market. .These commercial products will then still have to be registered in the relevant Member States but this is expected to be a faster and simpler procedure than the review of the active substances. As long as these final products are not being registered the local regulations (if any) remain in force.
REACH The other relevant regulation is REACH. BPD reviewed biocides will automatically be exempted from (pre)registration BUT ONLY TO THE EXTENT THEY ARE COVERED BY BIOCIDE APPLICATIONS. This means that customers using Halamid for applications that are different from biocides (=explicitly claimed biocidal or inherently when it is clear that the actual use is for controlling micro organisms) will fall under REACH and not the BPD regulation. Axcentive has pre-registered Halamid® for those usages that we consider non-biocide and we will in the near future contact our customers in order to collect the required down stream use details required for the REACH dossier.