The Biocide Directive and Disinfectants
Since the 6th September 2006, all chemical products purposely intended for use as bio-cides have had to be approved. This means that many substances, previously sold as disinfectants to both the private and public sector, now have to be evaluated for possible risks to health and the environment as well as their effectiveness.
The Biocide Directive is an EU regulation. It was adopted by the EU in 1998 and became part of Danish legislation in May 2000.
The Biocide Directive distinguishes between the active chemical substance in a disinfectant and the finished product as sold. This means that all the active chemical components have to be approved at the EU level, whereas the finished disinfectants have to be approved at the national level. Disinfectants may therefore only be sold as long as the active chemical components are approved by the EU, and the finished products are approved by the land in which they are to be used.
In addition to approval of the active ingredients in new disinfectants, the Biocide Directive also means that all existing active substances must be re-evaluated within the EU. A transitional agreement was made to ease the process of implementation of the new directive. Active ingredients that are registered to the re-evaluation program may still be imported, sold and used in the EU after the 1st September 2001. Those that have not been registered may not.
To be approved, EU law demands scientific documentation of both a disinfectant’s safety and effect. The documentation consists of an extensive dossier that must be sent to the authorities for approval. The Biocide Directive has been in effect since 2000, and is expected to be replaced in the near future by fully binding EU regulations.
Last revised 23 January 2012