The implementation of the Guideline 98/8/EG in national Biocide Acts has been
carried out in most member states of the European Union in the first two years
of this century. But only today, with a quite long delay, the act yields
consequences for many pharmaceutical manufacturers' disinfection concepts.
For older disinfectants (biocides) that were sold prior to 14 May 2000
manufacturers were granted a transition period regarding the notification for
APIs and biocides. Biocides that were not submitted for approval according to
the biocide act cannot be sold to consumers any longer after 2009. For that
reason some products will not be available any more in the future, for others
there will be changes in their formulation if single APIs are not registered.
Both cases will require a re-validation or at least a change control process in
the pharmaceutical production.
Frequently biocide manufacturers are not aware of this fact, simply because most
of their customers like hospitals, nursing homes, contract cleaners and others
do not need a validation of their disinfection systems. That's why often there's
no information with regard to discontinuation or change of a disinfectant. For
manufacturers with a validated disinfection system it is therefore recommended
to request information on possible changes at the supplier of disinfectants.
The guideline itself can be downloaded as PDF at:
The guideline, annexes and further information can be found at
Axel H Schroeder
On behalf of the European Compliance Academy (ECA)