Very soon all disinfectants in the European Union will have to be approved before being sold, whether they are for use in the home, in hospitals, or for use in the food and feed industries. The approval requires scientific documentation not only for the safety but also for the efficacy of the disinfectant products.
DHI has joined forces with the Danish medical institute Statens Serum Institute (SSI) and offers a unique package combining our expertise in the regulatory affairs of disinfectants with the SSI's laboratory testing of efficacy.
"Kills germs" – yeah, right
At DHI we have been working within the approval process of disinfectants for some years by advising industry of what's needed for approval. One of the key requirements is that the disinfectant, in fact, disinfects and that this efficacy is scientifically documented. Tests have to show that the product actually kills or at least inhibits the growth of specific, unwanted microorganisms. Only then can a company selling a disinfectant make a claim on the label like "Protects against mould", or "Kills 99.99% of germs in the kitchen."
Evaluation of disinfectant efficacy
SSI has a long history of microbiological expertise and can offer testing of efficacy of disinfectants. SSI conducts efficacy tests on virucides, bactericides, and fungicides. It is particularly noteworthy that SSI can evaluate disinfectant efficacy towards viruses. As of today, very few other laboratories in Europe have this expertise and experience.
The regulatory background
The requirements for the scientific documentation for efficacy of disinfectants that are sold in the EU are laid down in the Biocidal Products Directive (the BPD). All the documentation must be compiled into a single, expansive dossier before it is submitted to an authority for pre-market approval. The BPD started to have effect in 2000 and will soon be replaced by an EU regulation.