In my previous blog post, I presented the differences between notification and authorisation of a biocidal product.
It quickly becomes clear that EU biocidal authorisation procedures are extremely complex, expensive and can take many years. If it is not possible to demonstrate a safe use of such a product, it may even get rejected!
At BENS Consulting, we strive to make our customers' work as easy as possible and to simplify the sale of their biocidal products without unnecessary delays and enormous costs.
Once all active substances in a biocidal product have been approved, the only possible procedure for registering such a product is authorisation. Unfortunately, the authorisation procedure brings a lot of problems, but it also offers many opportunities that you can use to your own advantage.
Examples of such opportunities are copies (NA-BBS procedures) and administrative changes (NA-ADC procedures) of existing authorised biocidal products. In the case of a sufficiently similar or identical composition of the biocidal product, it is possible to join another holder of the authorisation. This way the costs and duration of the authorisation are significantly reduced. In the case of these procedures, the duration is somewhere between 3 and 6 months and the costs around 1,000 € for one such procedure, which is significantly less than a new authorisation procedure (150,000 € and a duration of more than 4 years). With these procedures, all administrative data such as the authorisation holder, the source of the active substance and trade names can be changed. Other data related to the use of the product must remain the same.
The problem here is the identification of a sufficiently similar product in the EU, since the compositions of biocidal products are not publicly available, and also obtaining consent from the holder of the existing authorisation to carry out such a procedure.
These procedures do not come into consideration in the event that no sufficiently similar biocidal product has yet been authorised in the EU. In such a case, the only option is a new authorisation, which can often turn out to be quite difficult.
If you need help with the registration of biocidal products or if you have any other question regarding the chemical legislation, you can contact me at tim.bencik@bens-consulting.eu.
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