If you sell biocides in Bosnia and Herzegovina (or plan to), you are already familiar with the obligations you need to meet.
Today, I want to clarify the procedure for biocides that are registered in the European Union.
What does it mean for a biocide to be registered in the European Union?
When I say registration, I actually mean authorization – the process of approving biocides for their intended use. There are two possibilities.
The first is that the biocide is approved at the EU level – the so-called Union authorization. This allows the biocide to be sold throughout the European Union.
The second possibility is the authorization of biocides in one of the member countries – national authorization. This type of approval allows the biocide to be sold only in that country.
If a biocide has been granted national authorization, it is possible to request the recognition of that approval in another country – the mutual recognition process.
Now let’s return to Bosnia and Herzegovina.
As you know, the Biocides Act is only in force in the Republic of Srpska, which means that to place biocides on the market in Bosnia and Herzegovina, it is necessary to meet the conditions of this law.
The procedure involves issuing a permit to place the biocide on the market in two phases:
- The entry of the biocide into the Technical Dossier Submission Program, and
- The issuance of a permit for the biocide based on the submitted technical dossier for the active substance(s) and the biocide.
Currently, only the first phase is being implemented in the Republic of Srpska – the entry of the biocide into the Technical Dossier Submission Program, which is a kind of temporary registration. This process allows you to sell the biocide on the market of the Republic of Srpska, but also throughout Bosnia and Herzegovina.
The Biocides Act of the Republic of Srpska provides for the procedure of "recognition of foreign approval." This applies to biocides approved in the European Union, either at the Union level or in one of the member states. However, this procedure has not yet been applied to any product.
Unlike the two-phase biocide registration process, the procedure for recognizing foreign approval is carried out in one phase, which shortens the duration of the process.
Additionally, in the two-phase registration process, two fees are paid (BAM300 or €153 for the first phase and BAM500 or €256 for the second phase), and the Biocides Commission is involved in the second phase of the process.
The Biocides Commission is not involved in the process of recognizing foreign approval, and a single fee of BAM300 or €153 is paid.
However, as I mentioned earlier, the procedure for recognizing foreign approval has not yet been implemented in any case. The reason might be that a summary of the dossier for the biocide and the contained active substance must be submitted for the biocide. These are documents that manufacturers are often unwilling to share with a representative in Bosnia and Herzegovina.
Whatever the reasons, one thing is certain: if you want to place biocides on the market in Bosnia and Herzegovina, register them in the Technical Dossier Submission Program. This will allow you to sell biocides on this market without interruptions for many years.
I know this can be a demanding task. If you need help, contact me at nina.pajovic@bens-consulting.eu.
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