BIH: What procedures apply to the import of biocidal active substances?

I have written several times about the procedure for importing biocides into Bosnia and Herzegovina. Considering the specific regulations on biocides in the Republic of Srpska, I have discussed the particular conditions for placing biocides on the market in the Republic of Srpska.

However, I recently received an inquiry regarding the import of biocidal active substances from the European Union into Bosnia and Herzegovina. Therefore, today I will try to clarify the similarities and differences between the procedures for finished biocidal products and biocidal active substances.

Let me remind you that biocide legislation is currently in force only in the Republic of Srpska, so the described procedure is in accordance with the Biocides Act of the Republic of Srpska.

The procedure for biocidal active substances is not much different from that for finished biocidal products. They also need to be registered in the Technical Dossier Submission Program. This procedure is conducted by the manufacturer or the legal representative of a foreign manufacturer (importer) based in the Republic of Srpska.

For an active substance, or a concentrate of an active substance, a similar scope of documentation is submitted as for the finished product, with certain adjustments.

The key difference is in the efficacy test. For a finished product, proof of the biocidal product's efficacy on target organisms during the intended use is submitted.

On the other hand, for an active substance, an efficacy test is submitted for the biocide whose production is planned based on the imported active substance.

There is also another option: submitting a statement that the test for the finished product will be provided after production (after the import of the active substance). In this case, a statement with publicly available references explaining the efficacy of the planned biocide production is attached.

As with the registration of a finished biocidal product, for an active substance, it is necessary to submit a statement of origin of the active substance. This statement confirms that the active substance from a specific manufacturer/supplier is on the market in the European Union. For active substances not from EU member states, it must be proven that they are on the market in those countries in accordance with regulations.

The fact that an active substance is registered in the European Union, or is on the so-called Article 95 List, is not sufficient. Such an active substance still cannot be freely imported into Bosnia and Herzegovina. The local procedure must be followed just as with a finished product.

Nevertheless, the registration of biocidal active substances and finished products that are on the market in the European Union should be straightforward. Adequate documentation and sufficient data are available to facilitate this process. 

One more thing is important. An active substance that, besides its biocidal function, has another purpose and is used not only for biocide production but also for other non-biocidal purposes, needs to be registered in the Chemicals Inventory. This means that two procedures may be prescribed for one substance, depending on its purpose and intended use.

This is the case with ethanol, which is an active substance for producing disinfectants (biocides). It can also be used in the production of detergents, as a solvent, or for other industrial purposes when it must be registered in the Chemicals Inventory.

I note that in the Federation of Bosnia and Herzegovina, the procedure for importing poisons still applies. If a biocidal active substance is on the Poisons List, the prescribed import permits must be obtained.

If you have additional questions about importing biocidal active substances, or need help preparing documentation, feel free to contact me at nina.pajovic@bens-consulting.eu