Recently, a company attempted to import biocides produced in the European Union into Bosnia and Herzegovina. Although these biocides were registered in the country of production and several other EU countries, they could not be imported into Bosnia and Herzegovina.
How is this possible?
Bosnia and Herzegovina is harmonizing its regulations with the European Union, so it seems logical that products approved in EU countries could also be approved in Bosnia and Herzegovina. It would be expected. But there are reasons why this is not always the case.
Yes, Bosnia and Herzegovina is a candidate for EU membership and has committed to aligning its regulations and standards with those of the EU. This means adopting and harmonizing its own regulations with European ones.
Considering that regulations on chemicals and biocides in the European Union frequently change, implementing these changes into the legislation of Bosnia and Herzegovina is no easy task. It requires resources (human and material), which are often scarce.
Therefore, some rules already in force in the European Union are still not valid in Bosnia and Herzegovina.
It should be noted that regulations on biocides currently exist only in the Republika Srpska. Regulations in the Federation of Bosnia and Herzegovina do not recognize the term "biocide," so there are no specific obligations for this type of product.
The Biocide Law of the Republika Srpska was adopted in 2009 and was harmonized with the then-applicable Biocidal Products Directive (98/8/EC). Partial alignment with the new Biocidal Products Regulation (Regulation (EU) 528/2012) and its implementing acts was achieved by amending some bylaws.
This is also the case with the List of Active Substances Permitted in Biocidal Products, established by a specific Rulebook. This list, first issued in 2010, has been amended several times to include active substances approved in the European Union.
The current version is from 2018, meaning that for six years there has been no alignment with changes in the European Union. Since then, new substances have not been added to this list, even if they are approved for use in the European Union.
This is precisely why the company mentioned at the beginning of the story could not place EU biocides on the market in the Republika Srpska. The specific products contained active substances which, although allowed in the European Union, are not permitted for use in the Republika Srpska.
Examples of such active substances include:
- Icaridin,
- Hydrated, cyclic lemon eucalyptus oil,
- Active chlorine generated from sodium chloride by electrolysis,
- Free radicals generated from ambient air, etc.
I have already written about the procedure for placing biocides on the market in the Republika Srpska. The key thing to do when planning to import biocides is to check the status of the active substance. If the active substance is not listed on the approved (evaluated) substances list or substances under review, the biocide cannot be placed on the market in the Republika Srpska.
Such biocides can be placed on the market in the Federation of Bosnia and Herzegovina, adhering to poison regulations. In this case, you must ensure that the products do not reach the market of the Republika Srpska, which is not always simple in the single market of Bosnia and Herzegovina.
If you want to refresh your memory on which biocide lists exist and the difference between permitted and approved active substances, then this text is for you.
In this example, we can see how rules applicable in the European Union can't be directly applied in Bosnia and Herzegovina. Therefore, it is important to have a good understanding of local regulations even when dealing with a product registered in the European Union.
Have you encountered a similar situation? Which active substances were problematic in that case? Contact me at nina.pajovic@bens-consulting.eu.
Avtor izvirne slike Sayantani Ghosh dastidar on Pixabay
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