Recently, a company wanted to import biocides into Bosnia and Herzegovina that were produced in the European Union. Although they were registered in the country of production and some other EU countries, they could not be imported into Bosnia and Herzegovina.
How is that possible? Bosnia and Herzegovina is aligning its regulations with the European Union, so it seems logical that products approved in EU countries could also be approved in Bosnia and Herzegovina.
Well... 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 harmonizing its regulations and standards with those of the EU. This actually means that it will adopt its own regulations based on and aligned 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 (both human and material) which we often lack.
As a result, some rules already in effect in the European Union are still not applicable in Bosnia and Herzegovina.
Let's remember that biocide regulations in Bosnia and Herzegovina currently exist only in the Republic of 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 Biocides Law of the Republic of Srpska was adopted in 2009 and was aligned with the then-current Biocidal Products Directive (98/8/EC). Alignment with the new Biocidal Products Regulation (Regulation (EU) 528/2012) and implementing acts was partially done by amending some by-laws.
This is also the case with the List of Active Substances Allowed in Biocidal Products established by a specific regulation. This list has been amended several times since its first version in 2010 to include active substances approved in the European Union.
The current version is from 2018, which means 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 allowed for use in the European Union.
This is precisely why the company at the beginning of the story could not market EU biocides in the Republic of Srpska. The specific products contained active substances that, although permitted in the European Union, are not allowed for use in the Republic of Srpska.
Examples of such active substances include:
- icaridin,
- lemon eucalyptus oil, hydrated, cyclic,
- active chlorine generated from sodium chloride by electrolysis,
- free radicals generated from ambient air, etc.
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 among the approved (evaluated) substances or substances under review, you cannot market the biocide in the Republic of Srpska.
You can market such biocides in the territory of the Federation of Bosnia and Herzegovina, complying with poison regulations. You must then ensure that the products do not reach the market of the Republic of Srpska. And that is not always simple in the single market of Bosnia and Herzegovina.
This example shows how rules applicable in the European Union cannot be directly applied in Bosnia and Herzegovina. Therefore, it's important to be well-acquainted with 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 your case? Contact me at nina.pajovic@bens-consulting.eu.
Original image by Sayantani Ghosh dastidar on Pixabay
nina.pajovic@bens-consulting.eu
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