Application of Biocide Regulations in Bosnia and Herzegovina – Problems and Most Common Mistakes

Managing biocides in Bosnia and Herzegovina can be challenging, especially due to the fact that there is no unified regulation governing this issue. Instead, each entity regulates this area for itself – defining procedures and determining competent authorities.

However, biocides are currently precisely regulated only in Republika Srpska. Regulations that are partially harmonized with European Union regulations have been in force since 2009. I have previously written in detail about the procedures that apply in Republika Srpska, so you can review them in this article.

Therefore, biocide registration in Republika Srpska generally enables biocide marketing throughout Bosnia and Herzegovina.

Nevertheless, although biocides are not defined or regulated as such in the Federation of BiH, there are other regulations that also apply to biocides. Poison regulations may also apply to biocides that you produce or import into the Federation of BiH. I wrote about everything you need to pay attention to in this article.

Brčko District still does not have biocide regulations, but companies often act according to regulations that apply in Republika Srpska – they carry out the prescribed registration.

Biocide regulations in Bosnia and Herzegovina, not even those in Republika Srpska, are not yet harmonized with Regulation (EU) 528/2012 (BPR). This additionally complicates biocide marketing for companies that also operate in the EU market, and some biocides sold in the EU cannot reach the Bosnia and Herzegovina market.

In such a complex regulatory environment, it is easy to make a mistake. These are the most common ones:

1. The prescribed regulatory procedure has not been conducted:

• a trader from the Federation of BiH has not carried out biocide registration in Republika Srpska, but sells it in that market,
• a trader from the Federation of BiH has registered a biocide in RS, but has not obtained a permit for importing poisons into the Federation of BiH, if the biocide is considered a poison,
• a D permit for importing certain biocides has not been obtained.

2. The importer believes they can import biocides registered by someone else:

• the Ministry of Health and Social Protection of Republika Srpska publicly publishes a list of registered biocides, but this does not mean that any importer can freely import these biocides,
• import of biocides registered in Republika Srpska can only be imported by the person who carried out the registration (permit holder),
• permits for importing poisons and D permits are issued to a specific importer and cannot be applied to another person.

3. The active substance is not permitted:

• active substances in biocides must be on lists of permitted active substances,
• lists of permitted active substances in Republika Srpska are harmonized with the EU, but with delay (they were last updated in 2018).

4. The product is incorrectly categorized:

• the product has a biocidal function that is highlighted on the label (e.g., destroys bacteria), but is not marked as a biocide,
• the purpose of the product is not precisely stated, i.e., the type of biocide.

5. The product is not adequately labeled:

• data is not provided in one of the official languages in BiH,
• the label does not include all data required for biocidal products,
• data on the label differs from that in the safety data sheet.

The Bosnia and Herzegovina market is very complex: different regulations apply in a unified market. Therefore, good preparation and verification of all applicable regulations is essential before placing a biocide on the market.

If you need help checking which regulations apply to your product, contact me at nina.pajovic@bens-consulting.eu. I can certainly make this preparatory phase easier for you.