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If you're a manufacturer or importer of biocides in Bosnia and Herzegovina, you've likely noticed a key peculiarity in local regulations: the registration procedure for biocides currently exists only in the Republic of Srpska.
In practice, this means that the regulations of the Republic of Srpska on biocides sometimes apply even when a company is registered in the Federation of BiH. If a product is placed on the market in the Republic of Srpska, it must be registered according to the regulations of the Republic of Srpska regardless of where the manufacturer or importer is from.
Although the basic principles haven't changed significantly in recent years, there are always questions about the application of the procedure in each specific case. That's why today I'm writing about the basic steps for registering biocides in the Republic of Srpska.
According to the Biocides Law, the registration procedure for biocides is conducted in two phases:
- enrollment in the Program for submitting a technical dossier based on basic information about the biocide and
- issuing a permit that approves placing the biocide on the market based on the technical dossier.
Only the first phase, known as temporary registration, is still being conducted. Although the law prescribes a procedure for recognizing foreign permits for products approved in the European Union, this procedure is not being implemented in practice.
The application for registering biocides in the Program for submitting a technical dossier is submitted by a legal entity that is the manufacturer of biocides or the representative of a foreign manufacturer, i.e. an importer based in the Republic of Srpska.
If the manufacturer or importer of biocides is based in the Federation of BiH, they can submit applications through a business unit registered in the Republic of Srpska. Alternatively, they can hire another legal entity from the Republic of Srpska as their representative for registration purposes.
Before submitting an application, the applicant must be registered in the Register of Chemical Manufacturers and Importers and must have a chemical advisor.
The application must be accompanied by the following documentation:
- a prescribed form with basic information,
- a safety data sheet (SDS),
- a label,
- instructions for use,
- proof of biological efficacy,
- other administrative documentation (statements, contracts, etc.).
The most important issue to resolve before submitting an application is the status of the active substance. In practice, this is the most common reason for registration issues. A biocide can only be registered if it contains an active substance that is approved or is in the appropriate review program for the relevant product type (PT).
Lists of active substances in the Republic of Srpska are aligned with those in the EU, but with some delay. The lists in the Republic of Srpska were last updated in 2018.
Another key element of registration is proving that the product is indeed effective for its declared purpose. This means that antibacterial, fungicidal, insecticidal or other biocidal claims must be supported by appropriate testing.
Upon completion of the registration process, if all conditions are met, the Ministry issues a decision on enrollment in the Program for submitting a technical dossier whose number must be included on the label. Based on this decision, the biocide can be placed on the market in the Republic of Srpska. But keep in mind: it is crucial to monitor the validity periods of the decision.
Although the procedure seems straightforward, in practice there can be difficulties, whether some documents are not aligned, or you can't obtain the necessary data. Therefore, it's crucial to conduct a regulatory assessment before starting the registration process.
Since there are still no specific regulations on biocides in the Federation of Bosnia and Herzegovina, manufacturers and importers from that entity face many dilemmas. I hope this text can clarify some of them.
If you need assistance with preparing documentation for registering biocides in the Republic of Srpska, feel free to contact me at nina.pajovic@bens-consulting.eu.
Autor izvirne slike je Towfiqu barbhuiya na Pexels.com
nina.pajovic@bens-consulting.eu
