In last week's article, I wrote about how the detailed procedure for placing biocides on the market in Bosnia and Herzegovina is currently prescribed only in the Republic of Srpska.
Even if you are a biocide importer based in the Federation of Bosnia and Herzegovina, if you have customers in the Republic of Srpska, you must comply with the regulations in force in that entity.
Let's take a look at the procedure for the first phase of obtaining a biocide permit – registering the biocide in the Program for Submitting the Technical Dossier in accordance with the Biocides Act.
The application for registering a biocide in the Program for Submitting the Technical Dossier is submitted by the biocide manufacturer or the legal representative of a foreign manufacturer (importer) with a headquarters in the Republic of Srpska.
A biocide importer based in the Federation of Bosnia and Herzegovina can submit the application through a business unit registered in the Republic of Srpska.
The applicant must first be registered in the Register of Chemical Manufacturers and Importers in accordance with the Chemicals Act.
The application for registering a biocide in the Program for Submitting the Technical Dossier is submitted to the Ministry of Health and Social Welfare of the Republic of Srpska. The application must include basic information about the biocide and other necessary documentation (proof of the biological efficacy of the biocide, safety data sheet, label, instructions for use, etc.), and a fee is paid for the procedure.
The form and content of the safety data sheet are defined by chemical regulations. Additionally, the basic content of the label regarding hazard markings is defined by the regulations on the classification and labeling of chemicals. However, the Biocides Act and relevant bylaws also set additional requirements for labeling biocides.
Let's recall for a moment what I talked about two weeks ago. We mentioned the two key elements that define a biocidal product:
- the product must contain a substance considered to be a biocidal active substance, and
- the intended use of the product must be biocidal (control of undesirable organisms).
These are precisely the two key criteria that are checked in the process of registering a biocide in the Program for Submitting the Technical Dossier.
When assessing the composition of a biocide, it is determined whether the active substance is allowed for use for the intended purpose of the product. Permitted active substances are defined by a bylaw that aligns with the lists of biocidal active substances of the European Union.
The second important step is to verify the efficacy of the biocide for the intended purpose to ensure that the declared purpose of the biocide is genuine and does not mislead the consumer.
Biocidal claims stated on the product label (or in any other product documentation) that indicate the biocidal action of the product must be proven by adequate laboratory testing. Such testing is usually provided by the biocide manufacturer, but the importer can also conduct the testing (often in neighboring countries, and for some types of biocides, in Bosnia and Herzegovina).
If these two key criteria are met – the product contains a permitted active substance and has proven efficacy for the intended purpose, and all other conditions for the product are met (the required documentation is submitted, the product is adequately classified, labeled, and packaged, etc.), a decision is issued for registration in the Program for Submitting the Technical Dossier.
Based on the issued decision, the biocide can be placed on the market of the Republic of Srpska until the completion of the second phase of biocide registration, i.e., the issuance of the permit.
The deadline for completing the second phase of registration, or "submitting the technical dossier" for the active substance and biocide, is determined by the decision on registration in the Program for Submitting the Technical Dossier, and primarily depends on the status of the active substance: whether it is approved for use or is under review.
In practice, there are often ambiguities regarding the interpretation of the validity period of the decision due to its connection with the status of the active substance, so I will write more about that in a separate text.
As I mentioned last week, since the Biocides Act has been in force in the Republic of Srpska since 2009, not a single product has completed (or even started) the second phase of registration, nor has a permit been issued for a biocide as the final outcome of the registration process.
Therefore, by registering a biocide in the Program for Submitting the Technical Dossier, you ensure several years of uninterrupted placement of the biocide on the market.
If you need help preparing documentation for a biocide, contact me at nina.pajovic@bens-consulting.eu.
Original image by: Monstera Production on Pexels
nina.pajovic@bens-consulting.eu
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