A detailed procedure for placing biocides on the market is currently prescribed only in the Republic of Srpska.
Even if you are an importer of biocides 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 look at the procedure for the first phase of obtaining a biocide permit – the entry of biocides into the Technical Dossier Submission Program in accordance with the Biocides Act.
The request for entry of biocides into the Technical Dossier Submission Program is submitted by the biocide manufacturer or the legal representative of a foreign manufacturer (importer) with headquarters in the Republic of Srpska.
An importer of biocides based in the Federation of Bosnia and Herzegovina can submit the request through a business unit registered in the Republic of Srpska.
The applicant must be previously registered in the Register of Manufacturers and Importers of Chemicals in accordance with the Chemicals Act.
The request for the entry of biocides into the Technical Dossier Submission Program is submitted to the Ministry of Health and Social Protection of the Republic of Srpska. Basic information about the biocide, along with other necessary documentation (proof of biological efficacy of the biocide, safety data sheet, label, instructions for use, etc.), must be attached to the request, and a fee is paid for the procedure.
The form and content of the Safety Data Sheet (SDS) are defined by chemical regulations. Additionally, the basic content of the label regarding hazard marking is defined by the regulations on the classification and labeling of chemicals. However, the Biocides Act and relevant by-laws also set additional labeling requirements for biocides.
Let's recall what I wrote about defining products as biocides. 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 product's purpose must be biocidal (control of unwanted organisms).
These are precisely the two key criteria that are checked during the entry of biocides into the Technical Dossier Submission Program.
When assessing the composition of a biocide, it is determined whether the active substance contained is allowed for use for the intended purpose of the product. Permitted active substances are defined by a by-law aligned with the lists of biocidal active substances of the European Union.
The second important step is verifying the efficacy of the biocide for the intended purpose to ensure that the declared purpose of the biocide is real and not misleading to the consumer.
Biocidal claims made on the product label (or in any other product documentation) indicating the biocidal action of the product must be proven by adequate laboratory tests. Such tests are generally provided by the biocide manufacturer, but the importer can also conduct testing (often in neighboring countries, and for some types of biocides, also 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 (prescribed documentation is submitted, the product is adequately classified, labeled, and packaged, etc.), a decision is issued for entry into the Technical Dossier Submission Program.
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 a permit.
The deadline for completing the second phase of registration, i.e., "submission of the technical dossier" for the active substance and biocide, is determined by the decision on entry into the Technical Dossier Submission Program and primarily depends on the status of the active substance: whether it is approved for use or under review.
In practice, there are often uncertainties regarding the interpretation of the validity period of the decision due to its connection with the status of the active substance.
The Biocides Act has been in force in the Republic of Srpska since 2009. Since then not a single product has completed (nor even started) the second phase of registration, i.e., no permit has been issued for a biocide as the final outcome of the registration process.
Therefore, by entering the biocide into the Technical Dossier Submission Program, you ensure years of uninterrupted placement of the biocide on the market.
If you need help with preparing documentation for a biocide, contact me at nina.pajovic@bens-consulting.eu.
Autor fotografije Monstera od pexels.com.
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