If you have in the past period registered biocide and received a decision from the competent authority, you may have found yourself in a dilemma about how to interpret its validity period.
Validity period of the decision is important because it determines the period during which placing biocide on the market is legal. However, due to the way the validity period is displayed on the decision, it is not always easy to determine until when the decision is valid.
Therefore, let's look together at how the validity periods of decisions are interpreted, so you can check the status of the biocide you are placing on the market.
To begin with, it is important to remember that a biocide in Bosnia and Herzegovina can only be registered in the Republic of Srpska. It is a process of entering biocide into the Technical Dossier Submission Program in the Republic of Srpska.
This process represents a temporary registration that allows trade until the issuance of a permit. Therefore, the validity period of the decision is „temporary“, until the registration process is completed in the second phase.
The period on the decision determines the deadline for submitting the technical dossier required for the second phase of registration. This period is not the same for all products and primarily depends on the status of active substances. Let's see how this looks in practice:
1. If the biocide contains an active substance that is already approved, the period is counted from the date of issuance of the decision.
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Example: For a product that contains isopropanol , which is approved for use in biocides types 1 and 2. the period is determined from the moment of issuance of the decision:
„The applicant is obliged to submit a technical dossier to the ministry within three years from the date of issuance of this decision for the biocide to obtain a permit for placing the biocide on the market.“
2. If the biocide contains a substance that is under review, the validity period starts only when that substance is approved.
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Example: For a product that contains ethanol , which is under review for use in biocides types 1 and 2, the period is determined from the moment of approval of the active substance:
„The applicant is obliged to submit a technical dossier to the ministry within three years from the date of listing the active substance on the list of approved substances for the biocide to obtain a permit for placing the biocide on the market.“
3. If the product contains multiple substances, both approved and those under review, the validity period depends on the last substance to be approved.
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Example: For a product that contains isopropanol , which is approved and ethanol, which is under review, the period is determined from the moment of approval of the substance that is under review:
„The applicant is obliged to submit a technical dossier to the ministry within three years from the date of listing the active substances on the list of approved substances for the biocide to obtain a permit for placing the biocide on the market.“
Since the status of substances in the biocide is crucial, it is necessary to monitor the lists of approved substances. Only then can you correctly assess the validity period of the decision.
If you find that the decision period is about to expire soon, you must contact the competent ministry and request an extension of the deadline for submitting the technical dossier. This is a common practice and allows you to continue legally trading the biocide.
And since the second phase of registration has not yet started, this is also the only option – extending the validity period of the temporary decision.
However, if the specified period has already expired, and you did not request an extension in time, the decision is considered invalid. This means that the biocide to which it refers can no longer be placed on the market. You must start a new process, i.e. submit a new application for entry into the Technical Dossier Submission Program and pay the prescribed fee.
Therefore, check today whether your decision for the biocide is valid:
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Review the decision and determine the deadline for submitting the technical dossier.
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Check the status of active substances in your product.
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If the deadline is near, request an extension of the deadline from the competent authority.
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If the deadline has expired, prepare a new application for registration.
If you need help, write to me at nina.pajovic@bens-consulting.eu.
Slika autora RDNE Stock Project sa pexels.com
nina.pajovic@bens-consulting.eu
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